Root cause: the root cause was determined to be a pulling error.The employee responsible for pulling the required gauze went to the incorrect bin location, and the team leader responsible for verifying the correctness of componentry failed to do so.Both instances were the result of isolated employee errors.Corrective action: the employee and team leader were given confidential disciplinary actions that will be maintained in their personnel files.Investigation summary: an internal complaint (call (b)(4)) was received reporting that an ent pack (part number 89-7324) contained non-rfid gauze instead of rfid gauze.The quality control supervisor reviewed the bom and device history record for the finished good.No discrepancies were identified.The defective sample was not returned for evaluation.The bill of materials and work order for the reported lot number contain raw material number 901431, which is an rfid gauze.The bin location for this item is m7f1a.There is a similar gauze located in bin m7c1a.Preventive action: no preventive action has been taken.Given the isolated nature of this complaint, no potential errors were identified.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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