Mock Audit by External Consultant (ISO 13485)

L

Luwak

#1
Our facility (contract manufacturing) has been registered with the FDA not too long ago. We want to prepare well for a possible FDA audit, but our team is relatively inexperienced and only has little experience with ISO 13485 audits. Our notified body for ISO audits has offered us to perform a 3-day mock audit for conformity to FDA 21 CFR part 820 requirements.

Does anyone have experience with mock audits by external experts? Is this an effective way of preparing for a real FDA audit? Are there any alternative ways to get the support of external parties in preparing an FDA audit?
 
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T

TRD00001

#2
Re: Mock audit by external consultant?

Mock audits or pre-assessment audits conducted by an external party is fine as long as the criteria of audit is clearly defined.

Also make sure that the team who will conduct the mock audit have extensive knowlegde and experience in FDA 21 CFR part 820 requirements. Otherwise the audit will not value to your organization.
 
L

Luwak

#3
Re: Mock audit by external consultant?

Also make sure that the team who will conduct the mock audit have extensive knowlegde and experience in FDA 21 CFR part 820 requirements. Otherwise the audit will not value to your organization.
Thanks for this remark, I will definitely ask for the CV of the consultant involved.
 
#4
Re: Mock audit by external consultant?

Mock audits or pre-assessment audits conducted by an external party is fine as long as the criteria of audit is clearly defined.

Also make sure that the team who will conduct the mock audit have extensive knowlegde and experience in FDA 21 CFR part 820 requirements. Otherwise the audit will not value to your organization.
Isn't 21 CFR part 820 the audit criterion?

To have a NB do the "mock" audit might not be as helpful as having a competent (consultant) auditor do it. A NB cannot give anything but simple compliance statements and no advice, so you might find their reports a little one dimensional, rather than have a consultant give you a full debrief.
 

TWA - not the airline

Trusted Information Resource
#5
First of all, you can find a lot of useful information on FDA's homepage. Then there are a lot of organizations that offer trainings. But even if you have a lot of experience with 13485 audits, you should have at least one good FDA mock audit to prepare for an FDA inspection as the audit style typically is completely different.
 
T

treesei

#6
TWA hit the spot. No matter who does the mock audit, it has to be done in the FDA scope and style.
 
L

Luwak

#8
According to our NB the auditor is a competent consultant and trainer in FDA regulations as well. Since we are a small company the question is whether the investment in the mock audit is worth it. Obviously the requirements are clearly mentioned on the FDA website and in QSIT, what we are aiming at is emulating the style and atmosphere of an FDA inspection. However, I also understand that this can change from one FDA inspector to the other..
 
G

Gert Sorensen

#9
I work with an ex-fda employee who conducts mock inspections to 21CFR820. I will be more than happy to refer you to him.
 
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