Risk
Failure Mode and Effects AnalysisFMEA
A structured analysis of how components can fail and the effect of each failure.
FMEA assigns a Risk Priority Number (RPN = Severity × Occurrence × Detectability) to each failure mode. High-RPN modes get corrective action priority. DFMEA covers product design; PFMEA covers manufacturing process. Required by IATF 16949 for automotive suppliers and common in aerospace (AS9100) and medical device contexts.