C
Under FDA CFR 820/ISO 13485 (FDA/International medical device quality requirements) when you have product that is outside release specifications (the prints), you have Non-Conforming Product. Such product is to be segregated, labeled and formally documented first off. The options to resolving non-conforming product, as far as the part is concerned, are 1) Destroy 2)Return to supplier 3)Rework 4)special disposition (use as is). Under most company quality systems, the last three are rarely recommended or used. The required paperwork/liability is not usually worth it, especially for only one part. Destroy is the preferred response, which gives everyone incentive to identify and fix the problems upstream.
Rework of Medical product requires a documented Rework Procedure, documented training on the procedure, Validation of the rework successfully making the product conforming, and re-inspection.
More importantly, if the non-conformity was returned by a customer, that is probably a Complaint. Complaints require mandatory reporting to the FDA/ISO if the non-conformity could have harmed a patient in any way. Too many reported complaints and they could shut down the product.
Rework of Medical product requires a documented Rework Procedure, documented training on the procedure, Validation of the rework successfully making the product conforming, and re-inspection.
More importantly, if the non-conformity was returned by a customer, that is probably a Complaint. Complaints require mandatory reporting to the FDA/ISO if the non-conformity could have harmed a patient in any way. Too many reported complaints and they could shut down the product.