Digital Manufacturing in Medical Technology with SAP MES

Since self-medication is always primarily a matter of trust in the products and the associated reputation of the provider, they cannot avoid seamlessly documenting the production process in accordance with validation regulations. Changing and new business processes could not be easily mapped in the existing system. The manual effort required in the course of paper-based production was correspondingly high. The situation was further complicated by a proprietary system landscape caused by several stand-alone in-house developments and interfaces. In addition, the MES, which had been set to "end-of-life" in 2023, created pressure to act. Continued support was thus out of the question.

"The challenges we faced were at the same time a great opportunity to future-proof the processes and introduce efficient paperless production," reports Frank Wüstenberg, Project Manager at Ypsomed. System-supported process management was to help avoid errors and reduce effort. "The decision in favor of SAP ME was made at that time because the solution is very future-proof for us," says Wüstenberg. "We have very good ERP integration, high standard coverage, and the MES is of course release and rollout ready. A highly configurable system and compatibility with S/4HANA were also important for us. We found that with SAP ME."

To maintain product safety and traceability, automated process interlocking and control were to contribute in addition to seamless digital documentation of the manufacturing progress. With SAP ME as the central MES, it will also be possible in the future to use key figures or key performance indicators (KPIs) as a basis for further productivity increases. Last but not least, the prospect of vendor independence was also a decisive aspect. This is because the successive internal development of Ypsomed's own SAP ME expertise makes it possible to provide in-house services such as rollouts and system enhancements, thus reducing external services to a minimum.

In the selection process, IGZ, the SAP project house for production and logistics from Falkenberg, was awarded the contract as consulting and implementation partner. "IGZ convinced us with its project references, which point to many years of experience in the production environment with various companies," says Frank Wüstenberg, explaining the decision. "Further insights were gained in the direct exchange of experiences with other SAP ME customers at the IGZ Day Forum and ultimately also in the context of the deployment analysis carried out in advance. Thanks to this analysis, we not only found in-depth know-how, but also received reliable budgeting and scheduling for the project."

At the start of the "injection molding" manufacturing process, the raw materials in the granulate warehouse are first scanned via a mobile dialog. The batch stored is used for traceability in the further production process. At the coupling station, the pipes for feeding the granulate to the injection molding machine are connected. SAP ME checks the status of the batch, the status of the machine equipment and the correct linkage. During the subsequent setup process of the injection molding machine for the next job, the MES provides system-supported process control. In this process, the required molds as well as the batch-managed components used are checked and the validated master parameter data set is sent to the system.

Furthermore, the production employee must perform so-called acceptances in SAP ME, i.e. confirm quality-relevant process points. SAP ME then triggers the printing of the material identification cards and the generation of inspection lots. In parallel, the tools and parts list components are checked. The final quality control certifies that production has been carried out exactly in accordance with currently applicable regulations.

The assembly line contains a large number of feed points (material slots) via which components are prepared for the production order. These are also validated with the material using mobile scan routines. This ensures batch traceability while ensuring that the required material components have been set up according to the bill of materials. During physical set-up, the production worker has clear digital work instructions available in the MES.

Furthermore, the entire manufacturing process is processed in the system. As with injection molding, SAP ME records production times and quantities. With machine data recording and acceptance confirmations, purely digital production documentation is achieved - keyword "paperless production". Production-accompanying quality assurance measures also take place in assembly. The strict process interlock with the quality-relevant breakpoints is dynamically integrated into the SAP ME process for each product.

The intuitive operator interfaces, or PODs (Production Operator Dashboards), run on industrial tablets with integrated scanners. Thanks to a dynamic and flexible SAP ME configuration concept, they are optimally tailored to Ypsomed's requirements. All the information that the production operator needs for his work on the system can be found in these stationary terminals. Particularly noteworthy is the function of strict SAP ME process and order control via SAP ME acceptances. In some cases, these must also be carried out using the dual control principle. For example, the line clearance concept specifies the check that the line has been handed over cleanly after completion of a preceding order. This must always be done by two employees and confirmed in the MES.

In addition, user-friendly, intuitive mobile SAP UI5 dialogs have been implemented for production employees. They run on smartphone-sized devices as well as on scanners and are primarily used to efficiently record, validate and link component batches to the assembly line and to the SAP ME production order. This means that production staff always have mobile solutions at their fingertips in order to be able to carry out the corresponding component registrations on the shop floor or at the extensive plant. The system can be used in the injection molding area as well as in the assembly area, for example in the granulate warehouse or at the coupling station.