Six Process Improvement Makeover Secrets for Better Decisions


Process Improvement efforts are not getting healthcare and clinical research organizations the results they seek. This is also true for complex operations across businesses of all kinds. As far back as 2010, the Wall Street Journal reported studies suggesting nearly 60% of all corporate Six Sigma initiatives failed to yield desired results.1 With more sophisticated technology-dependent data management, a more remote workforce, and an increasingly onerous regulatory environment, process improvement efforts have become more challenging. At the same time, the costs and risks of inefficient operations and regulatory noncompliance are increasing. Organizations cannot afford to forgo continuous efforts to find better solutions with greater returns and protections for the enterprise. The “process” of process improvement is going to need a makeover if organizations want to achieve better results in the current environment.

Why is it that admittedly highly educated and experienced leaders with dedicated resources are not creating sustainable reliable solutions? Experts are pointing to the shortcomings of traditional process improvement efforts.

In 2015, Nicole Fallon of Business News Daily discussed the 5 biggest obstacles to innovation. Fallon spoke extensively with business leaders who discussed the biggest innovation obstacles companies face, and how to overcome them. "Sometimes the best ideas come from team members who aren't packing the pedigreed credentials or working in the C-suites…. The companies that have risen above others challenge their staff to be innovative in an all-inclusive community. Executives must constantly collaborate with staff at all levels and make each person feel no idea is bad or too far-fetched. Inclusion is also important, as it empowers individuals and gives them a sense of ownership. And in the end, if it works, it turns into a team win."

If we look at traditional approaches to process improvement, opportunities for engaging staff at all levels is not well captured, nor are opportunities for meaningful inclusion, empowerment, or ownership. Rather, traditional engagements for process improvement look something like this:

  1. Difficulty identifying all relevant stakeholders and participants
  2. Difficulty coordinating schedules across multiple calendars and among participants sitting in geographically distant locations. The result is delay and lack of participation.
  3. Frustration on the meeting day when one or more critical minds don’t show and meetings have to be rescheduled – delay, delay, delay
  4. Diversion of significant worktime to scheduling and meetings
  5. Limited meaningful inclusion or empowerment because individual candor, creativity and thought diversity are sacrificed in high pressure, silo-thinking, face-to-face meetings that perpetuate bias, fear, pressure, group think, fatigue, and status quo.
  6. The final outcome of the initial meeting is, at best, identification of the problem, limited real current process understanding, confirmation of already visible gaps, and a “nice” preliminary draft Visio of a process map.
  7. Identifying any meaningful solutions? – repeat steps 1-5 over and over before ever getting to hard implementation, training, validating or continuous improvement
  8. Then critical participant(s) leave the organization? The bottom falls out

In spite of great minds, the reality is long timelines and significant diversion of time/effort away from usual work before meaningful organizational change is actualized, if at all. 

If there are in fact meaningful process improvement outcomes, they represent a point in time. Future assessment for continuous improvement involves the same broken process, which often is sacrificed to address newly identified issues. Process improvements routinely go without validation and/or quickly become outdated. Opportunities for continuous process improvement are lost because the organization has moved on to the next challenge while presuming the prior challenge is resolved.

Based on these emerging understandings of process improvement failures, an intelligent make-over of the traditional approach should strive to achieve:

  • Wider participation: Engage everyone from executive leadership to the end-user workforce in the conversation to get more ideas and greater individual commitment, sense of inclusion, and empowerment through full participation
  • Free Thought diversity: Create an environment where participants feel free to speak candidly, to share real experience and personal perspectives, and offer individual creative solutions without fear, pressure, or bias
  • Efficiency: Minimize calendaring, geographic, and fatigue barriers by maximizing the use of virtual, remote environments that can be accessed for participation outside the 9 to 5 work time block
  • Solutions: Replace the process map and the written report with meaningful action strategies that are achievable in short sprints so progress is measurable. Agility at its best.
  • Continuity: Engage the same approach for efficient and meaningful continuous evaluation and improvement. The one thing that is constant is change! If we don’t continually pick up the changes the process will be out of date again in no time.
  • Board Confidence: Give your Board the confidence that your workforce is engaged, participating, committed, understands and has bought-in.


This may sound too good to be true, but the truth is organizations cannot afford to keep doing it the same old way. The cost and risks of noncompliant operations and regulatory noncompliance are simply too high to not seek better solutions. If you would like help with a makeover of your approach for meaningful change in operations and culture, call us.

Shanley J. Curran
Founder/President/CEO of ROCS
Research, Operations & Compliance Solutions, Inc. 
ROCS-Better Solutions for the Healthcare Industry 

Shanley Curran and her team deliver process improvement solutions and program development powered by the Powernoodle platform in healthcare and clinical research operations and compliance at academic medical centers and community health systems.

Shanley is a California licensed RN and Attorney, certified in healthcare and healthcare research compliance, with over 20 years’ experience in healthcare delivery, clinical research administration and healthcare/clinical research compliance.

Footnote 1 Where Process-Improvement Projects Go Wrong - Six Sigma and other programs typically show early progress. And then things return to the way they were. By SATYA S. CHAKRAVORTY, The Wall Street Journal. January 25, 2010.