Many QA /HR Training Managers have the responsibility for providing a train-the-trainer course for their designated trainers. While some companies send their folks to public workshop offerings, many chose to keep the program in-house. And then an interesting phenomenon occurs. The course content grows with an exciting and overwhelming list of learning objectives.
The supervisors of these SMEs struggle with the loss of productivity for the 2 – 3 day duration and quickly develop a “one and done” mindset. Given the invitation to “train” newly identified SMEs as Trainers, the QA Trainer gets one opportunity to teach them how to be trainers. So s/he tends to add “a lot of really cool stuff” to the course in the genuine spirit of sharing, all justifiable in the eyes of the designer. However, there is no hope in breaking this adversarial cycle if the Training Manager doesn’t know how to cut his/her own content.
From 16 to 8 to two 4hr blocks of time
I used to deliver a two-day (16 hour) workshop for OJT Trainers. I included all my favorite topics. Yes, the workshop was long. Yes, I loved teaching these concepts. I honestly believed that knowing these “extra” learning theory concepts would make my OJT SMEs better trainers. Yes, I was in love with own my content. And then one day, all that changed.
Do they really need to know Maslow’s Hierarchy of Needs?
During a rapid design session I was leading, I got questioned on the need to know Maslow’s Hierarchy of Needs. As I began to deliver my auto-explanation, I stopped mid-sentence. I had an epiphany. My challenger was right. Before I continued with my response, I feverishly racked my brain thinking about the training Standard Operating Procedures (SOPs) we revised, the forms we created, and reminded myself of the overall goal of the S-OJT Program. I was searching for that one moment during an OJT session when Maslow was really needed. When would an OJT Qualified Trainer use this information back on the job, if ever I asked myself?
It belongs in the Intermediate Qualified Trainers Curriculum, I said out loud. In that moment, that one-question exercise was like a laser beam cutting out all nice-to-know content. I eventually removed up to 50% of the content from the workshop!
Oh, but what content do we keep?
Begin with the overall goal of the training program, not just the TTT course: a defendable and reproducible methodology for OJT. The process is captured in the redesigned SOPs and does not need to be repeated in the workshop.
Seek agreement with key stakeholders on what the OJT QTs are expected to do after the workshop is completed. If these responsibilities are not strategic or high priority, then the course will not add any business value. Participation remains simply a means to check the compliance box. Capture these expectations as performance outcomes.
Once there is an agreement with the stated performance outcomes, align the learning objectives to match these.
Performance outcomes are not the same thing as learning objectives
Some folks might say that I’m mincing words, but I beg to differ. The expectations for training delivery are that participants learn the content, aka learning objectives, and then use or apply them back on the job thus improving departmental /organizational performance. Are you providing the training and then keeping your fingers crossed that they can deliver on their performance outcomes? Are you including practice activities within the workshop? This ensures that learners have an opportunity to begin the transfer process. And the facilitator is able to complete formative assessments in real-time while providing immediate feedback where needed.
Yes, there is still ample room in the course for learning theory, but it is tailored for the need to know only topics. When challenged to add certain topics, the instructional designer now refers to the performance objectives and ranks the consequences of not including the content in the workshop against the objectives and business goals for the overall program.
What happens when the Instructor is over-ruled by their boss? Read Robert’s learning journey here.
What is the value of the written assessment?
With the growing demand for training effectiveness, the addition of a written test was supposed to illustrate the commitment to compliance expectations around effectiveness and evaluation. To meet this client’s need, I put on my former teacher hat and created a 10 question open book written assessment. This addition resulted in needing additional time to execute and hence, more content was cut to accommodate the classroom duration.
My second epiphany occurred during the same rapid design project, albeit a few weeks later. What is the purpose of the classroom written assessment when back on the job the OJT QTs are expected to deliver (perform) OJT; not just know it from memory?
