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Preface xiiiHigh quality and low quality; poor quality and good quality 23 Differences between existing automotive quality system requirements 48 Contents... Ensuring that the supplier h

Automotive Quality Systems Handbook

Automotive Quality Systems

Handbook

David Hoyle

225 Wildwood Avenue, Woburn, MA 01801-2041

A division of Reed Educational and Professional Publishing Ltd

A member of the Reed Elsevier plc group

OXFORD BOSTON JOHANNESBURG

MELBOURNE NEW DELHI SINGAPORE

First published 2000

© David Hoyle 2000

All rights reserved No part of this publication

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to reproduce any part of this publication should be addressed

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British Library Cataloguing in Publication Data

A catalogue record for this book is available from the British Library Library of Congress Cataloguing in Publication Data

A catalogue record for this book is available from the Library of Congress ISBN 0 7506 7243 9

Typeset by Butford Technical Publishing, Great Milton, Oxford

Printed and bound in Great Britain

Preface xiii

High quality and low quality; poor quality and good quality 23

Differences between existing automotive quality system requirements 48

Contents

Chapter 4 Implementing ISO/TS 16949 61

Establishing a documented quality system (4.2.1) 159

Ensuring effective implementation (4.2.2.1b) 183

Coordinating contract review activities (4.3.1) 224 Ensuring that the requirements are adequately defined and

Ensuring that the supplier has the capability to meet contractual

Meeting customer-specific requirements (4.3.2.2) 230

Document and data review and approval (4.5.2.1) 289 Identifying the current revision of documents (4.5.2.1) 292 Ensuring the availability of controlled documents (4.5.2.1a) 292 Obsolete and invalid documents (4.5.2.1b and 4.5.2.1c) 295 Control of customer engineering specifications (4.5.2.2) 297

Ensuring purchased product conforms to specified requirements (4.6.1.1) 308 Customer-approved subcontractors (4.6.1.2) 311 Satisfying regulatory requirements (4.6.1.3) 311 Evaluation and selection of subcontractors (4.6.2.1a) 312

Records of acceptable subcontractors (4.6.2.1c) 322 Developing subcontractor’s quality systems (4.6.2.2) 324 Subcontractor delivery performance (4.6.2.3) 324

Contents vii

Chapter 8 Product identification and traceability 339

Compliance with reference documents (4.9.1.1c) 356 Controlling process and product characteristics (4.9.1.1d) 357 Approval of processes and equipment (4.9.1.1e) 358

Maintenance of equipment (4.9.1.1g and 4.9.1.5) 359

Maintaining cleanliness of premises (4.9.1.2) 364

Designation of special characteristics (4.9.1.4) 366 Process capability and process control (4.9.1.1g and 4.9.3) 366

In-process inspection and testing (4.10.3a) 384

Layout inspection and functional testing (4.10.4.2) 389

Identifying measurements to be made and accuracy required (4.11.2a) 409 Selecting appropriate inspection, measuring, and test equipment (4.11.2a) 410

Chapter 13 Control of nonconforming product 433

Ensuring that nonconforming product is not used (4.13.1.1) 436 Identifying nonconforming product (4.13.1.1 and 4.13.1.2) 436 Documenting nonconforming product (4.13.1.1) 437 Evaluation of nonconforming product (4.13.1.1) 438 Segregation of nonconforming product (4.13.1.1 and 4.13.1.2) 438 Disposition of nonconforming product (4.13.1.1) 438

Defining disposition responsibility (4.13.2) 439 Review of nonconforming product (4.13.2, 4.13.3, and 4.15.3.2) 440 Use of nonconforming product (4.13.2 and 4.13.1.3) 443 Deviating from approved processes (4.13.4) 444 Recording the actual condition of nonconforming product (4.13.2) 445 Re-inspection of repaired and reworked product (4.13.2) 445

Corrective and preventive action procedures (4.14.1.1) 452 Assessing the degree of corrective and preventive action necessary (4.14.1.1) 453 Implementing and recording changes in procedures (4.14.1.1) 453

Monitoring performance to customer delivery requirements (4.15.6.2) 486

Demonstrating conformance to specified requirements 499 Demonstrating the effective operation of the quality system 500

Contents ix

Chapter 17 Internal quality audits 507

Verifying compliance with planned arrangements (4.17.1) 512 Determining the effectiveness of the system (4.17.1) 514

Providing for training (4.18.1 and 4.18.3) 529

Evaluation of training effectiveness (4.18.2) 532

Increasing sensitivity to customer requirements (4.18.3) 534

Identifying the need for statistical techniques (4.20.1) 548 Implementing and controlling the application of statistical techniques (4.20.2) 550 Knowledge of basic statistical concepts (4.10.4) 550

The quest for quality has seen many initiatives and of these the pursuit of compliancewith national and international standards is not abating, despite opinions that they havenot brought about their intended results It is a fact of life that unless something is man-dated by government or customers, suppliers won’t do it We might learn by listening toothers or reading books but we don’t necessarily do anything with the knowledge until

we have to The biggest motivator is that if we don’t act now we will lose our existingcustomers and may lose a market to competitors who have acted more promptly.Since 1994, the automotive industry in the USA and Europe has been operating quali-

ty system certification schemes that extended the requirements of ISO 9001,ISO 10011, and EN 45012 One of these schemes was addressed by my QS-9000Quality Systems Handbook, published in 1996 In the same year the automakers of theUSA and Europe formed the International Automotive Task Force (IATF) which, incooperation with the technical committee of the International Organization ofStandardization (TC 176), produced ISO/TS 16949 Use of and registration to this newstandard is currently voluntary It is intended that following the first revision to incorpo-rate ISO 9000:2000, the ISO/TS 16949 certification scheme will be mandated by allmajor vehicle manufacturers on their Tier 1 suppliers As a result, the standard will becascaded along the supply chain, ultimately reaching all suppliers to the global automo-tive industry

Although the second revision of the ISO 9000 series of standards is promised for thefourth quarter of the year 2000, there is no reason to wait until that standard hits thestreets Many of the requirements in ISO/TS 16949 are likely to be found in the year

