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.

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.

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How Big is the Change Readiness Gap – Part 1

This blog is Part 1 of an impact story about recognizing what a robust training system (RTS) meant for the future of a small vitamin and supplements company.  But first, they needed to build their change foundation in order to sustain their desired state.

First comes awareness: discovering where the gaps are

Miguel finished his preliminary assessment of the company’s quality systems as part of his first 90 days task list.  The Training Quality System was the last one on his list.  He sighed.  This is not going to be easy, he said to himself.  With so many systems needing to be updated, I cannot do this alone, he concluded.  So, he clicked on his laptop and located a recent congratulations email from a LinkedIn contact who happened to be a performance consultant (PC).  In the subject line, he typed, “I need your help, got time to chat?“.

Miguel explained to Cara the PC, that he was recently hired as VP of Quality.  His first major initiative was to get the organization ready for a comprehensive systems-based inspection.  They had been successfully producing products with sales above forecasted targets for several years now.  Previous regulatory inspections were favorable and did not indicate GMP compliance issues that couldn’t be mitigated with a few minor procedure updates.  “So, the Board of Directors decided it was time to launch a new product line and become a commercial manufacturer”.  He took a breath and continued.

“What I am finding is that they have very basic rudimentary systems for making OTC supplements, but without upgrading the quality systems, they (we) will not pass a full-blown inspection, I’m afraid,” Miguel said.

To which, Cara asked, “What about training?  What’s in place?”

Nothing, really.  I mean they have a procedure and all, but it’s not like what you did for me last time.  It’s nowhere close to today’s standards or FDA’s expectations.

Current State of Affairs

Miguel then went on to describe the small QA Training staff, their reporting structure and then asked when Cara could be on site.  She refreshed Miguel on her approach and reiterated that an assessment of the current state was in order.  He gave her the contact information for his Quality System Manager and ended the call relieved that his PC was available and interested in helping him succeed with his initiative. 

After two days of back-to-back interviews and a review of the requested documents, Cara wrote the report with recommendations and arranged for a conference call with Miguel and his site trainer.  With observations confirmed, the remainder of the discussion focused on a review of the project phases in which the recommendations would be implemented.  Cara requested an on-site meeting with the primary stakeholders to debrief the findings and provide an overview of the Robust Training System (RTS) project.  Together they were going to be asking for a team of cross-functional resources.  Miguel agreed it was a good idea and they set a date and time. 

“… but without upgrading the quality systems, they (we) will not pass a full-blown inspection, I’m afraid,” Miguel said.

Is training really a priority?

The day before the meeting, Miguel learned that his boss would not be on-site and therefore unable to attend the meeting.  He called his PC and together they picked a new date; one month out.  Once again the meeting was canceled due to the unavailability of Miguel’s boss and his peers to attend a 60-minute briefing on what they all deemed was a critical and important project for the company’s future state.  This time, Miguel did not automatically re-schedule.  Instead, he postponed the meeting indefinitely.

Three months later, he contacted Cara.  “I apologize for the delay.  I believe we are now ready to have you come back on-site,” he said.

“Okay, this is great news.  What happened?”

“After I canceled your meeting for the second time, I had a heart-to-heart ‘chat’ with my boss.  Believe me, it was not an easy conversation to have with him.  I told him that without his support and I meant physically show up and attend this debriefing meeting, no one else will show up nor take this project seriously.”

“Wow!  That was a bold move for you just being hired and all,” Cara exclaimed.

“Oh, I already told them in my interview that I was going to shake things up and that if this isn’t what they wanted, don’t hire me.  But if you are serious about growing your business, I’m the quality guy to make that happen for you,” he replied.

“So how did you leave it with him?  Is he going to attend the meeting?” Cara asked.

“No.  A lot has changed since you were here.  All good and in the right direction.  I mean with the leadership and with funding.  We are finally getting job requisitions approved and attracting experienced candidates for interviews,” he explained.

“This is good news; we are going to need those people to help implement many of the quality system improvements,” Cara responded.

(Re)-DESIGNING A SYSTEM: PROJECT LAUNCH

They switched gears and focused on the agenda for the debriefing meeting.  Miguel asked Cara to emphasize certain slides in her presentation; namely, the collaboration benefits and the shared ownership of the quality training system.  More specifically, he wanted to hone in on the message that this project was not just a QA program, but a robust training system that impacts all employees.  This time the meeting occurred and was fully attended by all invitees.  

After the executive briefing meeting, Miguel asked Cara to join him in his office. 

“Okay, that went better than expected, don’t you think?” asked Cara.

“Yes, there was a lot of discussions last week about the importance of this (your) RTS project,” he replied.

“Oh good.  I’m glad we waited three months.  The project would have floundered and then died on the vine,” Cara replied.

Seriously, yes, but now we have another problem.  Let’s call it a challenge; a training and development challenge that I believe is right up your alley,” he said.

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

He explained further. “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.”

“Oh, okay.  This does change things a bit”, Cara replied.

“I was thinking about your curricula building background and quality systems work.  You could work with them and provide the necessary training that they need” he suggested.

