Historical Analysis and Risk Management Framework for Particle Detection
Program: Applied Biotechnology Master's Degree — Business Management
Host Company: Dendreon Pharmaceuticals
Location: Seal Beach, California (onsite)
Student: Luis Corona
The project aimed to enhance quality control and risk management at our company by analyzing historical foreign particle incidents, categorizing them, and developing a risk assessment framework. By meticulously examining past incidents based on particle type, source, and impact, we will identify patterns and common sources of foreign particles. This analysis will enable us to categorize incidents into a structured database, aiding in the understanding and prevention of future contamination risks. The main goal is to create a framework for risk assessment that assesses the possible impacts of the introduction of various particle types on the quality and safety of products. By prioritizing risks according to their severity and likelihood of occurrence, this approach will enable us to concentrate our mitigation efforts where they are most needed. To prevent the danger of particles in the process stream, a thorough risk mitigation plan will be developed, defining detection tactics and preventative actions.