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1. TQM application has its limitations. Do you agree with this statement? Justify your answer giving examples. The past decade has seen many firms focusing on Total Quality Management (TQM) as a means of improving profits, market share and competitiveness. Although TQM is a proven approach for success in manufacturing, services and the public sector, several organizations failed in their campaigns because of its. The main limitation of TQM can be summarized as follows 1. Attitude of management For an effective implementation of TQM it is important to have management commitment. However in India implementation of TQM is difficult due to the conservative attitude of the management. 2. Lack of initiatives In order to introduce TQM we need a participative management style. 3. SlowProcess TQM is a slow process. A total change in the outlook of the management and employees is required and the results of TQM can be seen in long run 4. Practically Difficult The success of TQM depends upon team work, participative management and total commitment to quality on the part of management and employees is required which is practically very difficult. However TQM also leads to a synergy of benefits to the firm. 1. A philosophy that improves business from top to bottom [everybody in the organization is involved towards the same objective] 1
25
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Transcript
Page 1: TQM 1

1 TQM application has its limitations Do you agree with this statement Justify your answer giving examples

The past decade has seen many firms focusing on Total Quality Management (TQM) as a means of

improving profits market share and competitiveness Although TQM is a proven approach for success in

manufacturing services and the public sector several organizations failed in their campaigns because of

its

The main limitation of TQM can be summarized as follows

1 Attitude of management

For an effective implementation of TQM it is important to have management commitment However in

India implementation of TQM is difficult due to the conservative attitude of the management

2 Lack of initiatives

In order to introduce TQM we need a participative management style

3 SlowProcess

TQM is a slow process A total change in the outlook of the management and employees is required and

the results of TQM can be seen in long run

4 Practically Difficult

The success of TQM depends upon team work participative management and total commitment to

quality on the part of management and employees is required which is practically very difficult

However TQM also leads to a synergy of benefits to the firm

1 A philosophy that improves business from top to bottom [everybody in the organization is

involved towards the same objective]

2 2A focused systematic and structured approach to enhancing customers satisfaction [helps to

increase sales profit of the organization ]

3 Process improvement methods that reduce or eliminate problems ie non conformance costs

[improves the efficiency of the process and better results]

4 Tools and techniques for improvement - quality operating system [improved working methods

for improves results ]

5 Delivering what the customer wants in terms of service product and the whole experience [helps

to tailor the productservice to match customer requirements and the customer satisfaction]

1

6 Intrinsic motivation and improved attitudes throughout the workforce

[improved work conditions means employees are motivated to perform better]

7 Workforce is proactive - prevention orientated [it helps to prevent accidents quality rejects

etc ]

8 Enhanced communication [it encourages discussion among employees between managers

and employees]

9 Reduction in waste and rework [continual discussion continual improvements proactive

attitude helps to prevent waste rework reduces rejects]

10 Increase in process ownership- employee involvement and empowerment [setting of quality

circles problem solving teams improves the employee involvement and empowers employee

to make decisions]

11 Everyone from top to bottom educated [TQM involves continual training at all levels which

helps the development of the individuals ]

12 Improved customersupplier relationships (internally amp external) [TQM takes the system across

all working units including all departments internally and external stakeholders integration]

13 Market competitiveness[TQM helps to improve the customer servicing and helps

the competitive positioning of the company in the market]

14 TQM through education management and staff are given the tools to achieve all the above

Education provides for guided innovation from all levels Training which is a cost shows a

commitment by management

15 15 TQM helps Individual staff self improvement which is a motivator

Thus staff will collectively provide continual improvement of company systems By working together

communicationdepartmental barriers will be broken down The standard of service can be set

maintained and then improved Suppliers will be working with rather than working for the company

The standard of staff and management will improve through education

Direct benefits of TQM are as follows

bull Increased pride of workmanship among individual workers

bull Increased readiness

bull Improved sustainability caused by extended time between equipment failures

bull Greater mission survivability

bull Better justification for budgets because of more efficient operations

bull Streamlined maintenance and production processes

The bottom line of TQM is ldquomore bang for the buckrdquo The Concept of Quality Management The concept

2

behind quality management revolves around a change from management by results to management by

process (quality) improvement Managers are tasked with continuously improving each and every process

in their organization That means combining quantitative methods and human resource management

techniques to improve customer-supplier

The overall benefits of an TQM ISO 9000 quality management system are the following

Increase Revenue

1 Access wider geographic markets by complying with a globally recognised standard

2 New customers who require ISO 9000 compliance

Preserve Existing Revenue

1 Reduce customer rejection of productsservices because of poor quality

2 Improve customer loyalty

Reduce Costs

1 Reduce or eliminate repetition of work

2 Reduce warranty and customer support costs

3 Reduce management time spent on ldquoputting out firesrdquo

4 Improve productivity by ldquodoing it right the first timerdquo

3

3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two

Broadly the following considerations are taken into account for the Deming Application Prize

The emphasis of examination is on the implementation of TQM The actual implementation of TQM

practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation

and implementation of statistical methodology are more important

Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies

Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of

TQM

Examiners judge features that have been applied by the company The Examination Viewpoint includes

bull Top Management Leadership Vision Strategies

bull TQM Frameworks

bull Quality Assurance Systems

bull Management Systems for Business Elements

bull Human Resource Development

bull Effective Utilisation of Information

bull TQM Concepts and Values

bull Scientific Methods

bull Organisational Powers (Core Technology Speed Vitality)

bull Contribution to Realisation of Corporate Objectives

Successful companies should score

bull 70 points or higher in the Executive Session

bull 70 points or higher as the company average excluding the Executive Session

bull 50 points or higher for any examined unit of the company

According to Juran the selected individual must serve as a role model for any one or more of the following

ten criteria

1 Demonstration of outstanding leadership in establishing customer-driven quality

2 Demonstration of outstanding leadership in combining statistical thinking and management which

results in high quality of products and services

4

3 Demonstration of outstanding leadership in improving the supplier aspects of quality

4 Demonstration of outstanding leadership in improving the human aspects of quality

5 Evidence of effective quality management training andor consulting in the manufacturing service

and small business sectors

6 Evidence of successful design development and marketing of quality management publications

books and instruction systems

7 Evidence of substantial original research on the processes tools and techniques for quality

management

8 Evidence of substantial original quality management research that has social significance

9 Evidence of furtherance of quality awareness through articles conventions and other means

10 Evidence of distinct philanthropy dedicated to the promotions of quality management

The common outcome the two concept are seeking are delivery of ever-improving value improvement of

overall organizational effectiveness and capabilities and finally organizational and personal learning

