Quality System Basics Section 1

Quality System Basics

Section 1

ISO Survey (As of December 2007)

• At least 9,51,486 ISO 9001:2000 certificates had been issued in 175 countries and economies

• Out of the top ten countries China ranks first with 2,10,773 certificates

• Italy, Japan and Spain follow • India ranks fifth with 46,091 certificates • Followed by Germany, U.S.A., U.K., France

and Netherlands with 18,922 certificates

The DEMING PDCA Cycle

Support Processes

Customers

Schematic Representation of Process Approach

inputs outputs

•Top management processes - planning, allocation of resources, management review, etc.•Realization processes - customer related processes, design and development, product realization, etc.•Support processes - training, maintenance, etc.

Customers

Top Management Process

REALISATION PROCESSES

A B C

Model of Process based Quality Management System

Continual Improvement of the quality management system

ProductProduct

Realization

ManagementResponsibility

ResourceManagement

Measurement, Analysis &

Improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

58

7

6

4

PLAN

D0

CHECK

Application of PDCA Cycle

• The ultimate aim of any management system is continual improvement of its performance

• To achieve this, Deming’s PDCA cycle of improvement is interwoven in the structure ISO-9001:2008 as illustrated in the next slide

• Plan – Do – Check - Act

ACTImplementation of

improvement( Clause 4.1f )

PLANIdentification of

sequence, interactioncriteria & methods( Clause 4.1 a,b,c )

CHECKMonitoring,

Measurement& Analysis

( Clause 4.1e)

DOImplementation of

the planning( Clause 4.1.d)

PDCA Cycle applied to ISO 9001:2008 clause 4.1

Deploying Quality Improvement Process

Continual improvement process of Quality Management System can be deployed throughout the organization by undertaking PDCA activities at various levels

Department/Section Heads

PLAN• Establish procedures and instruction for

departmental activities• Define responsibilities• Establish objectives• Plan resources including training of personnel• Establish communication channel for

instructions and feed-back

Department / Section Heads

DO

• Allocate clear responsibilities• Provide resources and support• Coordinate and harmonize activities• Resolve problems

Department/Section Heads

CHECK

• How is my department doing?• Are processes under control?• What are my employees telling me?• Are we meeting customer requirements?• Am I meeting my objectives?• What are the key problems in my area?• How can we improve?

Department / Section Heads

ACT

• Systematic problem-solving (based on importance, risks involved etc)

• Develop action plans• Concentrate on improvement (incremental or

“breakthrough” improvements)• Review existing procedures, and need for new

procedures

Quality Systems and Standards Development

Section 2

Quality Misconceptions

• Quality means expense• Quality Systems are expensive nice to haves• Good Quality is high specification• Quality Control about testing and checking• Quality is the responsibility of the Quality

Department• Quality comes from Inspection

Prevention vs. Detection• Inspection was once considered the normal means

of attaining quality• Inspection has been proved to be expensive as it is

always performed after the problem has occurred• Inspection does not always find all the faults and

there is a risk that faulty items can be received by the customer

• As there is always a delay between the problem happening and the inspection it means that many more faulty items can be produced at cost

Prevention vs. Detection …contd.

• Quality planning is carried out to plan exactly how consistent quality can be achieved

• Quality planning is less expensive as it involves a few peoples’ time and does not tie up the production line equipment and staff or waste materials

• Controlling suppliers and getting them to ensure the quality of the supplies is cheaper and more reliable than inspection

• Training of staff in understanding the processes they operate and control is more efficient than employing inspectors

Control of ProcessesWe control processes by controlling the inputs into the processes rather than inspecting the outputs• People – By training or qualification• Materials – Control of suppliers and

specification• Methods – By procedures & standards• Machines – By maintenance systems• Environment – By organisation and care

Process Approach

• Process – Set of interrelated or interacting activities which transforms inputs to outputs

• Product ( Service ) – Result of a process• Outputs of one process may be inputs into

another process• Control the inputs to ensure outputs meet

requirements• Analyse and review for continual Improvement

8 Principles of Quality1. Customer Focus2. Leadership3. Involvement of People4. Process Approach5. System Approach to Management6. Continual Improvement7. Factual Approach to Decision Making8. Mutually Beneficial Supplier Relations

1. Customer Focus

• Understand current and future customer needs and expectations

• Plan to meet customer requirements and exceed expectations

• Clause 5.2 requires that Top Management shall ensure that requirements are determined and are met to enhance customer satisfaction

2. Leadership

• Leaders establish unity of purpose and direction of the organisation

• Leaders shall create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives

3. Involvement of People

• People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation's benefit

4. Process Approach

• A desired result is achieved more efficiently when activities and related resources are managed as a process

• People, Machines, Methods, Materials and Environment are the classic inputs

• Consistent inputs produce consistent outputs

5. System Approach to Management

• Identifying, understanding and managing interrelated processes as a system contributes to the organisation’s effectiveness and efficiency in achieving its objectives

• Outputs of one process are often inputs into the next process

• Materials and information flow through systems, the smoother the flow, the greater the efficiency

6. Continual Improvement

• Continual improvement of the organisation’s overall performance should be a permanent objective of the organization

• This shall be planned and managed throughout the whole organization

• No one and no system is ever perfect• There is always room for improvement

7. Factual Approach to Decisions

• Effective decisions are based on the analysis of data and information

• Methods and measures planned• Data needs to be gathered factually,

independently and without bias• Information needs to be communicated in a

usable format to decision makers

8. Mutually Beneficial Supplier Relationships

• An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value

The Quality Approach

• Prevention should take place before the problems arise

• It is cheaper and more effective to run preventive systems than to run inspection based systems

• Preventive measures include planning activities carefully analyzing inputs and outputs, training, writing and implementing procedures, and auditing the activities

