Quality Auditing Quality Auditing

Quality Auditing

David Mills MIQA

SPRINGER-SCIENCE+BUSINESS MEDIA, B.V.

First edition 1993

© 1993 Springer Science+Business Media Dordrecht Origina1ly published by Chapman & Hali in 1993 Softcover reprint ofthe hardcover lst edition 1993

ISBN 978-94-010-4300-7 ISBN 978-94-011-0697-9 (eBook)

DOI 10.1007/978-94-011-0697-9

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Contents

Dedication

Introduction

Chapter One: An overview of audits Where have quality audits come from? Auditing status Where are quality audits heading?

Chapter Two: What is a quality audit? Audit types Customer needs Audit categories Terms and difinitions Definitions published in standards

Quality audit Auditors Client Auditee Observation Objective evidence

Applications of definitions

Chapter Three: Why audit? Audit objectives Compliance

Variations to complaince audits Results compliance auditing

Effectiveness Improvement

Mandatory audits

xiii

xv

1 3 6 8

9 11 13 14 14 15 16 17 18 19 19 20 20

22 24 24 26 27 28 29 29

Contents

Dedication

Introduction

Chapter One: An overview of audits Where have quality audits come from? Auditing status Where are quality audits heading?

Chapter Two: What is a quality audit? Audit types Customer needs Audit categories Terms and difinitions Definitions published in standards

Quality audit Auditors Client Auditee Observation Objective evidence

Applications of definitions

Chapter Three: Why audit? Audit objectives Compliance

Variations to complaince audits Results compliance auditing

Effectiveness Improvement

Mandatory audits

xiii

xv

1 3 6 8

9 11 13 14 14 15 16 17 18 19 19 20 20

22 24 24 26 27 28 29 29

vi

Motivation for audits Continuity

CONTENTS

The auditee's motivation for audit Relationships between the audit personnel

Trainee auditors Technical experts Observers Interpreters Management representatives

Chapter Four: The audit maze Categories of audit Internal Audits External audits Extrinsic audits? Supplier visitations A need for sub-categories? Further audit definitions Audit types Performance audits Product audits

Chapter Five: Audit boundaries Step 1. Reason Step 2. Measures Step 3. Coverage Step 4. Location Step 5. Resources Audit depth or involvement Resources Time Manpower Facilities Skills Audit scope decision

30 32 33 33 36 36 36 37 38

39 40 41 42 43 44 46 48 49 50 51

53 54 55 55 56 56 57 59 59 61 62 63 63

vi

Motivation for audits Continuity

CONTENTS

The auditee's motivation for audit Relationships between the audit personnel

Trainee auditors Technical experts Observers Interpreters Management representatives

Chapter Four: The audit maze Categories of audit Internal Audits External audits Extrinsic audits? Supplier visitations A need for sub-categories? Further audit definitions Audit types Performance audits Product audits

Chapter Five: Audit boundaries Step 1. Reason Step 2. Measures Step 3. Coverage Step 4. Location Step 5. Resources Audit depth or involvement Resources Time Manpower Facilities Skills Audit scope decision

30 32 33 33 36 36 36 37 38

39 40 41 42 43 44 46 48 49 50 51

53 54 55 55 56 56 57 59 59 61 62 63 63

CONTENTS

Chapter Six: Audit personnel Personnel with accountability Audit team Size of team The make-up of a team

Trainee auditors Experts Observers Team selection Audit member's tasks and responsibilities Lead auditor's general responsibilities Lead auditor's specific duties Objectivity of audit personnel

Chapter Seven: Auditor qualifications Areas of competence Knowledge

Education Training Auditing skills Technical skills Languages Working experience Auditing experience

Human factors Fairness Honesty Awareness and sensitivity Tenacity Behaviour under pressure Analysis and decision making Natural born auditors?

