How medical device FMEA fits into the ISO 14971 risk management file: hazard vs failure mode, RMF structure, and why automotive AP tiers fail audits.
Learn how to evaluate current controls and assign FMEA detection ratings consistently. Includes a structured decision path, 1-10 scale with control types, and a control upgrade path for improving detection.
Learn how to determine FMEA occurrence ratings using Cpk data, historical failure rates, or engineering judgment. Includes a complete 1-10 scale with Cpk equivalents and manufacturing examples.
Complete FMEA severity rating scale with 1-10 definitions anchored to specific manufacturing and assembly failure examples. Includes worked injection molding PFMEA example and team calibration techniques.
Walk through all seven steps of a process FMEA using the AIAG-VDA method with a real injection molding example. Covers structure analysis, function analysis, failure analysis, risk ratings, optimization, and results documentation.
Compare FMEA Action Priority (AP) and Risk Priority Number (RPN) side by side. Learn why the AIAG-VDA 2019 handbook replaced RPN, how the AP lookup table works, and a practical transition approach for your FMEA program.
Learn how to calculate Risk Priority Number (RPN) in FMEA with a full worked example from a manufacturing PFMEA. Covers severity, occurrence, and detection rating scales, common thresholds, and when to use RPN vs. AIAG-VDA Action Priority.