Tips to improve your experience

by Nigel J Smart PhD

During this time of modified practices there is still the need to keep our businesses moving along. One critical area relates to supply inspections, especially where CMO’s are being used to make investigational medical products all licensed products. Social isolation and distancing continue to make this a challenge to assure compliance, but provided a well-planned strategy is followed, it is possible to keep appropriate oversight responsibilities in place and to maintain quality compliance at the required levels. Although our technique for dealing with this has been covered in a previous communication, due to the criticality, we will focus on a few issues that through our own experiences, we see as potential pitfalls.

From experience we see two aspects of the virtual inspection that have the potential to generate problems. Not surprisingly, the live streaming tour of the facilities can be a significant source of these types of issues, and these are associated with the connection and quality of the live feed. The other is the interview process connected with addressing questions and providing answers.

Live streaming is a technically challenging task and depending upon the quality of the link, the process can be either successful or very poor.

Over the course of this Covid 19., our experience has enabled us to explore several possibilities and from this we developed several key features to improve the level of success and operational dependability. Our experiences have involved both local and distanced domestic scenarios operating in various time zones, as well as international time zones where the spread of the team separation has included multiple time zones and 9 to 10 hours of separation. In these circumstances, with differing levels of Internet connectivity and quality, it is prudent to break up the livestream portions to maximize effectiveness. Our experience has shown that in some cases during the facility tour, the link is lost. In some cases, this is not always apparent to the tour guides and this could cause a gap in the proceedings. Inevitably this leads to confusion and frustration among the parties and is very disruptive. To counter this we recommend that the host company tests the various areas for connection reception well ahead of time and provide a separate cell phone link to maintain communications in the event of a disconnection of the video live streaming link. Secondly, we recommend breaking up the live streaming link into sections. This provides a safeguard against issues with a single facility link or defective link and provides the auditor a few moments to process what they have seen before they gather their questions.

We advocate breaking up the Livelink in the following way:
1. the loading dock and warehouse area
2. the process production suite
3. the laboratories

Refining your approach in this way should provide a better audit experience for the auditor and better represent the capabilities of the host company.

The second feature that we feel impacts the experience is to ensure that the video camera is on for both sides of the audit during questioning. This approximates to the normal experience as closely as possible and is a distinct benefit for both those auditing and the host. In the case of the auditor, it enables one to gauge the level of the host’s preparedness and whether they have capability issues in addressing questions. And, in the case of the host staff, is an opportunity for them to demonstrate that they are authentic and genuine in their response and to showcase their expertise. This is difficult to achieve if the camera is off.

These are a few tips to help in your process which we hope you will find useful. Remember, using the experience of a quality industry consultant is a way to maximize your success. Do not reinvent the wheel, call instead!