The true measure of effectiveness for the workshop is whether they can deliver OJT according to the methodology, not whether they retained 100% of the course content! So I removed the knowledge test and created a qualification activity for the OJT QTs to demonstrate their retained knowledge in a simulated demonstration using their newly redesigned OJT checklist. If I’m asking for 8 hours of time to deliver a workshop, it must be value-added. -VB
The more trainer/instructor driven the course is, the less participation is required from the learner. For example, the instructor makes all the decisions about the course objectives and content, develops the course, delivers the course and conducts the assessment.
This blog has been merged with “Batteries Not Included: Not All Trainers are Instructional Designer or Classroom Facilitators”.
When I left the manufacturing shop floor and moved into training, full-time trainers presented in the classroom using a host of techniques, tools and relied on their platform skills to present content. Subject matter experts (or the most senior person) conducted technical training on the shop floor in front of a piece of equipment, at a laboratory station or a workbench.
This blog post has been merged with “Batteries Not Included: Not All Trainers are Instructional Designer or Classroom Facilitators.
While lecture has its merits, today’s learners want engaging content that is timely, relevant and meaningful. Yet, most SMEs tend to suffer from the “curse of too much knowledge” and find it difficult to separate the need-to- know from the nice-to-know content.
This blog has been merged with “Batteries Not Included: Not All Trainers are Instructional Designer or Classroom Facilitators”.
You might also want to get up to speed with the current trend for SMEs – check out the blog post – Are all your SMEs Qualified? Comments welcomed.
Hint: It’s more than 100% complete with your curricula requirements!
First there was “Just go follow Joe around” training …
And then came “and it shall be documented” …
Next the follow up question: “Are they trained in everything they need to know?”
So, line managers used the SOP Binder Index and “Read and Understand SOP” became a training method…
But alas, they complained that it was much too much training and errors were still occurring …
So, training requirements were created, and curricula were born.
Soon afterwards, LMS vendors showed up in our lobbies and promised us with a click and a report, we could have a training system!
But upper management called forth for METRICS! So, dashboards became a visible tool. Leader boards helped create friendly competition among colleagues while “walls of shame” made folks hang their heads and ask for leniency, exemptions and extensions …
Why Traditional OJT Takes So Long
While the introduction to this blog poked fun at how we’ve evolved over the last 30 + years, allow me to step back in time for a brief refresher about On the Job Training. Traditional OJT (TOJT) is not planned so for the new hire it comes across as informal almost incidental. Monikers like “follow Joe or Jane around” or “Sink or Swim” accurately described how TOJT occurred. My personal favorite is “trial by fire”. It can certainly feel like that when the “trainer” albeit a SME, is not qualified to train resulting in inaccurate steps and possible bad habits like unsafe short cuts. It causes anxiety for the new hire especially when the daily schedule dictates what will be “taught” by the technician assigned to that task. Sometimes, over-anxious new hires quit before on boarding is finished because of their chaotic OJT sessions and lack of confidence in their trainers.
Structured OJT Defined (SOJT)
SOJT is the process in which a qualified employee (trainer) passes job knowledge and skills to another employee in an organized, personalized and thoughtfully planned manner. It involves both learning and doing at the same time.
For first time managers, SOJT appears to take a lot of work and time. They would rather focus on the production schedule convincing themselves that new hires are being trained while shadowing their training buddy. Managers are evaluated on how productive they are, not on how many new hires are being trained effectively. They also tell themselves, that it takes 6 – 12 months to get fully up to speed, so why spend even more time planning and scheduling a new hire’s learning journey. In spite of that impression, the Quality of OJT directly impacts:
time it takes to “bring someone up to speed”
how Employees perceive the training they receive
how satisfied Employees feel about their jobs and working conditions
how quickly Employees can be re-trained on new SOP revisions.
But Managers Find the Time to Train Twice!
Yet that is exactly what happens when the root cause of a deviation or a mistake is deemed as Human/Operator Error. The corrective action is often “repeat training”. This training involves unlearning the first sessions and then relearning the proper way, causing more strain on the new hire’s space for learning capacity (cognitive overload). This is why TOJT takes so long. If, SOJT had been executed instead, the error more than likely would not have happened. It’s an argument that I have been defending for over 30 years with Senior Leaders. Why punish the New Hire for management’s decision to make production more important than effective training?
