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CFR 21 Part 820.72--Have you heard of "Once Only Calibration??

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#11
#11
Re: CFR 21 Part 820.72--Have you heard of "Once Only Calibration”?

Chitchat said:
I’m concerned that this practice would not stand up to the full rigors of an audit particularly when one reads CFR 820.72(a) “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained."
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Maybe I'm reading this wrong, but I infer that the underlying assumption of the OP is that FDA regards "routine" as meaning "every year", or as having some other short-period meaning.

I understand that statement to require a definite periodicity, but not necessarily a short periodicity. I don't know why it would be unacceptable upon acquisition of an instrument that the manufacturer's spec or your analysis determines requires calibration and maintenance every ten years, to establish a procedurized routine for calibration and maintenance of that instrument every ten years.

The same approach would be used if the period needed to be ten minutes. Whatever period is needed, set up a procedure to make it routinely happen.

I think the FDA's point in that requirement was/is that maintenance and calibration should occur regularly and automatically, not only after it's been discovered via manufacturing bad product that something is out of calibration.

So, have a documented analysis of what the calibration/ inspection/ checking/ maintenance interval(s) need to be, then make sure that you have a procedure in place so each of those operations happens routinely.

For some instruments, I don't see why your analysis might not conclude that they need to be checked daily, inspected monthly or if check is failed, maintained never (i.e. replace if inspection failed), and calibrated once.
 
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