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

Foreword
Notes to the Reader
Acknowledgments
Overview

x
xiii
xiv
xvii
xviii

Part I Auditing Fundamentals

Chapter 1 Types of Quality Audits/Part IA

1. Method
2. Auditor-Auditee Relationship
3. Purpose
4. Common Elements with Other Audits

2
2
4
6
8

Chapter 2 Purpose and Scope of Audits/Part IB

Audit Reason
1. Elements of Purpose and Scope
2. Benefits of Audits

11
11
13
16

Chapter 3 Criteria to Audit Against/Part IC

Discussion
Audit Requirements

18
18
18

Chapter 4 Roles and Responsibilities of Audit Participants/Part ID

Audit Participants
Roles and Responsibilities

21
21
22

Chapter 5 Professional Conduct and Consequences for Auditors/Part IE . . .

1. Professional Conduct and Responsibilities
2. Legal Consequences
3. Audit Credibility . . . i

26
26
38
41

Part II Audit Process

47

Chapter 6 Audit Preparation and Planning/Part HA

1. Elements of the Audit Planning Process
2. Auditor Selection
3. Audit-Related Documentation

49
51
59
63

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Contents
4. Logistics
5. Auditing Tools and Working Papers
6. Auditing Strategies
7. Communication and Distribution of the Audit Plan

67
70
75
79

Chapter 7 Audit Performance/Part IIB

1. On-Site Audit Management
2. Opening Meeting
3. Audit Data Collection and Analysis
4. Establishment of Objective Evidence
5. Organization of Objective Evidence
6. Exit and Closing Meetings

82
82
85
89
97
98
101

Chapter 8 Audit Reporting/Part IIC

1. Report Development and Content
2. Effective Reports
'
3. Final Audit Report Steps

107
107
116
118

Chapter 9 Audit Follow-up and Closure/Part IID

1. Elements of the Corrective Action Process
2. Review of Corrective Action Plan
3. Verification of Corrective Action
4. Follow-up on Ineffective Corrective Action
5. Audit Closure

121
121
123
126
128
129

Part III Auditor Competencies

133

Chapter 10 Auditor Characteristics/Part IHA

Education and Experience
Interpersonal Skills
Personal Traits

134
134
136
138

Chapter 11 On-Site Audit Resource Management/Part HIB

Time-Management Skills

139
139

Chapter 12 Conflict Resolution/Part IIIC

Causes of Conflict
Managing Difficult Situations
Team Conflict

:.

141
141
142
144

Chapter 13 Communication and Presentation Techniques/Part HID

Basic Rules for Effective Communication
Communication Technology
Presentation Techniques
*

145
145
146
150

Chapter 14 Interviewing Techniques/Part HIE

Conversational Process
Avoid Asking Leading Questions
Interviewing a Group of People
Using a Translator
Corroborating Information
Potential Problems

151
151
152
153
153
153
154

CONTENTS

vii

Chapter 15 Team Dynamics/Part HIF

1. Team Building
2. Team Facilitation
3. Stages of Team Development

157
157
159
160

Part IV Audit Program Management and

Business Applications

163

Chapter 16 Audit Program Management/Part IVA

1. Senior Management Support
2. Staffing and Resource Management
3. Auditor Training and Development
4. Audit Program Evaluation
5. Internal Audit Program Management
6. External Audit Program Management (Supplier Audits)
7. Best Practices
8. Organizational Risk Management
9. Management Review Input
Management Review

164
164
165
166
170
174
181
186
188
194
195

Chapter 17 Business and Financial Impact/Part IVB

1. Auditing as a Management Tool
2. Interrelationships of Business Processes
3. Cost of Quality (COQ) Principles
4. Emerging Roles of the Auditor

196
196
199
200
205

Part V Quality Tools and Techniques

207

Chapter 18 Basic Quality and Problem-Solving Tools/Part VA

Pareto Charts
Cause-and-Effect Diagrams
Flowcharts and Process Mapping
Statistical Process Control (SPC) Charts
Checklists, Check Sheets, Guidelines, and Log Sheets
Scatter Diagrams
Histograms
Root Cause Analysis
Plan-Do-Check-Act (PDCA/PDSA) Cycle

208
208
209
210
215
220
224
225
227
230

Chapter 19 Process Improvement Techniques/Part VB

1. Six Sigma and the DMAIC Model.
2. Lean
\

232
232
234

Chapter 20 Basic Statistics/Part VC

1. Measures of Central Tendency
2. Measures of Dispersion
3. Qualitative and Quantitative Analysis
Patterns and Trends

250
250
251
253
255

Chapter 21 Process Variation/Part VD

1. Common and Special Causes (Theory of Variation)

260
260

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Contents

2. Process Performance Metrics

3. Outliers

264
265

Chapter 22 Sampling Methods/Part VE

Types of Sampling
Statistical Sampling (Random and Systematic)
Sampling Standards (Acceptance Sampling)
Proportional Stratified Sampling
Risks in Sampling
Sampling Summary

266
266
268
269
272
273
275

Chapter 23 Change Control and Configuration Management/Part VF

Document Control
Configuration Management Control
Conclusion
,

278
278
279
280

Chapter 24 Verification and Validation/Part VG

Techniques
Process Auditing and Techniques

281
281
282

Chapter 25 Risk Management Tools/Part VH

Quantification of Risk
Failure Mode and Effects Analysis
Critical to Quality
HACCP
HHA

283
283
284
285
287
288

Appendix A

291

ASQ Code of Ethics

Appendix B Notes on Compliance, Conformance, and Conformity

Compliance
Conformance
Conformity

292
292
292
292

Appendix C Example Guide for Technical Specialists

(or Subject Matter Experts)
Introduction
Contact
Job Description
The Report

294
294
294
294
295

Appendix D The Institute of Internal Auditors Code of Ethics

Introduction
Applicability and Enforcement
Principles
.*
Rules of Conduct

296
296
296
297
297

Appendix E History of Quality Assurance and Auditing

Quality Assurance and Audit Functions
Theories and Practices in Auditing
Environmental, Safety, and Health Programs and Audit Functions

299
299
301
304

CONTENTS

Appendix F Certified Quality Auditor Body of Knowledge

Six Levels of Cognition based on Bloom's Taxonomy (Revised)

ix

306
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
Glossary
Index

351
358
363

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