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Automotive
Quality Systems
Handbook
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Automotive
Quality Systems
Handbook
David Hoyle
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Butterworth-Heinemann Ltd
Linacre House, Jordan Hill, Oxford OX2 8DP
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
may be reproduced in any material form (including
photocopying or storing in any medium by electronic
means and whether or not transiently or incidentally
to some other use of this publication) without the
written permission of the copyright holder except
in accordance with the provisions of the Copyright,
Designs and Patents Act 1988 or under the terms of a
licence issued by the Copyright Licensing Agency Ltd,
90 Tottenham Court Road, London, England W1P 9HE.
Applications for the copyright holders written permission
to reproduce any part of this publication should be addressed
to the publishers
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
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Preface xiii
Acknowledgements xv
Part 1 Understanding ISO/TS 16949 1
Chapter 1 The origins 3
Emergence of sector requirements 4
Emergence of a common certification scheme 13
Benefits 15
Chapter 2 Basic concepts 19
Quality 19
Classification of products and services 20
Quality and price 22
Quality and cost 22
High quality and low quality; poor quality and good quality 23
Quality characteristics 24
Quality, reliability, and safety 25
Quality parameters 25
Dimensions of quality 26
Achieving, sustaining, and improving quality 28
Quality control (QC) 31
Quality improvement (QI) 34
Quality assurance (QA) 37
Quality goals 40
Quality systems 41
Quality and ISO/TS 16949 43
A postscript on definitions 44
Chapter 3 The differences 45
Provisions of ISO/TS 16949 45
Scope of the standard 46
Differences with ISO 9001 46
Differences between existing automotive quality system requirements 48
Additional requirements 58
Removed requirements 60
Contents
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Chapter 4 Implementing ISO/TS 16949 61
Step 1 Coherence check 62
Step 2 Cultural analysis 62
Step 3 System analysis 63
Step 4 Process analysis 64
Step 5 System integration 64
Chapter 5 Third party assessment 65
The ISO/TS 16949 certification scheme 66
Effect of the rules 68
Summary 78
Chapter 6 Self assessment 79
Part 2 Satisfying ISO/TS 16949 requirements 85
Chapter 1 Management responsibility 87
Scope of requirements 87
Quality policy (4.1.1.1) 88
Defining quality objectives (4.1.1.1, 4.1.1.2, and 4.1.4) 102
Customer satisfaction (4.1.1.3) 105
Continuous improvement (4.1.1.4) 109
Responsibility and authority (4.1.2.1) 113
Resources (4.1.2.2) 127
Management representative (4.1.2.3) 130
Organizational interfaces (4.1.2.4) 133
Management review (4.1.3) 134
Business plans (4.1.4) 140
Analysis and use of company level data (4.1.5) 144
Employee motivation, empowerment, and satisfaction (4.1.6) 145
Impact on society (4.1.7) 149
Chapter 2 Quality system 157
Scope of requirements 157
Establishing a documented quality system (4.2.1) 159
Preparing the quality manual (4.2.1) 160
Maintaining a quality system (4.2.1) 170
Quality system procedures (4.2.2) 174
Ensuring effective implementation (4.2.2.1b) 183
Quality planning (4.2.3) 186
Product realization (4.2.4) 196
Plant facility and equipment planning (4.2.5) 212
Tooling management (4.2.6) 214
Process improvement (4.2.7) 215
Quality system performance (4.2.8) 215
Chapter 3 Contract review 221
Scope of requirements 221
Procedures for contract review (4.3.1) 223
Coordinating contract review activities (4.3.1) 224
Ensuring that the requirements are adequately defined and
documented (4.3.2.1a) 225
Resolving differences (4.3.2.1b) 227
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Ensuring that the supplier has the capability to meet contractual
requirements (4.3.2.1c) 227
Identifying cost elements (4.3.2.2) 229
Meeting customer-specific requirements (4.3.2.2) 230
Amendments to contract (4.3.3) 230
Maintaining records of contract reviews (4.3.4) 231
Application of requirements 231
Chapter 4 Design control 235
Scope of requirements 235
Design procedures (4.4.1) 237
Design and development planning (4.4.2) 238
Design interfaces (4.4.3) 242
Design input (4.4.4) 245
Design optimization (4.4.5.2) 250
Design output (4.4.5) 251
Design reviews (4.4.6) 255
Design verification (4.4.7) 259
Design validation (4.4.8) 264
Design changes and modifications (4.4.9) 269
Chapter 5 Document and data control 281
Scope of requirements 281
Document control procedures (4.5.1) 285
Control of external documents (4.5.1) 288
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
Document and data changes (4.5.3) 298
Issuing changed documents (4.5.3) 301
Chapter 6 Purchasing 307
Scope of requirements 307
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
Control of subcontractors (4.6.2.1b) 320
