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.

May I See Your Implementation Plan for this Change Control?

In Part 1, we find Cara, a performance consultant has been hired to help a former client with implementing a robust training system. After waiting 3 months for the executive leadership group to get aligned around the priority for Miguel’s RTS project, Cara finally got to debrief her assessment findings. But a new development surfaced that was unexpected.

In part 2, we observe how Cara brings her inexperienced design team up to speed on how to be a team.

In part 3, we learned how Cara facilitated the design team of SMEs through various stages of working as a team to manage internal politics and a team member’s personal agenda.

In this Final Part of the Change Readiness Gap Impact Story, the design team launches and gets a surprise visit from the agency.

“But future state is being designed on the assumption that change control will be redesigned first.  We still have a lot of preparation work to do before we are even close to submitting these for change control.  And that is why change control is out of scope for this team.  We will not delay our deliverables because we decided mid-stream to go fix change control first.   There are plans for a change control project team to begin and some of you may be tapped to participate.”

After the change control rant from their distressed team mate, whenever anyone even mentioned the word change control, they joked and said: “we’re not allowed to discuss change control anymore, remember?”

Robust Training System SOPs: IMPLEMENTATION: The GO-LIVE STRATEGY

Through the efforts of Miguel negotiating behind the scenes, a new quality manager, Stuart, was hired right as the team began to work on the implementation strategy.  The timing was ideal because the team was ready to present their recommendations on how to go live and this was Stuart’s first priority.

Meet your new project leader

While Stuart got caught up to speed and completed his onboarding tasks, Cara transitioned out of the project manager role and back into external consultant mode.  The team had successfully designed their process flows and together decided the number of procedures that made sense for the organization as well as where to park the content.  They collaborated on the design of forms while leaving room for flexibility given the nature of work for each department.  The team had two proposals that competed with each other and Stuart, now fully up to speed weighed in with his decision.

Critical vs Important Focus

Critical vs. important: OJT documentation or curricula accuracy

The first proposal mapped a path forward based on OJT as the priority.  This was clearly identified in the gap assessment report and what appealed the most to the executives given their business objectives.  The second proposal was logical and made more sense to start from an overhaul of the curricula; ensuring that the training and qualifications were the right requirements for the right roles.  At the next meeting, Stuart took the lead and announced that he chose the curricula proposal and would defend this choice to Miguel and the executives as his first major task assignment.

Stuart was successful in his curricula proposal pitch with the executives.  He was able to make a compelling argument for both efficiency and effectiveness.  His next task was to finalize the implementation plan.  So he asked the team to meet once again to refine the “Go-Live Strategy”. 

“Please Pardon Our Appearance”

In order to move forward with the necessary tasks, the team needed the authorization to complete the work using the newly designed forms and process without approved Standard Operating Procedures (SOPs).   Releasing the new design before the sub-tasks were complete, would create an “out of compliance” situation at the onset of launch.  And yet, going forward without an approved procedure also put them in SOP violation status.

GMP Redesign SOP Dilemma

As part of the team’s drafted implementation plan, Stuart generated a change control package that documented the project, articulated the necessary steps, included the process flow diagrams as well as the forms.  Included in this packet, was the timeline for execution.  The effect of this documentation was to communicate that all these changes were not out of control but rather a controlled and planned change in the current procedures in order to make them standard once the subtasks were in place such as the updated position curricula.

Delivering the Qualified Trainers Workshop was a critical implementation task that needed to be timed with the SOP roll out.  The day before the Qualified Trainer’s workshop was to be delivered by Cara, Stuart called Cara and announced that a regulatory inspection was to begin on the same day.  While disappointed with the delay, Cara was optimistic that the training portion of the inspection would be favorable.   One month later, Stuart phoned her back.

“Can you deliver the workshop next week?” Stuart inquired.

“Yes, I’ll clear my calendar.  But how did training do?”

All in all, it went well.  We have some issues of course,” Stuart added.

