PFMEA (Process Failure Mode and Effects Analysis)

Systematic analysis of potential failures in manufacturing or service processes, distinct from Design FMEA which analyzes product design failures. PFMEA examines each process step to identify how it could fail, effects of that failure, and actions to prevent or detect failures. Assigns Risk Priority Number (RPN) based on Severity × Occurrence × Detection. Focus areas include equipment failures, operator errors, material variations, and environmental factors. Used in 8D D5 to evaluate proposed PCAs, Six Sigma Improve phase, and process validation. Essential in automotive (IATF 16949) and required before production launch. Updated throughout product lifecycle as process changes.