Getting Ahead of the Chaos: Documenting What You Do

Change Management Connected Organization Growth Process
BY BETSY BELDING

When early stage drug development companies expand, new roles and fresh faces appear almost daily. Everyone is dedicated to delivering life-altering treatments, and it’s both exciting and fulfilling!  No one is thinking about documenting process.

The catch is the increasing number of hours spent getting the same amount of work done. Small, co-located organizations (under 50 people) operate smoothly when “Joel” can ask his neighbor “Katrina” a question and get an immediate, clear answer. Once rapid growth sets in, everything changes: 

  • New co-workers bring their past experiences and ways of working.
  • Evolving org structures make it hard to know who is making critical decisions.
  • Teams become less connected to their cross-functional partners.
  • Time is of the essence, and doing work feels more urgent than writing down “how we work.” 
Tribal knowledge vs documenting process

As drug development progresses toward human trials and FDA reporting, spending a little time on internal processes and documentation minimizes confusion, helps prevent “hero-fatigue,” fosters a better workplace and company culture, and eases growing pains.  

But we don’t want to over complicate our process!” 

Documenting process doesn’t have to mean a slew of Standard Operating Procedures (SOPs) or a pile of complex swimlane maps. Instead, start at a high level, so cross-functional teams can agree on the “who, when, what, and how.” A simple graphic built in PowerPoint can serve as the foundation for a more detailed set of policies, SOPs, and work instructions of a mature organization. But completing your full documentation suite can wait until you have the resources—and the urgency—to do so. 

How do you get cross-functional teams on the same page?” 

Facilitated workshops are a great way to rapidly create consensus. One of our pre-commercial partners was in the midst of several phase two studies, and they wanted to get in front of escalating challenges and daily rework. During a two-day, intensive workshop with over forty key drug development stakeholders, Future State helped them articulate end-to-end steps that defined the owners, decision points and critical inputs/outputs for high-level processes ranging from IB approval to CSR Filing.  

Defining owners and decision points

“Wow, you achieved all of that in two days?!” 

Not exactly. Workshops are typically the culmination of weeks to months of pre-work, but the pre-work doesn’t need to be painful. Prior to the process workshop, we created initial, draft process maps based on client interviews and our pharmaceutical process knowledge. We confirmed the ideal outcomes, activities, and participants from the client’s point of view. We listened, asked questions, and invited the right people to the discussion.  

During the workshop and armed with visual maps, attendees focused on agreed processes and prioritized improvements. But they also planned ahead for unchartered territory, such as filing their first CSR. They have since launched a process governance forum that owns their processes, will help embed a process mindset into their organization and, with our initial support, will evolve their processes over time.  

As an additional benefit, participants built new bonds and engaged in cross-functional conversations that don’t come up during tactical, get-it-done meetings. As their vice president of clinical operations said, “The workshop was the highlight of the project. It not only focused on the process improvement but was a good team-building event as well.”  

Process workshops are a highlight for me, too. I love facilitating people toward clarity and the a-ha moments that invariably happen. It’s a rewarding experience for both the client and the Future State team! 

Sounds like so much work—where would we start? 

While we recommend an end-to end approach for the work of your organization, ultimately, there is no one right place to begin. The important steps are to:  

  • Assess your greatest points of confusion, rework and risk 
  • Identify the context—where are you starting and where are you ending? 
  • Create visual representations of the work, including:
    • WHAT is done 
    • WHO does the work 
    • WHAT is needed to do the work (input) 
    • WHAT is the result of the work (output) 
    • WHO or what group makes critical decisions 
  • Define common terms and acronyms
  • Ask for input from a representative of every group involved to build and confirm cross-functional documentation

People feel prepared and supported when they know what’s expected, how to proceed, and whom to collaborate with; this is even more essential now, as we have shifted to virtual work! Creating the right level of documentation for your organization will mitigate your growing pains; orient and welcome valuable new employees; and provide a foundation for future compliance and inspection-readiness to, ultimately, make a difference for the patients you serve.