By Sean Fenske, Editor-in-Chief
 
The disruptions created by the pandemic has rarely been seen on such a wide scale in many decades. It created an environment that caused companies to “change gears” and shift standard protocols almost on the fly. As such, many regular processes were suddenly being adjusted and participants were discovering best practices on what seemed like a daily basis.
 
One such familiar activity for medical device manufacturers and their supply partners is audits. Due to the conditions created by the pandemic, in-person audits were no longer possible for an extended period of time. Companies had to transition to a remote audit model, leveraging video conferencing and other digital solutions to achieve the same result.
 
Since remote audits were performed with widely varying levels of success across medical device manufacturing, Matt Knutson, vice president of Manufacturing Operations at Donatelle, offered his insights on some best practices that worked for his firm. In the following Q&A, he speaks to what should be done before, during, and after the audit to help ensure a smooth, successful process.
 
Sean Fenske: The pandemic pushed remote audits into the spotlight due to necessity. Will this practice continue even though we are returning to more of a pre-pandemic environment?
 
Matt Knutson: Many organizations have realized great efficiencies by performing remote audits over on-site audits. This is especially true for OEMs with large approved supplier lists and/or their suppliers are spread out geographically. Organizations can perform more audits in the same number of days, at minimal cost, when travel is not involved.
 
Remote audits conducted over video conferencing can be an effective way to assess a supplier’s Quality Management System documentation, as well as development, production, and quality records.
 
Another benefit of video conferencing is the ability to easily include representatives from multiple facilities for all or part of the audit. This helps save redundancy and may help eliminate or reduce required audits at multiple divisions or sites.
 
Fenske: What challenges were encountered in the “rush” to perform remote audits and how can they be resolved given the lessons learned?
 
Knutson: Early on, there were some compatibility and connectivity issues as organizations were first learning the various teleconference services. As time went on, the standard platforms became a more seamless experience for both parties. If compatibility was in doubt, Donatelle would schedule a test meeting ahead of time, so there were no issues come the day of the actual audit.
 
The most smooth and streamlined remote audits Donatelle participated in were ones where the auditor did not request copies of all the documents they intended to audit ahead of time. It saved us time and reduced our efforts by only needing to present them during the remote audit. During the audit, if it was determined that a copy of a document was required, the auditor requested the document and it was added to a tracking log of what had been provided.
 
Fenske: What considerations should be addressed by an auditor prior to a remote audit?
 
Knutson: It is important for the auditing organization to clearly communicate the scope of the audit and the expected duration. With remote audits, since travel is not involved, there could be a tendency to push audits into subsequent days or weeks. Organizations should make every effort to treat a remote audit the same as an on-site audit. There should be an opening meeting, a schedule of activities, and a closing meeting.
 
If a supplier is largely manual in their recordkeeping, provisions will need to be made in advance to ensure information can be shared during the remote audit. This may include converting requested records to an electronic format, or through use of a video camera to view the manual documents.
 
Fenske: On the other hand, how should a supplier properly prepare for a remote audit?
 
Knutson: Suppliers should carefully review the audit plan and ask questions in advance, if any clarification is needed. They will need to ensure the scope of the audit is something that can be accomplished remotely.
 
Suppliers with a robust Quality Management System with electronic data and recordkeeping should really not have much to prepare for a remote audit, as it will be performed similar to an on-site audit. Assuming they have experienced individuals being audited, they should be able to efficiently retrieve and share the required information. There should be no need to spend days prepping for the remote audit and gathering stacks of records.
 
The most efficient type of information/record reviewed during a remote audit is electronic data—manually filled out forms converted to electronic records—that can be accessed from native systems, such as SPC software or from a supplier’s document control system. Donatelle converted to 100% electronic data systems years ago, and it has truly made remote auditing very efficient.
 
Fenske: What are some best practices during the actual process for both the auditor and auditee, and also, what should they both avoid?
 
Knutson: Both organizations should reserve a conference room or other quiet area for the audit. A remote audit shouldn’t be conducted where day-to-day distractions can interfere with its progress. Remote audits should be treated just the same as if it was face-to-face in a conference room.
 
Again, ensure the platform to be used is compatible for both parties. You don’t want to start a critical audit off on the wrong foot by not being able to connect.
 
Auditors may need to complete corporate audit checklists or questionnaires as a result of the remote audit (same as with an on-site audit). Some of these may need to be adapted to reflect the remote audit process. Additionally, internal standard operating procedures and work instructions may need to be updated to reflect this approach as being allowable.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Knutson: Remote audits can be an effective option for OEMs to add to their Supplier Controls toolkit. They have been successfully used during the pandemic, and are expected to continue to be used by organizations in the future.
 
Donatelle has successfully hosted many remote audits over the course of the pandemic. This is made possible through full integration of electronic quality records using our validated ERP system and the extensive knowledge and experience of our Quality Services group.
 
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