CFR Title 21 820.72.b states that "Calibration procedures shall include specific directions and limits for accuracy and precision." Is just stating +/- measurement tolerances adequate or is this statement to be taken literally and both must be indicated?

CFR Title 21 820.72.b states that "Calibration procedures shall include specific directions and limits for accuracy and precision." Is just stating +/- measurement tolerances adequate or is this statement to be taken literally and both must be indicated?Take it literally as with all regulatory requirements. Look at the FDA QSR Manual calibration section (http://www.fda.gov/cdrh/qsr/07.html#measuring_equipment).

Take it literally as with all regulatory requirements. Look at the FDA QSR Manual calibration section (http://www.fda.gov/cdrh/qsr/07.html#measuring_equipment).

As an example, would we say, the device is 99.9988% accurate with 99.9990% precision? Or would it acceptable to say the device measurement uncertainty is +/-12 ppm?

As an example, would we say, the device is 99.9988% accurate with 99.9990% precision? Or would it acceptable to say the device measurement uncertainty is +/-12 ppm?In your previous post, you left out some of the stated requirement. For your purposes, I think the part not quoted is a key to this question. The subsection is:Calibration. 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.And I have highlighted an important point of this section. You can decide if based on measurement uncertainty of the calibration, you can meet the requirement.

In your previous post, you left out some of the stated requirement. For your purposes, I think the part not quoted is a key to this question. The subsection is:And I have highlighted an important point of this section. You can decide if based on measurement uncertainty of the calibration, you can meet the requirement.

I have read the regulation and the Quality Manual however, it is still unclear to me on what format the FDA is requiring. I work for a large organization and have been through a few FDA audits without any findings in the instrument control system. But some of our other facilities have been cited for not stating accuracy and precision separately.

I was interested if anyone has any experience dealing directly with this issue.
Thanks,
Jim