21 CFR Part 820.40(b) Clarification on Required Document Approvers

S

Simbot

#1
Within our organization, there is some debate around the interpretation of this statement in 820.40(b).

"Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise."

Our current process has a narrow definition of how this is handled. We have our functional groups broken down into very narrow categories. For example, under the main Functional group "Engineering", we have something like 20 sub-groups. The current powers are interpreting the above Reg to mean that if the original approver was from sub-group #6, then someone from that sub-group must continue to approve all subsequent changes until the end of time. Someone from Engineering sub-groups #8 or 2, or any other sub-group can't approve.

I'm proposing that anyone from the top level group (any sub-group), of "Engineering" in this case, can approve and we are still in compliance with the intent of 820.40(b).

Is anyone aware of any documentation or guidance that addresses this subject? And I'd be interested to hear how some of you approach it.

Thanks
 
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yodon

Staff member
Super Moderator
#2
No guidance that I know of.

It might put you in a more defensible position if you incorporate your logic in your Doc Control SOP.

I would think, though, if there's no logical connection between sub-group (e.g., sub-group 6 is Software Engineering and they originally signed and sub-group 8 is Mechanical Engineering), it might be a difficult position to defend. And of course, you want the sub-group to be cognizant of what they are signing (so as not to be rubber-stamping).
 
I

isoalchemist

#3
Look at the intent. They want individuals that can understand the change and potential ramifications to approve and be responsible for the change. They will question an electrical engineer signing on mechanical changes or a supervisor signing in place of a director. A buddy might sign off on a change that your manager never would.

As a rule of thumb I've always tried to enforce a 1-level up concept on signatures within major groups. Not always possible, but those are usually few that can be handled in other ways.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
...unless specifically designated otherwise.
All you need to do is add provisions (in your SOPs) for controlled approval when you need to cross sub-group boundaries.

Further, I assume that your sub-grouping is captured somewhere in your QMS. May I suggest that you consider a less fine-grit division within groups? What purpose is served by this very fine division?

Cheers,
Ronen.
 
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