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Who is the Author, Vivian Bringslimark?

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Taking the Agile Learning Plunge

When Rapid Design for eLearning found its way into my vocabulary, I loved it and all the derivatives like rapid prototyping, etc.  And soon, I started seeing agile this and agile that.  It seemed that agile was everywhere I looked.  When Michael Allen published his book, LEAVING ADDIE for SAM, I was intrigued and participated in an ATD sponsored webinar.  It made a lot of sense to me and “I bought into the concept”.  Or so I thought …

I joined a project that was already in-progress and had to “hit the ground running to get caught up to speed”.  The element of urgency was the anticipation of a post FDA visit following a consent decree.   If you’ve experienced this “scene” before, you can relate to the notion of expedited time.   As part of remediation efforts, training events needed to be conducted.  I learned during a meeting sometime my first week, I was to be the trainer.  Okay, given my instructional design background and classroom facilitation experience, that made sense.  Sure, in a few weeks when we have the new procedure in place, I’d be happy to put the training materials together, is what I was thinking.  Wait, what, in two weeks?  Are you kidding me?  I’m not the SME and I don’t even have the software loaded on my laptop yet.  Well, some cleaned up version of those words was my response.

My biggest challenge was to get out of my own design way

I’m classically schooled in *ADDIE with 30+ years as an instructional designer and very comfortable with how to design, develop and deliver training.  All I needed was more time; more than two weeks, for a process that was changing daily!   And then I found myself thinking about all the buzz for rapid design and prototyping I had been reading about.  

*ADDIE = Analysis, Design, Develop, Implement, Evaluate: a project management approach to training projects.

In theory, I totally bought into it. But this is different I argued with myself.  This is compliance with a quality system for a company that is undergoing transformative change as a result of a consent decree!  Furthermore, I teach GMP Basics and conduct Annual GMP Refreshers several times a year. My GMP dilemma challenged the very essence of my “learned” compliance beliefs about following the 1st basic GMP Work Habit – “thou shall follow written procedures” otherwise, it’s a deviation. 

Are we really planning to deviate from the SOP while under a consent decree?

While it was the intention of the business unit leader to deviate from the approved set of work instructions, a planned deviation would not be appropriate in this case.  I mean we were talking about a corrective action for a consent decree item.  Were we really considering a PLANNED DEVIATION to intentionally teach unapproved procedures and then submit the documentation as a completed corrective action for the CAPA to the agency?  I was truly baffled by how I was going to pull this off in two weeks.  I’m not a magician, I can’t pull this rabbit out of my laptop is what I was thinking when I left the VP’s office.

Yet on the other hand, how could I teach a work instruction that was known to be broken; was being re-designed and not yet finalized?  The instructional designer side of me screamed – how can you teach flawed content?  That’s wasted training that results in scrap learning. How is that training going to be effective not to mention having to explain a failed effectiveness check during the post inspection?

And then, it hit me!  I was so focused on WHAT I NEEDED, that I was missing the urgency of the learners’ needs. Julia Lewis Satov refers to this situation as ‘agility by fire’ – “the ability to move quickly but not easily, and still excel”, (p. 50, 2020). It was time to put theory into practice and take the agile learning plunge into the realm of the unknown.  If I could come up with a way to document what we were doing and get it approved, then I could reconcile my GMP dilemma and satisfy my instructional designer. 

 With a little help from my validation colleagues – the training implementation plan

Validation engineers use protocols to capture their “change in process” work.  Whether it’s experimental batches, 3 batches for process validation or **IQ-OQ-PQ protocols for equipment qualifications.  They are validating the procedure or the new process before it can become the standard operating procedure by developing the plan, developing acceptance criteria, managing deviations and capturing the results.  So why couldn’t I borrow the concept and adapt it to my situation?

**Installation Qualification, Operational Qualification, Performance Qualification

The purpose of the initial training session was to test the new sequence of steps and confirm the robustness of the software responses for each field entry and then make correct decisions where needed.  The learners were still in compliance with the quality policy for complaint handling and were still meeting the intention for Medical Device Reporting requirements.  They were essentially testing the future “how-to steps” for the proposed new work instructions.

Agile QT’s processing their learning experience

I did not copy and paste the validation protocol template. I did, however, include a please pardon our appearance while we are under construction” paragraph in the training plan to document the departure from the current set of work instructions.  This protocol-like section also included our intentions for the outcomes of the sessions. We also stipulated that required SOP training of all affected users including the Qualified Trainers, would be mandatory once the finalized set of work instructions were approved.

Anybody want to play in the sand-box?

By shifting the prioritization away from perfectly designed classes with pristine training materials, I was able to diagnose that the need was to get the learners into a live classroom. But first I needed a small group of super users who wanted to see the database software in action and “play in the sandbox”; the training materials could follow afterwards. 

It didn’t take long for them to find me.  These “learning-agile individuals” wanted the challenge of not only learning something new but seemed to thrive on the idea that they would be managing their part of the training implementation plan.  They were not at all worried about the lack of available training materials for themselves.  They allowed the learning experience to occur spontaneously.  Their ability to learn new knowledge and skills did not get in the way of previously learned skills. They embraced the changes rather than resist them.

A new breed of SMEs as Agile Qualified Trainers?

I shifted my role to facilitator and allowed these learning agile SMEs to navigate the software screens and then work out the explanation of how to complete field transactions.  In the Center for Creative Leadership “Learning Agility” white paper, authors Adam Mitchinson and Robert Morris explain that learning-agile individuals understand that experience alone does not guarantee learning; they take time to reflect, seeking to understand why things happen, in addition to what happened”, p. 2.

