SOJT needs a clearly defined scope. If you don’t articulate the boundaries, you can end up hearing statements like “only a Qualified Trainer (QT) can deliver deviation related training sessions” and wonder how in the world did this get so out of hand? It comes back to how well you define the scope of their responsibilities. More specifically, are there different categories of QT’s or is it strictly a manufacturing program/ initiative? For example, do you have qualified trainers who deliver OJT (on the job training) and SMEs as Classroom Trainers who are qualified to deliver warning letter corrective actions for overhauled quality systems? The scope will clarify who is responsible for what kind of training situation.
SOJT includes a deliberate review of regulatory, departmental and positional /functional requirements. Yes, this is curricula. But having curricula is not enough to call it SOJT as discussed in the previous blog. It also includes a TRAINING SCHEDULE for the curricula requirements and an individualized learning plan for new hires; not just a matrix with their name highlighted in yellow marker.
SOJT is formal and it’s documented. For years, we have been documenting that we’ve read and understood our required SOPs, so that part is covered. QT’s need “Quality Control Unit” approved documents (aka SOPs) to use as the main document to train with and the proper documentation to record an OJT session. But documenting OJT sessions has been a bit of a challenge for the life sciences industry. Perhaps a future blog can reveal some of the issues.
Even more challenging is adding the OJT requirement to curricula. Unfortunately, it generates almost double the requirements. So for companies who focus solely on the number of requirements, this is daunting. What helps is differentiating between R & U stage and completion of the actual OJT events. Some organizations go one step further and also add the Qualification Event as a final requirement unless their LMS can be configured to mimic the OJT Methodology steps; thus reducing the number of times the same procedure is listed albeit for a different training step. HPISC Robust Training System also includes the OJT methodology that delineates the steps to conducting OJT and the qualification process. Stay tuned for a future blog about OJT Methodologies.
SOJT is also delivered by a department SME qualified to deliver OJT. The old adage for selecting department trainers based on seniority and documented R & U SOP paperwork no longer meets regulatory expectations. You need a QA approved process for qualifying SMEs that includes a train-the-trainer workshop that focuses on hands on training and NOT how to develop power point slides. In future blog(s), I will provide more discussion points regarding Qualified Trainer requirements.
So it’s as easy as that, right
Actually no. Last time, I blogged about QT’s indicating that their organizations are just at the brink of SOJT and that scheduling seems to be the barrier to moving into SOJT. In future posts, I will share with you some organizational issues to manage as well as shifting the managers’ mindset that all we need is
Until then, you might enjoy the HPISC Impact Story below: