DERMABOND Topical Skin Adhesive Sampling Plans Optimization Project between Ethicon San Lorenzo & Cornelia

Abstract

This project investigates the optimization of sampling plan for DERMABOND Topical Skin Adhesive products, focusing on reducing lead times for the Critical to Quality attributes: viscosity, purity, and packaging peel strength. Currently, each raw material and finished goods lot undergoes extensive testing, which this study proposes to evaluate for potential reductions based on product homogeneity. Through the application of statistical techniques, including Mann-Whitney tests and Two-sample T-tests, the research aims to establish the feasibility of reducing testing frequency. The goal of this study is to achieve a 75% reduction in lead times by Q4 2025, which would improve product release timelines and customer satisfaction. The expected outcomes recommend a streamlined quality assurance process in Ethicon, decreasing testing time by two hours per lot and reducing overall lead time by 20.5 days. This study highlights the importance of data analysis in enhancing manufacturing sampling plans and improving the cost of quality. Keywords - Cost of quality, Critical to quality Attributes, Manufacturing Sampling Plans, Statistical Techniques.