Assay Report Documentation and Storage Process Improvement Using DMADV Methodology

Abstract

As part of the Process Engineering team, one of our goals is to identify areas with opportunities in our current manufacturing processes. It was identified an opportunity to improve the assay hard copy documentation generated in the Analytical Laboratory area because the reports are printed in hardcopy, and the audit process requires 3 signs in every paper. The assay hardcopy documentation and audit trail process will be changed to a paperless process following the Design for Six Sigma (DFSS) systematic approach and DMADV to reduce costs of the process, transforming the documentation repository in an electronic data base for the client convenience. Key Terms ⎯ DMADV, Lean, Process Improvement, Six Sigma.