With 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 manufacturing floor of pharmaceutical, medical device, and biotech organizations. Specifically, the behavior and activity of cleanroom operators is under scrutiny, with organizations recognizing 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 organizations “from the shop floor to the boardroom.” 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 particular, 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 cleanroom training.
SOPs and GMPs are normally posted and available to everyone that steps into a controlled environment. 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 bioreactor, 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 not enough.
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 connect 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 classroom and in corporate training, mirroring its use across all types of communication—advertising, emails, social media, all regularly 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 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.
Video learning makes a difference in the cleanroom
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) dilution.
The difference using video learning is the visual impact that can be made, for example, during a discussion about source control. The SOP manual says, for example: “The most important method 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 operator and the product in production, are more compelling than reading a bullet list of potential contaminants.
Another video learning module, on isolators used in the cleanroom, uses very simple language to first describe the typical isolator: “Consider the isolator to be a box” (video moderator shows a box being drawn as the speaker speaks), “typically made of stainless steel with viewing panels made from chemically resistant and durable plastics” (video continues drawing the viewing panels and then one sees the HEPA filters popping onto the top of the cleanroom).
A movie using simple language and simple images takes a dry topic and makes it interactive through motion and visualization.
Videos can also convey emotion which is certainly another way to connect with the operator audience. For example a video module could emphasize that the products being handled by the operators daily, are medicine, being ingested or injected by operators’ loved ones—parents, wives, husbands, and children. This module teaches that the job they do each day is always patient-centric, everything from gowning up, or putting on a hairnet properly. It seems obvious, but developing a patient-centric philosophy and showing who will use the products being manufactured, go a long way towards driving the quality message.
Cultural barriers to handraising: Science helps
Differences in customs and traditions can come into play when implementing a quality culture, because some cultures discourage speaking out, subtly or overtly. Explaining the science behind the SOP and GMP manuals can go a long way towards encouraging operators to overcome cultural mindsets which discourage speaking out about problems. Experience has shown that if operators understand why a particular task is being performed in a particular way, then the likelihood increases that they will raise a hand when a task is being performed incorrectly.
A good example of this concerns injectables. Teaching manufacturing operators and technicians the simple science behind the SOPs comes alive when you talk about injectable products. Students are taught that injections bypass all the body’s defense mechanisms because the drug goes directly into the bloodstream. Creams, ointments, and tablets on the other hand benefit from many of the body’s own defense fortress, with natural filters such as the skin, stomach, liver, etc. before entering the bloodstream. But with injectables, there is no such natural defense; the drug goes directly into the bloodstream.
This knowledge lessens the cultural taboos against bringing problems to the attention of superiors, because the operator understands he/she is questioning the science and not his/her supervisor. Understanding the real science leads to a clearer understanding of the “whys” of GMP and can be a strong underpinning of a true quality culture.
It is more imperative than ever before to change the way we train the men and women who work the shifts inside our cleanrooms. This extends to discussing and mandating this same training inside the cleanrooms of the CMOs which can amount to hundreds and even thousands of operators, in the overall global manufacturing supply chain of the big pharmaceutical companies. As Rick Friedman, Associate Director, FDA Office of Manufacturing and Product Quality, recently noted at the 2014 Interphex conference, Big Pharma is responsible for the “weakest link” in their global supply chain and these weakest links need to be strengthened one by one, so that a quality culture can be built from the shop floor on up, to truly attain Woodcock’s and the FDA’s vision.
GetReskilled is a video learning company specifically focused on the pharmaceutical, medical device, and biotechnology industries. The company has offices in Boston, Mass. and Cork, Ireland.
This article appeared in the June 2014 issue of Controlled Environments.