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!
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!
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.