Part 1 of a two part impact story about how to truly align a training program to achieve business worthy success.
As Pam sent her last email, she glanced at her watch and determined that she could stop by the Qualified Trainers (QT) workshop to check-in and catch the final qualifying activity. As Director of Quality Systems, compliance training was part of her responsibilities. Since qualifying SMEs has a strong connection to Good Manufacturing Practices (GMPs), it was given to her group to manage.
Her training vendor had a long standing service agreement to deliver a Train-the-Trainer class 2 – 3 times a year upon request from Pam. Session evaluations were usually favorable. The length of the course was the only notable comment. Since one of her staff was always present during the delivery, Pam had no need to sit in the course and observe since the content was finalized over three years ago.
Pam quietly walked in and sat at the back of the room. Not long after, she is alarmed by what she observed. “Uhh, excuse me, but where are the SOPs?” she asked. A few participants who were engaged in the activity pointed to their printed copy of the SOP-in-use. It was sitting on the table in front of them. Looking directly at the vendor, she asked “Why isn’t the procedure being used during the demonstrations?”
How long has this been going on?
Pam patiently waited for the vendor to clarify that he included this requirement during the lesson on OJT (On-the-Job-Training) steps. Not convinced by his response, she stayed until the end of the course to ensure that all of the demos occurred with “equipment SOP in hand”. “This is our process and the whole point of the workshop”, she extoled aloud. Immediately after, Pam contacted the vendor’s employer to terminate the contract. Then she phoned her Performance Consultant (PC) and retold the story. “Do you think you can coach us?” Pam inquired.
Hindsight is 20-20 vision
The PC concluded that over time, participants including staff, got lax with the demonstration requirements and lost sight of the importance of mimicking the same conditions for qualifying an employee at the workstation as in the workshop. In a classroom setting, some of the steps need to be simulated or explained rather than actually performed. This is a reasonable constraint given the limitations of the classroom setting and logistics with time, travel, and gowning if in a sterile lab or GMP zone.
The PC continued with her diagnosis. Each time the workshop was delivered, it appeared that participants were “explaining” more and more of their procedure and not demonstrating the steps. As a result, the importance of the procedure being in hand to refer to got left behind on the table as more of an item to bring to class. In addition, the course was three days with demonstrations being the last activity. It was only natural that the energy, commitment and integrity to course design would wane. As a result, the final exercise which was supposed to be the overarching outcome of the course, got short changed. Folks were just too tired to fully comply and merely went through the motions including the vendor so they could end the course and go home.
Don’t tell me I have to start all over again?
Pam had already conducted an exhaustive search for a suitable vendor when she contracted with this agency. Before she reached out to her PC, she decided that it might be time to develop their own course internally.
“Can you maybe coach us along the way and provide an objective review of content at the end?” Pam requested. “We’ve already generated a course outline. Unfortunately our ever-increasing workload keeps bumping this project from our calendars. With your nudging us along, I really think we can work together to get this done. Do you agree?” she added.
What about starting from a completely different perspective?
The PC agreed and decided to take a different approach. Rather than build a course around suggested content, she asked the team to begin with the end in mind, literally. Recalling that training initiatives were now being tracked for effectiveness and “Return-On-Investment” from the Executive Leadership Team, the PC reminded them that this course would not be exempt from the same set of requirements.
Using a business analysis focus, the PC probed Pam for the goals and objectives that were linked to the OJT Workshop. Initially, the response was broad and vague. When the PC pressed further for measuring the goal alignment connection, Pam stopped trying to explain and returned to the room with a few documents she had prepared the week before. Hidden in these documents, were the very business drivers the PC was looking for. Pam also shared the corporate quality objective given to all directors. With this information, the PC plugged it into her Performance Improvement Worksheet and announced the next assignment was to be completed in two weeks.
Using the brainstormed outline of suggested content, Pam and Robert, the QA Training Supervisor, were to rank each item on a scale of 1 – 7; the criticality of consequences if not performed correctly with 1 being none and 7 being dire. To combat the tendency to mark everything “important to organization”, the PC instructed them to use the business drivers and corporate quality objective as the criteria.
Seriously, why can’t she just tell us what the content should be!
Being unfamiliar with quality instructional design, Robert fussed about the assigment and complained to Pam about it being a waste of everybody’s time after the session with the PC was over. “Why can’t your PC just tell us what content to include and be done with it?” he vented. But Pam recognized the beauty of the assignment and whole heartedly embraced it.
“Well,” she began, “since we started with the proposed content, we need to learn how to cut our own content and be comfortable with the why.” She also emphasized how strategic the rankings would be. As a department, they could finally justify why the course was really needed and how it would benefit all involved. Reluctantly, Robert completed the assignment. But was not in agreement that the benefits would outweigh his time spent for the “stupid” assignment.
At their next team meeting, the PC shared the compiled rankings. For items that ranked low, the team discussed alternative methods for providing the content either before or after the workshop. Items ranked higher got a second round of discussion that included why it should be included in the workshop. During the meeting, Robert made a lot of comments for keeping certain content in the course, but his justification was weak. Pam over ruled him many times. Annoyed that his comments weren’t winning favor with his boss, Robert began to withdraw from the discussion. He was not convinced that the highly ranked content would change behavior after the course was over so why not include some of “his” content, he muttered to himself.
