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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