Design of methodology to uncontrolled documents assessments for quality department

Abstract

A medical device company embarked on the journey of developing a program of control of possible human errors that can be applied in any place of manufacture. The project is based on the creation of a methodology to standardize documents not controlled for the change of the Department of quality control procedure. This provides a standard, simple and effective methodology towards the solution of problems. The creation of this methodology is essential. The initial objective of this project was to provide a program of prevention of Human Error through the development and design of tools and methodologies that can be applied in manual assembly and manufacturing processes. These tools would be designed and tested in all areas. Document control program, started with the current processes of manufacturing as a goal, but based on the obtained results will be applied to the new product introduction process. Key Terms - DMAIC, Human Error, Medical Device, Uncontrolled Documents.