1st Edition

Guidelines for Failure Modes and Effects Analysis for Medical Devices

By Dyadem Press Copyright 2003
    190 Pages
    by CRC Press

    190 Pages
    by CRC Press

    Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis.

    Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

    INTRODUCTION

    REGULATIONS & STANDARDS GOVERNING MEDICAL DEVICE MANUFACTURING
    Background
    United States Regulations
    European Union Regulations
    International Regulations
    EU/EC EN (European Norm) Standards

    RISK MANAGEMENT OF MEDICAL DEVICES
    Risk Management

    RISK ANALYSIS METHODOLOGIES
    Hazard and Operability Analysis (HAZOP)
    Fault Tree Analysis (FTA)

    OVERVIEW OF FMEA
    Overview
    Limitations of FMEA

    FMEA PROCEDURES
    Introduction
    FMEA Terminology
    FMEA Steps
    Preliminary Consideration of FMEA
    Preparation Before FMEA Sessions
    Conducting FMEA Sessions
    Follow-Up of FMEA

    FMEA TEAM
    Introduction
    Team Size
    Team Membership
    Team Leader (Facilitator)

    PITFALLS WITH FMEA

    COMMON TOOLS USED WITH FMEA
    Process Mapping/Process Flowcharts
    Block Diagram/Functional Diagrams
    Pareto Charts

    PRODUCT LIFE CYCLE & FMEA
    Introduction
    Different Types of FMEAs
    Integration of FMEA and Control Plan to Product Cycle

    PRODUCT/DESIGN FMEA
    Objectives
    Recommended Team Members
    Recommended Information in the Product/Design FMEA
    Worksheet
    Suggested Risk Guidelines for Product Design FMEA (D-FMEA)

    PROCESS FMEA
    Objectives
    Recommended Team Members
    Recommended Information on the Process FMEA
    Worksheet
    Suggested Risk Guidelines for Process FMEA (P-FMEA)

    APPLICATION FMEA
    Objectives
    Recommended Team Members
    Recommended Information in the Application FMEA
    Worksheet
    Suggested Risk Guidelines for Application FMEA (A-FMEA)

    SERVICE FMEA
    Objectives
    Recommended Team Members
    Recommended Information in the Service FMEA
    Worksheet
    Suggested Risk Guidelines for Service FMEA (S-FMEA)

    POST FMEA STUDY

    CONTROL PLANS
    Introduction
    Benefits of Developing and Implementing Control Plans
    Information Used to Develop Control Plans
    Control Plan Terminology and Recommended Information to Include

    OVERVIEW OF FAILURE MODE, EFFECTS, AND CRITICALITY ANALYSIS (FMECA)
    Overview of Criticality Analysis
    Criticality Analysis Terminology
    Criticality Worksheet/Report Final

    REFERENCES

    Biography

    Dyadem Press