Revolutionizing standard operating procedures in biomanufacturing

Abstract

In its quest to become a High Reliability Performance (HRP) organization, Amgen manufacturing operations desires to further improve its adherence to, and effectiveness of, its standard operating procedures (SOPs). SOPs are expected to provide clear guidance to operators to enable them to perform their job safely and effectively. This thesis aims to take a step back and answer the question "What is the best way to provide information and instruction to floor operators in order for them to perform their job in the best way possible?" Our hypothesis is that SOPs with content and style customized to the needs of the user will enhance performance along key operational metrics. This thesis includes an analysis of the current challenges of Amgen's existing SOPs including comparison to external benchmarks and academic research. Subsequently, we provide a recommendation on future SOP content, style and supporting infrastructure informed by our research. The analysis concludes with the results of a pilot project designed to evaluate our hypothesis. The analysis indicates that while our initial findings are encouraging, further research is required to conclusively determine the validity of our hypothesis.