The following is a guest article by xCellarate Technology Consulting Inc. Founder, Managing Director, and Principal Fenton Fong

Over the past 18 months, I have conducted numerous remote audits of manufacturing facilities and quality management systems (QMS) for a variety of purposes, including:

  • Supplier qualification/requalification
  • GMP gap analysis
  • Quality standards accreditation/recertification (i.e. ISO9001:2015 and ISO13485:2016)

I have found there to be a wide variety of experiences, as well as recurring themes. 

After viewing the May 18 virtual panel discussion webinar, Remote Audits, featuring presenters Barbara W. Unger, Jerry Chapman, and Stephanie Gaulding, I thought it would be fruitful to contribute to the discussion with my own experiences and lessons learned.

[Related: To access the full recording of this virtual panel discussion webinar, click here.]

Prior to March 2020, the practice and concept of remote audits was sparse, if not, unusual for the industry, certainly a rare exception, and not a top-of-mind choice. Fast forward 18 months into the pandemic and we now see rapidly increasing amounts of information about all aspects of remote auditing. There has been a rapidly forced, magnitude shift in the way we do things.  

There are benefits as well as limitations with remote auditing, many of these have been outlined in other publications, I will focus on my own experiences thus far. I do not believe that the industry will return to the way things were, at least anytime soon. Remote auditing is here to stay. 

Some observations and lessons learned that I’ll discuss here include:

  1. Types of audits that are ideal for remote audit format
  2. Preparing for and managing document reviews
  3. Lack of updated policies and procedures for the remote audit approach
  4. Video interfacing, live virtual tours, and backup plans

Remote Audits Better for Certain Types of Audits

We have discovered that for some circumstances, a remote audit is an overall superior method over onsite auditing. Such circumstances include auditee sites having a good and established history of compliance and/or having products or services of relatively low risk.

As a result, it is highly recommended that companies develop and adopt a risk-based approach in their SOP vendor qualification/monitoring program if they have not already done so. This approach enables companies to define which types of audits/vendors are more suitable for remote auditing.

Document Request and Review

It is important to ensure that all documentation anticipated being reviewed during an audit scope be requested ahead of time and confirmed to be available electronically in the information-sharing platform chosen (e.g., Dropbox). In particular, any and all hard copy documents identified as within the audit scope should be scanned ahead of the audit.

While some hard copy evidence can be shown effectively by video camera (i.e., single page logsheets hanging off equipment, equipment status stickers for PM/Cal), larger hard copy multipage documents are much more difficult to evaluate remotely.

Prior to March 2020, the practice and concept of remote audits was sparse, if not, unusual for the industry

Precious time is lost if the auditee must spend time during the audit to scan large numbers and sizes of documents. Smaller companies may have a particularly difficult challenge in this regard as they may have a lack of electronic document management systems and have greater reliance on paper-based QMS

Regarding document access control, it is best for the auditor to have inspection documents fully available, i.e., have scrolling control access to documents, rather than passive scrolling control by the auditee. Without the former, it is extremely difficult for the auditor to conduct a meaningful review of a document. As described by Barbara W. Unger during the webinar, when the auditor cannot control the scrolling of a document and instead relies on the auditee, this significantly changes the effectiveness of document review. The inspection activity shifts from being an evaluation of document content, instead of to a lightning Q&A session.

[Related: For more on documents and document sharing, check out the clip below from the webinar.]

As in face-to-face audits, there are a lot of documents to keep track of. I found that this is a unique challenge in remote auditing. In this case, all the paperwork is in electronic form with multiple files open simultaneously on a single screen. This can get overwhelming and difficult to keep track of. If your computer crashes or there is a signal drop, you lose precious time in recovery. It is highly recommended for the auditor to continuously back up your electronic notetaking! For both the auditor and auditee, it is recommended to use at least a second larger monitor, if not a third.

It is common for the auditee to be delayed in furnishing requested information and documents, sometimes being unable to furnish it at all by the end of the audit. Getting a feel for the causes of delays for document retrieval is more difficult during a remote audit. To echo Jerry Chapman’s comments about Health Canada, the agency has implemented a time-limit tool for document retrieval. Further, Health Canada has stated that it is imposing time limits/deadlines for providing requested docs ahead of time. If the deadline is not met, it is considered an audit observation.

Procedures Need Updating

For many of the remote audits that I have conducted, auditees have not yet fully updated their corporate standards, site policies, and procedures as applicable, to encompass the remote auditing format. For now, this gap is best perceived, not as a deficiency, but rather as a lag. It is also reflective of how fast and abrupt things have changed in 18 months. Auditee sites are encouraged to update their internal policies and procedures accordingly.