History of Quality Standards• US Military Standards• AQAP Standards• Motor Industry Standards• BS 5750 : 1979• ISO 10000 series• ISO 9000 : 1987 Series of Standards• ISO 9000 : 1994• ISO 9000 : 2000• ISO 9000 : 2008

Standards and Guidelines

• Standards regulate requirements that shall be met – ISO 9001

• Standards can be used to harmonise requirements or terms – ISO 9000

• Guidelines Documents – ISO 9004, ISO19011 Complement the Standards

Standards Development• National, European and International Standards

are produced on a consensus basis by committees and sub committees

• ISO TC 176 is responsible for quality management and quality assurance standards

• The ISO 9000 series are designed for international standardization of quality, environmental and health and safety management system standards

• Standards are reviewed for possible change every 6 years and the ISO 9000 – 2000 standards will continue to be reviewed and further developed

ISO 9000 Series Quality Management Systems Standards

1. ISO 9000:2005 –Fundamentals and vocabulary

2. ISO 9001:2008 – Requirements3. ISO 9004:2000 – Guidelines for

performance improvements4. ISO 19011:2002 – Guidelines for

Quality and /or Environmental Management systems Auditing

ISO 9000 : 2005Fundamentals and Vocabulary• Explains the Quality Management System

approach• Eight Quality Management Principles• Quality Policy and Objectives• Processes and responsibilities• Measurement methods and application• Means to prevent nonconformities• Applying process for continual improvement• Definitions

ISO 9001 : 2008 Quality Management Systems -

Requirements

• Specifies requirements for a QMS where an organization needs to demonstrate its ability to provide products/services that fulfill customer and regulatory requirements

• Requirements are generic and applicable to all products/services in all sectors of business

ISO 9004 : 2000 Guidelines for performance

improvements

• Provides guidance that consider both the effectiveness and efficiency of the Quality Management System

• Aimed at improvement of performance and satisfaction of customers and interested parties

• Used with ISO 9001 as a consistent pair of standards

ISO 19011:2002Guidelines For Quality and /or Environmental Management

Systems Auditing

• Principles of Auditing• Managing an Audit Programme• Audit Activities• Competence and Evaluation of Auditors

ISO 9000 : 2005 Definitions• Quality – Degree to which a set of inherent

characteristics fulfils requirements• Quality Management – Coordinated activities to

direct and control an organization with regard to quality

• Quality Management System – Management system to control and direct an organization with regard to quality

• Quality Policy – Overall intentions and direction of an organization related to quality as formally expressed by top management

ISO 9000 : 2005 Definitions … contd 2• Quality Control – part of quality management focused

on fulfilling quality requirements• Quality Assurance – part of quality management

focused on providing confidence that quality requirements will be fulfilled

• Quality Improvement – part of quality management focused on increasing the ability to fulfill quality requirements

• Supplier – Organization or person that provides a product

• Customer – Organization or person that receives a product

ISO 9000 : 2005 Definitions ..cont 3

• Audit - Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled

• Audit Criteria – Set of policies, procedures or requirements

• Audit Evidence – Records, statements of fact or other information which are relevant to the audit criteria and verifiable

• Audit Findings – Results of the evaluation of the collected audit evidence against audit criteria

Permissible Exclusions

• ISO 9001 Clause 1.2 Application• Permissible reductions of scope limited to

exclusions related to clause 7 - Product Realization and that such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements

• Exclusion shall be stated in the quality manual

ISO 9001 Clause 7 Product Realization

1. Planning of product realization2. Customer related processes/communications3. Design and Development4. Purchasing5. Control of production and service provision,

Validation of Processes, Identification and traceability, Customer property, Preservation of product

6. Control of monitoring and measuring equipment

Statement of Scope

• Scope of application should relate to the management of the organization, the site or sites, the activities covered and the standard used stating exclusions

• Conformity to the ISO 9001: 2008 standard cannot be claimed if exclusions are other than those in clause 7

The Benefits of ISO-9000

1. Organisation focus on "how they do business". Each procedure and work instruction must be documented and thus, becomes the springboard for Continuous Improvement.

2. Documented processes - basis for repetition - help eliminate variation within the process - efficiency improves - cost of quality is reduced.

3. With the development of solid Corrective and Preventative measures, permanent, company-wide solutions to quality problems are found.

The Benefits of ISO-9000 ….2

4. Employee morale is increased as they are asked to take control of their processes and document their work processes.

5. Customer satisfaction and customer loyalty grows. Company transforms from a reactive organization to a pro-active, preventative organization. It becomes a company people want to do business with.

6. Reduced problems resulting from increased employee participation, involvement, awareness and systematic employee training.

The Benefits of ISO-9000 ….3

7. Better products and services result from Continuous Improvement processes.

8. Fosters the understanding that quality, in and of itself, is not limited to a quality department but is everyone's responsibility.

9. Improved profit levels result as productivity improves and rework costs are reduced.

10. Improved communications both internally and externally which improves quality, efficiency, on time delivery and customer/supplier relations.

Delight

Performance

Basic

NeedsFully

Implemented

Delighted

Disgusted

NeedsAbsent

Customer Quality Perceptions – Kano Model

Product Function

Customer Satisfaction

Key Elements of Quality Management Systems

Section 3

Role of Management

• Demonstrate Commitment• Policy and Objectives• Motivation and environment• Customer focus• Provision of resources• Monitoring and review• Decisions and improvement actions

Quality Policy• Appropriate to the Organization’s purpose• Commitment to meet requirements and to

continual improvement• Provides framework for setting objectives• Communicated and understood at

appropriate levels• Reviewed for continuing suitability• Shall be controlled

Quality Policy

ITI is committed to provide Competitive & Reliable Products, Solutions and ServicesITI will achieve this through:

• Sound Quality Management Systems• Empowered Human Resources• Innovation

Continual Improvement, Mutual Respect and Customer Delight will be our guiding philosophy

