Results: a dhr review was performed on lot number 5156922.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications, in accordance with the in-process sampling plans.Per review it was noted that there were no related reject activity findings throughout the build of this lot that would impact upon the quality of the product.Conclusions: confirmation of the defect stated in the pr could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing.Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects stated in the pir.This incident is indeterminate.Corrective action project / capa (#): no sample was returned for evaluation and testing; therefore, a root cause could not be established.Severity is limited and occurrence is low.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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