Internal Audit Reports reviewed by management? 21 CFR 820.22 Interpretation

  • Thread starter passionforcompliance
  • Start date
P

passionforcompliance

#1
Can someone help on the interpretation of 820.22 about management reviewing the audit reports? Is it expected that management of the area audited sign the audit report or just evidence of distribution?
 
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#2
Can someone help on the interpretation of 820.22 about management reviewing the audit reports? Is it expected that management of the area audited sign the audit report or just evidence of distribution?
There is no signatory requirement, but the question will come up about how you can prove that management reviewed the report(s). Medical device industry tends to be considerable more focused on "proof" than general industry (and for good reason). Evidence of distribution does not mean they actually reviewed the report. But then again, neither does a signature.

On a personal level, I would like to see date and initials as a minimum. Not because I think it is a requirement, but because I want to make sure I know what went on. This way I have a good record. I can't trust my memory to remember who reviewed what and when.
 
G

Gmzita

#3
For our ISO 17025 QMS - its a requirement of Sec. 4.15 for Internal Audits to be reviewed during the Management Review of the QMS. During the meeting, I will read snippets from the Audit and I provide a PDF copy of the Internal Audit Report/s with the Meeting Minutes that are distributed via email to all Attendees for further review and feedback.

We use this review by Management to elevate any Auditor "observations" to higher levels - such as Improvement Plans or Preventative Actions. It helps get a bigger "bang for your buck" so to speak.

The Minutes and email act as my evidence of review by Management.
 
S

SuperGirl

#5
For our ISO 17025 QMS - its a requirement of Sec. 4.15 for Internal Audits to be reviewed during the Management Review of the QMS. During the meeting, I will read snippets from the Audit and I provide a PDF copy of the Internal Audit Report/s with the Meeting Minutes that are distributed via email to all Attendees for further review and feedback.

We use this review by Management to elevate any Auditor "observations" to higher levels - such as Improvement Plans or Preventative Actions. It helps get a bigger "bang for your buck" so to speak.

The Minutes and email act as my evidence of review by Management.
I do the same with our Audit reports.
 
M

MIREGMGR

#6
There is no signatory requirement, but the question will come up about how you can prove that management reviewed the report(s). (...) Evidence of distribution does not mean they actually reviewed the report. But then again, neither does a signature.
Yes, I agree here and with the other responses. An FDA inspector will ask you to convince him or her that management meaningfully reviewed the report(s). A signature might or might not get the job done. Discussion minutes and an attendee list from a formal management review meeting are the best approach.
 
P

passionforcompliance

#7
The process I'm actually following is discussing the observations during the closing meeting. I keep evidence of the information presented (powerpoint slide deck) and attendance sheet (signatures included). Then the formal audit report is distributed to management (via email). Monthly management reviews are also held in which I discuss the summary of the observations and keep track of the closure progress. Minutes and attendance are also kept.
 
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