Presentation: Finding What Matters - Implementing Review-by-Exception RtReports for Manufacturing at BioMarin

Long batch reports containing non-quality impacting information lead to long, inefficient lot release processes in the biopharmaceutical industry. BioMarin is implementing a Review-By-Exception (RBE) project to reduce batch review time by focusing on what matters for product quality. The journey starts with a robust and reliable PI System architecture built via BioMarin’s Enterprise Agreement with OSIsoft. PI Server Tags are created for data collection, PI Asset Framework (AF) hierarchies contextualize the data, and batch context is generated as PI Event Frames (EF) for every step of each manufacturing process. BioMarin then utilizes its PI System to implement RBE principles – defining unit operation review strategies, revamping alarm configurations, and deploying event-frame based RtReport templates. The end-result: simple yet elegant RtReports indicating exception status, PI Vision displays for process monitoring, and the foundation for initiatives to further reduce lot release times.