Hello Cove! I have learned much in the late months in which I’ve regularly come to the site to read questions and answers re: ISO 13485, C.A.P.A., and other topics. Our recently ISO 13485 accredited Contract mfg. facility does a good portion of "Job Shop" work. I’m a 15-months in Q.E. who’s accountable for evaluating complaints, returns and CAPA. I recently was advised by my boss regarding a return request for a stained small JS lot which shipped in 1/2010:
“we need to evaluate the situation when parts are returned that were shipped more than six months prior to the request for return. We recently accepted a return of parts that were shipped about 1.5 years before the return was requested . . . I presented a similar question to [my boss] and the answer was that we need to evaluate based on customer and quantity or cost of the return. Not sure what is contracted with the customers.”
There really isn’t any criteria in our SOPs to justify denying the return based on these criteria. Should I:
Try to get language into our SOPs regarding some shelf life or returnability period. I doubt this would fly to any less than several years w/ our medical Customers. Can a firm treat “non-medical” product differently if it’s only 13485 accredited? (no longer 9001);
Try to implement any such change only by really drilling down with the Sales dept. into the contract “Order processing and review” process? Neither part 7.1-7.2 of the standard, nor our corresponding SOPs , are helping me much here.
Am I out of my depth here regarding the relative role of QA? Would any acceptable restrictions on returnability exempt us from doing formal investigations per GMP 820.198(b)? Any help on any related insights or similar experiences others have had would be greatly appreciated.
“we need to evaluate the situation when parts are returned that were shipped more than six months prior to the request for return. We recently accepted a return of parts that were shipped about 1.5 years before the return was requested . . . I presented a similar question to [my boss] and the answer was that we need to evaluate based on customer and quantity or cost of the return. Not sure what is contracted with the customers.”
There really isn’t any criteria in our SOPs to justify denying the return based on these criteria. Should I:
Try to get language into our SOPs regarding some shelf life or returnability period. I doubt this would fly to any less than several years w/ our medical Customers. Can a firm treat “non-medical” product differently if it’s only 13485 accredited? (no longer 9001);
Try to implement any such change only by really drilling down with the Sales dept. into the contract “Order processing and review” process? Neither part 7.1-7.2 of the standard, nor our corresponding SOPs , are helping me much here.
Am I out of my depth here regarding the relative role of QA? Would any acceptable restrictions on returnability exempt us from doing formal investigations per GMP 820.198(b)? Any help on any related insights or similar experiences others have had would be greatly appreciated.
