Masters Thesis

Minimizing variability in the process validation of implantable silicone components with the aid of a process flow roadmap

In order for a process to produce conforming materials or products consistently, the process owners must understand the impact of the process inputs on the outputs. Historically, organizations have failed to isolate the sources of variation in their processes, resulting in unpredictable outcomes. Further, in the medical device industry, regulatory agencies mandate that processes with unverified process outputs be validated. Using the molding of implantable silicone components as an example, this thesis explores the use of a process flow roadmap to assist with process validation, from development through monitoring. The paper also discusses the use of quality tools to detect special causes of variation once the process is live. Statistical techniques at each of the major process validation steps provide a method to quantify variation in order to isolate sections of the process for improvement. The methodology is designed to provide a simple and logical approach to executing process validation.