Date: 05/05/2007 (PRITAM SINGH)Bangalore Chairman & Managing Director

Quality Policy - an example

• It is the policy of the Sheng Corporation to provide products and services to meet our customers expectations. We review and react to customers requests without delay. To do this everyone should operate the quality system to ISO 9001 requirements and actively strive for improvement. We consider and continually review our systems at all organizational levels

Quality Policy - Better• It is the Policy of Sheng Corporation to provide

catering products and services that exceed customer expectations. We shall react to customers requests without delay and provide planned professional services to all our customers. Everyone shall operate to the ISO 9001 quality system requirements and contribute to actively improving our performance. We shall continually review and improve our systems at all organizational levels

Quality Objectives

• Top Management shall ensure objectives are established at relevant function and levels

• Shall be MEASURABLE and consistent with the Quality Policy and the commitment to continual improvement

• Shall include those needed to meet requirements for product

Example of Quality Objectives

• Reduction in product defects to below 1%• Zero defects leaving the company• Reduction in material wastage• Reduction in order processing time• Reduce delivery times for main product lines• Next day delivery for orders before 2 pm• Improve MTBB for production line equipment

Quality Objectives

• Objectives should be aimed at improving the QMS

• Shall be measurable and measured• Shall be communicated and involve

people at all levels and functions• May also involve the supply chain• Shall be planned actions recorded and

reviewed by Top Management

Documentation

• Requirements in ISO 9001 : 2008 allow more flexibility

• Only 6 procedures required by the standard• Requires a Quality Manual• Requires that processes are identified and

described and responsibilities and authorities assigned

• Quality System should be planned• Cannot write NCR’s for absence of procedures

for processes

Procedures

Procedures required by the standard are –

1. Document Control2. Control of Quality Records3. Internal Audit4. Control of Non-conformity5. Corrective Action6. Preventive Action

DOCUMENTS and RECORDS

• A document is something that gives you information or instruction to do something

• It comes BEFORE THE EVENT• A record is evidence that the event took

place• It comes AFTER THE EVENT

Types of Documents• Quality Manuals• Flow Chart and Process maps• Procedures, Plans and Instructions• Drawings• Computer Programmes or Instructions• Actual Samples• Forms• Standards or Specifications, Contracts• Reference materials, charts, tables etc

Documentation Value

• Achieving the required quality• Evaluating the quality system• Quality Improvement• Maintaining Improvements• Demonstrating the quality system to

customers and potential customers

Possible Problem Areas• Can a stage 1 review be done off site• To what extent do processes need to be

documented• If they have a policy, objectives, flowchart of

processes, organization chart and 6 procedures required by the standard is it acceptable

• What records are needed to provide evidence that processes and products met requirements

• What if the objectives have not been meet

Analysis of Data

• Clause 8.4 requires Analysis of Data• Customer satisfaction, Communication• Conformance to customer requirements• Characteristics of products, processes

and trends. Decisions based on facts• Supplier performance. Relationships• Market and interested party needs

Corrective Action

• Reaction to problem that has occurred• Customer complaints• Rejects, internal failures• Mistakes and misunderstanding• Internal Wastage• NCR reports including audits• Outputs from data analysis

Preventive Action

• Use of Quality Tools• Actions before a problem arises• Identify potential nonconformity causes• Identify and implement actions• Record results• Review for effectiveness• Again records can be used to demonstrate

continual improvement

Preventive Actions

Sources of information –• Customer needs and expectations• Market Analysis, satisfaction measures• Process and product measures• Internal Audit and Management Review• QMS records• Service Records, Financial Analysis

Customer Satisfaction

• Shall monitor customer satisfaction• Methods for obtaining and using• Information on customer satisfaction

should input to all processes• Information from a variety of sources• Customer surveys, questionnaires,

meetings, visits, complaints, feedback from dealers and agents, and market

Internal Quality Audits

• Conducted for improvement not just compliance

• Auditors and auditees work together to identify opportunities for improvement

• NCR’s are negative• Results should be reviewed

Management Review• Conducted at planned intervals by Top

Management to ensure continuing suitability and effectiveness

• Review process performance and capability, corrective and preventive actions, objectives, customers’ requirements and satisfaction, internal audits and performance of QMS

• Look for opportunities for improvement and needs for change ( policy and objectives )

• Review and act on facts

Continual Improvement

• To increase the effectiveness of the QMS in meeting the policy and objectives of the organization

• Objectives need to be set and the organization must plan to achieve these objectives

• Continual improvement planned and implemented

• Reviewed by Top Management

Continual Improvement …cont

• An improvement process requiring progressive improvement and consolidation steps

• Should anticipate and focus on the growing and changing needs and expectations of the customer

• Should be measurable and measured• Use factual objective measures• Top Management should lead, plan, provide

resources and encourage

Possible Problem Areas• How much evidence of improvement• What if quality is decreasing? Major NCR• Is a telephone call and tick list enough• How often should the customer satisfaction be

reviewed• What is a ‘suitable’ method for monitoring a

process• Which functions or activities need a corrective

action procedure• Lack of communication and understanding

ISO 9001 : 2008 Quality Management Systems -

Requirements

Section 4

General

8 Clauses Describe the Process Model1. Scope 2. References 3. Definitions4. Quality Management System5. Management Responsibility6. Resource Management7. Product Realization8. Measurement Analysis and Improvement

1. Scope

States requirements for an organization to –• Demonstrate its ability to consistently provide

product that meets customer and applicable statutory and regulatory requirements, and

• Enhance customer satisfaction by effective application of the system, including processes for continual improvement and the assurance of conformity to customer and applicable statutory and regulatory requirements

1.2 Application

• Permissible reductions of scope limited to exclusions related to clause 7 Product Realization and that such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements

