Effective Implementation of Quality Management Systems (0857090011)

8/10/2019 Effective Implementation of Quality Management Systems (0857090011)

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Effective implementation ofquality management systems


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Effective implementation of

quality management systems

B. Purushothama

WOODHEAD PUBLISHING INDIA PVT LTD

New Delhi Cambridge Oxford


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Published by Woodhead Publishing India Pvt. Ltd.

Woodhead Publishing India Pvt. Ltd., G-2, Vardaan House, 7/28, Ansari Road

Daryaganj, New Delhi 110002, India

www.woodheadpublishingindia.com

Woodhead Publishing Limited, Abington Hall, Granta Park, Great Abington

Cambridge CB21 6AH, UK

www.woodheadpublishing.com

First published 2010, Woodhead Publishing India Pvt. Ltd.

Woodhead Publishing India Pvt. Ltd., 2010

This book contains information obtained from authentic and highly regarded

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Woodhead Publishing India Pvt. Ltd. ISBN 13: 978-93-80308-03-6

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Contents

Preface vii

1. Sustaining business 1

1.1 Introduction 1

1.2 Recession 2

1.3 Business sustainability 4

1.4 Evolution of QMS 4

1.5 Definition of quality 6

1.6 Imperatives of quality 8

1.7 Quality from a larger perspective 11

2. Understanding and implementation ofISO 9001:2008 14

2.1 Introduction 14

2.2 Fifty Steps for implementation 17

2.3 Undergo audits 46

2.4 Post-certification audits 47

2.5 Points to remember 48

3. Roles and responsibilities of managementrepresentative 49

3.1 Who should be the management representative? 49

3.2 Jobs expected from management representative 51

3.3 Tips for management representative 55

4. Internal quality audits: A strong tool forquality management 56

4.1 Need for audits 564.2 Internal quality audits 58

4.3 Quality control versus quality audits 58

4.4 Product audit versus system audit 60

4.5 Top management review versus quality audits 60


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vi

4.6 Types of internal quality audits 61

4.7 Pre-requirements of an auditor 62

4.8 What is to be verified? 64

4.9 Can we discontinue quality control investigation? 794.10 Process audits 80

4.11 Imperatives of effective audit 83

4.12 Linking exercises a strong tool for quality auditing 85

5. Measuring maturity in QMS implementation 95

5.1 Need for measurement 95

5.2 Measuring maturity by linking to the principles 96

5.3 Measuring maturity by considering the clauses 97

5.4 Guidelines for assessing maturity in QMS implementation 98

6. Welcome the complaints 133

6.1 Who is interested in complaining? 133

6.2 When customer complains? 134

6.3 When customer does not complain? 135

6.4 Customer a free consultant 136

7. Face the audits 1387.1 Why to face audits? 138

7.2 Basic human nature 140

7.3 What shall be audited? 140

7.4 Preparing for the audit 141

7.5 Face the audits 142

7.6 Role of a guide 143

7.7 Understand the non-conformities and observations 143

Appendix 1: Departmental objectives and expectations 146

References 157

Index 158

Contents


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Preface

To survive on this earth, it is necessary to keep ourselves fit. It might bean individual or an organization. One need to follow certain disciplines to

keep his body fit; similarly, an organization also has to follow certain basic

disciplines. The concepts of ISO 9001 give guidelines for helping an

organization to remain fit all the time. What is needed is to implement it

whole heartedly. Remember, one has to do his exercises and follow the

diet to remain fit. This cannot be delegated to others.

It is unfortunate that the need for implementation of ISO 9001 was

understood in a wrong way by majority of the people, and they consider itas a mere certification process to get entry to world markets. The

concentration is on getting the certificate. The organizations somehow

manage to convince the certifying body and get certificate with out even

understanding the basic concepts. As the number of ISO 9001 certified

organizations are increasing, the respect for the systems is coming down.

When all are ISO 9001, there is no value for the same. There is a need to

measure the level of implementation or the maturity of implementation.

In my experience of implementing ISO 9001 for last 18 years, I have

seen different types of managements and the people. There are very few,who have understood the real essence of the systems and implementing

them by heart. They are building a good foundation for their organization

to remain stable for long. However, majority of the companies I visited

are concentrating mainly on getting the certificate, somehow manage the

audits and keep auditors happy. The managements are not taking interest

and getting themselves involved in the internal quality audits. They blame

that ISO is increasing their work, adding the paper work and bureaucracy

and not helping improvement. People quote different quality systems like6 Sigma, Kaizen, Quality Circles etc., but do not understand that no system

can remain or give results unless one has the basic discipline of planning

and establishing the systems, implementing them through out the

organization, monitoring and measuring the performance, correct the


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viii

deviations and take preventive actions with the involvement of people and

a committed management. The real implementation actually reduces the

work, as you will be auditing, identifying the non-conformities and taking

corrective and preventive actions, and go on improving your systems on acontinual basis. As the activities are customer-focused, the sale is

guaranteed.

In this book, I have tried to explain the real need for implementing the

systems, the steps in implanting, the roles and responsibilities of

management representative, making effective internal quality audits by

linking exercises, assessing the level of implementation of ISO 9001,

inviting complaints and treating customer as a free consultant, and freely

facing the audits. I hope this book will drive out some of the misconcepts

and help the organizations to become strong and competitive.

B. Purushothama

Preface


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In earlier days, normally, the trade was a family business. People used tostick to their family trade, irrespective of the profitability. They were

respecting what their ancestors did. A carpenters son used to become a

carpenter and a soldiers son used to become a soldier. The community

was recognised by the trade they did, and it was even used as surname.

People were not entering in the trade of others, and an act of doing others

trade was even punishable. There was no competition as the productions

were less and the demand was certain.

The increase in demands and the desire to earn more and more led to

development of technology and ultimately to the industrial revolution.

Gradually as the concepts of management was developed, the concepts of

high speed production to reduce the cost of manufacturing pierced in the

minds of the industrialists and technicians. Organized industries started

replacing the earlier cottage industries or craftsmen business. The earlier

craftsmen were compelled to join the organized industries as labourers as

they were not able to compete with the industry by their craftsman skills.

Rapid technological developments and system developments were seen in

20th century as a by-product of the world wars. There were social reformsalso, and the barriers for others in the trade that was being managed by

particular family or community no longer exist. Now a son of a farmer can

become a doctor, and a teachers son can become an agriculturist. The

education is open to all and anyone can enter the business. The labourers

children no longer wish to work as a labourer as the earnings are much

less compared to other trades. It is now very difficult to get servants to do

petty jobs, where as earlier that was the main job of illiterate poor people.

Now people are able to make their own assessment and try to enter into

that trade where the earnings are more. A number of new industries are

being started because of the financial supports given by governments and

public. This very act led to the competition between units of the same

industry and also between industries.


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The recent developments of free trade and globalization opened the

markets that lead to the competition between countries. In earlier days,

the trade was restricted within certain regions. The local manufacturers

were protected by banning imports and the traders were able to sustaintheir business depending on the countries and their policies. To protect

themselves, regional trade associations were started and certain trade

barriers were put to prevent others entering in their segment.