2000 edition of ISO 9001 By acting now your organization can create a competitiveadvantage Although in the automotive industry the sector quality system requirements

do address many of the weaknesses of ISO 9001, there has been distrust with the fication schemes, as the effectiveness of these schemes is only as good as the auditorsemployed by the certification bodies By harmonizing the certification schemes and hav-ing binding agreements with all vehicle manufacturers, auditor competency will be

certi-enhanced, a higher level of confidence should begin to develop within the global motive industry, and product quality will improve – not that quality has been asignificant problem in the automotive industry in the last 10 years!

auto-I bought my first car in the mid 1960s, at a time when rust started to appear before carswere three years old Major repair became necessary before engines had done 40,000miles On the other hand, I recently sold my 10-year-old car and although it had done70,000 miles, there was not a sign of any rust and it had never left me stranded awayfrom home There are countless cars that have traveled more than 100,000 miles andremain in good working order Durability, however, is not the characteristic challengingthe automakers Safety is number one, followed by reliability and production cost, but

it is cost that drives the quest for better methods, better processes, and better ways ofpreventing defects

The book is in two parts, with the first part devoted to the origins of the standard andthe differences between ISO/TS 16949 and other automotive quality system require-ments, with some guidance on implementation I have included a chapter on basicconcepts from myISO 9000 Quality Systems Handbook, with some slight modification.The second part is divided into chapters that reflect the order of subsections in section

4 of the standard Each chapter dissects the requirements of ISO/TS 16949, taking each

“shall” statement and sometimes part of a “shall” statement and explaining the ing and the applicability, and offering a range of solutions At the end of each chapter is

mean-a tmean-ask list, questionnmean-aire, mean-and list of “do’s mean-and don’ts”

Although the book addresses all the requirements of ISO/TS 16946, readers are

strong-ly advised to have access to this technical specification, the ISO 9000 famistrong-ly ofstandards, and the various supporting publications referenced within them

David Hoyle

Monmouth

E-mail: hoyle@transition-support.com

January 2000

Other books by the same author:

ISO 9000 Quality Systems Handbook 3rd Edition 1998 (ISBN 0-7506-4024-3)QS-9000 Quality Systems Handbook 1996 (ISBN 0-7506-9861-6)

ISO 9000 Quality System Assessment Handbook 1996 (ISBN 0-7506-2563-5)ISO 9000 Quality System Development Handbook 1998 (ISBN 0-7506-2562-7)ISO 9000 Pocket Guide 1998 (ISBN 0-7506-4025-1)

In December 1998 I was fortunate to be invited to participate in the development of theISO/TS 16949 certification scheme and later to represent the UK Society of MotorManufacturers and Traders (SMMT) on the IATF Training Council, set up to design theauditor qualification program I would therefore like to acknowledge Bob Lawrie andRobert Coles of the SMMT for providing the opportunities in which I was able to learnabout the IATF and ISO/TS 16949

I acknowledge members of the IATF Training Council, including Robert Frank of theVDA, who assisted with interpretations, Markus Stang of the VDA, who providedVDA 6.1 and other documents, Antonio Ciancio of ANFIA, who provided AVSQ ’94,Jacques Letheicq of Euro-Symbiose, who provided EAQF ’94, and Al Peterson and JodiShorma of Plexus-Training, who with the other members of the Training Council creat-

ed an environment rich in ideas, knowledge, and experience

Extracts from BS EN ISO 9001:1994 are reproduced with permission of BSI underlicense PD\1999 0881 Complete copies of the standard can be obtained by post fromBSI Customer Services, 389 Chiswick High Road, London W4 4AL

Extracts from ISO/TS 16949 and the Rules for Achieving IATF Recognition are duced with permission of the IATF Complete copies of these documents can beobtained from SMMT, Forbes House, Halkin Street, London SW1X 7DS

pro-I am also indebted to Manfred Martelock of VDA and Robin Lock of SMMT for their tique and help during the final stages

cri-Part 1

Understanding ISO/TS 16949

The origins

ISO 9000 is now a familiar label to many organizations Since 1987 it has dominatedthe field of quality management and sometimes even to the exclusion of all other qual-ity issues To some it conjures up mountains of paperwork, bureaucratic procedures,form filling, and non-value added activities, a kind of demon let loose in the workplace!

To others it is just common sense, merely codifying principles that have been applied bysuccessful businesses for generations Both are right because the ISO 9000 family ofstandards is what people perceive it to be For a document to become an internationalstandard it must be acknowledged by many nations as defining good practice This doesnot mean the standard defines all practices that one should adopt Standards are “min-imums” not “maximums” Like hygiene standards, there is a minimum standard belowwhich disease becomes virtually inevitable Such standards do not and should not pro-hibit anyone in the group exceeding the standards Within the business community,ISO 9000 represents the minimum system requirements for achieving quality in prod-ucts and services In other words, if you do all the things in ISO 9000 there is no reasonwhy you should not consistently satisfy your customers

Most ISO 9000 registered organizations claim to provide quality products and services,

so why should there be so many dissatisfied customers when there are over 270,000organizations in the world certified to ISO 9001, 9002, or 90031? One of the principalrequirements in the standard is for the supplier to establish a quality system as a means

of ensuring that product or service meet specified requirements If an organization’sproducts or services do not meet specified requirements then clearly the system hasfailed, but the failure is no fault of the standard – it is a fault of the way the standard hasbeen applied and interpreted both by the organizations themselves and by the auditorswho determine conformity If the specified requirements are less than those of the cus-tomers, it is inevitable that products will bring dissatisfaction This realization has, in thecase of the automotive industry, led to two distinct needs:

1 The ISO Survey of ISO 9000 and ISO 14000 certificates – eighth cycle, December 1998

1 A need to harmonize fundamental supplier quality system requirements and nate multiple interpretations.

elimi-2 A need for a common certification scheme to ensure the integrity of the certificationprocess world-wide

