Are you looking for management support for the Qualified Trainers and the time needed to deliver SOJT? If only we were required to have a procedure for that! It may not be an SOP or even a policy document, but industry guidance documents provide a lot of references to management involvement.
ICH Q10 – Pharmaceutical Quality System
While not mandatory, management needs to seriously take notice of ICHQ10 guidance document released in April 2009 (1). In particular to the following:
- MANAGEMENT RESPONSIBILITY 2.3 Quality Planning
“(d) Management should provide the appropriate resources and training to achieve the quality objectives”.
- “CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM
4.3 Outcomes of Management Review and Monitoring
The outcome of management review of the pharmaceutical quality system and monitoring of internal and external factors can include:
(b) Allocation or reallocation of resources and/ or
Under a Quality System: Managers Expectations for Training
Referencing the Sept. 2006 issue of Guidance Document for Quality Systems: IV. Management Responsibilities | B. Resources (2), we see alignment with the training CGMPs for continued training so “as to remain proficient in their operational functions and in their understanding of CGMP regulations.” “Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior).”
And my personal favorite, “When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.” The responsibility for training under a quality system is not assigned to just one person or one function. It is a shared responsibility across the entire organization.
Goals of the Train-the-Trainer Program (TTT) vs. OJT Program vs. Employee Qualification Program
In order to have qualified employees, they need to receive structured on the job training delivered by a qualified trainer who is content qualified and training process qualified via a Qualified Trainers’ workshop. Each of the three “programs” has defined outcomes that are dependent upon each other. Unfortunately, the term program has been a bit overused throughout the years and can have a variety of meanings for folks. For purposes of this blog, TTT program means OJT Qualified Trainers workshop, OJT Program means OJT
As you can see from the diagram, Qualified Trainers are at the core of
Readiness Factors for SOJT and an Employee Qualification Program
Let’s start with a written purpose statement for having qualified employees beyond it’s required. What is the company’s philosophy on achieving qualified status? Is there agreement among the leadership for the level of rigor required to demonstrate performance and achieve a pass rating? Where are the SOJT program goals written? Does a schedule exist for SOJT and qualification events other than an LMS printout with required due dates. That is not a schedule for SOJT. Do you have clearly defined objectives for the QT workshop captured in a document or perhaps a procedure? Is there a single owner for all three programs or is responsibility and accountability assigned accordingly?
Ronald Jacobs and Michael Jones, in their 1995 ground breaking book, Structuring on-the-Job Training, inform us that SOJT as a system functions within a larger context, namely the organization. SOJT is not a standalone program. Conflicts, competing priorities
Recognition for QTs and Qualified Status
Most QTs are not fully dedicated to delivering training for departments. There are pros and cons for this decision. For now, I will leave them out. Suffice it to say, they are tasked with both their “day” job and the responsibility for delivering training when needed. They are at times, doing two jobs. Whether or not they are compensated additionally for delivering SOJT, acknowledging their contribution to the department and the organization is part of management support. It takes more than “you are doing a good job, keep it up”.
Often supervisors and managers don’t know what else they are supposed to do to show their support, other than allow them to attend the QT workshop. The interested ones will “pop” in during lunch and chat with their direct reports. Others will show up at the end for the poster activity (equivalent to a written test) and some will come to learn about the parking lot issues that need follow up. The energy in the room when this happens is amazing.
“When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.”Guidance Document for Quality Systems, Sept 2006
To help ease the knowledge gap between a manager and their now Qualified Trainer, I started delivering the Leadership Briefing module prior to the QT workshop delivery. The purpose is to provide an overview of the content highlights, alignment with initiatives / CAPAs/ agency commitments and more importantly to secure agreement for the following:
- criteria for nominating a QT
- roles and responsibilities of QT
- scope of work QT’s can be assigned
- expectations for QT’s post launch
- what happens day one after workshop is done
- what is the status of the SOJT checklists
- scheduling and budget concerns.
If the organization says they support the qualification program, then what happens when employees achieve qualification status? Nothing? A non-event? Or is it announced in newsletters, plasma screens and other company announcements? Is it a big deal to be able to perform independently and free up a much-needed QT for another learner? I keep hearing over and over again about how there aren’t enough QT’s to deliver SOJT the right way. One would think qualification status on SOPs, especially big complex processes deserves SOME kind of recognition. Just how committed are the managers and supervisors? QTs and employees draw their own conclusions about the level of real management support for the programs.
If truth be told, after launching the QT workshop, many supervisors privately don’t support the program. They lose their top performers during the workshop and the hours it takes to train someone. Forget about giving QTs adequate time to complete the paperwork properly! And then leadership wonders why good documentation practice (GDP) issues continue to be a problem? The non-distracted performance observations that QT’s are expected to conduct for the qualification demonstration drive supervisors and line managers crazy the most – what, they can’t do anything else but observe? Hence, many QT’s are asked to
What Real Support Is Supposed To Look Like
My key take away message is that attending the TTT program/ QT workshop is not the end of the OJT program or the Employee Qualification Program but rather the launching point. Management support needs to go beyond just nominating QTs and allowing them to participate in the workshop. The real support is in the alignment of goals, clarifying expectations continuously, allocating resources for training and budgeting time to deliver OJT using an approved OJT methodology that includes qualification events. This commitment of time and sponsorship for qualified employees is a culture shift for many line managers and site leaders. But actions do speak louder than words. -VB
(1) Guidance for Industry Q10 Pharmaceutical Quality System | US Department of HHS | FDA | CDER | CBER April2009 ICH
(2) Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S.Department of HHS | FDA | CDER | CBER | CVM | ORA| September 2006 Pharmaceutical CGMPs
Jacobs RL, Jones MJ. Structured on-the-job training: Unleashing employee expertise in the workplace. San Francisco: Berrett-Koehler: 1995.
How can you tell if your site is ready for SOJT?
HPISC has created a 2 part checklist of questions and attributes to explore. The checklist is available gratis when you become a HPISC mailing list member. Just be sure to include that are you interested in receiving the SOJT Readiness Checklist.
Who is Vivian Bringslimark?
(c) HPIS Consulting, Inc.