Can "Test Laboratory" supplier be removed from the current supplier list if their test reports are still in use?

[zateek]

I'm interested to see if anyone has insight or suggestions on their approach in situations like these.
The new company I joined has third-party test laboratories that are listed as current suppliers, even though we have not used their services in more than 5 years. The reason provided was that we still use the test reports provided by them for registration and other regulatory purposes. They were passed as qualified suppliers at the time because they provided accredited ISO 17025:2005 certifications, however I believe the standard is now withdrawn and updated certificates are not available. However, my coworker believes it should still be on the list since their service provided is still in use. Any suggestions on how we can navigate this? Would it be ok to remove the suppliers altogether from the approved list but still use their test reports? Or should we update procedures to include active vs inactive approved suppliers? Hope my questions make sense! Thanks

 

[dwperron]

I'm interested to see if anyone has insight or suggestions on their approach in situations like these.
The new company I joined has third-party test laboratories that are listed as current suppliers, even though we have not used their services in more than 5 years. The reason provided was that we still use the test reports provided by them for registration and other regulatory purposes. They were passed as qualified suppliers at the time because they provided accredited ISO 17025:2005 certifications, however I believe the standard is now withdrawn and updated certificates are not available. However, my coworker believes it should still be on the list since their service provided is still in use. Any suggestions on how we can navigate this? Would it be ok to remove the suppliers altogether from the approved list but still use their test reports? Or should we update procedures to include active vs inactive approved suppliers? Hope my questions make sense! Thanks

You should retain them on your approved supplier list as a record in order to have proof that you were using an approved supplier in case it comes up in an audit. I think there should also be a note attached explaining that they are no longer 17025 accredited and they are no longer to be used for 17025 testing.

 

[Bev D]

If you archive records then you would have a version of your approved supplier list showing that tey were approved at the time of the test reports. OR some people simply update their supplier list and record that the list was updated to remove the supplier from the list and teh reason for doing so. I wouldn’t keep them on the approved list when they are not really approved anymore - that just seems like gamesmanship….

 

[Golfman25]

I'm interested to see if anyone has insight or suggestions on their approach in situations like these.
The new company I joined has third-party test laboratories that are listed as current suppliers, even though we have not used their services in more than 5 years. The reason provided was that we still use the test reports provided by them for registration and other regulatory purposes. They were passed as qualified suppliers at the time because they provided accredited ISO 17025:2005 certifications, however I believe the standard is now withdrawn and updated certificates are not available. However, my coworker believes it should still be on the list since their service provided is still in use. Any suggestions on how we can navigate this? Would it be ok to remove the suppliers altogether from the approved list but still use their test reports? Or should we update procedures to include active vs inactive approved suppliers? Hope my questions make sense! Thanks

Problem with keeping them on the list is what if someone decides to use them -- "hey they are on the approved list." Seems like you need some sort of in-between -- maybe "inactive" or "hold" or something. You don't want people using them for new things. Just document what you are doing, and I think you'll be fine.

 

[SeanN]

I think your concerns have been fully addressed by our quality experts. My 2 cents: it seems that you do not "revalidate" your approved vendors list every x year/s. If it's the case, you would not face this issue. You should "update procedures to include active ... approved supplier". Otherwise, there is a clear risk, as Golfman25 said above.

 

[FRA 2 FDA]

I added a separate tab on our approved supplier list for rejected suppliers. It includes the date of the decision and the reason. This might solve your problem. The supplier would no longer appear on your approved list but your would have a record of them having been approved at one time and the date and reason they were unapproved. Then later if something changed, you'd know why you removed them and could choose to reapprove them if, say, they became certified again and you were otherwise happy with them as a supplier.

 

[Ed Panek]

A risk assessment would determine that their current performance has no impact on previous performance so as long as they provide no service that might impact quality do as you wish.