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.

Are all your SMEs Qualified Trainers?

I got a phone call from my Lead SME’s boss one morning. “How many more sessions do you need”, I asked him. I had already delivered 4 back-to-back workshops with class sizes of 25-30 SMEs; which was beyond optimal. So I asked him why. I needed to find out what was driving the surge in identified Qualified Trainers (QTs). I learned that a retrospective qualification needed to take place in order to close out an inspection observation. The total number of SMEs needing “proper paperwork” was well over 700. Since the redesigned training system was now in effect, these undocumented SMEs as Trainers would have to follow the new procedure. Or would they? Our discussion shifted to what type of training these SMEs will be delivering.

I then shared a related story with him. Several years prior, I got entangled with a “CAPA crisis” that involved QTs. No sooner did we launched the QT program and put the new procedure into effect, the CAPA quality system temporarily shut down shipping over a weekend. Upon return to the site, I was summoned to an emergency meeting from the security gate. Amazingly, a new practice/rule that only a Qualified Trainer can conduct training evolved from “only OJT QT’s can deliver OJT and perform Qualification Events” as per the SOP! This was clearly a case of misunderstood scope.

Does every SME need to be qualified as a Trainer?

Trainers Grid for determining QTs Scope of Training

In the Life Sciences arena, there are 5 recurring situations that require training: Self, Corrective Actions, Classroom (ILT), Structured OJT, and Qualification Events (Final Performance Demos).

Self can be achieved by the individual reading the procedure and signing the training record. This is also known as Read & Understand (R & U) for SOPs. I personally don’t think of it as training, it is reading. Yet, in some situations, reading is all that is required to gather the SOP information.  If on the other hand, you need to execute the steps of the SOP and complete required forms, then additional training with the SOP Author or a QT is the appropriate next level of training.

Deviations/ Corrective Actions stemming from a Corrective Action Preventive Action incident. Minimally an SME or the SOP Author is needed to ensure the credibility of the content. These types of training sessions have become known as Corrective Actions “Awareness” Training.  And more and more SMEs are now being required to deliver this training in a classroom setting.  They need to be qualified to deliver classroom sessions especially if the event is related to a significant CAPA or regulatory inspection observation.

Classroom (Instructor-Led Training) is preferred for knowledge-based content affecting a wide range of employees. The skillset needed is facilitation / managing the classroom and delivering content as designed by the instructional designer. Think of GMP Refresher sessions in the Training Room.

Years ago, it was a lot clearer to distinguish between classroom trainers and SMEs as OJT Trainers.  OJT was delivered 1-1 by “following Joe/Jane” around.  Classroom Trainers delivered their content in a classroom of many learners using slides, flipcharts, and handouts.  They were usually full-time dedicated training staff.  Instructor-led training requires training in learning theory design and practice in what used to be referred to as platform skills.  Today, it is more commonly known as “Running a Classroom” or “Basic Facilitation Skills”.  

Many of today’s OJT QTs are also being requested to deliver “Group Training” sessions on content found within their SOPs.  While the target audience may be the same set of peers, the scope, objectives, and tools used to deliver instructor-led training is vastly different from the OJT train the trainer course.

Group Training vs. OJT
Are your QT’s becoming Duo-Purposed?

Structured OJT is On the Job Training delivered by a Qualified OJT SME using the approved OJT Methodology. OJT QT’s attend the Qualified Trainers Workshop which focuses on the OJT Steps Model, how to perform the equipment, and complex SOPs via hands-on and the challenges of Life as a Trainer.  Should every seasoned employee become a QT based on their seniority and subject matter expertise? No, not necessarily.  Because there are some SMEs that don’t want to share their knowledge and therefore, may not make an effective OJT Trainer.  Establishing a set of nominating criteria provides an objective rationale for additional interpersonal qualities that help define a more well- rounded SME. 

Qualification Events (the Final Performance Demonstration) are formally documented observations of learners performing the procedure/task at hand in front of a Qualified OJT SME using an approved SOJT Checklist or rubric.  It is these events that set apart a Technical SME from a Qualified Trainer.  The QT workshop includes a dedicated lesson on what to look for during Q-Events and what the QT signature means for the integrity of the Employee Qualification Program.

Can having too many QTs be a problem?

It can be when there is no one else to train; to deliver OJT steps. While many of you may be wishing for this situation, it can eventually happen if staffing levels are adequate, shifts are normalized and SOPs revisions are managed via R & U only with the LMS.   How do you keep your QTs engaged and fresh if there are no opportunities for OJT sessions? I have some ideas for you to explore.

Re-examine the practice of online R & U only for SOP revisions.  I bet some of those revisions were significant enough for a face to face discussion (aka Group Training)  and there is probably at least one SOP revision in the past year that should have required a demonstration of task for optimum transfer of learning back on the job.  *Just because all employees are now qualified, doesn’t mean the program sits in hiatus waiting for new hires to join the company

When you have too many QTs who may be underutilized, it is also an appropriate time to administer the Trainer Mojo Assessment.  Based on the QTs scores, it might be time to say thank you for a job well done for the low scoring QTs.  You may be pleasantly surprised by who is ready to walk away from the training role?  Or you may have a cadre of QTs who legitimately need more training and hence, the need for some new modules is now justified.  Many of your excess SMEs were identified long before criteria was put into a place or the SOP was established.  If the Trainer Mojo Assessment doesn’t bring any discussion, perhaps it’s time to “re-nominate” them using the criteria within the SOP and offer a refresher series on the QT Workshop content. Or arrange for developmental assignments that expand their subject matter expertise or advances their training repertoire into a classroom facilitators? 

