Failure Mode and Effects Analysis (FMEA)

Reviewed by Apex Insurance Brokers · Last reviewed 2026-06-22

Reviewed by Apex Insurance Brokers · Last reviewed 2026-06-22

Reviewed by Apex Insurance Brokers · Last reviewed 2026-06-22

Category: Risk identification & assessment · Reviewed by Al Jabbar, Broker · Specialist Risks · Last reviewed

Failure Mode and Effects Analysis (FMEA) is a systematic, bottom-up technique for identifying the ways in which components, processes or systems can fail, the effects of those failures and the actions that can mitigate them. It originated in 1940s US military reliability engineering (MIL-P-1629) and is now codified in IEC 60812 and IEC 31010.

Process

1. Define the system boundary — the equipment, sub-system or process under review.
2. List functions — what each component is supposed to do.
3. Identify failure modes — how each function could fail.
4. Identify effects — local effect on the sub-system, next-level effect, end effect on the customer or business.
5. Identify causes — the mechanisms that could trigger each failure mode.
6. Identify current controls — preventive and detective.
7. Rate severity, occurrence and detection — each typically on a 1–10 scale.
8. Calculate Risk Priority Number (RPN) — Severity × Occurrence × Detection.
9. Identify recommended actions for the highest-RPN failure modes.

Variants

• Design FMEA (DFMEA) — at design stage of a product.
• Process FMEA (PFMEA) — for manufacturing or service processes.
• System FMEA — at architectural level.
• FMECA — adds Criticality analysis for a more quantitative assessment.

Commercial insurance relevance

FMEA is referenced in product liability, recall and professional indemnity proposal forms — particularly for medical devices, automotive, food, aerospace and engineering risks. Evidence of disciplined FMEA can shift terms materially.

References

• IEC 60812:2018 — Failure modes and effects analysis (FMEA and FMECA).
• IEC 31010:2019, Annex B.10.
• US Department of Defense (1980). MIL-STD-1629A.

Cross-references

• FMEA (acronym)
• HAZOP study
• Root cause analysis

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