Simplify Process Events Documentation During the Manufacturing Process in a Pharmaceutical Industry

Abstract

For a pharmaceutical company to function better all events during manufacturing must be resolved in a promptly manner and documented properly. It is very important to have a simple yet effective process that helps to determine the best way to resolve events. The mayor problem in the Manufacturing Area of the company considered is that the current procedures do not establish the specific circumstances in which a process event needs to be documented. For this project the methodology of Six Sigma DMADV was used. Prior to the implementation of the Project all 25 lots evaluated had the form. After the implementation of the new process only 16 lots had an Occurrence Form. This means a reduction of 36%. As per the results and after the evaluation, it can be concluded that the new process was successfully implemented. Key Terms ⎯ DAMDV, Documentation, Manufacturing, Process Events, Simplification.