Guidelines for Process Safety in Outsourced Manufacturing Operations（2）

Wiley-AIChE（2026/03/16発売）

• 言語：ENG
• ISBN：9781394359950
• eISBN：9781394359967

Description

This book contains guidelines for clients who outsource manufacturing, brokers who aid in outsourcing, and manufacturers who develop and/or execute outsourced manufacturing on how to improve process safety performance by understanding and managing the risk associated with the process and learning from experience of outsourced operations. 

This book focuses on the outsourced manufacturing process and roles the affected parties assume. It applies the elements of risk based process safety to minimize the potential of process safety events. The book illustrates how the twenty Elements of the CCPS Risk Based Process Safety (RBPS) management approach can be used as the framework for a consistent, structured method to safely execute outsourced manufacturing. Additionally, ten case studies are provided detailing how breakdowns in the transfer of information in the various outsourced manufacturing process steps and failure for affected parties to understand their role in the process have led to process safety incidents.

Table of Contents

List of Figures xiii

List of Tables xv

Acronyms and Abbreviations xvii

Glossary… xxi

Acknowledgements xxvii

Dedication xxix

How to Use this Book and Accompanying Online Materials xxxi

Foreword… xxxiii

Chapter 1 Introduction 1

1.1 Challenges of Managing Process Safety in Outsourced Operations 2

1.2 Historical Context 2

1.3 Types of Outsourced Manufacturing 3

1.4 Scope 4

1.5 Audience 5

1.6 Why Outsource Manufacturing? 5

1.7 Disadvantages and Challenges of Outsourced Manufacturing 6

1.8 Joint and Individual Company Responsibilities in Outsourced Manufacturing 7

1.9 Process Safety Management Systems 8

1.10 Role of Leadership in Process Safety 12

1.11 Format of This Book 15

1.12 References 16

Chapter 2 Overview of the Outsourced Manufacturing Workflow 17

2.1 Introduction 17

2.2 Develop and Validate the Business Case for Outsourcing 19

2.3 Complete Applicable R&D 19

2.4 Perform Initial Screening of CMs and Brokers 20

2.5 Select Broker and CM 20

2.6 Perform Technology Transfer 21

2.7 Perform Final Assessment and Implement Manufacturing Contract 22

2.8 Pre-startup Activities and First Run 23

2.9 Managing Process Safety in Contract Operations 23

2.10 Key Concepts of RBPS in Outsourced Manufacturing 24

2.11 References 25

Chapter 3 Develop and Validate the Business Case for Outsourcing 27

3.1 Introduction 28

3.2 Evaluate the Need to Outsource and Develop the Scope of Work 28

3.3 Determine Scope of Work 31

3.4 Determine Initial Risk Based Process Safety (RBPS) Concerns 32

3.5 Perform Regulatory Checks/Reviews 32

3.6 Develop Expectations for Broker and CM 33

3.7 Summary 33

3.8 References 34

Chapter 4 Special Focus on Research and Development (R&D) 35

4.1 Introduction 35

4.2 Research and Evaluate Process Alternatives 39

4.3 Collection and Development of PSI 41

4.4 Lab-Scale Experimental Studies to Define Conceptual Process 50

4.5 Inherently Safer Design Analysis and Process Selection 52

4.6 Pilot-Scale Studies 54

4.7 Preliminary Technology Package 56

4.8 Process Development and Optimization 57

4.9 Technology Transfer Package 58

4.10 Continuous Improvement 59

4.11 Summary 59

4.12 References 60

Chapter 5 Initial Screening of CMs and Brokers 61

5.1 Introduction 62

5.2 Initial Search for a CM 65

5.3 Self-Evaluations 70

5.4 Screening Technology Package 71

5.5 Summary 72

5.6 References 73

Chapter 6 Broker and CM Evaluation 75

6.1 Introduction 76

6.2 Final Evaluation of Brokers 78

6.3 Final Evaluation of CMs 78

6.4 Broker and CM Evaluation of Client 85

6.5 Evaluating Recommended Changes from RFP Specifications 87

6.6 RBPS Elements to Consider 88

6.7 Performance Review 89

6.8 Going Forward with Selected CM 90

6.9 Summary 90

6.10 References 91

Chapter 7 Information and Technology Transfer 93

7.1 Introduction 93

7.2 Process Description 95

7.3 Hazards 96

7.4 Process Safety Information: Technology and Equipment Hazards 105

7.5 Process Safety Information: Unique Hazards 107

7.6 Process Safety Information & Knowledge Management Evaluation 108

7.7 Conceptual Design HIRA 109

7.8 Process Safety Events 111

7.9 Manufacturing: Steps and Process Flow 111

7.10 Supplemental information 112

7.11 Research and Development: Technology Transfer 112

7.12 Technology Transfer and Verification of Understanding 113

7.13 Summary 113

7.14 References 114

Chapter 8 Assessment and Final Contract 115

8.1 Introduction 115

8.2 Site Visit and Gap Assessment 117

8.3 HIRA, HSE, and Governance Assessment Activities 118

8.4 Final Contract 121

8.5 Summary 122

8.6 References 122

Chapter 9 Pre-Startup Activities and First Run 123

9.1 Introduction 123

9.2 Write or Revise Procedures 125

9.3 Competency Development and Training 134

9.4 Finalizing the HIRA for First Run 135

9.5 Security Assessments 135

9.6 Equipment Pre-commissioning 136

9.7 Pre-startup Safety Review (PSSR) 138

9.8 Joint Project Review 139

9.9 Equipment Commissioning and First Run 140

9.10 Summary 143

9.11 References 144

Chapter 10 Managing Process Safety in Contract Operations 145

10.1 Introduction 146

10.2 Manage Risk 149

10.3 Learn from Experience and Continuous Improvement 156

10.4 Governance 162

10.5 Idling and Decommissioning 163

10.6 Summary 169

10.7 References 169

Chapter 11 Call to Action: Outsourced Manufacturing Without PS Process Safety Accidents 171

11.1 The Opportunity 171

11.2 Conclusion 173

11.3 References 176

Appendix A Analysis of case studies 177

Appendix B Outsourced Manufacturing Project Checklist 181

Appendix C Example Technology Transfer Checklists 183

Appendix D CM Assessment and Self-Evaluation Checklists 201

Appendix E HIRA Scope Checklists for Outsourced Manufacturing 217

E.1 Introduction 217

E.2 HIRA S 217

E.3 HIRA Scope Checklist 220

Appendix F Selected Additional Resources 225

Appendix G An Optimal Outcome for the Optima Belle Case 233

G.1 Background 233

G.2 Developing the Business Case for Outsourcing 234

G.3 Client Self-Evaluation 234

G.4 Perform Initial Screening of Brokers and CMs 236

G.5 Complete Applicable R&D 239

G.6 Select CM 242

G.7 Perform Technology Transfer 243

G.8 Perform Final Assessment and Implement Contract 244

G.9 Pre-startup, Startup, and First Run 246

G.10 Manage Contract Operations 248

G.11 References 250

Index 251