FMEA
Failure Mode and Effects Analysis (FMEA) is a structured, systematic risk analysis technique used to identify potential failure modes in a product design (Design FMEA / DFMEA) or manufacturing process (Process FMEA / PFMEA), assess their severity, occurrence likelihood, and detection probability, and prioritize risk reduction actions. FMEA is required by IATF 16949 (automotive) and is strongly recommended by ISO 13485 (medical devices) and AS9100 (aerospace).
Why it matters
FMEA sits at the intersection of PLM and QMS — it consumes design data from PLM (product structure, design parameters) and produces risk records and control plan requirements that QMS governs and regulatory submissions require. Getting the FMEA-to-control-plan-to-inspection handoff right is one of the more complex data integration challenges in regulated manufacturing IT.
External References
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Cite this definition
Finocchiaro, Michael. “FMEA.” DemystifyingPLM PLM Glossary, 2026, https://www.demystifyingplm.com/glossary/fmea