Supplier Audits in the wake of COVID-19

pziemlewicz

Involved In Discussions
#1
As part of our Medical Device Risk Management process, we've elected to do onsite audits annually of contract manufacturers and suppliers where we own tooling. I currently have two which need to be completed, and certainly more will arise as the pandemic continues.

I'd prefer not to re-write the procedures, but would like to build in some flexibility for the current situation. I was leaning toward conducting virtual audits and approving via deviation process.

Has anyone's NB provided helpful guidance to this end?
 
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heiss

Starting to get Involved
#2
I'm not in the medical devices industry. But in automotive, IATF (International Automotive Task Force) is providing waivers to CBs. Did you try contacting your NB? To see if there are any special waivers/extensions for onsite audits during this pandemic?
 

yodon

Staff member
Super Moderator
#3
Even the NBs are shifting to remote / virtual audits as much as possible so I'm sure a well-documented rational regarding the approach would be acceptable. I've not seen any advise from NBs, though (and they've typically been hesitant to give any general advice for fear of appearing to be consulting). I've spoken with a few auditors and have learned that at least one AO is doing remote audits for everything except design and production. I asked why design couldn't be remotely audited and they said they didn't know but it was policy.

I'd suggest you update your audit planning (documentation) with your approach, outlining what you believe CAN be remotely audited effectively (and why) and defer the rest until after things settle out. I would agree that production cannot be effectively audited remotely so I wouldn't try to do that. And then, instead of asking what can be done, lay out what you plan to do and see if they have any concerns (and again, they may decline to comment for fear of consulting but you do what you can).
 
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