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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(c) HPIS Consulting, Inc.

Remember, we are not allowed to talk about 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 see how Cara facilitates the design team of SMEs through various stages of being of team.

“Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

“But, who are you?  I mean you just can’t walk in here and change our procedures!” she retorted.

“Ah, yes, I have been vetted by Miguel, you know, the VP of Quality and have already met several of his peers during the assessment debriefing meeting.  They have all read the assessment report and agreed for these SMEs to be the design team.  You can look me up in Linked-In later if you want to.  But for now, would you like to take a seat or will you stand for the rest of the lesson?” she asked.

The timing and sequencing for the last lesson, “Foundations of Teamwork” was not accidental.  Cara set up the curriculum to build knowledge first with an immediate need to apply in order to close their knowledge and experience gap and prepare them for the much-needed discussions without getting bogged down in terminology.  This last lesson introduced them to stages of team development and what to expect as the honeymoon phase of the project faded and the real work began.  A key piece of this lesson was to emphasize how to offer a different perspective while maintaining respect to team members (their peers) rather than remaining silent when not in agreement.

(Re)-DESIGNING A SYSTEM: FUTURE STATE VISION

With these 4 lessons delivered, Cara returned to the previous assignment of marked up process flows.  Cara anticipated that most of the team might have difficulty envisioning a future state that would be different from their current state.

Design Team Readiness Curriculum

“Thank you for your time and participation in the last four meetings and special thanks for those of you who have already been trained on these concepts.  The temptation to skip it and finish other pressing work was very real and your enthusiasm to show up and attend speaks volumes to your commitment to the team and for the project,” said Cara.

But that’s not how we do it here!

“Before we delve back into these marked-up process flows, I ask that you remain open to ideas and suggestions not only from me but from your colleagues who have come from other similar companies.  It may be difficult to envision a future state that looks different from today, but please don’t let that become a barrier for you.  If you find yourself thinking or saying ‘that’s not how we do it’, then you need to ‘fess up and ask for patience’ while you recognize what state you’re in.  Can you all do this?” Cara asked.

To quiet fears that this was all a big waste of time or that “management will never buy into any of this” Cara initiated a project issues log.  She assured them that this list would be on the agenda for each weekly check-in with Miguel.  And the updates would be reflected in the weekly project status updates.  Teams often stall or lose momentum when issues and concerns go unresolved, so Cara told the team that this was also part of her role as interim project manager.

“Remember, we are not allowed to talk about change control!”

Each week the team met to redesign one process flow at a time from the training policy to curricula management to qualified trainers, training delivery, and effectiveness measures.  Cara monitored how the team shared their differing points of view and how receptive they were to work on a joint process that could be implemented across the functions not just for Operations or for the QC lab. 

Without fail, the energy and momentum would derail when the discussion found its way to the current state of their change control quality system.  Once again, the role of Cara as interim project manager was to get them back on track, future-focused, and not get mired in current barriers.  For the most outspoken member of the team, this nearly shut her down.  It was a real barrier and nearly threatened to compromise the team’s future success.

“Yes, there is no denying that change control needs to be fixed.  That what we are proposing will not fly with how it is defined today,” said Cara. 

“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.”

And then Cara directed the next question to the member in distress.

“Can you proceed with us knowing that change control is out of scope for us?” she asked.

“No.  This is the wrong priority and all this work will have to be redone because it will be rejected by the Change Control Manager when it’s all said and done!” she retorted. 

“What if you were to be the Change Control Manager, would this change your viewpoint?” asked Cara.

“No, I don’t want to be the Change Control Manager.  I just want change control fixed now,” she snapped and then shared a litany of items that were being delayed because of the backlog in change control.

“Can you proceed with us or shall we find a replacement for you?” Cara asked again.

“Let’s continue and I’ll make a decision before our next meeting,” she mumbled.

The rest of the team sat still and watched the volley back and forth.  Apparently, this was not the first time the team experienced their peer’s change control rant.  This time, however, the team was mesmerized by how Cara maintained respect while letting their peer air her frustration; truly modeling team rules and getting to the heart of the matter.  Cara practiced what she taught in the earlier lessons.  After this episode, whenever anyone even said the word change control, they joked and said: “we’re not allowed to discuss change control anymore, remember?”