DOES HAVING CURRICULA MAKE OJT STRUCTURED?
Just having curricula doesn’t necessarily make OJT structured. SOJT includes a deliberate review of regulatory, departmental and positional /functional requirements. It also includes a TRAINING SCHEDULE for the curricula requirements and an individualized learning plan for new hires; not just a matrix with their name highlighted in yellow marker.
Isn’t The Training Matrix Enough?
Just ask an OJT Qualified Trainer that question and watch the reaction you get. Maybe a shrug and a half smile if you’re lucky. The matrix is only a listing of the requirements usually generated from the LMS or an excel spreadsheet for those who haven’t migrated to an LMS yet. In more sophisticated systems, it will include due dates. But most printouts don’t include the Qualified Trainers assigned to deliver the training or any additional information about the learner.
From this list, QTs are expected to manage the completion of the requirements, deliver effective training sessions, provide feedback in a safe and nurturing learning environment and qualify learners with qualification events / performance assessments. All that from a training matrix? Wow.
During the HPISC Qualified Trainers workshop, I present the difference between TOJT (traditional) and SOJT (structured). When I ask the QT’s where they feel their organization is, most of them will say still in the TOJT box but closer to the middle of the range. Why I ask? Invariably, they’ll tell me OJT is not scheduled. “Just because I have the list of curricula requirements doesn’t mean the training gets scheduled or that qualification events get conducted”. But rather, it happens when someone makes it a priority, an inspection is coming or a CAPA includes it as part of corrective actions.
There Is Still A Huge Misunderstanding Regarding R&U For Sops
For years, we have been documenting that we’ve read and understood our required SOPs. I can still recall my Employee Blue Card that listed every Monthly GMP and SOP meeting/discussion I attended. When I was asked about logging every SOP that I read during an interview, I responded that it was not a practice where I worked at the time. After I accepted the new position, I realized why that was such a watershed moment for me.
Oh, But Now We Have Curricula!
As an industry, we became obsessed with signing for our SOPs. Then LMSes were developed to help us not only record our R & U SOP dates but to give us a mechanism for tracking what SOPs were assigned to us, reporting 100% Trained metrics and overdue requirements. And for a short while, those records were sufficient.
But over the years, FDA Investigators began seeing a disconnect between the R & U training records and the actual performance of employees who signed that they understood the SOP. Upon the FDA site tour, they observed departures from the written procedures. They uncovered deviations involving Operator /Human Error, repeat deviations and even CAPAs for training fixes. So, is it falsification of records? Is it poorly written SOPs? Is the training ineffective?
FDA stepped up their expectations and began asking deeper questions. How do you know if your training is effective? This question applies to both GxP Training sessions as well as SOPs.
Who is qualified to train employees and how do they get qualified?
Are your employees qualified to perform their job functions and how do you know?
What does that documentation look like?
SOPs Are Now Online, But It’s Still Read and Understood for SOP!
Well, I’m told we are now more compliant with ensuring that only the most current version of the SOP is used for training. LMSes and eDoc platforms have given us efficient mechanisms to document that employees have completed their training curricula. But do they understand their procedures enough to perform them correctly back on the job?
It’s still Read and Understand SOPs! Whether we access our SOPs through an eDoc system or the LMS portal, we are still only reading them. To call this eLearning is a bit of a stretch especially when compared to the design of today’s eLearning courses. Nonetheless, some new hires are still being provided with a long list of required SOPs and trained on where to find them in the LMS. “Oh, we’ve made it easier for them to manage their SOP list. They’re online now!”
I’m excited that as an industry, we are evolving with our training practices to keep up with regulators’ expectations regarding GMP and SOP Training. But have we changed the training culture yet? Are we just replacing attendance forms for e-signatures or are we delivering effective training? Can we confidently say, “Yes, our employees are qualified prior to release to task”?
