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
190 Pages
by
CRC Press
Also available as eBook on:
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... Read more
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
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