ISO 9001 Clauses 2 & 3

2. Normative Reference – ISO 9000 : 2005, Quality Management Systems – Fundamentals and Vocabulary

3. Terms and definitions Product also means service

4 Quality Management System4.1 General Requirements

Shall establish, document, implement, maintain and continually improve QMS

a) Shall identify the processes neededb) Determine the sequence and interactionc) Determine criteria and methodsd) Ensure resources & information availablee) Measure, monitor and analyse processesf) Implement actions to achieve plans and

continual improvementControls over outsourced processes

4.2 Documentation Requirements4.2.1 General

• Documented Quality Policy and Objectives• Quality Manual• Documented procedures required by this

standard• Documents including Records to ensure

effective planning, operation and control of processes

Note – Documentation can be in any form or medium

4.2.2 Quality Manual

The Organisation shall establish and maintain a quality manual that includes –

• Scope and justification for exclusions• Documented procedures or reference• Description of interaction between

processes of the QMS

4.2.3 Control of Documents

Procedure to define controls –• Approval prior to issue• Review and re-approval• Changes and status identified• Documents available at point of use• Legible and identifiable• External documents identified, and controlled• Prevent unintended use of obsolete docs

4.2.4 Control of Records

• To provide evidence of conformity and effective operation of QMS

• Legible, readily identifiable, retrievable• Procedure to define controls for storage,

identification, protection, retrieval, retention and disposition

5. Management Responsibility 5.1 Management Commitment Top Management shall demonstrate commitment to

development, implementation and improvement of the QMS by –

• Communicating the importance of meeting customer and legal requirements

• Establishing Quality Policy and objectives• Conducting Management Reviews• Ensuring availability of resources5.2 Customer Focus Top Management shall ensure customer

requirements are determined and met with the aim of enhancing customer satisfaction

5.3 Quality PolicyTop Management shall ensure that theQuality Policy –

• Is appropriate• Includes a commitment to meet requirements

and continually improve effectiveness• Provides a framework for objectives• Is communicated and understood• Reviewed for continued suitability

5.4 Planning

5.4.1 Quality Objectives• Top Management shall ensure that objectives

are established at relevant levels and functions. Objectives shall be measurable and consistent with Policy

5.4.2 Quality PlanningTop Management shall ensure that the –• Planning carried out to meet requirements and

quality objectives• Integrity of the system is maintained and

changes are planned and implemented

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

Responsibilities and authorities and their interrelations are defined and communicated

5.5.2 Management Representative Top Management shall appoint a management

member who shall have responsibility and authority for

• Ensuring that processes of the QMS are established, implemented and maintained

• Reporting to top management performance and need for improvement

• Promoting awareness of customer requirements throughout organization

5.5.3 Internal CommunicationShall ensure appropriate communication processes are established and takes place

5.6 Management Review5.6.1 GeneralTop Management shall review the QMS at planned intervals to ensure continuing suitability, adequacy and effectiveness. Shall review need for changes to the system, policy or objectives

5.6.2 Review Input• Audit results and customer feedback• Process reports + conformity analysis• Status of preventive & corrective actions• Actions from prior reviews. Changes• Recommendations for Improvement

5.6.3 Review OutputOutputs from the review shall include actions related to

• Improvement of the effectiveness of the QMS and processes

• Improvement of product related to customer requirements

• Resource needs

6. Resource Management6.1 Provision of ResourcesThe organisation shall provide resources needed to•Implement and maintain the QMS and continually improve its effectiveness

•enhance customer satisfaction by meeting customer requirements6.2 Human Resources6.2.1 General Personnel performing work affecting quality shall be competent on the basis of appropriate education, training, skills and experience

6.2.2 Competence awareness and training

• Determine competency needs• Provide training or take other actions to

satisfy these needs• Evaluate effectiveness of actions taken• Ensure that employees are aware of the

relevance and importance of activities and contribution to meeting objectives

• Maintain records

6.3 Infrastructure• Determine and maintain infrastructure to

achieve conformity to requirements –• Buildings, Workspace and Utilities• Equipment, hardware and software• Supporting services6.4 Work Environment Determine and manage the work

environment to achieve conformity

7. Product Realization7.1 Planning Product RealizationPlan and develop processes & determine – • Quality objectives & requirements for product • Need for processes, documents, and provide

resources• Verification, validation, monitoring and test

activities, and criteria for acceptance• Records to provide evidence of conformity• Outputs shall be in a suitable form

7.2 Customer – related processes

7.2.1 Determination of requirements related to the product

The organisation shall determine requirements• Specified by the customer including delivery

and post delivery• Not specified by the customer but necessary for

intended use• Statutory and regulatory requirements• Any others

7.2.2 Review of Requirements Related to the Product

Review the identified needs before commitment to supply – ensure that

• Product requirements are defined• Requirements differing from those previously

expressed are resolved• Requirements can be met• Records of reviews and actions kept• If requirements change, documents change &

personnel shall be made aware of changes

7.2.3 Customer Communication

Determine and implemented plans for customer communications relating to –

• Product Information• Enquiries, contracts or order handling

including amendments• Customer feedback and complaints

7.3 Design and Development7.3.1 Design and Development Planning

Plan control design and development – include• Stages of design and development• Review, verification and validation activities• Responsibilities and authorities for activitiesInterfaces managed to ensure clarity of communication and responsibilities

Planning output updated as appropriate

7.3.2 Design and Development Inputs

Requirements recorded and include – • Function and performance requirement• Applicable statutory and regulatory

requirements• Information derived from other similar designs

and any others needed• Review for adequacy, incomplete, ambiguous

or conflicting requirements resolved

7.3.3 Design and Development Outputs

• The outputs shall be recorded in a format that allows verification v inputs. Output documents reviewed & approved

