Title:
Automotive quality systems handbook : ISO/TS 16949 : 2002 edition
Personal Author:
Edition:
2nd ed.
Publication Information:
Oxford : Elsevier Butterworth-Heinemann, 2005
ISBN:
9780750666633
Available:*
Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
|---|---|---|---|---|---|
Searching... | 30000004728881 | TL278.5 H69 2005 | Open Access Book | Book | Searching... |
On Order
Summary
Summary
ISO/TS 16949:2002 (TS2) will have a huge impact on the whole of the automobile industry as it formalises, under a single world-wide standard, the quality system that must be met by vehicle manufacturers and their suppliers. This handbook is the only comprehensive guide to understanding and satisfying the requirements of ISO/TS 16949:2002. Written by best-selling quality author David Hoyle ( ISO 9000 Quality Systems Handbook ) this new book is ideal for those new to the standard or establishing a single management system for the first time, as well as those migrating from existing quality management systems. It will suit quality system managers and quality professionals across the automotive industry, managers and executive level readers, consultants, auditors, trainers and students of management and quality.
Author Notes
David Hoyle has worked in quality management for over 25 years in a number of industry sectors, including aerospace, automotive, and computers. He is a chartered engineer, a lead auditor registered with the IRCA, and an established consultant
Table of Contents
| Preface | p. xiii |
| Acknowledgements | p. xv |
| Part 1 Understanding ISO/TS 16949 | p. 1 |
| Chapter 1 The origins | p. 3 |
| Emergence of sector requirements | p. 4 |
| Emergence of a common certification scheme | p. 13 |
| Benefits | p. 15 |
| Chapter 2 Basic concepts | p. 19 |
| Quality | p. 19 |
| Classification of products and services | p. 20 |
| Quality and price | p. 22 |
| Quality and cost | p. 22 |
| High quality and low quality; poor quality and good quality | p. 23 |
| Quality characteristics | p. 24 |
| Quality, reliability, and safety | p. 25 |
| Quality parameters | p. 25 |
| Dimensions of quality | p. 26 |
| Achieving, sustaining, and improving quality | p. 28 |
| Quality control (QC) | p. 31 |
| Quality improvement (QI) | p. 34 |
| Quality assurance (QA | p. 37 |
| Quality goals | p. 40 |
| Quality systems | p. 41 |
| Quality and ISO/TS 16949 | p. 43 |
| A postscript on definitions | p. 44 |
| Chapter 3 The differences | p. 45 |
| Provisions of ISO/TS 16949 | p. 45 |
| Scope of the standard | p. 46 |
| Differences with ISO 9001 | p. 46 |
| Differences between existing automotive quality system requirements | p. 48 |
| Additional requirements | p. 58 |
| Removed requirements | p. 60 |
| Chapter 4 Implementing ISO/TS 16949 | p. 61 |
| Step 1 Coherence check | p. 62 |
| Step 2 Cultural analysis | p. 62 |
| Step 3 System analysis | p. 63 |
| Step 4 Process analysis | p. 64 |
| Step 5 System integration | p. 64 |
| Chapter 5 Third party assessment | p. 65 |
| The ISO/TS 16949 certification scheme | p. 66 |
| Effect of the rules | p. 68 |
| Summary | p. 78 |
| Chapter 6 Self assessment | p. 79 |
| Part 2 Satisfying ISO/TS 16949 requirements | p. 85 |
| Chapter 1 Management responsibility | p. 87 |
| Scope of requirements | p. 87 |
| Quality policy (4.1.1.1) | p. 88 |
| Defining quality objectives (4.1.1.1, 4.1.1.2, and 4.1.4) | p. 102 |
| Customer satisfaction (4.1.1.3) | p. 105 |
| Continuous improvement (4.1.1.4) | p. 109 |
| Responsibility and authority (4.1.2.1) | p. 113 |
| Resources (4.1.2.2) | p. 127 |
| Management representative (4.1.2.3) | p. 130 |
| Organizational interfaces (4.1.2.4) | p. 133 |
| Management review (4.1.3) | p. 134 |
| Business plans (4.1.4) | p. 140 |
