Calibration Audit Findings
I have been an auditor in the Medical Device field for over 21 years. I have performed external audits as a supplier QAE, internal audits as an employee, and in my most recent reincarnation as an independent consultant. During this time, I have identified an aspect of having a calibration program that is fundamental but is often misunderstood or ignored.
Past Due Equipment
Here’s what happens:
- You are in the shop or in a lab and you observe someone using and instrument.
- You ask to see if the instrument to check the calibration sticker.
- Fortunately you find one; however, the instrument is past due.
- You take some notes about the Cal ID number, the date calibrated, the date due, and other information for formulating the observation.
On the surface this appears to be straight forward observation such as; a micrometer, Calibration ID 347, past due for calibration, was observed in use the production area. All too often corrective action for this observation is to calibrate the instrument and return it to service. This addresses the observation…right???
As far as the corrective action goes it solves the immediate problem of the instrument being past due for calibration. If the instrument is found out of calibration you would need to study the potential impact but this is not the subject of today’s discussion. We need to ask some questions:
- Do the company’s calibration procedures require that the instrument be checked for status before use?
- Did the operator receive adequate training to perform their job?
- Was the operator pressured to “Get the Job Done” despite knowing the status of the instrument?
- What was the the nature of the failure of the calibration recall program that permitted the instrument to be available for use?
- Is using a “Past Due” instrument considered unimportant at your company?
The foregoing list is not inclusive but is designed to help establish the root cause of the problem. If you don’t know the root cause your preventive action is likely to be unsuccessful.
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2008-05-17 1:14 pm , Leave a Reply
Al Weisenborn