Automotive Quality Systems Handbook autottl.qxd 10/04/00 21:21 Page i autottl.qxd 10/04/00 21:21 Page ii Automotive Quality Systems Handbook David Hoyle autottl.qxd 10/04/00 21:21 Page iii 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 autottl.qxd 10/04/00 21:21 Page iv 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 autotoc.qxd 10/04/00 21:22 Page v 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 vi Contents autotoc.qxd 10/04/00 21:22 Page vi 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 autotoc.qxd 10/04/00 21:22 Page vii 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 viii Contents autotoc.qxd 10/04/00 21:22 Page viii 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 autotoc.qxd 10/04/00 21:22 Page ix 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 autotoc.qxd 10/04/00 21:22 Page x [...]... 19 24 DaimlerChrysler USA 19 98 - 50% Daimler UK 18 93 Ford USA 19 89 Mazda Japan 19 20 Ford USA 19 79 - 25% 19 96 - 33% Volvo Sweden 19 27 Ford USA 19 99 Aston Martin UK 19 14 Ford USA Jaguar UK 19 36 Ford USA 19 89 Holden Australia 19 31 GM USA 19 31 Adam Opel AG Germany 18 98 GM USA 19 29 Isuzu Japan 19 37 GM USA 19 71 Seat Spain VW USA 19 86 - 51% Saab Sweden 19 47 GM USA 50% Vauxhall UK 19 03 GM USA 19 25 Table 1- 1... Czechoslovakia 19 36 VW Germany 19 90 Audi Germany 18 99 VW Germany 19 69 Bugatti Italy 18 81 VW Germany 19 98 Rolls Royce UK 19 04 VW Germany 19 98 Alfa Romeo Italy 19 06 Fiat Italy 19 86 Ferrari Italy 19 40 Fiat Italy 19 69 - 50% 19 88 - 10 0% Lancia Italy 19 06 Fiat Italy 19 79 Kia Korea 19 44 Hyundai Korea 19 98 - 51% Lotus UK 19 48 Proton Malaysia 19 96 Simca France 19 30 Chrysler USA 19 67 Lamborghini Italy 19 21 Chrysler USA 19 87... 0-7506-4024-3) QS-9000 Quality Systems Handbook 19 96 (ISBN 0-7506-98 61- 6) ISO 9000 Quality System Assessment Handbook 19 96 (ISBN 0-7506-2563-5) ISO 9000 Quality System Development Handbook 19 98 (ISBN 0-7506-2562-7) ISO 9000 Pocket Guide 19 98 (ISBN 0-7506-4025 -1) autoack.qxd 10 /04/00 21: 25 Page xiv auto100.qxd 10 /04/00 21: 26 Page 2 auto1 01. qxd 10 /04/00 21: 26 Page 5 The origins 5 may seem to be a retrograde step... owns who? auto1 01. qxd 10 /07/00 16 :34 Page 10 10 The origins ANFIA Fiat Auto AVSQ IVECO FIEV PSA Peugeot Citroen Renault EAQF VDA IATF ISO/TS 16 949 Adam Opel Audi BMW Daimler Benz VDA 6 .1 Ford Werke VW AIAG Daimler-Chrysler Ford QS-9000 General Motors SMMT Figure 1. 1 Contributors to ISO/TS 16 949 Both Adam Opel AG and Ford Werke AG require QS-9000 compliance and both participated in VDA 6 .1 as well as... NATO Quality Control System standards in 19 73, 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 48 91, which was published in 19 72 In 19 74 this was followed by BS 517 9 with the title Operation and Evaluation of Quality Assurance Systems However, BS 517 9 was intended only as a guide and it was not until 19 79,... Opel AG and Ford Werke AG require QS-9000 compliance and both participated in VDA 6 .1 as well as QS-9000 auto1 01. qxd 10 /04/00 21: 26 Page 11 The origins 11 Harmonization The automotive industry has comprised multinational corporations for many decades but there has been little harmonization in quality system requirements across all plants QS-9000 harmonized these requirements not only in the USA but... 9000:2000 SMMT (UK) BS 5750 ISO 9000 :19 87 VDA (Germany) VDA 6 AIAG (USA) QS-9000 ANFIA (Italy) AVSQ CCFA/FIEV (France) EAQF IATF Figure 1. 2 Evolution of ISO/TS 16 949 ISO/TS 16 949 auto1 01. qxd 10 /04/00 21: 26 Page 12 12 The origins The interface between IATF and ISO/TC 17 6 was in the form of a pilot study to consider the implication of sector standards The output was in the form of a new ISO document:... perform any further quality system audits of ISO/TS 16 949 registered suppliers auto1 01. qxd 10 /04/00 21: 26 Page 18 18 The origins Reduction in multiple third party registrations Currently a supplier supplying customers in the USA and Europe needs to seek certification 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... ISO/TS 16 946, readers are strongly advised to have access to this technical specification, the ISO 9000 family of standards, 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 19 98 (ISBN 0-7506-4024-3) QS-9000 Quality Systems Handbook 19 96 (ISBN... Following publication of ISO 9000:2000 towards the end of 2000, work will commence on upgrading ISO/TS 16 949 It is anticipated that if ISO/TS 16 949:2000 is accepted by the international automotive community, QS-9000, VDA 6, AVSQ 94, and EAQF 94 will be withdrawn auto1 01. qxd 10 /04/00 21: 26 Page 14 14 The origins There are, however, many weaknesses: l In many countries, there is no law prohibiting an . requirements 87 Quality policy (4 .1. 1 .1) 88 Defining quality objectives (4 .1. 1 .1, 4 .1. 1.2, and 4 .1. 4) 10 2 Customer satisfaction (4 .1. 1.3) 10 5 Continuous improvement (4 .1. 1.4) 10 9 Responsibility. Automotive Quality Systems Handbook autottl.qxd 10 /04/00 21: 21 Page i autottl.qxd 10 /04/00 21: 21 Page ii Automotive Quality Systems Handbook David Hoyle autottl.qxd 10 /04/00 21: 21 Page. 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)