For many organizations, the sole purpose of refresher training is to satisfy compliance requirements. Hence, the focus is on just delivering the content. Ironically, the intent behind the 211.25 regulation is to ensure that employees receive training more than at orientation and frequently enough to remain current. The goal is to ensure compliance with GMPs and SOPs and improve performance where there are gaps. Improved business performance is the result and not just a checkmark for 100% attended.
And the practice of repeating the same video year after year as the annual refresher? Efficient yes, effective, well just look at your deviations and CAPA data to answer that one. When you shift your focus from delivering content only as the objective to a more learner-centered design, your sessions become more performance-oriented and your effectiveness reaches beyond just passing the GMP Quiz.
From passive lecture GxP refreshers to active learner centered sessions
Yet, senior leaders are not grasping that just “telling them the GMPs” is not an effective training technique, nor is it engaging. Even if it’s backed up with a slide deck, it’s either “death by PowerPoint” or click to advance to thenext slide for CBT refresher modules. Koreen Pagano, in her June 2014 T&D article, “the missing piece”, describes it as “telling employees how to swim, then sending them out to sink, hoping they somehow can use the information we’ve provided to them to make it shore”, (p.42). To make matters worse, employees can end up with disciplinary letters for deviations and CAPAs for failure to follow GMPs.
Look at the GXP Refresher course outline for the last 3 years at your company. What is the ratio of content to interactivity? When I dig a little deeper, I usually discover a lack of instructional design skills, and minimal creativity is a factor. And then I hear, “Oh but we have so little time and all this content to cover, there’s no more room. If I had more time, you know, I’d add it in.” Koreen informs us that “training is supposed to prepare employees to be better, and yet training professionals often stop after providing content” (p.43).
See What’s so special about SMEs as Course Designers?
What about using previously developed compliance materials?
I am not criticizing the use of previous course materials if they were effective. But asking an SME to “deliver training” using a previously created PowerPoint presentation does not guarantee effective delivery. Neither does replacing clip art with new images or updating the slide deck to incorporate the new company template. These visual “updates” are not going to change the effectiveness of the course unless the content was revised, and activities were improved.
For many SMEs and Trainers, having a previous slide deck is both a gift and a curse. While they are not starting with a blank storyboard, there is a tendency to use as-is and try to embellish it with speaker notes because the original producer of the slide was not in the habit of entering his/her speaking points for someone else to deliver. Speaker notes embedded at the bottom of the notes pages within PowerPoint slides is not a leader’s guide. While handy for scripting what to say for the above slide, it does not provide ample space for managing other aspects of the course such as visual cues, tips for “trainer only” and managing handouts, etc.
The SME has the burden to make content decisions such as what content is critical; what content can be cut if time runs out. Perhaps even more crucial is how to adapt content and activities to different learner groups or off-shift needs. Without a leader’s guide, the SME is unsupported and will fall back on the lecture to fill in the duration of the course.
Better Training Means an Investment in Instructional Design Skills
Interactive, immersive, engaging are great attributes that describe active training programs. But it comes at a price: an investment in instructional design skills. Trained course designers have spent time and budget to create an instructional design that aligns with business needs and has measurable performance outcomes. The course materials “package” is complete when a leader’s guide is also created that spells out the design rationale and vision for delivery, especially when someone else will be delivering the course such as SMEs in the classroom.
The Leaders Guide, invaluable for effective course delivery
A well-designed leader’s guide has the key objectives identified and the essential learning points to cover. These learning points are appropriately sequenced with developed discussion questions to be used with activities; thus, removing the need for the Trainer/SME to think on demand while facilitating the activity. This also reduces the temptation to skip over the exercise/activity if s/he is nervous or not confident with interactive activities such as virtual break out groups, etc.
A really good guide will also include how to segue to the next slide and manage seamless transitions to next topic sections. Most helpful, are additional notes about what content MUST be covered, tips about expected responses for activities and clock time duration comments for keeping to the classroom schedule. SMEs as Facilitators (Instructor Led SMEs| ILT SMEs) need to study the leader’s guide and pay attention to the icons and notes provided there. These cues indicate the differentiation from lecture, to an activity whether that be self, small group, or large group.
Given all the time and effort to produce the leader’s guide, it is wasted if the course designer and SME as Facilitator do not have a knowledge transfer session. Emailing the guide or downloading it from a share point site will not help the SME in following the guide during delivery unless an exchange occurs in which SMEs can begin to markup their copy.
During the knowledge transfer session/ discussion with the course designer, ILT SMEs make notes of how the instructor transitions from one slide to the next and how s/he provided instruction for the activity. This is a good time for ILT SMEs to ask how to modify content or an activity if certain conditions should occur. Especially important for SMEs to ask is what content is critical and what content can be skipped if time runs short. It is always a good idea for the ILT SME to mark-up his/her copy of the materials. And then again after the first delivery to really make it their own leader’s guide. For example, SMEs may want to experiment with different ways to “open a session”to get experience with a variety of techniques and observe which ones yield better results.
