| This work presents the methodology and results of the deployment of a quality system in a small business environment. This quality system was implemented at the Model Factory of the University of Puerto Rico, Mayaguez Campus, a small business which represents a manufacturing activity in academia. The activity at the Model Factory is run by engineering students under the guidance of faculty. The Model Factory, as most small businesses, has a limited number of resources, both in terms of personnel as well as funding.;The small business requirements for quality systems have been documented by regulatory agencies and are available in the literature. However, there is a limited number of technical papers on implementation experiences accessible to small business management. The Quality System Regulation (QSR), developed by the Food and Drug Administration (FDA), has served as reference for defining the quality management system for the Model Factory.;The implementation of the quality management methodology defined in this project contemplates a mid-long term impact that includes: (1) improved customer satisfaction by reducing customer complaints, (2) increased productivity, (3) less rework activities and (4) improved business organization. An immediate academic benefit of the project has been to allow students working in the Model Factory to be exposed and become familiar with FDA manufacturing regulations. |
