I had just taken over the calibration program for a branch of a pharmaceutical company. The person who had overseen the program before me had left a year earlier, and people with other full-time jobs had been standing in, so the program was not where it needed to be. It took me about a month, but eventually I managed to get everything back on track.
About a month after that, an auditor from corporate quality came to visit. He was a consultant with a long history in the industry. He offered some great insights into how the FDA interpreted the CFR's in several areas. He could quote lines from FDA 483 letters that various companies received. As we spoke one day, he was going through a cabinet where I kept my calibration standards. In the bottom of the cabinet was the“For Reference Only” box. I think every calibration department has one. A box of retired instruments. Some broken, some antiquated, some just because they look cool. I had been the diligent technician and gone through the box and made sure they were all labeled“For Reference Only”because those were the stickers I had in one of those spiral bound books of calibration stickers we all used to use. That’s when the auditor asked the question I couldn’t answer. “If you refer to it, shouldn’t it be calibrated?”
The term “for reference only”
I had never given the term any thought before that moment. These were just the stickers you put on things that didn’t get calibrated. I did a little digging and found out the term seems to come from engineering drawings where a dimension would be listed as for reference only. This was implied, in that world, to mean it wasn’t important. It was a non-critical dimension. I have a sneaking suspicion that the term made its way into the calibration world via the automotive industry, but I can’t confirm that. Anyway, we see it all the time. Unfortunately, the term has gotten a bad rap over the years because it is viewed as an attempt to circumvent a quality system.
Calibration not required
After a lengthy discussion about the subject, I ordered “Calibration Not Required” stickers, and wrote an SOP to explain when it was ok to use them.
I’m not going to tell you that you can’t use “For Reference Only”stickers. I will say, however, that an auditor is likely to question it. What I will tell you is that you should ensure that you have a documented way to determine what does and does not get calibrated.
And be consistent, it is a pretty horrible feeling having to explain to anyone why you used “For Reference Only”in one place and “Calibration Not Required”in another.
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