I got a phone call from my Lead SME’s boss one morning. “How many more sessions do you need”, I asked him. I had already delivered 4 back-to-back workshops with class sizes of 25-30 SMEs; which was beyond optimal. So I asked him why. I needed to find out what was driving the surge in identified Qualified Trainers (QTs). I learned that a retrospective qualification needed to take place in order to close out an inspection observation. The total number of SMEs needing “proper paperwork” was well over 700. Since the redesigned training system was now in effect, these undocumented SMEs as Trainers would have to follow the new procedure. Or would they? Our discussion shifted to what type of training these SMEs will be delivering.
I then shared a related story with him. Several years prior, I got entangled with a “CAPA crisis” that involved QTs. No sooner did we launched the QT program and put the new procedure into effect, the CAPA quality system temporarily shut down shipping over a weekend. Upon return to the site, I was summoned to an emergency meeting from the security gate. Amazingly, a new practice/rule that only a Qualified Trainer can conduct training evolved from “only OJT QT’s can deliver OJT and perform Qualification Events” as per the SOP! This was clearly a case of misunderstood scope.
Does every SME need to be qualified as a Trainer?
In the Life Sciences arena, there are 5 recurring situations that require training: Self, Corrective Actions, Classroom (ILT), Structured OJT, and Qualification Events (Final Performance Demos).
Self can be achieved by the individual reading the procedure and signing the training record. This is also known as Read & Understand (R & U) for SOPs. I personally don’t think of it as training, it is reading. Yet, in some situations, reading is all that is required to gather the SOP information. If on the other hand, you need to execute the steps of the SOP and complete required forms, then additional training with the SOP Author or a QT is the appropriate next level of training.
Deviations/ Corrective Actions stemming from a Corrective Action Preventive Action incident. Minimally an SME or the SOP Author is needed to ensure the credibility of the content. These types of training sessions have become known as Corrective Actions “Awareness” Training. And more and more SMEs are now being required to deliver this training in a classroom setting. They need to be qualified to deliver classroom sessions especially if the event is related to a significant CAPA or regulatory inspection observation.
Classroom (Instructor-Led Training) is preferred for knowledge-based content affecting a wide range of employees. The skillset needed is facilitation / managing the classroom and delivering content as designed by the instructional designer. Think of GMP Refresher sessions in the Training Room.
Years ago, it was a lot clearer to distinguish between classroom trainers and SMEs as OJT Trainers. OJT was delivered 1-1 by “following Joe/Jane” around. Classroom Trainers delivered their content in a classroom of many learners using slides, flipcharts, and handouts. They were usually full-time dedicated training staff. Instructor-led training requires training in learning theory design and practice in what used to be referred to as platform skills. Today, it is more commonly known as “Running a Classroom” or “Basic Facilitation Skills”.
Many of today’s OJT QTs are also being requested to deliver “Group Training” sessions on content found within their SOPs. While the target audience may be the same set of peers, the scope, objectives, and tools used to deliver instructor-led training is vastly different from the OJT train the trainer course.
Structured OJT is On the Job Training delivered by a Qualified OJT SME using the approved OJT Methodology. OJT QT’s attend the Qualified Trainers Workshop which focuses on the OJT Steps Model, how to perform the equipment, and complex SOPs via hands-on and the challenges of Life as a Trainer. Should every seasoned employee become a QT based on their seniority and subject matter expertise? No, not necessarily. Because there are some SMEs that don’t want to share their knowledge and therefore, may not make an effective OJT Trainer. Establishing a set of nominating criteria provides an objective rationale for additional interpersonal qualities that help define a more well- rounded SME.
Qualification Events (the Final Performance Demonstration) are formally documented observations of learners performing the procedure/task at hand in front of a Qualified OJT SME using an approved SOJT Checklist or rubric. It is these events that set apart a Technical SME from a Qualified Trainer. The QT workshop includes a dedicated lesson on what to look for during Q-Events and what the QT signature means for the integrity of the Employee Qualification Program.
Can having too many QTs be a problem?
It can be when there is no one else to train; to deliver OJT steps. While many of you may be wishing for this situation, it can eventually happen if staffing levels are adequate, shifts are normalized and SOPs revisions are managed via R & U only with the LMS. How do you keep your QTs engaged and fresh if there are no opportunities for OJT sessions? I have some ideas for you to explore.
Re-examine the practice of online R & U only for SOP revisions. I bet some of those revisions were significant enough for a face to face discussion (aka Group Training) and there is probably at least one SOP revision in the past year that should have required a demonstration of task for optimum transfer of learning back on the job. *Just because all employees are now qualified, doesn’t mean the program sits in hiatus waiting for new hires to join the company.
When you have too many QTs who may be underutilized, it is also an appropriate time to administer the Trainer Mojo Assessment. Based on the QTs scores, it might be time to say thank you for a job well done for the low scoring QTs. You may be pleasantly surprised by who is ready to walk away from the training role? Or you may have a cadre of QTs who legitimately need more training and hence, the need for some new modules is now justified. Many of your excess SMEs were identified long before criteria was put into a place or the SOP was established. If the Trainer Mojo Assessment doesn’t bring any discussion, perhaps it’s time to “re-nominate” them using the criteria within the SOP and offer a refresher series on the QT Workshop content. Or arrange for developmental assignments that expand their subject matter expertise or advances their training repertoire into a classroom facilitators?
What is exciting for me is that many OJT-QTs are stepping up and volunteering to attend the SMEs as Classroom Facilitators workshop as part of expanding their QT’s toolkit. Many of them want to learn more about teaching peers and working with adults. A few have now become promoted to full-time trainer for L&D /QA departments. Which of your OJT QTS are ready to step up and move into the classroom? It’s time to find out and be part of the current trend. -VB
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