Revised edition of: The quality audit handbook. 3rd ed. c2005

Machine generated contents note:

pt. I

Auditing Fundamentals --

ch. 1

Types of Quality Audits/Part IA --

1.

Method --

2.

Auditor-Auditee Relationship --

3.

Purpose --

4.

Common Elements with Other Audits --

ch. 2

Purpose and Scope of Audits/Part IB -- Audit Reason --

1.

Elements of Purpose and Scope --

2.

Benefits of Audits --

ch. 3

Criteria to Audit Against/Part IC -- Discussion -- Audit Requirements --

ch. 4

Roles and Responsibilities of Audit Participants/Part ID -- Audit Participants -- Roles and Responsibilities --

ch. 5

Professional Conduct and Consequences for Auditors/Part IE... --

1.

Professional Conduct and Responsibilities --

2.

Legal Consequences --

3.

Audit Credibility --

pt. II

Audit Process --

ch. 6

Audit Preparation and Planning/Part IIA --

1.

Elements of the Audit Planning Process --

2.

Auditor Selection --

3.

Audit-Related Documentation --

4.

Logistics --

5.

Auditing Tools and Working Papers --

6.

Auditing Strategies --

7.

Communication and Distribution of the Audit Plan --

ch. 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 --

ch. 8

Audit Reporting/Part IIC --

1.

Report Development and Content --

2.

Effective Reports --

3.

Final Audit Report Steps --

ch. 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 --

pt. III

Auditor Competencies --

ch. 10

Auditor Characteristics/Part IIIA -- Education and Experience -- Interpersonal Skills -- Personal Traits --

ch. 11

On-Site Audit Resource Management/Part IIIB -- Time-Management Skills --

ch. 12

Conflict Resolution/Part IIIC -- Causes of Conflict -- Managing Difficult Situations -- Team Conflict --

ch. 13

Communication and Presentation Techniques/Part HID -- Basic Rules for Effective Communication -- Communication Technology -- Presentation Techniques --

ch. 14

Interviewing Techniques/Part IIIE -- Conversational Process -- Avoid Asking Leading Questions -- Interviewing a Group of People -- Using a Translator -- Corroborating Information -- Potential Problems --

ch. 15

Team Dynamics/Part IIIF --

1.

Team Building --

2.

Team Facilitation --

3.

Stages of Team Development --

pt. IV

Audit Program Management and Business Applications --

ch. 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 --

ch. 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 --

pt. V

Quality Tools and Techniques --

ch. 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 --

ch. 19

Process Improvement Techniques/Part VB --

1.

Six Sigma and the DMAIC Model --

2.

Lean --

ch. 20

Basic Statistics/Part VC --

1.

Measures of Central Tendency --

2.

Measures of Dispersion --

3.

Qualitative and Quantitative Analysis -- Patterns and Trends --

ch. 21

Process Variation/Part VD --

1.

Common and Special Causes (Theory of Variation) --

2.

Process Performance Metrics --

3.

Outliers --

ch. 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 --

ch. 23

Change Control and Configuration Management/Part VF -- Document Control -- Configuration Management Control -- Conclusion --

ch. 24

Verification and Validation/Part VG -- Techniques -- Process Auditing and Techniques --

ch. 25

Risk Management Tools/Part VH -- Quantification of Risk -- Failure Mode and Effects Analysis -- Critical to Quality -- HACCP -- HHA --

Appendix A

ASQ Code of Ethics --

Appendix B

Notes on Compliance, Conformance, and Conformity -- Compliance -- Conformance -- Conformity --

Appendix C

Example Guide for Technical Specialists (or Subject Matter Experts) -- Introduction -- Contact -- Job Description -- Report --

Appendix D

Institute of Internal Auditors Code of Ethics -- Introduction -- Applicability and Enforcement -- Principles -- Rules of Conduct --

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 --

Appendix F

Certified Quality Auditor Body of Knowledge -- Six Levels of Cognition based on Bloom's Taxonomy (Revised) --

Appendix G

Example Audit Program Schedule --

Appendix H

Example Third-Party Audit Organization Forms --

Appendix I

Example Audit Reports --

Appendix J

Product Line Audit Flowchart --

Appendix K

First, Second, and Third Edition Contributors and Reviewers