Optimization, Standardization and Revision of the Label Review Policies and Procedures Manual using Lean Six Sigma at Polytechnic University of Puerto Rico

Abstract

The Label Review Department focuses on reviewing other companies label for compliance with FDA regulations by providing a one-on-one service accompanied with a report with recommended changes and a print-ready graphic file. As Covid-19 pandemic started, the organization shifted to a virtual environment that caused time and accessibility effects on the Label Review Policies and Procedures Manual. For this reason, this manual was modified, organized, and optimized to determine time documentation retrieval reduction using Lean Six Sigma methodology. The staff members were participated in a pre and post launch assessment. The new proposed manual was a successful on providing more accessibility, being updated, and becoming a tool for daily tasks. However, no significant time reduction of documentation retrieval due to high variability between staff members time response. Further investigations, analysis and actions must be taken to ensure that the new launched manual reduces documentation retrieval time significantly. Key Terms ⎯ Cloud System, Lean, Standardization, Six Sigma.