Keys to Preparing for Remote Inspections

Remote inspections by regulatory authorities require new considerations in the planning and preparation process. While current best practices in inspection readiness remain the same, there are areas that require additional forethought.

Types of Remote Inspections

One of the most difficult things to anticipate in a remote inspection is how the inspection will be conducted. In response to an emerging pandemic involving a novel virus, regulatory authorities announced changes in their ongoing inspection practices in early 2020 and began moving to alternative inspection techniques and tools. Three primary forms of alternative inspections emerged:

• Desktop Inspections: This type of inspection involves the exchange of information between the inspecting regulatory authority and either the facility being inspected or other regulatory authorities who may have recently inspected the facility.
• Distant Inspections: While similar to desktop inspections, this type of inspection differs primarily in the concurrent usage of teleconferences or web-conferencing to interview site personnel or discuss open questions on documentation.
• Virtual Inspections: This type of inspection simulates many of the same aspects of a traditional on-site inspection (e.g., tours and observation) through the use of mixed reality and 360° video streaming. More preparation is required by the facility being inspected including potential investment in new technology.

Each of these inspections involves extra preparation for managing communications and sharing information.

Managing Communications

Communications during an on-site inspection can be challenging due to several factors (e.g., complexity of the topic, native language of the inspector/facility personnel). During remote inspections, these challenges can be magnified as tone and body language are often missing in remote communications; therefore, it is paramount that professionalism is maintained in remote communications. Where written communications are used, institute a peer review process that checks for unintended tone or unclear explanations. When using remote verbal communications (e.g., telephone or web conferencing), preparation on communication best practices should also be provided to all persons presenting to or speaking with inspectors.

In remote inspections especially those involving heavy document exchange, consider designating a single point of contact on the inspection team to receive and respond to requests. This person should be the conduit through which information flows to and from the inspector. Ideally, this would be a different person from the person designated to assign and monitor requests and make sure information is flowing in a timely manner.

One additional complication of remote inspections is the potential for inspections to occur across multiple time zones. Inspection teams need to be prepared to work alternative hours. During on-site inspections, days are typically longer but the primary working time occurs during the local time zone of the facility. In remote inspections, there can be time zone differences of a few hours to almost half a day. Flexibility may be required to adjust the primary working hours of those supporting a remote inspection to match the time zone of the inspector.

Document and Information Sharing

There are several key aspects to regulatory agency inspections that still hold true for remote inspections: documentation review, facility tours, and staff interviews. Translating these inspection aspects into processes to support a remote inspection requires additional considerations. Using a secure content exchange platform is a better way to share documentation. A good platform provides an access-controlled portal where documents can be uploaded by the site and viewed by the inspector(s). When using these portals, the inspection team should check file formats and sizes prior to uploading. Consider the following:

• Is the file in a format that is both compatible with the platform and does not require special software to view? Recommended file formats include PDF, Word, Excel, and PowerPoint.
• Does the platform allow a viewer to rotate pages? If not, consider rotating pages prior to uploading the file to make the review process easier for the inspector.
• Is the file size large? If so, check that it displays properly in the platform (fully loads, time it takes to load, etc.). If large files take time to load, inform the inspector in advance.

These platforms, often used in due diligence efforts, allow the restriction of printing and downloading of documents, but processes should be in place to allow an inspector to request a copy of a document for retention.

There are many ways and technologies that support facility tours, observation of operations, and staff interviews (e.g., video conferencing, 360° video streaming, mixed reality). Each site needs to determine how they want to handle these requests. Video conferencing has become a standard part of the way we work, and it is a great way to handle interviews; however, it is important to verify that staff taking part in interviews are comfortable with the platform being used. To support the ability to host remote facility tours and allow inspectors to observe operations, some sites implement technology such as 360° video streaming or mixed reality. If this technology is new, be sure the technology is well tested prior to the inspection and ensure that support staff familiar with the technology are dedicated and available to support the inspection. These technologies require strong internet connections, so part of the testing should include verification of sufficient strength and availability of internet access throughout the facility, especially where tours frequently occur or where inspectors could want to observe operations. If areas of the facility do not have the ability to support use of the selected technology, be sure to communicate that to the inspector(s). Also, implementing new technology requires time for the inspection team to become familiar with it and may require some explanation of how to interact with it for the inspector(s), so anticipate these learning curves and educational needs as part of the preparation for a remote inspection.

These tips are summarized in an infographic. With additional thought and preparation using these tips, sites can host successful remote regulatory agency inspections.

View the summary infographic: Preparing for Remote Agency Inspections

For additional information or support in preparing for remote inspections, contact me via email.