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...Sheet pfmea and parameters quality tools failure mode effects analysis process description instructions this template is for use by product resources to record the medical other devices placed into production fmea also referred as modes criticality fmeca please see guidance in regarding before beginning a initiate action reduce rpn value triggering requiring mitigation reevaluate after completion of recommended actions severity sev regardless item responsibility number model prepared page core team date orig rev function potential effect s class cause mechanism occur current controls detec target results taken occ det...