FD-483 Observation: “Your site has numerous instances of R & U for SOPs”
So, when there is a large number of documented R & U events for SOPs, very little OJT documentation and they are still finding repeat errors, HE/OE deviations and a host of CAPAs, FDA Investigators are going to examine what is your training process and how effective is it.
SO, WHAT ELSE MAKES OJT STRUCTURED?
SOJT is formal and it’s documented. Without the use of approved training materials, department SMEs often use different methods each time they deliver training and the training content can vary from “trainer to trainer”. This causes confusion for the new hire during his/her onboarding phase which can then lead to Operator Error or non- compliant performance later.
During an on-site response to an urgent performance problem, the Head of Operations expressed deep concerns about inconsistent OJT being delivered by his trainers. During an FDA inspection, he was shown numerous examples from the Investigator, that his SMEs were teaching techniques for a critical process procedure that
Naturally, this led to a FD-483 observation, a high visibility corrective action project with global impact. As part of the CAPA (Corrective Action Preventive Action) investigation, trainers were interviewed. Their responses revealed the use of varied content; despite having an OJT checklist, the actual procedure, and knowledge of the site training SOPs.
QT’s need to use “Quality Control Unit” approved written procedures (aka SOPs) as the main document to train with and the proper documentation to record an OJT session. But documenting OJT sessions has been a bit of a challenge for Trainers, LMS Administrators, and QA Doc Control Staff.
What Is Considered An OJT Session?
The hardest question to resolve is “Are we required to capture every OJT session or just one?” My favorite lament is – “Do you know what that will do to our database not to mention the amount of paperwork that would create!” A workaround to all these questions and concerns is to capture at least one session along the progression of each OJT step as per your OJT Steps Model, thus documenting adherence to the procedure. If we keep it simple and document that our learners have experienced each step, then we are complying with our OJT process and minimally documenting their OJT progression.
Even more challenging is adding the required SOJT steps to curricula. Unfortunately, it generates almost double the requirements. So for companies who focus solely on the number of requirements, this is daunting. What helps is differentiating between R & U step and completion of the actual OJT events. Some organizations go one step further and also add the Qualification Event as a final requirement.
SOJT IS ALSO DELIVERED BY A DEPARTMENT SME QUALIFIED TO DELIVER OJT. The old adage for selecting department trainers based documented R & U SOP paperwork no longer meets regulatory expectations. The expectation today is to have a QA approved process for qualifying SMEs. I’m not talking about a mere mention in your training policy. But a standalone process that depicts steps from start to finish. Yes, it is necessary if you want to answer “Yes, I have a procedure for Qualifying SMEs as Department Trainers”. Being able to present a SOP that addresses how your SMEs are qualified to sign the training records is priceless in the middle of an ongoing regulatory inspection.
What Belongs In The Qualified Trainer SOP?
Ideally, the procedure needs to include these 4 parts:
II. QT Workshop/TTT Equivalent
IV. Performance Demonstration
In some organizations there is no difference between SMEs and Trainers. And this is precisely why FDA has asked for clarification. Can anyone be a Qualified Trainer (QT)? Establishing criteria is the best way to reduce favoritism and the tendency to pick the most senior person. SMEs need to become QTs through a formal process. The selection criteria should be part of the qualifying documentation along with any supporting statements for eligibility selection (for example, nominated by supervisor or responded to the call for volunteers).
In this definition, everyone who is a QT is an SME in some specified area. All nominees need to be content qualified on the subject matter they will be teaching. This means being able to produce proper documentation confirming nominee’s eligibility. This is not always the case. I have seen this assumption backfire horribly and cause major ripple effects on project milestones. Find out now before an inspection, please.
II. QT Workshop/ TTT Equivalent
Sometimes known as Train-the-Trainer. The course needs to include learning theory, training and coaching adult learning peers and agreeing to use the proper documentation. Another key component of the OJT TTT workshop is exploring the challenges of “Life as a Qualifed Trainer”. Learning how to facilitate a live classroom event that can come later. In fact, many QT’s are stepping up and want to expand their trainer’s toolkit for “Basic Facilitation Skills / Running a Live Classroom Event”.