Emergence of sector requirements

As a set of minimum standards, ISO 9000 addresses the business community It wasintended for purchasers as a means for them to obtain products and services of consis-tent quality from their suppliers In place of purchaser-specified general qualitymanagement requirements, ISO 9000 became the common requirement and henceeliminated the need for such requirements As a consequence, it provides suppliers thatmeet its requirements with a demonstrable capability that others may not possess andhence such capability becomes a persuasive marketing tool that will increase marketshare ISO 9000 was also intended for application to all types of industry and thereforedid not contain requirements for any specific industry sector or type of products or serv-ices Partially due to the scope of misinterpretation and the degree to which particularindustries have common supplier requirements, certain industry sectors perceived theneed for harmonizing such requirements in a form that added to those requirements inISO 9000

The drive for these additional requirements has come not from the suppliers but fromusers, such as the automotive, utilities, telecommunications, software, and aerospaceindustries which purchase millions of products and services used to produce the goodsand services they provide to the consumer Rather than invoke customer-specific condi-tions in each contract, the larger purchasers perceive real benefits from agreeingcommon quality system requirements for their industry sector Quite often a supplier will

be supplying more than one customer in a particular sector and hence costs increase forboth the supplier and the customer if the supplier has to meet different requirements thatserve the same objective All customers desire products and services that consistentlymeet their requirements While the physical and functional requirements for the product

or service will differ, the requirements governing the manner in which their quality is to

be achieved, controlled, and assured need not differ Differences in quality systemrequirements may arise between industry sectors where the technology, complexity, andrisks are different

There are those who see the emergence of sector standards as a retrograde step, havingreached the stage where we have condensed all the world’s national quality system stan-dards into one group of 20 standards Those following the development of ISO 9000will already be aware that the 20 standards in the ISO 9000 family are soon to bereduced to four (ISO 9000, ISO 9001, ISO 9004, and a replacement for ISO 10011) It

may seem to be a retrograde step if these standards were regarded as the Mount Everestamong standards Unfortunately, ISO 9000 remains a “minimum” and hence does notand was not intended to meet the needs of all users The alternative to suppressing sec-tor standards at the international level is to see them emerge at the national level orcontinue with the practice of purchasers invoking their own quality system requirementswithin contracts, perpetuating fragmentation and duplication, and driving up costs.Until ISO 9000 emerged in 1987, the automotive industry used a variety of customer-specific standards to govern a supplier’s quality management practices.

The British contribution

Prior to the publication of ISO 9000, several nations had developed national quality tem standards, with many used only in the procurement of military equipment With theemergence of the NATO Quality Control System standards in 1973, the Quality Panel

sys-of the UK Society sys-of Motor Manufacturers set out to develop an equivalent standard fornon-military applications The result was BS 4891, which was published in 1972 In

1974 this was followed by BS 5179 with the title Operation and Evaluation of QualityAssurance Systems However, BS 5179 was intended only as a guide and it was not until

1979, with the publication of BS 5750, that major purchasers in the UK had a standardthat could be invoked in contracts A certification scheme was eventually established in

1983, following the UK government’s white paper on competitiveness2

In 1983, BSI approached the International Organization of Standardization in Genevawith a view to developing an international quality system standard and eventually a com-mittee was formed Using BS 5750 as its basis, the ISO 9000 series of standards was born.Although the UK, and in particular the UK automotive industry, had been at the fore-front of the development of non-military quality system standards, harmonization withinthe automotive sector beyond BS 5750 was believed too difficult to achieve Using

BS 5750 as a baseline only, the UK motor manufacturers continued to develop theirown supplementary standards, many of which are still in use today BS 5750, and itssuccessor ISO 9000, was enforced by the UK automotive industry and no further har-monization took place

The American contribution

In 1988, the Purchasing and Supply Vice Presidents of Chrysler, Ford, and GeneralMotors chartered a Task Force to standardize reference manuals, reporting formats, andtechnical nomenclature, resulting in five standardized reference manuals

The origins 5

2 Standards, Quality and International Competitiveness (HMSO, July 1982)

In 1992, the Chrysler, Ford, and General Motors Task Force set out to harmonize thefundamental supplier quality system manuals and assessment tools and produced QS-9000 This new standard embodied the requirements of ISO 9001 and added gener-

ic requirements, sector-specific requirements, and customer-specific requirements.QS-9000 was first published in August 1994 and is a harmonization of Chrysler’sSupplier Quality Assurance Manual, Ford’s Q101, and General Motor’s Targets forExcellence, with some input from the Truck Manufacturers It is pertinent that it was thePurchasing Vice Presidents of Chrysler, Ford, and General Motors that set up the taskforce and that the initiative was driven by purchasing to improve the quality of supplies.Hence QS-9000 was not intended to apply to the design and assembly plants ofChrysler, Ford, and General Motors

In 1995, the first edition of QS-9000 was revised and by March 1998 the third editionwas published

The German contribution

In 1991, the Verband der Automobilindustrie e V (VDA) published VDA 6.1, QualitySystem Audit, a questionnaire on quality system evaluation based on DIN EN ISO 9004.VDA 6 is a series of guides covering the basics for quality audits, auditing, and certifi-cation They were therefore not intended as supplementary requirements to ISO 9000but as guides for auditors performing audits of automotive suppliers Their intention was

to improve auditor competency in the industry by providing a uniform interpretation ofISO 9000 requirements and a common approach to automotive audits VDA 6.1 hasbeen revised several times and is currently in its fourth edition There are nine volumes

in the series (see Appendix A)

Unlike QS-9000, VDA 6.1 does not incorporate the requirements of ISO 9001 section 4.You won’t find the words from ISO 9001 in VDA 6.1 Each section carries a statement

of intent followed by a series of questions, cross-referenced to ISO 9001 and ISO 9004.Each question is expanded further by a definition and explanation of requirements.There are 23 elements, not 20 as in section 4 of ISO 9001, and the order is different tothat in ISO 9001; for example, section 03 addresses Internal Quality Audits, notContract Review Although the numbering of sections goes from 01 to 22, there is a sec-tion Z1 on Corporate Strategy that covers business planning While on first encounteringVDA 6.1, you may be forgiven for thinking “This is not a standard”, in fact it is moreuseful than ISO 9001 as it provides definitions and explanations more so than ISO 9004

