Reducing Exposure During Customer Audits

Medtech suppliers are accustomed to hosting a steady stream of visitors to their facilities, whether it’s sub suppliers, customer engineering staff, prospective customers, or regular visits from auditors performing required supplier audits.

As suppliers look to minimize virus exposure for their employees, much of the industry has pivoted to virtual alternatives in place of face-to-face interactions. In the auditing world especially, we see two trends emerging that serve to reduce exposure for both auditor and auditee while simultaneously reducing cost.

Trend 1: Remote Audits
The move to remote auditing as a default has been swift, as organizations make a good faith effort to comply with auditing schedules in the midst of a pandemic, yet not without growing pains. Some suppliers have practiced hosting a remote audit by undergoing a remote internal audit first. “That was very helpful,” one client said. “It was like a dry run and allowed us to get organized with our virtual back room activities and audit dynamics.”

Our clients have found that giving the auditors access to documents electronically can speed up the process, though one pointed out that also comes with risks since it makes it easier for them to search and find. Similarly, many now utilize some form of IM service (e.g., Slack, WhatsApp, etc.) to facilitate group conversations.

One staff member who recently supported a remote audit for a client said the process was easier than last year’s on-site event. “You have more time to figure things out and get a better answer to them. The auditors have been pretty understanding overcoming the challenges of remote auditing, pulling from a server to Dropbox location, etc.”

Different auditors may choose various ways to use video conferencing—some choose to stay live a large part of the time, replicating the on-site experience, while others may video conference only periodically throughout the audit days to ask questions or kick off the audit.

Managing the relationship side of an auditor over an extended period of time remotely involves both hard skills on the technical side as well as soft skills that recognize and deal with the challenges of not being in the same room.

During the live video portions of the audit, all parties should strive to have active video and avoid avatars. Communication will be more efficient and successful if participants pay attention to cadence, pace, and to the extent possible, eye contact. Training your eye on the webcam rather than the person’s face on the screen (at least from time to time) will improve connection. Talking over one another is a waste of time, so discuss it upfront under “housekeeping issues” and try to agree on the back and forth process, or to use the “hand up” icon in group activity, for example.

We see hardware-centric suppliers needing a little more practice to come up to speed with remote auditing than companies for whom software is a big part of the product. “As a software-based company, we’re used to operating remotely with distributed teams,” one client said. “But other entities are not as familiar with this approach, so it’s the rest of the industry catching up with technology a bit in that regard.”

The enhanced flexibility in scheduling that comes from not figuring in travel time is a plus, as is the dramatically reduced cost.

Overall, our clients report generally positive experiences and don’t anticipate going back to a default position of on-site and in-person, although on-site will continue to be preferable or even required in some situations.

Trend 2: Shared Customer Audits
As convenient and effective as remote auditing has proven to be, there are occasions where the need to be on-site cannot be avoided. In this case, shared customer audits also dramatically reduce exposure, while saving both auditor and auditee time and money. Shared audits are a concept we have seen in the industry for the past five years and is proving to be a very valuable option in our current paradigm. In a shared customer audit, the supplier makes one day available to a third party auditing company, who then audits on behalf of multiple customers at once.

Medtech suppliers have been successful consolidating 15 to 20 requests for customer audit into one comprehensive audit day. This not only greatly reduces exposure to plant employees compared to 15 to 20 different auditors, it also reduces the support time suppliers devote to customer audits by offloading the processing, agenda, auditing, and report generation to the third-party auditing company.

The win for the supplier’s customer is that a shared audit costs less than the customer conducting their own audit while still satisfying the audit requirement. Generally, the auditing company will conference in advance of the audit with all participants individually to ensure each participant’s individual issues and questions are addressed.

Conclusion
The majority of our clients see a lot of remote auditing in the future, driven by the cost savings and technological advancements like high-end telepresence robots that could make walk-arounds and manufacturing inspections feasible. “The pandemic is forcing us to figure out how to do it more effectively and routinely,” as one client recently said.