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PFMEA & Control Plan

PFMEA (Process Failure Mode and Effects Analysis) is a structured approach that assigns quality risk levels to each step in a process (manufacturing or transactional). PFMEA is a powerful prevention tool, since it does not wait for defects to occur, but rather anticipates them and implements countermeasures ahead of time.​

·   Provides organizational intellectual knowledge

·   Identifies potential process failure modes

·   Evaluates and classifies potential failure modes (risk assessment)

·   Explores cause(s) of the failure mode

·   Promotes proactive risk-management – “before it happens”

·   Eliminates and controls the ways a process can fail

·   Identifies countermeasures (i.e. action items needed to reduce risk)

·   Reduces the likelihood of failure (risk bases thinking approach)

·   Improves the likelihood of defect free parts

·   Leverages power of cross-functional/multi-disciplinary team

·   Uses “lessons learned” to prevent known quality concern reoccurrence ​