Critical Supplier Agreement acc. to NBOG 2010-1 Annex II

[htcoztrk]

We had an surveillance audit for CE certication according to Medical Device Directive 93/42/EEC.

One of the non-conformities is as following: "Contracts with critical suppliers do not meet all the requirements of NBOG 2010-1 ANNEX-II.
For example: The content of the contract does not include the requirement to be open to 3rd party inspections and responsibilities on each party are not defined."

We already had a quality agreement with the critical supplier in the past. We asked them to renewed it to close this non-conformity however they refused to agree any 3rd party audit or share their production records because they are already working with very big companies and they do not have time to spend for audit or other stuff because they find our company's purcahse volume small. But we're already working with this supplier since 2004 and we had no adverse event until today also we invested a lot for biocompatability tests, functional tests and product quality is very already confirmed by customers. So we do not want to change the supplier.

What should we do in this case? Is there any way to justify this sitaution so I can close the non-conformity?

-Hatice

 

[yodon]

As a contract manufacturer for a medical device, they have to agree to unannounced audits by the notified body. If you list them as a critical supplier then the NB has every right to show up, unannounced, and conduct an audit. If they refuse, you still bear the cost of the audit (not to mention your CE mark will likely be in jeopardy).

 

[htcoztrk]

As a contract manufacturer for a medical device, they have to agree to unannounced audits by the notified body. If you list them as a critical supplier then the NB has every right to show up, unannounced, and conduct an audit. If they refuse, you still bear the cost of the audit (not to mention your CE mark will likely be in jeopardy).

Thank you for your reply. The current issue is that they do not agree to sign an QA including a clause of announced or unannounced but without such clause the non-conformity won't be closed. So my question is what will happen to certified product in case if we cannot close this NC? We only have 1 month left for due time for final corrections. Could unable to provide a QA may cause suspension of our certificate?

 

[Sidney Vianna]

What should we do in this case? Is there any way to justify this sitaution so I can close the non-conformity?

Very likely, this supplier is under NB oversight themselves or via the fact that they are a critical supplier to other large customers. The records of such oversight activity might provide your NB with the assurance they need to consider this supplier properly monitored. If that is the case, your contract with the supplier could be phrased in a way to reflect that context.

Good luck.

 

[planB]

Hatice,

some ideas:
1) You design a new template for quality agreements for critical suppliers that contains the required 3rd-party audit clause, stating in you supplier-control procedure that this template has to be employed for new critical suppliers
2) You show your NB that your current supplier refuses to set-up and adapted quality agreement

By (1) and (2) you can demonstrate due diligence to your NB and that may be sufficient.

A note re. your supplier: the rationale of "other very big companies" is invalid, because in case they provide similar services of similar criticality to other larger-volume companies, they should be used to these kind of quality clauses. So in the long run, I would recommend you to look out for another supplier. At least for biocompatibility, there are plenty around that have no issue to sign contracts with 3rd-party audit clauses.

HTH,

Gerhard

 

[LBMURPHY]

Hi Hatice,
I was curious if you were able to find a resolution. In the past, we have had trouble getting some suppliers to agree to 3rd-party audits. They are a critical supplier to us but we are not a critical customer to them. In some cases it is simply not feasible to get a new supplier. I have in the past had suppliers agree to 3rd party audits if we pay compensation for the audit days.

Thanks!
LBM

 

[Juzaili]

Sorry to ask, we also just received the same NC from the NB. anyone can share a sample of the contract for Medical Devices. My NB said its too old and not as per NBOG_BPG_2010 annex 2. anyone can help me.

 

[planB]

Juzaili,

NBOG BPG 2010-1, Appendix 2 contains 15 items a NB body should check during an audit. Did your NB specifically cite out of this list when raising the NC?

 

[Juzaili]

Dear

Juzaili,

NBOG BPG 2010-1, Appendix 2 contains 15 items a NB body should check during an audit. Did your NB specifically cite out of this list when raising the NC?

Yes, The NB said
'Competency of suppliers raw materials specifications and quality certificates were not seen'

 

[planB]

Have to ask again: "Competency of suppliers raw materials specifications" is really the original wording of the NC? Which "quality certificates" is the NC referring to?