In sports, it's always the fundamentals that your coaches emphasize, like the techniques that you first learn when you’re starting to play baseball—how to hold the ball properly, how to stand and hold a bat, or how to field a grounder. The basics about the sport, if performed perfectly, yield a positive outcome and add to the whole game experience. It's the same with calibrations. With all the new technology and advancements that come with calibration tracking and performance, we tend to overlook the basics, which in the long run, may lead to an unfavorable outcome during an audit.
 
Calibration documentation is a function of your quality unit. Engineering, metrology team, vendor, or production personnel may perform the task of calibration, but the documentation review, verification, and follow-up is a quality function and should be treated as such. Whether you use upscale calibration software that complies with Food and Drug Administration (FDA) 21 CFR part 11, or a paper documentation trail, your systems still may seem to lack the required quality functions to keep the systems compliant. Why is it that during an audit, the auditors always find a documentation or traceability issue within your calibrations? It's those little issues that make it seem like you have no control of your systems.

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