It is, however, a guide to auditors and was not intended for suppliers

The Italian contribution

In 1994, ANFIA published AVSQ ’94 with the title ANFIA Evaluation of Quality Systems

– Guidelines for Use This consisted of both a checklist and a user guide For each tion in the checklist there are guidelines on interpretation that are specific to theautomotive industry The checklist of questions is placed on the left-hand page and theguidance on the right-hand page The guidance actually reads more like requirements,

ques-as in many statements the word “must” is used – although this could be translation errorand not intent The questions are derived from ISO 9001 ANFIA published a seconddocument that lists the same questions and includes evaluation forms for completion

By 1995, AVSQ ’94 was in the third edition, in which VDA 6 second edition, EAQF ’94,and ISO 9004-1:1994 have been used Thus reciprocal recognition at the Europeanlevel was achieved whereby certification to AVSQ ’94 was recognized as equivalent toVDA 6.1 and EAQF ’94 certification

Like VDA 6.1, AVSQ ’94 does not include the requirements of ISO 9001 In this wayissues of copyright are overcome, a practice shared by VDA and EAQF but not QS-

9000 However, unlike VDA 6.1, AVSQ ’94 follows the 20 elements of ISO 9001 withtwo additional elements, covering financial considerations and product safety Thosequestions that go beyond ISO 9001 are marked and as every question is numbered itsimplifies the evaluation process A scoring method is employed to classify organizations

in terms of a conformity index Each question is awarded a point (0, 2.5, 5, 7.5, or 10),where 10 points means full compliance, 7.5 points means minor inadequacies, 5 pointsmeans inadequacies in application requiring improvement, 2.5 points means seriousinadequacies in application, and 0 points is used for criteria not applied Unfortunatelyall questions carry the same weight as no account of the impact of omission on productquality or customer satisfaction is included

The French contribution

In 1990, PSA Peugeot-Citroen and Renault released a supplier quality assurance cation with the title Référentiel d’Evaluation d’Aptitude Qualité Fournisseurs (EAQF).The publication summaries the requirements of ISO 9001 section 4 but, as with VDA 6.1and AVSQ, the requirements of ISO 9001 are not incorporated The layout is very sim-ilar to AVSQ but the left-hand page contains statements of fact and the right-hand pagequestions for guidance There are many additional requirements to those in ISO 9001and guidance on the application in the automotive industry In 1994, the second editionwas published and integrated requirements of the German publication VDA 6.1 not pre-viously contained in EAQF ’90 Two additional chapters were included coveringfinancial considerations relative to the quality system and safety controls relative to theproduct The 1994 edition contains guidance for suppliers of prototypes, productionproduct spares, and accessories A scoring system similar to AVSQ is used to assess the

publi-The origins 7

degree of compliance As with AVSQ, each statement is numbered but the numberingbelow section level does not mirror that in ISO 9001 or AVSQ.

The motivation

In the last few years the motor industry has witnessed many mergers and joint ventures,not just within national boundaries but across nations The pride of British motor carmanufacturers, Rolls Royce, passed into German ownership in 1998 although the sale

is somewhat unusual The Rolls Royce marque will pass to BMW in 2003 with VWretaining the Bentley marque and the Rolls Royce factory at Crewe in England.However, the Rover Group which passed into German ownership in 1994 returned intoBritish ownership in March 2000 when it was sold to the venture capital companyAlchemy As we go to press, the scene changes as GM acquires a 30% stake in Fiat andFord a 33% stake in Mitsubishi Table 1-1 illustrates “Who owns who” and shows thatBritain is not alone among the countries that has sold its motor industry to foreign buy-ers This does not mean that Britain and other countries do not have a motor industry

– what it does signify is that the motor industry is now a global industry

Buying the competition has been a way of entering foreign markets and is not a recentphenomenon Ford chose another way, by building manufacturing plants overseas anddesigning and producing cars for the local market In Europe that market has grownbeyond a single country and although the cars may have different names they have thesame body parts and engines GM bought the British company Vauxhall in 1925 andthe German company Adam Opel in 1929, then in 1931 GM bought the Australiancompany Holden The Big Three (Ford, GM, and Chrysler) have been global players formany years In Europe acquisitions have been rather slower In 1969, VW bought Audiand then, after a long gap, acquired Seat in 1986

There are several joint ventures, such as the Multi Purpose Vehicles (MPV) that Ford,Nissan, and VW produce: exactly the same vehicle with slight modifications Ford, Seat,and VW also produce a common MPV and there are several partnerships, such as Roverengines being supplied to Proton, Ford, and Honda Lada get their chassis from Fiat andtheir engines from GM Mitsubishi build the Carisma in Holland in the same plant thatVolvo build the S40 The Porche Boxster is assembled in Finland by the same compa-

ny that assembles the Saab 9-3 cabriolet, and so on One cannot be sure who owns thecompany that makes your car, where the components come from, and where it is assem-bled What matters is that it meets your needs and expectations and this can only beachieved if there are some common systems in use in each of the countries, so that whoowns who and who builds what becomes irrelevant to customer confidence It is report-

ed that within 20 years there may only be six vehicle manufacturers left in the world3

3 Auto Express, January 1999

The origins 9

Marque Origin Est. Owneror Partner Origin Acquired

1988 - 100%

Chrysler

1996 - 33%

Table 1-1 Who owns who?

