The Complete Guide to the CQA
by Stephen M. Baysinger
Introduction xv
PART I: GENERAL KNOWLEDGE, PROFESSIONAL CONDUCT, AND ETHICS AND AUDIT ADMINISTRATION
Chapter 1 General knowledge 3
1. Section 1 Characteristics of audits 3
1. Section 1.1 Quality audits 4
1. Section 1.2 System, process, product, and compliance audits 5
1. Section 1.3 First party (internal), second party (external), and third party audits 15
1. Section 1.4 Qualitative and quantitative audit methods 20
1. Section 1.5 Objective evidence 21
1. Section 2 Use of standard auditing terms and definitions 22
1. Section 3 Benefits of audits 23
1. Section 4 Continuous education rescources for auditors 28
1. Section 5 Changes and trends in auditing 30
Chapter 2 Ethics and professional conduct 37
2. Section 1 American Society for Quality code of ethics 37
2. Section 2 Standards of behavior and performance for an auditor 39
2. Section 3 Confidentiality concerns throughout the audit process 41
2. Section 4 The auditor's ethical responsibilities 42
2. Section 5 Methods for resolving difficult situations 44
2. Section 6 Language when communicating with management 45
Chapter 3 Audit administration 49
3. Section 1 Audit program objectives 49
3. Section 2 Methods for building credibility in the audit function 50
3. Section 3 Management of the audit function 50
PART II: AUDIT PREPARATION
Chapter 4 Audit plan preparation and documentation 57
4. Section 1 Purpose 57
4. Section 2 Scope 62
4. Section 3 Assigning human resources to the audit team 63
Chapter 5 Audit team member selection criteria 67
5. Section 1 Credentials and expertise 67
5. Section 2 Auditor and lead auditor responsibilities 68
Chapter 6 Source of authority 71
6. Section 1 Standards 71
6. Section 1.1 National/governmental standards 74
6. Section 1.2 Industry standards 75
6. Section 2 Hierarchy of standards 76
6. Section 3 Organizational standards 78
6. Section 4 Regulatory standards 80
6. Section 5 Contractual standards 81
Chapter 7 Requirements against which to audit 85
7. Section 1 Standards 85
7. Section 2 Contracts 88
7. Section 3 Specifications 94
7. Section 4 Policy 94
Chapter 8 Importance and utility of quality documentation 97
8. Section 1 Appropriate, adequate, accurate and current 97
8. Section 2 Prior information 100
Chapter 9 Checklists 103
9. Section 1 The appropriate use of checklists 103
9. Section 2 Checklists tailored to the specific audit 104
Chapter 10 Development of data collection methods 109
10. Section 1 Selecting approproate tools 109
10. Section 2 Training the auditor in the use of data collection methods 110
10. Section 3 Criteria for selecting methods 119
Chapter 11 Audit plan 121
PART III: AUDIT PERFORMANCE
Chapter 12 conducting the entrance meeting 135
12. Section 1 Agenda 135
12. Section 2 Audit file folders and working papers folders 140
12. Section 3 Responsibilities and roles 141
12. Section 4 Entrance meeting attendees 143
Chapter 13 Audit team managements 145
13. Section 1 General auditing strategies 145
13. Section 1.1 Trace forward and trace backward 145
13. Section 1.2 Discovery 147
13. Section 1.3 Department and element examination 148
13. Section 2 Management of the audit team 148
Chapter 14 Audit implementation 151
14. Section 1 Interviewing/questioning techniques 151
14. Section 1.1 Individual and group 157
14. Section 1.2 Telephone and remote (questionnaire) 161
14. Section 2 Purposes and uses of data collection methods 163
14. Section 2.1 Detection 163
14. Section 2.2 Analysis and summary 165
14. Section 2.3 Presentation of data--visual aids 168
14. Section 3 Methods for verifying documents and records 171
14. Section 3.1 Tracing 171
14. Section 3.2 Sampling 174
14. Section 3.3 Physical examination 176
14. Section 4 Calibration principles and practices 177
14. Section 4.1 Traceability to recognized international and national standards 181
Chapter 15 Audit analysis 185
15. Section 1 Distinction between chronic and sporadic incidents 185
15. Section 2 Classification of nonconformances 187