• Design output shall –• Meet input requirements• Provide information for purchasing, production

and service provision• Contain or reference acceptance criteria• Specify characteristics essential to safe and

proper use

7.3.4 Design and Development Review

Formal reviews conducted as per plans to –• Evaluate capability to meet requirements• Identify problems and propose necessary

actionsParticipants to include representatives of

functions concerned with stages for reviewResults of design reviews and follow up actions

shall be recorded

7.3.5 / 6 Design and Development Verification / Validation

• Verification shall be planned and carried out to ensure outputs meet inputs

• Record results of verification and actions• Validation shall be performed to confirm

product / service is capable of meeting the needs of specific customer use

• If possible performed before delivery• Record results of validation and actions taken

7.3.7 Design Changes

• Changes shall be identified and recorded, and shall be reviewed, verified, validated and approved by authorized personnel before implementation

• Consider effects between elements and interaction between constituent parts and product already delivered

• Record review of changes and actions

7.4 Purchasing7.4.1 Purchasing Process

• Shall control purchasing processes to ensure conformance to requirements

• Type and extent of control depends on the effects on processes & final product

• Shall evaluate and select suppliers based on ability to meet requirements

• Criteria to be established• Results and actions recorded

7.4.2 Purchasing Information

Purchasing information shall describe the product to be purchasedMay include –• Requirements for approval of product, procedures, processes, and equipment• Requirements for qualification of personnel• Any system requirementsShall ensure adequacy prior to release

7.4.3 Verification of Purchased Product

• Shall establish and implement plans for verification of product / services

• Where verification is performed at the suppliers’ premises shall specify the verification requirements and method of release in purchasing documentation

7.5.1 Production and Service Provision

Shall control operations through –• Availability of product information• Availability of work instructions• Use of suitable equipment• Suitable working environments• Availability and use of inspection, measuring

and test devices• Monitoring and measurement activities• Release, delivery, post – delivery activities

7.5.2 Validation of ProcessesShall validate processes where output not verified

by monitoring and measurement. Includes faults appearing after delivery

Validation shall be planned and include –• Defined criteria for review and approval of

processes• Approval of equipment & personnel• Use of specific methods and procedures• Requirements for records & re – validation

7.5.3 Identification & Traceability

Where appropriate –• Identify status of product with respect to

monitoring and measurement requirements

• Where tractability is required shall control and record the unique identification of the product

7.5.4 Customer Property

• Exercise care with customer property• Identify, verify, protect and safeguard

customer property for use or inclusion• Any product or property lost, damaged

or unsuitable for use shall be recorded and reported to the customer

Note – May include intellectual property and personal data

7.5.5 Preservation of Product

• Shall preserve conformity of product during internal processing and delivery to intended destination

• Shall include identification, packaging, storage, handling and protection

• Applies to constituent parts of a product

7.6 Control of Monitoring and Measuring Equipment

• Shall determine monitoring and measurement equipment to be used to provide evidence of product conformity

• Establish and implement measurement processes to enable needs can be met

• Assess validity of previous inspections• Initiate actions if found out of calibration• Software shall be confirmed

Calibration

• To ensure valid results –• Calibrate at specified intervals or prior to use• Traceability to national standards• Adjusted as necessary• Identify to show calibration status• Safeguard against adjustment• Be protected from damage or deterioration

8 Measurement Analysis and Improvement

8.1 GeneralPlan & implement measurement monitoring,

analysis and improvement• To demonstrate conformity of product• Ensure conformity of QMS• Continually improve effectiveness of QMSIncludes determination of methods and extent of

use also Statistical Methods, Quality Tools to analyse data to bring about improvement

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction• Shall monitor information relating to

customer perception as to whether their expectations have been met

• Methods for obtaining and using this information and data determined

8.2.2 Internal Audit• Audits to determine if system is effectively

implemented and is current• Planned based on status and importance and

previous results• Define audit criteria, scope, methods, frequency• Auditors to be independent• Responsibilities for planning and conducting

audits and records defined in a procedure• Management shall ensure corrective actions taken

without undue delay• Follow up actions including verification and

reporting of results• See ISO 19011 for guidance

Measurement of Processes / product

8.2.3 Shall apply suitable methods for measurement of processes to meet customer requirements

• Results shall be used to determine opportunities for improvement

• If planned results not achieved must take corrective action

8.2.4 Monitor and Measure product at appropriate stages to verify product requirements met

• Evidence of conformity with criteria maintained• Records of authority for release

8.3 Control of Nonconforming Product• Shall ensure nonconforming product is

identified and controlled to prevent inadvertent use or delivery. Controls, responsibilities and authorities shall be defined in procedures

• Shall take actions to eliminate problem or authorize release by relevant authority, or take action to preclude its use

• Records of the nature of nonconformities and actions taken including concessions kept

• If product is corrected must be re – validated• If problem after delivery must take actions

8.4 Analysis of Data

Analyse of data for improvements –• Suitability and effectiveness of QMS• Process operation trends• Customer satisfaction• Conformity to requirements• Characteristics of process, product and

opportunities for preventive actions• Suppliers

8.5 Improvement

8.5.1 Shall continually improve effectiveness of QMS

8.5.2 Corrective Action – to eliminate causes of nonconformity

Procedure to define requirements for –• Reviewing nonconformities• Determining causes and need for actions• Determine, implement and record actions• Review actions taken

8.5.3 Preventive Action

Process for eliminating potential causes to prevent occurrence

Documented procedure to define –• Determination of potential problems and

causes• Evaluation of need for action• Determine and implement actions• Record results of actions taken• Review actions taken

Audit Preparation

Section 5

Audit

Definition – A systematic, independent and

documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled

CERTIFICATION

The act of formally recognizing that an organization’s management system conforms to specified published management system standards and any supplementary documentation required under the system

CERTIFICATION BODY

Definition – A third party that audits and Certifies or

Registers the quality system of an organization with respect to published quality system standards and any supplementary documentation required under the system

ACCREDITATION

Definition – The act of formally recognizing the

system and competence of a certification body as meeting the requirements of the published accreditation standard.

