Enhancing Change Control Efficiency for a Global Portfolio of Medicinal Products
Project Highlight by Indra Scheen
“Spread the word” was the client’s reaction to the results of my Lean Agile Black Belt project, which focused on improving the change management process at a global medical technology company. This response reflected a high level of satisfaction and highlighted the potential to replicate the improvements across other departments. Moreover, the project laid a solid foundation for continuous improvement. As a certified Lean Agile Black Belt, I can leverage this experience to help other organizations improve critical business processes and achieve measurable results.
Management Summary
This project successfully addressed delays in the change request approval process at a global medical technology company. The objective was to reduce approval lead times while establishing a more effective and efficient Change Control Board.
The evaluation identified three key causes of delay: the involvement of unnecessary stakeholders in the review and approval process, excessive documentation requirements, and the absence of a valid method for assessing the impact of proposed changes.
Within three months of project initiation, the team defined key stakeholders and implemented a structured Change Control Board, introduced a centralized tracking system for change requests and actions, and developed an impact-based workflow aligned with applicable product regulations.
Seven months after implementation, change request approval lead times had improved by 32.3%. The revised procedures and supporting tools were fully documented and provide a scalable model that can be deployed across other departments to drive further organizational improvements while maintaining regulatory compliance.
Challenge
The department in question manages a specific group of medicines distributed to various countries. These markets are subject to diverse regulations, depending on the product’s classification under applicable guidelines. Consequently, submitting change requests could be complex when multiple products are involved. As a result, the impact of proposed changes was not always properly assessed, leading to an incorrect initial classification of those changes.
There was no overview or transparent system for pending changes, nor were there established timelines for the approval and implementation of change requests. In some instances, changes were implemented without following the formal completion procedure. Changes that remained open for extended periods caused delays in production
Project Team and Approach
The complexity of the problem, which affected multiple company departments and involved external parties, necessitated a Black Belt-level project. The Lean Agile method was employed to streamline the process and rapidly implement improvements, enabling a timely response to the changing needs of stakeholders. I led the project as an external Quality Assurance (QA) specialist, and the team comprised internal stakeholders from QA, Project Management, and Regulatory Affairs (RA). The project sponsor was the head of the responsible business division.
Project Objectives
The project aimed to reduce the turnaround times for the approval of change requests. At the start of the project, only 62% of approved change requests were approved within three months. The project sought to ensure that, following the implementation of improvement plans, at least 80% of approved change requests were approved within three months. Additionally, the aim was to develop a method to monitor the status and criticality of the (proposed) changes and to correctly classify proposed changes from the outset.
Mapping the Problem
To further define and quantify the problem, I facilitated brainstorming sessions with the stakeholders. In addition, the project team examined the available data to identify gaps and redundant process steps. The investigation revealed that nine stakeholders were involved in the assessment, approval, and implementation of a change request. Change tasks were recorded twice: on the change request form and again on the change implementation form. The management of relevant documents was handled by different parties. There were only two change categories plus an “unknown category” option, and guidelines for classifying changes were lacking.
Analysis
The project team analyzed the issues using techniques such as the fishbone diagram and the ‘5 Whys’ method. Most issues were related to the working method:
- An excessive number of required signatures due to the involvement of irrelevant stakeholders, caused by the absence of a stakeholder definition resulting from an incomplete procedure;
- Unknown turnaround times for (proposed) changes due to the lack of a (clear) timeline for executing change tasks, resulting from a lack of traceability;
- Arbitrary classification of changes by QA, project management, or RA, caused by the absence of a classification definition resulting from an incomplete procedure.
Solutions
The various solutions were implemented in phases (see Table 1), allowing for continuous evaluation and adjustment. An Excel tracking file was introduced for the initiated changes, including the associated tasks, and for the minutes of the restructured and more frequent Change Control Board meetings. The change control procedure was revised twice: first to reduce the number of stakeholders involved, and subsequently to minimize administrative burdens, introduce a flowchart for change classification, and designate a single central point of contact for document exchange. The revised procedure was communicated to various departments through classroom-based training sessions.
Conclusion
The change control process has become effective and efficient. The tracking file provides stakeholders with insight into the status and criticality of ongoing changes, bottlenecks, and priorities, as well as the action items and assigned responsibilities established during Change Control Board meetings. Additionally, the file can easily be used to generate progress charts for management reporting.
The project goal has been achieved; 82% of the change requests are approved within 3 months (goal: 80%). The solutions are secured in a recorded and trained procedure. The company benefits from the revised process, as key changes can be implemented more quickly thanks to a compliant, transparent, and streamlined process.
Takeaways
The project demonstrated the value of combining broad stakeholder alignment with focused execution by a small core team. Early implementation of initial improvements, followed by continuous evaluation and refinement, proved effective in delivering
sustainable results. Throughout the project, team members gained a deeper understanding of each other’s areas of expertise and the quality, regulatory, and business requirements associated with product, process, and market changes.
The project’s impact extends beyond the participating team, delivering proven tools and processes that can be applied across the entire organization to support continuous improvement, regulatory compliance, and operational excellence.
Turn Challenges into Sustainable Improvement
At Progress, we help organizations turn complex process challenges into sustainable results. By combining Lean principles, agile ways of working, and strong team engagement, we streamline processes and deliver tangible improvements. Depending on the complexity of the challenge, we apply expertise ranging from Green Belt to Black Belt level.
Do you have a process that could be smarter, faster, or more effective? Contact Progress to discover how we can turn your business challenges into measurable improvements and empower your teams to drive continuous improvement.
