Supplier Audits in the wake of COVID-19

[pziemlewicz]

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?

 

[heiss]

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]

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).

 

[LauraConstantinescu]

My answer is probably not needed anymore, however, this is my opinion.

As part of our QMS (medical device industry), we have a process called, concessions. This process allows us to record planned deviations for processes and products based on a strong rationale, as suggested above. If you don`t have this kind of process, I strongly advise you to create one as it is beneficial to show and documents various activities that are not precisely in line with your predefined processes and specifications, giving you flexibility.

If you don`t want to change/create any new processes, you can update your annual plan though a change control and document your rationale there.

Another option would be to perform the audit remotely and to change the scope of your audit (exclude areas that cannot be covered) and to document in your audit report the reason for doing so.