Audit Process Optimization in the Manufacturing Area

Abstract

This project was developed to demonstrate a viable audit process optimization in the manufacturing area. The AbbVie site ubicated in Barceloneta, Puerto Rico,started with only one product back in 2003; by the end of 2021, the site has become a multidrug facility with six products. This increase in production has a higher requirement in the audit. The implementation of Release by exception will help mitigate the audit time and keep the production running as business needs. This project is a recommendation to accommodate the reality of the site. The use of a manufacturing execution system (MES) is expected in the pharmaceutical and biotechnological industries to perform the activities related to the manufacturing of a product. This tool, MES, have the potential to benefit the audit of the process, reducing the time to achieve a faster lot release. Using the DMADV framework on this project can improve the audit cycle time. KeyTerms⎯Audit, DMADV, MES, Release by Exception.