Why do ILT SMEs need their own Qualified Trainers workshop?
When GMP courses are designed with the learner’s needs in mind, including adequate duration for exercises and activities, learners begin to engage with the content through the skill of a qualified facilitator who can guide the experiential activities.
When learner-generated responses are immediately incorporated into the session and leveraged to enhance the debriefings, the involvement and future application back on the job is even greater.
In order to pull this off, ILT SMEs need to learn how to facilitate learning experiences such as preparing to have a facilitated discussion. One of the biggest fears ILT SMEs have when asked to facilitate an exercise or an interactive activity is the fear of it bombing such as discussions.
Discussions can often bomb
While popular and commonly used, discussions can also fail miserably if not designed well. Relying on the SME to facilitate the discussion without carefully preparing the path to the targeted outcome is leaving it to chance that the SME knows how to execute the activity successfully. It includes the upfront questions to ask, pertinent examples as reference, and application type activities in which clarifying comments can be addressed.
“It takes effort to get out of your head and connect with individuals.” Ludwig, D. Training Industry, Fall, 2015, p. 23.
“… So as to remain current in the practices they perform …”
Is once a year GXP refresher enough? Before you rush to answer this question, consider the following. Do you have:
a lot of human or operator error related deviations?
or regulatory observations that include failure to thoroughly investigate …?
or a large percentage of repeat deviations?
Then you might be sending the mixed message that your employees are NOT trained well enough or sufficient in their knowledge and application of the GXPs.
There’s a difference between GXP training content that is delivered as a repeat of the same materials vs. new and/or updated. Yes, new content takes resources and time. But, how many times do you want to sit through the same old slides and get nothing new from it? Recall the definition of insanity – doing more of the same while hoping for change. – VB
Ludwig, D. “Lets Get Serious about Live Instructor-led Training”, training industry, Fall, 2015, p. 23.
Pagano, K. “The Missing Piece”, T & D, June 2014, pp. 41 – 45.
Rock, D. “Your Brain on Learning”, CLO, May 2015, pp. 30 – 33,48.
Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips. Lexington Books, New York.
What’s so special about SMEs as Course Designers?
They have expertise and experience and are expected to share it via training their peers. But now the venue is the classroom as well. It’s training on course design methodology that is needed. SMEs and most trainers do not automatically have this knowledge. Some develop it by reading A LOT, attending well-designed courses, and over time with trial and error and painful feedback. The faster way is to provide funds to get SMEs as Course Designers at least exposed to how to effectively design for learning experiences so that they can influence the outcome of the objectives.
This is management support for SMEs as Trainers. SMEs who attend an ID basics course learn how to use design checklists for previously developed materials. These checklists allow them to confidently assess the quality of the materials and justify what needs to be removed, revised or added; thus, truly upgrading previously developed materials.
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.
For years, this distinction was clearly practiced where I worked. Trainers were in the classroom and SMEs delivered OJT. Occasionally a “fulltime” trainer would consult with an SME on content or request his/her presence in the room during delivery as a back-up or for the Q & A portion of a “presentation”. It seemed that the boundaries at the time, were so well understood, that one could determine the type of training simply by where it was delivered.
Training boundaries are limitless today
Today, that’s all changed. No longer confined to location or delivery methods, full-time trainers can be found on the shop floor fully gowned delivering GMP (Good Manufacturing Practices) content for example. And SMEs are now in the classroom more each day with some of the very tools used by full-time trainers! What defines a full-time trainer from an SME is less important, what is necessary however is what defines effective instruction.
Your title might have the word trainer in it. One of your responsibilities might be a qualified trainer. And you know how to use PowerPoint (PPT). Does this make you an Instructional Designer as well? Some say yes and others cry foul as they cling to their certificates and advanced degrees. So, forgive me when I say, not every Trainer or Training Manager has the skill set or ID competency embedded in his/her toolbox. It’s analogous to the toy box on the shelf at Toys R Us – “NOTE: Batteries Not Included”. Except in our case, the note may be missing from the resume, but definitely embedded into the job description if you are QA L&D or HR Training and Development.
Instructional Design is a recognized profession
Instructional Design (ID) as a field of study has been offered by many prominent universities for quite some time and is now more known as Instructional Technology. Underlying the design of a course or a learning event, is a methodology for “good” instructional design and really good instructional designers will confess that there is a bit of an art form to it as well. Unfortunately, with shrinking budgets and downsized L&D staff, there are less resources available to develop traditional course materials of the past. Not to mention, shrinking timelines for the deliverables. So, it makes sense to tap SMEs for more training opportunities since many are already involved in training at their site. But, pasting their expert content into a PPT slide deck is not instructional design.
What is effective design?
To me, effective design is when learners not only meet the learning objectives during training but also transfer that learning experience back on the job and achieve performance objectives / outcomes. That’s a tall order for an SME, even for fulltime trainers who have not had course design training.
