I got a phone call from my Lead SME’s boss one morning. “How many more sessions do you need”, I asked him. I had already delivered 4 back-to-back workshops with class sizes of 25-30 SMEs; which was beyond optimal. So I asked him why. I needed to find out what was driving the surge in identified Qualified Trainers (QTs). I learned that a retrospective qualification needed to take place in order to close out an inspection observation. The total number of SMEs needing “proper paperwork” was well over 700. Since the redesigned training system was now in effect, these undocumented SMEs as Trainers would have to follow the new procedure. Or would they? Our discussion shifted to what type of training these SMEs will be delivering.
I then shared a related story with him. Several years prior, I got entangled with a “CAPA crisis” that involved QTs. No sooner did we launched the QT program and put the new procedure into effect, the CAPA quality system temporarily shut down shipping over a weekend. Upon return to the site, I was summoned to an emergency meeting from the security gate. Amazingly, a new practice/rule that only a Qualified Trainer can conduct training evolved from “only OJT QT’s can deliver OJT and perform Qualification Events” as per the SOP! This was clearly a case of misunderstood scope.
Does every SME need to be qualified as a Trainer?
In the Life Sciences arena, there are 5 recurring situations that require training: Self, Corrective Actions, Classroom (ILT), Structured OJT, and Qualification Events (Final Performance Demos).
Self can be achieved by the individual reading the procedure and signing the training record. This is also known as Read & Understand (R & U) for SOPs. I personally don’t think of it as training, it is reading. Yet, in some situations, reading is all that is required to gather the SOP information. If on the other hand, you need to execute the steps of the SOP and complete required forms, then additional training with the SOP Author or a QT is the appropriate next level of training.
Deviations/ Corrective Actions stemming from a Corrective Action Preventive Action incident. Minimally an SME or the SOP Author is needed to ensure the credibility of the content. These types of training sessions have become known as Corrective Actions “Awareness” Training. And more and more SMEs are now being required to deliver this training in a classroom setting. They need to be qualified to deliver classroom sessions especially if the event is related to a significant CAPA or regulatory inspection observation.
Classroom (Instructor-Led Training) is preferred for knowledge-based content affecting a wide range of employees. The skillset needed is facilitation / managing the classroom and delivering content as designed by the instructional designer. Think of GMP Refresher sessions in the Training Room.
Years ago, it was a lot clearer to distinguish between classroom trainers and SMEs as OJT Trainers. OJT was delivered 1-1 by “following Joe/Jane” around. Classroom Trainers delivered their content in a classroom of many learners using slides, flipcharts, and handouts. They were usually full-time dedicated training staff. Instructor-led training requires training in learning theory design and practice in what used to be referred to as platform skills. Today, it is more commonly known as “Running a Classroom” or “Basic Facilitation Skills”.
Many of today’s OJT QTs are also being requested to deliver “Group Training” sessions on content found within their SOPs. While the target audience may be the same set of peers, the scope, objectives, and tools used to deliver instructor-led training is vastly different from the OJT train the trainer course.
Structured OJT is On the Job Training delivered by a Qualified OJT SME using the approved OJT Methodology. OJT QT’s attend the Qualified Trainers Workshop which focuses on the OJT Steps Model, how to perform the equipment, and complex SOPs via hands-on and the challenges of Life as a Trainer. Should every seasoned employee become a QT based on their seniority and subject matter expertise? No, not necessarily. Because there are some SMEs that don’t want to share their knowledge and therefore, may not make an effective OJT Trainer. Establishing a set of nominating criteria provides an objective rationale for additional interpersonal qualities that help define a more well- rounded SME.
Qualification Events (the Final Performance Demonstration) are formally documented observations of learners performing the procedure/task at hand in front of a Qualified OJT SME using an approved SOJT Checklist or rubric. It is these events that set apart a Technical SME from a Qualified Trainer. The QT workshop includes a dedicated lesson on what to look for during Q-Events and what the QT signature means for the integrity of the Employee Qualification Program.
Can having too many QTs be a problem?
It can be when there is no one else to train; to deliver OJT steps. While many of you may be wishing for this situation, it can eventually happen if staffing levels are adequate, shifts are normalized and SOPs revisions are managed via R & U only with the LMS. How do you keep your QTs engaged and fresh if there are no opportunities for OJT sessions? I have some ideas for you to explore.
Re-examine the practice of online R & U only for SOP revisions. I bet some of those revisions were significant enough for a face to face discussion (aka Group Training) and there is probably at least one SOP revision in the past year that should have required a demonstration of task for optimum transfer of learning back on the job. *Just because all employees are now qualified, doesn’t mean the program sits in hiatus waiting for new hires to join the company.
