When you think about evaluating training, what comes to mind? It’s usually a “smile sheet”/ feedback survey about the course, the instructor and what you found useful. As a presenter/instructor, I find the results from these surveys very helpful, so thank you for completing them. I can make changes to the course objectives, modify content or tweak activities based on the comments. I can even pay attention to my platform skills where noted. But does this information help us evaluate if the course was successful?
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
On the Job Training is as old as some of the original apprentice-style forms of learning and ranges from very informal like follow Joe around to structured OJT that is formally documented and includes a qualification event observed by a Qualified Trainer. While OJT means on the job training, the steps for OJT can also vary from trainer to trainer and from company to company unless the methodology is captured in an approved written procedure.
Multiple Performance Demonstrations Occur
One of the first instances of a demonstration occurs from the trainer himself. S/he shows the learner how to perform the technique, task, or process. The learner observes and asks questions. Then the roles reserve and the learner performs a mimicked rendition of what s/he observed. The trainer provides feedback and sometimes will ask questions intended to assess the knowledge gained as well.
Is one demonstration enough to determine OJT is done? Sometimes it is. When the task is simple, one time is all that most learners need. When the task or process is complicated, it will take more than one demonstration to get the SOP steps right. The nature of the SOP or the complexity of the task at hand determines this.
But, how do I proceduralize that, you ask? It starts by not arbitrarily picking the magic number 3. I have engaged in countless discussions regarding the exhaustive list of exceptions to forcing the rule of 3 times to practice. And some QT’s will argue for more than 3 sessions especially when the procedure is so infrequently performed. It’s not strictly about the number of times. We recognize that multiple sessions become practice sessions when the learner is still demonstrating the procedure under the supervision of his/her trainer. But documenting the number of demonstrations and/or practice sessions is still a challenge for the Life Sciences Industry.
At what point, is the learner going to be qualified to perform independently? As an industry, there is no standard number of times. There are no standard learners either. There is a range of “quick studys” to typical to slow learners. The caveat to this is monitoring both the quick study and the slow learner. In the QT workshops, this topic is explored using scenarios with tips and techniques that are shared during the debriefings. Qualified Trainers know what is typical and they are empowered to evaluate the outcome of the learner’s demonstration(s). Is the procedure being performed according to the SOP or is the learner still a bit hesitant about the next step? Is s/he relying on the QT for the assurance that the step is right? While the steps may be performed correctly, is it also the confidence of both the QT and learner that we are assessing as well.
How many times is enough? Until both the learner and the QT are confident that s/he is not going to have an operator error deviation a week after going solo. The QT is ultimately the one who has to assess progress and determine that “with a few more sessions”, my learner will get this or no, s/he may never get it and it’s time to have a discussion with the manager.
BTW, what does “Qualified Employee” mean?
Being SOP Qualified is the demonstrated ability of an employee to accurately perform a task or SOP independent of his OJT Qualified Trainer with consistency to meet acceptable quality standards. It satisfies the CFR ξ 211.25 (c ) regulation, “there shall be an adequate number of qualified employees to perform”.
Don’t be tempted to take the Performance Demo short-cut!
The end goal of OJT and the Qualification Event is for the employee to perform independently of his/her QT. In order to be “released to task”, a final performance demonstration is scheduled, observed, and documented by an OJT Qualified Trainer. But don’t be fooled into taking the performance demo short cut! The last step in the training portion of OJT is a performance demonstration to show the OJT-QT that the employee can perform the steps AND perform at the same level of proficiency as his/her peer group. If s/he can’t perform at this level, then the learner is not ready to “go solo”.
He may need more encouragement to build up confidence, correct paperwork documentation errors, and time to become proficient with his/her speed while maintaining accuracy. That’s what practice sessions are for; time to master confidence with the steps and increase speed. When his/her performance is on par with “business as usual” performance levels, then the employee is ready to perform the final demonstration aka the Qualification Event. While the “readiness indicator” may not be documented, the (Q-Event) must be formally captured, assessed with the outcome being documented and communicated to both the learner and his/her supervision. It is a separate event from the OJT demonstrations.
Final Performance Demo = Qualification Event
During the final performance demonstration, the QT observes the learner’s performance. When feedback is provided, it is evaluative and the rating result is formally documented. Granted, when someone is watching us, we tend to follow the rules. With enough repeated practice sessions, learners tend to perform procedures as “business as usual”. It’s how they learn the ebb and flow from their peers. This is the optimum moment to determine if s/he is truly ready to perform without coaching or supervision from his QT. If a QT has to interrupt to correct a misstep or remind the employee that his step is out of sequence, the event is terminated and documented as requires more review.