Figure 1.1 Contributors to ISO/TS 16949

as QS-9000

The automotive industry has comprised multinational corporations for many decadesbut there has been little harmonization in quality system requirements across all plants.QS-9000 harmonized these requirements not only in the USA but in every countrywhere GM, Ford, and Chrysler had suppliers With the emergence of VDA 6, AVSQ ’94,and EAQF ’94, European suppliers were now being faced with up to four different qual-ity system standards Hence a UK supplier might have customers such as Ford UKdemanding QS-9000, Peugeot in France demanding EAQF ’94, and VW in Germanydemanding VDA 6 Consequently, the purchasing executives of the large Europeanautomakers approached GM, Ford, and Chrysler with a view to harmonizing the USA,Italian, French, and German automotive quality system standards

In 1996, an International Automotive Task Force was established, comprising tatives of the vehicle manufactures and trade associations from the Americas andEurope (see Figure 1.1)

represen-The nations represented at the launch of the resulting standard were France, Germany,Italy, UK, and USA who together with representatives from ISO/TC 176 developed a sec-tor standard which became ISO/TS 16949 This technical specification incorporatessection 4 of ISO 9001:1994 and includes requirements taken from QS-9000, VDA 6,AVSQ ’94, and EAQF ’94 and some new requirements, all of which have been agreed

by the international members The evolution of ISO/TS 16949 is illustrated in Figure 1.2

1970 1980 1990 2000

VDA 6 AIAG (USA)

94 87

ISO 9000:2000

02

The interface between IATF and ISO/TC 176 was in the form of a pilot study to

consid-er the implication of sector standards The output was in the form of a new ISOdocument: a Technical Specification The requirements for such a document are for arevision within three years and a limit of only one revision, after which it must eithercease or become a full standard The document when submitted for ballot toISO/TC 176 significantly exceeded the 66% favorable majority required for its adoption.With the publication of ISO/TS 16949 occurring during the period that ISO 9000 isundergoing revision, many requirements or enhancements that may appear inISO 9000:2000 have been incorporated into ISO/TS 16949 Some of these are alreadycontained in QS-9000 but the most significant of these are requirements for:

l Goals and objectives to be defined

l Determination of customer satisfaction

l Continual improvement

l Analysis of data

l Ensuring compliance with regulations

l The management review to monitor strategic quality objectives and the ance of the system

perform-l Process verification

l Defining and maintaining plant, tooling, facilities

l Reviewing the effectiveness of training

By adopting ISO/TS 16949 now, suppliers to the automotive industry will be in a goodposition to meet ISO 9000:2000 when it is released Following publication ofISO 9000:2000 towards the end of 2000, work will commence on upgradingISO/TS 16949 It is anticipated that if ISO/TS 16949:2000 is accepted by the interna-tional automotive community, QS-9000, VDA 6, AVSQ ’94, and EAQF ’94 will bewithdrawn

Emergence of a common certification scheme

The requirements governing certification to ISO 9000 are contained in a number ofstandards:

ISO Guide 61:1996 General requirements for assessment and accreditation of

certification/registration bodiesISO Guide 62:1996 General requirements for bodies operating assessment

and certification/registration of quality systemsISO 10011 Guidelines for auditing quality systems

EN 45012 General criteria for certification bodies operating quality

system certification

EN 45013 General criteria for certification bodies operating

certifica-tion of personnelISO 9000 is not a statutory requirement and neither is certification, hence certification

is voluntary However, suppliers may be under pressure to obtain registration toISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts Within the ISO 9000certification scheme, the certification industry is regulated by accreditation bodies AnInternational Accreditation Forum (IAF) attempts to harmonize accreditation practicesworld-wide through ISO Guide 61 The accreditation bodies authorize certification bod-ies to conduct certification to prescribed standards – a process that is calledaccreditation The accreditation body performs witness audits and desk audits of the cer-tification body to ensure compliance with the conditions of accreditation

To receive ISO 9000 accreditation, a certification body must meet the requirements ofISO Guide 62 and EN 45012, which invokes ISO 10011 There is normally a mark ofaccreditation (a Crown and Tick in the case of UKAS accreditation) that certificationbodies use to signify their credibility Once accredited, a certification body may performaudits on suppliers offering products and services within the scope of accreditation Intheory, accreditation is granted only if the certification body has expertise (i.e compe-tent auditors) for the particular industry sectors (EAC codes) requested

Auditors working for certification bodies should meet the requirements of ISO 10011and in many countries there is an auditor registration scheme, which is designed so as

to ensure that auditors failing to meet prescribed standards are removed from the ter

regis-The origins 13

There are, however, many weaknesses:

l In many countries, there is no law prohibiting an organization setting up as either

an accreditation body or a certification body

l In many countries, both accreditation and certification bodies are commercialorganizations that operate without government funding and therefore they are gov-erned by supply and demand

l In many countries, there is no law requiring all certification bodies to be accredited

by registered accreditation bodies

l Certifications bodies are not compelled to deploy only those auditors qualified asmeeting ISO 10011

l There are gross differences in interpretation of requirements between certificationbodies

l There are differences in interpretation of requirements between different offices ofthe same certification body, especially those operating in different countries

l Auditor registration bodies are not compelled to be accredited to EN 45013

l Auditors are not compelled to register with an accredited auditor registration body

l The supplier may choose the certification and the scope of registration

l The supplier is deemed to be the client of the certification body, not theInternational Organization of Standardization (ISO)

l The customer does not have any power of veto over the issuing or withdrawal ofeither accreditation or certification

l The customers have little influence in the training, qualification, and selection ofauditors

Set up with the aim of improving confidence in the quality of supplies, with so manyloopholes, the integrity of the whole scheme is therefore questionable There are a fewmeasures customers can take to improve confidence:

l Demand that the suppliers be registered by an accredited certification body

l Demand that the accreditation body is recognized by the national government

l Recognize certain certification bodies as providing services that meet industryrequirements.

l Complain to the certification body whenever the auditor performance does notmeet expectations