The methodology a course designer follows be that ADDIE, Agile, SAM (Successive Approximation Model), Gagne’s 9 Conditions of Learning, etc., provides a process with steps for the design rationale and then development of content including implementation and evaluation of effectiveness. It ensures that key elements are not unintentionally left out or forgotten about until after the fact like evaluation/ effectiveness or needs assessment. In an attempt to expedite training, these methodology driven elements are easily skipped without fully understanding the impact of leaving them out can have on the overall training effectiveness. There is a science to instructional design.
PowerPoint Slides are only a visual tool
Using PowerPoint slides by themselves does not make the training successful. It’s one of the main tools a trainer uses to meet the objectives of the learning event, albeit the main one. The “art form” occurs when a designer creates visually appealing slides / eLearning scenes as well as aligned activities and engaging exercises designed to provide exploration, practice, and proficiency for the performance task back on the job. But there is a difference between a course that is created to help the Trainer achieve his/her agenda and one that successfully engages learners to participate, learn and then transfer their insights back home to the job where changed behavior improves the department’s metrics.
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.
As you move along the Learner Participation Continuum, the learner is required to participate more, and the trainer does less “talking”. The learner acquires knowledge and skills through activities that s/he experiences with the assistance of a “facilitator”. The facilitator is focused on helping the learners meet their needs and interests. It is through these firsthand experiences and facilitated dialogue with other learners that thoughtful analysis and interpretation can become the focus of the instruction. The end result is that learners take full responsibility for decisions, actions and consequences.
Moving from Presenter Controlled Training to Learner Focused Facilitation
Moving to a more Learner Focused approach shifts the effort of the design from “deliver this content” to facilitate learning transfer for performance back on the job; which is after all the end goal for a training event. The new design includes opportunities for group participation, utilization of participants’ expertise, and real-life problem solving; key principles of adult learning.
On the one end of the continuum is the lecture which is one-way communication and requires very little participation. At the other end, we have experiential learning and now immersive learning environments with the introduction of 3D graphics, virtual simulations, and augmented reality.
Most Trainers and 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. As a result, it shows up in the slide deck with overburdened slides filled with a lot of “stuff”. Training for them takes on a lecture-style format. The thought of facilitating an activity gives most SME a case of jitters and anxiety.
So, in the “SME as Facilitator” workshop, nominated SMEs as Facilitators are encouraged to step away from the podium and use their eyes, hands, and voice to engage with their audience. Easier said than done, yes. That’s why the course is designed to allow them to take small steps within the safety of a workshop environment.
But rather than trying to pull off a fully immersive session, SMEs as Facilitators are introduced to techniques that “liven up” the lecture. They are shown how to move back and forth from passive listening (sit, hear, see) to active involvement (write, construct, discuss, move, speak). This requires the ability to:
follow a well-organized design plan
capture and hold the attention of learners
use relevant examples and deviations if possible
show authentic enthusiasm
involve audience both directly and indirectly
respond to questions with patience and respect.
While lecture has its merits, today’s learners want engaging content; that is timely, relevant and meaningful. And while virtual reality and simulations are engaging and very immersive, courses and learning events using these techniques rely on well-funded budgets. Most Training Departments are not that fortunate. In the middle of the range are “lively lectures” and alternate methods such as:
Read and Discuss
Take the 1st shift right.
It’s really about starting with the learners’ expectations and the current organizational culture and then moving one step to the right. If they are used to lectures from SMEs, then work on delivering effective lectures before experimenting with alternate training methods. The overnight shift may be too big of a change for the attendees to adjust to despite their desire for no more boring lectures. Small incremental steps are the key.
Thoroughness in the preparation reflects care and thoughtfulness. Learners appreciate the personal desire to deliver a livelier lecture. Stepping away from the podium forces the Trainer/SME to take action and allow the learners to “get up close” with the SME as Facilitator. This in turn is reflected in the learner’s desire to respond to questions and dialogue during a facilitated discussion. The rule of thumb for lecturing is approximately 8-10 minutes max. For virtual sessions, the rule of thumb is approximately 5 minutes.
Take the 2nd Shift: Cut Content to Add Interactivity
How is this done? Upfront in the design of the course materials. The course designers have spent time and budget to prepare a leader’s guide that captures their vision for delivering the course. SMEs as Facilitators (Classroom SMEs) need to study the leader’s guide and pay attention to the icons and notes provided there. These cues indicate the differentiation from lecture, to an activity whether that be self, small group, or large group. While it may be tempting to skip exercises to make up for lost time, it is better for learner participation to skip lecture and modify an activity if possible.
“STOP TALKING and get learners engaged in some form of activity, practice or reflection exercise”, Vivian Bringslimark, HPIS Consulting, Inc.
One of the benefits of shifting to this learner focused design is the opportunity for learners to process the content, to make it meaningful for themselves and then associate memory links to it for later recall when the moment of need is upon them. This can’t happen while the trainer is lecturing. It happens during activities and reflection exercises designed to generate their own ideas during small group interactions and link it back to the course content/objectives. Learners are prompted to openly discuss issues and problems within a “learning lab” style environment. Trainers become empathetic listeners as they create a climate of trust and safety. They become a Facilitator.
