FMEA
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FMEA (Failure Mode and Effects Analysis) is a systematic method for identifying potential failures, their causes, and effects to prioritize preventive actions.
Definition
FMEA (Failure Mode and Effects Analysis) is a structured approach to identifying potential failures in a product or process before they occur. For each potential failure mode, teams assess the severity of its effect, likelihood of occurrence, and ability to detect it before reaching the customer. These three factors multiply into a Risk Priority Number (RPN) that guides improvement prioritization. FMEA originated in aerospace and is now standard practice across industries for proactive risk management.
Examples
A new assembly process FMEA identified that a connector could be installed backward (failure mode) causing complete product failure (severity: 10). Occurrence was estimated at 1-in-50 (score: 6) with no detection method (score: 10), yielding RPN of 600. The team added a poka-yoke fixture making backward installation physically impossible, reducing RPN to 20.
Key Points
- RPN = Severity × Occurrence × Detection (each scored 1-10)
- Address high-severity items first regardless of RPN
- FMEA is a living document—update as design/process changes
- Two main types: Design FMEA (DFMEA) and Process FMEA (PFMEA)
Common Misconceptions
Low RPN means low risk. A failure with severity of 10 (safety/regulatory) and low RPN due to low occurrence still demands attention. Severity-driven prioritization should complement RPN rankings.
FMEA is a one-time exercise. Effective FMEA requires ongoing updates as processes change, new failure modes emerge, or controls prove ineffective. Static FMEAs quickly become outdated and useless.