Calibration vendors considered Critical?

A

Achemd

#1
Hi,

We received an observation from out IS 13485 and CE Mark audit that our suppliers were not classified as critical or not. Do you consider the vendors that do calibration services critical? How do I determine who is critical?

Thanks
 
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G

Gert Sorensen

#2
Hi,

We received an observation from out IS 13485 and CE Mark audit that our suppliers were not classified as critical or not. Do you consider the vendors that do calibration services critical? How do I determine who is critical?

Thanks
That is one of the odd things about working in QA :) I have never seen a supplier evaluation of a calibration service provider, nor have I ever had one done. Basically, my standpoint on this is that:
1. The calibration company generally holds accreditation to the standards and therefor are qualified, with no need to evaluate them further.
2. We use the service at least two times a month, sometimes more, and since we only have one person who is in contact with them we have a pretty clear idea of the competency of the service.
3. Each and every certificate is being checked and approved by a different person than the one having the contact.

How do you determine who is critical? I would start by determining what is critical. Look at the products: How tight are the tolerances? What are the products used for? Do they need to fit with other products? Thinking like that should/could leave you with a few items that might be considered critical. For these items you should evaluate the measuring equipment used. This equipment should have a measurement uncertainty calculation performed. Relate the uncertainty to the products tolerances to give you an indication of whether the calibration of the item is truly critical. If so, you should take steps to either have a "tight" calibration or reevaluate the product design (tolerances).

Hope this helps :)
 
#3
Never heard of that before. You should have asked the auditor where the "shall" is for that observation. I can tell you there is none. Gert is right on. What is critical to your product or service would determine your critical suppliers.

Auditors are either taught or they sometimes interpret the standards in funny ways. I would, however, agree that calibration vendors would be among the "critical" type.
 
P

Phil Fields

#4
It also depends on how you procedures are written. Do yur procedures specify that suppliers will be classified as critical/non-critical? If so, was the calibration vendor not included in the classifcation?

Phil
 
A

Achemd

#5
It also depends on how you procedures are written. Do yur procedures specify that suppliers will be classified as critical/non-critical? If so, was the calibration vendor not included in the classifcation?

Phil

There is nothing in the SOP right now to classify anything, hence we received a minor observation. I am currently updating the SOP and creating a list. I have all the vendors tagged as Critical or Non critical but do not know what to classify the Calibration vendors as.
 
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