Guidelines for Failure Modes and Effects Analysis for Medical Devices: 1st Edition (Paperback) book cover

Guidelines for Failure Modes and Effects Analysis for Medical Devices

1st Edition

By Dyadem Press

CRC Press

190 pages

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pub: 2003-03-03
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Description

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.

Table of Contents

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

Subject Categories

BISAC Subject Codes/Headings:
TEC009060
TECHNOLOGY & ENGINEERING / Industrial Engineering
TEC021000
TECHNOLOGY & ENGINEERING / Material Science
TEC032000
TECHNOLOGY & ENGINEERING / Quality Control