The following are the common criteria for the two concepts

1 Leadership

2 Strategic Planning

3 Customer and Market Focus

4 Emphasis on Measurement Analysis and Knowledge Management

5 Workforce Focus

6 Effective Process Management

7 Towards Results

5

3 Explain giving examples as to how ISO standards can benefit the society

ISO (International Organization for Standardization) is the worlds largest and foremost developer and

publisher of international standards Because the organization is present globally and the name

International Organization for Standardization would be abbreviated differently in different countries the

founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-

governmental organization headquartered in Geneva Switzerland and networks the regional standards

institutes and regulatory bodies of 163 countries

The ISO structure with one member institute per country bridges the gap between the public and private

sectors and facilitates exchange of information between regulators and businesses In many countries

the member institute is a governmental entity whereas in other countries the member institute is a

private entity This part public-part private structure in different parts of the world enables ISO to develop

standards and solutions that benefit both the business sector and society as a whole making sure that

one entitys interests are not prioritized over another

The ISO official site contends that Standards make an enormous and positive contribution to most

aspects of our lives The importance of standards may be better appreciated when considering what

would happen in its absence when a product is made according to predefined standards and meets

customer expectations it is often taken for granted However in an environment without standards

people would very likely voice concerns about poor quality and unsafe products Whether a business

manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that

positive characteristics such as quality durability efficiency safety and environmental friendliness are

reinforced

ISO standards benefit to society by safeguarding their interests and by ensuring that the products and

services they purchase are safe and reliable The standards also help to reduce environmental impact of

business operations by publishing accepted levels of gas and radiation emission and controlling the

quality of water air and soil In addition ISO standards drive the move toward sustainable productions

processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying

down operational guidelines for different industries

The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast

majority of ISO standards are highly specific to a particular product material or process However the

standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as

generic management system standards Generic means that the same standards can be applied to

any organization large or small whatever its product ndash including whether its product is actually a

service ndash in any sector of activity and whether it is a business enterprise a public administration or a

government department Management system refers to what the organization does to manage its

processes or activities

6

Generic also signifies that no matter what the organization is or does if it wants to establish a quality

management system or an environmental management system then such a system has a number of

essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families

ISO 9000 is concerned with quality management This means what the organization does to enhance

customer satisfaction by meeting customer and applicable regulatory requirements and continually to

improve its performance in this regard ISO 14000 is primarily concerned with environmental

management This means what the organization does to minimize harmful effects on the environment

caused by its activities and continually to improve its environmental performance

7

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 2: TQM 1

6 Intrinsic motivation and improved attitudes throughout the workforce

[improved work conditions means employees are motivated to perform better]

7 Workforce is proactive - prevention orientated [it helps to prevent accidents quality rejects

etc ]

8 Enhanced communication [it encourages discussion among employees between managers

and employees]

9 Reduction in waste and rework [continual discussion continual improvements proactive

attitude helps to prevent waste rework reduces rejects]

10 Increase in process ownership- employee involvement and empowerment [setting of quality

circles problem solving teams improves the employee involvement and empowers employee

to make decisions]

11 Everyone from top to bottom educated [TQM involves continual training at all levels which

helps the development of the individuals ]

12 Improved customersupplier relationships (internally amp external) [TQM takes the system across

all working units including all departments internally and external stakeholders integration]

13 Market competitiveness[TQM helps to improve the customer servicing and helps

the competitive positioning of the company in the market]

14 TQM through education management and staff are given the tools to achieve all the above

Education provides for guided innovation from all levels Training which is a cost shows a

commitment by management

15 15 TQM helps Individual staff self improvement which is a motivator

Thus staff will collectively provide continual improvement of company systems By working together

communicationdepartmental barriers will be broken down The standard of service can be set

maintained and then improved Suppliers will be working with rather than working for the company

The standard of staff and management will improve through education

Direct benefits of TQM are as follows

bull Increased pride of workmanship among individual workers

bull Increased readiness

bull Improved sustainability caused by extended time between equipment failures

bull Greater mission survivability

bull Better justification for budgets because of more efficient operations

bull Streamlined maintenance and production processes

The bottom line of TQM is ldquomore bang for the buckrdquo The Concept of Quality Management The concept

2

behind quality management revolves around a change from management by results to management by

process (quality) improvement Managers are tasked with continuously improving each and every process

in their organization That means combining quantitative methods and human resource management

techniques to improve customer-supplier

The overall benefits of an TQM ISO 9000 quality management system are the following

Increase Revenue

1 Access wider geographic markets by complying with a globally recognised standard

2 New customers who require ISO 9000 compliance

Preserve Existing Revenue

1 Reduce customer rejection of productsservices because of poor quality

2 Improve customer loyalty

Reduce Costs

1 Reduce or eliminate repetition of work

2 Reduce warranty and customer support costs

3 Reduce management time spent on ldquoputting out firesrdquo

4 Improve productivity by ldquodoing it right the first timerdquo

3

3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two

Broadly the following considerations are taken into account for the Deming Application Prize

