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 of a Quality System

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.

Like the blog series? The rest can be found below:
  • Blog # 1 – Redesigning Quality Systems: Achieving User Adoption
  • Blog # 2 – Manage Your Stakeholders and Users Expectations
  • Blog # 3 – Gap Assessments are Necessary for Redesign Projects but so is the right level of support
  • 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?

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.