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!