III. QT Workshop Evaluation:
Simply attending this course isn’t enough. But whether a written test is the best measure to use is open for debate. Let’s start with the question: Why do we need an evaluation in the first place? If you’re tempted to say because FDA wants it, I suggest re-reading CFR x211.25 again. If you are anticipating the training effectiveness question, then you are in sync with industry practice. But it is less about “the test” and more about how you determine the effectiveness of the training event. Benchmarking from other certification courses, a written test usually follows the course. So, having a written evaluation is not unreasonable. The debate is about what format you use.
The Written Test
Most folks are familiar with taking a written test. When informed upfront, QT’s expect the test to come at the end of the workshop. But what is the outcome of test? What does it really measure? Is it a measure of their retention or comprehension? Since SOPs are not supposed to be memorized, how can we dictate memorization of the course content? Open book is allowed in some organizations. What then does the paper-n-pencil test accomplish? Having the knowledge doesn’t mean that they will use the concepts “in the moment of choice”.
Consider the Action Planner
If learning transfer is what we really want and expect to achieve, then wouldn’t some kind of post workshop action planner be a more appropriate measure of effectiveness? “Oh, but we can’t control what happens after the workshop”, you say? “Using an action planner requires buy-in from their managers. And commitment to follow through to host the 1-1 follow up meetings with their QTs” is what you might be thinking right now.
Let us not lose focus on the ultimate goal of the workshop. It’s a 3-way partnership between QTs, L&D/QA Training, and Managers. The real work happens AFTER the workshop is over. What better way to use classroom time to discuss strategies for barriers and challenges and document their commitment for applying the concepts and procedures than a post workshop action planner? Can the written test do all this?
IV. Performance Demonstrations
This is after all a qualification of SMEs as Trainers program and therefore, a performance demonstration is required. What type depends on where your site is with respect to employee qualifications. The two types are demonstrating a live OJT session in the classroom and conducting an employee qualification at the workstation.
RECAP: WHAT IT TAKES TO MAKE OJT STRUCTURED
Rigorous Curricula that includes SOJT and Qualification Events not just SOPs
Methodology for OJT Steps that includes documentation
Qualified Trainers who deliver SOJT curricula requirements
Individualized Learning Plans and schedules for New Hire’s Learning Journey
Ronald Jacobs and Michael Jones, in their 1995 groundbreaking 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.
Do these sound familiar?
Business priorities and organizational change initiatives
Upper managements real perception of the value of OJT
Union shop and potential violation to use SMEs as Qualified Trainers
Alignment of goals for training and goals for other quality systems
Willingness of line leaders and staff functions to manage and maintain SOJT after launch
The Training Quality System, in my opinion, is THE most cross functional system. It has to harmonize with other quality systems AND organizational systems in order to deliver performance improvement.
So, management support has to be more than lip service. The real support is in the alignment of goals, clarifying expectations, allocating resources and budgeting time to deliver OJT using an approved OJT methodology. This is a culture shift for many organizations but well worth the effort if management really believes in SOJT. The “proof is in the pudding”. Are your leaders “walking their talk”? – VB
Is your response, “Yes!” or is it “Yea, I think so. How can I be sure?”
Are you trying to explain what you dofor training or describe how your site handles the Quality Training System?
Who is your audience?
Who are the procedures being written for?
There shall be written procedures even for training!
Step back and take a big view of training from start to finish. There are three distinct segments: (1) preparation, (2) delivery, and (3) measuring effectiveness. To some leaders, the idea of creating more than one training procedure for these three segments is baffling. Training isn’t that hard. Why are you making this so complicated, they ask? The simpler the process is, the easier it is to follow and administer, is what they are really thinking.
Yet, training root cause analyses involving operator or human error often yields some contributing factors around how the individual was trained. On the Job Training is not that simple after all and requires more than a check on someone’s to-do list. Find out why in the e-Book, Training Root Cause Analysis. In spite of this, the level of detail in Training SOPs is always a concern for both SOP Author and Approver.