These measures, however, were insufficient for the automotive industry Hence a

glob-al certification scheme has been developed that addresses each of these weaknesses and

as a result creates a very robust system that will yield tremendous benefits for the try (see also Part 1 Chapter 5)

indus-Benefits

Until the ISO/TS 16949 is updated to align with ISO 9000:2000, its use is voluntary It

is likely that Ford, Daimler-Chrysler, General Motors, Fiat, Peugeot, VW, BMW, etc willcontinue to use their existing quality system requirements until the updatedISO/TS 16949 is published However, for suppliers there are distinct advantages inadopting ISO/TS 16949 now The members of IATF will recognize ISO/TS 16949 certi-fication as equivalent to QS-9000, VDA 6, etc and therefore rather than continue to runseparate systems or juggle with difficulties in responding to different requirements, sup-pliers can operate a system that will be accepted as satisfying all generic requirements oftheir customers

Improved product and process quality

Product and process quality will be improved as a result of implementing several newrequirements, including:

l Goal setting, measurement, and review

l Customer satisfaction measurement

l Product safety

l Compliance with regulations

l Process design management

l Application of common tools and techniques

The origins 15

l Regular measurement of quality system performance

l Accreditation of inspection, test, and calibration laboratories

l Making staff aware of the impact of nonconformities on customers

Additional confidence in global procurement

With one global scheme, disparities between the various schemes employed at a

nation-al level should be eliminated This will give a vehicle manufacturer in one countryprocuring product from another country the same level of confidence as would beobtained had the product been procured from the home country This will be achievedby:

l Employing a common standard to evaluate the capability of organizations ing product or service

supply-l Applying defined criteria to the selection of certification bodies that can awardISO/TS 16949 certificates

l Permitting only IATF qualified third party auditors who are sponsored by tion bodies contracted to perform ISO/TS 16949 audits

certifica-l Employing witness auditors sponsored by the vehicle manufacturers and first tiersuppliers to verify that the scheme is working effectively

Common quality system approach for subcontractor development

Many subcontractors supply product or services to several vehicle manufacturers.Therefore by harmonizing the standards by which subcontractor development will beconducted, variations in the approach to subcontractors will be minimal

Reduction of variation and increased efficiency

Variation in quality and delivery performance will reduce through common application

of requirements for:

l Continuous improvement in quality and delivery performance

l Mistake-proofing

l Failure modes analysis

l Statistical process control

l Measurement systems analysis

l Employee motivation

l On-the-job training

Efficiency will increase through common application of requirements for:

l Continuous improvement in cost

l Continuous improvement in productivity

l Employee motivation

l On-the-job training

l Measurement and review of product realization stages

l Use of common tools for FMEA, SPC, MSA

Reduction in second party system audits

Currently a supplier supplying customers in the USA, France, Italy, and Germany may

be subject to audit by one or more of their customers because of the customer’s lack ofconfidence in quality assurance schemes other than its own Hence a QS-9000 regis-tered supplier that supplies both Ford USA and BMW Germany could be subject to aVDA 6.1 audit, as the two standards are different By the USA, Germany, France, UK,and Italy agreeing a common standard and the associated registration scheme, registra-tion to ISO/TS 16949 is recognized by all the manufactures that are members of IATF.These organizations will therefore not find it necessary to perform any further qualitysystem audits of ISO/TS 16949 registered suppliers

The origins 17

Reduction in multiple third party registrations

Currently a supplier supplying customers in the USA and Europe needs to seek cation to QS-9000 and either VDA 6.1, AVSQ ’94, or EAQF ’94 Within Europe,certification to any one of the three European quality system requirements is, at least intheory, recognized by customers in the other countries

certifi-Common language to improve understanding of quality system requirements

A common language in quality system requirements is achieved through a commonstandard The baseline language of the standard is English and all translations should bemade from English to the other language, thereby minimizing scope for error However,

it is common to find that terms in one language do not have the same meaning inanother language Hopefully, through the deliberations of the IATF, any differences will

be identified and resolved

Chapter 2

Basic concepts

Quality

We all have needs, requirements, wants, and expectations Needs are essential for life,

to maintain certain standards, or essential for products and services, to fulfill the purposefor which they have been acquired Requirements are what we request of others andmay encompass our needs but often we don’t fully realize what we need until after wehave made our request For example, now that we own a mobile phone we discover wereally need hands-free operation when using the phone while driving a vehicle Henceour requirements at the moment of sale may or may not express all our needs Ourrequirements may include wants – what we would like to have but do not need: nice tohave but not essential Expectations are implied needs or requirements They have notbeen requested because we take them for granted – we regard them to be understoodwithin our particular society as the accepted norm They may be things to which we areaccustomed, based on fashion, style, trends, or previous experience Hence one expectssales staff to be polite and courteous, electronic products to be safe and reliable, police-men to be honest, etc

In supplying products or services there are three fundamental parameters which mine their saleability They are price, quality, and delivery Customers require productsand services of a given quality to be delivered by or be available by a given time and to

deter-be of a price that reflects value for money These are the requirements of customers Anorganization will survive only if it creates and retains satisfied customers and this willonly be achieved if it offers for sale products or services which respond to customerneeds and expectations as well as requirements While price is a function of cost, profitmargin, and market forces, and delivery is a function of the organization’s efficiency andeffectiveness, quality is determined by the extent to which a product or service success-fully serves the purposes of the user during usage (not just at the point of sale) Priceand delivery are both transient features, whereas the impact of quality is sustained longafter the attraction or the pain of price and delivery have subsided

The word quality has many meanings: a degree of excellence; conformance withrequirements; the totality of characteristics of an entity that bear on its ability to satisfystated or implied needs; fitness for use; freedom from defects, imperfections, or con-tamination; and (a phrase which is gaining popularity) delighting customers These arejust a few meanings; however, the meaning used in the context of ISO/TS 16949 is theone concerned with the totality of characteristics that satisfy needs The “fitness for use”definition is shorter, more easily remembered and can be used when making decisionsabout quality The specification is often an imperfect definition of what a customerneeds; because some needs can be difficult to express clearly, it doesn’t mean that bynot conforming, the product or service is unfit for use However, a product that con-forms to requirements may be totally useless It all depends on whose requirements arebeing met For example, if a company sets its own standards and these do not meet cus-tomer needs, its claim to producing quality products is bogus On the other hand, if thestandards are well in excess of what the customer requires, the price tag may well be toohigh for what customers are prepared to pay – there probably isn’t a market for a gold-plated mousetrap, for instance, except as an ornament perhaps!