The emphasis of examination is on the implementation of TQM The actual implementation of TQM

practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation

and implementation of statistical methodology are more important

Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies

Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of

TQM

Examiners judge features that have been applied by the company The Examination Viewpoint includes

bull Top Management Leadership Vision Strategies

bull TQM Frameworks

bull Quality Assurance Systems

bull Management Systems for Business Elements

bull Human Resource Development

bull Effective Utilisation of Information

bull TQM Concepts and Values

bull Scientific Methods

bull Organisational Powers (Core Technology Speed Vitality)

bull Contribution to Realisation of Corporate Objectives

Successful companies should score

bull 70 points or higher in the Executive Session

bull 70 points or higher as the company average excluding the Executive Session

bull 50 points or higher for any examined unit of the company

According to Juran the selected individual must serve as a role model for any one or more of the following

ten criteria

1 Demonstration of outstanding leadership in establishing customer-driven quality

2 Demonstration of outstanding leadership in combining statistical thinking and management which

results in high quality of products and services

4

3 Demonstration of outstanding leadership in improving the supplier aspects of quality

4 Demonstration of outstanding leadership in improving the human aspects of quality

5 Evidence of effective quality management training andor consulting in the manufacturing service

and small business sectors

6 Evidence of successful design development and marketing of quality management publications

books and instruction systems

7 Evidence of substantial original research on the processes tools and techniques for quality

management

8 Evidence of substantial original quality management research that has social significance

9 Evidence of furtherance of quality awareness through articles conventions and other means

10 Evidence of distinct philanthropy dedicated to the promotions of quality management

The common outcome the two concept are seeking are delivery of ever-improving value improvement of

overall organizational effectiveness and capabilities and finally organizational and personal learning

The following are the common criteria for the two concepts

1 Leadership

2 Strategic Planning

3 Customer and Market Focus

4 Emphasis on Measurement Analysis and Knowledge Management

5 Workforce Focus

6 Effective Process Management

7 Towards Results

5

3 Explain giving examples as to how ISO standards can benefit the society

ISO (International Organization for Standardization) is the worlds largest and foremost developer and

publisher of international standards Because the organization is present globally and the name

International Organization for Standardization would be abbreviated differently in different countries the

founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-

governmental organization headquartered in Geneva Switzerland and networks the regional standards

institutes and regulatory bodies of 163 countries

The ISO structure with one member institute per country bridges the gap between the public and private

sectors and facilitates exchange of information between regulators and businesses In many countries

the member institute is a governmental entity whereas in other countries the member institute is a

private entity This part public-part private structure in different parts of the world enables ISO to develop

standards and solutions that benefit both the business sector and society as a whole making sure that

one entitys interests are not prioritized over another

The ISO official site contends that Standards make an enormous and positive contribution to most

aspects of our lives The importance of standards may be better appreciated when considering what

would happen in its absence when a product is made according to predefined standards and meets

customer expectations it is often taken for granted However in an environment without standards

people would very likely voice concerns about poor quality and unsafe products Whether a business

manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that

positive characteristics such as quality durability efficiency safety and environmental friendliness are

reinforced

ISO standards benefit to society by safeguarding their interests and by ensuring that the products and

services they purchase are safe and reliable The standards also help to reduce environmental impact of

business operations by publishing accepted levels of gas and radiation emission and controlling the

quality of water air and soil In addition ISO standards drive the move toward sustainable productions

processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying

down operational guidelines for different industries

The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast

majority of ISO standards are highly specific to a particular product material or process However the

standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as

generic management system standards Generic means that the same standards can be applied to

any organization large or small whatever its product ndash including whether its product is actually a

service ndash in any sector of activity and whether it is a business enterprise a public administration or a

government department Management system refers to what the organization does to manage its

processes or activities

6

Generic also signifies that no matter what the organization is or does if it wants to establish a quality

management system or an environmental management system then such a system has a number of

essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families

ISO 9000 is concerned with quality management This means what the organization does to enhance

customer satisfaction by meeting customer and applicable regulatory requirements and continually to

improve its performance in this regard ISO 14000 is primarily concerned with environmental

management This means what the organization does to minimize harmful effects on the environment

caused by its activities and continually to improve its environmental performance

7

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 3: TQM 1

behind quality management revolves around a change from management by results to management by

process (quality) improvement Managers are tasked with continuously improving each and every process

in their organization That means combining quantitative methods and human resource management

techniques to improve customer-supplier

The overall benefits of an TQM ISO 9000 quality management system are the following

Increase Revenue

1 Access wider geographic markets by complying with a globally recognised standard

2 New customers who require ISO 9000 compliance

Preserve Existing Revenue

1 Reduce customer rejection of productsservices because of poor quality

2 Improve customer loyalty

Reduce Costs

1 Reduce or eliminate repetition of work

2 Reduce warranty and customer support costs

3 Reduce management time spent on ldquoputting out firesrdquo

4 Improve productivity by ldquodoing it right the first timerdquo

3

3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two

Broadly the following considerations are taken into account for the Deming Application Prize

The emphasis of examination is on the implementation of TQM The actual implementation of TQM

practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation

and implementation of statistical methodology are more important

Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies

Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of

TQM

Examiners judge features that have been applied by the company The Examination Viewpoint includes

bull Top Management Leadership Vision Strategies

bull TQM Frameworks

bull Quality Assurance Systems

bull Management Systems for Business Elements

bull Human Resource Development

bull Effective Utilisation of Information

bull TQM Concepts and Values

bull Scientific Methods

bull Organisational Powers (Core Technology Speed Vitality)

bull Contribution to Realisation of Corporate Objectives

Successful companies should score

bull 70 points or higher in the Executive Session

bull 70 points or higher as the company average excluding the Executive Session

bull 50 points or higher for any examined unit of the company

According to Juran the selected individual must serve as a role model for any one or more of the following

ten criteria

1 Demonstration of outstanding leadership in establishing customer-driven quality

2 Demonstration of outstanding leadership in combining statistical thinking and management which

results in high quality of products and services

4

3 Demonstration of outstanding leadership in improving the supplier aspects of quality

4 Demonstration of outstanding leadership in improving the human aspects of quality

5 Evidence of effective quality management training andor consulting in the manufacturing service

and small business sectors

6 Evidence of successful design development and marketing of quality management publications

books and instruction systems

7 Evidence of substantial original research on the processes tools and techniques for quality

management

8 Evidence of substantial original quality management research that has social significance

9 Evidence of furtherance of quality awareness through articles conventions and other means

10 Evidence of distinct philanthropy dedicated to the promotions of quality management

The common outcome the two concept are seeking are delivery of ever-improving value improvement of

overall organizational effectiveness and capabilities and finally organizational and personal learning