| Analysis and use of company level data (4.1.5) | p. 144 |
| Employee motivation, empowerment, and satisfaction (4.1.6) | p. 145 |
| Impact on society (4.1.7) | p. 149 |
| Chapter 2 Quality system | p. 157 |
| Scope of requirements | p. 157 |
| Establishing a documented quality system (4.2.1) | p. 159 |
| Preparing the quality manual (4.2.1) | p. 160 |
| Maintaining a quality system (4.2.1) | p. 170 |
| Quality system procedures (4.2.2) | p. 174 |
| Ensuring effective implementation (4.2.2.1b) | p. 183 |
| Quality planning (4.2.3) | p. 186 |
| Product realization (4.2.4) | p. 196 |
| Plant facility and equipment planning (4.2.5) | p. 212 |
| Tooling management (4.2.6) | p. 214 |
| Process improvement (4.2.7) | p. 215 |
| Quality system performance (4.2.8) | p. 215 |
| Chapter 3 Contract review | p. 221 |
| Scope of requirements | p. 221 |
| Procedures for contract review (4.3.1) | p. 223 |
| Coordinating contract review activities (4.3.1) | p. 224 |
| Ensuring that the requirements are adequately defined and documented (4.3.2.1a) | p. 225 |
| Resolving differences (4.3.2.1b) | p. 227 |
| Ensuring that the supplier has the capability to meet contractual requirements (4.3.2.1c) | p. 227 |
| Identifying cost elements (4.3.2.2.) | p. 229 |
| Meeting customer-specific requirements (4.3.2.2) | p. 230 |
| Amendments to contract (4.3.3) | p. 230 |
| Maintaining records of contract reviews (4.3.4) | p. 231 |
| Application of requirements | p. 231 |
| Chapter 4 Design control | p. 235 |
| Scope of requirements | p. 235 |
| Design procedures (4.4.1) | p. 237 |
| Design and development planning (4.4.2) | p. 238 |
| Design interfaces (4.4.3) | p. 242 |
| Design input (4.4.4) | p. 245 |
| Design optimization (4.4.5.2) | p. 250 |
| Design output (4.4.5) | p. 251 |
| Design reviews (4.4.6) | p. 255 |
| Design verification (4.4.7) | p. 259 |
| Design validation (4.4.8) | p. 264 |
| Design changes and modifications (4.4.9) | p. 269 |
| Chapter 5 Document and data control | p. 281 |
| Scope of requirements | p. 281 |
| Document control procedures (4.5.1) | p. 285 |
| Control of external documents (4.5.1) | p. 288 |
| Document and data review and approval (4.5.2.1) | p. 289 |
| Identifying the current revision of documents (4.5.2.1) | p. 292 |
| Ensuring the availability of controlled documents (4.5.2.1a) | p. 292 |
| Obsolete and invalid documents (4.5.2.1b and 4.5.2.1c) | p. 295 |
| Control of customer engineering specifications (4.5.2.2) | p. 297 |
| Document and data changes (4.5.3) | p. 298 |
| Issuing changed documents (4.5.3) | p. 301 |
| Chapter 6 Purchasing | p. 307 |
| Scope of requirements | p. 307 |
| Ensuring purchased product conforms to specified requirements (4.6.1.1) | p. 308 |
| Customer-approved subcontractors (4.6.1.2) | p. 311 |
| Satisfying regulatory requirements (4.6.1.3) | p. 311 |
| Evaluation and selection of subcontractors (4.6.2.1a) | p. 312 |
| Control of subcontractors (4.6.2.1b) | p. 320 |
| Records of acceptable subcontractors (4.6.2.1c) | p. 322 |
| Developing subcontractor's quality systems (4.6.2.2) | p. 324 |
| Subcontractor delivery performance (4.6.2.3) | p. 324 |
| Purchasing data (4.6.3) | p. 326 |
| Supplier verification at subcontractor's premises (4.6.4.1) | p. 328 |
| Customer verification of subcontracted product (4.6.4.2) | p. 329 |
| Chapter 7 Customer supplied product | p. 333 |
| Scope of requirements | p. 333 |
| Verification of customer supplied product (4.7.1) | p. 334 |
| Storage of customer supplied product (4.7.1) | p. 335 |
| Maintenance of customer supplied product (4.7.1) | p. 335 |
| Reporting problems to the customer (4.7.1) | p. 336 |
| Marking customer-owned tooling (4.7.2) | p. 337 |
| Chapter 8 Product identification and traceability | p. 339 |
