Many QA/ L&D Training Managers are tasked with improving their training system and focus their efforts on the process, procedures and executable forms. An integral component of a robust quality training system is the Qualified Trainers (QT). Having a cadre of existing department Subject Matter Experts (SMEs) as Trainers can be very helpful when implementing the roll out of the new design to meet regulatory commitments and expected timelines. But, sometimes it can also lead to sustainability issues after the launch is over and the next big project becomes the new site priority.
During my on-site response to an urgent performance problem, the Head of Operations expressed deep concerns about inconsistent OJT being delivered by his trainers. A series of significant non-conformances occurred in his area. As part of the CAPA (Corrective Action Preventive Action) investigation, trainers were interviewed to uncover how they trained the identified employee(s) and what was said specifically for each step of the procedure. Their responses revealed a lack of consistent process and the use of varied content; despite having an OJT checklist, the procedure, and approved training SOPs (Standard Operating Procedures).
Once a Trainer; forever a Trainer
I was then invited into a conversation with the Training Operations Manager (My Performer), regarding her desire to upgrade the existing department SMEs as Trainers. Responsible for the effectiveness check of the CAPA corrective action and the overall quality of Operations OJT sessions, she complained that many of the trainers should no longer be considered Dept. Trainers. While she had position title influence, she was frustrated by the lack of support for her “improvement suggestion”. I became her catalyst to help her push through the fixed barrier regarding SMEs.
The site followed a cultural assumption regarding department SMEs: once a trainer; always a Trainer; regardless of feedback and informal impressions of their ability. Without any tangible criteria and lack of assessment tools, my Performer had no authority to remove under performing Dept. Trainers. Granted these SMEs were long ago chosen when the widely accepted practice of being proficient as a technician after a year earned them the designation of subject matter expert and automatically, a Dept. Trainer. Today, the Life Sciences Industry, with FDA investigators observations, has evolved their understanding to endure that it takes more than seniority and SOP training to become an OJT QT. Unfortunately, the environment where my Performer worked, the mindset about acquired expertise still held.
Significant CAPAs can be drivers for change
Undaunted, my Performer seized the CAPA as an opportunity for change. Leveraging suggested criteria and the use a form to document justification for each Dept. Trainer, she now had a process (SOP with form) that she could “educate” her colleagues on what it takes to become a Qualified Trainer. The focus of her message dramatically changed. She became strategic in her communications, using the effectiveness check portion of the CAPA as her “Why / WIIFM for Operations Managers”. In order to close out the CAPA, Managers had to complete their portion of the form.
The long-term success of my Performer depended on her owning her solution. She never lost of her original desire; she was patient and waited for her colleagues to accept today’s best practices for OJT QTs. In the meantime, we brainstormed on a variety of feedback options that could be used to evaluate the current status of each SME at the same time the Managers completed the new form. My Performer chose a rating system and arranged for a 1-1 sessions with Operations Managers to discuss what rating they would use for each criteria if they got challenged during a CAPA investigation or a regulatory inspection.
While the results were not formally documented, my Performer was effective with the assessment rating exercise. The Managers reconsidered who they wanted to nominate based on the new formal criteria and the informal ratings discussions. They did not automatically submit the form for all existing Dept. Trainers. A constructive dialogue then ensued regarding skills remediation support for those SMEs deemed as potentials. At last, my Performer achieved her desired outcome. “As catalysts, we build a bridge, light the path, and give [ ] our hand to help [ ] demolish or jump over obstacles”, (Haneberg, 2010, p.96). I was privileged to be part of a dramatic shift in their training culture.
An alternate alignment exercise
For many, adding ratings suggests a formal performance assessment and this can raise HR issues if not fully supported by the organization. In addition, many Operations Managers do not have the luxury of “weeding out undesirables”. They simply do not have enough SMEs to complete the training curricula generated requirements. Yet, there needs to be mutual consent between manager and identified SME in order to effectively deliver the OJT Methodology and to ensure a successful learner experience.
For those situations where automatically re-nominating existing SMEs is raising a red flag, I created the Trainer Mojo Assessment. Nominated SMEs and existing SMEs as Trainers rate themselves on 10 attributes that align with the characteristics of an effective OJT Trainer. Low scoring SMEs/QTs are encouraged to have a discussion with their management regarding continuation in the program and possible action steps. For SMEs/QT’s that score in the On-Target range, this is both validation of the nomination and confirmation that manager and QT are in sync. For high scoring QTs, this is also confirmation and an early indicator for potential QT Rock Stars!
Haneberg, L. Coaching up and down the generations. Alexandria, Virgina:ASTD, 2010.
You might be interested in the Impact Story – From Dept. SME to QT.