“SMEs are true front-line and onsite educators” says Satov.  Every organization has employees who are brimming with intelligent and diverse ideas and are eager to share their talent producing work deliverables. “[…] Our focus must shift to finding and developing individuals who are continually able to give up skills, perspectives, and ideas that are no longer relevant, and learn new ones that are”, (Mitchinson and Morris, 2014, p.1).

We documented these sessions as training because we all learned how to navigate the screens; albeit it was learning on the fly.  We recognized that learning the software was the goal.  Developing the process steps and eventually the work instructions was the secondary goal.  This training documentation became the qualifying evidence for their train-the-trainer knowledge transfer.  And collectively they decided what choices end users were to pick from the drop down tables.  

Is this “learning on the fly” or agile learning in practice? You decide.

1 + 1+ 1 is more than 3

I shifted my role again to become a scribe and worked on sequencing these pages for the next round of end-users. To my surprise and delight, my new breed of Agile QTs volunteered to paste screen shots into participant worksheets so their “students” could take additional notes.  Together, we all collaborated to meet the urgent need of the end-users. Each of us in our niche roles experienced first-hand the value the others brought with them to that room.  And in that time away from our regular job tasks, we became more valuable to the organization.

The learners were paired up with their Agile QT for guided instruction of real entry into the live system.  The following week, the department was able to go live with a project plan that focused on a series of interim roles, changed roles and transitioning responsibilities within established roles.  The project launched on time to meet commitments promised to the agency.

Why are they thanking me?

It was an energizing and empowering learning experience for the super-users. A truly collaborative experience for the SMEs and the biggest surprise of all was that they thanked me.  Me?  I did not deliver the training; I was not the SME, nor did I provide perfect training materials.   If I had pursued my classically trained ADDIE approach, we would have waited for the perfect SOP to deliver those sessions and woefully miss FDA committed timelines. While I’m not ready to throw ADDIE overboard yet, Satov makes a compelling plea, “move aside elite and long-standing establishments of formal education”. 

My lesson learned was this: when the demand is for speed and the content design is not the key focus, I need to give up control to the true onsite educators and focus on facilitating the best learning experience given the daily change challenges and system constraints. Satov would agree, “the role of learning is to capitalize and create the architecture of the hybrid-mind”.  Is this “learning on the fly” or agile learning in practice?  You decide. But agile instructional design is here to stay if QA L&D is going to keep up with the fast-paced, often reactive, and regulated world of the Life Sciences Industries. – VB

  • Allen, M. Leaving ADDIE for SAM: An Agile Model for Developing the Best Learning Experiences. ASTD, 2012.
  • Mitchinson, A & Morris, R. Learning Agility. Center for Creative Leadership white paper, 2014.
  • Satov, JML. “Agile by Fire”, Chief Learning Office, July/ August, 2020, p. 50.
Need to expedite a CAPA remediation project? |Looking for a facilitator/ quality systems project manager to align your SMEs for collaborative deliverables?

Who is the Author, Vivian Bringslimark?

(c) HPIS Consulting, Inc.

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

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

Will the real objective please stand up?

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

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

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

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

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

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

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

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

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

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

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

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

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

Momentum Continues to Grow

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

Lesson Learned / Insights

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

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

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

Quotes

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

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About HPIS Consulting, Inc.

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

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

(c) HPIS Consulting, Inc.

I’ve Fired My Vendor. Can you help me instead?

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.

Part Two Continues next time.

Can’t wait to finish the story?

Who is the Author, Vivian Bringslimark?

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(c) HPIS Consulting, Inc.

Remind Me Again Why We Need Compliance Refreshers

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 the next 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. 

“SMEs put down those speaker’s notes and step away from the podium!” Vivian Bringslimark, HPIS Consulting, Inc.

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.  

Resource from SME as Facilitators Workshop

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.

Twice a year has fast become the new norm.

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

References:

  • 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.

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Who is the Author, Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Batteries Not Included: Not All Trainers are Instructional Designers 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. 

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, fulltime 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 fulltime trainers!   What defines a fulltime 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? 

Basic Elements of Course 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.

From passive to active to immersive

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:

  • Shift one step to right to begin the move to active learningDemonstrations
  • Case Study
  • Guided Teaching
  • Group Inquiry
  • Read and Discuss
  • Information Search.

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.

Shift to the right when ready for the upgrade

Moving from Lecture to Delivering an EFFECTIVE Lecture

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

References:

Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips.  Lexington Books, New York.

Who is the Author, Vivian Bringslimark?

HPISC Library has articles, impact stories and white papers.

SME Impact Story: The Real Meaning of TTT

White Paper: Step Away From the Podium

(c) HPIS Consulting, Inc.

Compliance Training: No More Passive Learning

Special Thanks to LTEN for Publishing this article!

Looking for inspiration to liven up a lecture? I have 10 ideas for you.

HPISC Library has articles, impact stories and white papers.

No More Boring GMP Lectures |Impact Story about how to introduce more interactivity into GMP Refresher sessions.

More GMP Resources Available here.

Available HPISC GMP Refresher Course | Looking for More Choices?

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Moving from Presenter Controlled Training to Learner Focused Facilitation

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”.

(c) HPIS Consulting, Inc.

Instructional Design: Not Just for Full Time Trainers Anymore

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.

(c) HPIS Consulting, Inc.