A systematic group of activities intended to: recognize and evaluate the potential failure of a product or process and the effects of that failure recognize and prioritize ALL potential causes of each failure. assess risk throughout the entire process (not just manufacturing) identify actions that could eliminate or reduce the chance of the potential failure occurring be a living document that should always be updated to reflect current conditions, including changes FMEA Process objectives:

The FMEA drives product and process improvements Addresses all high risk failure modes Used to develop control plans Integrated with process flow diagram and the process control plan Considers all major “lessons learned” (i.e. nonconforming product, warranty data, customer complaints, corrective actions, etc.)

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