A product which possesses features that satisfy customer needs is a quality product.Likewise, one that possesses features which dissatisfy customers is not a quality product

So the final arbiter on quality is the customer The customer is the only one who candecide whether the quality of the products and services you supply is satisfactory andyou will be conscious of this either by direct feedback or by loss of sales, reduction inmarket share, and, ultimately, loss of business

There are other considerations in understanding the word quality, such as grade andclass These are treated in ISO 8402:1994 but will be addressed briefly here so as to give

a complete picture

Classification of products and services

If we group products and services (entities) by type, category, class, and grade we canuse the subdivision to make comparisons on an equitable basis But when we compareentities we must be careful not to claim one is of better quality than the other unless theyare of the same grade Entities of the same type have at least one attribute in common.Entities of the same grade have been designed for the same functional use and there-fore comparisons are valid Comparisons on quality between entities of different grades,classes, categories, or types are invalid as they have been designed for a different use orpurpose

Let us look at some examples to illustrate the point Food is a type of entity Transport

is another entity Putting aside the fact that in the food industry the terms class and grade

are used to denote the condition of post-production product (see bottom of this page),comparisons between types is like comparing fruit and trucks – there are no commonattributes Comparisons between categories is like comparing fruit and vegetables.Comparisons between classes is like comparing apples and oranges Comparisonsbetween grades is like comparing eating apples and cooking apples.

Now let us take another example Transport is a type of entity There are different gories of transport such as airliners, ships, automobiles, and trains; they are all modes

cate-of transport but each has many different attributes Differences between categories cate-oftransport are therefore differences in modes of transport Within each category there aredifferences in class For manufactured products, differences between classes implies dif-ferences in purpose Luxury cars, large family cars, small family cars, vans, trucks,four-wheel drive vehicles, etc fall within the same category of transport but each wasdesigned for a different purpose Family cars are in a different class to luxury cars; theywere not designed for the same purpose It is therefore inappropriate to compare aCadillac with a Chevrolet or a Rolls Royce Silver Shadow with a Ford Mondeo Entitiesdesigned for the same purpose but having different specifications are of different grades

A Ford Mondeo GTX is a different grade to a Mondeo LX They were both designed forthe same purpose but differ in their performance and features

Now take another example from the service industry: accommodation There are ous categories, such as rented, leased, and purchased In the rented category there arehotels, inns, guest houses, apartments, etc It would be inappropriate to compare hotelswith guest houses or apartments with inns They are each in a different class Hotels are

vari-a clvari-ass of vari-accommodvari-ation within which vari-are grvari-ades such vari-as 5 stvari-ar, 4 stvari-ar, 3 stvari-ar, etc., cating the facilities offered

indi-You can legitimately compare the quality of entities if comparing entities of the samegrade If a low-grade service meets the needs for which it was designed, it is of the req-uisite quality If a high-grade product or service fails to meet the requirements for which

it was designed, it is of poor quality, regardless of it still meeting the requirements for thelower grade There is a market for such differences in products and services but shouldcustomer expectations change then what was acceptable as a particular grade becomes

no longer acceptable and regrading has to occur

Where manufacturing processes are prone to uncontrollable variation it is not mon to grade products as a method of selection The product that is free ofimperfections would be the highest grade and would therefore command the highestprice Any product with imperfections would be downgraded and sold at a correspond-ingly lower price Examples of such practice arise in the fruit and vegetables trade andthe ceramics, glass, and textile industries In the electronic component industry, grading

uncom-is a common practice to select devices that operate between certain temperature ranges

In ideal conditions all devices would meet the higher specification but due to

manufac-Basic concepts 21

turing variation only a few may actually reach full performance The remainder of thedevices have a degraded performance but still offer all the functions of the top-gradecomponent at lower temperatures To say that these differences are not differences inquality would be misleading, since the products were all designed to fulfill the higherspecification As there is a market for such products it is expedient to exploit it There is

a range over which product quality can vary and still create satisfied customers Outsidethe lower end of this range the product is considered to be of poor quality

Quality and price

Most of us are attracted to certain products and services by their price If the price is side our reach we don’t even consider the product or service, whatever its quality, exceptperhaps to form an opinion about it We also rely on price as a comparison, hoping that

out-we can obtain the same characteristics at a loout-wer price In the luxury goods market, ahigh price is often a mark of quality but it is occasionally a confidence trick aimed atmaking more profit for the supplier When certain products and services are rare, theprice tends to be high and when plentiful the price is low, regardless of their quality Onecan purchase the same item in different stores at different prices, some as much as 50%less, many at 10% less than the highest price You can also receive a discount for buy-ing in bulk, buying on customer credit card, and being a trade customer rather than aretail customer Travelers know that goods are more expensive at the airport than fromthe country craft shop However, in the country craft shop, defective goods or “seconds”may well be on sale, whereas at the airport the supplier will want to display only the bestexamples as a rule Often an increase in the price of a product may indicate a betterservice, such as free on-site maintenance, free delivery, free telephone support line Thediscount shops may not offer such attractions

The price label on any product or service should be for a product or service free ofdefects If there are defects the label should say as much, otherwise the supplier may well

be in breach of national laws and statutes Price is therefore not a feature or istic of the product but is a feature of the service associated with it Price is negotiablefor the same quality of product Some may argue that quality is expensive but in reali-

character-ty, the saving you make on buying low-priced goods could well be eroded by inferiorservice or differences in the cost of ownership

