Supplier re-evaluation

evan_kim90

Involved In Discussions
Hi,

I have a quick question regarding the supplier.
I know we should monitor suppliers based on ISO standards.

But if we are not buying regularly, we do not have plans to buy from the supplier in the next 2-3 years.
Still, do we need to re-evaluate them or hold them and re-evaluate them when we purchase the next batch?

Thanks in advance.
 

Enghabashy

Quite Involved in Discussions
*yes sure , the suppliers list covering thousands of suppliers although we deal with 3 hundreds through the previous 2 years , the list should be still valid without removing anyone ; the assessment should cover the suppliers through the performance criteria of the actual deals;
**from time to time ' the suppliers lists should be regularly checked to assess its contents ; many suppliers may stop their activity or joint with others - this happen without the submitting of the updated information to their customer
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
ISO says to monitor but not how to do it. You get to define that. Define a method that would make you feel comfortable that when it is time to buy from them again, you will receive what you want, when you want and in the expected condition.
 

DanMann

Quite Involved in Discussions
If you're not planning to buy in the next 2-3 years, why not remove them from the Approved Supplier List, then re-add them based on previous performance prior to using them in 2-3 years. Alternatively, set their re-evaluation period to 2-3 years or every time you use them.
 

Chrisx

Quite Involved in Discussions
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.
 

DanMann

Quite Involved in Discussions
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.
Agree with this approach - as you say, this is a deliberately conservative approach, so someone else might use a longer time (maybe based on risk-level, like 2 years for low risk suppliers and 1 year for high risk suppliers) or you could give some credence to the previous performance of former suppliers in the new evaluation or have an abbreviated initial supplier evaluation for former suppliers. It'll depend on the profiles of your suppliers what approach will work best, but the concept presented here is exactly the concern I would have.
Without any orders, you have no information to judge supplier performance.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
If you're not planning to buy in the next 2-3 years, why not remove them from the Approved Supplier List, then re-add them based on previous performance prior to using them in 2-3 years. Alternatively, set their re-evaluation period to 2-3 years or every time you use them.
We do exactly this. We have an inactive column on our ASL. It indicates the preferred supplier and the process purchasing must undertake to make them active again, including reviewing their ISO certifications and some level of audit based on risk.

The reality is if you are not actively purchasing from them and generating revenue for them, any audit/info requests won't be taken as a priority.

So the risk of buying products from them if the Qty =0, Risk =0
 

contigo123

Involved In Discussions
As a follow up question... on our ASL we have suppliers of testing equipment used for our product release. However after the initial purchase, we don't "use" or interact with the equipment manufacturer in any way (e.g., calibrations are done by another approver supplier). Do you keep equipment suppliers on the ASL for some period of time after purchase, or just as long as they are approved at the time of purchase is that sufficient?
 

DanMann

Quite Involved in Discussions
I'd have an equipment register with the initial assessment for why you think that equipment can do what you want it to do (which might include some assessment if the supplier), but I would not keep them on the ASL. If this logic gets forgotten, perhaps he'll a separate tab or category for these suppliers with a note on how you manage one-off procurement of equipment.
I used to treat software similarly, but most are constantly being updated or are SaaS these days, so I find they need their own approach.
 

normzone

Trusted Information Resource
We define our Approved Supplier List as the set of all suppliers in our Oracle system - if a supplier is formally disapproved we flip a flag in there that makes it impossible for a buyer to order from them - we have done this for only a few suppliers, but it's real.

We define re-evaluation as the process of the buyer deciding whether or not to purchase based on the supplier's ability to provide what we want/meet specification, price, delivery schedule, customer service, and review of their deliverables by inspection and/or test.
 
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