The following are the common criteria for the two concepts

1 Leadership

2 Strategic Planning

3 Customer and Market Focus

4 Emphasis on Measurement Analysis and Knowledge Management

5 Workforce Focus

6 Effective Process Management

7 Towards Results

5

3 Explain giving examples as to how ISO standards can benefit the society

ISO (International Organization for Standardization) is the worlds largest and foremost developer and

publisher of international standards Because the organization is present globally and the name

International Organization for Standardization would be abbreviated differently in different countries the

founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-

governmental organization headquartered in Geneva Switzerland and networks the regional standards

institutes and regulatory bodies of 163 countries

The ISO structure with one member institute per country bridges the gap between the public and private

sectors and facilitates exchange of information between regulators and businesses In many countries

the member institute is a governmental entity whereas in other countries the member institute is a

private entity This part public-part private structure in different parts of the world enables ISO to develop

standards and solutions that benefit both the business sector and society as a whole making sure that

one entitys interests are not prioritized over another

The ISO official site contends that Standards make an enormous and positive contribution to most

aspects of our lives The importance of standards may be better appreciated when considering what

would happen in its absence when a product is made according to predefined standards and meets

customer expectations it is often taken for granted However in an environment without standards

people would very likely voice concerns about poor quality and unsafe products Whether a business

manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that

positive characteristics such as quality durability efficiency safety and environmental friendliness are

reinforced

ISO standards benefit to society by safeguarding their interests and by ensuring that the products and

services they purchase are safe and reliable The standards also help to reduce environmental impact of

business operations by publishing accepted levels of gas and radiation emission and controlling the

quality of water air and soil In addition ISO standards drive the move toward sustainable productions

processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying

down operational guidelines for different industries

The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast

majority of ISO standards are highly specific to a particular product material or process However the

standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as

generic management system standards Generic means that the same standards can be applied to

any organization large or small whatever its product ndash including whether its product is actually a

service ndash in any sector of activity and whether it is a business enterprise a public administration or a

government department Management system refers to what the organization does to manage its

processes or activities

6

Generic also signifies that no matter what the organization is or does if it wants to establish a quality

management system or an environmental management system then such a system has a number of

essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families

ISO 9000 is concerned with quality management This means what the organization does to enhance

customer satisfaction by meeting customer and applicable regulatory requirements and continually to

improve its performance in this regard ISO 14000 is primarily concerned with environmental

management This means what the organization does to minimize harmful effects on the environment

caused by its activities and continually to improve its environmental performance

7

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 4: TQM 1

3 Discuss in brief the philosophies of Deming and Juran and do the comparative assessment of the two

Broadly the following considerations are taken into account for the Deming Application Prize

The emphasis of examination is on the implementation of TQM The actual implementation of TQM

practices is appreciated Usage of advanced statistical methods is not the basis for success appreciation

and implementation of statistical methodology are more important

Similar patterns of evaluation are adopted for both manufacturing and non-manufacturing companies

Examination viewpoint criteria are not a check-list for assessment These provide an overall picture of

TQM

Examiners judge features that have been applied by the company The Examination Viewpoint includes

bull Top Management Leadership Vision Strategies

bull TQM Frameworks

bull Quality Assurance Systems

bull Management Systems for Business Elements

bull Human Resource Development

bull Effective Utilisation of Information

bull TQM Concepts and Values

bull Scientific Methods

bull Organisational Powers (Core Technology Speed Vitality)

bull Contribution to Realisation of Corporate Objectives

Successful companies should score

bull 70 points or higher in the Executive Session

bull 70 points or higher as the company average excluding the Executive Session

bull 50 points or higher for any examined unit of the company

According to Juran the selected individual must serve as a role model for any one or more of the following

ten criteria

1 Demonstration of outstanding leadership in establishing customer-driven quality

2 Demonstration of outstanding leadership in combining statistical thinking and management which

results in high quality of products and services

4

3 Demonstration of outstanding leadership in improving the supplier aspects of quality

4 Demonstration of outstanding leadership in improving the human aspects of quality

5 Evidence of effective quality management training andor consulting in the manufacturing service

and small business sectors

6 Evidence of successful design development and marketing of quality management publications

books and instruction systems

7 Evidence of substantial original research on the processes tools and techniques for quality

management

8 Evidence of substantial original quality management research that has social significance

9 Evidence of furtherance of quality awareness through articles conventions and other means

10 Evidence of distinct philanthropy dedicated to the promotions of quality management

The common outcome the two concept are seeking are delivery of ever-improving value improvement of

overall organizational effectiveness and capabilities and finally organizational and personal learning

The following are the common criteria for the two concepts

1 Leadership

2 Strategic Planning

3 Customer and Market Focus

4 Emphasis on Measurement Analysis and Knowledge Management

5 Workforce Focus

6 Effective Process Management

7 Towards Results

5

3 Explain giving examples as to how ISO standards can benefit the society

ISO (International Organization for Standardization) is the worlds largest and foremost developer and

publisher of international standards Because the organization is present globally and the name

