Guidelines for Failure Modes and Effects Analysis for Medical Devices

ISBN-13: 9780849319105 / Angielski / Miękka / 2003 / 190 str.

Dyadem Press;Press Dyadem; Press Press

Opis

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. These guidelines focus 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.Guidelines for Failure Modes and Effects Analysis for Medical Devices is written as a practical guide to achieving corporate consistency while dramatically cutting the time required for studies. It will help you prevent patient injuries, costly product recalls, and production department down-time. 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 mor

Spis treści

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

O autorze

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