CFR Title 21 820.72.b Calibration Procedure Accuracy and Precision Requirements

J

jrcook5

#1
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?
 
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Al Rosen

Staff member
Super Moderator
#2
jrcook5 said:
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.
 
Last edited:

Al Rosen

Staff member
Super Moderator
#4
jrcook5 said:
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.
 
J

jrcook5

#5
Al Rosen said:
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
 

Chitchat

Registered Visitor
#6
Re: CFR Title 21 820.72.b accuracy and precision

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?
 

normzone

Trusted Information Resource
#7
I've stumbled into this issue and am looking for an example of language regarding this same issue - my example is basic mechanical measurement of a very simple part.

I don't want to reinvent the wheel if I can see a good wheel functioning and use it as a model for the wheel I need. Anybody point me to an extant document I could review?

As always, thanks for your help. This site is my second home.

:bonk:
 

dgriffith

Quite Involved in Discussions
#8
Re: CFR Title 21 820.72.b accuracy and precision

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?
That document is withdrawn. Do you know what the replacement is?
 

normzone

Trusted Information Resource
#9
I'm an ISO 9001 veteran but a novice at medical. I'll be reading the forum a lot, but any guidance would be gratefully accepted.

:bigwave:
 
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