How committed to SOJT is your organization?

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 personnel training.”

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 methodology/procedure and Qualified Employee program means having a robust quality training system beyond the newest Learning Management System (LMS).

As you can see from the diagram, Qualified Trainers are at the core of all three “programs”.  The OJT QT Workshop is designed to prepare the QT’s for the realities of life as a Qualified Trainer. It includes the pre-work of familiarizing themselves with the Quality Training System procedures and then in class: exploring basic learning theory and committing to what the QT signature means. The OJT Program is about delivering structuring on the job training consistently following the approved methodology. An Employee Qualification Program is the validation of training effectiveness of the OJT methodology and the clarity of the underlying procedures.

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 and mixed messages can influence the success of your SOJT program.  What else is going on in the organization that will compete for the same set of QTs? Remember they are also your most experienced and technical subject matter experts.  How is the overall Employee Qualification program aligned with the other quality systems? 

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.  

Supporting QTs is more than participation in QT Workshop

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 multi-task just to get the work done: not enough resources they are told.  For supervisors, productivity and the workload will always trump SOJT and qualification events, until their bonuses include completion of training and qualification events.

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.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Have you flipped your OJT Train the Trainer Classroom yet?

When I got introduced to the flipped classroom back in 2012, I fell in love with the concept immediately. But I was stymied on how to sell the mind shift to management. And then it occurred to me that I was already delivering the flipped classroom for my Qualified OJT Trainers Workshop and have been for quite some time.

In the academic model, students study the concept at home using video instructions and other learning technologies. Then they come to class to do the homework in a collaborative and mentor style environment. The corporate approach can be tweaked if you rethink when and where learners (aka employees) access the content. If the content exists elsewhere, why waste valuable classroom time lecturing on it when you can create a facilitative and experiential learning lab?

But what content are we talking about?

As part of a Robust Training System, procedures are established that describe how to execute the many elements of a training system including how to quality a department SME as trainer and the OJT Methodology. These standard operating procedures (SOPs) become the basis of the Qualified Trainer (QT) curriculum, for LMS tracking purposes. Upon release (or by the effective date), flagged employees read the required Training SOPs and become aware of implementation timelines. The “Read and Understood” portion is completed in advance and outside of the classroom. Hence, the content of the QT workshop is not a slide deck repeat of the curriculum content.

OJT TTT Workshop is NOT SOP Training

Recently I was challenged about why I was working with the company SMEs at all. If I didn’t work at this company, wasn’t engaged with day to day processing activities or involved in writing their SOPs, how could I possibly teach the SMEs anything about teaching their processes, my contender demanded. Furthermore, he marveled at my audacity to assist with rebuilding their quality training system.

ttt-infographic

Seemingly, there is still some confusion about the purpose of an OJT TTT workshop. This stakeholder’s frame of reference was entirely research oriented and analytical in execution. In his experience, train the trainer meant true expert trains others on the subject matter (technical SOPs) via a knowledge transfer session. See graphic below. It took multiple conversations and an invitation to join the training design team for him to embrace the notion that SMEs should and could be taught learning theory. Also see The Real Meaning of TTT. 

The “flip” is in the instructional design

If I am asking for 8 hours of participation from SMEs in a classroom setting, then it MUST BE value added. The focus of the workshop design is “Life as a Qualified Trainer” and the realities of delivering OJT on the shop floor and/or in the analytical QC lab. Attendees will not find this content in their curriculum or in the e-DOC system for SOPs. And this is precisely why the classroom is the most effective environment to come together in a structured, guided and facilitated learning experience.

It means that the instructor-trainer is no longer the sage on the stage, but becomes a guide on the side, where the QTs are doing most of the talking. This switch in learning design reinforces collaboration among the QTs and better transfers the knowledge building so that scrap learning is significantly reduced. Activities are designed to be active and participatory thus promoting “learning by doing” practice and honing their learning for each step of the OJT Methodology while recognizing robust training system key concepts in action. The final activity requires engagement and participation of each nominated QT in order to complete the course.

A community of internal QT graduates

During the experiential activities, QT’s will share anecdotes or a “war story” from their past. Listening to those stories creates a connection and often the insights gained forms a bond with each other. A wonderful consequence of the TTT flipped classroom design is the community of internal QT graduates that grows after the workshop is over. QTs leave the classroom able to articulate and share what they learned and experienced together. This does not happen when the course is delivered as eLearning/CBT or self advanced power point slides.

Today’s classroom is still viable

The modern learner needs a modern learning experience. And while modern tech tools are fast on the rise, let’s not dismiss what a flipped classroom can produce – confident, competent and valued Qualified Trainers. Are you ready to flip your learning design to meet today’s modern learners? – VB