More training practice is then scheduled until readiness is once again achieved. And this also means the learner cannot sign for his work without his trainer’s co-signature or initials. Do not misinterpret this as signing for the verification entry aka the second check. In this situation, the Qualified Trainer cannot be both the co-signer and the second check person verification/reviewer. You will need three sets of initials to properly document the supervision of a learner requiring more practice. Otherwise you violate data integrity rules around independent verification.
Qualification events are not intended to be a rushed get ‘er done / one and done paperwork exercise. Sufficient time for proficiency and expected department productivity levels is required to ensure knowledge has been retained and skill can be accurately repeated. OJT demonstrations are not to be misused as the Q-Event. This distinction is critical to ensuring a successful qualification event and the confidence of consistently performing the SOP tomorrow, next week, etc. And not creating a deviation one day or one week after declaring the learner qualified.
It happens when QT’s are urged to “get’em done” by impatient or overly anxious supervisors consumed with productivity and not quality metrics. With the qualification event being so recent, the QT will most certainly be interviewed as part of the investigation. The checklist will also be examined. This tool is supposed to help the QT be as objective as possible and consistently evaluate performance as demonstrated. But typically, the checklist used to qualify individuals shows all Yeses; otherwise, they wouldn’t be qualified status. And that, of course, depends on how well the critical steps and behaviors are captured in the OJT Checklist. Yes, he was able to demonstrate the step, critical task, and/or behavior, but what we don’t know is how well? Are we to assume that No means “No, not at all” and Yes means performed “Well” or it is “As Expected” or “Adequate” or maybe, in this case, it was “Sort of”? The comments column would have been the ideal place to record observations and enter comments.
Validating Your SOP Effectiveness
Meeting FDA expectations for qualified employees is paramount. But the “100% Trained on Curricula Requirements” printouts aren’t winning favor with FDA. In the March 2015 article, “Moving Beyond Read & Understand SOP Training”, I asserted that the current 100% trained reports and SOP quizzes would not be enough to satisfy the performance challenge for training effectiveness. Are your employees qualified? How do you know? has become the training effectiveness question asked at every inspection. The use of “100% completed” reports is a metric for completeness only; a commonly used data point from the LMS. It does not address the transfer of learning into performance back on the job. Neither does the 5-question multiple-choice “SOP Quiz”. The true measure of effective OJT is an observed performance demonstration of the SOP; aka the qualification event.
Employee Qualification is the ultimate Level 3 Training Effectiveness Strategy
The focus of Employee Qualification is about the employee’s ability to apply knowledge and skill learned during OJT back on the job or in the workplace setting. I call this Transfer of Training. Others in the training industry refer to this as Level 3 – Behavior Change. Actual performance is the ultimate assessment of learning transfer. If an employee is performing the job task correctly during the final performance demonstration (Q-Event), his performance meets the expectation for successful “OJT Required SOP”.
Yet, according to the 2009 ATD research study “The Value of Evaluation”, only 54.6% of respondents indicated that their organization conducts Level 3 evaluations. The top technique used is follow-up surveys with participants (31%), while observation of the job was fourth (23.9%).
If on the job assessment is the “ultimate” measure of transfer, then why isn’t it being used more frequently? “Post-training” assessments are time and labor-intensive. But for organizations that have to meet compliance requirements (46.9% of survey respondents), documenting training effectiveness is now on FDA performance radar.
Not all SOPs require a Qualification Event
SOPs generally fall into two categories: FYI-type and OJT Required. The more complex an SOP is, the more likely errors will occur. Observing “critical to quality” steps is a key focus during the final performance demonstration. However, a 1-1 documentation path for every OJT related SOP may not be needed. Instead, batch SOPs a/o multiple SOPs of similar processes can be grouped into a “module” with documentation supporting similarity. Where there are differences in these SOPs, then the Q Event would also require observation of these unique CTQ differences.
An active Employee Qualification Program also verifies that the training content in this case the SOP, accurately describes how to execute the steps for the task at hand. If the SOP is not correct or the qualifying documentation (checklist) is too confusing, a cause analysis needs to be conducted. Successful qualification events also validate the OJT methodology is effective. That Qualified OJT Trainers are consistently delivering OJT sessions for “OJT Required SOPs”.
What does “Qualified Employee” mean for a company?
Qualified Employee status is not only a compliance imperative but a business driver as well. A qualified workforce means a team of well-trained employees who know how to execute their tasks accurately and with compliance in mind, own, and document their work properly. When anyone in the organization can emphatically answer “Yes, my employees are qualified and yes, I have the OJT checklists to back that up”, then the Employee Qualification Program is not only working but is also effective at producing approved products or devices fit for use. The bonus is a renewed level of confidence in the ability of employees to deliver on performance outcomes for an organization.
*The Value of Evaluation: Making Training Evaluations More Effective. An ASTD Research Study, 2009, ASTD.
What happens when the performance demonstration becomes more of a "this is how I do it discussion" instead of an actual demonstration? Read the Impact Story - I've Fired My Vendor - to learn more.
