Training in Life Sciences: The Underdog of Quality – Part 1

By Natasha Koolmees, Verista Quality Consultant

A few years ago, when I was working at a large pharmaceutical company, I attended a meeting to discuss why our cleanrooms were having high contamination rates across all our U.S. sites. This is a major issue when you’re manufacturing a product that must be aseptic, free of most foreign particles or organisms. The group consisted of site leadership and little ol’ me sitting at the end of the table because I was the official – and only – on-the-job trainer for the site. I was in that meeting because the company had identified that we didn’t have aseptic training for most of our production employees. What a major gap!

Everyone knows training is important and that effective training improves quality, but can you explain exactly “how” it does this? If you can, then you’ve already got a leg up. It’s a subject that has multiple factors and, in my experience, only one or two of those factors ever get recognized. Effective training drives quality but it isn’t always given the attention it deserves. This blog introduces some of the main ways that training drives quality with the hopes that you can take training off the back burner of your next project and improve quality in the long run.

Training is a multifaceted topic and oftentimes the department you come from determines how you look at it. The best trainers usually don’t start as trainers; or those that do are very good at working cross functionally. Typically, they start out in Operations, Quality Assurance, Document Control, or any other combination that would give them a different perspective other than just training. This is important because a successful training program not only combines multiple viewpoints (e.g., an operator, learner, trainer, quality associate, teacher, etc.), but it also aligns the process with multiple departments’ requirements. For this blog, trainers can be taught the process of teaching (e.g., Step 1, Step 2, Step 3), whereas teachers understand the concepts of Instructional Design: the process of creating the training materials and methods.

All these factors and perspectives are important when developing a training program, either at the site level or even just for a piece of new equipment, because everyone has a hand in the process. That meeting I mentioned earlier had experts from Operations, Quality, Training (me), Operational Excellence, along with the site head. I was able to leverage my experiences and knowledge, and share them with the people in the room to create a lesson plan that not only focused on the gap, but also on the learner for long term success.

In part 2 of this 2-part series, we will share more insight  best practices on how to create and implement successful quality training.

Feel free to contact us at [email protected] for more information if you have any quality training needs.