I’ve Fired My Qualified Trainer Workshop Vendor – Part 2

In part one of this impact story, we meet Pam who happened to take a peek at the live Qualified Trainer’s Workshop session only to discover some serious departures from the agreed upon content from her vendor. We also meet Robert, a direct report of Pam, who’s not really encouraged about re-designing their Qualified Trainer Workshop course ….

Will the real objective please stand up?

The PC noticed the change in Robert’s level of participation.  So she asked a few more clarifying questions.  “Robert, is the goal of the course to produce better OJT checklists or is it to ensure that all QTs deliver the OJT Methodology consistently?” she asked.  Before Robert could respond, Pam responded with “consistent OJT methodology”.  Robert unenthusiastically chimed in.  Sensing that was not going to be his answer, the PC requested that they refer to the rankings worksheet. 

“We ranked ‘Development of OJT Checklists’ quite high and are devoting a serious % of classroom time to achieve this performance objective,” the PC reported.  “Is this not as important as the OJT methodology?” she continued.  “Yes, of course”, they both responded.

“So let me ask the next question, are all QTs going to be required to generate OJT checklists as well?”  Robert lowered his voice and explained his no response.

“So while OJT checklists rank high as a consequence for the organization, is it appropriate to use this much classroom time for something most of them will not be required to complete AFTER the course is over?” inquired the PC. 

“But it’s good for them to understand how they are generated and if asked to write one, they’ll know how to do it”, responded Robert very rapidly and with heightened energy.

At this point Pam took the lead and asked the next question.   “Robert, why are we not requiring the QTs to write at least one OJT checklist?”

Oh gosh, their managers will not give them the time and when they rush these, I have to send them all back!” he moaned.   

“So, why don’t we have a conversation with the managers?” questioned Pam.

“Been there, done that and it never works! Why can’t we just tell them how to do it in the workshop?”  Robert whined.

Pam sighed and waited for Robert to continue.  He eventually acquiesced and agreed to contact a few of the managers to confirm QT responsibilities and the manager’s expectations for their QTs post-workshop.  Much to his surprise, the discussions went well. So Robert provided them with an update on the timeline for the course delivery and asked for their advanced endorsement for the workshop. 

At the next meeting, Robert shared how successful the managers meetings went and that he hosted several more than he originally anticipated.  With the managers support for the revised course, the outline of the new course was finalized.  The duration went from 3 full days to 1.5 days with the OJT checklists and the qualifying demonstrations taking on a heighted importance as the final outcomes of the workshop.

End ResultsCut Course Content by 50% with better post workshop results!

Pam was estatic.  “I can’t believe we could develop a better course in less time and have QTs more prepared to deliver OJT than I ever imagined, especially after I fired my first guy. And the course evaluations reflect very happy campers”, she added during their debriefing call.   Robert was truly amazed with the change in energy for the demonstrations and was delighted overall with how the new design came together.  “I’m already looking forward to the next round”, he exclaimed.

Momentum Continues to Grow

The workshop follow up three months later revealed even more positive indicators of change.  Robert reported back to the team, that the number of first time OJT checklist returns were significantly down; only a handful were now being returned for complete re-writes.  And for those needing minor tweaks, either he could fix them himself or have the SME fix them easily after a brief discussion.   Since all employees were up to date with training requirements, no new OJT sessions were scheduled but Pam and Robert were anticipating a ramp up again later in the year.

Lesson Learned / Insights

While Robert is the Training Supervisor, he had never been formally trained in instructional design.  For years, this gap was mitigated by either outside vendors or internally developed materials using Power Point and a few good books on design.   Robert held on to the notion that if he included content in the course, the participants would “learn and use it” when they returned to their jobs.  For him, as long as the course met the learning objectives, his training was successful.  This was their metric for years.

But the PC carefully guided him and Pam to stretch past learning objectives and to focus the design on helping the QTs to successfully use the tools and checklists after the workshop.  She helped them recall that “the end in mind” was to align with the overall business goals and the corporate quality objective. 

In order for Pam and Robert to be successful, they had to “fall out of love” with their own content.  This meant being disciplined to not add “they need to know this too” content and focus on the content that ranked high enough to warrant classroom face time.   It also required additional exercises and practice time be added to the course clock to ensure techniques were properly reinforced.  In the end, all were rewarded for their hard work.

Quotes

“[Learning objectives] help drive the results of projects, clarify expectations, secure commitment and make for a much more effective program or project.”  “If business results are desired, a program or project should have application, impact, and, in some cases ROI objectives.” [1]  Seeking agreement with stakeholders on the performance objectives prior to project launch is the key mechanism to ensure transfer and impact on business goals occurs.

OJT Checklist
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About HPIS Consulting, Inc.

HPIS Consulting, Inc. is a quality systems training and performance improvement consulting firm specializing in linking learning to strategically transfer back on the job that improves departmental performance.

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[1] Phillips, JP, & Phillips, PP.  (2008). Beyond learning objectives: Developing measurable objectives that impact the bottom line.  Alexandria: ASTD, p. 16.

(c) HPIS Consulting, Inc.

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.

May I See Your Implementation Plan for this Change Control?

In Part 1, we find Cara, a performance consultant has been hired to help a former client with implementing a robust training system. After waiting 3 months for the executive leadership group to get aligned around the priority for Miguel’s RTS project, Cara finally got to debrief her assessment findings. But a new development surfaced that was unexpected.

In part 2, we observe how Cara brings her inexperienced design team up to speed on how to be a team.

In part 3, we learned how Cara facilitated the design team of SMEs through various stages of working as a team to manage internal politics and a team member’s personal agenda.

In this Final Part of the Change Readiness Gap Impact Story, the design team launches and gets a surprise visit from the agency.