Chapter Eight: Audit activities The preparation phase The data collection phase Initial review phase

vii

65 66 66 67 69 69 70 71 73 75 79 80 80

82 84 84 84 86 87 89 90 90 92 92 93 93 94 95 96 97 98

99 99

102 104

CONTENTS

Chapter Six: Audit personnel Personnel with accountability Audit team Size of team The make-up of a team

Trainee auditors Experts Observers Team selection Audit member's tasks and responsibilities Lead auditor's general responsibilities Lead auditor's specific duties Objectivity of audit personnel

Chapter Seven: Auditor qualifications Areas of competence Knowledge

Education Training Auditing skills Technical skills Languages Working experience Auditing experience

Human factors Fairness Honesty Awareness and sensitivity Tenacity Behaviour under pressure Analysis and decision making Natural born auditors?

Chapter Eight: Audit activities The preparation phase The data collection phase Initial review phase

vii

65 66 66 67 69 69 70 71 73 75 79 80 80

82 84 84 84 86 87 89 90 90 92 92 93 93 94 95 96 97 98

99 99

102 104

viii CONTENTS

The reporting phase 107

Chapter Nine: The audit plan The audit plan Who is involved? Content of the plan Pre-announced or suprise audits?

Chapter Ten: Working methods Audit assignments Solo auditing Auditing in pairs Team auditing Other team members Tasking the auditors Auditing tools To examine by asking questions

What? Why? When? How? Where? Who?

The tactics of questioning Understanding the question The form of questions The summary question I may be stupid but? Intervals Input vs. output questioning Applied questioning Verification

Chapter Eleven: Guiding the audit Audit checklists Aide-memoire Guiding the process

110 112 113 114 119

122 123 123 124 125 126 126 127 127 128 128 129 130 130 130 131 131 133 134 134 135 136 136 138

143 144 145 147

viii CONTENTS

The reporting phase 107

Chapter Nine: The audit plan The audit plan Who is involved? Content of the plan Pre-announced or suprise audits?

Chapter Ten: Working methods Audit assignments Solo auditing Auditing in pairs Team auditing Other team members Tasking the auditors Auditing tools To examine by asking questions

What? Why? When? How? Where? Who?

The tactics of questioning Understanding the question The form of questions The summary question I may be stupid but? Intervals Input vs. output questioning Applied questioning Verification

Chapter Eleven: Guiding the audit Audit checklists Aide-memoire Guiding the process

110 112 113 114 119

122 123 123 124 125 126 126 127 127 128 128 129 130 130 130 131 131 133 134 134 135 136 136 138

143 144 145 147

CONTENTS ix

Lower order working documents 149 Other working documents 150

Chapter Twleve: On-site procedure 154 Initial or opening meeting 155

Initial meeting attendees 156 Conducting the meeting 156 Reassuring the auditee 157 The auditee's role in the opening meeting 158 Timescale 159

Examination 159 The exit or closing meeting 160

Basic agenda 161 Meeting method and control 162 Conducting the meeting 164

The 'buffer' stop situation 167 Ethical questions 168

Chapter Thirteen: Reporting the audit 169 'In-process' reports 170 Audit results reporting 172 Preparation of the report 177 Acceptability of the report 180 Strength and weakness reporting 182 Corrective action 184 Presentation of the report 186

Chapter Fourteen: Problems during the audit 188 Pre-audit problems 189

The timetable 190 The 'missing person' 191

'On-site' auditing problems 192 Timewasting 192

At the opening meeting 192 The verbal Tolstoi 194 Management unavailability 194 Excessive hospitality 195

CONTENTS ix

Lower order working documents 149 Other working documents 150

Chapter Twleve: On-site procedure 154 Initial or opening meeting 155

Initial meeting attendees 156 Conducting the meeting 156 Reassuring the auditee 157 The auditee's role in the opening meeting 158 Timescale 159

Examination 159 The exit or closing meeting 160

Basic agenda 161 Meeting method and control 162 Conducting the meeting 164

The 'buffer' stop situation 167 Ethical questions 168

Chapter Thirteen: Reporting the audit 169 'In-process' reports 170 Audit results reporting 172 Preparation of the report 177 Acceptability of the report 180 Strength and weakness reporting 182 Corrective action 184 Presentation of the report 186