Quality and cost

Philip Crosby published his book Quality Is Free in 1979 and caused a lot of raised brows among executives because they always believed the removal of defects was an

eye-in-built cost in running any business To get quality you had to pay for inspectors todetect the errors! What Crosby told us was that if we could eliminate all the errors andreach zero defects, we would not only reduce our costs but increase the level of customersatisfaction by several orders of magnitude In fact there is the cost of doing the rightthings right first time and the cost of not doing the right things right first time The latterare quality costs or the cost incurred because failure is possible If failure of a product, aprocess, or a service is not possible, there are no quality costs We could classify the costs

as avoidable costs and unavoidable costs We have to pay for labor, materials, facilities,machines, transport, etc These costs are unavoidable but we are also paying in addi-tion some cost to cover the prevention, detection, and removal of errors Shouldcustomers have to pay for the errors made by others? There is a basic cost if failure isnot possible and an additional cost in preventing and detecting failures and correctingerrors because our prevention and detection programs are ineffective If you reducecomplexity and install failure-prevention measures you will be spending less on failuredetection and correction There is an initial investment to be paid, but in the long termyou can meet your customer requirements at a cost far less than you were spending pre-viously Some customers are now forcing their suppliers to reduce internal costs so thatthey can offer the same products at lower prices

High quality and low quality; poor quality and good quality

When a product or service satisfies our needs we are likely to say it is of good qualityand likewise when we are dissatisfied we say the product or service is of poor quality.When the product or service exceeds our needs we will probably say it is of high quali-

ty and likewise if it falls well below our expectations we say it is of low quality

These measures of quality are all subjective What is good to one may be poor to

anoth-er In the undeveloped countries, any product, no matter what the quality, is welcomed.When you have nothing, even the poorest of goods is better than none A product maynot need to possess defects for it to be regarded as poor quality – it may not possess thefeatures that we would expect, such as access for maintenance These are design fea-tures which give a product its saleability Products and services that conform to customerrequirements are considered to be products of acceptable quality However, we need toexpress our relative satisfaction with products and services and hence use subjectiveterms such as high, low, good, or poor quality If a product that meets customer require-ments is of acceptable quality, what do we call one that does not quite meet therequirements, or perhaps exceeds the requirements? An otherwise acceptable producthas a blemish – is it now unacceptable? Perhaps not It may still be far superior to othercompeting products in its acceptable features and characteristics

Basic concepts 23

While not measurable, these subjective terms enable customers to rate products andservices on the extent to which they satisfy their requirements and are therefore suitablefor their purpose However, to the company supplying products and services, a moreprecise means of measuring quality is needed To the supplier, a quality product is onethat meets in full the perceived customer requirements.

Quality characteristics

Any feature or characteristic of a product or service which is needed to satisfy customerneeds or achieve fitness for use is a quality characteristic When dealing with productsthe characteristics are almost always technical characteristics, whereas service qualitycharacteristics have a human dimension Some typical quality characteristics are given

in the table below

Product Quality Characteristics

Availability Interchangeability Susceptibility

Appearance Maintainability Storability

Disposability Reliability Transportability

Flexibility Security

Service Quality Characteristics

These are the characteristics which need to be specified and their achievement trolled, assured, improved, managed, and demonstrated These are the characteristicswhich form the subject matter of the specified requirements referred to in ISO 9000.When the value of these characteristics is quantified or qualified they are termed quali-

con-ty requirements or requirements for qualicon-ty ISO 8402:1994 defines requirements forquality as an expression of the needs or their translation into a set of quantitatively orqualitatively stated requirements for the characteristics of an entity to enable its realiza-tion and examination While rather verbose, this definition removes the confusion overquality requirements and technical requirements (An additional definition is provided inAppendix A.) Technical requirements for a product or service are quality requirements.The requirements of ISO 9000 are quality system requirements

Quality, reliability, and safety

There is a school of thought that distinguishes between quality and reliability and ity and safety Quality is thought to be a non-time-dependent characteristic andreliability a time-dependent characteristic Quality is thought of as conformance to spec-ification regardless of whether the specification actually meets the needs of the customer

qual-or society If a product qual-or service is unreliable, it is clearly unfit fqual-or use and hence of poqual-orquality If a product is reliable but emits toxic fumes, is too heavy, or not transportablewhen required to be, it is of poor quality Similarly, if a product is unsafe it is of poorquality even though it may meet its specification in other ways In such a case the spec-ification is not a true reflection of customer needs A nuclear plant may meet all thespecified safety requirements but if society demands greater safety standards, the plant

is not meeting the quality requirements of society, even though it meets the immediatecustomer requirements You therefore need to identify your real customers in order todetermine the quality characteristics that need to be satisfied Customers are not onlythe buyers They may be users, consumers, shareholders, and society in general Theneeds of all these people have to be satisfied in order for quality to be achieved This isborne out by ISO 8402:1994 which defines the requirements of society as the obliga-tions resulting from laws, regulations, rules, codes, statutes, and other considerationsand the standard advises that all requirements of society should be taken into accountwhen defining the requirements for quality

Quality parameters

Differences in design can be denoted by grade or class but can also be the result of poorattention to customer needs It is not enough to produce products that conform to thespecifications or supply services that meet management’s requirements Quality is a

Basic concepts 25

composite of three parameters: quality of design, quality of conformance, and quality ofuse:

l Quality of design is the extent to which the design reflects a product or service thatsatisfies customer needs and expectations All the necessary characteristics should

be designed into the product or service at the outset

l Quality of conformance is the extent to which the product or service conforms tothe design standard The design has to be faithfully reproduced in the product orservice

l Quality of use is the extent by which the user is able to secure continuity of use fromthe product or service Products need to have a low cost of ownership, be safe andreliable, maintainable in use, and easy to use

Products or services that do not possess the right features and characteristics either bydesign or by construction are products of poor quality Those that fail to give customersatisfaction by being uneconomic to use are also products of poor quality, regardless oftheir conformance to specifications

to health, safety, and legal regulations

l The product quality dimension This is the extent to which the products and

servic-es provided meet the needs of specific customers

l The organization quality dimension This is the extent to which the organizationmaximizes its efficiency and effectiveness, achieving minimum waste, efficient man-agement, and good human relations Companies that do not operate efficiently or

do not meet their employees’ expectations will generally find their failure costs to behigh and will lose their best people This directly affects all aspects of quality