Audit Plan for Sub-Contractor Design & Development

PPcricket

Starting to get Involved
#1
Hi All, we are due to visit our sub-contractor to carry out an audit of our product being manufactured

We also plan to look at the Design and Development in depth, are there any tips, audit plans, templates out there to view? product is a class III device....we will look at the ISO13485 clauses & the relevant FDA guidelines. Any help would be appreciated.

Many thanks, P
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: Audit plan for design & development

I always give similar advice in questions like this:

Prepared templates would offer me little for this purpose that I couldn't easily produce myself with a copy of the standard and table using Word or Excel.

So I could go with the typical stuff, asking how customer requirements are determined, etc., but this can amount to a dog and pony show - surely the time and expense of your visit is worth more than that.

So I would start making my plan by assembling a list of historical concerns, snafus, examples of less-than-exemplar performance. I would use that as my sample and ask for evidence showing the processes had been performed according to requirements and the supplier's promises.

I would also ask for ways I might help, as there are times problems are not owned by one side only. If there are communication opportunities, logistical disconnects or conceptual misunderstandings, now is the time to flesh these out and resolve them.

I hope this helps!
 
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