What is exciting for me is that many OJT-QTs are stepping up and volunteering to attend the SMEs as Classroom Facilitators workshop as part of expanding their QT’s toolkit.  Many of them want to learn more about teaching peers and working with adults.  A few have now become promoted to full-time trainer for L&D /QA departments.  Which of your OJT QTS are ready to step up and move into the classroom?  It’s time to find out and be part of the current trend.  -VB

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(c) HPIS Consulting, Inc.

The Big Why for Deviations

As part of my #intentionsfor2019, I conducted a review of the past 10 years of HPIS Consulting.  Yes, HPISC turned 10 in August of 2018, and I was knee deep in PAI activities.  So there was no time for celebrations or any kind of reflections until January 2019, when I could realistically evaluate HPISC: vision, mission, and the big strategic stuff.  My best reflection exercise had me remembering the moment I created HPIS Consulting in my mind.

Human Performance Improvement (HPI) and Quality Systems

One of the phases for HPI work is a cause analysis for performance discrepancies.  The more I learned how the HPI methodology manages this phase the more I remarked on how similar it is to the Deviation /CAPA Quality System requirements.  And I found the first touch point between the two methodologies.  My formal education background and my current quality systems work finally united.  And HPIS Consulting (HPISC) became an INC.  

In my role of Performance Consultant (PC), I leverage the best techniques and tools from both methodologies.  Not just for deviations but for implementing the corrective actions sometimes known as HPI solutions.  In this new HPISC blog series about deviations, CAPAs, and HPI, I will be sharing more thoughts about HPISC touch points within the Quality Systems. For now, lets get back to Big Why for deviations.

Why are so many deviations still occurring? Have our revisions to SOPs and processes brought us farther from a “State of Control”? I don’t believe that is the intention. As a Performance Consultant, I consider deviations and the ensuing investigations rich learning opportunities to find out what’s really going on with our Quality Systems.

The 4 cross functional quality systems

At the core of the “HPISC Quality Systems Integration Triangle” is the Change Control system.  It is the heartbeat of the Quality Management System providing direction, guidance and establishing the boundaries for our processes.  The Internal Auditing System is the health check similar to our annual physicals; the read outs indicate the health of the systems.  Deviations/CAPAs are analogous to a pulse check where we check in at the current moment and determine whether we are within acceptable ranges or reaching action levels requiring corrections to bring us back into “a state of control”.  And then there is the Training Quality System, which in my opinion is the most cross-functional system of all.  It interfaces with all employees; not just the Quality Management System.  And so, it functions like food nourishing our systems and fueling sustainability for corrections and new programs.

Whether you are following 21CFR211.192 (Production Record Review) or ICHQ7 Section 2 or  820.100 (Corrective and Preventive Action), thou shall investigate any unexplained discrepancy and a written record of the investigation shall be made that includes the conclusion and the follow up. Really good investigations tell the story of what happen and include a solid root cause analysis revealing the true root cause(s) for which the corrective actions map back to nicely.  Thus, making the effectiveness checks credible. In theory, all these components flow together smoothly.  However, with the continual rise of deviations and CAPAs, the application of the Deviation /CAPA Management system is a bit more challenging for all of us.  

Remember the PA in C-A-P-A?

Are we so focused on the corrective part and the looming due dates we’ve committed to, that we are losing sight of the preventive actions? Are we rushing through the process to meet imposed time intervals and due dates that we kind of “cross our fingers and hope” that the corrective actions fix the problem without really tracing the impact of the proposed corrective solutions on the other integrated systems? Allison Rossett, author of First Things Fast: a handbook for performance analysis, explains that performance occurs within organizational systems and the ability to achieve, improve and maintain excellent performance, depends on integrated components of other systems that involve people. 

Are we likewise convincing ourselves that those fixes should also prevent re-occurrence? Well, that is until a repeat deviation occurs and we’re sitting in another root cause analysis meeting searching for the real root cause.  Thomas Gilbert, in his groundbreaking book, Human Competence: engineering worthy performance tells us, that it’s about creating valuable results without using excessive cost.  In other words, “worthy performance” happens when the value of business outcomes exceeds the cost of doing the tasks.  The ROI of a 3-tiered approach to solving the problem the first time, happens when employees achieve their assigned outcomes that produce results greater than the cost of “the fix”. 

Performance occurs within three tiers

So, donning my Performance Consulting “glasses”, I cross back over to the HPI methodology and open up the HPI solutions toolbox.  One of those tools is called a Performance Analysis (PA). This tool points us in the direction of what’s not working for the employee, the job tasks a/or the workplace. The outcome of a performance analysis produces a 3 tiered picture of what’s encouraging or blocking performance for the worker, work tasks, and/or the work environment and what must be done about it at these same three levels.  

Root cause analysis (RCA) helps us understand why the issues are occurring and provides the specific gaps that need fixing.  Hence, if PA recognizes that performance occurs within a system, then performance solutions need to be developed within those same “systems” in order to ensure sustainable performance improvement.  Otherwise, you have a fragment of the solution with high expectations for solving “the problem”.  You might achieve short-term value initially, but suffer a long-term loss when performance does not change or worsens. Confused between PA, Cause Analysis and RCA? Read the blog – analysis du jour.

Thank goodness Training is not the only tool in the HPI toolbox!   With corrective actions /HPI solutions designed with input from the 3 tiered PA approach, the focus shifts away from the need to automatically re-train the individual(s), to implementing a solution targeted for workers, the work processes and the workplace environment that will ultimately allow a successful user adoption for the changes/improvements.   What a richer learning opportunity than just re-reading the SOP! -VB

  • Allison Rossett, First Things Fast: a handbook for Performance Analysis; 2nd edition 
  • Thomas F. Gilbert, Human Competence: Engineering Worthy Performance
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