In the Coronavirus Era You May Experience Your First-ever Remote Audit
Author: Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant
Audits are unavoidable in the medical device industry. Even a global pandemic can’t stop them.
While COVID-19 may have grounded planes, audits that provide the necessary checks and balances on quality systems, confirm that suppliers meet expectations, and enable manufacturers to maintain their certifications are still required to ensure the quality and safety of medical devices.
During this unprecedented time, Notified Bodies, including BSI Group, TUV SUD, UL, and others, have ramped up virtual audits. Also known as a remote audit, a virtual audit is conducted without face-to-face interaction and data can be exchanged electronically. This is in response to travel restrictions within companies and guidance from the European Commission allowing for postponement or remote audits.
As the pandemic continues, some expect the FDA to shift to virtual inspections following their announcement earlier this year to postpone domestic facility inspections.
Virtual audits are not new to the medical device industry. Before COVID-19, remote reviews of lower-risk, non-critical suppliers were already becoming commonplace and acceptable practice.
As an ASQ-Certified Quality Auditor involved in countless audits over the years, including many completed remotely, I’ve gathered some best practices to help you prepare for a virtual audit.
Whether you’re preparing for a Notified Body audit, FDA inspection, medical device supplier quality assessment, or an internal audit, these tips will help your team assemble a game plan to pass your next, and possibly first, virtual audit.
What to Expect During a Virtual Audit
In speaking with some manufacturers, I was surprised to hear people expect a virtual audit to be easier and more relaxed.
My most important piece of advice to those preparing for a virtual audit is that you should treat them just as rigorously as an in-person audit — adequate preparation is critical.
The amount of documentation and sample size the auditor will review is the same. The audit duration and turnaround time to receive the results of your audit, including any reports of non-conformance, will also happen within a similar time frame as an onsite audit.
The appropriate team members should clear their schedules and make themselves 100 percent available to the auditors during the process, just as you would for an in-person audit. The auditing team will likely ask for clarification or seek your input, and it’s essential that you respond to them promptly to avoid extending the length of your audit.
Other than an actual in-person visit, the requirements for a virtual audit are nearly identical to those of an in-person one. From a preparation standpoint, I recommend you follow the standard processes and procedures your company already has in place to prepare for an audit.
Five Questions to Ask Your Virtual Auditor in Advance
To ensure the audit runs as smoothly as possible, be proactive in establishing expectations.
As you plan for the auditor(s) to visit your facility virtually, here’s a list of questions to ask:
- What’s on the agenda? You should preview the schedule and have a call in advance to hear what your auditor expects from you.
- What are the communication protocols between your team and the auditor? You should know before the audit how you will be communicating. Is it a conference call, WebEx, Zoom, or other video conferencing platform? If it is a video conference, you will want to test it in advance to ensure you have the latest updates and that your video is set up correctly to share.
- How will you share documentation back and forth? For multipage procedural manuals and other written documentation, you will want to confirm if those will be exchanged via email or some other method. If the auditors need to review software, you need to make sure they can access it remotely.
- How will the auditor select sample records to inspect? While you may want to cherry-pick what you show your auditor, just like an in-person audit, the auditor will want to examine a representative sample of their choosing. Because the auditor will not be there in-person, establish a process in advance for how they will access and review your records.
- Is there a checklist of specific items the auditor would like to see? Your auditor will give you instructions in advance. Make sure to get them in writing and ask if they can provide a checklist so that you’re both on the same page.
What are the Differences between an In-Person and a Virtual Audit?
While you can expect your virtual auditor to be every bit as meticulous, there are a few notable differences between an in-person and remote audit of which you should be aware.
During a virtual audit, you have the added responsibility of ensuring the auditors can access the documents and records they require.
You may have tested your WebEx account, and it worked fine a few days ago, but on the day of the audit, you’re unable to share your screen. Or what if one of the files they are requesting is too large to email? These situations not only add stress, but they may unduly extend the length of your audit. This is why planning for these scenarios is critical.
It is also harder to react to visual cues remotely. During an in-person audit, it’s easier to see if your auditor is confused or struggling to make sense of your documentation, and it is natural for you to jump in to provide clarification. It is challenging to build that type of trusted relationship over the phone or via video conferencing. Talking to your auditor and building a rapport in advance will help you overcome this hurdle.
Are You Ready for a Virtual Audit?
With no COVID-19 vaccine on the immediate horizon and employers focused on the health and safety of their employees, virtual audits are here to stay for the foreseeable future.
If you seek a trusted partner with real-world medical device quality systems knowledge and mastery of industry protocols to conduct a virtual audit or need help preparing to host or respond to an FDA inspection or Notified Body audit, we can help.
Lean into our ISO 13485 audit expertise.
