Risk_Assessment_PDA 风险管理

Foreword Preface

Introduction Acknowledgements

1. An Incomplete History of Risk Management

Concern Over Technological Risks Responses to Risks Conclusion

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2. Hazards and Risks: Concepts and Definitions of Important Terms

Hazard Risk

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Accidents, Failures, and Other Undesired Events

Risk Management Conclusion

3. How We Think About Risk

Risk Perception Risk Judgment

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vi Risk Assessment and Risk Management

Rules That Shape Our Decisions About Risk

Representativeness

Options and Decision Making

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The Role of Trust in Communicating Risk

What All This Means As We Assess and Manage Risks

4. Accident Theory

Single-Event Model

Chain-of-Events Models Hierarchical Models Factorial Model Systems Accident Conclusion

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Individual and Human Factors

5. An Overview of the Risk Management Process

System Definition Risk Estimation Risk Evaluation Risk Control

Hazard Identification

Risk Monitoring and Re-evaluation Risk Communication Conclusion

6. Risk Communication

Elements of a Risk Communication Process Problems in Risk Communication Effectively Communicating Risks Conclusion

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Table of Contents

7. An Overview of Risk Assessment Tools

Inductive and Deductive Tools Tabular or Graphic Tools Qualitative, Semi-quantitative, or Quantitative Tools Where Do They End? Tasks Common to All Tools

Preliminary Risk Analysis (PRA) and Preliminary Hazard Analysis (PHA)

Description Background Limitations When Used

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Features and Benefits

Conducting a Preliminary Risk Analysis

Failure Mode and Effects Analysis (FMEA) or Failure Mode, Effects, and Criticality Analysis (FMECA)

Description Background

Features and Benefits Limitations When Used

Conducting an FMECA Description Background

Features and Benefits Limitations When Used

Conducting a Fault Tree Analysis

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Fault Tree Analysis (FTA)

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Event Tree Analysis (ETA)

Description Background

Features and Benefits Limitations When Used

How to Perform an Event Tree Analysis Description Background

Features and Benefits Limitations When Used

How to Perform a HAZOPS

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Hazard and Operability Studies (HAZOPS)

Conclusion

8. Risk Evaluation

Three Possible Outcomes of a Risk Evaluation Evaluating Risks Safety Factor Conclusion

9. Risk Control

Prevent or Protect Control Measures Layers of Control

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Problems with Automated Controls Problems with Procedural Controls Selecting Controls Conclusion

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Table of Contents 10. Risk Monitoring

Conclusion

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11. Risk-Related Documentation and Records

Types of Documents and Records Purpose of Risk-related Documents and Records “Risk Management File” “Risk Management Plan”

“Risk Management Report”

Documents and Records Required by HACCP “Risk Information Library” Conclusion

12. Hazard Analysis and Critical Control

Points (HACCP)

Information Needed for HACCP Definitions Used in HACCP Conducting a HACCP

Preliminary Tasks HACCP Principles Functional Documents Records

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Conclusion

13. Preliminary Risk Analysis (PRA)

Types of PRAs Information Needed Performing a PRA Conclusion

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14. Failure Mode, Effects, and Criticality Analysis (FMECA)

Types of FMECAs Information Needed

Terminology Used in FMECAs Performing an FMECA Conclusion

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15. Hazard and Operability Studies (HAZOPS)

Types of HAZOPS

Information Required Terminology Used in HAZOPS Performing a HAZOPS A HAZOPS Variation CHAZOPS: HAZOPS for Computerized Systems Procedural HAZOPS Conclusion

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16. Fault Tree Analysis (FTA)

Definitions

Events Gates AND Gates OR Gates Specialized Gates

Structure of a Fault Tree

Conducting an FTA Documentation Conclusion

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Table of Contents

17. Event Tree Analysis (ETA)

Definitions

Performing an ETA Documentation Conclusion

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18. Auditing a Risk Management Program

Items to Consider When Auditing a Risk Management Program Items to Consider When Auditing a Risk Assessment Conclusion

19. The Organization and Risk Management

Enterprise Risk Management Integrating Risk Management and Quality System Elements Problem Investigations

The Risks of Being Risk Adverse Supporting Risk Management Managing Risk in the Future

References Index

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