Improve the Cycle Time of Stat Testing in Quality Control Laboratory Applying Kaizen Analysis

Abstract

Quality Control Laboratory of Biopharma Company was selected for develop a design project, using the technique of Kaizen Project. Manufacturing area of Biotech Company produces a biological product. Biologic Bulk Drug substance must be tested for protein content. Manufacturing area needs analytical tests results to continue the Fermentation/Purification process. The main objective is reducing the cycle time for Stat Testing. The goal is identify wastes and eliminates what does not add value during analytical process. The problem is often longer of “Lab cycle time” to completed Stat testing for inprocess samples. Kaizen Analysis, Value Stream Mapping, and Spaghetti diagram were executed to identify all wastes during the Sialic Testing. Quality Control Lab needs to re-design the layout of the inprocess lab to eliminates the wastes and non- value activities to maintain continuous improvements in quality processes. Key Terms - Kaizen Analysis, Laboratory Cycle Time, Sialic Testing, Stat Testing.