Virtual auditing of suppliers
Good day, 
I am a SQE for a small med-device manufacturer.  At present I am updating our procedures/forms used within our Supplier Quality Management System.  The update will to add provision for performing virtual audits.  To clarify, a virtual audit is performed remotely (like a desktop audit) but includes much person-to-person interaction through the use of teleconferencing via the Internet.  I am hoping that others who have already established virtual audit processes can respond and report on, for example, what works well and what does not?  Perhaps a top three of each, or similar.  
Some concerns that I have: 
  • File sharing.  When the supplier is willing to share, is there one method that works best?  Using cloud sites like dropbox, or email? 
  • Virtual Facility Tours.  What are some of the tools that folks have used for this moving video capture?  
  • Risk analyses.  In my case, most of the suppliers for whom a traditional onsite audit is required might be a candidate for a virtual audit.  However, the fact that they are being audited at all is usually indication that they have a process deemed critical. We will have to determine if a virtual observation of the process will be satisfactory.  The worse-case is that all of our virtual audits would have to include onsite follow-up, at least to observe the critical process(es).   Any thoughts on this topic? 
Thank you. 

Regards, Will Leonard 
3 Replies
Trish Borzon
687 Posts
Hi Will - I'm going to pull in a couple of community members to help answer this.  I know Jeremiah Genest‍ had mentioned in another post "At my current employer we've been doing remote audits that have included both document review and facility tours utilizing 360-degree camera setups. Been successfully executed for internal audits and client audits. Just shared a draft policy we wrote over on the FDC Division community.' 
Duke Okes‍ is another who might be able to provide some insights.  

Good Luck! 
Trish 
Duke Okes
146 Posts
Although I've not performed any virtual audits, I've watched several presentations on it.  I certainly believe it can cover a large portion of an operation, especially if the right technologies and strategies are used.  For specific areas where perhaps close visual analysis is necessary, especially if concerned about the supplier not being honest about what is going on on the shop floor it is unlikely to be sufficient by itself.  I also don't know if the medical device industry is accepting them.  If course it may also depend on whether the supplier is dealing with class I, II or III products.
Hi William Leonard‍, 

I'm adding a link to a recent Quality Progress article my Lance Coleman‍ that might be helpful to you: 

https://asq.org/quality-progress/articles/making-remote-work?id=6e5c3fdedf294d10bbec7b55f23bce49

Best, 

Gretchen Peterson