Over the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general public.
Aside from working from home, one big change for medical device manufacturers is in auditing. We’ve completely shifted from onsite audits to virtual audits, with many certification bodies offering virtual audits as an option moving forward even with the economy re-opening.
Working at a contract manufacturing firm for medical devices, many of my colleagues have been through their fair share of audits. I recently surveyed three of them to gain a better understanding of the pros and cons of virtual auditing.
- Have you participated in both onsite and virtual audits? Are you the auditee or the auditor?
- What are some pros and cons with having an onsite audit?
- What are some pros and cons with having a virtual audit?
- What is your preference?
+ Onsite Audits
I have participated in both but my preference is onsite audits. You have the ability to build a better relationship with the auditee, and you can also read body language. It’s much easier to inspect physical space, equipment and product.
With virtual audits, it’s more challenging to do the walk-through since you don’t necessarily know what to look out for. The auditee dictates what you see, and can very easily bypass things they don’t want shown.
However, with virtual audits there is the aspect of saving travel time and expenses. The client can work on pulling more records as you review what they have already provided, and it’s potentially easier to have other auditees join the call.
Deborah Pinchev, QA/RA Manager
+ Virtual Audits
I have participated as an auditee for onsite audits and both the auditee and auditor for virtual audits. My preference leans towards having a virtual audit; there is the convenience of not needing to be in the same room and I don’t see the necessity for an onsite audit when auditing an e-QMS.
While I do agree that an onsite audit allows you more visibility in terms of the facility, and an opportunity to get to know the auditee better, it seems more cost prohibitive and time consuming if the travel is over several time zones.
The virtual audit allows you the ease of sharing screen and showing certain documents without requiring multiple machines to view a file.
Taimoor Khan, Quality Assurance Specialist
+ / – For Virtual and Onsite Audits
“I’ve participated in only a handful of remote audits, but have been involved in several hundred onsite audits.
The biggest pros I’ve found with onsite audits is the ability to see the facility and processes in all dimensions. There is no camera limitation, you can take the lead and choose what you want to see. If the audit is taking place at an animal or chemical plant, you can integrate a whole new level of cleanliness into the audit, including if there are any foul or out of place smells.
Cons to having an onsite audit though would have to be the travel time and expenses. This would be a cost incurred by the client.
With regards to virtual audits, once all documents are uploaded for viewing you can scan through them at your own pace. This also allows the client to continue their own work until needed. The downside is being shown only what the client wants you to see.
My preference is having a mix of virtual and onsite audits, depending on whether the audit is a full inspection or a surveillance audit. “
Vesna Janic, Director of QA/RA
As you can see, there are differing opinions for virtual and onsite audits, but the ‘new norm’ will likely be a mix of both. I, personally, prefer the idea of moving to virtual audits considering the cost of travel and accommodations, but I can also appreciate the rapport that comes from having an audit face to face with the client.
Auditors will be taking into account travel costs and scope of the audit to gauge whether an onsite audit or if a virtual audit is the better choice. Either method can provide the certification body with the information they are seeking. And at the end of the day, that’s all that really matters.
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Azra Rajwani is a StarFish Medical QA/RA Specialist. A graduate of the UVIC Biomedical Mechanical Engineering Program and former member of our biotechnology team, some of Azra’s work projects include water quality and neural networks.