Records of acceptable subcontractors (4.6.2.1c) 322
Developing subcontractors quality systems (4.6.2.2) 324
Subcontractor delivery performance (4.6.2.3) 324
Purchasing data (4.6.3) 326
Supplier verification at subcontractors premises (4.6.4.1) 328
Customer verification of subcontracted product (4.6.4.2) 329
Chapter 7 Customer supplied product 333
Scope of requirements 333
Verification of customer supplied product (4.7.1) 334
Storage of customer supplied product (4.7.1) 335
Maintenance of customer supplied product (4.7.1) 335
Reporting problems to the customer (4.7.1) 336
Marking customer-owned tooling (4.7.2) 337
Contents vii
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Chapter 8 Product identification and traceability 339
Scope of requirements 339
Procedures for identifying product 340
Traceability 341
Chapter 9 Process control 345
Scope of requirements 345
Planning production, installation, and servicing processes (4.9.1.1) 347
Ensuring that work is carried out under controlled conditions (4.9.1.1) 348
Documented procedures and job instructions (4.9.1.1 and 4.9.2) 352
Suitable production, installation, and servicing equipment (4.9.1.1b) 355
Suitable working environments (4.9.1.1b) 355
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
Workmanship criteria (4.9.1.1f) 358
Maintenance of equipment (4.9.1.1g and 4.9.1.5) 359
Special processes (4.9.1.1) 362
Maintaining cleanliness of premises (4.9.1.2) 364
Preparing contingency plans (4.9.1.3) 365
Designation of special characteristics (4.9.1.4) 366
Process capability and process control (4.9.1.1g and 4.9.3) 366
Verification of job set-ups (4.9.4) 369
Appearance items (4.9.5) 370
Chapter 10 Inspection and testing 375
Scope of requirements 375
Inspection and test planning (4.10.1) 377
Receiving inspection and testing (4.10.2) 379
In-process inspection and testing (4.10.3a) 384
Final inspection and testing (4.10.4.1) 386
Layout inspection and functional testing (4.10.4.2) 389
Inspection and test records (4.10.5) 390
Laboratory requirements (4.10.6) 392
Chapter 11 Inspection, measuring, and test equipment 397
Scope of requirements 397
Inspection, measuring, and test equipment procedures (4.11.1.1) 399
Control of inspection, measuring, and test equipment (4.11.1.1) 401
Calibration of inspection, measuring, and test equipment (4.11.1.1) 402
Maintenance of inspection, measuring, and test equipment (4.11.1.1) 404
Control, calibration, and maintenance of test software (4.11.1.1) 404
Ensuring measurement uncertainty is known (4.11.1.1) 405
Proving test hardware, comparative references, and test software (4.11.1.1) 406
Measurement systems analysis (4.11.1.2) 408
Identifying measurements to be made and accuracy required (4.11.2a) 409
Selecting appropriate inspection, measuring, and test equipment (4.11.2a) 410
Calibration operations 413
Protection of measuring equipment 419
Chapter 12 Inspection and test status 427
Scope of requirements 427
Identifying inspection and test status 427
Maintaining inspection and test status 430
Inspection and test status procedures 430
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Chapter 13 Control of nonconforming product 433
Scope of requirements 433
Classifying nonconformities 435
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
Nonconformity reduction plan 439
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
Chapter 14 Corrective and preventive action 449
Scope of requirements 449
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
Corrective action (4.14.2) 454
Preventive action (4.14.3) 462
Chapter 15 Handling, storage, packaging, preservation, and delivery 473
Scope of requirements 473
Handling, storage, packaging, preservation, and delivery procedures (4.15.1) 475
Handling (4.15.2) 475
Storage (4.15.3) 476
Inventory (4.15.3.2) 479
Controlling packing, packaging, and marking processes (4.15.4.1) 480
Preserving and segregating product (4.15.5) 483
Delivery (4.15.6) 484
Monitoring performance to customer delivery requirements (4.15.6.2) 486
Chapter 16 Control of quality records 491
Scope of requirements 491
Types of quality records 491
Identification of quality records 495
Collection of quality records 496
Indexing of quality records 496
Access to quality records 496
Filing quality records 497
Storage of quality records 497
Maintenance of quality records 498
Disposition of quality records 499
Demonstrating conformance to specified requirements 499
Demonstrating the effective operation of the quality system 500
Pertinent subcontractor quality records 501
Retention of quality records 501
Availability of quality records 502
Quality records procedures 503
Authentication of records 503
Contents ix
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Chapter 17 Internal quality audits 507
Scope of requirements 507
Audit procedures (4.17.1) 508
The audit program (4.17.1) 510
Planning quality audits 511
