Notified Body (NB) Audits of Sub-Contractors and Critical Suppliers

[Ronen E]

Re: NB Audits of Sub-Contractors and Critical Suppliers

How then, do I determine what suppliers need to have contracts that allow for unannounced audits if the NB has the authority to visit a supplier that I have not identified as critical?[/LEFT]

I believe that the following clause from the MEDDEV is key:

Whether the subcontractor is undertaking the supply of a part, material or service, which may affect the compliance of the device with the essential requirements.

Cheers,
Ronen.

PS At the end of the day it is a matter of risk management. If you estimate that the odds of the NB deciding to audit a supplier - due to lack of controls on your part, quality consistency issues or else - are low, you may decide that the risk is low enough (acceptable) and skip the audit-access provisions in the contract. If you do so, however, I recommend that those odds are estimated in a formal, documented process that represents top management support.

 

[somashekar]

Re: NB Audits of Sub-Contractors and Critical Suppliers

How then, do I determine what suppliers need to have contracts that allow for unannounced audits if the NB has the authority to visit a supplier that I have not identified as critical?

Its a good manufacturing practice to establish contracts across your subcontracting suppliers. Its also a good practice to include about audit agreements by self or second party, at any point of time with reasonable prior information, without infringement on the suppliers other processes that are not connected. You may never audit most of your subcontracting suppliers per your discretion, but that is an other matter.

 

[Pads38]

"It is the responsibility of the manufacturer to determine which are critical items or processes and how their purchase is controlled. This depends on the manufacturer’s risk management activity. However, the auditing organization may decide to visit suppliers deemed by the manufacturer to be non-critical."

So it is up to you to decide - but your NB may disagree with you.

Your NB obviously knows about any suppliers listed on your certification and in this case I would suggest that the agreement you have with such a supplier would need to explicitly state the need for support for audits (both announced and unannounced).

Your other suppliers will be subject to your "Supplier Evaluation" process, which will be examined as part of any routine NB audit. It is at this stage where the NB may decide that your control over a particular supplier is not robust enough, so this identifies other suppliers with which you may need formal audit agreements in place. (Though, as Somashekar suggests, it is probably good practice to have that in place for all supply agreements).

 

[PearlKetchup]

Old thread BUT hoping for some advice as I am rather inexperienced with these logistics. Our NB just scheduled our R audit for Aug this year. I wasn't with the company last year when their critical supplier, viz contract manufacturer, was audited in an unannounced visit. It caused an understandable disturbance at the CM. I'm wondering if I should reach out to our supplier and let them know that they may be visited during our scheduled audit? If I was this supplier, I'd love to get the same heads up this far in advance. Would this be kosher? What are your thoughts? I will reach out to our NB contact but wanted to gather some opinions first. Many thanks!

 

[yodon]

I wouldn't expect your suppliers to be audited during your audit. The unannounced audit is just now part of life under 13485. You should definitely coordinate with your CM (and any other critical suppliers that might be visited) to get plant shutdown dates so you can communicate those to your NB. If they don't know those dates and show up on a day the plant is closed down, you will still get billed for the audit (and they'll still have to do an audit sometime).

 

[PearlKetchup]

I wouldn't expect your suppliers to be audited during your audit. The unannounced audit is just now part of life under 13485. You should definitely coordinate with your CM (and any other critical suppliers that might be visited) to get plant shutdown dates so you can communicate those to your NB. If they don't know those dates and show up on a day the plant is closed down, you will still get billed for the audit (and they'll still have to do an audit sometime).

Thank you Yodon, this is great advice. Unfortunately, things aren't in the greatest state with this supplier at the moment. They were mishandled before I came in last year and by my estimates, recovery could take a while. I have my work cut out but this makes me feel confident we can turn over a new leaf.