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.
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.
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Who is the Author, Vivian Bringslimark?
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