Video Interface

Video conferencing using software solutions such as Zoom or MS Teams has fundamentally shifted our collective experience and forced us to adjust our comfort with using technology to represent ourselves in the online world. While there is no specified requirement for the auditor and auditee to be live on video camera during the audit, it has been my observation that there is wide variability in comfort and practice of auditees attending by live video, whether in part or in whole.

In a few instances I experienced, the auditee flat out refused from the outset to attend with their camera turned on and stated that it was not a regulatory requirement. Part of it is the comfort level of both the auditee and the auditor to this new medium of self-representation. It may also be that the camera is a convenient tool to use to hide behind (whereas in an onsite audit, there is less opportunity to hide). By not being able to be present together with the auditee team in the same room via video feed, the nuances from body language and unspoken communication are completely lost. This has potentially large impacts on the quality of the audit and the value obtained from the audit for both the auditor and the auditee. 

Precious time is lost if the auditee must spend time during the audit to scan large numbers and sizes of documents

Some auditees leave their cameras on for longer periods, while other auditees barely, if at all, turn on their cameras and enable the auditor to have visual communication. It is best to have two-way video camera presence with the auditee for most of an audit, even though it is not a requirement. Two-way video creates a more authentic and meaningful experience. 

Oftentimes there is no ability for a site tour via live video. Explanations include poor Wi-Fi and/or interference with production activities. Live, real-time video is always preferred, lack of a live video and/or use of prerecorded video tours extremely limits the productivity of the site inspection.

Auditors should always request a site facility floorplan to use while following along with a live or prerecorded video. This is helpful for using in conjunction with back-and-forth Q&A with the auditee tour guide to understand where the auditor is situated in the facility at a given moment during the virtual tour. In one recent inspection of a manufacturing site, the auditee refused to provide me with a floor plan drawing and there was no video tour, live or prerecorded! In this instance, I was essentially blind, relying entirely on verbal descriptions and Q&A regarding the physical facility. The quality and value of information obtained from the exercise were severely compromised.

Ensure Stable Wi-Fi Strength

To echo Stephanie Gaulding’s comment, companies must start building an infrastructure that better accommodates remote auditing. As part of facility preparedness for the new age of remote audits, auditees are recommended to conduct an assessment of their Wi-Fi/phone signal strength throughout their facility and organization.

Auditees should invest in resources to ensure strong Wi-Fi signal connectivity throughout their facility. Variability in quality of video feeds (e.g., choppy footage, delayed responses, cut-offs, poor resolution, etc.) during virtual tours while using  Zoom or MS Teams on a laptop or smartphone camera has an impact on the value of a visual inspection. A particular problem area is lack of Wi-Fi signal strength in enclosed spaces such as the walk-in cooler and utility rooms. This has been the case for me on several audit occasions. 

Inspections of such enclosed specialty environments are an important part of the audit. This is an area of improvement that would add value to remote auditing. It is extremely beneficial to proactively determine ahead of time with the auditee how good/poor their Wi-Fi signal reception is and plan around it accordingly. 

Live, real-time video is always preferred

I notice that the quality of objective evidence is sometimes harder to evaluate. By not being present together with the auditee team in the same room, the nuances from body language and unspoken communication are missing. An auditor must be extra attentive to evaluating requested information; I think this is a bit more of a challenge remotely. It is important for the auditor to give themself enough “space” to conduct the document review work. Clearly specified time with the camera off for the auditor to disappear and review document information is an important tool. 

Have a backup plan in case of technology failure. At a minimum, conduct a dry run to test out the video conferencing platform. In one very recent instance, I was unable to connect via an MS Teams invitation which turned out to be due to a Windows OS incompatibility within an intranet platform. I suggested switching to Zoom but surprisingly the auditee did not have experience with using Zoom, which I found hard to believe! In the end, we came up with a third option, Skype, requiring me to resurrect my old Skype account that I had not used in a long time. 

Even with the experience and recommendations, I have described here, and the most thorough advanced planning, we are dealing with multiple simultaneous technology platforms. And there is a lot occurring on multiple levels during a remote audit. Glitches are bound to happen; they require significant time to sort out.

Be patient, friendly, and flexible!

About the Author

Fenton Fong

Fenton Fong has over 25 years of corporate and consulting experience in pharma, biotech, and related industries. He is an ISO9001:2015 certified lead auditor and a member of the Editorial Board of the PDA Journal of Pharmaceutical Science and Technology (JPST). His experience includes QA management, manufacturing facility operations, and CMC for a blockbuster parenteral product NDA. He has engaged in numerous audits, GMP, and QMS remediation projects, both domestic and international.

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