FMEA
Failure Mode and Effects Analysis · pfmea · dfmea
Structured risk-analysis tool — list every failure mode, score severity × occurrence × detection, prioritise the high-RPN items. Required content of ISO 14971 for medical devices.
FMEA decomposes a process (PFMEA) or design (DFMEA) into its functions, lists every credible failure mode, and scores each on Severity, Occurrence and Detection (typically 1–10 each). RPN = S × O × D. Items above your action threshold drive risk-control measures, which feed back into a revised RPN.
For medical devices, FMEA is the foundational tool of ISO 14971 risk management. V5 stores FMEAs as living documents linked to product / process change control, so any change auto-triggers RPN re-scoring.
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