International Organization for Standardization would be abbreviated differently in different countries the

founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-

governmental organization headquartered in Geneva Switzerland and networks the regional standards

institutes and regulatory bodies of 163 countries

The ISO structure with one member institute per country bridges the gap between the public and private

sectors and facilitates exchange of information between regulators and businesses In many countries

the member institute is a governmental entity whereas in other countries the member institute is a

private entity This part public-part private structure in different parts of the world enables ISO to develop

standards and solutions that benefit both the business sector and society as a whole making sure that

one entitys interests are not prioritized over another

The ISO official site contends that Standards make an enormous and positive contribution to most

aspects of our lives The importance of standards may be better appreciated when considering what

would happen in its absence when a product is made according to predefined standards and meets

customer expectations it is often taken for granted However in an environment without standards

people would very likely voice concerns about poor quality and unsafe products Whether a business

manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that

positive characteristics such as quality durability efficiency safety and environmental friendliness are

reinforced

ISO standards benefit to society by safeguarding their interests and by ensuring that the products and

services they purchase are safe and reliable The standards also help to reduce environmental impact of

business operations by publishing accepted levels of gas and radiation emission and controlling the

quality of water air and soil In addition ISO standards drive the move toward sustainable productions

processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying

down operational guidelines for different industries

The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast

majority of ISO standards are highly specific to a particular product material or process However the

standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as

generic management system standards Generic means that the same standards can be applied to

any organization large or small whatever its product ndash including whether its product is actually a

service ndash in any sector of activity and whether it is a business enterprise a public administration or a

government department Management system refers to what the organization does to manage its

processes or activities

6

Generic also signifies that no matter what the organization is or does if it wants to establish a quality

management system or an environmental management system then such a system has a number of

essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families

ISO 9000 is concerned with quality management This means what the organization does to enhance

customer satisfaction by meeting customer and applicable regulatory requirements and continually to

improve its performance in this regard ISO 14000 is primarily concerned with environmental

management This means what the organization does to minimize harmful effects on the environment

caused by its activities and continually to improve its environmental performance

7

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 5: TQM 1

3 Demonstration of outstanding leadership in improving the supplier aspects of quality

4 Demonstration of outstanding leadership in improving the human aspects of quality

5 Evidence of effective quality management training andor consulting in the manufacturing service

and small business sectors

6 Evidence of successful design development and marketing of quality management publications

books and instruction systems

7 Evidence of substantial original research on the processes tools and techniques for quality

management

8 Evidence of substantial original quality management research that has social significance

9 Evidence of furtherance of quality awareness through articles conventions and other means

10 Evidence of distinct philanthropy dedicated to the promotions of quality management

The common outcome the two concept are seeking are delivery of ever-improving value improvement of

overall organizational effectiveness and capabilities and finally organizational and personal learning

The following are the common criteria for the two concepts

1 Leadership

2 Strategic Planning

3 Customer and Market Focus

4 Emphasis on Measurement Analysis and Knowledge Management

5 Workforce Focus

6 Effective Process Management

7 Towards Results

5

3 Explain giving examples as to how ISO standards can benefit the society

ISO (International Organization for Standardization) is the worlds largest and foremost developer and

publisher of international standards Because the organization is present globally and the name

International Organization for Standardization would be abbreviated differently in different countries the

founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-

governmental organization headquartered in Geneva Switzerland and networks the regional standards

institutes and regulatory bodies of 163 countries

The ISO structure with one member institute per country bridges the gap between the public and private

sectors and facilitates exchange of information between regulators and businesses In many countries

the member institute is a governmental entity whereas in other countries the member institute is a

private entity This part public-part private structure in different parts of the world enables ISO to develop

standards and solutions that benefit both the business sector and society as a whole making sure that

one entitys interests are not prioritized over another

The ISO official site contends that Standards make an enormous and positive contribution to most

aspects of our lives The importance of standards may be better appreciated when considering what

would happen in its absence when a product is made according to predefined standards and meets

customer expectations it is often taken for granted However in an environment without standards

people would very likely voice concerns about poor quality and unsafe products Whether a business

manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that

positive characteristics such as quality durability efficiency safety and environmental friendliness are

reinforced

ISO standards benefit to society by safeguarding their interests and by ensuring that the products and

services they purchase are safe and reliable The standards also help to reduce environmental impact of

business operations by publishing accepted levels of gas and radiation emission and controlling the

quality of water air and soil In addition ISO standards drive the move toward sustainable productions

processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying

down operational guidelines for different industries

The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast

majority of ISO standards are highly specific to a particular product material or process However the

standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as

generic management system standards Generic means that the same standards can be applied to

any organization large or small whatever its product ndash including whether its product is actually a

service ndash in any sector of activity and whether it is a business enterprise a public administration or a

government department Management system refers to what the organization does to manage its

processes or activities

6

Generic also signifies that no matter what the organization is or does if it wants to establish a quality

management system or an environmental management system then such a system has a number of

essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families

ISO 9000 is concerned with quality management This means what the organization does to enhance

customer satisfaction by meeting customer and applicable regulatory requirements and continually to

improve its performance in this regard ISO 14000 is primarily concerned with environmental

management This means what the organization does to minimize harmful effects on the environment

caused by its activities and continually to improve its environmental performance

7

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 6: TQM 1

3 Explain giving examples as to how ISO standards can benefit the society

ISO (International Organization for Standardization) is the worlds largest and foremost developer and

publisher of international standards Because the organization is present globally and the name

International Organization for Standardization would be abbreviated differently in different countries the

founders chose the name ISO derived from the Greek term isos which means equal ISO is a non-

governmental organization headquartered in Geneva Switzerland and networks the regional standards

institutes and regulatory bodies of 163 countries

The ISO structure with one member institute per country bridges the gap between the public and private

sectors and facilitates exchange of information between regulators and businesses In many countries

the member institute is a governmental entity whereas in other countries the member institute is a

private entity This part public-part private structure in different parts of the world enables ISO to develop

standards and solutions that benefit both the business sector and society as a whole making sure that

one entitys interests are not prioritized over another

The ISO official site contends that Standards make an enormous and positive contribution to most

aspects of our lives The importance of standards may be better appreciated when considering what

would happen in its absence when a product is made according to predefined standards and meets

customer expectations it is often taken for granted However in an environment without standards

people would very likely voice concerns about poor quality and unsafe products Whether a business

manufactures goods or provides serviceswhen it meets standards relevant to its industry it ensures that

positive characteristics such as quality durability efficiency safety and environmental friendliness are

reinforced

ISO standards benefit to society by safeguarding their interests and by ensuring that the products and

