Pros & Cons of FDA viewing QAU Audit Report Findings

AnaMariaVR2

Trusted Information Resource
#1

What would be the pros and cons of having FDA view the contents (findings) of QAU audit reports during surveillance or for cause GLP inspections?

 
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M

MIREGMGR

#2
I'm assuming that this document substantially describes your context.

The only upside, I think, is if your internal audit report is absolutely clean, or identifies only trivial issues.

If on the other hand your internal report identifies anything more complex, you'd be doing two things: pleading "guilty" to charges that haven't even been brought yet, and likely damaging your QAU's further effectiveness.
 

AnaMariaVR2

Trusted Information Resource
#3
Thanks MIREGMGR for the document.

Washing dirty linens in public is never a good idea, so in other words weaknesses are surrendered to inspectors altering their objectivity in the process.

The cons are obvious...are there any other pros out there to consider?
 
J

jscholen

#4
The only Pro is that you would establish confidence in the investigator in your ability to audit yourself adequately and that your CAPA system is doing what is intended in bringing about change that is effective.

i don't know that I agree with the comments that you open yourself to observations by the investigator....yes, if you don't have an adequate system, No, if your CAPA systems work.

I bring up CAPA because we funnel observations from our Internal Audits into our CAPA system. Not everyone maybe doing this because there is fear that FDA has access to your CAPA system...this is a half truth. If your CAPA items include corrective action from your Internal Audit system, you can exclude those files from view....just don't highlight the finding in the CAPA log.

As long as you have a corrective action system that works, AND I stress Works, you should be fine.

But as a general rule, investigators are all different, so one may be fine with what you are doing, and another may not. I would suggest you side with caution and not VOLUNTEER anything.
 

AnaMariaVR2

Trusted Information Resource
#5

As long as you have a corrective action system that works, AND I stress Works, you should be fine.
Good point & I agree:agree1:

During systems-based inspections, one statement stands out: "the auditor should compare his or her observations to the approved procedures." So I guess the downside of showing internal findings is that it's not information the inspector needs as part of his/her inspection process.


Surrendering such data would undermine the intent of conducting internal audits? Does anybody has any thoughts on this?
 

Doug Tropf

Quite Involved in Discussions
#6

Surrendering such data would undermine the intent of conducting internal audits? Does anybody has any thoughts on this?
The QSR Manual indicates that the FDA's policy of normally not requesting internal audit records was established because the agency does not wish to prejudice audits by having auditors concerned that their comments will be reviewed by FDA investigators.
 

AnaMariaVR2

Trusted Information Resource
#7


But if the inspector will push for those documents to be surrendered, wouldn't this type of inspection technique be counterproductive to quality improvement?

The QSR Manual indicates that the FDA's policy of normally not requesting internal audit records was established because the agency does not wish to prejudice audits by having auditors concerned that their comments will be reviewed by FDA investigators.
Good point, Doug.:agree1:

The only exception to this might occur in a "for cause" inspection, in which case a subpoena would be issued for those records...but then will turn from an inspection to a criminal investigation, & that is another story.

:thanks:


 

AnaMariaVR2

Trusted Information Resource
#8
I think everyone knows it is "policy" not to ask for QA findings, and by the way there is a lot more to GLP QAU than just 58.35 (b) (4), the status reports are just one of many types of inspections done in GLP QAU, and they are all protected from the regulatory request process under normal biomonitoring inspectionper 21 CFR 58.15:


"The records inspection and copying requirements shall not apply to
quality assurance unit records of findings and problems, or to actions
recommended and taken."
Regardless of reason, the FDA inspector can ask, and be refused, and it does not constitute a "refusal" of inspection.

The same is not true of records collected under 820.22. The FDA inspector probably will not ask for those records, because of the guideline.

But policy is not regulation, and if the inspector asks, you must provide records collected under 21 CFR 820, and to refuse constitutes a refusal of inspection. :bonk: Ouch!

The policy gives direction to the inspectors not to ask under most circumstances. The agency realizes that the findings of QAU will happen, and hopefully human errors are corrected properly/on-time & follow-up happens adequately, and so the QAU records should not in most cases be relevant to regulatory inspection.

But the agency has not chosen to extend the same "right of refusal" to other types of QAU that is written into GLP.

Push back is one thing, but outright refusal could net you a 483 for the refusal, even if they do not find anything else, and more.
 
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