Review of the Change Control Project in a swiss based Pharma Company

Review of the Change Control Project in a swiss based Pharma Company

Recently, we were able to work on a second project with an internationally active pharma company based in Switzerland. Our goal was to optimize the processes in preparation for the migration of a new system. Find out whether we have achieved the goal in this change control project and what steps we have taken towards the end result.

Initial situation and goal of the Change Control project in the Pharma Industry

The client is a Swiss-based specialized Pharma SME. Its quality control department is responsible for the process to manage changes to raw materials, production method, equipment, etc., as such changes can impact the end-product. This so-called Change Process (i.e. the process for managing any changes in the way of producing the end-product) has been run fairly successfully, but the client wanted to improve it even further. Among the key improvement points were enhanced features of the software tool to manage the pipeline of changes, better guidance of those submitting change requests, and better visibility on the changes and their constituent Action Items that were completed on time in full. The final aim was not to increase throughput time or rate of changes processed per se, but rather to implement more qualitative steps forward in the experience of the Change Process.

How did we proceed in the Project?

Although the project was not an operational excellence project in the classic sense, we did follow the similar approach of our prozessraum toolbox, including the 5-Lens methodology.

The first key activity was the mapping of the process steps in the current change process with an interdisciplinary, representative team of the stakeholders in this process. The next phase was to list all issues and improvement ideas per process step – this was a motivational exercise for the participants, as no one before had had a complete overview of all process challenges. Third, we consolidated, cleaned, prioritized, and distributed the key issues among the team participants for more detailed description and solution definition. For this, our kyro tool proved essential. It helped us keep track of everyone’s measures, the milestones per measure, and the activities within each milestone. After an initial learning curve, the participants used the tool to plan and report their progress – we had one single source of truth for the project implementation.

The achievements in the Change Control Project

The project team did implement several incremental process improvements. This included an automated KPI tracker to show the most important metrics on the implementation of process changes and the corresponding action items, as well as the progress on the measures that constitute our improvement project. Additionally, we have progressed on streamlining meetings (who should (not) participate in which meetings, and how), and setting up improved documentation and check-list for those users or change owners who do not submit changes regularly. This helps increase process output stability and reduces the risk of overseeing e.g. audit-relevant impacts of the change, as well as the risk of having to re-do a change request because it was incomplete (First-Time-Right rate, in Lean Six Sigma parlance).

And this is what our customer said about the project and our collaboration: „We got to know prozessraum through an internal reccomendation, as a cooperation in another department has already been successfully completed. We especially appreciated that prozessraum did just as much as necessary but not too much during the project. Both our employees and prozessraum were very committed to their work. Our goal was to optimize the processes in preparation for the migration of the system – and we have clearly achieved this goal. We can recommend prozessraum without hesitation.“

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