The Basics of FMEA Book

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