How to deal with an ISO 13485 Supplier Audit nonconformance

#1
Hi All,

I am new to the forum.

I have recently audited a supplier for which I found 2 non-conformances that I raised and supplier has come back with an corrective action plan. I suppose my question is, how to deal with it from my end. Do I need to raise an internal non-conformance report/CAPA to deal with the non-conformances raised during the audit.

There is nothing within ISO13485 that states how to deal with non-conformances raised during supplier audits.

Any advice would be very welcome.
 
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Jim Wynne

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#2
Welcome to the Cove. :bigwave: The first thing to do is to identify any risks for your company that might result from the supplier NCs. I'm not a medical-device expert by any means, but whatever you do in that regard should be documented. I would think that your audit reporting process would be a good way to deal with it.
 

shimonv

Trusted Information Resource
#3
Laura,
What does your supplier control procedure say about supplier audits and corrective action?
Since these nonconformities are external to your organisation, they should be handled by the suppler with your follow-up / involvement. The level of your involvement should be linked to the level of risk. Again, this comes back to your SOP.

Shimon
 
#4
Hi Both,
Thanks for replying on this matter.
There isn't really much information relating to raising NC's/CAPA's following a supplier audit, I have only found the following statement under the Supplier audit procedure;
1. Should any non-conformities be raised that have a direct bearing on the quality of company's products, the Supplier shall implement, and report upon, suitable corrective and, if deemed appropriate, preventive actions.

There is nothing under the CAPA/NC procedures that state how to deal with supplier NC's.

Laura
 

shimonv

Trusted Information Resource
#5
Then you should consider opening a CAPA on your supplier management process. This is an opportunity for improvement.
Specific to the current situation, I suggest you save their planned corrective action with your report and ask the supplier to update you when the corrective action is complete.
 
#6
Thanks Shimon.

My thought would be to open a CAPA but I was unsure whether I would need to initially raise an NC. I am newest to quality so still learning.
 

shimonv

Trusted Information Resource
#7
I think it's okay to open a CAPA directly. If this would come up during internal audit, then it would make sense to open an NC first.
 
#8
Would there be a need to raised a NC when this is raised at the suppliers end? I haven't raised NC's in the past for notified body audit findings, just CAPA's.
 

shimonv

Trusted Information Resource
#9
Your procedure is not clear, so you have a bit of freedom how to go about it. I suggest to aim at minimum while you study the processes of supplier and internal audit controls.
 
#10
The internal audit controls are specific that a NCR will be done should a NC be found. Its the supplier audit controls that seem to be an issue, would you suggest to raise an internal NC as a minimum? This has never been brought up as an issue in NB audits before.
 
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