Of course, this shift also requires that site leadership and local management not only support the facilitated learning lab concept but follow through on issues and concerns that surface. Failure to do so undermines not only the facilitator’s credibility but the entire training program.
Wow, won’t this take longer to design, you ask? Yes, in the sense that the design is now from the learner’s point of view. This means that the designer will need to research examples, collect data, and might have to develop a story from an incident, a deviation or significant CAPA, etc. The reward is that the Trainer/ Classroom SME stops talking and gives employees more engaging learning sessions. So learners become more accountable for participating and guess what – the SME’s session is no longer a boring podium speech.
Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips. Lexington Books, New York.
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.
An urgent request to fix a broken training system is typically the point of entry for my Robust Training System (RTS) makeovers. When I join the conversations, I discover that a lot of “work” has already begun. So, I take a deep dive into the documentation to “hit the ground running and get caught up to speed” as quickly as I can. By this time, the agency response letter has already been sent with commitments to correct observations and promises to fix system issues. And immediately, CAPAs are opened to track these activities. Sigh. [CAPA = Corrective Action Preventive Action]
So often, immediate fix CAPAs are generated so quickly and only focused on the fast fix of the observation, that the short-term benefit becomes a major barrier for the long-term prevention of a systems upgrade. The advice that is given to a CAPA owner is “don’t fixate on the big picture right now, we can always revise it later…”. “We’ve only got 15 days to respond to the agency”. While revisions are part of our SOP management system, revising the CAPA fix to something else in the next revision can appear to look like it was only for the FD-483 observation or the Warning Letter response.
And a lot of the time, those CAPA fast-fixes conflict with a proposed future state. It can become a huge obstacle to redesigning an effective and efficient quality training system. There is a belief that it takes too long to map out the proposed future state and pinpoint exactly where the observation or citation gets corrected. Given how some redesign projects are managed, there is a lot of truth to that belief. So, the rule of thumb is to correct first, then come back and “improve” later when site employees have a moment to catch their breath. But closing out those fast-fix CAPAs in record time prevents redesign projects from moving forward because available SMEs are busy executing the corrective actions. What’s really frustrating is realizing that the fast fix is incompatible with the proposed future state. Sigh again.
Little CAPAs and Big CAPAs
By little CAPAs I am referring to the immediate fix corrective actions and in no way am I minimizing their importance. Their scopes tend to be single focused and short term. By comparison, big CAPAs are created when many of the little CAPAs are rolled into one big CAPA. The scope is expanded to include the related little CAPAs because the corrective actions relate to each other, impact each other, and may produce repetitive paperwork. So, all the CAPAs get bundled together in an overall CAPA aka, the big CAPA.
When this occurs, be careful that little CAPA commitments to the agency via response letters don’t get lost in translation. By that I mean, the fast fixes need to remain visible or traceable in the deliverables of the project. If by chance those steps were removed or changed, be prepared with heavily documented justification with appropriate approved signatures like Department Heads. Take note, merging little CAPAs into one big overarching CAPA usually changes the completion timeline given that the scope of the big CAPA is bigger. For most projects, this is a welcomed relief. It can also change the timelines of the little CAPAs. Be mindful of the commitments made to the agency.
But We’ll Be Out Of Compliance The Second The SOPs Go Into Effect!
One way to keep multiple CAPAs visible is to create subprojects that are also managed within the overall future state project. Sometimes these projects have completion dates projected to be 6 – 9 months out. Yet, the future state quality system procedures need to be operational before these subprojects can come to fruition. In essence, the day the SOPs go into effect, the site would automatically be out of compliance and numerous deviations would have to be initiated. To manage the SOP change gap, an overarching CAPA (the Big CAPA) can be generated to allow the organization to meet agency milestones and move forward with the new process while working on the subprojects. The key to this approach is ensuring that the implementation plan is written, approved, up to date, and indicating progress forward.
During the development of the last set of redesigned SOPs for a client, FDA conducted a follow-up visit for the original FD-483 inspection. One of the little training CAPAs was not yet completed. It was waiting for the redesigned set of procedures to go into effect. The new version would encompass this observation and essentially close it out.
As part of their Go-Live strategy, a decision was made to schedule the release of the revised procedures all at once when the final set of SOPs was ready to go to Change Control. It was determined that too many little changes for the Training System would result in confusion, retention issues, and a paperwork nightmare controlling which version of the form was correct. This is a popular option for design teams because the coordination of new changes happens on the same day and is much easier to track. Albeit the learning curve can be high as the site works on closing the size of their change gap.
Unfortunately, this incomplete CAPA created a hold for product to be released. As a result, the priority to complete a retrospective qualification of 700(+) SMEs as Trainers derailed the Training Quality System project for close to 4 months. Painfully, additional immediate fix CAPAs were also generated. Ironically, these CAPAs could have been avoided if the design team chose to release each SOP as it was ready instead of waiting for all of the SOPs to go into effect all at once.
Be Mindful Of The Quest For The Perfect SOP
The most typical corrective actions involve revising procedures to include a changed step, a form revision, or in some cases, a completely overhauled process that includes multiple work instructions or SOPs. Standard Operating Procedures mean a description of the approved steps for the task at hand to be followed repeatedly without exception or deviation. But SOPs are not static, they change frequently which is a good thing for folks who seek improvement and a source of exasperation for the end users assigned to keep current with their procedure revisions.
