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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorPesante Santana, José A.
dc.contributor.authorMurillo Pagán, Roberto M.
dc.date.accessioned2020-08-05T11:33:02Z
dc.date.available2020-08-05T11:33:02Z
dc.date.issued2012
dc.identifier.citationMurillo Pagán, R. M. (2012). Improvement of the statistical techniques quality system element in a medical device industry [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/489
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractAbstract - This project is focused on reducing the compliance risk of a Medical Device Manufacturer by improving its Statistical Techniques Quality System Element. Lean Sigma Methodology was used to identify the inputs or major contributors to the compliance risk. The Methodology section explains further how the tools were used. By reducing the compliance risk, the organization expects to achieve zero observations related to Statistical Techniques on regulatory inspections performed by the Food and Drug Administration (FDA). Key Terms - Compliance Risk, DMAIC, FDA, Statistical Techniquesen_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2012;
dc.relation.haspartSan Juanen_US
dc.subject.lcshSix sigma (Quality control standard)en_US
dc.subject.lcshLean manufacturingen_US
dc.subject.lcshMedical instruments and apparatus industry--Quality controlen_US
dc.subject.lcshQuality control--Statistical methodsen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleImprovement of the Statistical Techniques Quality System Element in a Medical Device Industryen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolcen_US


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