When you have too many QTs who may be underutilized, it is also an appropriate time to administer the Trainer Mojo Assessment. Based on the QTs scores, it might be time to say thank you for a job well done for the low scoring QTs. You may be pleasantly surprised by who is ready to walk away from the training role? Or you may have a cadre of QTs who legitimately need more training and hence, the need for some new modules is now justified. Many of your excess SMEs were identified long before criteria was put into a place or the SOP was established. If the Trainer Mojo Assessment doesn’t bring any discussion, perhaps it’s time to “re-nominate” them using the criteria within the SOP and offer a refresher series on the QT Workshop content. Or arrange for developmental assignments that expand their subject matter expertise or advances their training repertoire into a classroom facilitators?
What is exciting for me is that many OJT-QTs are stepping up and volunteering to attend the SMEs as Classroom Facilitators workshop as part of expanding their QT’s toolkit. Many of them want to learn more about teaching peers and working with adults. A few have now become promoted to full-time trainer for L&D /QA departments. Which of your OJT QTS are ready to step up and move into the classroom? It’s time to find out and be part of the current trend. -VB
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 about 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
For companies who are required to have standard operating procedures (SOPs), managing changes and ensuring affected employees are up to date is a constant challenge. Especially for companies whose weekly revision churn rate is from 10 to 150+ revisions. The standard approach is to “get ‘em done” in the fastest amount of time. The end goal for most people is the proverbial (√) and lots of records claiming “read and understood” the procedure.
What’s a Trainer now Performance Consultant to do? With all this focus on training effectiveness and return on stakeholder expectations, how does a Training / Performance Consultant demonstrate his/her worth when the real outcome is a rushed end-user who has less than 20 minutes to train on the changes?
According to Rummler and Morrill*, it comes down to how serious do the changes need to be? Performance consulting is about closing gapsin results, training is about closing gaps in knowledgeand skill. So, consider analyzing what precipitated the SOP change. Was is it a significant CAPA issue or FDA commitment that requires a solution more than “Read and Understood”/ e-sign for the revised SOP?
In other words, isolate the underlying issue that prompted the change. How significant is the change in the procedure? Is it vital enough to improve performance results? Then take a performance consulting approach for these changes. Don’t fret about the others requiring only knowledge. Those SOP revisions can be managed using routine training techniques whose goal is numbers trained.
What Do They Really Need to
Know About the Revised SOP?
The HPI/HPT approach ties the results back to the business outcomes. If the end goal is truly a √ for SOP revision training, you have met the expectations. But as Trainer/ Performance Consultants, we know this is not an acceptable measure for any type of formal review. (Human Performance Improvement / Human Performance Technology).
What we can do is use a modified root-cause approach to address why the procedure changed and then incorporate the what, the where and the when into the training session. Take advantage of the revision history page if available. The SOP Author has listed what changed. Call him/her and ask why the change was made. Perhaps it is related to a deviation or audit observation that other employees need to know about. Find out when the changes will go into effect and how will folks be notified.
Will it be upon an effective date?
Or a trigger condition that now has a different decision path?
Or is it a completely overhauled FORM to be used?
Include these notes as part of your
preparation for end-users to recognize when to make the changes in their tasks.
PLEASE NOTE: Revision
training is not to be used as a substitute for planned OJT or new hire SOP
SOP Revisions Needing Real OJT: Will Management Agree with Your Recommendation?
But what if the SOP revision requires more than a “tell and forget” discussion?
Are the changes significant enough to require a demonstration?
Will a one-time demo by the Qualified Trainer (QT) be enough to call it OJT?
Does the revision require some practice to unlearn the old way and learn the new steps?
How confident are your Qualified Trainers in redirecting this discussion with management regarding the most effective method to use, despite that it will take longer to complete the training notification flags?
First and foremost, the QT signature means that learners were assessed as having learned the content of what was delivered. Can the QT confidently say their colleagues are trained in the revision and can perform the revision without errors? Again, it comes down to how critical-to-quality is the new change? Can the department / site / organization incur waste as in mistakes, scrap work, delayed release of product, and/or re-work as a result of “lack of proper training for the revision”? After the fact, many managers have “a case of amnesia” about their original directive regarding the SOP revisions. “Just tell them what the changes are, better yet, have them R & U and sign the darn form already!” With more deviations being opened, these same managers now question why they have QTs in the first place. Funny how there’s time to do the training properly a second time?
I realize this is easier said than done especially for new QT graduates. A directive is a directive, I understand. In these cases, documentation matters and needs to be explicit that demonstration requirements were waived by “Management Decision”. When the investigation points back to a QT, the documentation will provide what content was covered and to what level of demonstration and practice was included; if any. If none are required, then the risk for mistakes is minimal. These questions, as painful as they are can be excellent references for future events where OJT is really needed for a significant SOP revision. -VB
*Rummler, G. and Morrill, K. “The Results Chain”. T &
D, Feb 05; 26—37.