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  bullet green arrow 25 Documented process to determine the use of appropriate error-proofing methodologies

bullet green arrow 25Details of methods documented in the PFMEA (or equivalent) - test frequencies in the control plan

bullet green arrow 25Testing of error-proofing devices for failure or simulated failure. Records must be retained

bullet green arrow 25Challenge parts shall be identified, controlled verified and calibrated

bullet green arrow 25Error proofing device failures must have a reaction plan
   
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