When Your GXP Learning Provider Becomes Your Strategic Partner

“So, they want me to ask if you would do the GMP refresher for us.”

“No.  I did the GMP Basics last year.  It’s only been 4 months and I am not going to repeat the content or water it down or “just tell them the GMPs”. 

“Well, I can’t do it by myself, not after you’ve introduced us to activities.  I don’t know how to create meaningful exercises.”

“Let me think about this some more.  What’s currently happening on site, other than last year’s 483? Do you have any updates we can use?”

“Oh, there was an audit done and you know they found stuff.  Folks are kind of hot about it, actually.”

“Okay, now we have something to work with.  I’ll do it on two conditions.  1.) That we use the audit observations and 2.) I need 90 minutes.”

“Nope, not going to happen.  No way for the 90 minutes. Oh, and they want to keep the audit observations ‘confidential’.  We’re not allowed to use them.”

“Then you’ll have to find another consultant to do it. After the training we did last year, I cannot go back to lecture only.  I built trust with your employees.  And you and I learned that we need to add time so that they can complete the quiz at the end and not feel rushed”. 

“I really want you to do it.  I will go back to the management team and tell them you said yes. But I need a proposal justifying the 90 minutes and describing what you will do with audit observations.”

The Quality of Previous Learning Provider Engagements

This organization is a leading manufacturer and distributor of regulated products.  They received Form FD-483 observations the year before.  Among the remedial actions, was a “Back to GMP Basics” training program for the entire site including indirect support and non-GMP staff.   

Not only were sessions content tailored for varying roles, but employees were also introduced to interactive exercises and collaborative activities that encouraged them to share responses with their seatmates.  For many of them, this was a totally different GMP learning experience.  Employees were no longer grumbling about the training and management was able to produce the required paperwork to the agency. 

As part of the remediation plan, the client also pledged to increase the frequency of GMP refreshers to twice a year.  Given the favorable outcome from the previous GMP Training program, it was suitable that the management team extended an offer to conduct a refresher.  What was a surprise, however, was that the management team wanted their old – “gloom and doom, thou shall follow these regulations” style of telling them the GMPs from the podium.  Why? Was this a form of punishment?  It sure felt like it.

Management Team Knew Their Priority

At the time of the above request, 4 months of the year had already transpired.  During which, a follow-up audit of their GMP systems was conducted by a separate consulting group.  The audit found numerous examples of recent noncompliance.  The site leadership team was also reminded that the 1st GMP refresher was coming due.  The head of Quality made the decision to use the GMP refresher as a corrective action for the audit.

Kudos to the Head of Quality for doing three things.  First, he recognized that the c in CGMPs was the audit findings and resulting noncompliance examples.  Two, he leveraged the resource of QA Training and demonstrated just how strategic the role should be to the organization by elevating the importance of this refresher.  He used a systems approach when he tagged the delivery of this refresher to the corrective actions for the independent audit.  This was quite novel at the time.  And third, he approved the request to provide his Training Manager some help. He connected all the dots between the independent solos!

Their Decision to Outsource

Their “GMP Trainer” was also the manager of the company-wide training database.  He was a department of one whose primary duty was data entry into a complicated and non-user-friendly training database.  Time to develop and deliver the GMP refresher was something this manager did not have.  The sooner it could be delivered, the sooner the training manager could get back to the mounting stacks of attendance records awaiting data entry.

 “Just tell them the GMPs” one more time is what the management team was originally asking for.  The learners were expected to sit and listen.  After all, they used to be scolded for poor compliance results. One employee referred to it as “shame and blame” sessions with their heads down to avoid eye contact with the presenter; especially if it was a leader from Quality Operations.

The management team wanted to bring back their learning provider and they wanted to dictate how the refresher would be conducted.  To revert to lectures only would break the trust the learners had built with the GMP Learning Provider and jeopardize any successful transfer of behavior change to the workplace.

Corrective Actions are supposed to remediate, right?

The independent audit revealed several examples of non-compliant actions taken.  When categorized, these actions clustered around three main areas.  If the “corrective actions training” aka the GMP refresher was going to remediate these findings, just telling them what the regs say without any discussion or collaborative processing of what these examples were showing, would have no effect on eliminating or reducing further GMP “mistakes”.  What did the management team expect to happen because of the training?  I imagine no more examples of GMP violations?  

Aligning Business Needs with Quality Objectives Yield a Strategic Focus

Shifting the behavior towards appropriate compliance begins with shifting mindsets around compliance.  Working with the three categorized areas, the management team agreed to the following three business outcomes:

  1. Continued commitment to comply with our GMP Work Habits
  2. Follow Good Documentation Practices for our controlled documents
  3. Perform our responsibilities for operating equipment in our work areas

While these outcomes were great goals, they were also very broad and hard for learners to put into daily practice; let alone change their behavior.  Effectiveness checks for training was another commitment to the agency as part of the GMP Training program improvements.

