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How to Audit the

Process-Based QMS
Second Edition

Dennis R. Arter, Charles A. Cianfrani,


and John E. (Jack) West

ASQ Quality Press


Milwaukee, Wisconsin

Contents

List of Figures and Tables

xiii

Preface

xv

Part I Process-Based Auditing

Chapter 1 Audit Concepts, Principles, and Requirements


Audit Defined
Audit Principles
Internal Audit Requirements of ISO 9001:2008
Requirements for the Audit Program
Requirements for Follow-up on Audit Results

3
5
5
10
10
11

Chapter 2 The Process Approach


Process Focus for Quality Management Systems
The Process Approach as a Concept
The Processes of the Quality Management System
Process Interactions

Improving the Processes of the Quality Management System ..


The Key Processes Concept
Process Champions and Process Owners
The Processes for Product Realization
Summary

13
13
15
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21
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25

Chapter 3 Auditing the Process-Based Quality


Management System
Monitoring versus Measurement
Quality Management System
:
Relationship of Documentation to the Process Approach
Extent of Documentation
System Audits versus Process Audits
vii

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? 30
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33

viii Contents

Alternative Strategies for ISO 9001:2008 Audit Programs


Summary

34
35

Chapter 4 Audit Objectives: Meeting Requirements and


Performance Improvement
Concepts Related to Auditing to Verify that Requirements
are Being Met
Concepts Related to Auditing for Improved Performance
Auditing for Performance Improvement and Consulting

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38
41

Part II Audit Program Management

43

Chapter 5 The Audit Program


Chartering of the Audit Program
Decisions that Should be Made During the
Chartering Process
Disseminating the Audit Charter
Establishing an Audit Process
Preparing an Audit Procedure
Annual Audit Scheduling
Maintenance of the Audit Schedule
Assignment of Auditors
Monitoring and Measuring the Audit Process
Management Review

45
45

Chapter 6 Auditors
Number of Auditors
Selection of Auditors
Auditor Competence
Auditor Certification
EthicsAgain

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62

Chapter 7 Use of Audit Information and Results


Performing Analyses
Presenting the Results of the Analysis

63
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Part III The Process of Auditing

67

Chapter 8 The Audit Planning Phase


Four Phases of the Audit
Seven Items for Audit Planning
Define the Audit Objectives
Define the Audit Scope
Define the Audit Team

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Contents ix

Define the Audit Criteria


Prepare the Audit Plan
Review, Study, and Understand the Documents
The Preparation Package
Chapter 9 Audit Performance Phase
Process and Personal Aspects
Process Aspects of the Performance Phase
Keep Audit Objectives in Mind
Personal Aspects of the Performance Phase
Opening Meeting
Observe the Processes
Observe Activity Result
No Documented Procedures Available
Pause for Reflection
Ask Questions
Gather Objective Evidence
Keep Great Notes
Analyze Information
Synthesis of All That is Seen and Heard and
Reaching Conclusions
Hold a Closing Meeting
Personal Characteristics
Caution Areas
Summary

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Chapter 10 Audit Reporting Phase


Output of the Audit
:
Components of the Report
How to Write a Finding
How to Write a Positive Practice
Delivery of Oral Report (Exit Meeting)
Delivery of Written Report

103
103
103
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108
Ill
112

Chapter 11 Audit Closure Phase


Transfer of Audit Issues to Action Requests
Three Situations
Development of Corrective Action Requests from the
Audit Report
Correcting Identified Nonconformities or Problems
The Corrective Action Process
Development of Preventive Action Requests from the
Audit Report

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'
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Contents

The Preventive Action Process


Documenting Examples of Excellence or Best Practices from
the Audit Report
.'
The Audit Boss's Responsibility for Follow-up
Chapter 12 Reinventing the Audit Process
Signs of QMS Maturity
Reevaluate Your Use of Audit Data
Re-charter the Audit Program
Don't Forget the Basic Principles
The Audit Boss Needs to Act
Part IV Aids for Audit Program Implementation

'

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Chapter 13 Tools, Checklists, and Questions


133
Item 1 Worksheet: Audit Approaches (Horizontal,
Vertical, Combination of Horizontal and Vertical)
135
Item 2 Worksheet: Audit Objectives and Criteria
138
Item 3 Worksheet: Audit Program Charter
140
Item 4 Checklist: Items to Consider when Preparing an
Auditing Procedure
141
Item 5 Worksheet: Developing an Overall Audit Schedule
for an Organization
142
Item 6 Checklist: Auditor Characteristics
143
Item 7 Checklist: Responsibilities of Audit Personnel
144
Item 8 Checklist: Training and Experience to Ensure
Auditor Competence
145
Item 9 Checklist: Areas to Consider when Reviewing Data
Resulting from Audits
146
Item 10 Checklist: Examples of Requirements to Consider
When Planning an Audit
147
Item 11 Worksheet: Audit Plan Development Worksheet
148
Item 12 Form: Columnar form Audit Checklist
149
Item 13 Form: Free Form Audit Checklist
150
Item 14 Checklist: Activities to be Performed Prior to
Starting an Audit
151
Item 15 Checklist: Activities that Should be Considered for
1
EachAudit
7
'152
Item 16 Checklist: Things to do in Every Opening Meeting . . . 153
Item 17 Checklist: Examples of Areas to Consider When
Observing any Process or Function
154
Item 18 Form: Audit Interview Form
156

Contents xi

Item 19 Checklist: Minimum Things to Include in


Closing Meetings
Item 20 Form: Audit Report
:
Item 21 Form: Findings Sheet
Item 22 Form: Positive Practice Record
Item 23 Form: Best Practice Record
Item 24 Questions: Typical Audit Items for Compliance with
ISO 9001:2008

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Further Reading List

ISO/TC 176 Product Introduction and Support Packages


for ISO 9001:2008
Index

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