Verifying compliance with planned arrangements (4.17.1) 512
Determining the effectiveness of the system (4.17.1) 514
Scheduling quality audits (4.17.1) 515
The independence of auditors (4.17.1) 516
Reporting the results of audits (4.17.1) 517
Taking timely corrective action (4.17.1) 518
Follow-up audits (4.17.1) 519
Auditor qualification (4.17.3) 519
Chapter 18 Training 525
Scope of requirements 525
Identifying training needs (4.18.1) 527
Providing for training (4.18.1 and 4.18.3) 529
Qualification of personnel (4.18.1) 531
Evaluation of training effectiveness (4.18.2) 532
Maintaining training records (4.18.1) 533
Increasing sensitivity to customer requirements (4.18.3) 534
Chapter 19 Servicing 537
Scope of requirements 537
Performing servicing (4.19.1) 539
Reporting that services meet specified requirements (4.19.1) 541
Verifying that servicing meets specified requirements (4.19.1) 543
Communication of service concerns (4.19.2) 543
Servicing agreements with customer (4.19.3) 544
Chapter 20 Statistical techniques 547
Scope of requirements 547
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
Appendices
A Glossary of terms 553
B Acronyms 567
C Bibliography 568
D Relationship of clauses 570
Index 571
x Contents
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[...]... 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) autoack.qxd... acted more promptly Since 1994, the automotive industry in the USA and Europe has been operating quality system certification schemes that extended the requirements of ISO 9001, ISO 10011, and EN 45012 One of these schemes was addressed by my QS-9000 Quality Systems Handbook, published in 1996 In the same year the automakers of the USA and Europe formed the International Automotive Task Force (IATF) which,... in two parts, with the first part devoted to the origins of the standard and the differences between ISO/TS 16949 and other automotive quality system requirements, with some guidance on implementation I have included a chapter on basic concepts from my ISO 9000 Quality Systems Handbook, with some slight modification The second part is divided into chapters that reflect the order of subsections in section... certification/registration bodies ISO Guide 62:1996 General requirements for bodies operating assessment and certification/registration of quality systems ISO 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 certification of personnel ISO 9000 is not a statutory... invoking their own quality system requirements within contracts, perpetuating fragmentation and duplication, and driving up costs Until ISO 9000 emerged in 1987, the automotive industry used a variety of customerspecific standards to govern a suppliers quality management practices The British contribution Prior to the publication of ISO 9000, several nations had developed national quality system standards,... equipment With the emergence of the NATO Quality Control System standards in 1973, the Quality Panel of the UK Society of Motor Manufacturers set out to develop an equivalent standard for non-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 Quality Assurance Systems However, BS 5179 was intended only... Geneva with a view to developing an international quality system standard and eventually a committee 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 forefront of the development of non-military quality system standards, harmonization within the automotive sector beyond BS 5750 was believed too... competency will be autopref.qxd 10/04/00 21:23 Page xii NEE 2HAB=?A enhanced, a higher level of confidence should begin to develop within the global automotive industry, and product quality will improve not that quality has been a significant problem in the automotive industry in the last 10 years! I bought my first car in the mid 1960s, at a time when rust started to appear before cars were three years... is not a quality product So the final arbiter on quality is the customer The customer is the only one who can decide whether the quality of the products and services you supply is satisfactory and you will be conscious of this either by direct feedback or by loss of sales, reduction in market share, and, ultimately, loss of business There are other considerations in understanding the word quality, ... differences are not differences in quality would be misleading, since the products were all designed to fulfill the higher specification 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 Outside the lower end of this range the product is considered to be of poor quality Quality and price Most of us . Automotive
Quality Systems
Handbook
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Automotive
Quality Systems
Handbook
David. 19
Quality 19
Classification of products and services 20
Quality and price 22
Quality and cost 22
High quality and low quality; poor quality and good quality
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