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 the SMEs struggle with the loss of productivity for the 2 – 3 day duration and quickly develop a “one and done” mindset. Given the opening to “train” newly identified SMEs as Trainers, the instructional designer 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 content.
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 Trainers better trainers. Yes, I was in love with own my content. And then one day, that all 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 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 Workshop, 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: 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. See Have you flipped your OJT TTT Classroom yet?
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 objectives.
Once there is agreement with the stated performance objectives, align the content to match these. Yes, there is still ample room in the course for learning theory, but it is tailored for the need to know only topics.
In essence, the learning objectives become evident. 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 goal for the overall program.
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 for compliance expectations around effectiveness and evaluation. To meet this client need, I put on my former teacher hat and created a 10 question open book written assessment. This proved to need 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. Now the OJT QT Workshop is value added and management keeps asking for another round of the workshop to be scheduled. -VB
Oh but if it did, life for a supervisor would be easier, right? Let’s face it, “people” problems are a big deal for management. Working with humans does present its challenges, such as miscommunications between staff, data entry errors, or rushing verification checks. Sometimes, the task at hand is so repetitive that the result is assumed to be okay and gets “a pass”. Add constant interruptions to the list and it becomes even harder not to get distracted and lose focus or attention to the detail.
Actual behavior vs. performing as expected
In their book, Performance Consulting: Moving Beyond Training, Dana Gaines Robinson and James C. Robinson describe performance as what the performer should be able to do. A performance problem occurs when the actual behavior does not meet expectation (as in should have been able to do). Why don’t employees perform as expected? Root cause analysis helps problem solvers and investigators uncover a myriad of possible reasons. For Life Sciences companies, correcting mistakes and preventing them from occurring again is at the heart of CAPA systems (Corrective Actions Preventive Actions).
A closer look at performance gaps
Dana and James Robinson conducted research regarding performer actions and sorted their results into three categories of obstacles:
Hopefully, employees are trained using an approved OJT (On the Job Training) Methodology in which they are shown how to execute the task and then given opportunities to practice multiple times to become proficient. During these sessions, they are coached by Qualified Trainers and given feedback on what’s right (as expected) and given specific instructions to correct what’s not right with suggestions for tweaking their performance so that their final performance demonstration is on par with their peer group. At the conclusion of the qualification event, employees must accept that they now own their deviations (mistakes) from this point forward. So what gets in the way of performing “as they should” or in compliance speak – according to the procedure?
Is it a lack of knowledge, skill or is it something else?
The Robinson’s explain that performance is more than the training event. It’s combination of the overall learning experience and the workplace environment that yields performance results. Breaking that down into a formula per se, they suggest the following: learning experience x workplace environment = performance results.
The root cause investigation will include a review of training and the qualification event as well as a discussion with the performer.
Is it a lack of frequency; not a task often performed?
Is it a lack of feedback or delayed feedback in which the deviation occurred without their awareness?
Is it task interference?
The work environment includes organizational systems and business unit processes that together enable the performer to produce the outcomes as “expected”. These workplace factors don’t always work in perfect harmony resulting in obstacles that get in the way of “expected” performance:
Lack of authority – unclear roles, confusing responsibilities?
Lack of time – schedule conflicts; multi-tasking faux pas?
Lack of tools – reduced budgets?
Lack of poorly stored equipment/tools – lost time searching?
Isn’t it just human nature?
Once the root cause investigation takes on a human element attention, it’s easy to focus on the performer and stop there. If it’s the first time for the performer or first instance related to the task, it’s tempting to label the event as an isolated incident. But when it comes back around again, it becomes apparent there was a “failure to conduct an in-depth investigation” to correct and prevent. Not surprisingly, a push back of “Operator Error as Root Cause” has forced organizations to look deeper into the root causes involving Humans.
Who’s human nature?
Recall that one of the categories of the researched obstacles was “conditions of the immediate managers”. This makes managers uncomfortable. With so much on their plates, managing a people performance problem is not what they want to see. A silver bullet like a re-training event is a nice activity that gets a big red check mark on their to-do list. However, Robert Mager and Peter Pipe, in their book, Analyzing Performance Problems, provide insights to managing direct reports that may lead to unintended consequences. A brief list can be found here – scroll to Tool: Performance Causes. (It’s not always the performer’s fault.)
It takes all three to correct a performance problem
The third category of researched obstacles clustered around “conditions of the organization”. I’ve already discussed task interference above. To suggest that organizations are setting up their employees to fail is pushing it just a bit too far. So I won’t go there, but it is painful for some leaders to come to terms with the implication. In order to prevent issues from reoccurring, an examination of the incidents and quite possibly a restructuring of systems have to occur, because automatic re-training is not the only solution to a “people performance problem”. –VB