Guidelines for process safety in outsourced manufacturing operations

CONTENTS Preface xi Acknowledgments xiii Acronyms and Abbreviations xv 1 INTRODUCTION 1.1. This Guideline’s Scope 1 1.2. The Guideline’s Audience 2 1.3. What Is Outsourced Manufacturing? 4 1.4. Why Toll? Business, Technical, and Safety Considerations 5 1.5. Advantages and Disadvantages of Tolling 7 1.6. Joint Responsibilities 8 1.7. Using Process Safety to Ensure Safety, Product Quality, and Environmental Compliance 10 1.8. How to Use This Guideline 11 2 THE TOLLER SELECTION PROCESS 2.1. Potential Candidates: How to Find One—How to Be One 13 2.1.1. Identifying Technical Specialties and Expertise 15 2.1.2. Prequalified Tollers—The Preferred Route 20 2.1.3. Finding a New Toller—Technical and Trade Association Networking 21 2.2. The Initial Qualification Process 23 2.2.1. Assessing the Candidates—Lines of Communication 23 2.2.2. A Typical Questionnaire 23 v 2.2.3. Weighing Special Technical Competencies 24 2.2.4. Financial 25 2.2.4. Consider Location 26 2.2.6. Consider the Environmental Baseline 27 2.2.7. Verifying Safety, Quality, and Contractual Obligations 28 2.2.8. Process Equipment Capabilities 28 2.2.9. Personnel Capabilities and Expertise 29 2.2.10. Capability to Scale-up Production 30 2.2.11. Process Safety 30 2.2.12. Security 32 2.2.13. Corporate Health, Safety, and Environmental Policies 33 2.2.14. Housekeeping and Appearance 33 2.2.15. Insurance Review and Experience Modifiers 34 2.1.16. Conducting a Site Visit 35 2.2.17. Compatibility with Ongoing Operations 37 2.2.18. Initial Qualification of International Tollers 38 2.3. Making the Final Selection 39 2.3.1. Comparing and Ranking the Initial Qualification Information 40 2.3.2. Audit and Verification Process 40 2.3.3. Confidentiality Agreements 40 2.3.4. Finalizing the Technology Package 42 2.3.5. Evaluating Proposals 43 2.3.6. Contract Award and Negotiation 45 3 MUTUAL AGREEMENTS, OBLIGATIONS, AND CONTRACT CONSIDERATIONS 3.1. Defining the Rights and Expectations of the Parties 47 3.2. Legal Obligations, Defining Boundaries, Contract Topics 51 3.3. Technology Transfer 53 3.4. Technology Developed during Tolling Operations 54 3.5. Knowledge Enhancement for Both Parties 54 3.5.1. New Learning about Processing Hazards and Production Efficiency 54 3.6. Roles and Responsibilities 55 3.6.1. What Is Contained in a Detailed Technology Package? 56 3.6.2. Scale Up Technology 57 3.6.3. Emergency Response Considerations 57 3.6.4. Wastes and Emissions 58 3.6.5. Establishing and Maintaining Communication 59 3.6.6. Participation in PHAs: Resolving the Issues 59 3.6.7. Training Requirements 60 vi CONTENTS 3.7. Health, Safety, and Environmental Considerations 60 3.8. Management Systems 62 3.8.1. Management of Change, Including Change of Personnel 61 3.8.2. Defining and Executing Training Requirements 62 3.9. Access and Right to Audit 63 3.10. Requalification: The Time Frame Issue 63 3.11. Equipment Selection, Preparation, and Decontamination 64 3.12. Performance Clauses and Bonuses 64 3.13. Insurance Requirements 64 3.14. Permit Requirements: Required Filings 65 3.15. Escape and Termination Clauses 65 3.16. Notification of Accidents, Incidents, Releases and Agency Inspections 66 3.17. Right to Assist in Investigation 66 3.18. Pre-startup Safety Review (PSSR) 67 3.19. Formalizing