“But future state is being designed on the assumption that change control will be redesigned first.  We still have a lot of preparation work to do before we are even close to submitting these for change control.  And that is why change control is out of scope for this team.  We will not delay our deliverables because we decided mid-stream to go fix change control first.   There are plans for a change control project team to begin and some of you may be tapped to participate.”

After the change control rant from their distressed team mate, whenever anyone even mentioned the word change control, they joked and said: “we’re not allowed to discuss change control anymore, remember?”

Robust Training System SOPs: IMPLEMENTATION: The GO-LIVE STRATEGY

Through the efforts of Miguel negotiating behind the scenes, a new quality manager, Stuart, was hired right as the team began to work on the implementation strategy.  The timing was ideal because the team was ready to present their recommendations on how to go live and this was Stuart’s first priority.

Meet your new project leader

While Stuart got caught up to speed and completed his onboarding tasks, Cara transitioned out of the project manager role and back into external consultant mode.  The team had successfully designed their process flows and together decided the number of procedures that made sense for the organization as well as where to park the content.  They collaborated on the design of forms while leaving room for flexibility given the nature of work for each department.  The team had two proposals that competed with each other and Stuart, now fully up to speed weighed in with his decision.

Critical vs Important Focus

Critical vs. important: OJT documentation or curricula accuracy

The first proposal mapped a path forward based on OJT as the priority.  This was clearly identified in the gap assessment report and what appealed the most to the executives given their business objectives.  The second proposal was logical and made more sense to start from an overhaul of the curricula; ensuring that the training and qualifications were the right requirements for the right roles.  At the next meeting, Stuart took the lead and announced that he chose the curricula proposal and would defend this choice to Miguel and the executives as his first major task assignment.

Stuart was successful in his curricula proposal pitch with the executives.  He was able to make a compelling argument for both efficiency and effectiveness.  His next task was to finalize the implementation plan.  So he asked the team to meet once again to refine the “Go-Live Strategy”. 

“Please Pardon Our Appearance”

In order to move forward with the necessary tasks, the team needed the authorization to complete the work using the newly designed forms and process without approved Standard Operating Procedures (SOPs).   Releasing the new design before the sub-tasks were complete, would create an “out of compliance” situation at the onset of launch.  And yet, going forward without an approved procedure also put them in SOP violation status.

GMP Redesign SOP Dilemma

As part of the team’s drafted implementation plan, Stuart generated a change control package that documented the project, articulated the necessary steps, included the process flow diagrams as well as the forms.  Included in this packet, was the timeline for execution.  The effect of this documentation was to communicate that all these changes were not out of control but rather a controlled and planned change in the current procedures in order to make them standard once the subtasks were in place such as the updated position curricula.

Delivering the Qualified Trainers Workshop was a critical implementation task that needed to be timed with the SOP roll out.  The day before the Qualified Trainer’s workshop was to be delivered by Cara, Stuart called Cara and announced that a regulatory inspection was to begin on the same day.  While disappointed with the delay, Cara was optimistic that the training portion of the inspection would be favorable.   One month later, Stuart phoned her back.

“Can you deliver the workshop next week?” Stuart inquired.

“Yes, I’ll clear my calendar.  But how did training do?”

All in all, it went well.  We have some issues of course,” Stuart added.

“What about the training implementation plan? Was it accepted or challenged?” Cara asked.

“Well, we didn’t get cited for being ‘out of compliance’ so that was good.  But it was clearly stated that the plan MUST be executed ASAP! Hence, the reason for my call, today,” he answered.

Cara was pleased to hear that the Robust Training System (RTS) training project finally became a “Top Site Priority”.

END RESULT: Future State is now Current State

A few months later, Cara also delivered a GMP Basics course and qualified the site trainer to deliver it routinely as per the new training procedures. The RTS project was now officially closed and life as new normal began.   Their next follow up inspection was favorable.  A few minor issues and some verbal comments for training.  With this earned “regulatory approval”, the company was able to move forward with plans for launching their new product.

LESSONS LEARNED: Breaking down silos one meeting at a time

While the project team of SMEs learned how to collaborate in order to achieve project charter deliverables, the business units were very much still entrenched in their functional silos, defending current practices.  Deviating from approved procedures, even with a regulatory recommendation to prioritize the execution of the training plan, was not well received.  Stuart and his staff faced resistance from front-line supervision with right-sizing their curricula.  Through determination and persistent “working meetings”, the curricula sub-project finished.

Given the curricula “battle”, Stuart initially backed off from communicating the big project picture in the hopes that early accomplishments would inspire the front line to continue with the tasks and not overwhelm them with too much change at once.  

Instead, the OJT checklist sub-project was also slow, tedious, and a struggle.  Incumbent subject matter experts (SMEs)were reluctant to share their expertise or participate in the generation of the OJT Checklists, let alone be required to use them and not change the content without following the change control process.  Ironically, as new SMEs were vetted, the quality of the content improved and the checklists became a non-issue.

KEY TAKEAWAYS:

  1. The decision to delay project launch until Miguel felt confident that the executive leaders would sponsor the project and approve resources for the design team was paramount for keeping the momentum going forward after the initial launch meeting.
  2. Miguel recognized early on that the identified design team SMEs needed a specially developed curriculum to prepare them for the challenges that lay ahead.  The first four meetings as introductory lessons provided context as well as content and established the project lexicon while reinforcing team ground rules.
  3. Being prepared to defend the change control packet and explain the “Go-Live” Implementation Plan with FDA investigators not only gave credence to the project but it also elevated the importance of plan execution and made completion an urgent priority. -VB

Who is Vivian Bringslimark?

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(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.

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?

Explore the Flipped TTT Course Content Bundle Kit here.

(c) HPIS Consulting, Inc.