Chapter Fourteen: Problems during the audit 188 Pre-audit problems 189

The timetable 190 The 'missing person' 191

'On-site' auditing problems 192 Timewasting 192

At the opening meeting 192 The verbal Tolstoi 194 Management unavailability 194 Excessive hospitality 195

x CONTENTS

Disruptions to the schedule 195 Distracting the auditor 197

Obstructing the audit 198 Biasing the sample 198 Variations to the system 198 'Trying it on' 199 Language problems 201

The auditor's difficulties 201

Chapter Fifteen: Finished? 204 Corrective action 206

The client 206 The auditee 207 The auditor 207 The process 208

A poser for the auditor 215 The final solution? 216

Chapter Sixteen: Special cases? 217 What special cases? 217 The single product concept 219 The case of the tangible vs. intangible 220 Generic quality audits 223 The case by definition 225 The four categories 226 Practical applications 227 Conclusion 228

Chapter Seventeen: Managing an audit programme 230 The definition of audit programme management 231 The functions of audit programme management 232 Audit programme management staff 232 Policy and strategy 233 Provision of audit staff 234 Audit team selection 235 Audit performance monitoring 235 Monitoring auditors' performance and consistency 236

x CONTENTS

Disruptions to the schedule 195 Distracting the auditor 197

Obstructing the audit 198 Biasing the sample 198 Variations to the system 198 'Trying it on' 199 Language problems 201

The auditor's difficulties 201

Chapter Fifteen: Finished? 204 Corrective action 206

The client 206 The auditee 207 The auditor 207 The process 208

A poser for the auditor 215 The final solution? 216

Chapter Sixteen: Special cases? 217 What special cases? 217 The single product concept 219 The case of the tangible vs. intangible 220 Generic quality audits 223 The case by definition 225 The four categories 226 Practical applications 227 Conclusion 228

Chapter Seventeen: Managing an audit programme 230 The definition of audit programme management 231 The functions of audit programme management 232 Audit programme management staff 232 Policy and strategy 233 Provision of audit staff 234 Audit team selection 235 Audit performance monitoring 235 Monitoring auditors' performance and consistency 236

CONTENTS xi

Supplying the required training for auditors 239 Audit effectiveness and worth 240 Resourcing levels 242 Operational review 243 Codes of ethics 244

Chapter Eighteen: Product auditing 245 Definition and history 246 Developments in product auditing 247 Current product auditing processes 250

Sample selection 250 Unpacking and installation 252 Product features and operational testing 253 Measures, evaluation of findings and reporting 254

The final goals 259 The customer expectation audit (CEA) 261

Reporting the audit result 266 Use of the CEA type audit 269 The management of a CEA programme 271

Chapter Nineteen: Economical auditing 274 ~~ro~ m Sub-contracting the audit 277 Systems audit benefits 277 Control of systems audit costs 279 Product audit benefits 281 Control of product audit costs 283

Chapter Twenty: Auditing at the end of the road 285 Past and current status of auditing functions 288 A future for the audit role? 290 Future auditing methods 293 Conclusion 294

Chapter Twenty-one: Auditing in the ISO 9000 environment 296

The first phase revisions 297

CONTENTS xi

Supplying the required training for auditors 239 Audit effectiveness and worth 240 Resourcing levels 242 Operational review 243 Codes of ethics 244

Chapter Eighteen: Product auditing 245 Definition and history 246 Developments in product auditing 247 Current product auditing processes 250

Sample selection 250 Unpacking and installation 252 Product features and operational testing 253 Measures, evaluation of findings and reporting 254

The final goals 259 The customer expectation audit (CEA) 261

Reporting the audit result 266 Use of the CEA type audit 269 The management of a CEA programme 271

Chapter Nineteen: Economical auditing 274 ~~ro~ m Sub-contracting the audit 277 Systems audit benefits 277 Control of systems audit costs 279 Product audit benefits 281 Control of product audit costs 283

Chapter Twenty: Auditing at the end of the road 285 Past and current status of auditing functions 288 A future for the audit role? 290 Future auditing methods 293 Conclusion 294

