Failure Modes & Effects Analysis (FMEA) is a risk management tool that identifies and quantifies the influence of potential failures in a process. FMEA analyzes potential failures using three criteria:
- Occurrence (failure cause and frequency)
- Severity (impact of the failure)
- Detection (likelihood of failure detection)
Once assessed, prioritized failures are addressed with mistake-proofing for preventable failures and contingency plans for unpreventable risks.