Control of Nonconforming Product - Customer and/or Regulatory Approval

RCW

Quite Involved in Discussions
#1
With regards to 8.3 Control of Nonconforming Product....

For build-to-customer-print products, currently my quality procedure calls out for customer concession before using nonconforming product "as-is" or if it will be repaired. The way it is set up, the responsibility is on my customer to say yea or nea. Would I still need to include that we ensure regulatory requirements have been met too, especially if it's the customer call?
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: Nonconforming Product - customer and/or regulatory approval

With regards to 8.3 Control of Nonconforming Product....

For build-to-customer-print products, currently my quality procedure calls out for customer concession before using nonconforming product "as-is" or if it will be repaired. The way it is set up, the responsibility is on my customer to say yea or nea. Would I still need to include that we ensure regulatory requirements have been met too, especially if it's the customer call?
That is a tough question. I am no "expert" in 13485, but the way the Standard reads, one could interpret that the supplier should only ask for a concession when/if you know that no regulatory requirements are being violated. So, it could be understood that you, as a tier 1 (or 2) supplier, might be expected to assess the NC condition against the product regulations, which sometimes you don't even know what they are because the customer might deliberately conceal the information from you.
You can always word your procedure to state that it is your customer responsibility to assess the situation against regulations, but can you enforce what your customer does?
 

Helmut Jilling

Auditor / Consultant
#3
With regards to 8.3 Control of Nonconforming Product....

For build-to-customer-print products, currently my quality procedure calls out for customer concession before using nonconforming product "as-is" or if it will be repaired. The way it is set up, the responsibility is on my customer to say yea or nea. Would I still need to include that we ensure regulatory requirements have been met too, especially if it's the customer call?

I agree with the guidance that Sidney already gave you. I would further suggest, that since product liability issues could be involved here, consulting with your company's attorney might be appropriate, before you define your official policy on this item.
 

RCW

Quite Involved in Discussions
#4
I would further suggest, that since product liability issues could be involved here, consulting with your company's attorney might be appropriate, before you define your official policy on this item.
The legal aspects of being a contract manufacturer of medical devices could be a nice, lengthy post in and of itself. If you manufacturer your own medical devices, you should hopefully have a clue what your legal responsibilities are. When you are a subtier supplier, there are a lot of uknowns. As Sidney commented on previously, a customer has already concealed important information from me so that is a reality.
 

Helmut Jilling

Auditor / Consultant
#5
The legal aspects of being a contract manufacturer of medical devices could be a nice, lengthy post in and of itself. If you manufacturer your own medical devices, you should hopefully have a clue what your legal responsibilities are. When you are a subtier supplier, there are a lot of uknowns. As Sidney commented on previously, a customer has already concealed important information from me so that is a reality.
Understandable. All the more reason to make sure that a competent attorney is part of the review team, when that is appropriate.
 
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