Furthermore, measuring the effectiveness of the GMP refresher training would require more than a knowledge check if behavior change back at the workplace was their end game.  What would the CAPA effectiveness checks look like for this corrective action as well? Recall, the two quality system activities were now interlinked.

In further discussions with the Head of Quality, the business outcomes were transcribed into quality themes and key messages.  These then drove the decisions for specific content pieces and activities that targeted what compliant behavior should look like regarding the 3 quality themes. 

To further quell any negative ramifications using audit findings, the chosen examples were approved by the Head of Quality and a courtesy copy of the refresher materials was provided to the management team in advance. 

Designing, developing, and delivering the refresher course topics with even more interactive opportunities all the while ensuring that the previous GMP Basics content was refreshed, not just repeated, became the basis for the activities.  It was analogous to “a Part 2” in which employees were allowed to “interact” with both the regulations and real-time scenarios (selective audit observations). 

When a Learning Partnership Works

One of the advantages of working with a previous learning provider is the ability to create an ongoing learning path built upon previously delivered content; not just provide a “canned” presentation on the requested topic.  There is a willingness to work with internal resources and integrate existing artifacts such as audit findings into the course design so that the organization achieves its business outcomes beyond just closing the CAPAs and getting a checkmark for delivering the first of two promised refreshers. 

Value and Impact: Training Effectiveness Results

  • Assembling into pairs and groups was achieved in less time than when first introduced in the GMP Basics series.  The Learning Provider now had credibility and the employee’s earned trust. The relevance of the audit finding examples kept employees engaged with many of them asking private questions at the end of the sessions.  This was unheard of previously, thus initiating the “transfer back to my job”.  They were thinking about how these examples and the GMP content applied to them.
  • A 5-question quiz was administered as part of their effectiveness training check.  This is the classic tool for knowledge comprehension and their newly revised SOP now included Knowledge Checks (KCs) for GMP Training.  400+ employees completed the quiz.  The mean score was 91% with several achieving 100% and a few failing scores.

Why Knowledge Checks Don’t Tell the Whole Story …

Using an item analysis can reveal a lot of information about the construction of the GMP KC questions.

As always, it is possible that some memorization and sharing the correct lettered responses happen despite that there were three versions of the KC.  It is also possible that some folks do not take the time to read questions thoroughly.  And some folks don’t recognize when “all of the above” choice applies.  They are in a rush to exit the class. 

Pay attention to incorrect responses that are clearly wrong as in they don’t make sense.  It may indicate a “cheating trend” if only one version of a quiz is provided.  In this case, three versions of the quiz were used.

When responses are troubling; a follow-up discussion with an SME or a “legacy” employee is needed to determine if an old, outdated, and non-GMP practice was acceptable at one time.  Knowing this gives some insight into why it was chosen but disheartening that the behavior is still prevalent.  If the behavior is still happening, it warrants further discussions with site leadership and the Head of Quality.  It may be isolated to a few individuals and can be managed via the HR performance management system.

Sometimes verbal responses to a question in class, don’t match the chosen response in the quiz.  The quiz results could be a matter of confusion with the wording of the question especially for Assessment A in which the question had a NOT worded in it, rendering the answer to be False.  It’s akin to a double negative and it trips up a lot of people who are not test-savvy.  So be careful with questions that can be confusing or tricky.  For this client, it was worded to capture a real scenario that happens in the industry. 

This client was urged to address failing scores; results below 80%.  Their Training SOP had recently been revised to include formal assessments for GMP Training and Critical Task SOPs as part of their effectiveness checks for training.

  • The priority for the refresher was agreed to by the site management team and communicated to everyone during the sessions.  The FDA remediation plan was still a focused site objective, and this refresher was part of those activities; not something in addition to like an after-thought or add-on.
    • Three outcomes were identified as the business needs and became the driver behind content and decisions for activities. The “Big Why” for this refresher was clear and compelling.  Tangible work-behaviors were user-generated for peers to model as examples of complying with the GMP Work Habits.
    • There was continuity with previous GMP content.  The existing GMP Learning Provider connected the dots with prior content and reinforced the relevancy and importance of the GMP Work Habits.  Rapport was re-established and on-going trust for an engaging and interactive session of 90 minutes was achieved.  Minimal repeat of previous content; refresh enough to complete an activity.
  • Learning Provider negotiated with Site Management Team on behalf of the Learners Needs: to include real workplace audit observations and an additional 30 minutes of classroom time that included the GMP quiz and debrief of the correct answers. Employees left each session with the correct responses to 5 questions; their final take away from the sessions.
  • The design followed a 3-step learning model: Learn, Experience, Apply. 
    • Learn: Short lectures or vignettes was used to learn/refresh on content. 
    • Experience: Variety of ways in which the Learners engaged with the audit observations; not just a slide for each observation but small group discussion and tangible activity to complete and report back on.
    • Apply: peer feedback, debriefing.

