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FMEA & Risk Prioritization

Risk & FMEA

Process FMEA with RPN prioritization; action plans for high-risk failure modes.

Executive Summary

High-risk failure modes were not systematically addressed. This project applied Process FMEA with RPN (Risk Priority Number) to prioritize failure modes, then implemented controls and detection improvements for the top risks. Outcomes: ~50% reduction in high-RPN items, clearer control plans, and audit-ready FMEA documentation.

  • ~50% reduction in high-RPN failure modes
  • Clearer control plans and detection methods
  • Audit-ready FMEA documentation

Context & Problem

Critical process steps had undocumented failure modes and no clear prioritization. The organization needed a structured way to identify failure modes, assess severity/occurrence/detection, and focus improvement on the highest risks first.

Methodology & Frameworks

The approach used AIAG/VDA-style Process FMEA: process steps, failure modes, effects, causes, current controls. RPN (S×O×D) prioritized items; high RPN received action plans (reduce occurrence, improve detection, or reduce severity). RPN was re-scored after actions.

Implementation

A cross-functional team built the Process FMEA. Items above the RPN threshold received owners and due dates. Actions were implemented and the FMEA and control plan were updated and aligned.

Outcomes

Lessons Learned

FMEA is only useful when the team acts on high RPNs. Cross-functional input improved completeness. Linking FMEA to the control plan made the connection visible to auditors and operators.

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