The 21st century started with fierce competition and a number of

organizations boasting to be world leaders started collapsing, as they could

not beat the competition. The world is changing very fast. The thinking,

ideologies, and the expectations are all changing. We can see rising

expectations worldwide and open-market economies are forcing people

to compete with each other, more often on the basis of quality. It holdsgood for all, even to industry and business, and all have a number of players.

As the technology progressed, the speeds of production increased. The

latest high speed machines can produce more than 34 times compared to

the machines that were running two decades back. Further, the

developments in engineering aspects assured good quality product evenat the high speed. Therefore, the industries preferred replacing their old

machines with latest state of the art machines to get higher production and

better quality.

Along with the growth of technology, the cost of living also started

increasing. People demanded higher and higher remunerations as the speed

of production increased. As people preferred to work where salaries are

high, a scarcity was developed for skilled human workers, those could

work at a lower wage. The latest technologies, therefore, concentrated on

reducing the human dependency in the activities by automating whereverpossible. The term rationalization of employment came to restrict the

component of employee cost in the total cost of manufacture. Voluntary

retirement scheme (VRS) was introduced in the industries as well as service

organizations including government establishments to reduce the number

of employees.

As the technology was developed, old machinery was removed and new

high speed machines were put. The skilled people in a number of industries

opted for VRS and started their own small units by purchasing the old

machines on which they were working earlier as an employee. The

governments supported small scale industries by giving them tax benefits

and soft loans. These small industries became competitors for large

industries because of the cheapness of their products. Also, the eruption


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of small industries added to total products available in the market, and the

supply exceeded the demands.

Adapting high speed machines and increasing productions were

preached as an easy way of reducing the contribution of overheads perunit production and increasing profitability by the costing and management

experts. The calculations were simple. The manufacturing industries started

expanding and increasing their productions in volumes to reduce the cost

of manufacture of unit piece. They were able to achieve this, but

unfortunately were not able to sell their products, as the total demands

remained same or started reducing because of the improved quality products

that were durable.

It is observed that the recession is a cyclic phenomenon. It is repeating

every 1012 years. As the technology developed, new machineries areinstalled and the production is increased. This led to competition and surplus

material in the market leading to recession. The weak performers have to

shut their operations, and even the good performers make loss during the

recessions and reduce their productions. After some time, reduction in

production leads to short of materials and the demand starts. This is called

as a boom period. Recession is cyclic so also the boom period. When the

boom period comes, everyone invests and expands, leading to recession

again (Fig 1.1). Companies with good forward thinking does not simplyexpand, but also try to bring innovative products to the markets and will

always be first to introduce new products and capture the market.

The recession affects the organizations and the economy as a whole.

The planned projects cannot take off and people lose confidence among

themselves. Numbers of hasty decisions are taken during recession leading

to further worsening of the situation.


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One cannot keep quite just because recession is cyclic. The recession is

cyclic only for those who survive in a recession. One should have strategies

and action plans to face the recession and survive. Any organization should

first sustain before thinking of anything. Sustained success is more

important than making profit in some years and expanding, and making

losses later and retrenching the people. A long-term approach is essential

for sustaining the business. Dr. Ali AL-Zubaidi (1) explains sustained

success as a result of the ability of an organization to achieve and maintain

its objectives in the long term under dynamic organizations environment.

He explains organizations environment as a combination of internal and

external factors and conditions that can affect the achievement of anorganizations objectives, and its behaviour towards its interested parties.

Everyone wants to be a winner as only a winner can survive (2). The

technology and systems adopted have a wide variation from man to man,

organization to organization and depends much on the culture developed

over a period of time, the community and the economic systems. There is

nothing like monopoly in any field and the competition is very high.

Patenting, to some extent, protects the inventors of technology, but no one

can prevent copying and adopting of good and effective systems developed

elsewhere. Surviving has become difficult if one is not competitive.Everyone tries to adopt a system best suited for his environment, so as to

achieve the best possible results, which is often called as Management

System. The systems designed are trying to address the activities needed

to achieve the required results right at the first time, with least expense.

One who implements and succeeds in sustaining the benefits of the strategic

decisions taken is called a good manager or a winner, and the organization

becomes a winning organization.

The Quality Management Systems (QMS) was developed in response to

the challenges of increasing market globalization (3). The concepts of ISO

9000 series of standards are widely accepted world over as the basic

guidelines for implementing a system that can help the organization to

sustain in the changing environment. These standards are viewed as

powerful tools for effective management not only for products and services,

but also for business operations irrespective of their sector.The present concepts of documented quality management system was

developed during the second world war and were maintained as military

secret till 1976, when British Standard Institute came out with BS 5750.

The same was adopted in total as ISO 9000 standards in 1987 by ISO, the


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International Organization for Standardization at Geneva. These standards

went through amendments in 1994, 2000 and 2008.

The guidelines given by ISO are the minimum requirements for

implementation of a quality management system and it is expected for theorganizations to move further by keeping this as a base. A number of quality

management systems were developed by different trade groups, corporate

offices, consultants, state award committees, etc., all with a view to help

the industry sustain in the changing scenario. However, the base of ISO

9000 holds good for all the quality management systems.

The International Organization for Standardization (ISO) defines quality

management system as:

The organisational structure, responsibilities, procedures, processes and

resources for implementing quality management. ISO 8042 (ISO, 1986)The QMS provides a structure to ensure that process is carried out in

formal and systematic way (7). The ISO 9001:2000 guidelines insists that

implementing a quality management system within an organization needs

to be a decision by top management. (8)

Pradeep Kumar Mathur (4) defines the term quality management system

as The process of management of the systems of an organization, with

regard to its quality related activities, for meeting and enhancing customer

satisfaction and also taking care of all other interested parties such aslegislative and regulatory bodies, shareholders, suppliers, employees, etc.

Navin Shamji Dedhia (5) defines Quality Systems as a series of functions

or activities (sub processes, stages, etc.) within an organization that work

together for the aim of the organization. It comprises the processes in an

organization intended to yield consistency or improvement to the enterprise

of the corporation.

The definition for quality systems by the author in his book Guidelines

for Process Management in Textiles (6) was An un-interrupted follow up

of procedures for doing a work, which are written after judicious studiesin order to achieve the best possible results and A system designed to

achieve reliability and performance is quality system.

The Engineers International (9) observes that the design and

implementation of a quality management system vary depending on the

type, size and products of the organization. Each company will have its

own objective; however, most companys objective is to increase

profitability. A quality management system will assist by managing costs

and risks, increasing effectiveness and productivity, identifyingimprovement opportunities and increasing customer satisfaction. A well-

managed quality system will have an impact on customer loyalty and repeat

business, market share, operational efficiencies, flexibility and ability to

respond to market opportunities, effective and efficient use of resources,


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cost reductions, competitive advantages, participation and motivation of

human resources, industry reputation and control on all processes.

From all the above definitions we can understand that strategically

planned and well-designed quality management systems enable us inachieving our company objectives, which is mainly to help sustenance by

achieving customer and stakeholder satisfaction while maintaining the

operations rationally and economically.