| Scope of requirements | p. 339 |
| Procedures for identifying product | p. 340 |
| Traceability | p. 341 |
| Chapter 9 Process control | p. 345 |
| Scope of requirements | p. 345 |
| Planning production, installation, and servicing processes (4.9.1.1) | p. 347 |
| Ensuring that work is carried out under controlled conditions (4.9.1.1) | p. 348 |
| Documented procedures and job instructions (4.9.1.1 and 4.9.2) | p. 352 |
| Suitable production, installation, and servicing equipment (4.9.1.1b) | p. 355 |
| Suitable working environments (4.9.1.1b) | p. 355 |
| Compliance with reference documents (4.9.1.1c) | p. 356 |
| Controlling process and product characteristics (4.9.1.1d) | p. 357 |
| Approval of processes and equipment (4.9.1.1e) | p. 358 |
| Workmanship criteria (4.9.1.1f) | p. 358 |
| Maintenance of equipment (4.9.1.1g and 4.9.1.5) | p. 359 |
| Special processes (4.9.1.1) | p. 362 |
| Maintaining cleanliness of premises (4.9.1.2) | p. 364 |
| Preparing contingency plans (4.9.1.3) | p. 365 |
| Designation of special characteristics (4.9.1.4) | p. 366 |
| Process capability and process control (4.9.1.1g and 4.9.3) | p. 366 |
| Verification of job set-ups (4.9.4) | p. 369 |
| Appearance items (4.9.5) | p. 370 |
| Chapter 10 Inspection and testing | p. 375 |
| Scope of requirements | p. 375 |
| Inspection and test planning (4.10.1) | p. 377 |
| Receiving inspection and testing (4.10.2) | p. 379 |
| In-process inspection and testing (4.10.3a) | p. 384 |
| Final inspection and testing (4.10.4.1) | p. 386 |
| Layout inspection and functional testing (4.10.4.2) | p. 389 |
| Inspection and test records (4.10.5) | p. 390 |
| Laboratory requirements (4.10.6) | p. 392 |
| Chapter 11 Inspection, measuring, and test equipment | p. 397 |
| Scope of requirements | p. 397 |
| Inspection, measuring, and test equipment procedures (4.11.1.1) | p. 399 |
| Control of inspection, measuring, and test equipment (4.11.1.1) | p. 401 |
| Calibration of inspection, measuring, and test equipment (4.11.1.1) | p. 402 |
| Maintenance of inspection, measuring, and test equipment (4.11.1.1) | p. 404 |
| Control, calibration, and maintenance of test software (4.11.1.1) | p. 404 |
| Ensuring measurement uncertainty is known (4.11.1.1) | p. 405 |
| Proving test hardware, comparative references, and test software (4.11.1.1) | p. 406 |
| Measurement systems analysis (4.11.1.2) | p. 408 |
| Identifying measurements to be made and accuracy required (4.11.2a) | p. 409 |
| Selecting appropriate inspection, measuring, and test equipment (4.11.2a) | p. 410 |
| Calibration operations | p. 413 |
| Protection of measuring equipment | p. 419 |
| Chapter 12 Inspection and test status | p. 427 |
| Scope of requirements | p. 427 |
| Identifying inspection and test status | p. 427 |
| Maintaining inspection and test status | p. 430 |
| Inspection and test status procedures | p. 430 |
| Chapter 13 Control of nonconforming product | p. 433 |
| Scope of requirements | p. 433 |
| Classifying nonconformities | p. 435 |
| Ensuring that nonconforming product is not used (4.13.1.1) | p. 436 |
| Identifying nonconforming product (4.13.1.1 and 4.13.1.2) | p. 436 |
| Documenting nonconforming product (4.13.1.1) | p. 437 |
| Evaluation of nonconforming product (4.13.1.1) | p. 438 |
| Segregation of nonconforming product (4.13.1.1 and 4.13.1.2) | p. 438 |
| Disposition of nonconforming product (4.13.1.1) | p. 438 |
| Nonconformity reduction plan | p. 439 |
| Defining disposition responsibility (4.13.2) | p. 439 |
| Review of nonconforming product (4.13.2, 4.13.3, and 4.15.3.2) | p. 440 |
| Use of nonconforming product (4.13.2 and 4.13.1.3) | p. 443 |
| Deviating from approved processes (4.13.4) | p. 444 |
