Received Material on Hold

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
MDSAP Audit this week. We received some material that we ordered but we noticed problems with it so I asked it to be put on hold. its tagged and segregated properly. It was received last week and our QMS permits holding for up to 3 months pending QA Inv and disposition

Is our auditor allowed to probe on this material? Whats wrong with it? Why isn't there a SCAR? Let me watch you measure it per the approved drawing. Things like this?
 

qualitynewbie

Involved In Discussions
We recently underwent our MDSAP audit, and we had materials kept in the quarantine area along with the assigned NCR form. At that time, we had not conducted any investigation on those parts; we had only assigned NCR numbers and provided a brief description of the non-conformance. Our auditor was satisfied with this approach. Good luck.
 

Ron Rompen

Trusted Information Resource
I know very little about the requirements of MD, however I do know that they fall pretty much in line with ISO 9001 and IATF 16949. If you have identified and segregated the material, and you are within the limits of your QMS retention period, then the auditor doesn't really have much to poke into. The question regarding the SCAR might be valid, however if you are still doing an internal investigation into the material, then that is up to you. As for watching you measure it per the approved drawing, why would you even want to resist this? It's an easy 'gimme' for you.
 
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