services they purchase are safe and reliable The standards also help to reduce environmental impact of

business operations by publishing accepted levels of gas and radiation emission and controlling the

quality of water air and soil In addition ISO standards drive the move toward sustainable productions

processes ISO synchronizes and aligns businesses to cleaner and safer production methods by laying

down operational guidelines for different industries

The ISO 9000 and ISO 14000 families are among ISOs most widely known standards ever The vast

majority of ISO standards are highly specific to a particular product material or process However the

standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as

generic management system standards Generic means that the same standards can be applied to

any organization large or small whatever its product ndash including whether its product is actually a

service ndash in any sector of activity and whether it is a business enterprise a public administration or a

government department Management system refers to what the organization does to manage its

processes or activities

6

Generic also signifies that no matter what the organization is or does if it wants to establish a quality

management system or an environmental management system then such a system has a number of

essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families

ISO 9000 is concerned with quality management This means what the organization does to enhance

customer satisfaction by meeting customer and applicable regulatory requirements and continually to

improve its performance in this regard ISO 14000 is primarily concerned with environmental

management This means what the organization does to minimize harmful effects on the environment

caused by its activities and continually to improve its environmental performance

7

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 7: TQM 1

Generic also signifies that no matter what the organization is or does if it wants to establish a quality

management system or an environmental management system then such a system has a number of

essential features which are spelled out in the relevant standards of the ISO 9000 or ISO 14000 families

ISO 9000 is concerned with quality management This means what the organization does to enhance

customer satisfaction by meeting customer and applicable regulatory requirements and continually to

improve its performance in this regard ISO 14000 is primarily concerned with environmental

management This means what the organization does to minimize harmful effects on the environment

caused by its activities and continually to improve its environmental performance

7

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 8: TQM 1

4 List out the conventional seven quality control tools Explain any two in brief

1 Histograms

A histogram is a bar graph that shows frequency data Histograms provide the easiest way

to evaluate the distribution of data

A histogram is a graphical display of tabular frequencies shown as adjacent rectangles Each

rectangle is erected over an interval with an area equal to the frequency of the observations in the

interval The height of a rectangle is also equal to the frequency density of the interval ie the frequency

divided by the width of the interval The total area of the histogram is equal to the number of data A

histogram may also be based on relative frequencies It then shows the proportion of cases that fall into

each of several categories with the total area equaling The categories are usually specified as

consecutive non-overlapping intervals of a variable The categories (intervals) must be adjacent and

often are chosen to be of the same size

Histograms are used to plot density of data and often for density estimation estimating the probability

density function of the underlying variable The total area of a histogram used for probability density is

always normalized to 1 If the length of the intervals on the x-axis is all 1 then a histogram is identical to

a relative frequency plot

2 Pareto Chart

Pareto charts are used to identify and prioritize problems to be solved They are actually

histograms aided by the 8020 rule adapted by Joseph Juran (80 of the problems are created by

approximately 20 of the causes)

3 Cause and Effect Diagram

The cause and effect diagram is also called the Ishikawa diagram or the fishbone diagram It

is a tool for discovering all the possible causes for a particular effect The major purpose of

this diagram is to act as a first step in problem solving by creating a list of possible causes

4 Scatter Diagrams

Scatter Diagrams are used to study and identify the possible relationship between the changes observed

in two different sets of variables

5 Flow Charts

A flow chart is a pictorial representation showing all of the steps of a process

8

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 9: TQM 1

6 Run Charts

Run charts are used to analyze processes according to ti me or order Run charts are useful

in discovering patterns or significant events that occur during a time period

7 Control Charts

Control charts are used to determine whether a process will produce a product or service with consistent

measurable properties

A control chart consists of

Points representing a statistic (eg a mean range proportion) of measurements of a quality

characteristic in samples taken from the process at different times [the data]

The mean of this statistic using all the samples is calculated (eg the mean of the means mean

of the ranges mean of the proportions)

A center line is drawn at the value of the mean of the statistic

The standard error (eg standard deviationsqrt(n) for the mean) of the statistic is also calculated

using all the samples

Upper and lower control limits (sometimes called natural process limits) that indicate the

threshold at which the process output is considered statistically unlikely are drawn typically at 3

standard errors from the center line

The chart may have other optional features including

Upper and lower warning limits drawn as separate lines typically two standard errors above and

below the center line

Division into zones with the addition of rules governing frequencies of observations in each zone

Annotation with events of interest as determined by the Quality Engineer in charge of the

processs quality

Chart usage

If the process is in control all points will plot within the control limits Any observations outside the limits

or systematic patterns within suggest the introduction of a new (and likely unanticipated) source of

variation known as a special cause variation Since increased variation means increased quality costs

a control chart signaling the presence of a special-cause requires immediate investigation This makes

the control limits very important decision aids The control limits tell us about process behavior and have

no intrinsic relationship to any specification targets or engineering tolerance In practice the process

mean (and hence the center line) may not coincide with the specified value (or target) of the quality

9

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 10: TQM 1

characteristic because the process design simply cant deliver the process characteristic at the desired

level

Control charts limit specification or targets because of the tendency of those involved with the process

(eg machine operators) to focus on performing to specification when in fact the least-cost course of

action is to keep process variation as low as possible Attempting to make a process whose natural center

is not the same as the target perform to target specification increases process variability and increases

costs significantly and is the cause of much inefficiency in operations process capability studies do

examine the relationship between the natural process limits (the control limits) and specifications

however The purpose of control charts is to allow simple detection of events that are indicative of actual

process change This simple decision can be difficult where the process characteristic is continuously

varying the control chart provides statistically objective criteria of change When change is detected and

considered good its cause should be identified and possibly become the new way of working where the

change is bad then its cause should be identified and eliminated

The purpose in adding warning limits or subdividing the control chart into zones is to provide early

notification if something is amiss Instead of immediately launching a process improvement effort to

determine whether special causes are present the Quality Engineer may temporarily increase the rate at

which samples are taken from the process output until its clear that the process is truly in control Note

that with three sigma limits one expects to be signaled approximately once out of every 370 points on

average

10

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 11: TQM 1

5 Suppose that you are working in an organization which wants to develop an effective implementation methodology for ISO 9000 Quality Management System How will you help your organization in developing an effective implementation methodology

