Supplier re-evaluation

Golfman25

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Here is how the FDA inspector explained it to me before issuing the 483. If you haven't used a supplier for a significant period time, then that supplier's performance may have significantly changed since the last order. Without any orders, you have no information to judge supplier performance. We now un-approve all suppliers if there has been no activity for over a year. If we need to use them again, then they have to go through the initial supplier approval process again. Admittedly, the 1-year is arbitrary and we were understandably conservative in our response.

I know this was FDA and not necessarily ISO 13485. However, the QSR and ISO are not that different in this regard and about to get much closer.
The only issue I would have with that, is 1 or 2 orders per year really enough "information to judge supplier performance?" Granted, you have to come up with something, but let's not kid ourselves -- 1 or 2 orders doesn't mean much.
 

Chrisx

Quite Involved in Discussions
If I'm purchasing only 1-time per year, then the supplier has to be approved, correct? I suppose one could set a minimum number of orders to stay on the ASL, but then I would probably have to go through the supplier re-approval process each time I purchased from these rarely used suppliers. Either way, the supplier is going to have to be evaluated. I don't see a big difference.
 

Sidney Vianna

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If I'm purchasing only 1-time per year, then the supplier has to be approved, correct? I suppose one could set a minimum number of orders to stay on the ASL, but then I would probably have to go through the supplier re-approval process each time I purchased from these rarely used suppliers. Either way, the supplier is going to have to be evaluated. I don't see a big difference.
I think people needs to have common sense. What is the purpose of supplier screening, approval, monitoring, reevaluation, etc? Simply to maximize the chances of receiving conforming products/services.

If you are purchasing/receiving products from a supplier once a year and you can, in a cost-effective manner ensure the PRODUCT being received is 100% conforming to requirements, I would much rather use the resources in this product verification exercise, rather than a supplier reevaluation questionable gimmick.
 

Chrisx

Quite Involved in Discussions
100% inspection of all conforming requirements from a supplier is often difficult to achieve. For example, how would I 100% inspection a new CNC mill? I don't have any of the prints and there are 100's of components in a CNC mill. Of course, there qualifications requirements for a new piece of equipment, but 100% inspection is not practical or warranted in many cases.
 

Sidney Vianna

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100% inspection of all conforming requirements from a supplier is often difficult to achieve. For example, how would I 100% inspection a new CNC mill? I don't have any of the prints and there are 100's of components in a CNC mill. Of course, there qualifications requirements for a new piece of equipment, but 100% inspection is not practical or warranted in many cases.
If you are talking about a supplier of capital equipment, I don’t see a requirement for such category of vendor in the standards. The issue has been discussed here many a time.

As for supplier evaluation of a production equipment, most organizations have no technical expertise nor resources for a meaningful exercise. Specialized user reviews would be probably be the best path for that.
 

Chrisx

Quite Involved in Discussions
I found this post "How to treat large Manufacturing Equipment providers - Opinions and comments wanted". I didn't find anything in the post that would suggest that I could completely disregard supplier evaluation for this type of supplier. Perhaps, I am not understanding your point " I don’t see a requirement for such category of vendor in the standards."? Are you suggesting these suppliers are not required to be on the ASL?

We do not require approving all suppliers. Suppliers that have no potential impact on fulfilling customer or requirements don't require approval. However, suppliers of manufacturing equipment do require approval in our QMS. However, these being lower risk suppliers, the evaluation is abbreviated and fairly simple to perform. We put most of the emphasis on supplier controls towards suppliers that perform activities directly on medical devices or supply device components.
 

Chrisx

Quite Involved in Discussions
Thanks for sharing, it is an interesting discussion. However, it seems to be on ISO 9001. ISO 13485 7.4 does not seem to have the provisions found in ISO 9001 8.4.1. I do agree with the general premise of the thread that neither standard requires all suppliers to be approved.
 

gpainter

Quite Involved in Discussions
What does your system say to do? If it is followed, has it caused any issues? Does this supplier supply any critical parts?
 
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