Re: Suitability and capablity of measuring equipment
Tony, Welcome to the Cove
What GMP is trying to do is ensure you can trust your equipment. So the question is how can you have faith in your devices? The answer needs to be 1) valid, and 2) documented. Now, there may be some room for argument about #2. Calibration records 820.72 (b) (2), relate to calibration (they are a subset of 820.72 (b) (2), not 820.72 (b) (1). However, at the bottom of 820.72 (b) (1), there is the language "These activities shall be documented." This requires answer to the question of how you ensure your equipment is suitable, and can produce valid results be documented.
As Dave mentioned, a Gauge R&R is one way of showing capability (and one I too, would recommend), but it is not required.