Auditing the Development function of my company - Strictly a Desk Audit?

M

Mark Smith

#1
I find myself in the unenviable position of having to perform an audit of the Development function of my company. Although I have plenty of experience auditing all other functions, this one is a little different. So many of the QSR requirements are not applicable.

Does it seem reasonable to assume that I can perform a desktop audit of one of the design history files for a recent project and determine compliance to both the QSR and ISO 9001?
 
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D

David Guffey

#2
No. A sample of one is not sufficient unless you can provide a very firm defense as to why one was enough. (Like, it was the only one.)
 
M

Mark Smith

#3
Huh? I believe that my strategy would be identical to what the FDA inspectors are doing now according to their QSIT manual.
 
D

Don Winton

#4
If you follow the Design Control subsystem of the QSIT, you should be fine.

I would suggest a flow chart and checklist similar to the one on page 29 and go from there.

There are other documents you may also want to review, such as Design Control Guidance, Do It by Design and Chapter 3 of the Small Entity's Compliance Guide. Some are here in the PDF Zone or follow the links at my site below.

Remember, the FDA cannot review your audit results, just the audit plan. The QSIT is a good starting point for this plan.

Regards,
Don

------------------
Just the ramblings of an Old Wizard Warrior.
 
M

Mark Smith

#5
Don,

I thought as much. thanks again!
P.S. - suggested resources have already been committed to memory / practice!
 
M

Mark Smith

#6
Don,

I thought as much. thanks again!
P.S. - suggested resources have already been committed to memory / practice!
 
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