• Melita Ball

March 31, 2020 Blog Post


As people sometimes say, “desperate times call for desperate measures.”  Some of my clients and I have found ourselves in that exact position.  You see, I have a number of clients that rely on us to provide critical audit services to help them prepare for upcoming regulatory audits. 


Many of them have to conduct internal audits before they can host a Registrar or Notified Body. If this is a new facility trying to achieve their certification to manufacture and ship product, they cannot distribute needed medical devices or diagnostic kits or drugs to certain countries without it. 


COVID-19 has required us all to think about things differently and get creative.  That’s exactly what we’ve done and I am pleased to report that I’ve just completed my first ever fully virtual audit.  I’d like to share the results with you and provide some lessons learned just in case you need to get creative.


First, let me frame this up for you. 


Most auditors out there have conducted “desk audits” from time to time so I’d like to explain what is different about this “virtual audit.”


  • Desk Audits review procedures that are provided by the Auditee usually offline.The scope is limited to evaluating the procedural compliance to the requirements but gives the auditor little to no context for how those procedures are implemented and followed.The auditor also cannot physically see and review manufacturing as it is being conducted.

  • A Virtual Audit is fundamentally different in that it is a live audit in real time with video.Of course, procedures can still be provided ahead of time for a pre-review but the valuable face to face conversation and ability to ask questions in real time makes all the difference.The live video feed not only allows the auditor to pick up on non-verbal communication like facial expressions and body language but also affords a physical walk through of the facility similar to what is done during an onsite audit.


Now, let’s review some of the important components needed to make this work.


  1. Choose your tools carefully!Not all video platforms are created equal.There are a number of video hosting conference platforms out there.For this initial virtual audit, we used two of them … WebEx and Zoom. Zoom proved to be the superior choice anytime we were mobile.It was easy to use and stable even in the manufacturing area.I’m thinking that streaming from a Go-Pro affixed to someone’s head or on an extension stick may even work better.If I am able to test that out in subsequent virtual audits, I will report back.If you do, please share your experiences!

  2. Planning is vitally important to a Virtual Audit.The proper cadence doesn’t just happen, it must be planned out.Some things to consider are:

  • Prepare a more detailed audit agenda that includes specific requests for each video session.This helps ensure that the right SMEs are available and ready to walk through their process and records.

  • Provide regular checkpoints to the larger audit team throughout the audit.In an onsite audit, these checkpoints are naturally more efficient because everyone is in the same physical location.In a virtual audit, providing more frequent check points for the entire team helps everyone stay connected and in touch with where the audit is and where it’s going.

  • Plan for document and record pre-review time before each video session.That way, everyone stays on track (including the auditor).  


3. Limit video sessions to 2-hour blocks with longer breaks in between. Unlike an onsite audit, the video is in motion as it moves through the facility and the virtual participants are stationary. After some time, this can cause a bit of motion sickness or can be somewhat disorienting. Providing frequent breaks allows everyone to get centered again. Additionally, trying to see details in the facility on video can be mentally exhausting if the sessions go too long. Limiting video session time and allowing more frequent breaks go a long way to help people recover their mental acuity.


In summary, a virtual audit is not a desk audit!  Virtual audits can be as effective as onsite audits with the proper planning and the appropriate tools.  I will be adding virtual audits to my permanent service offerings and plan to continue to improve this service offering.  So, don’t let your internal or supplier audit schedules slide due to our current situation!  You can stay on track and even save some money on travel expenses in the process.


As always, thanks for reading and stay safe and well!


Thoughts? Please comment below …


Cheers!


Melita Ball

CEO and Principal Consultant


Copyright © 2020R  MBC & Affiliates, Inc|,  All rights reserved.


Our mailing address is:

9910 N Camino Del Plata

Tucson, AZ 85742

(520) 665-9081

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