Machinery Acceptence Criteria Determination? Chemical Blending (Pharmaceutical Plant)

samer

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while i was working in one pharmaceutical plant for the preparation of the operation qualification "OQ" ,i found some parameters without acceptence criteria or any reference ie Ampere amd RPM for the main moter for v blender machine

I caculated my own acceptence criteria by calculating STDEV for various readings taken with a period of one month to have finaly a history log

even it was excepted from the swedish auditors but im not satisfied since the values were respectivly high
is there special way to calculate your own acceptence citeria?more professional way I mean !!

thanx
samer
 
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