Implementation of TQMISO 9000 affects the entire organization right from the start If pursued with total

dedication it results in cultural transition to an atmosphere of continuous improvement

The process of implementing ISO 9000 depends on

The sophistication of your existing quality program

The size of your organization and

The complexity of your process

The 14 essential steps briefly described below are to be followed through in order to implement ISO

9000 quality management system successfully

Step 1 Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a

determination to implement an ISO 9000 quality management system in the organization Without top

management commitment no quality initiative can succeed Top management must be convinced that

registration and certification will enable the organization to demonstrate to its customers a visible

commitment to quality It should realize that a quality management system would improve overall

business efficiency by elimination of wasteful duplication in management system

The top management should provide evidence of its commitment to the development and implementation

of the quality management system and continually improve its effectiveness by

1 Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements

2 Defining the organizations quality policy and make this known to every employee

3 Ensuring that quality objectives are established at all levels and functions

4 Ensuring the availability of resources required for the development and implementation of the

quality management system

5 Appointing a management representative to coordinate quality management system activities

and

6 Conducting management review

The top management should also consider actions such as

Leading the organization by example

Participating in improvement projects

11

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 12: TQM 1

Creating an environment that encourages the involvement of people

This type of top management commitment may be driven by

Direct marketplace pressure requirements of crucial customers or parent conglomerates

Indirect marketplace pressure increased quality levels and visibility among competitors

Growth ambitions desire to exploit market opportunities

Personal belief in the value of quality as a goal and quality management systems as a means of

reaching that goal

The top management should identify the goals to be achieved through the quality management system

Typical goals may be

Be more efficient and profitable

Produce products and services that consistently meet customers needs and expectations

Achieve customers satisfaction

Increase market share

Improve communications and morale in the organization

Reduce costs and liabilities

Increase confidence in the production system

Step 2 Establish Implementation Team

ISO 9000 is implemented by people The first phase of implementation calls for the commitment of top

management - the CEO and perhaps a handful of other key people The next step is to establish

implementation team and appoint a Management Representative (MR) as its coordinator to plan and

oversee implementation Its members should include representatives of all functions of the organization -

Marketing Design and development Planning Production Quality control etc In the context of the

standard the MR is the person within the Organization who acts as interface between organization

management and the ISO 9000 registrar His role is in fact much broader than that The MR should also

act as the organizationrsquos quality management system champion and must be a person with

Total backing from the CEO

Genuine and passionate commitment to quality in general and the ISO 9000 quality

management system in particular

The dignity - resulting from rank seniority or both - to influence managers and others of all levels

and functions

Detailed knowledge of quality methods in general and ISO 9000 in particular

The members of the implementation team should also be trained on ISO 9000 quality

management systems by a professional training organization

12

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 13: TQM 1

Step 3 Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the

ISO 9000 quality management system the advantage it offers to employees customers and the

organization how it will work and their roles and responsibilities within the system Suppliers of materials

and components should also participate in these programs

The awareness program should emphasize the benefits that the organization expects to realize through

its ISO 9000 quality management system The program should also stress the higher levels of

participation and self-direction that the quality management system renders to employees Such a focus

will go far to enlist employee support and commitment The programs could be run either by the

implementation team or by experts hired to talk to different levels of employees

Step 4 Provide Training

Since the ISO 9000 quality management system affects all the areas and all personnel in the

organization training programs should be structured for different categories of employees - senior

managers middle-level managers supervisors and workers The ISO 9000 implementation plan should

make provision for this training The training should cover the basic concepts of quality management

systems and the standard and their overall impact on the strategic goals of the organization the changed

processes

and the likely work culture implications of the system In addition initial training may also be necessary on

writing quality manuals procedures and work instruction auditing principles techniques of laboratory

management calibration testing procedures etc When in-house capacity to carry out such training is not

available it may be necessary to participate in external training courses run by professional training

organizations

Alternatively an external training institution could be invited to conduct in-house training courses

Step 5 Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system The goal of ISO 9000 is to create a

quality management system that conforms to the standard This does not preclude incorporating

adapting and adding onto quality programs already in place So the next step in the implementation

process is to compare the organizationrsquos existing quality management system if there is one -- with the

requirements of the standard (ISO 90012000)

For this purpose an organization flow chart showing how information actually flows (not what should be

done) from order placement by the customer to delivery to this customer should be drawn up From this

13

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 14: TQM 1

over-all flow chart a flow chart of activities in each department should be prepared With the aid of the

flow charts a record of existing quality management system should be established A significant number

of written procedures may already be in place Unless they are very much out of date these documents

should not be discarded Rather they should be incorporated into the new quality management system

Documents requiring modification or elaboration should be identified and listed This exercise is some

times referred to as gap analysis During these review processes wide consultation with executives

and representatives of various unions and associations within the organization is required to enlist their

active cooperation

In the review process documents should be collected studied and registered for further use possibly

after they have been revised Before developing new quality management system documentation we

need to consider with which quality requirements or department we should start The best is to select an

area where processes are fairly well organized running effectively and functioning satisfactorily

The basic approach is to determine and record how a process is currently carried out We can do this by

identifying the people involved and obtaining information from them during individual interviews

Unfortunately it often happens that different people will give different contradicting versions of a process

Each one may refer to oral instructions that are not accurate or clear This is why the facts are often not

described correctly the first time around and have to be revised several times Once it has been agreed

how to describe the current process this process has to be adapted supplemented and implemented

according to the requirements of the quality standard (ISO 90012000) This requires organizational

arrangements the drawing up of additional documents and possible removal of existing documentation

(eg procedures inspectiontest plans inspectiontest instructions) and records (eg inspectiontest

reports inspectiontest certificates)

In introducing a quality management system the emphasis is on the improvement of the existing

processes or the re-organization of processes In general the steps to follow are the following