Quality is defined by number of people in different ways (10). Joseph Juran

and Frank Gryna define Quality as Fitness for use. The ISO 9000 defines

it as The totality of characteristics of an entity that bear on its ability tosatisfy stated or implied needs. Armand Feigenbaum explains Quality as

A customer determination based upon a customers actual experience

with a product or service, measured against his or her requirements stated

or unstated, conscious or merely sensed, technically operational or entirely

subjective and always representing a moving target in a competitive

market. American Society for Quality (ASQ) opines that quality denotes

an excellence in goods and services, especially to the degree they conform

to requirements and satisfy customers. Peter Senge et al, in their book TheFifth Discipline Field Book, explains Quality is a transformation in the

way we think and work together, in what we value and reward, and in the

way we measure success. All of us collaborate to design and operate a

seamless value-adding system that incorporates quality control, customer

service, process improvement, supplier relationships, and good relations

with the communities we serve and in which we operate all optimizing

for a common purpose. Daves definition is Quality is a really, really

boring definition that has no real meaning to most humans on this planet

unless you are a millionaire consultant writing a new book or a qualitycoordinator applying for some Quality award or certification so you can

quit and become a millionaire consultant who writes books and produces

infomercials from his private island in the Caribbean.

The definitions given by most are centred on meeting customer

requirements effectively. It includes providing right quality goods and

services at the affordable prices and at the committed time. Let us discuss

on this in detail.

Dreaded smuggler late Veerappan was cutting sandal wood trees and

smuggling out of the forests in southern Karnataka and Tamil Nadu. He

was also killing wild tuskers for the ivory. Why he was cutting sandal

wood only and not other trees? His customers demanded sandal wood, so

he was cutting sandal wood. Why he was killing elephants? He had to kill

them because elephants were not giving ivory if he asked. The elephants


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were wild and they could have killed him if he tried to take ivory without

killing them. He stayed in the forests where there were no houses, no luxury,

no facilities and no protection. He had to spend day and night in forests

along with wild animals. The police were after him, so he had to fightwith them and kill the police. He had very good communication systems

in those forest areas that never used mobile phones or satellite services.

He was able to get the information about the movement of police precisely,

where as police were finding very difficult to access he area in spite of

having electronic gadgets, mobile phones, wireless, etc. From the point of

definitions discussed above, i.e. fitness for purpose, working for customer

satisfactions, totality of characteristics of an entity that bear on its ability

to satisfy stated or implied needs of a customer, etc., we must honour him

as the Best Quality Person. We are not ready to sacrifice our life or familyfor the sake of customers, but Veerappan did it. Why are we not recognizing

such quality persons and rewarding them?

Take the examples of terrorists. They plan well and attack. They do

their work right at first time for the sake of their customers, who are looking

after their families and community. Can we call them as quality persons?

Certainly we do not accept smugglers, poachers, thieves, robbers,

terrorists as quality people. Then what is missing in the definition of

Quality?Take some more examples.

A garment company is producing good quality garments at a very low

price and their customers are very happy. The deliveries are given in time

as agreed in the contracts. They boast themselves as having the lowest

lead time. To achieve this, the employees, who come from poor families,

toil in a bad working condition. They are paid less and kept almost as

bonded labour much away from their families. The supervisors and

workers work extra hours without getting the overtime wages as per the

rules. The ladies are not looked after well. No facility of crche is providedfor the babies. The company makes profit, and worlds best brands get

their garments stitched from them. The buyer s agents who come for doing

compliance audit give a clean chit to that factory, because, if they disqualify

that factory, then they need to pay more and purchase from others. They

shall become uncompetitive. The certifying bodies also give certificates

of ISO 9001, SA 8000, etc, as their business depends on giving more

certificates to the organizations. If they do not give certificate, they will

loose the business and some one will give the certificate. Can you call thatcompany as a good Quality Company? They are meeting the requirements

of their customers. The actions taken by the management are fit for the

purpose, i.e. providing the quality goods to the customers at lowest possible

price and at lowest lead time. It meets the definition given by Armand


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Feigenbaum that Quality as a customer determination based upon a

customers actual experience with a product or service, measured against

his or her requirements stated or unstated, conscious or merely sensed,

technically operational or entirely subjective and always representing amoving target in a competitive market.

Another profit-making company was producing good quality and

meeting the complete requirements of customers, but

The company is polluting the environment.

Employees are harassed.

Suppliers are not paid in time.

Taxes are not paid to government as should have been paid by making

some intelligent manipulations. Roads are frequently blocked because of the parking of heavy trucks.

Roads are frequently getting spoiled because of the movement of

heavy vehicles.

Strikes and agitations disturbing the normal life of public.

Can we call this as a quality company? The definition of quality has

gone much beyond the product requirements to the customer requirements

and the International Quality Standards cover a bigger sphere. The quality

does not restrict itself to fulfilling the customer requirements, but it should

also consider the ethical and society needs and regulatory requirements.

Understanding society needs and requirements and developing the systems

and strategies to help community is essentially a part of quality. Any act

that does not address human values is not a quality. The quality can thus

be defined as Achieving the customer and stakeholder satisfactions while

adhering to business ethics, human values and the statutory, legal and

regulatory requirements.

The quality should consider the following requirements:

Customer Product features and tolerances, the delivery in time,

reasonable price and quick and prompt service. The technology and

systems adopted should be appropriate to the quality requirements.

The training should be adequate for the people to produce the quality.

The plant should have the capacity to produce the required quantity

to deliver in time, and the management should have planned theresources and provided them in time to help delivering the goods in

time.

International standards Measuring systems adapted should be inline

with internationally recognized systems. Similarly, the labelling and


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marking should meet the statutory and regulatory requirements. They

should not mislead or confuse the customers and ultimate users. They

should be user friendly.

Regulatory requirements Safety of product as well as users is themain concern of any regulation. The general interests of the

community and environment are taken into consideration while

developing the regulatory standards. It is essential for any

organization to adhere to legal, statutory and regulatory requirements.

Ethical requirements The ethical requirements consider human

values, business ethics and social obligations. One can make a short-

term profit by not adhering to ethics, but the affected people shall be

waiting for an opportunity to over throw such establishments.

Supplier Timely payment for the materials supplied is the mainexpectation of suppliers. Suppliers cannot survive if their payments

are not made in time, and hence the organization cannot expect the

quality products and services from them. It affects the performance

in terms of quality and productivity.

Employees Employees are the backbone of any organization. Unless

the employees are involved in the activities by heart, it is not possible

to get the required performance in terms of quality, productivity, cost,

customer satisfaction, reputation, etc. Remunerations for the workand security of job and self are the main requirements of the

employees, and it is the duty of the management to provide this. The

scope to grow, the social security and the welfare activities are the

secondary requirements. They are also very important.

Community The community supports an industry as it gives

employment to the people either directly or indirectly. The community

around us has to survive if our organization wants to survive. Providing

a pollution free environment is one of the prime responsibilities of

any organization. Legal and regulatory requirementsshould consider

No violation of the law of the land like minimum wages,

working hours, overtime, minimum age for employment,

providing crche facilities where women employees are

working, safety regulations, bonus, PF and other welfare

measures.

