| In order to stay competitive, suppliers to the medical device manufacturing industry must continually improve and respond to ever changing customer demands. To implement a rigid and costly improvement methodology can take years and doesn't allow for sufficient flexibility to take advantage of emerging and breakthrough methodologies. This project instead proposes creating a practical hybrid system, based on concepts taken from four well-established methodologies, which can be used as a model for improvement. The four methodologies: Quality Function Deployment, Total Quality Management, Six Sigma, and Lean Manufacturing have been chosen because they represent a wide range of principles developed over the past 50 years in the field of Quality Assurance. The project also uses the certification process of ISO 13485, the medical device standard, in a small injection molding company as a demonstration of the process and sets the foundation for applying the system to future improvement projects. |
