Engineering, Merck KGaA
Prior to the TRACKTS! – Smart.Serialization, Track & Trace Minds expert forum in Berlin, we.CONECT spoke with Klaus Egner from Merck KGaA. Mr. Egner talked about the stages of a track & trace implementation and the organization of support once your technology is up and running. He has been working at Merck in automation for almost 20 years. First laboratory and pilot plant units were his areas of responsibility. As continuing education he qualified as Master of Technical Management (CCI). From 2005 he worked in pharma area (MES, production and packaging of solid dose). Since 2011 his main duty is serialization in packaging.
Klaus Egner: We are in the rollout of track & trace at the packaging lines at several sites. The IT systems are evolving in parallel, additional functionalities and interfaces are being implemented. Based on our growing experience with track & trace we are optimizing our systems continuously.
Currently we are mainly matching regulatory require-ments. In future I expect that especially the process after production will gain efficiency. For production itself track & trace is an additional task and we must optimize continuously to minimize the effort. The different regulatory requirements in different parts of the world make it not easy to use the benefits of track & trace.
Our equipment and the processes must be flexible enough to handle all requirements. As not all of these requirements are clear from the beginning on and new requirements are coming with short lead times we have an eye on flexibility in all our projects. Information about track & trace regulations is collected centrally and internal guidelines are written for all affected sites.
We have a global core team communicating with all affected sites. At each site we have a contact for track and trace. But it is not easy because track and trace affects more departments than one might think. More and more people must be aware of the topic because it affects nearly everything in packaging context.
I am no IT-specialist, so better ask my colleagues. During the last years I had the impression that different worlds must grow together. I come from automation and when I met the colleagues from IT we had to learn from each other. Track and trace is something new and must find it’s way into the existing landscape.
We have a global core team in charge of vendor selection. Locally we have project teams for implementation. We stay in close contact with each other to share the knowledge.
The project teams stay in close contact with each other and the global core team. We have regular telcos including the vendor to coordinate everything and to share the knowledge. When the first line is installed at a site the local colleagues are supported by those who are already experienced with the technology.
Training is key. Everyone who has to work with the new equipment and systems needs training. Our support concept is based on internal people and a maintenance contract with the vendor. In addition, major issues can be escalated via the core team.
Starting with track & trace not only means to buy some machinery and an IT-system, but the start of a learning curve. The role of organization and processes is often underestimated. Track & trace is cross-functional and the organization must learn about new constraints and who has to communicate with whom to make it running. Because of the learning curve it is essential to start not too late, ramping up is much easier than switching on the systems in the last moment.
Interview Partners: Klaus Egner and Josefin Fügener