Regulatory Open Forum

Updating supplier agreements to ensure they include, among other things, the consent of our critical suppliers to unannounced NB audits.  A couple of questions....what has been the group's general reception by your critical suppliers to this requirement?  And, can anyone share language you've used or even an example.  Thanks 

I have a follow-up question regarding this topic: What if the supplier being used is already ISO 13485 certified - shouldn't they already know per their auditors that unannounced audits are possible especially if they are the contract manufacturer?  My reasoning for this is that I'm seeing this along the lines of these suppliers in the US who already know that FDA can come by at any time at their facility if they support a company that is selling products regulated by FDA.  Companies didn't necessarily write in a contract that FDA can come by at any time because of this.  I'm curious if other folks have any other thoughts.  Thanks.

I have a follow-up question regarding this topic: What if the supplier being used is already ISO 13485 certified - shouldn't they already know per their auditors that unannounced audits are possible especially if they are the contract manufacturer?  My reasoning for this is that I'm seeing this along the lines of these suppliers in the US who already know that FDA can come by at any time at their facility if they support a company that is selling products regulated by FDA.  Companies didn't necessarily write in a contract that FDA can come by at any time because of this.  I'm curious if other folks have any other thoughts.  Thanks.

Unannounced audits apply to the European Union only. In many cases, a supplier, even a contract manufacturer, may not know if the customer puts the CE Mark on the medical. For example, a customer may require that a supplier implement ISO 13485:2003. However, the customer could market the medical device in the US only, Canada only, or the EU only.

The supplier needs to know if the customer has identified them to the customer’s NB. In addition, the customer needs to inform the NB of the supplier’s production schedule, especially scheduled plant shutdowns. This implies a strong working relationship between the parties.

The supplier will probably charge the customer for the cost of the unannounced audit. To prevail, the unannounced audit needs to be in the contract and, thereby, open to an invoice.

The supplier may have an ISO 13485:2003 registrar different from the customer’s NB. Contract manufacturers could face unannounced audits from multiple NBs, depending on their customers. Of course, the NBs could coordinate and share information, but it is not likely in my opinion.

Dan - If we have a CE product, whether its manufactured in the US or not, wouldn't we still be subject to unannounced audits in the US (not just EU)?  That would certainly make life easier, but its not how I interpreted guidance.  To compound matters, one of our critical suppliers may very well be in Mexico, so lets just add another country to the mix.....    

I said, “Unannounced audits apply to the European Union only.” While it was clear to me when I wrote it, I now see it is ambiguous. I was trying to point out that other jurisdictions, such as Canada, don’t employ unannounced audits as a regular component of surveillance.

I didn’t intend to imply that unannounced audits take place in the EU only. When a company puts the CE Mark on a device, regardless of the directive, then the company and its suppliers are subject to unannounced audits anywhere in the world. This is not to say that all suppliers would receive an unannounced audit.

To come back to the original question, a supplier, even with a ISO 13485:2003 QMS, would not always know if the customer were putting the CE Mark on the product.

Dan - If we have a CE product, whether its manufactured in the US or not, wouldn't we still be subject to unannounced audits in the US (not just EU)?  That would certainly make life easier, but its not how I interpreted guidance.  To compound matters, one of our critical suppliers may very well be in Mexico, so lets just add another country to the mix.....    

Updating supplier agreements to ensure they include, among other things, the consent of our critical suppliers to unannounced NB audits.  A couple of questions....what has been the group's general reception by your critical suppliers to this requirement?  And, can anyone share language you've used or even an example.  Thanks 

Thank you to Dan and David.  I needed to see different perspectives and you both offered them.

Since I feel as though I hijacked Larry's question - anyone able to answer his questions?  Thanks.

Updating supplier agreements to ensure they include, among other things, the consent of our critical suppliers to unannounced NB audits.  A couple of questions....what has been the group's general reception by your critical suppliers to this requirement?  And, can anyone share language you've used or even an example.  Thanks 

Thanks!  

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Larry Lugo
Carlsbad CA
United States