8.15 Failure Mode and Effects Analysis (FMEA)

FMEA is the engine of risk reduction. It assigns a quantitative Risk Priority Number (RPN) to potential failures to prioritize engineering resources.

8.16 The RPN Calculation

RPN = Severity (S) \times Occurrence (O) \times Detection (D)

• Severity (1-10): How bad is the failure? (10 = Safety hazard without warning).
• Occurrence (1-10): How often will it happen? (10 = Inevitable).
• Detection (1-10): Will we find it before it ships? (10 = Cannot be detected, 1 = Auto-detect/prevent).

8.17 The Action Threshold

• High RPN: Any item with RPN > 100 (or Severity 9/10) requires mandatory mitigation (e.g., poka-yoke tooling, design change).

Final Checklist