When the activities are outsourced, it is the responsibility of

the organization to ensure that the people are paid the minimumwages as per the Act, and the number of hours worked does no

exceed the limits for both regular working and for overtime.

The employees need to be insured for their safety and health.

All safety aspects are to be maintained as per the law of the

country


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The training of the employees is the responsibility of the

organization, as they are committing the quality to the

customers.

Regulatory requirements relating to product safety and thesafety of the consumer include number of factors, for e.g., in

a garment industry.

Use of metal free buttons and other accessories in garments.

Avoiding carcinogenic azonic dyes.

Preventing metal pieces like broken needle parts and staple

pins in the garments.

The washing instructions are to be given with the

internationally accepted symbols.

The product safety requirementsdepend on the nature of the product,the culture and the conditions in which the users live and use the

products. It depends upon the basic objective of the product.

General regulatory requirements consider

The quantity despatched should match exactly the invoice and

the delivery challan.

The product features mentioned should match the actual

product features.

The packages should have the details of manufacturer, theperiod of manufacture and the country of manufacture.

Specifying expiry date is very essential for perishable products.

Specifying maximum retail price (MRP) is essential for

commodity products.

Business ethics include

The product shown in the catalogue to match with the final

material delivered.

Performance according to the promises given to the buyer,

either personally or as claimed in the advertisements. The product quality to match the samples shown while taking

orders.

Proper documentation as agreed during negotiations.

High quality label and instructions clearly describing the

products and explaining their method of use and the precautions

to be taken.

Timely delivery of material is as important as its quality and

price. Making in-time payment to suppliers, contractors, service

provides and the government.

Trade regulationsrequirements

Apart from the International Standards, it is necessary to refer


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to the trade practices and the regulations prevailing in the

country to which the exports are made.

It might include the ban on certain chemicals, packing materials,

packing systems, permissible limits for the traces of heavy metals,pesticides, etc., depending on the product and the end use.

Societal safety factorsemphasize that

Products do not create problem to the user because of its

constituents and finishes.

No loss is made to society or environment because of the processes.

The industry should follow ethical standards and consider the

community requirements.

There should not be any disturbance to the community, like the

noise disturbing the sleep of people, frequent traffic jams becauseof the movement or parking of heavy and long trucks in narrow

lanes adjacent to the factory, frequent strikes and lockouts

because of unhealthy industrial relation approaches, etc.

The discussions made above indicate that the quality is not a simple word,

but has a large perspective. The quality not only addresses the basic product requirements, but

also other requirements of customers as well as of society.

We need to work towards achieving both in order to survive in the

competitive international market.

We need to have appropriate procedures to address the requirements,

implement the systems, verify the results and compare with the

competitors and reengineer the systems to achieve improved results.

Adherence to quality systems and ethics should be developed as a

culture, and not for getting certified by third party.

The certificates might give a confidence for new customers for

entering into business with a supplier, but the actual quality and

services, the ethics in dealing and the transparency are the real factors

considered by the customers to stay in business.

The basic need is to adhere to Agreed Quality Standards. Quality

standards must be recognized and agreed by all levels of management. In

the absence of such agreement the operative does not know what is

expected of him or her, becomes frustrated, and leaves, with the ensuing

needlessly high labour-turnover and training costs of new labour.

The next step is to identify the unspecified needs of the customers and

address them. The unspecified needs are very important, as they are the

deciding factors for continuation of a business.


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Getting certified for ISO 9001 is not the end, but it is the starting point.

It gives confidence to the customers that you are on the right track. Unless

you move, you cannot reach the destination.

ISO 9001 explains the minimum requirements that are given asguidelines for us to design a quality management system and it is not the

end. We need to improve our systems on a continuous basis taking the

help of guidelines given in the standards.

The true implementation of ISO 9000 guidelines does not allow your

company to slip down from what you have already achieved. It shall prevent

you from making mistakes as you shall be following a procedure designed

by you to achieve the results expected by you and you are continuouslymonitoring whether you are adhering to your systems and are taking

suitable corrective and preventive actions in time or not.

If you are not adhering to the requirements of the systems and just boast

of having a certificate, you shall be hanged by your customers similar to

as you are hanging your certificate.

ISO 900 1C ertif icatex xx

If your ISO cert if icate i s me ant only forhanging in your off ice, your organizat ion wi l l

be hanged by your custom ers


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ISO 9000 series of standards, popularly known, as Documented Quality

Management Systems were amended and new guidelines forimplementation of Quality Management Systems were released in

November 2008, with slight changes from ISO 9001:2000. All the certified

companies and the companies to be certified a fresh, need to adopt the

amended guidelines. Let us discuss the steps involved in implementing

the new system.

The standards have 8 clauses as follows:

1. Scope

2. Normative reference3. Terms and definitions

4. Quality management system

5. Management responsibility

6. Resource management

7. Product realization

8. Measurement, analysis and improvement.

The scope of the standard specifies the requirements of quality

management systems, where an organization needs to demonstrate itsability to consistently provide the product and services that meets the

customers and applicable statutory, legal and regulatory requirements, and

aims to enhance customer satisfaction through the effective application of

the system. This includes processes for continual improvement and

assurance of conformity to customer and applicable regulatory

requirements. When we talk of the scope of the application for ISO 9000,

we talk about the sections of the organization, which shall be offering

them for third party audits to get themselves certified. When we write the

Quality Manual, it is essential to specify the scope of the application, andalso mention if any sub-clauses from Clause No. 7 are not applicable to

us. This shall depend on the nature of activity. For e.g., Clause No. 7.5.4

viz. Customer Property might not be applicable to a factory or organization

where they are not doing any job work, nor getting any materials from the


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customers to be incorporated in the final product. One needs to really see

in detail to decide on the clause that could be excluded, as the exclusion

of the clause should not come in the way of meeting customer requirements

and also applicable statutory, legal and regulatory requirements.The clause on normative referencesspecifies that the organization should

refer the latest version of applicable procedures, standards and norms.

There are standards developed by ISO for writing quality manual, vendor

rating systems, preparing quality plans, project management, configuration

management, auditing, quality assurance for measuring equipments,

managing the economics of the quality, guidelines for performance

improvements, training, application of statistical techniques, etc. We need

to work out as to which standard is applicable to us, and adopt it so as to

get the benefits of the systems. It is advisable to have continuous touchwith the national body for standards, and get the information on the

amendments in standards from time to time. In India, Bureau of Indian

Standards provides the information on the changes in standards through

their periodicals.

Following are the standards referred in ISO 9001:2008:

1. ISO 9004 Managing for the sustained success of an organization

A quality management approach.

2. ISO 10001 Quality Management Customer Satisfaction Guidelines for codes of conduct for organizations.

3. ISO 10002 Quality Management Customer Satisfaction

Guidelines for complaint handling in organizations.

4. ISO 10003 Quality Management Customer Satisfaction

Guidelines for dispute resolution external to organizations.

5. ISO 10005 Quality Management Systems Guidelines for quality

plans.

6. ISO 10006 Quality Management Systems Guidelines for qualitymanagement in projects.

7. ISO 10007 Quality Management Systems Guidelines for

configuration management.

8. ISO 10012 Measurement Management Systems Requirements

for measurement processes and measuring equipments.