Change fatigue is real and can often be the root cause of SOP deviations. CAPA owners need to be made aware of the learning curve for major revisions. Hence, awareness training and primary end-user workshops are integral for implementation strategies. However, the antidote for SOP change fatigue is not waiting for the perfect SOP that will never change again! But knowing in advance that a procedure is going to revise multiple times is also frustrating. Just when end users get used to the change(s), the SOP changes again and quite possibly re-introduces a host of deviations almost suggesting that the changes are a waste of time and energy.
There Is No Such Thing As The Perfect SOP; Don’t Delay CAPAs Unnecessarily
What then is the remedy? Conducting impact assessments of the change(s) and then managing the go-live strategy for awareness training, triage support, and FAQ type communications depending on how big the change gap is. And this is exactly the approach that one Quality System L & D Manager implemented as part of the go-live strategy for a major overhaul of her training system.
With careful examination of what tasks, forms, and steps were actually changing, the Project Lead was able to realistically determine how much time it would take to mitigate the impact. Subtasks such as final form revisions and revisions to other documents were monitored and project tracked as well. This information shaped a pragmatic and timed sequence of events that lead to the conclusion that releasing one SOP at a time was the most effective way to transition into future state with minimal disruption despite that the overall quality system policy document would have to be revised multiple times during the transition period. The project lead volunteered to be the task master on those subsequent policy changes and updates for the stakeholder briefings.
Agile Approach Enables SOP Change Resilience
The timed sequencing of these revised SOPs addressed potential version confusion and change fatigue. By managing smaller rollouts, there was less impact on the organization. The Training Manager was able to introduce the employees to SOP change resilience by combining awareness training, project briefings and end user feedback for the “next SOP revision”. Rather than dread the next release, end users discovered that their feedback was taken into consideration. And in most SOPs, the next release didn’t really change anything but rather added another component or element of the future state that they were now ready to implement.
The iterative design and roll out expedited a continuous improvement cycle that kept the project moving forward to meet FDA commitments, milestones, and stakeholder expectations. -VB
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After weeks if not months of waiting for your new hire, she is finally here, finishing up 1st-day orientation. Day 2, she’s all yours. Are you excited or anxious? The LMS (learning management system) printout of training requirements is overwhelming; even for you. Bottom line question running through your mind — when can s/he start carrying their weight for the department workload?
If your department onboarding is like most in the Life Sciences industry, your next milestone is the completion of all the required SOPs to be done Day 1, Week 1, and quite possibly Month 1. After that, the learning journeys for new hires follow different paths depending on whether they will operate equipment or generate controlled documents and review reports.
For folks who run laboratory instruments or operate manufacturing equipment, a significant portion of the LMS printout of training requirements is to be delivered via On the Job Training (OJT); SOJT more specifically. Structured on the job training (SOJT) is an organized and planned step by step approach for completing hands-on training requirements. The SOJT approach uses some variation of the following OJT steps: Read, Observe, Practice, Qualify. And is managed by a qualified trainer who is monitoring the new employee’s progress until s/he is fully qualified.
Pay Now or Pay Later
Yet for many line managers, they want their trainees now. Ironically, the faster you “push” trainees through their training matrix, the slower the learning curve. This proactive vs. reactive dilemma is not new. Traditional OJT aka “follow Joe around” looks like a win – win for everyone on the surface. The new hire gets OJT experience, a SME is “supervising” for mistakes, and supervisors are keeping up with the production schedule. So what’s wrong, you ask? This hurry up and get ‘em done push often leads to more errors, deviations, and quite possibly CAPA investigations for numerous training incidents. It’s a classic case of pay now or pay later.
After 6 months or so, the trainee isn’t new anymore and everyone “expects” the new employee to be fully qualified by then with no performance issues and no deviations resulting from human error. Assumptions have been made about what he/she has learned based on time in the department. Unfortunately, this is the very reason for “getting the SOPs all out of the way” the first 30 days. What is needed, is the ability to schedule when training requirements are needed based on the number of days from the start date. Really good LMSes offer smart curricula; when the first curricula requirements are satisfied the next curricula is then assigned with realistic due dates and so on.
Is SOJT Applicable Beyond Manufacturing and the Lab?
What about the new hire who is assigned to Quality Assurance? Surely their role and job responsibilities are critical to the organization. They may not operate complex equipment or run highly specialized testing instruments, but the documents they generate and approve using modern Quality Management System software are just as important for compliance. Could the SOJT methodology be used here as well? Perhaps for the e-doc processes. And in many organizations, first round super users receive training from the vendor.
But what about all the other non-equipment functions within the organization that are compliance-focused? What happens after new hires reach “100% complete” with their training requirements? What is their version of On-the-Job Training? If we require them to use the SOJT methodology, we bump into challenges. For example, the following table highlights where the nature of their tasks do not fit neatly into the steps and certainly would not be consistently executed across the rest of the organization.