But SMEs like KISS for Training
From an end-user perspective, I need enough detail so I can accomplish what I need to do without over-complicating my task, stay within compliance, and be effective as a qualified trainer. Since most Qualified Trainers are not full-time training professionals, the training procedures become their how-to tools not just a bunch of QA or HR rules about training. Without defining what your program includes and how to execute it, Qualified Trainers and other SMEs will conduct their training delivery assignments in a manner that is as simple as possible and may not be 100% compliant. Administrative procedures are not for them, they argue.
It takes 6 elements to make a training system robust
The big view of training may have 3 Big Blocks (preparation, delivery, and measuring effectiveness), but it takes 6 elements to execute it well. They are:
GxP and Training Curricula
Planned OJT for Procedures
Use of Qualified Trainers
Employee Qualification and Training Effectiveness Measures
On-Going GxP Refresher Series
Training Documentation Process
For each of these elements, there needs to be a set of “how-to-execute” instructions. However, it is not enough to describe what these elements are. That leaves a lot of room for interpretation and inconsistent documentation or no documentation at all. For example:
Does your organization complain about over-allocated curricula?
Do they understand the documentation requirements for your LMS?
Does your training document explain how to conduct OJT? You’d be surprised just how many different techniques SMEs have for conducting OJT on their watch.
Can anyone who has a signed training record be a department trainer? If yes, you need to upgrade your criteria and create a process around nominating and qualifying SMEs for OJT. Training is on the top 10 list for inspections.
So how is this not complicating Training?
The debate for the 1 All-Encompassing SOP (standard operating procedure) vs. multiple tailored work instructions will always bring comments after the latest version goes into effect. This includes non-QT end-user feedback criticizing how complicated and confusing the procedures are! When pressed further for specifics, most admit that they just want to train themselves and not deal with the documentation requirements. So, addressing one set of concerns can actually create more complaints around the very changes. See the table below for pros and cons.
Remind me again who these procedures are for?
The real question is to what level of detail is appropriate. And the answer lies in the culture of the department and the company’s history with the FDA. I once worked in an organization where the procedures were stripped to bare essentials, even the definitions were removed! A recent warning letter left battle scars for the General Manager.
But seriously, how much is enough? Another way to answer this question is by looking at your document control hierarchy of documents. If your site differentiates between SOPs and Work Instructions, the need for detail can be relocated into a suitable work instruction that is designed to provide detailed how-to steps. AKA Level 3 type documents. Refer to the diagram below. The SOP (Level 2) can then provide a broader high-level overview addressing “the what” without getting encumbered into the “how-to execute” steps. Some document pyramids include a Level 4 in which much detail can be used for training purposes.
Back to the opening question
While addressing ease of navigation and use concerns is laudable, it is not always realistic to satisfy all users. You need to explain what your Training “Program” contains, a high level policy that answers “the what”. But you also need to describe how your training is conducted. Ask yourself the following two questions:
Does the “Training SOP” contain many pages detailing steps for each of the 6 elements? This is an indicator that you need to consider some Level 3 Work Instructions.
Do you have too many standalone task-focused SOPs (or Level 3 Work Instructions) that could be grouped into a few larger processes? Recall the 3 Big Blocks of Training.
From experience working with SME teams, three “how-to” procedures are usually sufficient: preparation process, delivery and documentation process, and measuring training effectiveness process. So the next time you find yourself in the level of detail discussion, consider which of the levels (1,2,3,4) is the best place to park your “detailed” content. – VB
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: 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”.
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.
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.
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.
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.
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
To the newly minted and seasoned performance consultant, the answer is NO. But for your client, internal customer, or the VP of Quality, or whoever is your requestor, it still may look like “a training solution”, so don’t argue with them. You do, however, want to be able to explain why it is more than a classroom instructor-led session or a quick and dirty PPT slide with audio recording.