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Interested in Robust Training System resources?

You might find the Redesigning Quality Systems blog series insightful. Read the series here.

Congratulations, you have been selected to be on the Design Team

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.

Miguel then went on to explain, “they don’t know how to be a team. They know even less about project management concepts like scope and project charters and they lack fundamental concepts like quality systems and systems based inspections. And they certainly don’t know about process mapping. It’s not their fault, many of them never worked anywhere else but here. They have been siloed far too long.”

In part 2, we pick up with Cara meeting the design team for the first time.

“Do you know why you are here?” asked Cara.  As expected, most of the SMEs shrugged sheepishly.  To that end, Cara provided a brief explanation of the request and then presented a high-level view of the assessment gaps to the SMEs as the basis for the project scope.

For some of you, being on a team and working with process maps is quite familiar.  Yet, there are others here today, where this will be their first project as a team of SMEs.  I’ve been asked to provide a few short introductory ‘lessons’ to help orient us around a set of ground team rules and establish a common lexicon for this project.

SME Design Team Readiness Curricula

Cara continued.  “Over the next few weeks, we will begin our time together with one of these lessons.  As a team, we will use ‘live’ aspects of our project work to illustrate the concept and apply its principles to our progress and development of a team. Let’s begin with ‘Six Elements of Robust Training System’ .”

After the lesson was presented, Cara asked the SME design team to locate the assessment report and match the gaps to the six elements.  This exercise helped the team achieve one of the learning objectives and at the same time rendered the report more meaningful for their project kick-off. 

Miguel then went on to explain, “your ‘Design Team of SMEs’ has very limited experience working cross-functionally or as a team.”

The next lesson “Launching a Project Team” introduced the team to project management 101 terms and the concept of a project charter.  The application exercise became the completion of their project charter and familiarize themselves with the project management terms being used for the RTS project. In preparation for the third lesson, the team was asked to review a set of generic training process maps and mark up their copies with comments and questions.

“Excuse Me, Who are You?”

At the beginning of the next lesson, a nominated SME stepped into the room just as Cara finished the opening of their third lesson “Process Mapping Quality System Documents”.

“Hello, are you joining us today or only staying for the presentation?” asked Cara.

“Well that depends on how you answer my question,” she replied. 

“Please sit down and I’ll do my best to answer it,” Cara responded.

But she stood in the doorway anyway and continued. 

“Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

“As I explained during the kickoff and then again during the first two lessons that you were absent from, I am not here to train you on your procedures.  These folks here are the experts on that.  I am here to work with them on your training process.  Training is a quality system and your process needs to be robust enough to handle all of the training elements within that system.  The assessment I conducted revealed many areas that are not up to today’s standards nor FDA expectations,” Cara replied.

“But, who are you?  I mean you just can’t walk in here and change our procedures!” she retorted.

“Ah, yes, I have been vetted by Miguel, you know, the VP of Quality and have already met several of his peers during the assessment debriefing meeting.  They have all read the assessment report and agreed for these SMEs to be the design team.  You can look me up on Linked-In later if you want to.  But for now, would you like to take a seat or will you stand for the rest of the lesson?” she asked.

Reluctantly, she stepped into the room and found a seat.  This third lesson oriented the team on process mapping diagram shapes and commonly used terms, as well as a balanced discussion on vertical process flows vs. horizontal “swim” lanes.  Using their marked-up copies, Cara facilitated a question and answer exercise on project management terms, concepts and flow only. 

The team was asked to continue reviewing the process flow diagrams as their homework task but this time to focus only on content within the shapes and was told that after the next lesson, the collaboration of ideas and suggestions would begin.

Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

The timing and sequencing for the last lesson, “Foundations of Teamwork” was not accidental.  Cara set up the curriculum to build knowledge first with an immediate need to apply in order to close their knowledge and experience gap and prepare them for the much-needed discussions without getting bogged down in terminology. 

This last lesson introduced them to stages of team development and what to expect as the honeymoon phase of the project faded and the real work began.  A key piece of this lesson was to emphasize how to offer a different perspective while maintaining respect to team members (their peers) rather than remaining silent when not in agreement.