9. ISO 10013 Guidel ines for qual i ty management system

documentation.

10. ISO 10014 Quality Management Guidelines for realizing financial

and economic benefits.11. ISO 10015 Guidelines for training.

12. ISO 10017 Guidelines for statistical techniques.

13. ISO 10019 Guidelines for selection of quality management system

consultants and use of their services.


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14. ISO 14001 Environmental management Systems Requirements

with guidance for use.

15. ISO 19011 Guidel ines for qual i ty and/or environmental

management systems auditing.16. IEC 60300-1, Dependability management Part I, Dependability

management systems.

17. IEC 61160 Design review.

18. ISO/IEC 90003 Software engineering Guidelines for the

application of ISO 9001 to computer software.

The purpose of the Clause 3, i.e. the Terms and Definitions, is to give

clarity about the terms used in the documents as well as in our daily

communications. We can see that in normal life we use some abbreviationsbut with different meanings at different places leading to confusion. For

e.g., TV is refereed as television, transfer voucher, tere-viscose, etc. The

abbreviation MIS is used for management information systems, material

issue slip, monthly income statement, materials in stock, etc. The term

AGM is referred for additional general manager, assistant general

manager and also for annual general body meeting. Some times we see

same activity or material is referred by different names or abbreviations.

For example GRN (Goods Receipt Note) and GIN (Goods Inward Note)

for the materials received at stores. CEO (Chief Executive Officer), COO(Chief of Operations), Executive Director, VP (Vice President) Operations,

Sr. Vice President Operations, GM (General Manager) Operations, etc.,

are the different nomenclature for the simple term Head of the Unit.

These different nomenclatures are developed for satisfying the ego of

certain people, but can lead to confusion for the people in understanding

their roles and responsibilities. One word should have only one meaning,

so that there can be no confusion. To avoid confusions, ISO 9000:2005

was prepared as a guideline for vocabulary, by which every one in theorganization, and also the auditors use the same terms and avoid confusion

in understanding. It is suggested for the organizations to make a list of all

abbreviations used in their organization and attach as an appendix to quality

manual and the procedure documents. More than documenting, it is

important to ensure that everyone uses the same nomenclatures and

abbreviations all the time. As far as possible, avoid the abbreviations.

The practical implementation in an organization starts from Clause 4,

which says that the organization shall establish, document, implement and

maintain a quality management system and continuously improve itseffectiveness. This starts with the identification of various processes,

determination of the sequence and interaction of the processes, determining

the criteria and methods needed to ensure the operation and control of the

processes, ensuring the availability of resources and necessary information,


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monitoring, measuring and analysis of the processes and implementing

necessary actions to achieve the planned results and to improve. However

to this activity, we need first to decide on the purpose for which we are

running our organization, and align all our activities to achieve ourcompany objectives. Again, each of the procedure developed should be

clear about the purpose for which that procedure was developed. We need

to have a mechanism to verify its effective implementation as without such

verification implementation cannot be effective.

The Clause No. 4 to 8 should be seen as one and not as separate, as

these are interconnected. We need to interpret the guidelines given and

decide the step-by-step implementation. The following 50 points are just

an effort to explain the concepts in simple language so that people working

in an industry or an organization can understand.

1. The first step in doing any activity is deciding on the purpose. We

need to be clear on the purpose of the organization. This is called as

Missionand need to be stated precisely as a Statement. This statement

is supposed to be prepared by the top management; however, in a

number of companies it is seen that these are left to some juniors orto some consultants. None other than the top management can be

clear about the purpose for which the organization is being run. The

consultants or the junior staff cannot really know the real purpose,

which the top management wants to achieve. For e.g., a co-operative

spinning mills might be having a mission of uplifting the cotton

growers of their area and supply yarns at a reasonable price to the

weavers in their area, where as some other mill might be having a

purpose of exporting maximum so as to enhance the foreign exchange

earnings of the nation. Some mills have only short-term goals ofmaking quick profits, where as some are interested in the development

of community around them. Some management are interested in

diversification where as some others are interested in remaining in

one field and emerging out as leaders. Unless the purpose is clear,

planning the activities and identifying the processes shall not be

proper. Therefore, defining the purpose shall be the first job of the

top management.

2. Once the purpose is clear, the top management needs to spell out

their Vision.It means what they would like to be over a period of

time; this is worked out by understanding the trends and the possible

developments in the future. Some companies are having a vision of

expanding the activities and be the largest manufacturer in their field,

where as some are interested in maintaining the same strength of


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employees and achieve higher sales turnover and value additions.

Some are interested in maintaining the same capacity of production,

but change the product mix to get higher revenues. It is very essential

to have a practical vision by considering the facts relating to strengths,weaknesses, opportunities and threat, or else, the vision shall remain

only on paper.

3. The policy is the path in which we need to move to make the vision

a reality while adhering to the purpose. In ISO 9000, it is termed as

Quality Policy as here the concentration is on implementing the

quality management system. The quality policy should be appropriate

to the purpose of the organization, and should be committed to comply

with the requirements of the quality management systems and to have

continuous improvement in the systems. The quality policy shouldprovide a framework to review the company objectives, and should

be communicated down the line so that every one in the organization

understands the policy and works in line with the policy. The top

management should use the quality policy as a means for leading the

organization towards improvement of its performance. It should be

a consistent part of companys overall policies and strategies. One

should ensure that quality objectives are understood and pursued

through out the organization. The quality policy should demonstratethe commitment and leadership of top management for achieving

quality and for providing necessary resources for achieving the

objectives. It should demonstrate the commitment for continuous

improvement as related to satisfaction of customers and other

interested parties like share holders, suppliers, employees,

community, government, etc. Therefore, the quality policy is not a

slogan for advertisement, but is a guide for implementing the systems.

It should be written in as simple language as possible and ensure

that every one understands it.4. The quality objectives are derivatives of quality policy and the

strategic planning of the organization. The top management should

establish these objectives for leading the organization for

improvement. These are to be capable of being measured in order to

facilitate an effective and efficient review by management. These

should consider the current and future needs of the organization and

market served, relevant findings from the management review, current

product and process performance, levels of satisfaction of interestedparties, self-assessment results, benchmarking, competitor analysis,

opportunities for improvement and the resources needed to meet the

objectives. The communication of the objectives through out the

organization shall be called as effective, when people in the

organization can contribute effectively for the achievement. These


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objectives should be periodically reviewed and amended as per the

change in the scenario. Therefore, we should not write vague phrases

as quality objectives.

The quality objectives of the organization should help in derivingquality objectives of each department and section of the organization.

There should be a clear link between the company objectives and

departmental objectives. It is suggested to prepare a matrix as shown

in Fig. 2.1 and verify the linkages.

5. Once we are clear about our mission, vision, policy and objectives,

we can work out the action plan. The plan should consider various

aspects like the processes required, the present situation and the

changes needed, the sequence and interaction of processes, the

authorities and responsibilities, the control points and check points,

the review frequency, skills and knowledge needed by the

organization, resources needed, need for improvements at differentlevels, method of improving them, training needed to adopt the

improved process or to experiment the proposed process to achieve

the result, documentation and recording. Inputs for effective and

efficient planning include the strategies of the organization, the


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objectives, defined needs and expectation of customers and other

interested parties, evaluation of the applicable statutory and regulatory

requirements, performance data of the product and processes, the

process capability and the maturity of systems, lessons learned fromprevious experiences, the strength, weakness, opportunity and threat

analysis, etc.

