Change control: Impact analysis for the setting up of chemotherapy banded doses

Introduction
Over the past 10 years, the production unit has seen its activity double with the preparation of 40 400 chemotherapies in 2022. Pending a capacity expansion, a project to implement a dose-banding (DB) network within the production unit is being planned.

Objectives
To analyze molecules and doses to be standardized to optimize the production flow.
To carry out an impact analysis in order to anticipate and assess changes before they are implemented in the chemotherapy unit production.

Method
Choice of molecules according to 6 criteria (number of preparations/years, stability, cost, first molecule in protocols, frequently discarded molecules, 60% of needs covered by the maximum production of 5 DBs).
Use of Excel^® GERPAC to select DB and determination of the target stock.
Creation of a working group and steering of the project through 4 meetings.
Application of a "Change control" management method inspired by techniques used in various industries:
* Identification of impacts on production and support processes: SWOT analysis
* Impact analysis: impact rating based on 3 criteria (blocking, troublesome, acceptable)
* Determination of control measures
* Implementation of an action plan: Gantt chart

Results
Selection of 5 molecules (Oxaliplatine, Paclitaxel, Irinotecan, Gemcitabine, 5FU) with 5 DB, representing 25% of the annual production. The SWOT analysis highlighted 25 impacts across the entire process. 5 of them were rated as acceptable, 9 as troublesome and 11 as blocking. The stages of dispensing, manufacturing, control and management of the information system are the most impacted with blocking impacts on bag relabeling, equipment availability, storage capacities, the procedure to follow in case of a microbiological contamination, and on tests and configuration of the business software. The Gantt chart gathers 15 corrective measures. 9 corrective actions concern blocking impacts and must be completed before the implementation of DB. 6 of them have already been completed. The remaining actions are in the process of being implemented and deal with the drafting of quality documents, as well as staff training.

Discussion /Conclusion
The change control process enables the management of complex projects involving many variables, as well as impact mapping. It also ensures that changes are introduced in a controlled and coordinated way. Thanks to the Gantt chart, we were able to organize, plan and prioritize the implementation of corrective measures. This approach enabled us to have an a priori management of risks induced by a major modification of organization, and it contributed to the success of this implementation. This method can be reiterated whenever there is a change in practice.

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