Unfortunately, the only “plan” for these employees is the list of required SOPs with due dates and possibly a few required courses. The SOPs are listed for them via curricula and can either be found in an e-doc system, shared drive, or a similar controlled share point repository. How to manage this list between now and the due date is really up to the employee. After all, we hire adult professionals and if they are experienced, they know what they need to do; get their curricula done. It is up to them to manage their own path.
And in many ways, this individualized approach looks a lot like informal learning. Jay Cross in his TD article, “Not Without Purpose”, tells us that informal learning respects workers. Moreover, he believes that “employees thrive when given the freedom to decide how they will do what is asked of them.”
When the formal curricula of R & U for SOPs is completed, the new hire begins his/her on the job experience. And this is where non-linear learning takes place. It’s where learning and performing intersect. Where the demands of the job function require the learner to put into practice what he read and “understood” about the procedure. Now the procedures come to life as daily problem solving gives rise to real learning opportunities. In reality though, the retention rate for those early R & U SOPs is pretty dismal. The best we can hope for is that they remember a procedure exists and they know how to search for it. They are in essence repeating that exercise making the 1st round a waste of time and effort.
Yet, on the job experiences are the biggest source of learning for employees. It is what ultimately qualifies them for their job. But we are not formally capturing it. At best, we remind our folks to update their CVs once a year. In the SOJT model, it’s called practice and at least one time we document it. Then we formally evaluate the performance demonstration and capture it as the Qualification Event. But in this other approach, gaps in performance go unchecked despite having 100% trained reports. What documents their current qualified status, the original CV that was used at the time of hire?
“Unfortunately, the only ‘plan’ for these employees is the list of required SOPs with due dates and possibly a few required courses.” Vivian Bringslimark, HPIS Consulting, Inc.
Training, Education and Experience or Any Combination Thereof
Through our recruiting and hiring process we hire experienced people or at least that is the intention. For clinical operations, it is paramount to successful recruiting. When filling clinical operations roles, potential hires need to have solid compliance foundations and previous experiences. But it’s their expertise that gets them hired. So, you would think they don’t need much new training. And yet, many of the SOPs, protocols and trial studies are new and evolving so they need to know what’s in these documents. When high performance includes compliance achievement, it is a must have for these roles.
The good news is that these new hires are highly intelligent, have a strong desire and work ethic. They are conditioned to facilitate their own learning to transfer their knowledge and clinical skills. After receiving their curricula assignments, their learning journey resembles more like the organic nature of informal learning where they experience natural learning discoveries on their own. It is not uncommon then, that Clinical Operations departments tend to operate independently from the rest of the CMC organization with their own set of SOPs and unfortunately form independent silos.
Expanding QA L & D Scope
More recently, QA L&D has begun to partner with ClinOps to better meet the needs of this population and support their role in the future of the organization. At first glance, inserting ClinOps into the Quality Training System may sound like the easy solution. But when 300 must-read / need-to-know documents show up in an LMS printout, “it just does not make sense” remarked a Director of Quality Systems.
So rather than structuring their on the job experiences as in the SOJT approach, these folks need an On-the-Job Learning (OJL) methodology that curates their documents and information they need while learning in the flow of their work assignments; not at all once at the beginning of their journey. Employees want to learn their procedures when they need it the most. It saves time and reinforces what they read because now they are applying what they just read.
The effectiveness check is truly their work product. We can evaluate how well they followed the procedure to produce the output of their responsibility. This is a far better measure than a 5- question multiple-choice knowledge check for the procedure during week 1 of onboarding. Some would argue that productivity is hindered because the task is suspended while the learner is searching for the procedure. Which is more lost productivity, reading the SOP for the second time or reading it the first time and executing the task correctly immediately after?
Ken Taylor, President and Editor in chief for Training Industry, Inc., believes that formalization allows us to recognize the impact that this self-directed learning approach has on their performance. The formal part is the list of documents “that they need to know”. What’s missing is their “final performance demonstration” when we can declare the employee is qualified! When is their Qualification Event captured?
REAPS for COJL
If we revisit the SOJT Model above with the intention to modify for C-OJL, Curated On the Job Learning, it might look like the following:
While 300 documents is overwhelming, the better approach is to ask, “what will they do with the information they read”? And then ask, “when do they need to know this” rather than assign it too far in advance. Believe it or not, there are times when reading may be acceptable. When the outcome is awareness only or for information only and no effectiveness check is required or a performance outcome affected by the application of the information, then read can be used. But please do not call it training.
The initial onboarding should not just be a hyper focus to get the list done. “As L&D Professionals, we need to provide context over content to our audiences”, says Mark D’Aquin. Context can be achieved when the curricula requirements are presented as an intended curated list of “content” for the individual’s role and how carefully the requirements have been mapped to performance-based outcomes. Not only does it add a layer of personalization, it highlights just how important the job functions and the outcomes are to the organization. These discussions with the supervisor and possibly the mentor(s), involves not only the role, but timelines, expected work products and “reports” that will be peer reviewed for compliance and company standards.
Assigning a buddy or pairing them with a peer mentor provides just enough structure to allow the new hire to build positive relationships with peers and begin to build psychological safety where they feel safe to contribute or challenge the status quo without fear of being rejected or isolated. For example, many professionals bring with them their previous employer’s procedures and practices.
