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Introduction | |
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What Is an FMEA? | |
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The History of FMEAs | |
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What Is the Purpose of an FMEA? | |
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Part of a Comprehensive Quality System | |
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FMEAs and Bottom-Line Results | |
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Example 1 | |
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Example 2 | |
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Example 3 | |
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ISO 9000, ISO/TS 16949, and FMEAs | |
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The FMEA Process | |
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Evaluating the Risk of Failure | |
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Assessing the Risk Priority Number | |
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The FMEA Team | |
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FMEA Team Size | |
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FMEA Team Membership | |
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FMEA Team Leader | |
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The Role of the Process Expert | |
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Training the FMEA Team | |
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FMEA Boundaries of Freedom | |
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FMEA Scope | |
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FMEA Start-Up Worksheet | |
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Product/Design versus Process FMEAs | |
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Product/Design | |
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Process | |
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Ten Steps for an FMEA | |
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The FMEA Worksheet | |
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Review the Process or Product | |
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Brainstorm Potential Failure Modes | |
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List Potential Effects for Each Failure Mode | |
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Assigning Severity, Occurrence, and Detection Rankings | |
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Assign a Severity Ranking for Each Effect | |
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Assign an Occurrence Ranking for Each Failure Mode | |
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Assign a Detection Ranking for Each Failure Mode and/or Effect | |
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Calculate the Risk Priority Number for Each Failure Mode | |
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Prioritize the Failure Modes for Action | |
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Take Action to Eliminate or Reduce the High-Risk Failure Modes | |
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Calculate the Resulting RPN as the Failure Modes Are Reduced | |
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FMEA Case Study | |
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Review the Process | |
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Brainstorm Potential Failure Modes | |
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List Potential Effects of Each Failure Mode | |
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Assign a Severity Ranking for Each Effect | |
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Assign an Occurrence Ranking for Each Failure Mode | |
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Assign a Detection Ranking for Each Failure Mode and/or Effect | |
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Calculate the Risk Priority Number for Each Failure Mode | |
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Prioritize the Failure Modes for Action | |
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Take Action to Eliminate or Reduce the High-Risk Failure Modes | |
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Calculate the Resulting RPN as the Failure Modes Are Reduced or Eliminated | |
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When and Where to Use FMEAs | |
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Safety | |
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Accounting/Finance | |
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Software Design | |
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Information Systems/Technology | |
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Marketing | |
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Human Resources | |
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Purchasing | |
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Creating a Process Flowchart | |
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Brainstorming | |
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Brainstorming Rules | |
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Reaching Consensus on Severity, Occurrence, and Detection Rankings | |
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Team Voting | |
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Get the Process Expert Involved | |
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Defer to One of the Team Members | |
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Rank Failures and Effects within a Ranking Category | |
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Talking It Out | |
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Use the Higher Ranking | |
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Examples of Custom Ranking Scales | |
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Process Improvement Techniques | |
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Mistake Proofing | |
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Design of Experiments | |
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Statistical Process Control | |
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Team Problem Solving Using CI Tools | |
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ISO/TS 16949 Requirements Referencing FMEAs | |
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Alternative FMEA Worksheets | |
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FMEA Glossary of Terms | |
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Index | |