Regulatory Assist

ISO 14971: FMEA examples that actually pass audits

Lessons learned from building and defending FMEAs with auditors.

What auditors really look for

Structure that keeps teams fast

Keep columns purposeful. If a field never informs a decision or a control, drop it. Your traceability and clarity matter more than page count.

Example row skeleton

Function → Potential Failure Mode → Effects → Causes → Current Controls → S (1–5) → O (1–5) → D (1–5) → RPN
Recommended Actions → Owner → Due → Verification Evidence → Residual Risk → Link to Hazard/HS
Discuss your RMF