90 Pages 19 B/W Illustrations
    by Productivity Press

    102 Pages
    by Productivity Press

    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.

    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

    Biography

    Raymond J. Mikulak