Integrated

Management Systems

QMS, EMS, OHSMS, FSMS including

Aerospace, Service, Semiconductor /

Electronics, Automotive, and Food

Updated to the latest Standard changes including

ISO 9001:2015, ISO 14001:2015, and ISO 45001:2016

Includes guidance on integrating

Corporate Responsibility and Sustainability

Chad Kymal, Gregory Gruska, and R. Dan Reid

ASQ Quality Press

Milwaukee, Wisconsin
 Contents

List ofFigures and Tables ix

Preface xiii

About the Authors xvii

Chapters

1 What are Integrated Management Systems,

including PAS 99? 1
Introduction 1
Integrated Processes 1
Integrated Risk 5
Integrated Audits 6
PAS 99 7
Summary 8

2 Integration vs. StandardizationWhy We Need Both 13

Integrated ProcessesEnterprise 14
Standardization of Management Systems 15
Integrated AuditsEnterprise 18
Summary 19

3 Integrating Processes between QMS, EMS, OHSMS,

and FSMS 25
Integration Within One Site 25
Designing the Manual (Apex Document)Level I 27
Process Approach, the Key to IntegrationLevel II 29
Developing Integrated Management Systems Procedures
Level II 35
Developing Integrated Management Systems Work
InstructionsLevel III 39

v
vi Contents

Developing Integrated Management Systems

Forms / ChecklistsLevel IV 40
Enterprise Integration 40
Summary 41
AppendixBusiness Flanning Process 42

4 Integrated Risk Management and Enterprise Risk 51

Using the Same Risk Methodology Process 51
Identifying Q, E, and HS Risk in a Manufacturing Process 53
Identifying Q, E, and HS Risk in a Process in the Process Map.. 55
Understanding Severity, Occurrence, and Detection 55
Security, Occurrence, and Detection Ratings 55
FMEA and HACCP Methodologies 56
Enterprise Risk 59

5 Conducting Integrated Audits 61

Integrated Audits 61
Integrated Audit Types 65
Enterprise Audits 71
Corrective Action Categories 73
Audit Duration and Schedule 74
Auditor Qualification 75
Performance Analysis and Continual Improvement 76

6 How an Integrated and Standardized Management System

Performs For Maximum Effectiveness 79
Process Maps and Process Definitions 79
Enterprise Processes 81
Site Processes 81
Developing the Performance Management System
Operating System 81
Manufacturing Process Control 90
Risk and Change Management 91
Summary 93
 Contents vii

7 Integration with GFSI Standards in the Food Industry 95

Documenta tion Development 100
Process Improvements from the Implementation 102
Process Improvements 104
Developing a New Product Development Phase Gate Process .. 106
Audits 106
Third-party Audits 107

8 Integration in an Automotive Organization 109

9 Integration in a Service Environmenta Case Study 121

10 Integration in an Aerospace Organizationa Case Study ... 127

11 Integration in a Semiconductor Organization

a Case Study 135

12 Software Enabled Integrated Management System

f or the Enterprise 143
Integrated Enterprise Processes 148
Summary 152

13 Lessons Learned from IMS Implementations 153

Top Management Mindset and Involvement in
the Integration 154
Scoping the Implementation 156
Improvement versus Documentation 157
Summary of the Five Implementations 162

14 Integrating QMS, EMS, OHSMS, and FSMS 163

Appendix A: Integrating and Standardizing QMS, EMS, and OHSMS

Management SystemsAn Executive Management Primer 167

Appendix B: Implementing Corporate Sustainability and Responsibility (CSR) ... 277

Glossary 185

Bibliography 189

Index 191