Masters Thesis

Using Lean tools to improve a product risk management process

Lean is a process that drives improvement in manufacturing facilities. With Lean’s focus on customer needs and continuous improvement, companies have used Lean tools and techniques to improve products and decrease manufacturing costs. Application to a specific office process, product risk management, is explored in this paper. Most medical device regulatory agencies around the world require risk management. Compliance theoretically results in medical devices designed and manufactured in a manner resulting in safe and effective devices. Standards contain descriptions of tools used to analyze hazards and describe how to associate risk levels with these hazards. This paper presents the use of Lean tools and methodology to simplify the risk management process, making it understandable and compliance easy. Case studies of similar administrative projects are reviewed, and lessons learned are applied to this project. Additionally, risk management systems at three medical device manufacturers are evaluated, using Lean techniques.