Are all your SMEs Qualified Trainers?

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 (Performance Demos).

Self can be achieved by the individual reading the procedure and the signing the training record. This is also known as Read & Understand (R & U) for SOPs.

Deviations/ Corrective Actions stemming from a Corrective Action Preventive Action incident. Minimally a SME or the SOP Author is needed to ensure credibility of the content.

Classroom (Instructor Led Training) is preferred for knowledge-based content affecting a wide range of employees. The skill set needed is facilitation / managing the classroom and delivering content as designed by the instructor. A new trend is emerging for SMEs to deliver this training. And, they need to be qualified to deliver classroom sessions especially if the event is related to a significant CAPA or regulatory inspection observation. This is NOT the same course as the OJT-QT Workshop.

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.

Qualification Events (Performance Demonstrations) are formally documented observations of learners performing the procedure/task at hand in front of a Qualified OJT SME.

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.

When this situation occurs, it’s 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.

Another activity to pursue is re-examining the practice of online R & U only for SOP revisions. I bet some of those revisions were worthy of a face to face discussion and there is probably at least one in the past year that 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.

What else can you offer bored and under utilized QTs? What about a 30 minute refresher series or developmental assignments that expand their subject matter expertise or advances their training repertoire into a classroom facilitators? Just an idea or is it a viable solution? – VB

Leave a Reply

Your email address will not be published. Required fields are marked *