A question for all: During an internal inspection of a lab I discovered an aparatus was out of calibration for a period of time and that tests were run using this instrument. The lab claimed that there was no impact to the product tested after the date of the missed calibration as the initial calibration was successful and the late calibration failed to indicate any out of operating parameters. I stated that the testing performed after the missed date of calibration was invalid as once a piece if equipment passes its recalibration date "all bets are off" as it were.
This issue was raised at the recent equipment use and calibration course I conducted overseas.
The answer is not straightforward. Some instruments do not require calibration in practice, such as a ruler or a measuring tape (purists will disagree with me).
The legal basis is to adhere to the equipment manufacturer's guidelines for calibration. Best practice would compel the user to calibrate each day before use.
In general, I agree that measurements taken with an out of calibration equipment are invalid. However, some equipment warns the user when they need calibration, in spite of recommended calibration intervals, so for practical purposes the measurements could be used (not for legal formal use)
If the calibration procedure provides "As Found" data, and the results are acceptable, then the information collected while the unit was past it's calibration date is still acceptable.
To further confirm the operation of the unit was still ok after the calibration expire date, check the calibration history for the unit. Is there a trend of the unit needing no adjustment, or was it frequently adjusted during calibration.
If the "As Found" data is unacceptable, then the information collected would be invalid.
Regardless, there is a problem with your training program if employees are using equipment that is out of calibration.
I agree, the results should be considered invalid. However, if the results were accepted without prior knowledge of the state of the equipment, i.e., Operator Error. The approach should be to confirm that the state of the equipment during this period of "Out of Calibration" was valid given historical documentation as it relates to calibration frequency. So, I agree that the results are invalid until there is documentary evidence to prove otherwise, justification supported by scientific sound documentation.
In my opinion, It is always not possible to do exactly recalibration as per predetermined schedule. It is recommend to define in the respective SOP for flexiblity like with in a week from calibration expiry date. However we have to ensure the equipment performance qualification on regular basis without fail. The result of PQ will support data generated (specific to applicaiton requirements) eventhough Calibration (specific to user mult applications) fails whcih is performed on later dates due to justifiable error/Operator Error observed on the recalibration day.
04-12-04 12:25 AM -