Chapter Twenty-one: Auditing in the ISO 9000 environment 296

The first phase revisions 297

xii CONTENTS

The ten year review 297 Reviews and audits - what's the difference? 298 Compliance with the 9000 series standards 300 Understanding the standard's requirements 303 Relationship between quality systems compliance and product quality 304 Does poor performance equal lack of conformity? 307 Auditing to the ISO 9000 family of standards from the client's view 308 The auditor's viewpoint and responsibilities 308 Audit management 309 The role of the consultant 310 Integration 312

ReferenceslBibliography 313

xii CONTENTS

The ten year review 297 Reviews and audits - what's the difference? 298 Compliance with the 9000 series standards 300 Understanding the standard's requirements 303 Relationship between quality systems compliance and product quality 304 Does poor performance equal lack of conformity? 307 Auditing to the ISO 9000 family of standards from the client's view 308 The auditor's viewpoint and responsibilities 308 Audit management 309 The role of the consultant 310 Integration 312

ReferenceslBibliography 313

Dedication

I would like to dedicate this book to that very professional group of friends and colleagues who formed Working Group 7 of ISO TCl176/SC2.

In particular I would offer it as something of a tribute to the late Jacques Chove, the convener of the group, who by his inspired leadership, 'brought home the goods' in the form of ISO 10 011 in record time. His conveners hip was a model to all others and was appreciated by the members of this group of expert and professional working auditors.

Dedication

I would like to dedicate this book to that very professional group of friends and colleagues who formed Working Group 7 of ISO TCl176/SC2.

In particular I would offer it as something of a tribute to the late Jacques Chove, the convener of the group, who by his inspired leadership, 'brought home the goods' in the form of ISO 10 011 in record time. His conveners hip was a model to all others and was appreciated by the members of this group of expert and professional working auditors.

Introduction

There are as many views on audits and auditing as there are people who have ever thought about the subject and the process.

Any author writing about it is faced with some common problems, such as how to make a description of a technical process anything less than dry to read. How to deal with the general belief that anyone can conduct an audit without any specific training or experience.

Auditing is often viewed as a waste of time, money and resources with little, if any, real value to an organization.

It is seen as something of a judgemental process. People see themselves as being under scrutiny and examination and as very few of us enjoy such a process, audits are not generally welcomed at first.

I cannot claim to have found solutions to these problems or to have come up with an easy five-minute way of understand­ing the detailed points that make up this whole subject.

As with any form of technical textbook, this work must not be viewed as a volume to be read in one sitting from cover to cover but used to dip into as and when required.

Thankfully the practice of auditing, in real life has compensa­tions for those involved. Those being audited, the auditees, if sensible, will be able to learn from what is hoped will be an objective and skilled overview of the areas and subjects being audited.

Extracts from British and International Standards are reproduced with permission. Complete copies can be obtained in the UK from BSI Sales, Linford Wood, Milton Keynes MK14 6LE, UK.

Introduction

There are as many views on audits and auditing as there are people who have ever thought about the subject and the process.

Any author writing about it is faced with some common problems, such as how to make a description of a technical process anything less than dry to read. How to deal with the general belief that anyone can conduct an audit without any specific training or experience.

Auditing is often viewed as a waste of time, money and resources with little, if any, real value to an organization.

It is seen as something of a judgemental process. People see themselves as being under scrutiny and examination and as very few of us enjoy such a process, audits are not generally welcomed at first.

I cannot claim to have found solutions to these problems or to have come up with an easy five-minute way of understand­ing the detailed points that make up this whole subject.

As with any form of technical textbook, this work must not be viewed as a volume to be read in one sitting from cover to cover but used to dip into as and when required.

Thankfully the practice of auditing, in real life has compensa­tions for those involved. Those being audited, the auditees, if sensible, will be able to learn from what is hoped will be an objective and skilled overview of the areas and subjects being audited.

Extracts from British and International Standards are reproduced with permission. Complete copies can be obtained in the UK from BSI Sales, Linford Wood, Milton Keynes MK14 6LE, UK.

xvi INTRODUCTION

Those performing audits will also learn much from the extensive review of varying organizations, manufacturing plants, offices and all the other types of site that they will be involved in.

