THE ASQ AUDITING

HANDBOOK
*
PRINCIPLES, IMPLEMENTATION, AND USE

Fourth Edition

ASQ Audit Division

J. P. Russell Editor

ASQ Quality Press

Milwaukee, Wisconsin
 Contents

List of Figures and Tables x

Foreword xiii
Notes to the Reader xiv
Acknowledgments xvii
Overview xviii

Part I Auditing Fundamentals 1

Chapter 1 Types of Quality Audits/Part IA 2
1. Method 2
2. Auditor-Auditee Relationship 4
3. Purpose 6
4. Common Elements with Other Audits 8
Chapter 2 Purpose and Scope of Audits/Part IB 11
Audit Reason 11
1. Elements of Purpose and Scope 13
2. Benefits of Audits 16
Chapter 3 Criteria to Audit Against/Part IC 18
Discussion 18
Audit Requirements 18
Chapter 4 Roles and Responsibilities of Audit Participants/Part ID 21
Audit Participants 21
Roles and Responsibilities 22
Chapter 5 Professional Conduct and Consequences for Auditors/Part IE . . . 26
1. Professional Conduct and Responsibilities 26
2. Legal Consequences 38
3. Audit Credibility . . . i 41

Part II Audit Process 47

Chapter 6 Audit Preparation and Planning/Part HA 49
1. Elements of the Audit Planning Process 51
2. Auditor Selection 59
3. Audit-Related Documentation 63
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4. Logistics 67
5. Auditing Tools and Working Papers 70
6. Auditing Strategies 75
7. Communication and Distribution of the Audit Plan 79
Chapter 7 Audit Performance/Part IIB 82
1. On-Site Audit Management 82
2. Opening Meeting 85
3. Audit Data Collection and Analysis 89
4. Establishment of Objective Evidence 97
5. Organization of Objective Evidence 98
6. Exit and Closing Meetings 101
Chapter 8 Audit Reporting/Part IIC 107
1. Report Development and Content 107
2. Effective Reports ' 116
3. Final Audit Report Steps 118
Chapter 9 Audit Follow-up and Closure/Part IID 121
1. Elements of the Corrective Action Process 121
2. Review of Corrective Action Plan 123
3. Verification of Corrective Action 126
4. Follow-up on Ineffective Corrective Action 128
5. Audit Closure 129

Part III Auditor Competencies 133

Chapter 10 Auditor Characteristics/Part IHA 134
Education and Experience 134
Interpersonal Skills 136
Personal Traits 138
Chapter 11 On-Site Audit Resource Management/Part HIB ; 139
Time-Management Skills 139
Chapter 12 Conflict Resolution/Part IIIC 141
Causes of Conflict 141
Managing Difficult Situations 142
Team Conflict :. 144
Chapter 13 Communication and Presentation Techniques/Part HID 145
Basic Rules for Effective Communication 145
Communication Technology 146
Presentation Techniques * 150
Chapter 14 Interviewing Techniques/Part HIE 151
Conversational Process 151
Avoid Asking Leading Questions 152
Interviewing a Group of People 153
Using a Translator 153
Corroborating Information 153
Potential Problems 154
 CONTENTS vii

Chapter 15 Team Dynamics/Part HIF 157

1. Team Building 157
2. Team Facilitation 159
3. Stages of Team Development 160

Part IV Audit Program Management and

Business Applications 163
Chapter 16 Audit Program Management/Part IVA 164
1. Senior Management Support 164
2. Staffing and Resource Management 165
3. Auditor Training and Development 166
4. Audit Program Evaluation 170
5. Internal Audit Program Management 174
6. External Audit Program Management (Supplier Audits) 181
7. Best Practices 186
8. Organizational Risk Management 188
9. Management Review Input 194
Management Review 195
Chapter 17 Business and Financial Impact/Part IVB 196
1. Auditing as a Management Tool 196
2. Interrelationships of Business Processes 199
3. Cost of Quality (COQ) Principles 200
4. Emerging Roles of the Auditor 205

Part V Quality Tools and Techniques 207

Chapter 18 Basic Quality and Problem-Solving Tools/Part VA 208
Pareto Charts 208
Cause-and-Effect Diagrams 209
Flowcharts and Process Mapping 210
Statistical Process Control (SPC) Charts 215
Checklists, Check Sheets, Guidelines, and Log Sheets 220
Scatter Diagrams 224
Histograms 225
Root Cause Analysis 227
Plan-Do-Check-Act (PDCA/PDSA) Cycle 230
Chapter 19 Process Improvement Techniques/Part VB 232
1. Six Sigma and the DMAIC Model. 232
2. Lean \ 234
Chapter 20 Basic Statistics/Part VC 250
1. Measures of Central Tendency 250
2. Measures of Dispersion 251
3. Qualitative and Quantitative Analysis 253
Patterns and Trends 255
Chapter 21 Process Variation/Part VD 260
1. Common and Special Causes (Theory of Variation) 260
viii Contents

2. Process Performance Metrics 264

3. Outliers 265
Chapter 22 Sampling Methods/Part VE 266
Types of Sampling 266
Statistical Sampling (Random and Systematic) 268
Sampling Standards (Acceptance Sampling) 269
Proportional Stratified Sampling 272
Risks in Sampling 273
Sampling Summary 275
Chapter 23 Change Control and Configuration Management/Part VF 278
Document Control 278
Configuration Management Control 279
Conclusion , 280
Chapter 24 Verification and Validation/Part VG 281
Techniques 281
Process Auditing and Techniques 282
Chapter 25 Risk Management Tools/Part VH 283
Quantification of Risk 283
Failure Mode and Effects Analysis 284
Critical to Quality 285
HACCP 287
HHA 288
Appendix A ASQ Code of Ethics 291
Appendix B Notes on Compliance, Conformance, and Conformity 292
Compliance 292
Conformance 292
Conformity 292
Appendix C Example Guide for Technical Specialists
(or Subject Matter Experts) 294
Introduction 294
Contact 294
Job Description 294
The Report 295
Appendix D The Institute of Internal Auditors Code of Ethics 296
Introduction 296
Applicability and Enforcement 296
Principles .* 297
Rules of Conduct 297
Appendix E History of Quality Assurance and Auditing 299
Quality Assurance and Audit Functions 299
Theories and Practices in Auditing 301
Environmental, Safety, and Health Programs and Audit Functions 304
 CONTENTS ix

Appendix F Certified Quality Auditor Body of Knowledge 306

Six Levels of Cognition based on Bloom's Taxonomy (Revised) 315
Appendix G Example Audit Program Schedule 317
Appendix H Example Third-Party Audit Organization Forms 323
Appendix I Example Audit Reports 333
Appendix J Product Line Audit Flowchart 343
Appendix K First, Second, and Third Edition Contributors and
Reviewers 345
Notes 351
Glossary 358
Index >. 363