Audit Principles

• Independence of Auditors• Detailed Effective Planning• Competence of Auditors for the Audit• Records of Objective Evidence• Integrity – Confidentiality• Auditors Code of Conduct

Reasons for Audits

• To determine conformity to requirements• To determine effectiveness of the system• For improvement of the system• To meet regulatory requirements• To meet contract requirements• To gain registration for marketing and

customer assurance purposes

Reasons for Auditing• To determine the effectiveness of one’s own system. (1st Party)• To evaluate a supplier. (2nd Party)• To determine the effectiveness in meeting

contract requirements• To verify (continued) conformity for

registration purposes. (3rd Party)• To improve business efficiency

Audit Types

• Improvement. (includes consultancy)• Management System• Regulatory Compliance• Product• Internal – 1st Party• Supplier – 2nd Party• Independent – 3rd Party

Audit Types …contd 2

• Compliance Audits – For compliance with a specific requirement – Legal

• May be regulations, contracts, industry standards or agreed procedures

• Conformance Audits – For conformance with management systems or other standards

• Product Audits – Made on the product itself and the components and processes associated with it

Audit Types …contd 3

• 1st Party – Internal audits of business system

• 2nd Party - Supplier Audits• 3rd Party - Independent or

Certification Audits

1st Party Audits

• Auditors – Own Staff• Beneficiaries – Audi tees / our company• Style – Can be relaxed and friendly• Planning – Less demanding as systems

and locations already known• Depth – Areas audited in detail• Follow up – fairly simple – own company

2nd Party Audits

• Customer audits supplier with their staff• Beneficiaries – Supplier and Customer• Style – Can be very formal or informal

depending on whether the contract is at stake or whether for improvement

• Planning – depends if new supplier• Depth – Detail depends on the contract• Follow up – depends on contract

3rd Party Audits

• Auditors – Independent• Beneficiaries – Company• Style – Formal according to procedures• Planning – Done in detail to procedures• Depth – Sufficient to check compliance

and effectiveness• Follow up – CA always checked

Overview• Initiating the Audit• Information gathering• Documentation Review• Preparation for audit• The on site implementation Audit• Audit Reports and Records• Corrective Action• Follow up activities

Terms

• Audit Team – Team Members• Auditor – Competent to conduct audits• Lead Auditor – Team Leader• Auditee – Company Audited• Audit Plan – Prepared by Team Leader• Audit Programme• ISO 9001 : 2008 – Audit Standard• ISO 9004 : 2000 – Audit Guidance

Auditing Organization

• Determines Audit Scope and objectives• Selects the Team Leader• Provides Audit Team Resources• Determines competence of Auditors• Ownership of the audit report• Controls follow up action

Responsibilities – Lead Auditor• Determine the scope and objectives• Obtain background information• Conduct Documentation Review• Select and assign audit team members• Prepare the plan including date and duration• Representing the team at all stages including

Opening and Closing Meetings• Resolution of any problems arising• Evaluation of Evidence and Results Reporting• Prepares and presents the report makes

recommendations, and follow up, reports findings and recommends actions

Responsibilities - Auditor

• Competent to conduct the audit• Prepare checklists• Conduct audits according to audit plan• Communicate with Auditees and Team• Record and report observations clearly• Safeguard audit documents• Follow protocols and plans• Check on Corrective Actions if required• Confidentiality – Code of Conduct

Responsibility - Auditors

• Keep within the agreed scope• Carry out assigned tasks• Work objectively• Collect and analyse evidence• Remain alert• Act in an ethical manner• Support the Audit Team Leader

Responsibility - Auditees

• Assist auditors by supplying information and documents as requested

• Answering questions• Making themselves available at the

appropriate times• Providing facilities as agreed• Guide the auditors where to go

Auditees Management

• Inform all employees about audit scope and objectives of the audit

• Provide resources and facilities• Supply guides• Provide information and supply documents• Provide access• Ensure Auditee cooperation• Take corrective action

Initiation• Client sets the scope of the audit considering

permissible exclusions• May consult Lead Auditor or registration body• Questionnaire or application data reviewed

along with any other data and industry guides• LA reviews written documentation for

conformance with the standard and policies done on site to review the QMS processes

• Reports findings of document review

Initial Document Review• Performed to determine the state of readiness• Preliminary on site visit may be made to gather

further information to plan the audit• Identify key areas and technical expertise and

exclusions as allowed by the standard• Compliance with the audit standard and

applicable legislation is assessed. Usually done on site to view coverage of processes

• Deficiencies are reported for corrective action• An audit programme should be in operation• Management review must be completed

Preparation

• Who, When & Where• Objective and Scope• Methods, Procedures & working documents• Identification of key staff to interview• Identification of units to audit• Decide on key and priority areas• Produce an audit plan• Pre-Audit Visit to the organization if feasible

Preparation …Contd

• Selection of Team Members• Must ensure competence of team• Standards and reference documents• Language and experience in the culture• Lunches and other requirements• Shift changeovers, breaks, prayer times• Timing and Meeting Schedule• Report Process Format and Confidentiality• Record retention

Audit Plans and Audit Programmes

• Audit Plan is a detailed time schedule for who will conduct what activities for a single audit

• Usually produced by the Lead Auditor from the flowcharts, quality manual or organization charts provided by the auditee organization

• Sent to auditors and auditees• Audit Programme is the schedule of audit

activities for a single organization over a defined period

• Required for all types of audits

Audit Plan• Prepared from business documented system• Identify all the key processes and activities and

allocate the time to audit• Link related processes and activities• Consider how the 8 principles are applied• Allocate the activities to the team• Balance the auditing times with key areas of

importance and start and finish of operations• Compatible with auditees operating practices

