Calibration of gauges is due for re calibration on 04.03.2009,but we are winding up our present mfg. unit in another 20 - 30 days and moving to new facility.So I feel getting gauges calibrated for just 30 days does not make sense as again the gauges are re calibrated once we start our qualification activities next month in new facility.
Pls advise me how to handle this situation, whether I can take a deviation for extension and how to justify so that it is acceptable by authorities.
I’m going to take a shot at answering your question. I understand where you are coming from in that you will be using the gauges a month past the calibration due date. I will try to explain my thinking by using expiry dating. In expiry dating of product, there is stability data to show that the product will contain 100% of that active until that date (expiration date). However, it is possible that the product will contain 100% of the active some time after the expiration data, BUT there is no data to prove this and that’s why it is highly suggested not to use a product pass the expiration date.
For calibration of a gauge I see it in the same manner. After the calibration due date of the gauge, the gauge may still give an accurate reading, however it may not. Just like in the above example there is no data to show that after the calibration due date that the gauge will still give accurate reading. That’s what I think the auditors/regulators will look at.
I know it may not be the most popular or easiest choice but when in doubt it is always best to take extra precautious. I would suggest either not using it after the calibration date or get it recalibrated. That way there is no doubt.
Dear Narahari,
The calibratiuon frequency can be relaxed. The practice is that the guazes will be calibrated prior to the period mentioned by the supplier sometimes. In such cases it is not a problem. and moreover if its the same period what you can do see the trend of the callibration history of that particular guaze and handle through deviation.
tx,
Kalyan
[quote=kalyan]Dear Narahari,
The calibratiuon frequency can be relaxed. The practice is that the guazes will be calibrated prior to the period mentioned by the supplier sometimes. In such cases it is not a problem. and moreover if its the same period what you can do see the trend of the callibration history of that particular guaze and handle through deviation.
tx,
Kalyan[/quote]
Thanks Kalyan, Recently I subscribed in this site.
[quote=kalyan]Dear Narahari,
The calibratiuon frequency can be relaxed. The practice is that the guazes will be calibrated prior to the period mentioned by the supplier sometimes. In such cases it is not a problem. and moreover if its the same period what you can do see the trend of the callibration history of that particular guaze and handle through deviation.
tx,
Kalyan[/quote]
Kalyan,
To settle my curiosity about your statement, I would like to know how you would justify what you are saying to an auditor.
I think there are one or two thinks being stated here that the regulators would take as contentious.
You never produce regulatory controlled product using instruments that are not calibrated, or out of calibration. If you do, you could find yourself in very serious trouble with the regulators.
The FDA has stated quite categorically that the only place for an un-calibrated sensor is in the bin.
However if you document it correctly thirty days can just about be made acceptable.
If you have solid calibration records for at least two annual calibrations before hand, you can write a justification for your actions based on the calibration history of the instruments. Stating that they have shown the instrument to be stable, over this period, and there was no indication of any trend that could take them out of tolerance during this extension period.
Make sure you have the records, and then get you justification documented and approved by your QA. If any instrument does not conform, then list it, and calibrate it.
Not mentioned in this thread, but before transferring you manufacturing to the new facility you need to calibrate your equipment. This will provide the evidence that your equipment has been in the calibrated/validated state until the end of use. Transportation will induce a significant risk to the calibrated state of the equipment. You do not want to find yourselves in troubles when after re-installing the equipment is out of spec without evidence that before the transportation the equipments was within spec. With this end-of-use calibration you will also have the evidence that the delayed calibration had no impact on products. If you want to be strickt you can put your products manufactured by using equipment past its calibration due date on QA hold. But I expect calibrating is less time consuming than a QA hold. I agree with a justification based on historic date, providing evidence for a low risk situation.
Hi all. One could handle this situation with ease. Compile the deviation report and attach the past 2 years worth of certificates (as mentioned) and data (ie if there were any changes/alterations required to the gauges during calibration). Included in this you would use a calibrated device to verify that your gauge is still within spec. So, one could use a hand held manometer to verify that the magnahelic gauge is in fact still indicating the correct pressure. As this is a once off situation for this equipment, verify the gauge at the beginning of every shift until the equipment is de-commissioned and add that data to the deviation on close out, to prove that you have kept the system in a state of control.