The plans should be written as precisely as possible, so that the

implementers should not have any doubts or confusion. A chart may

be prepared as shown in Table 2.1 to guide people as to which are

the procedures that are to be referred for a particular action plan and

the person responsible for that process.

There should be periodical review to ensure that the persons shown

as responsible have understood the action plan and are monitoringthe activities.

6. Once the action plans are ready, we need to decide on theprocedures

for implementing the plans. They should clearly specify the

objectives, the responsibility and the actions, how to do the work,

when to do, where to do, what to control, what to check, when to

check, how to check, what is to be recorded, where to record, in case

of deviations what is to be done, etc., depending on the process. The

procedures, therefore, should aim at the achievement of goals, whichare to be revised from time to time depending on the situation.

Therefore, procedures cannot remain same all the time, and the

procedures written by some one cannot be copied and adopted at a

different place, unless we have the same goals as the other person,

and do not wish to improve. If it is the case, there is no meaning of

implementing ISO 9001, as it aims at continuous improvement. It is,

therefore, necessary to review all the procedures, instructions, job

descriptions, process parameters, etc., periodically and amend them

as per the changed situation. Some times, we may find some procedure/ instruction / job description / process parameter as suitable in todays

context, it can be re-approved; but reviewing is a must.

7. The procedures depend on the processes involved, the type of

equipments and infrastructures available, the competency of the men

involved, the customer feed back relating to our quality and services,

the resources available, and the goals to be achieved. When we talk

of processes in a factory, normally people refer to manufacturing

activities. But there are a number of other processes, which are asessential as manufacturing to make the company efficient and

effective. Some of the examples are customer order fulfilment

process, complaint management process, human resource

management process, procurement process, supply chain management


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process, quality assurance process, company policy deployment

process, product design process, investment process, information

management process, strategic planning process, management review

process, etc. When we talk of identifying the process and theirsequence and interactions, we need to address all these.

8. Each process should have some objectives, those should be specified

clearly. We need to identify the measurable parts of the objectives.

These are called as key result areas (KRA). It is essential to develop

methods and means to measure the same and periodically review the

progress. The targets need to be fixed for each of the result area, and

communicated down the line so that the men on spot are aware of

the requirements and expectations. It is a good practice to display


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the departmental KRAs so that every one in the department shall be

clear about the same. The sectional KRA has to be displayed in the

section and individuals need to be given their KRA in writing with a

copy to the concerned HOD.9. A documented quality manualhas to be prepared to guide the people

in implementing the systems. This manual should give an over view

of the company, the mission statement, the product range, the target

customers and market, the company policies and the steps taken to

implement them, the authorities and responsibilities of key personnel

implementing the systems, the process and procedures involved, the

system of monitoring, measurement and taking suitable corrective

and preventive actions, maintenance of records, reference to the

procedures adopted against each clause of the standard, etc., so thatany one can easily understand the systems. It is advisable to refer

ISO 10013, that give guidelines for developing quality manuals and

quality management system documentation, so that all necessary

points are covered.

10. Effective internal communication is a very important means of

implementing the systems to achieve the objectives, as there are a

number of inter relations between the processes. A free, clear and

interacting communication is very essential for the success of notonly the systems but also for the organization. Therefore, the

transparency of the system has to be maintained at all levels; however,

it should be ensured that the information flow is restricted to the

people involved in the operations, and should not go to unconnected

persons, as it can create more problem than any help.

11. The customer focusis often talked, and one of the responsibilities of

the top management is to communicate down the line the customer

requirements. Here we need to understand a lot. It does not mean

that all the terms and conditions of sales are to be told to each andevery person in the organization. It also does not mean that the top

management should conduct open programme and announce that

meeting the customer requirements are important. The top

management should demonstrate by their deeds that they are

respecting the customer needs in all their activities, which shall

automatically percolate down the line. There is a saying that People

follow the deeds of a leader and not the talks. Same thing holds

good here also. It is needed to explain to the concerned peopleregarding the specific requirements of the customers. For e.g., the

delivery schedule should be known to the production in-charge, the

production planning person and the despatch person, where as the

product quality related requirement is to be known to even the


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operators in production, but need not be to the despatch person. There

are a number of commercial and trade regulatory requirements, which

are to be known to the concerned persons, so that they monitor and

fulfil the requirements.


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In some of the companies, there is a system of nominating one of

their middle management personnel as a custodian of a particular

customer, who in addition to his/her regular activities, verify the

processes and quality of the materials that are being produced andshall have direct interaction with the buyer. In garment factories, it

is a normal practice to have quality assurance persons and the

merchandisers nominated for different customers. There are

companies who boldly display the name of the customer for whom

the materials are being manufactured and the previous complaints of

that customer regarding the products and services. This system helps

the operators and middle management to be alert in the specific areas

where the customer has a concern. Some companies have a system

of sending their senior workers and middle management staff to theircustomers on a periodic basis to understand the performance level of

their products and to get their changed requirements if any, which

are not normally identified and discussed while placing orders or

taking orders by the commercial people. Some companies publish

periodicals, either monthly or quarterly, exclusively for the use of

their staff and workmen, in which they discuss about the market feed

back and the changing requirements of the customers.

The customers needs could be grouped as primary needs andsecondary needs. It is essential to meet the primary needs, but in a

number of cases, the business is lost not because of meeting the

secondary needs effectively.

12. Another important responsibility of the top management is to

communicate down the line theregulatory requirements.Here again,

we need to understand what is to be communicated. The section heads

should have a list of legal and regulatory requirements applicable

for their section, and it is their responsibility to update themselves

regarding the changes and implications. We cannot expect the topmanagement to interpret all the changes and explain to the section

chiefs. If it is the case, why it is put in the top management

responsibility? It is because, the top management is responsible in

case of any violation, they need to periodically review and ensure

that the required statuary and legal requirements are being met.

It is a normal practice in number of companies to have one senior

HR manager exclusively for compliance. They boast of meeting all

the regulatory requirements and they take various certificates ofcompliance. However, when we see in detail, that person shall be

more interested in preparing the documents to convince the auditors,

and also shall spend more time in entertaining the auditors and

government officials. The standards want people to respect and follow


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the legal and regulatory requirements all the times. Each one should

be aware of the legal and regulatory requirements concerning to the

activities being done and the product being produced. The standards

insist more on implementation of the system rather than on convincingthe auditor and getting certificate. There is a need to educate people

concerned regularly on the legal requirements and the changes if

any, and ensure that they work as per the requirements, rather than

having a separate person to patch up the records to show to the

auditors.