Ascertain and establish the following What is the present operationprocess What already

exists

Analyze the relevant sections of the quality standard - ISO 90012000 What is actually required

If necessary supplement and change operational arrangements in accordance with the standard

develop documents and records and describe operationsprocesses What is the desired

operationprocess

Step 6 Create a Documented Implementation Plan

14

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 15: TQM 1

Once the organization has obtained a clear picture of how its quality management system compares with

the ISO 90012000 standard all non-conformances must be addressed with a documented

implementation plan Usually the plan calls for identifying and describing processes to make the

organizationrsquos quality management system fully in compliance with the standard

The implementation plan should be thorough and specific detailing

Quality documentation to be developed

Objective of the system

Pertinent ISO 90012000 section

Person or team responsible

Approval required

Training required

Resources required

Estimated completion date

These elements should be organized into a detailed chart to be reviewed and approved The plan should

define the responsibilities of different departments and personnel and set target dates for the completion

of activities Once approved the Management Representative should control review and update the plan

as the implementation process proceeds

Step 7 Develop Quality Management System Documentation

Documentation is the most common area of non-conformance among organizations wishing to implement

ISO 9000 quality management systems As one company pointed out When we started our

implementation we found that documentation was inadequate Even absent in some areas Take

calibration Obviously its necessary and obviously we do it but it wasnt being documented Another

area was inspection and testing We inspect and test practically every item that leaves

here but our documentation was inadequate

Documentation of the quality management system should include

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures and records required by the standard ISO 90012000

and

15

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 16: TQM 1

Documents needed by the organization to ensure the effective planning operation

and control of its processes Quality documentation is generally prepared in the three levels

indicated in the box that follows

Level A Quality manual

States the scope of the quality management system including exclusions and details of their justification

and describes the processes of the quality management system and their interaction Generally gives an

organization profile presents the organizational relationships and responsibilities of persons whose work

affects quality and outlines the main procedures It may also describe organizations quality policy and

quality objectives

Level B Quality management system procedures

Describes the activities of individual departments how quality is controlled in each department and the

checks that are carried out

Level C Quality documents (forms reports work instructions etc)

Work instructions describe in detail how specific tasks are performed include drawing standards

methods of tests customers specifications etc

Presents forms to be used for recording observations etc

In small companies the above levels of documentation could be presented in one manual otherwise

separate manuals should be prepared A list of the documents to be prepared should be drawn up and

the responsibility for writing the documents should be assigned to the persons concerned in various

functional departments They should be advised to prepare the drafts within a specific time frame

Step 8 Document Control

Once the necessary quality management system documentation has been generated a documented

system must be created to control it Control is simply a means of managing the creation approval

distribution revision storage and disposal of the various types of documentation Document control

systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 90012000

requirements and that is all

Document control should include

Approval for adequacy by authorized person (s) before issue

16

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 17: TQM 1

Review updating and re-approval of documents by authorized person (s)

Identification of changes and of the revision status of documents

Availability of relevant versions of documents at points of use

Identification and control of documents of external origin

Assurance of legibility and identifability of documents and

Prevention of unintended use of obsolete documents

The principle of ISO 9000 document control is that employees should have access to the documentation

and records needed to fulfil their responsibilities

Step 9 Implementation

It is good practice to implement the quality management system being documented as the documentation

is developed although this may be more effective in larger firms In smaller companies the quality

management system is often implemented all at once throughout the organization Where phased

implementation takes place the effectiveness of the system in selected areas can be evaluated It would

be a good idea initially to evaluate areas where the chances of a positive evaluation are high to maintain

the confidence of both management and staff in the merits of implementing the quality management

system

The implementation progress should be monitored to ensure that the quality management system is

effective and conforms to the standard These activities include internal quality audit formal corrective

action and management review

Step 10 Internal Quality Audit

As the system is being installed its effectiveness should be checked by regular internal quality audits

Internal quality audits are conducted to verify that the installed quality management system

Conform to the planned arrangements to the requirements of the standard (ISO 90012000) and

to the quality management system requirements established by your organization and

Is effectively implemented and maintained Even after the system stabilizes and starts

functioning internal audits should be planned and performed as part of an ongoing strategy A

few staff members should be trained to carry out internal auditing Use ISO 19011 for guidance in

auditing auditor qualification and programmes

17

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 18: TQM 1

Step 11 Management Review

When the installed quality management system has been operating for three to six months an internal

audit and management review should be conducted and corrective actions implemented The

management reviews are conducted to ensure the continuing suitability adequacy and effectiveness of

the quality management system1048578 The review should include assessing opportunities for improvement

and the need for changes to the quality management system including the quality policy and quality

objectives The input to management review should include information on

Results of audits

Customer feed back

Process performance and product conformity

Status of preventive and corrective actions

Follow-up actions from previous management reviews

Changes that could affect the quality management system and

Recommendations for improvements

Management reviews should also address the pitfalls to effective implementation including lack of CEO

commitment failure to involve everyone in the process and failure to monitor progress and enforce

deadlines

Step 12 Pre-assessment Audit

When system deficiencies are no longer visible it is normally time to apply for certification However

before doing so a pre-assessment audit should be arranged with an independent and qualified auditor

Sometimes certification bodies provide this service for a nominal charge The pre-assessment audit would

provide a degree of confidence for formally going ahead with an application for certification

Step 13 Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized a formal

application for certification could be made to a selected certification agency The certification agency first

carries out an audit of the documents (referred to as an adequacy audit) If the documents conform to

18

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19

Page 19: TQM 1

the requirements of the quality standard then on-site audit is carried out If the certification body finds the

system to be working satisfactorily it awards the organization a certificate generally for a period of three

years During this three-year period it will carry out periodic surveillance audits to ensure that the system

is continuing to operate satisfactorily

Step 14 Continual Improvement

Certification to ISO 9000 should not be an end We should continually seek to improve the effectiveness

and suitability of the quality management system through the use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive actions

Management review

ISO 90042000 provides a methodology for continual improvement

19