Streamlining Pharma Compliance with Lean Innovation
Case Study Preview: As anyone who works in the bio-pharma industry will attest, compliance with documented procedures is not optional. Unfortunately, constant pressure to meet compliance standards often leads to unforeseen and burdensome consequences. Read how the Director of Training & Development at a highly-regulated bio-pharma company ensured workforce compliance with complex procedures by engaging her staff in "Lean thinking and doing" using a simple-yet-innovative approach to rapid process redesign.
In the bio-pharma Industry, where life-saving drug therapies are produced for rare and complicated medical conditions, strict adherence to documented manufacturing and product handling practices is absolutely mandatory.
However, when a newly-hired Training Director arrived at a leading bio-pharma firm, she found an organization struggling with a compliance training process described by her fellow managers as a "two-ton weight on our shoulders." Driving the problem was an automated training system designed to speed communication and testing of Standard Operating Procedures (SOPs). While installed with the right intentions, the system had become an anchor weighing down the organization's ability to respond to a rapidly changing regulatory environment.
Breaking from Long-Held Beliefs and Practices
As is often the case when automation is applied to complex processes, the unintended consequences of this flawed compliance training process were rework, delays and frustration, as the software was only as effective as the underlying process and human practices. The Training Director sensed that solving this complex problem with the current compliance training process would not be easy for her staff as well as other functional departments.
Based on her experiences at the global pharma company Pfizer, the Training Director believed the situation called for nothing less than a "clean sheet rethinking and reinvention" of the current end-to-end compliance training process. She engaged Leap Technologies to facilitate the effort using their Breakthrough approach for rapid, cross-functional process reengineering.
"Leap had a long track record with me from prior roles tackling urgent process performance turnaround situations that require a credible external facilitator to ask the tough questions and a fast-action approach to process improvement."
According to the Training Director, "Leap had a long track record with me from prior roles tackling urgent process performance turnaround situations that require a credible external facilitator to ask the tough questions and a fast-action approach to process improvement."
Out-of-the-Box Thinking with Breakthrough
While Lean principles and methods are unrivaled in solving process problems, their application to complex, non-manufacturing processes can be challenging because of two main factors: first, is an inability to see the entire process in action from end-to-end; and second, is a spiderweb-like interplay between many processes and systems. In this company's case, the compliance training process was the most visible target among an array of processes that required rethinking and potential reinvention.
Leap's Breakthrough approach to complex process redesign combines proven Lean concepts and tools with innovation and change management methods that equip teams to cut through the "fog of complexity" to performance-changing process solutions. The cornerstone of this approach is the Breakthrough Workshop, an intensive process redesign experience that engages cross-functional process stakeholders.
The Breakthrough Workshop provided a laboratory for the Training Department staff and representatives from across the organization to collectively examine the current compliance training process, uncover root causes of performance problems, and most importantly, brainstorm and test potential solutions using Lean principles and methods.
"It became clear through the workshop activities that improving the compliance training process could only happen by improving coordination with other key processes and challenging assumptions about our team's ability to make changes."
As noted by one workshop participant, "It became clear through the workshop activities that improving the compliance training process could only happen by improving coordination with other key processes and challenging assumptions about our team's ability to makes changes."
A Leaner Approach to Compliance Training
The outcome of three days of intensive small- and large-group analysis, discussion and idea testing was a five-pronged action agenda, as follows:
- "Clear the Decks" of non-value adding activities in the current approach to compliance training and documentation without requiring major process redesign.
- Adopt a risk-based approach to prioritizing compliance-training needs that focuses more attention on the compliance gaps that pose the greatest threats to quality assurance.
- Redesign the end-to-end compliance training delivery process to synchronize with daily work team meetings, creating better retention while reducing the build-up of training backlogs.
- Institute a Training Help-Desk to respond to emergency compliance training issues to prevent production line shutdowns.
- Create the business case to develop a competency-based skill and knowledge development program to improve employee core capability in order to meet compliance requirements while reducing the need for remedial compliance training sessions.
"It was great having our colleagues from other departments like Quality Assurance in the workshop because it got us all on the same page about the root causes of our problems and the best ways to fix the problems."
As if the actions developed by the Breakthrough team weren't impressive enough, the workshop also succeeded in breaking down walls between internal functions. As one of the trainers remarked, "It was great having our colleagues from other departments like Quality Assurance in the workshop because it got us all on the same page about the root causes of our problems and the best ways to fix those problems."
Better Compliance with Less Effort
Within 60 days of the Breakthrough workshop, many of the action plans were already yielding results, most dramatically in the reduction of staff hours devoted to remedial training and error correction. In addition, the adoption of the new approaches to compliance training and competency development improved morale at the work unit level and improved the perception of the Training Department across the entire organization.
Compliance Training with Breakthrough
40hours per week reduction in non-value-adding activities
5improvement action plans deployed
60 daysfrom team launch to completion
"Breakthrough helped me convert the frustration my staff was experiencing into positive actions that got us on the right path and restored the organization's confidence in us."
For the new Training Director, the Breakthrough project validated her notion that an "out-of-the-box" thinking and doing approach was the best course of action to solve the compliance training complexity challenge. As she noted, "Breakthrough helped me convert the frustration my staff was experiencing into positive actions that got us on the right path and restored the organization's confidence in us."
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