Guidelines for failure mode and effects analysis for medical devices

Table of Contents Glossary xi CHAPTER 1 Introduction 1 CHAPTER 2 Regulations & Standards Governing Medical Device Manufacturing 3 Background. 3 United States Regulations 3 European Union Regulations 4 International Standards 5 EU/EC EN (European Norm) Standards 7 CHAPTER 3 Risk Management of Medical Devices 8 Risk Management 8 CHAPTER 4 Risk Analysis Methodologies 12 Hazard And Operability Analysis (HAZOP) 12 Fault Tree Analysis (FTA) 13 CHAPTER 5 Overview of FMEA 15 Overview 15 Limitations of FMEA 17 CHAPTER 6 FMEA Procedures 18 Introduction 18 FMEA Terminology 18 FMEA Steps 21 Preliminary Consideration of FMEA 23 Preparation Before FMEA Sessions 23 Conducting FMEA Sessions 25 Follow-Up of FMEA 26 CHAPTER 7 FMEA Team 27 Introduction 27 Team Size 27 Team Membership 27 Team Leader (Facilitator) 27 CHAPTER 8 Pitfalls with FMEA 28 CHAPTER 9 Common Tools Used with FMEA 30 Process Mapping/Process Flowcharts 30 Block Diagrams/Functional Flow Diagrams 30 Pareto Charts 31 CHAPTER 10 Product Life Cycle & FMEA 34 Introduction 34 Different Types of FMEAs 34 Integration of FMEA and Control Plan to Product Cycle 36 CHAPTER 11 Product/Design FMEA 39 Objectives 39 Recommended Team Members 39 Recommended Information in the Product/Design FMEA Worksheet 39 Suggested Risk Guidelines for Product/Design FMEA (D-FMEA) 41 CHAPTER 12 Process FMEA 44 Objectives 44 Recommended Team Members 44 Recommended Information in the Process FMEA Worksheet 44 Suggested Risk Guidelines for Process FMEA (P-FMEA) 47 CHAPTER 13 Application FMEA 50 Objectives 50 Recommended Team Members 50 Recommended Information in the Application FMEA Worksheet 50 Suggested Risk Guidelines for Application FMEA (A-FMEA) 52 CHAPTER 14 Service FMEA 55 Objectives 55 Recommended Team Members 55 Recommended Information in the Service FMEA Worksheet 55 Suggested Risk Guidelines for Service FMEA (S-FMEA) 58 CHAPTER 15 Post FMEA Study 61 CHAPTER 16 Control Plans 62 Introduction 62 Benefits of Developing and Implementing Control Plans 62 Information Used to Develop Control Plans 62 Control Plan Terminology and Recommended Information to Include 62 CHAPTER 17 Overview of Failure Mode, Effects, and Criticality Analysis (FMECA) 66 Overview of Criticality Analysis 66 Criticality Analysis Terminology 66 Criticality Worksheet/Report Format 68