NCR, NCMR, CAPA, Deviations - Medical Device Distributor

[anonymous16]

Hello!!

I work in a Medical Device company, they don't manufacture just distribute. They consider production as being part of the distribution team.. anyway to give you an idea of what I'm a little confused about: they do NCRs and NCMRs mainly for packaging/labeling, if a label needs correction or when mislabeled or when the items don't meet specification standards, then the product is nonconforming.


Now my questions: At what point should a deviation be considered? For instance, they had a situation with labeling and barcodes so a deviation was written to accept the item after re-labeling with the correct readable barcode. In that case is that a deviation or an NCR? Should we be writing CAPAs for any of these instances? Will this deviation take away the NCR? Or should we be using both? At what point is planned or unplanned? Also, can a deviation be closed or kept opened...? I was under the impression that deviation are more like a one time "detour" of standard procedures (ie. an OOS for a raw material to be used in a batch, then the deviation is for that one lot of that one raw ingredient), am I wrong? I mean when will it be considered opened or closed? Should it be monitored? I think if its written to be opened for several items, several lots then, there's a problem with your system? right? Maybe that needs to be addressed and not "patched up" with a deviation...?

Note: This company follows ISO 13485, while I'm used to FDA codes of regulation for pharmaceutical when a deviation is used in situations such as OOS. This seems familiar yet different... Help???

Thank you in advance!

 

[pkost]

I think your terminology is confusing matters, I don't believe deviation is defined by the standard, therefore it is whatever you chose it to be:

if you receive a product with an incorrect label, it is non conforming.

you may take action to correct that issue (i.e. relabel); you will also assess the non conformance to evaluate whether a full CAPA is required


Please note:
1. In certain circumstances mislabelling is a reportable incident after it has been released by the manufacturer
2. Relabelling is close to manufacture and not really something a distributor should really be doing without oversight of the manufacturer (FDA requires relabellers to be registered; in the EU you are at risk of falsifying the product)

 

[anonymous16]

Re: NCR, NCMR, CAPA, Deviations

Thanks for replying pkost!
I understand what you are saying about relabeling product, but I brought it up since that is the main reason for NCRs, but deviations were barely used until now.

I feel like it is so confusing because they don't have a clear understanding themselves (at my company) for me to even begin to comprehend at what point or time you would choose one over the other or use them combined.

I come from full manufacturing pharma dealing with FDA to just distribution dealing with ISO. Am I just overthinking it?