FDA Medical Device Audit Checklist.

Hi,

I found a great Audit Checklist on this site. At 44 pages, it is very inclusive. My problem is we're preparing for an FDA medical device audit and the checklist I found is geared toward ISO.

Does anyone have an FDA checklist I could use as a guide? Thanks in advance.

Ted

Re: Quality System Audit Checklist

http://www.fda.gov/cdrh/qsr/17audit.html

Here's a link to a checklist on FDA's web site that might be useful. :

Re: Quality System Audit Checklist

Thanks, I was reading it as you replied.

I was hoping for an actual checklist......

The ISO list was all laid out with reference codes, suggested questions, tips, and really good stuff.

It looks like I'll actually have to work.

Thanks again. Ted

Re: Quality System Audit Checklist

TJG954 said:

Thanks, I was reading it as you replied.

I was hoping for an actual checklist......

The ISO list was all laid out with reference codes, suggested questions, tips, and really good stuff.

It looks like I'll actually have to work.

Thanks again. Ted

Click to expand...

I was thinking that maybe sheets 2-6 in the link (scroll down a little ways) would be more like what you were looking for, even though they are not in a regular "form" format, they did have sections referenced, suggested questions, "yes/no" columns, etc..

There may be an actual checklist in the Post Attachments List or the More Free Files link at the top of this page...

You're welcome.

Re: Quality System Audit Checklist

Sorry, but I can´t hold myself to ask why the "Captain Underpants" ?

Ted (the other Ted) sorry for the plagiarism Dave

Re: Quality System Audit Checklist

Come on..... it's so obvious!

Tighty-whities

Red Cape

Bald head

Who better represents the world of Quality Assurance than Captain Underpants?

That's how I picture the Auditors when they come in.

Re: Quality System Audit Checklist

TJG954 said:

Come on..... it's so obvious!

Tighty-whities

Red Cape

Bald head

Who better represents the world of Quality Assurance than Captain Underpants?

That's how I picture the Auditors when they come in.

Click to expand...

Got it !

Re: Quality System Audit Checklist

TJG954 said:

Hi,

I found a great Audit Checklist on this site. At 44 pages, it is very inclusive. My problem is we're preparing for an FDA medical device audit and the checklist I found is geared toward ISO.

Does anyone have an FDA checklist I could use as a guide? Thanks in advance.

Ted

Click to expand...

Use the QSIT document. There are flow charts in it that you can use. Follow this thread for it as well as a checklist.

Re: Quality System Audit Checklist

Exactly! Thank you very much.

Re: Quality System Audit Checklist

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

There are many areas where you are able to obtain quality system audit checklists. One is contained in FDA's QSR manual- (part of the audit chapter of the QSR manual contained in the website http://www.fda.gov/cdrh/comp/gmp.html). Others can be obtained for a small fee from a search at amazon.com or ebay.

However, I caution using these "canned" checklists. First, you have to amend them to your system. For example, if the device is one which does not require servicing, and your audit checklist states to audit 21 CFR 820.200 (servicing), then your audit is partially incomplete (because you are not following your approved procedure- i.e. your checklist) + your audit procedure (i.e. your checklist) is inaccurate (because you do not have to conduct any servicing operations).

Second, the use of checklists really limits the audit ability. They can be used as ticklers/guides, but not as sole audit tools because they will cause you may miss items that FDA may catch. If these items are repeats (especially major repeats) noted during the prior FDA inspection, then FDA will add another deviation to the list- an ineffective audit.