Stay tuned for Part 3, where Cara works with the Design Team to envision the future state for their robust training system.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Learn more about Robust Training Systems here.

What to expect when process mapping with SMEs as teammates

Process Mapping the Redesign

While there is value in mapping the current state of the quality system, teams can often get bogged down in disagreements over the level of detail and the sequence of explicit steps.  They miss the point that a future state design is our desired outcome from this stage.  The danger lies in members becoming so entrenched in the current state, that they have difficulty envisioning any other possibilities including a better future process for the named quality system.  The gap assessment interviews and report findings were the opportunity to focus on the current state of affairs. The Project Manager can either suggest that they refresh on the gap assessment report or take 5 minutes to let design team members work out which “state” they are operating out of.

To keep the project moving forward and team members engaged, begin the process mapping sessions with a marked-up, “proposed” future state model and have the design team members identify what needs to change, be eliminated or added using the gap assessment report.  During these discussions, another layer of discovery is often revealed.  The project manager frequently learns that recommended steps suggested forms, etc. were previously included in the SOPs only to have been removed in later change control requests with limited or no rationale provided.

Use process maps to work out the process conceptually first

Occasionally, one or two members will find themselves stuck in “the way we do it here” mindset and cannot embrace the change(s) being proposed.  This is when the project manager needs to switch roles and become a facilitator (or hire one) to put into practice the training concepts from team-building like staying open-minded, respecting different viewpoints, actively listening to each other and reaching consensus.

Change is a process.  As a project manager, I could just come in and tell the design team “this is the future state and these are the SOPs and new forms you will be following.  Now, will someone help me get this packet of documents into the change control queue? We have FDA due dates to meet”.  I don’t envision any of my team will raise their hand.  Would you?  And yet, most Quality Systems redesign projects are executed this way under the guise of the SME team.  If the design team isn’t buying the need for changes, how can I expect the rest of the users to embrace it, let alone comply with the new design?

“This Will Never Work Here!”

Another barrier to staying focused on future state mindset is succumbing to the fear that “management will never buy into any of this”. A good project manager will maintain a project issues log that becomes the agenda for weekly check-ins with the sponsor.  This is why it so crucial to keep the sponsor up to date with anticipated barriers and challenges sooner rather than later during the implementation stage.  It is also wise to reflect the tracking of these items in the written project status updates.  It is the responsibility of the project manager to track resolution and report back to the team in order to keep momentum, encouragement and continued trust within the team.

If the design team isn’t buying the need for changes, how can I expect the rest of the users to embrace it, let alone comply with the new design?

Vivian Bringslimark, HPIS Consulting, Inc.

But we’ve already got our process in place!”

Once in a while, I am presented with a range of progress on implementing a Robust Training System, where some departments are very far along with their executed tasks and some departments haven’t even begun.  It’s like a race to see who crosses the finish line first.  Being first allows the department to carve its way as the best practice and the process for the rest of the organization to follow.  AKA – they like to think they can influence the policy and/or SOPs with little regard for the nuances of other department’s unique processes. So, be mindful of resistance to adapt, adjust, or even participate in design team meetings, when one group is heavily entrenched in their departmental training practices, especially the unwritten ones.

Spend the team’s meeting time wisely and focus on the process maps first.  Get a consensus on the flow diagrams before proceeding to the SOPs.  This accomplishes a number of benefits.  Having a process flow diagram keeps the discussion centered on the process conceptually and not hung up in SOP semantics.  Word-smithing comes after an agreement for the future state has been achieved. 

Another barrier to staying focused on future state mindset is succumbing to the fear that “management will never buy into any of this”.

Vivian Bringslimark, HPIS Consulting, Inc.

Include your sponsor and select executive stakeholders on the update.  This is the opportunity to inform them about major changes and anticipated impact on the organization. Be sure to speak about eliminated redundancies and/or any anticipated efficiencies gained from the future state.  Keep the discussion at the conceptual level for now.  But also be prepared to field specific or detailed concerns i.e. will this result in a change of headcount?  Note: If your sponsor or key executive stakeholder prefers “seeing” the process via printed SOP steps, accommodate this preference and have a good working draft prepared.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.