I can still picture my employee “blue card” that listed my department training events when I think of training records. Long before the days of LMSes, we logged events like the monthly Safety and GMP Meetings and an occasional deviation awareness session. But logging every SOP? That was unheard of until I was asked about it during an interview. After I accepted the position, I soon found out why that was such a watershed moment for the industry and me.
So we’ve evolved with our training practices to keep up with regulators expectations regarding GMP training. But have we changed the training culture yet? Are we just pushing attendance forms for e-data entry or are we delivering meaningful training? Can we confidently say, “Yes, our employees are qualified prior to release to task”?
What can “Qualified Employee” mean for a company?
For starters, it satisfies the CFR ξ 211.25 (c ) regulation … shall have the adequate number of qualified employees to perform. Successful qualification events also validate the OJT Program and confirm that the OJT methodology is working. And that Qualified OJT Trainers are consistently delivering on the job SOP training sessions. Meeting FDA expectations for qualified employees is paramount. The bonus is a renewed level of confidence in the ability of its people to deliver on performance outcomes for an organization. Qualified Employee status is not only a compliance imperative but a business driver as well. See also – Moving beyond R & U SOP Training.
What then does the Qualification process look like?
The end goal is for an employee to perform independent of his/her QT coach. In order to be “released to task”, a final performance demonstration observed and documented by a qualified OJT trainer needs to take place. But don’t be fooled into taking the performance demo short cut! The last step in the training portion of the methodology is a performance demonstration to show the OJT-QT that the employee can mimic the steps of the QT. Can they perform at the same level of proficiency as their peer group? Probably not.
They may need more encouragement to build up confidence, correct paperwork documentation and time to become proficient with his/her speed while maintaining accuracy. That’s what practice sessions are for; time to master confidence with the steps and increase speed. When his/her performance is on par with “business as usual” performance levels, then the employee is ready to perform the final demonstration.
Performance Demos happen at least twice
During the final performance demonstration, the QT observes the performance. The feedback is evaluative and the result is formally documented on the OJT checklist. Granted, when someone is watching us, we tend to follow the rules. With enough repeated practice sessions, employees follow the procedure as “business as usual” regardless of who is watching them. It’s how they learn the ebb and flow from their peers. This is the optimum moment to determine if s/he is truly ready to perform without coaching or supervision from his QT. If a QT has to interrupt to correct a misstep or remind the employee that he is out of sequence, the event is terminated and documented as requires more review. More training practice is then scheduled.
Not all SOPs require a qualification event.
SOPs generally fall into two categories: FYI-type and Needs-OJT. The more complex an SOP is, the more likely errors will occur. Observing critical to quality (CTQ) steps is a key focus during the final performance demonstration. However, a 1-1 documentation path for every OJT related SOP may not be needed. Instead, batch SOPs a/o multiple SOPs of similar processes can be grouped into a “module” with documentation supporting similarity. In addition, there are minimal operator error related deviations tagged to the SOPs listed in the module packet. Where there are differences, the qualification event will document the observation of these CTQ elements.
Effective OJT enables a high quality workforce
Qualification events are not intended to be a rushed get ‘er done / one and done paperwork exercise. This distinction is critical to ensuring a successful qualification event and the increasing the confidence of repeating performance of task tomorrow, next week, etc. Whatever you call your last step in the OJT model (assess, qualify, evaluate, etc.) be sure to separate the training and coaching sessions with sufficient time in between to ensure knowledge has been retained and skill can be accurately reproduced.
Getting the paperwork right is important, don’t get me wrong. Inspections run much smoother when all the t’s are crossed and i’s have been dotted, no doubt. Yet, the effectiveness of an OJT program lies beyond the LMS printouts for QT Trainers and Qualified Employees. A qualified workforce means a team of well-trained employees who know how to execute their tasks accurately and with compliance in mind, own and document their work properly. And management considers them as key performance enablers for meeting organizational goals. When this happens, we have changed the training culture.