Calibration Certificates - Do Calibration Certificates Need to be Reviewed?

BradM

Staff member
Admin
#41
In our first surveillance audit I also received this same feedback. Verbatim the 'deviation' (or finding) states: 'Objective evidence to show review and approval of Calibration Certificates not available for all certificates sampled and test data from service provider not always present'. We have our equipment calibrated by an outside source, and the data is available per request. Initial data comes with the equipment, but subsequent calibration data is a pass/fail. Per our policy the certificates of calibration are checked into our electronic calibration system, therefore reviewed.

During the audit I challenged this, and the auditor said that they were going to check on it with some collegues. I was just curious if I had a leg to stand on or do I just accept it? BTW I am talking ISO 13485:2003, and the supplier of the calibration service has been approved. My argument was: if we approve the supplier for use, why would question that they haven't done their job? If we were questioning whether or not their calibration abilities are satisfactory, why would we have them as our approved supplier?

Thank-you in advance for any feedback!
How timely the same subject pops up in such a short window.

After this thread came out, I began to ask around to people in my circle of influence (primarily related to FDA). Bottom line: You review the certificates, and sign them to show you reviewed them. Now, if your electronic system has electronic signature that shows you reviewed it, that should be acceptable.

Reviewing the calibration certificate is not about questioning who did the work. It's looking to assure no typos, was your requirements satisfied, is it OK, as-is, to go back into use, etc. The way I look at this is- I would rather find the error than the internal customer, QMS auditor, and lastly (and the most damaging) an FDA auditor.
 
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#42
FOLLOW UP TO THIS THREAD

Since we had to implement this review, now the FDA would like the supervision to review the reviewer (when will this ever end). According to the FDA, "calibration supervision shall additionally conduct a documented sampling review of calibration records per an accepted sampling plan monthly".

So we have now added a statement in our procedures discussing this sample. We will be using ANSI-ASQC Z1.4 General Inspection Level II, AQL 0.65 for critical items, and AQL 2.5 for all others.

The cirtical items will be training requirements, compliance to calibration procedures, and verification of data and results. Non-critical will be documentation practices.

I just wanted to bring this sore subject up again, as it seems the FDA is really pushing this type of review for those companies in the medical side, especially in the pharma side.

What will it be next???
 
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