How do you demonstrate compliance to this requirement specifically in relation to precision?
"Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented."
According to the FDA QSR Manual,
Equipment and Calibration ?Precision has no unit of measure and only indicates a relative degree of repeatability, i.e., how closely the values within a series of replicate measurements agree with each other. Repeatability is the result of resolution and stability.?
What limits do you document for precision and how do you demonstrate a gage?s precision during routine calibrations?