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Retrospective (Retroactive) Supplier Qualifications

D

Dr. Electron

#1
There's been a procedural requirement at our facility that a qualification strategy be filled out for each new supplier.

This almost never happened. Maybe 5% of the suppliers had this strategy filled out for them over the last ten years.

We're looking at this now and we want to be in compliance. The suggestions so far are to retrospectively fill out the forms. But is it right to go back and fill out forms that dictate a plan to qualify a supplier, when that supplier has been shipping product to us for years?

Is there anything we can do to help ourselves when we get audited and this gets looked at?

Thank you!
 
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harry

Super Moderator
#2
Re: Retrospective Supplier Qualifications

.............. The suggestions so far are to retrospectively fill out the forms. But is it right to go back and fill out forms that dictate a plan to qualify a supplier, when that supplier has been shipping product to us for years? ....................
Should happen for any organizations that choose to start this practice for the first time. While it is generally right to assume that existing suppliers had been filtered throughout the years, there are also occasions when you find good reasons to reject the unqualified ones that remained because nobody cares or they have good relations or connections with some one out/up there.
 
M

MIREGMGR

#3
Re: Retrospective Supplier Qualifications

The suggestions so far are to retrospectively fill out the forms. But is it right to go back and fill out forms that dictate a plan to qualify a supplier, when that supplier has been shipping product to us for years?
Yes.

The operative principle is "better late than never".

Your retrospective qualification should include a case-by-case analysis of what evidence exists that previously accepted products/services from such a vendor conformed to the applicable specifications and were consistent with the associated device-product being safe and effective. That should include a review of your MDR/adverse event/customer complaint logs to determine what records are relevant.
 
S

silentrunning

#4
Re: Retrospective Supplier Qualifications

If I was presented with this problem I would first write up a Corrective Action Request. This shows acceptance and knowledge of the problem. I would get with all the management involved and write up a correction plan with milestones. As each milestone is reached I would verify effectiveness. Once the entire Corrective Action Plan was completed I would close it out and verify effectiveness. I can't see any top management or auditor finding fault with this method. I would not just try to do a hurried job of meeting the minimum requirements of ISO.
 

somashekar

Staff member
Super Moderator
#5
Re: Retrospective Supplier Qualifications

There's been a procedural requirement at our facility that a qualification strategy be filled out for each new supplier.

This almost never happened. Maybe 5% of the suppliers had this strategy filled out for them over the last ten years.

We're looking at this now and we want to be in compliance. The suggestions so far are to retrospectively fill out the forms. But is it right to go back and fill out forms that dictate a plan to qualify a supplier, when that supplier has been shipping product to us for years?

Is there anything we can do to help ourselves when we get audited and this gets looked at?

Thank you!
Why in retrospective ?
You were in no way wrong to be working with a supplier before your audit who was consistently giving you acceptable parts.
This very reason and sufficient records of acceptance will stand in your support to qualify a supplier.
There's been a procedural requirement at our facility that a qualification strategy be filled out for each new supplier.
The past good supplies record is in itself a strategy.
This almost never happened. Maybe 5% of the suppliers had this strategy filled out for them over the last ten years.
It is you who has to qualify your supplier based on your (organization) criteria and not the supplier filling out something that qualifies him.
You may fill no forms for suppliers who are good with you prior to the form procedure. They being good itself qualifies them when you have objective evidences.
 
D

Dr. Electron

#6
Re: Retrospective Supplier Qualifications

Yes.

The operative principle is "better late than never".

Your retrospective qualification should include a case-by-case analysis of what evidence exists that previously accepted products/services from such a vendor conformed to the applicable specifications and were consistent with the associated device-product being safe and effective. That should include a review of your MDR/adverse event/customer complaint logs to determine what records are relevant.
Yes, this was my angle as well. I don't think it's right to fill out a strategy after the fact, because then you could just choose the "future actions" that were already complete. For instance, say you didn't have a First Article for a part the supplier made...well now we can go back into the strategies and say that a first article is not required for that part. But where is that justified? And we've got 200+ suppliers we're looking at...it would take a lot of time and resources just to go back and justify each supplier.
 
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