What is the process for conducting a Process Failure Mode and Effects Analysis (PFMEA)?

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Accepted Answer

PFMEA is a systematic approach to identify and mitigate potential process failures and their effects.

1. Define the scope: Identify the process to be analyzed, such as assembly or manufacturing.
2. Assemble a team: Include cross-functional members like engineers, quality, and production staff.
3. Identify potential failure modes: List ways the process could fail, e.g., incorrect assembly.
4. Determine effects of failures: Assess the impact on product quality or safety, like defects or recalls.
5. Assign severity ratings: Rate the seriousness of each effect on a scale (1-10), e.g., 9 for safety issues.
6. Identify causes: Determine root causes for each failure mode, such as operator error or equipment malfunction.
7. Assign occurrence ratings: Rate the likelihood of each cause occurring, e.g., 4 for frequent issues.
8. Assess detection controls: Evaluate existing measures to detect failures before they reach the customer.
9. Calculate Risk Priority Number (RPN): Multiply severity, occurrence, and detection ratings to prioritize risks.
10. Develop action plans: Create strategies to mitigate high-risk failure modes, such as training or redesign.

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