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Failure Mode and Effects Analysis (FMEA) examines how a process might fail, the consequences, possible causes, current controls and actions to reduce risk.
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Use it before introducing a changed process or when reviewing known vulnerabilities in an existing one.
It makes preventive discussion systematic and records why the team prioritizes one concern over another.
Use Root Cause Analysis to investigate an event that already occurred. Use Control Plan to record the agreed ongoing checks after risk review.
Fictional example snapshot
A fictional supplier reviews a label mismatch failure mode.
| Current controls | Manual order-to-label check |
|---|---|
| Agreed example ratings | S = 5, O = 4, D = 3; RPN = 60 |
| Follow-up | Test a revised check; reassess only after observed evidence |
These figures illustrate the method; they are not clinical instructions, universal targets or verified results from a real organization.
Read the complete worked example and its interpretationThe full guide includes prerequisites, interface-specific steps, two fictional examples, common mistakes and interpretation help. It is available without registration.
FMEA: guide & examplesOpen FMEAMeasure
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