Checklists

• Checklists guide the auditor through the audit and to cover all the main points

• Checklists usually consist of bullet points• Normally prepared from a process flow map

added to by relevant clauses of the ISO 9001 standard and the application of 8 principles

• Should cover both horizontal & vertical issues• Useful as a record of the topics covered as

auditors can put comments against each point• Remember objectives / continual improvement

Process Auditing

Section 6

Auditor Selection

• Auditors shall be selected with regards to their knowledge and experience plus availability

• They shall also be selected on their ability to interact with the other members of the team and the auditees

• Technical experts and translators may be required to assist the auditors

• Balance costs with needs of the audit

Auditor Qualities• Good listener• Note taker• Communicator• Fair• Knowledgeable• Systematic• Patient• Punctual

• Observant• Logical• Polite• Assertive• Independent• Confident• Diplomatic• Persistent

Undesirable Avoidable

• Easily lead• Unsure• Aggressive• Careless• Opinionated

• Unprepared• Demanding• Unpunctual• Inconsistent• Poor record

keeper

On Site Audit Stages

• Opening Meeting• Examination and evaluation• Team Meeting• Agreement of results• Closing Meeting• Reporting• Recommendation• Follow up

Opening Meeting

• Lead Auditor Chairs Meeting• Introduce both sides• Team contribute as directed by Team

Leader• Time wasting is avoided• Keep it short & relaxed• Give yourself more time than you think

you will need

Opening Meeting Agenda• Introductions• Record attendees• Agree scope & objectives• Confirm the audit plan• Method of conduct of audit• Confirm auditee co-operation• Establish lines of communications• End of Day briefings• Promote auditees participation in audits

Opening Meeting Agenda …contd

- Reporting Procedure and Closing Meeting- Confirm the Lunch arrangements- Confirm any resources requested• Role of Guides• Conduct of the Audit• Health and Safety Issues• Access to facilities• Private Room for Team Discussions• Any questions

Guides• Guides are requested and made available to

assist the auditors to go to the places as easily and as quickly as possible

• They must not interfere or interrupt the audit and must only answer questions when asked

• If they do not follow this they should be politely reminded of their role

• If they need to leave temporarily they should agree a time with the Auditor or find a replacement before leaving

Process Control Map

Men

Materials

Methods

MachinesEnvironment

INPU

TS

OU

TPUTS

Process

3 Components of AuditingThere are 3 components of a process audit.

Horizontal and Vertical paths and Audit Trails• Following the horizontal path we follow the

steps of the process from start to finish• For the vertical path we must look at the

activities of managers, supervisors, operatives, clerks and assistants up or down the activity or process. We look at business measures down to records of the activity

• Audit trails develop a logical sequence of questions and interviews to explore and link activities

Collecting Evidence - Overview

• Observations of activities and conditions• Interviews if no procedure ask about controls• Check documents and Records by Sampling• Comprehensive notes of all checks / evidence• Follow trails and links between systems,

processes, documents and records• Use the Checklists as a memory aid• Look over, under and around

FINDING OUT THE FACTS• Information can be gathered through interviews,

observation, checking records and reading documentation

• Records and documentation often need to be cross – checked with other records or procedures in that area and in other parts of the system

• You will not be able to check every record. Take a small sample and check those thoroughly

• Check controls and feedback of processes, the responsibilities and authorities and role of management must go up and down the structure

Audit Techniques

Ask Observe

Audit Diamond

Record Check

A-R-C-O

Question Style• Open – What, Where, Why, When, How, Who• Closed – Used to confirm the facts• Hypothetical – Used to check in depth• Silent – Can be useful to draw out information• Leading – Avoid• Trick – Unprofessional• Multiple – Bad practice as auditee has the

choice of which to answer, may also pressurise the auditee

INTERVIEWS• Introduce yourself to the head• ASK About scope of activities / responsibilities,

policy and objectives• CHECK where responsibilities are defined• Interview persons responsible for activities• ASK about activities, controls and records• OBSERVE the activities and controls• CHECK records, procedures or systems• RECORD the facts, Names, items checked,

procedure titles and revisions, records, details of conformance or non – conformance

• THANK the persons interviewed

Listening• Auditors must demonstrate interest and listen

to the information that is being related during interviews

• In many cultures it is insulting not to• More essential than before as there may be no

procedures to check• Listen to all the information not just the bits

you want to hear. (Beware of gushers )• Do not get distracted as information may be

missed• Do not interrupt whilst responses remain

meaningful and objective

OBSERVATION• Materials and information flow through

organizations and processes. The smoother the flow the more efficient the process can be

• Look around you and try to identify the system flow. Ask people to describe it

• Check that the process conforms to the plan or system. How is the plan documented

• Identify any areas or items that appear to be irregular or outside the normal system flow

• Check these thoroughly

Checking out Systems• Some systems may appear to be good but the

auditor must test them out using examples• Systems include Documentation. Training,

Calibration, Maintenance, Purchasing etc• As we go round the organization we encounter

people, equipment, materials and procedures and instructions. Check these comply with plans

• We must record details of these in order to check out the systems with actual examples e.g. Show me the training record for Joe Soap from the warehouse. What is the current revision status of the Packing Procedure P34. Who is responsible

Note Taking• Good notes are essential to a good audit as you

will never remember everything without notes• Do not be embarrassed to stop and take notes• Make sure that your notes are legible and

organized• Record who you are interviewing, the activity,

procedure details and records• Note any unexpected observations• Keep your notes safe

Cultural Differences

• Auditors should be aware of the needs of delegates associated with cultures and religions

• At certain times of the day prayers may be taken. This should be planned

• Some cultures do not like to say no• Smiles are welcomed everywhere

Auditing• Interviews are more important with ISO 9001-2008• Understand the process and the controls they have

put in place. Flowcharts are useful• Do not jump into detail too quickly• Follow the flow and links between processes• Develop Audit Trails• Once you understand the system they are using ask

selected detail and check evidence and records that it operates according to the plan or procedure and records confirm effective controls

