Debunking the Two Great Myths About Calibration: Traceability to NIST and, If You Cannot Adjust, You Cannot Calibrate!

摘要

We've all heard and used the term: "Our calibrations are traceable to NIST." Most of us have also heard the following from our managers and supervisors, but mostly from ISO auditors and FDA inspectors: "If you cannot adjust the test instrument, you cannot calibrate it." The real travesty about these statements is that for decades we have believed both of these myths. It is time to set the record straight. The learning objectives of this paper/presentation are: 1. The definitions and meaning of calibration and traceability as they relate to the metrology community; 2. What requires calibration and what does not; 3. How to properly document traceability in your calibration records. The attendees will learn from examples provided on how to properly make traceability statements within their calibration records; what requires calibration as opposed to what similar items do not require calibration; and what the true meaning of calibration is from the VIM, along with plain common sense. While this paper/presentation is geared toward the calibration/metrology departments of biotech, pharmaceutical, medical device and healthcare industries, metrology professionals of any industry will find benefits.