“What about the training implementation plan? Was it accepted or challenged?” Cara asked.

“Well, we didn’t get cited for being ‘out of compliance’ so that was good.  But it was clearly stated that the plan MUST be executed ASAP! Hence, the reason for my call, today,” he answered.

Cara was pleased to hear that the Robust Training System (RTS) training project finally became a “Top Site Priority”.

END RESULT: Future State is now Current State

A few months later, Cara also delivered a GMP Basics course and qualified the site trainer to deliver it routinely as per the new training procedures. The RTS project was now officially closed and life as new normal began.   Their next follow up inspection was favorable.  A few minor issues and some verbal comments for training.  With this earned “regulatory approval”, the company was able to move forward with plans for launching their new product.

LESSONS LEARNED: Breaking down silos one meeting at a time

While the project team of SMEs learned how to collaborate in order to achieve project charter deliverables, the business units were very much still entrenched in their functional silos, defending current practices.  Deviating from approved procedures, even with a regulatory recommendation to prioritize the execution of the training plan, was not well received.  Stuart and his staff faced resistance from front-line supervision with right-sizing their curricula.  Through determination and persistent “working meetings”, the curricula sub-project finished.

Given the curricula “battle”, Stuart initially backed off from communicating the big project picture in the hopes that early accomplishments would inspire the front line to continue with the tasks and not overwhelm them with too much change at once.  

Instead, the OJT checklist sub-project was also slow, tedious, and a struggle.  Incumbent subject matter experts (SMEs)were reluctant to share their expertise or participate in the generation of the OJT Checklists, let alone be required to use them and not change the content without following the change control process.  Ironically, as new SMEs were vetted, the quality of the content improved and the checklists became a non-issue.

KEY TAKEAWAYS:

  1. The decision to delay project launch until Miguel felt confident that the executive leaders would sponsor the project and approve resources for the design team was paramount for keeping the momentum going forward after the initial launch meeting.
  2. Miguel recognized early on that the identified design team SMEs needed a specially developed curriculum to prepare them for the challenges that lay ahead.  The first four meetings as introductory lessons provided context as well as content and established the project lexicon while reinforcing team ground rules.
  3. Being prepared to defend the change control packet and explain the “Go-Live” Implementation Plan with FDA investigators not only gave credence to the project but it also elevated the importance of plan execution and made completion an urgent priority. -VB

Who is Vivian Bringslimark?

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Do I really need a Go-Live Strategy for Redesigned SOPs?

Develop Your Go-Live Strategy Before Opening up a Change Control Request

Don’t underestimate what Go-Live will look like the day the new SOPs go into effect.  The overall project plan may reflect one lined task – [Go-Live] and the date, but who is responsible for making it happen?  Doc Control administration hits a button and the eDoc system sends out a notification or perhaps folks find out about the revisions and effectiveness date from their LMS notification. What else needs to be done, you ask?  Actually, a lot of things and without a detailed plan of assigned tasks or a set of instructions, the first week of Go-Live could be disastrous if not managed well.  Whether it is broken down further in the project plan or contained in the communication strategy, the plan needs to drill down into specifying how tasks and activities will be managed, by whom and by when. 

5 Basic Steps for a GO-LIve Plan
Steps to take BEFORE draft SOPs are sent to Doc / Change Control

Go-Live: Step 1 – Transition Options

Most quality system redesigns include more than one SOP.  Sometimes the project includes multiple work instructions that are designed to work in tandem.  Releasing one without the other automatically creates a departure from the new SOP.  One approach design teams take is to release the package all at once.  Other teams decide to release serially, one after the other with timed intervals to manage the learning curve. Other approaches include pairs or high priority clusters similar to a wave or a phased tactic.  All have their advantages and disadvantages. 

And all need an impact assessment that examines the details about what will change, how that change will be handled and how many users will be involved.  In other words, how many tasks could be out of compliance when the procedure(s) goes into effect?  Will the release shut down the organization on Day 1?

Now vs. Later – Timing is Everything!

