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.


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.

Gap Assessments are necessary for QS redesign projects but so is the right level of support

This is the 3rd blog in the on-going Redesign Quality Systems: Achieving Successful User Adoption series. Visit Blog 1 and 2 here.

Assessments – “Truth Be Told”

Assessing the current state of the targeted quality system is analogous to collecting the “voice of the customer” input.  Discovering what is and is not working is vital to ensuring a successful redesign and ultimately user adoption. This is more than a review of the SOPs and forms; however.  Interviews are key to this phase of the project.  From the system owner to primary users, QA staff and even the LMS or the eDoc administrator are essential.  The more cross functional the input, the better the confirmation of the “data” and the “evidence”.  Which in turn, provides a truer gap assessment.

Most interviewees know the system’s weaknesses and they know how to fix it.  But they are frustrated with ignored attempts to change it.  Many simply give up trying to get it changed on their own or within their circle of responsibility.  So, when quality systems interviews are being conducted with an external consultant, some are eager to share the “dirt” on just how broken the system really is.  And some of the “fixes” are political and can only be handled when trust has been earned or when the sponsor deems it so.

We recognize Training is important but …

A small vitamin and supplements company set out to become a commercial manufacturer of pharmaceutical drug products.  Naturally, their quality systems were not robust enough to meet 21CFR 211 code of regulations. So, assessments were conducted for the major quality systems.  The Training Quality System assessment revealed several positive activities that were enabling current success and a lot of gaps that would need to be addressed to meet regulatory expectations for today’s pharmaceuticals companies. 

The sponsor explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously.

The sponsor routed the Training Gap Assessment Report to his peers and the CEO with an invitation to attend the first in-person briefing.  No one showed up except the sponsor, his direct reports and the consultant.  The meeting was rescheduled for a month later when all executives’ schedules showed availability.  One month later, the sponsor learned that key executives would be out of office during the meeting, so he postponed the briefing indefinitely.

The sponsor then arranged for a one-on-one follow-up session with the CEO and explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously. He also reiterated that in order to grow the business as intended, resources needed to be hired and the quality systems including Training needed immediate prioritization.  Or else the company would not receive approval to manufacture and could further impact its current relationship with the agency.

Three months later the meeting was scheduled.  However, the agenda took on a different focus. Particularly, the collaboration benefits of working cross-functionally with department managers and the shared ownership for the Training Quality System.  More specifically, the training 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.  

Change Readiness for the Design Team

With the briefing finally conducted, the sponsor explained to the consultant, that the “Design Team of SMEs” had very limited experience working cross-functionally or as a team. They knew even less about project management concepts like scope and project charters and they lacked fundamental concepts like quality systems and systems-based inspections.  And they did not know how to process map. They had been silo’d far too long.

SME Readiness Curriculum
Design Team of SMEs Readiness Curriculum

The consultant’s background included curricula building, instructional design, and quality systems redesign experience. She sketched a brief outline of the mini-curriculum for the Design Team of SMEs and the Sponsor agreed.   Over the next few weeks, they used their meeting time to work through the 4 introductory lessons.  And as a team, they used the “live” aspects of the project work to illustrate the concept and apply its principles to the progress and development of their team.   In essence, they were taught just what they needed to know at the moment the project needed it, similar to learning in the flow of work.  Four weeks later, the team was ready to begin their process mapping sessions together.

How Big is the Change Readiness Gap?

Who is Vivian Bringslimark?

The rest of the blog series can be found below:
  • Blog # 1 – Redesigning Quality Systems: Achieving User Adoption
  • Blog # 2 – Manage Your Stakeholders and Users Expectations
  • Blog # 4 – What to Expect When Processing Map with SMEs
  • Blog # 5 – Field Testing Your Final Draft of Redesigned SOPs and Forms: Helpful or Seen as unnecessary?
  • Blog # 6 – Change Management and It’s Little Cousin Training
  • Blog # 7 – Do I Really Need a GO-Live Strategy?
  • Blog # 8 – Is an Awareness Training Only Session Enough for Successful User Adoption?
  • Blog # 9 – So, We Went Live, What Happens Next?

(c) HPIS Consulting, Inc. All rights reserved.