What documents would an FDA auditor want to see in an FDA Audit of Quality System

[AJayC]

What documents would an FDA auditor typically ask for during a routine audit of the quality system?

We manufacture mostly Class I 510 exempt devices.
We have some Class II 510K devices (relabled) and a few Class II 510K Exempt devices (spec developer).

We are being audited at our non-manufacturing site, which is responsible for design development and complaint handling.

 

[Ronen E]

What documents would an FDA auditor typically ask for during a routine audit of the quality system?

We manufacture mostly Class I 510 exempt devices.
We have some Class II 510K devices (relabled) and a few Class II 510K Exempt devices (spec developer).

We are being audited at our non-manufacturing site, which is responsible for design development and complaint handling.

Hi,

It's not a FDA audit and not a FDA auditor. It's a FDA investigator conducting an inspection.

510(k)s are irrelevant, unless something specific in the inspection would draw the investigator's attention to them (in which case the relevant documentation would be the submission file, including all correspondence, additional info submitted and the SE letter).

The inspection, unless a for-cause one, will likely be focused on your compliance with part 820 (QSR) and the MDR regulations (have a look at 21 CFR 803).

If you go through some warning letters, you could get an idea about what mostly bothers FDA during inspections, and what sort of documentation they expect.
http://www.accessdata.fda.gov/scripts/warningletters/wlFilterBySubject.cfm

A more telegraphic list of inspection findings can be found here:
http://www.fda.gov/ICECI/EnforcementActions/ucm326984.htm#devices

Also have a look at the FDA's QSIT (Quality System Inspection Technique):
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm

Good luck,
Ronen.

 

[AJayC]

My first audit, am nervous.

 

[Ronen E]

My first audit, am nervous.

You first inspection, you mean...

Don't worry, your situation sounds quite simple to handle. If your QMS is functional and you have your MDR procedures up and running, just do your homework as I suggested above, and you'll be fine. At most, you'll get some "improvement tips" on a nice 483 form, get them sorted and move forward...

Would you please come back and tell us how you did?...

Cheers,
Ronen.

 

[harry]

If you had not done so, you may want to go through some of the previous discussions related to the subject.

 

[Gert Sorensen]

You should read the QSIT guide to get a quick idea of what to expect.

 

[sagai]

Another tricky way of ensuring higher level of confidence to pass the inspection is to leave some minor stuff deliberately in the system to keep them busy with those rather than with others stuffs.

 

[silentrunning]

Another tricky way of ensuring higher level of confidence to pass the inspection is to leave some minor stuff deliberately in the system to keep them busy with those rather than with others stuffs.

I'm glad to see that I'm not the only one that leaves some "low hanging fruit" for the auditors.

 

[sagai]

Older boys, smarter toys

 

[AJayC]

You first inspection, you mean...

.... Would you please come back and tell us how you did?...

Cheers,
Ronen.

We received 1 observation for CAPA being inadequately documented.
Specifically, we did not use our Supplier Corrective Action Request Form for a recent complaint. Fortunately the complaint was for a minor issue.