13. The standards requires certain documents to be maintained as

mandatory, which include the quality policy, quality objectives, quality

manual, documented procedures required by the standards, documents

needed by the organisation to ensure effective planning, operation andcontrol and records required by the standards. If one reads calmly, he

can understand that the scope of documentation covers all the essential

activities of the organization. There is a need to identify and define

the documents and relevant records needed to establish, implement

and maintain the quality management systems, and to support an

effective and efficient operation of the organizations processes. The

nature and extent of the documentation should satisfy the contractual,

statutory and regulatory requirements, and the needs and expectationsof customers and other interested parties. This also should be

appropriate to the organization. The documents can be in any form or

medium suitable for the needs of the organization. For e.g., written

procedures for implementing regulatory requirements, where as we

can think of a video cassettes for showing the work practices like

material handling systems, assembling and checking the parts,

operating fire extinguishers, etc. We can have sign boards at appropriate

places to give instructions to workmen relating to Dos and Donts,

or can have online work instructions on each machine for attending toroutine problems. The option is left to the organization, but one should

ensure that the documents are properly controlled. Figure 2.2 illustrates

the documents needed for effective implementation of quality

management systems in any organization.

14. What do we understand by the word document control? It means the

documents are (a) approved by certain authorised and responsible

persons after ensuring its adequacy and relevance to the operations,

(b) are suitably identified to ensure that only the current version arein use, (c) given only to the concerned users and avoided from going

to unauthorized persons, (d) the obsolete documents are promptly

removed from the place of use, and (e) they are legible and easily

identifiable.


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It is normal practice to have a control copy seal and a control copynumber on the documents to show it as a Controlled Document.

The organizations also maintain number of Uncontrolled documents

and Records, but are not clear as to why it should be uncontrolled.

When asked, people normally reply that controlled documents were

for ISO purpose and the uncontrolled were for their day-to-day

activities. The controlled documents are kept in clean folders, where

as there are number of over writings and some important tips about

the activities. People should understand, if any document is required

for the effective functioning of the organization, those documents

need to be controlled. There is no need to have separate documents

for ISO 9001 purpose. If anyone is maintaining certain documents

that are not related to the organizations functioning, for e.g. technical


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articles collected from some magazines for reference, the activities

of annual social gatherings, felicitations to some achievers etc.,

they can be kept as uncontrolled. However, if the employee

development is one of the objectives, even these records need to becontrolled.

15. In the documents relating to meeting the satisfaction of customer

and other interested parties, the management should consider the

contractual requirements from the customers as well as the

requirements of the interested parties; acceptance of international,

national, regional and industry sector standards, relevant statutory

and regulatory requirements, decisions by the organization, source

of external information relevant for the development of the

organizations competencies and information about the needs andexpectations of the interested parties. Therefore, it is essential to

identify and control the distribution of documents ofexternal origin.

Access to documentation needs to be ensured for people in the

organization and to other interested parties depending on the

organizations communication policy and requirements. The other

interested parties include customers, suppliers, employees, share

holders, government and the community around us.

16. The method of doing a work or performing a process is often calledasprocedure, where as what was done and its effects are recorded

as a document is normally referred as record. The records are the

data bank giving information about various aspects while

implementing a procedure. They serve as an input for review and

planning. Therefore, they should be preserved properly. However,

the life of the records changes depending on the nature of data

and its utility. Hence the management should decide on the life of

each record. The records should be easily retrievable when needed

and hence proper identification and storage is necessary. As therecords are meant for using by others for review and decision-

making, they need to be legible and protected from damages due

to handling or any other reasons. People should develop the habit

of keeping back the records in their original designated place

immediately after the work. It is a good practice to specify the

cupboard number and rack number also on the records along with

the department and the sections. A full-proof method of putting a

diagonal band as suggested by Shyam Talawadekar

11

is a very goodsystem. Figure 2.3 gives an illustration of that simple, but very

effective system.

In order to have easy retrieval of information, it is essential to have

standardformats

for data gathering and presentation. This shall avoid


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1 2 3 4 5 6 7 8 9

duplication of work and also help in computing the data for analysis.

It is essential to list all the formats, index them and display so that

people do not create a new format or use a wrong format. It is normal

practice to allocate form numbers to all formats, and give reference

of that format in the procedures, work instructions and jobdescriptions.

17. One of the prime functions of any management is to review the

activities to ensure that they are effective and helping to meet the

company objectives. This is called as management review. This


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includes the review of all activities relating to the implementation of

quality management systems, product and process performance,

feedback from customers and other interested parties, adhering to

legal and regulatory requirements, actions proposed and taken tocorrect the deviations found in internal and external audits, and the

changes in policies. The management review should be a planned

activity and cover all the areas; however, the periodicity might depend

on the criticality of the activity. Normally people refer management

review to a meeting held after internal/external audits for ISO 9001

compliance, but it is not correct. It is only a management review for

quality management system implementation; however, for the process

conformance, product conformance, company performance, customer

requirements analysis, financial commitments, supplier performance,human resource management, etc., the reviews need to be held at

different levels, and the overall performance reviewed by the top

management. Some people think that reviews should be done in a

meeting only, where as, it is sufficient that the top management review

the situation and take appropriate action in-time to correct the

deviations and to improve the situation. A meeting shall help in

solving the differences if any and brings people closer. The

commitment of the top management to review the situationconsidering all the requirements of the system and the organization

is very important. Following Table 2.3 gives an illustration as to how

the reviews can be delegated and made effective

18. The provision of resources is very important part from the top

management commitment point of view. However, there should be a

justification for the resources to be provided. It should help the

management in enhancing customer satisfaction and satisfaction ofother interested parties, i.e. stakeholders, to achieve the company

objectives and fulfil the applicable statutory and regulatory

requirements. Hence, the top management should identify the

resources essential to the deployment of strategy and the achievement


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32 Effective implementation of quality management systems

Table 2.4Competency requirements of a tester

S.No.

Jobs done Skills needed Education needed

1. Collect samplesfrom eachmachine fortesting

1. Identify the machines2. Identify the materials3. Understand the

properties to betested

4. Decide on the samplesize

5. Identify and record theexact source ofsample in multipledelivery machines

1.

Able to read thenumbers

2. Able to understandthe codifications

3. General awarenessof the properties tobe tested

4.

General awarenessof deciding samplesize

5.

Able to identify the

delivery positions

2. Marking thesamples, recordingthe sample details.

1.

Identify the labels onsamples and signswritten on machines(Needs to have a good

eye sight)

1.

Able to read andwrite English

3. Test for therequiredparameters

1. Operating the testingequipment

2.

Checking thecalibration before

starting the test3. Handling the sampleswith out disturbing orhurting self

1.

Able to read the

standardprocedures andconduct the test

2.

Able to check thecalibration ofmaterials

3.

Understand theproperty ofmaterials, studysample handlingsystems andsafety precautions

4. Entering the datain register or in

computer systems

1.

Data entering inregisters or systems

without mistake2.

Working out the mean,deviations andhighlight the majordeviations

1. Basics of dataentry in computers

and registers2. Basic

mathematics,fundamentals ofstatistics

5. Carrying thesamples frommachine to testinglab and returningthe samples backafter testing

1. Material handling skills(Should be physicallyfit to carry thesamples)

1. Education is not amust for thisoperation

6. Submitting theresults toconcernedsupervisor or fitterfor taking action

1.