A few years ago, a client received a pretty involved FD-483.  One of the corrective actions was to enhance the Training Quality System.  So, a project team was deployed, process maps verbally approved, and the revised SOPs were in various stages of being ready for a field test.  The design team was concerned that SOP decisions for in-process drafts could impact the final drafted SOPs significantly. The team needed to be able to update a final draft SOP immediately without getting bogged down in their change control process.  Not to mention managing a new round of awareness training that could change a week later!

So, as part of the Go-Live strategy, a decision was made to schedule the release of the procedures all at once when the final set of SOPs were ready to go to Change Control.  It was determined (assessed), that too many little changes for the Training System would result in confusion, retention issues, and a paperwork nightmare controlling which version of the form was correct.  This is a popular option for design teams because the coordination of new changes happens on the same day and is much easier to track. Albeit the learning curve can be high as the site works on closing the size of their change gap.

During the development of the last set of SOPs, FDA conducted a follow-up visit for the FD-483.  One of the training CAPAs was not yet completed. It was waiting for the redesigned set of procedures to go into effect.  The new version would encompass this observation and essentially close it out.   Unfortunately, this incomplete CAPA created a hold for product to be released.  As a result, the priority to complete a retrospective qualification of 700(+) “trainers” derailed the Training Quality System project for close to 4 months.  Additional immediate fix CAPAs were also generated.  Ironically, these CAPAs could have been avoided if the design team chose the serial release option. 

Go-Live: Step 2 – Who Will Do What, When?

Establish roles, responsibilities, and priorities for the transition period.  This means identifying the beginning and end date for the transition from what we used to do to what we will do by what date. When do we anticipate being fully operational with the new procedures?  Is the end date automatically the day the procedures go into effect? Or is there a sequence of tasks that need to be executed before the Go-Live date? Have those tasks been assigned to individuals with clear expectations and due dates?

We’re Still Open During Our Construction Phase!

One client began their Go-Live Strategy with Step 2 to help assess the impact of the changes to her organization which dictated the decision to release each SOP serially; one at a time.  Using a worksheet, each targeted SOP was listed vertically while impact criteria were listed horizontally.  The team need to “see” associated form numbers, cross-referenced SOPs, the actual impact, mitigation steps, how to transition, other impacted documents, disposition status and dates of those other documents and of course next steps. 

With careful examination of what tasks, forms, and steps were actually changing, the Project Lead was able to realistically determine how much time it would take to mitigate the impact.  Subtasks such as final form revisions and revisions to other documents were being monitored and project tracked as well. 

This information shaped a pragmatic and timed sequence of events. Resulting in the conclusion that releasing one SOP at a time was the most effective way to transition into the future state with minimal disruption despite that the overall policy document would have to be revised multiple times during the transition period.  The project lead volunteered to be the taskmaster on those subsequent policy changes and updates for the stakeholder briefings.

What else needs to be done, you ask? Actually, a lot of things and without a detailed plan of assigned tasks or a set of instructions, the first week of Go-Live could be disastrous if not managed well.

Vivian Bringslimark, HPIS Consulting, Inc.

Included in this impact assessment were numerous immediate response CAPA corrective actions.  It was vital to ensure that future state procedures did not eliminate commitments that were made to the agency.  These CAPAs resulted in subprojects that also needed to be managed within the overall quality system redesign project.  Given the scope of these projects, completion dates were projected to be 6 – 9 months out.  Yet, the future state quality system procedures were expected to be operational way before these subprojects came to fruition. 

In essence, the day the SOPs went into effect, the site would automatically be out of compliance and numerous deviations would have to be initiated.  To manage the SOP change gap, an overarching CAPA was approved to allow the organization to meet agency milestones and move forward with the new process while working on the subprojects.   With each planned release of a future state SOP, the impact assessment worksheet was updated with feedback including future release notes.

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Catch up on the previous redesigned Quality Systems blogs here.

Who is Vivian Bringslimark?

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