But most importantly perhaps, will be what can be gained from the interfacing of both the auditees and the auditors involved in the total audit process.

There can be a danger too, that auditors become too con­cerned with their own importance and this should not be allowed to happen. A leavening of suitable humour should be part of any auditing team's make-up, for in performing audits much will be found to amuse and lighten the stress of the day-to-day auditing itself.

As to the process itself, auditing is not something that is self-generating. But today it is becoming more and more something that is imposed upon organizations, mainly through the need to meet the requirements of the ISO 9000 series of Quality Systems Standards.

While this may be the initial cause it is believed and certainly hoped, that from it will spring a genuine feeling and under­standing of the worth of audit, to those organizations af­fected.

In setting out this volume, I have attempted to give practical help to those who are not expert in the process and wish to learn about it. The subject matter has been approached from a logical stand point, keeping the audit process in perspective and not allowing it to become inflated with its own importance. I have kept to a minimum, any jargon or 'technical speak'. Auditing is a tool to be employed in obtaining the true total quality environment within any organization, and should never be inflated into becoming an end in itself.

Hence in the book, there has been an attempt to simplify the stages of the total process, trying to avoid the problems that stem from the 'we are a special case' arguments so often put forward by varying sectors and industries.

So I hope that the following chapters will not only give practical assistance to auditors and trainee auditors, but that

xvi INTRODUCTION

Those performing audits will also learn much from the extensive review of varying organizations, manufacturing plants, offices and all the other types of site that they will be involved in.

But most importantly perhaps, will be what can be gained from the interfacing of both the auditees and the auditors involved in the total audit process.

There can be a danger too, that auditors become too con­cerned with their own importance and this should not be allowed to happen. A leavening of suitable humour should be part of any auditing team's make-up, for in performing audits much will be found to amuse and lighten the stress of the day-to-day auditing itself.

As to the process itself, auditing is not something that is self-generating. But today it is becoming more and more something that is imposed upon organizations, mainly through the need to meet the requirements of the ISO 9000 series of Quality Systems Standards.

While this may be the initial cause it is believed and certainly hoped, that from it will spring a genuine feeling and under­standing of the worth of audit, to those organizations af­fected.

In setting out this volume, I have attempted to give practical help to those who are not expert in the process and wish to learn about it. The subject matter has been approached from a logical stand point, keeping the audit process in perspective and not allowing it to become inflated with its own importance. I have kept to a minimum, any jargon or 'technical speak'. Auditing is a tool to be employed in obtaining the true total quality environment within any organization, and should never be inflated into becoming an end in itself.

Hence in the book, there has been an attempt to simplify the stages of the total process, trying to avoid the problems that stem from the 'we are a special case' arguments so often put forward by varying sectors and industries.

So I hope that the following chapters will not only give practical assistance to auditors and trainee auditors, but that

INTRODUCTION xvii

there will be sections that cause the reader to challenge what may be the more commonly accepted view.

Maybe in fact, neither the current nor the proposed view is the correct one, but quality is a living, growing thing, changing as new ideas come along and the culture of organizations changes within the general business environment.

It is for this reason in particular, that I believe that the simplest, most logical approach will serve the interests of auditing best in the future.

If nothing else is achieved but to make readers think about the total process and resolve in their own minds the true needs and requirements for the types of audit programmes they wish to undertake, this in itself would be a very fair return on effort.

Good luck and successful auditing to all those who make use of this book.

INTRODUCTION xvii

there will be sections that cause the reader to challenge what may be the more commonly accepted view.

Maybe in fact, neither the current nor the proposed view is the correct one, but quality is a living, growing thing, changing as new ideas come along and the culture of organizations changes within the general business environment.

It is for this reason in particular, that I believe that the simplest, most logical approach will serve the interests of auditing best in the future.

If nothing else is achieved but to make readers think about the total process and resolve in their own minds the true needs and requirements for the types of audit programmes they wish to undertake, this in itself would be a very fair return on effort.

Good luck and successful auditing to all those who make use of this book.