• Use the checklist to ensure you do not miss important controls keep an eye on the time

Possible Problem Areas• How do we assess competence• If they use computers do we always need a

computer expert to judge competence• What if there are no procedures and no records

of process conditions• How do we know that we have covered all the

processes if there are no procedures• How do we know that all 3 shifts do it the same

way if no procedures• Will handling and storage always be the same if

there are no control procedures• How do we judge the working environment

Reporting the Audit Findings and Follow up

Section 7

Auditors Team Meeting

• Held at the end of the audit by the Lead Auditor attended by all the team members

• Auditors identify the items that they consider should be reported and check that they have sufficient evidence

• Lead Auditor asks team members what they have found and collates all of the information

Auditors Team Meeting …contd

• Lead Auditor collects and discusses all the nonconformities to be raised and combines items if similar examples of the same problem checking evidence

• Decides whether major or minor• Checks on conformity and good points• Allocates writing of NCR’s

Good Practice

• Use the forms provided• Present the facts concisely• Supply sufficient detail so that anyone

can go to the same areas and check the facts

• Refer to the reference standard, company documentation or legislation to state the deficiency

Good Practice Statement

Example 1• The 0.150mm vernier caliper serial No.

1423 at the Inward Goods area had no indication of its calibration status. Calibration System requires that “all measuring equipment must be identified with a label indicating the calibration due date”

Good Practice Statement …contd

Example 2• There were no licenses or records of

training for the forklift truck drivers in the stores area nor in personnel

• There were several boxes of components T45 and W37 damaged by forklift truck forks

• There was no review of competence needs for forklift truck drivers

AVOID

• Naming Names• Jargon• Generalities be specific• Emotive terms. (Awful, worst etc.)• Repetition. Try to group similar non

conformities together as examples of the same problem

Nonconformity

• The non fulfillment of a requirement

MAJOR NONCONFORMITY

• The absence or total breakdown of a system to meet a requirement of the standard. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity

Major Nonconformities

May arise from –• A single major quality system, product or

service deficiency, or lack of controls needed to satisfy an agreed requirement

• Planned arrangements not being implemented consistently

Major Nonconformity (QS 9000 )

• Any noncompliance that would result in the probable shipment of a nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purposes

Minor Nonconformity

• May be either a failure in some part of the supplier’s quality system relative to the standard or a single observed lapse in following one item of a company’s quality system

Minor Nonconformities

• May arise when there is a defined system and arrangements which generally satisfy agreed requirements and the organisation being audited is able to demonstrate an acceptable level of implementation overall, but there are minor discrepancies or lapses in discipline

Observations

• Audit and surveillance reports may contain “Observations” which relate to existing conditions which, in the Auditor’s judgment, warrants clarification or investigation so as to improve the overall status and effectiveness of the quality system

• Note – may constitute consultancy

Adding Value

Value can be added to reports through identification of –

• Areas for improvement• Benefits that can be realised from action• Identification of strengths that can be

used to improve weaker areas• Identification of sources of information

that can be accessed for guidance

Agreement of NCR’s

• NCR’s are usually agreed with the QMR following the Auditors Team Meeting and before the Closing Meeting

• Points can be clarified and checked• If a genuine error or misunderstanding

has been made withdraw the NCR• All other NCR’s stand

Closing Meeting

• Use an agenda or checklist• Organize the team on the presentation• Record attendees and proceedings• Cover the points briefly• Do not use jargon or emotive terms• Stick to the facts and be prepared to

clarify points and give detail if asked

Closing Meeting Agenda

• Re-state scope and objectives• Thanks for cooperation• Summary of Findings. (Strengths)• Define NCR major and minor• Disclaimer• Recommendations• Report of NCR’s

Closing Meeting Agenda …contd

• Invite questions• Confidentiality• Top person to sign the report• Inform about further actions• Ask auditees to nominate corrective

actions and time scales• Return Documents – Thanks – Close

The Report

• May be written on site or afterwards• Stick to the facts• Follow the agreed format and procedure• Often need two reports one for internal

use and one for the auditees• Make use of NCR forms• Should reflect the verbal report

Report Contents

• Date, organization and site• Audit team and auditee’s representative• Scope and objectives• Reference documents• Summary and recommendations as to

certification or approval if appropriate• Any problems encountered

Report Contents …contd

• Details of NCR’s• Judgment on the overall performance

and ability to meet quality objectives• Recommendations as to actions to be

taken if appropriate• Report distribution and confidentiality• Comments from the Closing Meeting

Corrective Action

• After the closing meeting the auditee organization must complete any agreed corrective actions

• They need to analyse the problem to identify the root cause, plan, implement and record the actions taken and check or re-audit the corrective action to ensure it has been effective

• They would then inform the LA for follow up

Follow Up• Agreed corrective actions are followed up by

the Lead Auditor usually by re-visiting and re-checking the part of QMS where a deficiency was found

• Some certification bodies do this at the next surveillance visit

• Checks are done on the process links inputs and outputs where the deficiency was found to determine if the cause of the deficiency has been addressed

Certification System

• Certification Body – Review reports and recommendations and decide on the granting of certificate

• Surveillance – Visits are carried out by the certification body, normally one per year, auditing parts of the system to a planed coverage to ensure that the system continues to meet requirements

Trienial Re-Assessment

• They are required every 3 years whereby the whole system is subjected to a full assessment usually in one visit including documentation review and the implementation audit

• Certificates are therefore valid for 3 years

Audit Records

• Audit Plan, checklists and notes• Agenda and attendance of opening and

closing meetings• Written Reports of stages 1 and 2• NCR’s plus any notes made• Report by LA on team performance• Follow up and surveillance reports