Hi everyone,
I work for a company that is FDA regulated and ISO. We have a product that tests women for a certain type of virus. I have been running the calibration dept for some time now and all of a sudden people started taking calibrated equipment "Out of Service" without having the "As Found" Data. Must be memory lapse and of course I can't get an answer from those above. Does 21 CFR 820.72 section B pretty much cover this situation? Our form for changing the status of a piece of equipment says to attach the calibration form for this status change but I guess some people like to read at a different level.
Thanks,
Keith

:argue:

I don't have the CFR handy (I do have a copy of booklet form here somewhere). But I can tell you "logically" why I "believe" that would be the case.

If an instrument has been used to test conformance (or what ever appropriate term), when you put it out of service, you need a way to determine that during the last calibration interval while in use that it remained in tolerance for that entire interval. It is the same logic as if you did not put it out of service. At the end of the interval when it is re-calibrated, if out of tolerance, you provide that data to the user so they can review for potential product impact. If put out of service, you provide as found data to the user (of out of tolerance) for possible product impact. If in-tolerance at the time it goes out of service, the data is documentation that the instrument remained in tolerance while in use during its final calibration interval.

That is my logic as why in an FDA compliant environment the instrument may need as found data done.

Good reply from Jerry. The company I work for is also FDA regulated.
If a gauge that is found to be out of tolerance during calibration, the data is required to be able to determine the impact of safety and efficacy on the product.
If the out of tolerance condition has a negative impact, there may be grounds for a product recall.


Phil

Good reply from Jerry. The company I work for is also FDA regulated.
If a gauge that is found to be out of tolerance during calibration, the data is required to be able to determine the impact of safety and efficacy on the product.
If the out of tolerance condition has a negative impact, there may be grounds for a product recall.


Phil

Phil, I thought I remember you providing a citation for this. I looked through a few of them, but could not find it. I can't think of the citation either, but I think the word "impact" in your post is the key. :yes:

P.S.-Hello, Keith, and welcome to the Cove! I really hope to see you adding your input on other threads here!