Communication skillsto explain the realdeviation and theactions needed

2.

Communicate theactions to be taken

1.

Able to read, writeand speak in thelanguage of thepeople takingaction

(Contd.)


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and from that we need to work out the quality objectives of the

product. This explains what is expected out of the product when it

reaches the customers end. Let us take some examples:

(a) Textile mill(i) Ne10scombed hosiery yarn As the name indicates the

yarn is going for knitting application, and hence the yarn

should be soft twisted and waxed. The yarn is combed

and expected to be free from kitties and neps and

imperfections should be lower. The yarn should have

sufficient strength and elongation to give a trouble free

performance. However, we do not know as to what type

of knitting machine the customer has. Now think of

socks knitting, one for baby socks and the other forsports socks. For baby socks, the comfort of wear is

more important, where as for sports socks, wear

resistance is very important. Hence for baby socks we

need to give a lower T.M. compared to sports socks.

The short-term variations in yarn looks prominent in

socks as the same yarn shall be coming again and again.

(ii) Same Ne10s combed hosiery for doubling to use in

sweaters In this case, as the doubling operation is doneat customers end, we have to give un-waxed yarn. The

short-term variations might not be critical as in the case

of socks. Uniformity in shade of yarn is very important,

as the yarns are likely to be dyed and used as an outerwear.

(iii) Ne10scombed soft twist going for candlewicks In this

case, uniformity in terms of thick and thin places are

very important, and a kitty free yarn is required. The

shade variation is not critical for this end use, and also

the strength of yarn.(b) Engineering workshop

Customer wants a shaft to be fitted to a drive. The basic

question is: how much load it is supposed to carry. On that

basis the diameter and the material is designed. The second

question is about the speed on which it has to work, on which

the bearing shall be decided. The third question shall be the

atmosphere to which the shaft is exposed, on which the material

to be used for the shaft shall be decided. The functional aspectsare very important in deciding the product objectives.

(c) Cafeteria

Food is to be prepared for 10 people for lunch. We need to be

clear as to whether they need light working lunch or heavy

lunch. The purpose for which the lunch was ordered is very


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important, i.e. whether it was a happy occasion or just a simple

gathering or lunch for people engaged in a specific official

work. The age and sex of the people coming for lunch and

their culture also have a say on the food to be served.The quality objectives of products depend on the purpose for

which it is being used. We need to work out the objectives of

the product against each product and for each customer or

contract, so that all precautionary measures are taken while

producing.

25. We need to work out the quality planfor each contract or purchase

order, which should consider the starting date and time, the machines

to work, the men to be engaged, the quality checks to be done,

completing day of the production, despatching day, the proceduresto be followed and the records to be maintained.

It should be documented and circulated to all the concerned in the

supply chain/activity. Follow up is required to ensure that the

activities are carried out as per plan. A typical quality plan can be

as below:


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Some companies give date wise break up of machineries to be allotted,

and maintain the records of production in a minusing register that

will be giving the numbers out standing as on date or shift.

26. In order to understand the real requirements relating to the product,it is needed to have a close contact with the customers and day-to-

day interactions relating to changing requirements. We need to

understand the critical requirements those affect the performance and

quality at customers end and the regulatory requirements if any. The

critical requirements depend on the type of machines the customer is

having, the working atmosphere, the work culture, the expectation

of their customers, the end use of the materials and the changes in

regulatory requirements.

27. Once we understand the requirements, we need to verify whether wecan supply the same in terms of required quality, price, delivery

schedule, after sales service requirements if any, and the regulatory

requirements specified. It is common practice to have periodic studies

of process capability and product capability so that one can then enter

into a contract with confidence of fulfilling it. This is called as

contract review. In case we are not in a position to fulfil any of the

requirements, it needs to be suitably conveyed to the customer and

get the contract amended. Similarly, if the customer needs any change,he needs to inform the supplier and get the contract amended. The

attitude of giving false assurances to get the orders can lead to

dissatisfaction of customers and finally they shall go away from us.

Customers believe in what they got and not on what you assured.

28. We need to have facilities and systems for an effective communication

with customersrelating to the product information, changes in market

positions, performance of our materials at customers end, actions

taken on complaints and feedbacks, the information required by

customers relating to product features offered by us, the contractsand the production schedules, likely delivery positions, payments,

etc. This shall reduce confusions and complaints, and help in building

a good relationship so that we can have long-term association.

The present day trend is to give free access to the customer to the

ERP systems implemented so that they can see the position of their

orders on line. Some companies have even given the test results online

to the customers.

29. Once the product requirements are clear, we need to design anddevelop the product so that it suits the exact requirements of the

customers. Some manufacturers say that they do not design the

products, as they are making only standard items as per customers

designs. But if we see in detail, we need to do some changes

depending on the raw material properties, seasonal changes, changes


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in the machinery configuration, etc., even though the basic

specifications remain unchanged. Further, depending on the

production requirement, we need to select the raw materials, change

the speeds, settings, timings and temperatures etc., which are all apart of product design.

For designing we need to consider the inputs like the customer

requirements, the availability of raw materials, the type and condition

of the machinery we have, the regulatory requirements, the

competency of people working, etc. The designer should have the

complete knowledge of the risks involved and the way in which the

material is likely to be handled at the customers end. He should also

have the knowledge of the process capability of his factory and a

sound knowledge of statistical quality control to draw inferences fromthe data obtained while conducting trials.

The design should give information relating to the requirement of

raw materials and spares, the process parameters to be adopted, the

modifications in the machines required, the quality levels achievable,

the controls required, safety precautions required, the cost of

manufacture, the risks involved and the training required to be given

to the employees.

30. The designs need to be verified to ensure that the assumptions andcalculations are correct, reviewedto predict the problems the product

can pose to the organization as well as to customers if manufactured

in bulk, validatedby making prototype samples to ensure that the

product meets the customer requirements, documentedso that there

are no lapses while implementing in a large scale, and controlled

from being leaked till the process of design is complete and given

for regular manufacturing while ensuring that the design does not

reach the wrong hands which can harm the companys interests. It is

a normal practice in number of companies, especially where largebrand owners are purchasing the materials, the samples from the

development stage as well from the materials being manufactured

are validated by the customer.

31. Once the design is clear, the materials could be procured to start the

production. We need various types of materials, like raw materials,

spares, packing materials, lubricants, capital equipments, etc. If we

need the quality as per our expectations, and the costs as calculated,

we should purchasematerials from such suppliers whom we feel ascapable and reliable for supplying materials as per our requirement.

Hence we need to select vendors and periodically review their

performance and ensure that they are suitable to meet our

requirements. For vendor rating, we can make use of IS 12040:2001

by giving suitable weightage for critical factors like quality, price,


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delivery, service, approachability, etc. The weightage given are to be

decided item wise considering its importance in manufacturing and

in achieving the quality level. The cost factor and the space for storage

is also a point of consideration. For example, for precision spareparts, the weightage for quality shall be very high compared to price

and delivery, whereas for packing materials, the delivery schedule

becomes more important. Following Table 2.5 gives an idea of giving

weightage

Effective Implementation of Quality Management Systems (0857090011)

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