15. Section 3 Measures for determining effectiveness of controls 187
Chapter 16 Exit meeting 191
16. Section 1 Elements of the closing meeting 191
PART IV: AUDIT REPORTING, CORRECTIVE ACTION, AND CLOSURE
Chapter 17 Reporting 199
17. Section 1 Format and contents of the formal audit report 199
17. Section 2 Techniques for prioritizing significant findings, observations and conclusions 205
17. Section 2.1 Pareto analysis 205
17. Section 2.2 Cost and risk benefit analysis 211
17. Section 2.3 Criticality 213
17. Section 3 Recognition of potential effects for similar conditions elsewhere in the system/organization 214
Chapter 18 Corrective action and follow-up 217
18. Section 1 Corrective action 217
18. Section 2 Criteria for acceptable corrective action--timeliness 221
18. Section 3 Strategies for verifying the effectiveness of corrective action 222
18. Section 3.1 Check action versus standard 222
18. Section 3.2 Review the quality of data 227
18. Section 3.3 Documentation evaluation 229
18. Section 3.4 Follow-up audit 230
18. Section 4 Relationship between the auditing function and continuous improvement 232
Chapter 19 Closure 239
19. Section 1 Criteria for closure 239
19. Section 1.1 Time period 239
19. Section 1.2 Corrective action received, verified and accepted 240
19. Section 1.3 Pertinent paperwork and retention criteria 241
19. Section 1.4 Notice to auditee of audit closure 241
PART V: AUDITING TOOLS AND TECHNIQUES
Chapter 20 Auditing techniques 247
20. Section 1 Observation techniques 247
20. Section 2 Physical examination tools and techniques 250
20. Section 3 Presentation methods and techniques 250
20. Section 4 Time management techniques 253
20. Section 5 Sampling theory, procedures and applications for auditing 259
Chapter 21 Auditing tools 263
21. Section 1 Definition and use of charts 263
21. Section 1.1 Flowchart/process maps 263
21. Section 1.2 Pareto charts 264
21. Section 1.3 Cause-and-effect diagrams 265
21. Section 1.4 Control/trend charting
21. Section 1.4.1 Variables 270
21. Section 1.4.2 Attributes 271
21. Section 2 Graphs 272
21. Section 2.1 Histograms 272
21. Section 2.2 Frequency distributions 279
21. Section 2.3 Process capability 281
21. Section 3 Pattern and trend analysis (using run charts) 286
21. Section 4 Root cause analysis 293
21. Section 5 Descriptive statistics 298
21. Section 5.1 Central tendency 298
21. Section 5.2 Range and standard deviation 299
Appendix list of tables 301
Appendix A Quality procedures--examples 303
Appendix A.1 Example of inspection procedure 303
Appendix A.2 Example of a warehouse procedure 306
Appendix B Quality manual example--Myria Aircraft Company 309
Appendix C Glossary of standard auditing terms and definitions 325
Appendix D Quality system audit checklist 337
Appendix D.1 Quality policy and management 337
Appendix D.2 Engineering (design control and management) 341
Appendix D.3 Documentation (management and control) 342
Appendix D.4 Purchasing 343
Appendix D.5 Control of customer supplied parts, material or equipment 344
Appendix D.6 Product identification and traceability 345
Appendix D.7 Process control 346
Appendix D.8 Inspection and evaluation of product or service 347
Appendix D.9 Measurement and Test Equipment (M & TE) calibration and tracking 348
Appendix D.10 Management and disposition of nonconforming material 350
Appendix D.11 Corrective and preventative action 351
Appendix D.12 Quality information and cost analysis 352
Appendix D.13 Internal quality audits 353
Appendix D.14 Training 354
Appendix D.15 Statistical process control 354
Appendix D.16 Consumer satisfaction assessment 355/font>
Appendix E The ISO 9000 registration process 357
Appendix F ANSI Standard N45.2 (Quality assurance program for nuclear power plants) 361
Appendix G Electronic document management technology 365
Appendix H NASA's Supplier Process-Product Integrity Audit (SPPIA) 369
Appendix I Control charts 377
Appendix J Statistical analysis of process capability data 411
References 423
Index 429
About the author 443
| 
