Using value stream mapping to improve documentation processes in the biopharmacutical industry

Abstract

This thesis describes how a 55% reduction in error rate and a 92% decrease in cycle-time were achieved in a batch production records process in a biotech manufacturing facility by utilization of value-stream mapping. The project focuses on careful analysis of the current state of a batch production record review process, including an in-depth value stream map, to identify sources of rework and waste in the current process. Analysis of the value stream map led to the recommendation of real-time review of the documentation by Quality Assurance and Manufacturing on the production floor, enabling significant cycle-time and error rate improvements.