“Yes, it means more time on-site and I need to push out the due dates for the deliverables.  But I’m concerned about content overload.  Why don’t I teach them what they need to know in the moment the project needs it, you know like just in time training?”  she said aloud.

Miguel nodded his approval and Cara left his office with a sketched outline of a mini-curriculum for the Design Team of SMEs.  Two weeks later the team met for the Project Kickoff meeting.

Part Two: Cara has to teach and coach her design team of SMEs on how to be a team, introduce them to quality systems, project management concepts and how to process map a quality system.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Change Management and It’s Little Cousin Training

Training can be considered a change in what the learner knows now | can do now and what s/he knows and does afterward.  Training can close these gaps when knowledge and skill are lacking.  Thus, a trainer has a dual role: trainer and change agent. While on the surface, the actions a trainer takes looks like change management, it is a sub-part of the larger change management plan.  The scope is narrower.  It is focused only on the training content.  But the expectations for successful transfer back to the job and improved organizational results remain the same. One allocated and approved session designed and delivered by the training department is supposed to shift years of a mindset, alter behaviors and change the company’s culture.  Amazing!

This expectancy or shall I say management assumption is very real and prevalent in fast-moving start-up companies whose leaders claim to have a limited budget for “training” and no time to sit in frivolous meetings planning “the people side” of change.  I’m supposed to be grateful that I get an hour session.  What happens next also amazes me.  Training on the proposed system changes is reduced to an hour-long awareness session on the SOPs that have already gone into effect and folks are told – “Go with the flow. Change is part of our everyday life around here.  Get with it or get out”.  And here’s the rub for me, errors rise, deviations spike, users are annoyed, pissed off or disenfranchised and management blames the trainer for a failed change effort. Wow! Is this the management support that was promised to folks at the town hall meetings? 

The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs.  Assess the size of the change gap and the impact the new design will have on the culture; “the way we normally handle changes around here”.  Training rollout sessions are already time-crunched.  There is not enough time “allowable” to manage all the other non-training change issues like feelings, job security concerns, why the need for change retorts, lack of supervisory support post-training, etc. that actually get in the way of a successful learning transfer. And later create hurdles for improvement results.

Let’s look at the HPISC 5 Step Change Management Plan and apply it to quality system redesign projects.  (See the sidebar below.)

5 necessary parts of a Change Management Plan

QS Change Management Plan Considerations

1. Why is the change needed?

  • This may be really obvious when the site receives a Warning Letter.  But an explanation of how this became a driving force for the needed changes will do wonders for your employees to feel the urgency about the change.

2. What is really changing?

  • Will the changes be incremental or a huge transformational change such as “changing the quality culture”?
  • How are these SOP changes part of the GMP culture?

3. What are the pros and cons of the change?

  • Who benefits and who loses?
  • Are customers hurt or helped?
  • What are the stakeholder’s benefits from the change?
  • What about the benefits for the primary users?

4. What does success look like?

  • What will the outcomes of the change look like?
  • How will you and others know if the change has been successful?
  • What benchmarks will help you track progress?
  • When is the day or timepoint we get to declare success?

5. What other initiatives are we competing with

  • And how will adding the new change requirements impact already heavy workloads?

Will Awareness Training be the only vehicle for announcing the new changes?

Are the answers to the change management questions sitting with the trainer/training department or with the site leadership team?  Perhaps the answers can be found within the steering committee members?  Is the trainer supposed to address all of these questions in a 60-minute awareness session that also includes the SOP changes?  If successful user adoption is paramount to your strategic action plan, warning letter remediation plan, or CRL commitment response, you need to ensure that change management messages regarding these changes are included in the overall communication plan.  Don’t just rely on the design team members to deliver these messages casually at huddle updates.  That is not a communication plan. 

“The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs”.

Vivian Bringslimark, HPIS Consulting, Inc.

The design team with the aid of the project manager needs to schedule special change management sessions where the Affected Users are briefed on the status of the project and the answers to the questions listed above addressed.  Some leaders do not want to “waste time” on these sessions.  They are concerned that it will become a gripe session.  Instead, they think it’s better to just present the users with the revised procedures.  There’s less time to fret and grumble over it.

There is a false belief that once the Affected Users see the changes in a QA-locked down version, they will follow them “because it’s now in the approved SOP”.  Forced acceptance is not a change management strategy despite rampant practice in our industry. If awareness training will be the first time affected users are learning about significant system changes and the “Go-Live” date, be prepared to receive A LOT OF FEEDBACK FROM UPPER MANAGEMENT regarding how awful the awareness training sessions went. 

“Change is disturbing when it is done to us, exhilarating when it is done by us”.

Rosabeth Kanter, 1984, p. 64.

Who is Vivian Bringslimark?

This is 6th in the Redesigning Quality Systems series.

Camp, RR, Blanchard, PN. & Huszczo. Toward a More Organizationally Effective Training Strategy & Practice. New Jersey: Prentice-Hall, 1986.

Kanter, RM. The Change Masters. New York: Simon and Schuster, 1984, 64.

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