GetReskilled W ith 483s being issued at a higher rate than ever before, more and more attention is being focused on what is happening with regards to quality on the manufac- turing floor of pharmaceutical, medical device, and
biotech organizations. Specifically, the behavior and activity of
cleanroom operators is under scrutiny, with organizations rec-
ognizing that SOPs and GMPs are simply not enough, at most
companies, to elicit behaviors that consistently produce quality
medicine and devices.
How can companies help employees stay engaged and alert
inside the cleanroom, and on the manufacturing floor in general?
Isn’t it critical that these steps in the production of medicine, and
medical devices, be completely error-free and quality-perfect?
Janet Woodcock was quite clear in her 2013 plenary speech
at the national ISPE meeting in Washington, D.C. The FDA, she
said, is interested in creating a quality culture inside organiza-
tions “from the shop floor to the board-
room.” There is growing recognition
that operating training needs to show
operators the “whys?” using a simplified
version of the science behind cleanroom
SOPs and GMPs. Video training in par-
ticular, is coming to the forefront, as it
is quick and can be delivered in small,
easily absorbed nuggets of information.
Videos may be part of a solution for
new approaches and new answers in
SOPs and GMPs are normally posted
and available to everyone that steps into a controlled envi-
ronment. Operators are told how to gown up, move through
personnel airlocks, how to use ports to take samples, perform
testing, the proper method for adding ingredients to a biore-
actor, and a multitude of other tasks. But as often as operators
perform these tasks, and probably because of this repetition
and the tedium it causes, mistakes still occur. There is growing
evidence that rote behavior, i.e. simply following instructions, is
It has been shown that to understand why a particular task
is necessary will lead to correct implementation more often.
The Center for the Integration of Research, Teaching, and
Learning says, “The use of practical examples can help you con-
nect theory with practical applications for more effective teaching
and learning. The introduction of practical examples does not
imply an elimination of theory, but rather an enhancement of the
theory taught in the classroom. It is important to simultaneously
develop a theoretical and a practical base for knowledge, since
neither is useful without the other.”
Video training is an excellent tool for delivering these practical
examples, and the use of video training is increasing in the class-
room and in corporate training, mirroring its use across all types
of communication—advertising, emails, social media, all regular-
ly include video links for friends, colleagues and clients.
Video’s visual aspects, which showcase a concept using motion,
versus static images, engages both hearing and sight, and has been
shown to increase our retention of the information, versus listening to a lecture or even reading about a concept. Perhaps the most
significant factor in relation to developing a quality culture though,
is that video learning can encourage cleanroom operators to make
connections between disparate concepts.
The National Teacher Training Institute says: “Teachers who
Video learning makes a difference in the cleanroom
use instructional video report that their students retain more
information, understand concepts more rapidly and are more
enthusiastic about what they are learning. With video as one
component of a thoughtful lesson plan, students “often make
new connections between curriculum topics” and discover links
between these topics and the world outside the classroom.”
If operators are encouraged to think outside of their rote
tasks, and make/see connections, anomalies around quality may
be more easily spotted, and reported.
Short video training modules, no more than two to five minutes long at the start of a shift, during breaks, or even in a classroom environment specifically set aside for operator training,
can be a powerful tool for mitigating errors on the job in the
complex world of cleanrooms.
One video offered by GetReskilled takes a common cleanroom training topic: Controlling Air Quality and makes it more
interesting through the use of video. The classic classroom
approach on this topic delivers the message that maintaining
acceptable indoor air quality (IAQ) depends on the judicious
use of three methods: 1) source control; 2) filtration; and 3)
The difference using video learning is the visual impact that can
Early adopters look to video learning to achieve FDA vision and demonstrate how
be made, for example, during a discussion about source control.
The SOP manual says, for example: “The most important meth-
od of maintaining acceptable indoor air quality is by controlling
sources of contaminants and pollutants...”
The video version shows one common source of indoor
pollution as being caused by mold, and the visual of the spores
and dead particles of mold visually and adversely affecting the
See a short video on