Design of methodology to uncontrolled documents assessments for quality department
Zusammenfassung
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.