Agreements, Obligations, and Other Considerations 67 4 PRE-STARTUP AND STARTUP ACTIVITIES 4.1. The Path to a Successful Toll 81 4.2. Establishing Specifications and Analytical Techniques 83 4.3. Developing or Revising Required Procedures 83 4.3.1. Operating Procedures 84 4.3.2. Maintenance Procedures 86 4.3.3. Material Control/Purchasing Procedures 87 4.3.4. Emergency Response Plan Procedures 88 4.3.5. Safe Work Practice Procedures 88 4.3.6. Laboratory Procedures 88 4.4. Process Hazard Analysis 89 4.4.1. Defining the PHA Team 90 4.4.2. Selecting the PHA Method 92 4.4.3. Performing the PHA 93 4.5. Training the Startup Team 94 4.6. Performing a Pre-startup Safety Review 96 4.6.1. Resolving PSSR Issues and Action Items 98 4.6.2. Considerations for Restart after Extended Downtime 98 CONTENTS vii 4.6.3. Defining When the Process Is Ready for Startup 99 4.6.4. Confirming Permits Are Complete 101 4.7. Management of Change Considerations 101 4.8. Other Process Safety Elements That May Affect Startup 101 4.9. Test Runs for the Process 103 4.9.1. Value of Performing Test Runs 103 4.9.2. Guidelines for Performing a Test Run 104 4.10. Qualifying and Controlling Raw Materials 106 4.11. Starting the Process 106 4.12. Post-Startup Review 106 4.13. Monitoring Scale-up Concerns 107 5 ONGOING OPERATIONS: AUDITS AND FOLLOW-UP 5.1. Audit as Appropriate for the Process and Product 109 5.1.1. Regulatory Requirements: PSM, RMP, and Others 111 5.1.2. Management Systems 112 5.1.3. Documenting the Audits 112 5.1.4. Auditing as Specified in the Technical Package 114 5.2. Consulting 115 5.2.1. Points of Contact 115 5.2.2. Communication 116 5.2.3. Periodic Visits 116 5.3. Managing Issues: Guidelines and Suggestions 117 5.3.1. Management of Change Issues 117 5.3.2. Process Issues 118 5.3.3. Personnel Issues 121 5.3.4. Acquisition of a Toller by Another Company 121 5.3.5. Regulatory Issues 123 5.3.6. Handling, Transporting, and Storing Materials and Waste 126 5.3.7. Incident Investigations 128 5.3.8. Analysis of New Hazards 129 5.4. Performance Monitoring 131 6 CLOSURE AND AUDIT 6.1. Health, Safety, and Environmental Considerations 134 6.1.1. Decommissioning and Clean Up 136 viii CONTENTS 6.1.2. Proper Waste Disposal 137 6.2. Business and Contractual Concerns 138 6.2.1. Return of Proprietary Documents 138 6.2.2. Governmental Notification 138 6.2.3. Sample Retention and Record Retention 138 6.3. Closure Review Checklist 139 6.4. Analysis of the Operation 144 6.5. Tolling Operation: Final Evaluation 144 Appendix A SAMPLE TOLLER PRE-ASSESSMENT QUESTIONNAIRE 151 Appendix B SAMPLE TOLLER HS&E ASSESSMENT 165 Appendix C SAMPLE TOLLER ASSESSMENT: QUANTITATIVE FORMAT 179 General Scoring Guidelines 180 Evaluation Summary 182 Assessment Forms 183 Audit Protocols for the Assessor 190 1. Management Responsibility 190 2. Training 192 3. Quality Manual, Plan and Standards 193 4. The Toller of Goods or Services 193 5. The Client 195 6. Personnel 195 7. Operations 196 8. Maintenance 197 9. Reporting Investigating and Analysis 197 10. Administrative Support 198 11. Safety 198 12. Occupational Health/Environmental Protection 199 13. Security 200 14. Self-Audit 201 Appendix D THE ISD MODEL AND JOB TASK ANALYSIS TECHNIQUES 203 CONTENTS ix Appendix E LIST OF REFERENCED REGULATIONS 207 Appendix F SELECTED RESOURCES 209 Bibliography 211 Glossary 213 Index 219