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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorGonzález Miranda, Carlos J.
dc.contributor.authorMaldonado Santiago, Adlin
dc.date.accessioned2020-06-23T16:49:38Z
dc.date.available2020-06-23T16:49:38Z
dc.date.issued2018
dc.identifier.citationMaldonado Santiago, A. (2018). Quality system improvement [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/183
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThis research project is focused on the improvement of the quality system in a healthcare/medical industry. Quality system is defined as the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. Based on the FDA regulation, each manufacturer shall stablish and maintain a quality system that is appropriate for the specific for the medical device designed and/or manufactured. Basically, is important to ensure that the quality systems requirements are effectively stablished and maintained in accordance with the regulations. A set of activities belonging to different sub-systems are monitored consistently with the purpose to define the health of the quality system and understand what is needed to be improved. This project seeks the improvement of the quality system by looking the performance of the subsystems. This will provide a better standing of the company within the regulatory requirements and will simplify processes. The DMAIC methodology will be used to conduct the analysis and define opportunities to improve. DMAIC were selected as the appropriate method to use since is a data-driven quality strategy used to improve processes. Key Terms - Continuous Improvement, Quality System, Regulations, Subsystems, System Monitoring.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering
dc.relation.ispartofseriesFall-2018
dc.relation.haspartSan Juanen_US
dc.subject.lcshSix sigma (Quality control standard)
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Posters
dc.titleQuality system improvementen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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