The Basics of FMEA: 2nd Edition (Paperback) book cover

The Basics of FMEA

2nd Edition

By Raymond J. Mikulak, Robin McDermott, Michael Beauregard

Productivity Press

90 pages | 19 B/W Illus.

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Description

Demonstrates How To Perform FMEAs Step-by-Step

Originally designed to address safety concerns, Failure Mode and Effect Analysis (FMEA) is now used throughout the industry to prevent a wide range of process and product problems. Useful in both product design and manufacturing, FMEA can identify improvements early when product and process changes are relatively easy and inexpensive to make.

Updated to include changes reflected in ISO/TX-16949:2002 standards and 2008 AIAG guidelines, The Basics of FMEA, Second Edition continues to provide the expert advice needed to help shorten the learning curve for FMEA teams to conduct effective and efficient FMEAs, even if it is their very first one.

Includes Ready-to-Use Worksheet Templates

Using a manufacturing case study, readers learn step-by-step how to use FMEAs to assess, evaluate, and prioritize areas of risk, and then to implement the actions needed to reduce risks to an acceptable level. It shows the steps needed to ferret out potential problems and prevent making inferior products that could endanger public and worker safety and compromise profits as well as the future of all stakeholders.

Although engineers have typically analyzed processes and products for potential failures, the FMEA process standardizes the approach and establishes a common language that nontechnical as well as technical employees can use at all levels. Unlike other improvement tools, FMEA does not require complicated statistics. However, they require a full commitment to quality and a willingness to take a team approach that involves all stakeholders.

Table of Contents

What Is an FMEA?

The History of FMEAs

What Is the Purpose of an FMEA?

Part of a Comprehensive Quality System=

FMEAs and Bottom-Line Results

ISO 9000, ISO/TS 16949, and FMEAs

The FMEA Process

Evaluating the Risk of Failure

Assessing the Risk Priority Number

The FMEA Team

FMEA Team Size

FMEA Team Membership

FMEA Team Leader

The Role of Process Expert

Training the FMEA Team

FMEA Boundaries of Freedom

FMEA Scope

FMEA Start-up Worksheet

Product/Design versus Process FMEAs

Product/Design

Process

Ten Steps for an FMEA

The FMEA Worksheet

Step 1: Review the Process

Step 2: Brainstorm Potential Failure Modes

Step 3: List Potential Effects for Each Failure Mode

Steps 4–6: Assigning Severity, Occurrence, and Detection Rankings

Step 4: Assign a Severity Ranking for Each Effect

Step 5: Assign an Occurrence Ranking for Each Failure Mode

Step 6: Assign a Detection Ranking for Each Failure Mode

and/or Effect

Step 7: Calculate the Risk Priority Number for Each

Failure Mode

Step 8: Prioritize the Failure Modes for Action

Step 9: Take Action to Eliminate or Reduce the High-Risk

Failure Modes

Step 10: Calculate the Resulting RPN as the Failure Modes

Are Reduced

FMEA Case Study

Case Study Step 1: Review the Process

Case Study Step 2: Brainstorm Potential Failure Modes

Case Study Step 3: List Potential Effects of Each Failure Mode

Case Study Step 4: Assign a Severity Ranking for Each Effect

Case Study Step 5: Assign an Occurrence Ranking for Each

Failure Mode

Case Study Step 6: Assign a Detection Ranking for Each Failure

Mode and/or Effect

Case Study Step 7: Calculate the Risk Priority Number for Each

Failure Mode

Case Study Step 8: Prioritize the Failure Modes for Action

Case Study Step 9: Take Action to Eliminate or Reduce the

High-Risk Failure Modes

Case Study Step 10: Calculate the Resulting RPN as the Failure

Modes Are Reduced or Eliminated

When and Where to Use FMEAs

Safety

Accounting/Finance

Software Design

Information Systems/Technology

Marketing

Human Resources

Purchasing

Appendix 1 Creating a Process Flowchart

Appendix 2 Brainstorming

Brainstorming Rules

Appendix 3 Reaching Consensus on Severity, Occurrence, and

Detection Rankings

Team Voting

Get the Process Expert Involved

Defer to One of the Team Members

Rank Failures and Effects within a Ranking Category

Talking It Out

Use the Higher Ranking

Appendix 4 Examples of Custom Rankings Scales

Appendix 5 Process Improvement Techniques

Mistake-Proofing

Design of Experiments

Statistical Process Control

Team Problem Solving Using CI Tools

Appendix 6 ISO/TS 16949 Requirements Referencing FMEAs

FMEA Glossary of Terms

Subject Categories

BISAC Subject Codes/Headings:
BUS007000
BUSINESS & ECONOMICS / Business Communication / General
BUS053000
BUSINESS & ECONOMICS / Quality Control