Are you thinking about outsourcing your next compliance?  Why not form a training partnership with an industry GXP Learning Provider?  -VB

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When to Outsource Your GMP Refresher

Tips for Writing KCs

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About Vivian Bringslimark, President of HPIS Consulting, Inc.

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I’m in love with my own content!

Many QA /HR Training Managers have the responsibility for providing a train-the-trainer course for their designated trainers.  While some companies send their folks to public workshop offerings, many chose to keep the program in-house.   And then an interesting phenomenon occurs.  The course content grows with an exciting and overwhelming list of learning objectives.

The supervisors of these SMEs struggle with the loss of productivity for the 2 – 3 day duration and quickly develop a “one and done” mindset.   Given the invitation to “train” newly identified SMEs as Trainers, the QA Trainer gets one opportunity to teach them how to be trainers.  So s/he tends to add “a lot of really cool stuff” to the course in the genuine spirit of sharing, all justifiable in the eyes of the designer.  However, there is no hope in breaking this adversarial cycle if the Training Manager doesn’t know how to cut his/her own content.

From 16 to 8 to two 4hr blocks of time

I used to deliver a two-day (16 hour) workshop for OJT Trainers. I included all my favorite topics.  Yes, the workshop was long.  Yes, I loved teaching these concepts.  I honestly believed that knowing these “extra” learning theory concepts would make my OJT SMEs better trainers.  Yes, I was in love with own my content.  And then one day, all that changed.

Do they really need to know Maslow’s Hierarchy of Needs?

During a rapid design session I was leading, I got questioned on the need to know Maslow’s Hierarchy of Needs.  As I began to deliver my auto-explanation, I stopped mid-sentence.  I had an epiphany.  My challenger was right.  Before I continued with my response, I feverishly racked my brain thinking about the training Standard Operating Procedures (SOPs) we revised, the forms we created, and reminded myself of the overall goal of the S-OJT Program.  I was searching for that one moment during an OJT session when Maslow was really needed.  When would an OJT Qualified Trainer use this information back on the job, if ever I asked myself?

It belongs in the Intermediate Qualified Trainers Curriculum, I said out loud.  In that moment, that one-question exercise was like a laser beam cutting out all nice-to-know content.  I eventually removed up to 50% of the content from the workshop!

Oh, but what content do we keep?

Begin with the overall goal of the training program, not just the TTT course: a defendable and reproducible methodology for OJT.  The process is captured in the redesigned SOPs and does not need to be repeated in the workshop. 

Have you flipped your OJT TTT Classroom yet?

Seek agreement with key stakeholders on what the OJT QTs are expected to do after the workshop is completed.  If these responsibilities are not strategic or high priority, then the course will not add any business value.  Participation remains simply a means to check the compliance box.  Capture these expectations as performance outcomes.

How to align the purpose of a course to business goals

Once there is an agreement with the stated performance outcomes, align the learning objectives to match these.

Performance outcomes are not the same thing as learning objectives

Some folks might say that I’m mincing words, but I beg to differ.  The expectations for training delivery are that participants learn the content, aka learning objectives, and then use or apply them back on the job thus improving departmental /organizational performance.  Are you providing the training and then keeping your fingers crossed that they can deliver on their performance outcomes? Are you including practice activities within the workshop? This ensures that learners have an opportunity to begin the transfer process. And the facilitator is able to complete formative assessments in real-time while providing immediate feedback where needed.

Yes, there is still ample room in the course for learning theory, but it is tailored for the need to know only topics. When challenged to add certain topics, the instructional designer now refers to the performance objectives and ranks the consequences of not including the content in the workshop against the objectives and business goals for the overall program.

What happens when the Instructor is over-ruled by their boss? Read Robert’s learning journey here.

What is the value of the written assessment?

With the growing demand for training effectiveness, the addition of a written test was supposed to illustrate the commitment to compliance expectations around effectiveness and evaluation.  To meet this client’s need, I put on my former teacher hat and created a 10 question open book written assessment.  This addition resulted in needing additional time to execute and hence, more content was cut to accommodate the classroom duration.

My second epiphany occurred during the same rapid design project, albeit a few weeks later.   What is the purpose of the classroom written assessment when back on the job the OJT QTs are expected to deliver (perform) OJT; not just know it from memory?

The true measure of effectiveness for the workshop is whether they can deliver OJT according to the methodology, not whether they retained 100% of the course content!   So I removed the knowledge test and created a qualification activity for the OJT QTs to demonstrate their retained knowledge in a simulated demonstration using their newly redesigned OJT checklistIf I’m asking for 8 hours of time to deliver a workshop, it must be value-added.  -VB

Find out what happens when the most critical aspect of a course is “accidentally” left out.

I’ve fired my vendor! Can you help me? |HPISC Impact Story

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Blog: Compliance Training: No More Passive Learning

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.

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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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, 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? 

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:

  • Demonstrations
  • 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?

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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.