| Recording the actual condition of nonconforming product (4.13.2) | p. 445 |
| Re-inspection of repaired and reworked product (4.13.2) | p. 445 |
| Chapter 14 Corrective and preventive action | p. 449 |
| Scope of requirements | p. 449 |
| Corrective and preventive action procedures (4.14.1.1) | p. 452 |
| Assessing the degree of corrective and preventive action necessary (4.14.1.1) | p. 453 |
| Implementing and recording changes in procedures (4.14.1.1) | p. 453 |
| Corrective action (4.14.2) | p. 454 |
| Preventive action (4.14.3) | p. 462 |
| Chapter 15 Handling, storage, packaging, preservation, and delivery | p. 473 |
| Scope of requirements | p. 473 |
| Handling, storage, packaging, preservation, and delivery procedures (4.15.1) | p. 475 |
| Handling (4.15.2) | p. 475 |
| Storage (4.15.3) | p. 476 |
| Inventory (4.15.3.2) | p. 479 |
| Controlling packing, packaging, and marking processes (4.15.4.1) | p. 480 |
| Preserving and segregating product (4.15.5) | p. 483 |
| Delivery (4.15.6) | p. 484 |
| Monitoring performance to customer delivery requirements (4.15.6.2) | p. 486 |
| Chapter 16 Control of quality records | p. 491 |
| Scope of requirements | p. 491 |
| Types of quality records | p. 491 |
| Identification of quality records | p. 495 |
| Collection of quality records | p. 496 |
| Indexing of quality records | p. 496 |
| Access to quality records | p. 496 |
| Filing quality records | p. 497 |
| Storage of quality records | p. 497 |
| Maintenance of quality records | p. 498 |
| Disposition of quality records | p. 499 |
| Demonstrating conformance to specified requirements | p. 499 |
| Demonstrating the effective operation of the quality system | p. 500 |
| Pertinent subcontractor quality records | p. 501 |
| Retention of quality records | p. 501 |
| Availability of quality records | p. 502 |
| Quality records procedures | p. 503 |
| Authentication of records | p. 503 |
| Chapter 17 Internal quality audits | p. 507 |
| Scope of requirements | p. 507 |
| Audit procedures (4.17.1) | p. 508 |
| The audit program (4.17.1) | p. 510 |
| Planning quality audits | p. 511 |
| Verifying compliance with planned arrangements (4.17.1) | p. 512 |
| Determining the effectiveness of the system (4.17.1) | p. 514 |
| Scheduling quality audits (4.17.1) | p. 515 |
| The independence of auditors (4.17.1) | p. 516 |
| Reporting the results of audits (4.17.1) | p. 517 |
| Taking timely corrective action (4.17.1) | p. 518 |
| Follow-up audits (4.17.1) | p. 519 |
| Auditor qualification (4.17.3) | p. 519 |
| Chapter 18 Training | p. 525 |
| Scope of requirements | p. 525 |
| Identifying training needs (4.18.1) | p. 527 |
| Providing for training (4.18.1 and 4.18.3) | p. 529 |
| Qualification of personnel (4.18.1) | p. 531 |
| Evaluation of training effectiveness (4.18.2) | p. 532 |
| Maintaining training records (4.18.1) | p. 533 |
| Increasing sensitivity to customer requirements (4.18.3) | p. 534 |
| Chapter 19 Servicing | p. 537 |
| Scope of requirements | p. 537 |
| Performing servicing (4.19.1) | p. 539 |
| Reporting that services meet specified requirements (4.19.1) | p. 541 |
| Verifying that servicing meets specified requirements (4.19.1) | p. 543 |
| Communication of service concerns (4.19.2) | p. 543 |
| Servicing agreements with customer (4.19.3) | p. 544 |
| Chapter 20 Statistical techniques | p. 547 |
| Scope of requirements | p. 547 |
| Identifying the need for statistical techniques (4.20.1) | p. 548 |
| Implementing and controlling the application of statistical techniques (4.20.2) | p. 550 |
| Knowledge of basic statistical concepts (4.10.4) | p. 550 |
| Appendices | |
| A Glossary of terms | p. 553 |
| B Acronyms | p. 567 |
| C Bibliography | p. 568 |
| D Relationship of clauses | p. 570 |
| Index | p. 571 |
