FMEA (Failure Mode and Effects Analysis)

Systematic risk assessment tool that identifies potential failure modes in a product or process, evaluates their effects, and prioritizes actions to reduce risk. Assigns Risk Priority Number (RPN) based on Severity × Occurrence × Detection ratings. Two main types: Design FMEA (product design failures) and Process FMEA (manufacturing process failures). Used across all methodologies—8D for evaluating PCAs, Six Sigma Improve phase for risk mitigation, and A3 for assessing countermeasure risks. Essential in automotive (IATF 16949) and aerospace industries.