And while it may be the same industry, even the same role, invariably the new company will require differences in their procedures. This means new hires have to unlearn their previous knowledge and relearn new terms and methods rather rapidly. Mentors can facilitate this process by meeting with new hires to help them debrief and reflect on these changes, ensuring that the new hire leaves the conversation with the right summary of steps.
“Debriefing is a critical conversation to reframe the context of a situation to clarify perspectives and assumptions, both subjectively and objectively”. “The process of coming to know why an action was taken reveals the knowledge, assumptions, values, beliefs, and feelings behind the action and attaches meaning to information. Critical reflection bridges past learning within the context of a new situation.” NLN in collaboration with INACSL, June 2015.
In their TIQ May June 2020 article, Emily Blancato & Shelley Stanley, insist that “there must be structure not only around the task but who the new hire should be partnered with to complete it”. They recommend the following:
Identify what your existing employees need to support your new hires in these sessions.
Ensure the existing staff will have the time and balance necessary to provide a positive experience during their time with the new hire.
Confirm the staff understands the expectations of the program.
Prioritize the most common tasks first to allow both the new hire and the team to see immediate productivity gained.
When compared to the SOJT approach, this looks similar at first glance. The difference is that SOJT Qualified Trainer, is the primary driver in completing OJT indicating curricula requirements. In the COJL approach, the learner is the driver while the mentor is an appointed resource to foster connections with others to get clarity on content at the time of need and provide recommendations for additional resources.
When the work products start to become deliverables, this is the biggest opportunity to check for effectiveness of the training requirements and the balance of formalness vs. autonomy. It is not only performance oriented, there are feedback loops to have more powerful conversations focused on supporting the new hire’s learning experiences and growth.
“If you are not taking the time to be specific in your feedback and connecting that feedback to learning, your direct reports won’t be successfully competent or autonomous – or motivated”, Annemarie Spadafore, 2020, p.28.
It is not intended as control, but as specifics for areas to improve, stay accountable and therefore grow. For example, if Mentors are not skilled in facilitating debriefing discussions, supervisors can ask new hires to self-report their own learning debriefs and share them with their direct supervisors as a means to guide these periodic check in conversations.
“Jay Cross believes that ‘employees thrive when given the freedom to decide how they will do what is asked of them.’”
Ideally this would happen with the direct supervisor, but it is acceptable for the mentors and designated peers to perform this formal qualification event. What can be used as evidence? The final work product of the new hires as they successfully demonstrate their job responsibilities and functions as described in their Job Description. These Q-Events formally connect the dots of the new hire’s CV to Position Requirements to Job Function and back to Job Description, documenting the full cycle.
“By focusing on the complete journey of the learner and adding structure to that journey, we will be able to better understand the impact of all elements of the learning experience”, Ken Taylor, 2019, p.3.
Let’s go back to your new hire that you are anxiously waiting for. When was the last time you reviewed her training requirements? Have priorities changed? Does she truly need to read the first 100 SOPs by the end of the month? Will you entertain the idea of letting her read and UNDERSTAND them in the flow of her work rather than by some arbitrary due date? Who would you assign as her mentor or peer buddy to help her become more engaged and integrated into the company’s culture? Are you at all interested in her post-orientation onboarding experience? Most importantly, will she prematurely leave the company because of a subpar learning experience? – VB
Curated On the Job Learning (COJL) Step
Compliance Focused Role Based Training
Read – curated curricula documents
Present the list of documents as a curated mapping for the individual in their role.
Engage – in discussions with mentor
Create a vehicle for intentional social sharing exchanges.
Apply – what you read to your task
Schedule debriefing check-ins with supervisor.
Peer – review of finished work product – Does it meet approved document expectations?
Provide meaningful feedback to increase competence and professional growth.
Sign Off – Qualification Event
Formally capture documented evidence for each identified job responsibility check point as listed in the Job Description.
Adelman, P. “Developing the Next Generation of Physician Leaders”, CLO, MayJune, 2020, 45 -47, 52.
(Argyris, 1992; Argyris & Schon, 1974; Brookfield, 1986,1990, 1993, 1995, 2000; Freire, 1970/2000; Mezirow, 1978, 1990, 2000; Schon, 1983, 1987; Tennyson, 1990, 1992; Tennyson & Breuer, 1997; Tennyson & Rasch, 1988). In National League of Nursing, “Debriefing Across the Curriculum”, International Nursing Association for Clinical Simulation and Learning, June 2015.
Blancato, E., Stanley, S. “5 Ways to Maximize Your On-the-Job Training Program”, TIQ, MayJune, 2020,40-42.
Cross, J. “Not Without Purpose”, T&D, June, 2006, 42-44.
D’Aquin, M. “5 Steps to Formally Make the Informal Part of Your Content Strategy”, TIQ SeptOct, 2019, 36-39.
Jacobs, RL, Jones, MJ. Structured On – The – Job Training: Unleashing Employee Expertise In The Workplace. San Francisco: Berrett – Koehler,1995.