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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorVega Comas, Desireé
dc.date.accessioned2020-09-16T18:40:28Z
dc.date.available2020-09-16T18:40:28Z
dc.date.issued2015
dc.identifier.citationVega Comas, D. (2015). Enhancement of CAPA’s and audits responses in a medical devices industry [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/659
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractIn the regulated industry of medical devices, different issues can compromise regulatory certifications. The CAPA and Audit system were presenting a situation regarding the submission of responses; Timeliness. One of the objectives was to reduce the quantity of extensions requested. During the collection and presentation of data using DMAIC, 24 CAPA’s and 7 audits were analyzed. Identifying the quantity of extension and its justifications. The majority of justifications were about complete a criticality assessment in CAPA’s and incomplete trainings in audits. After a difficulty impact analysis, workload and decision making could be two of the principal contributors for timeliness. 25% of CAPA’s exceed the general rule of requesting only two extensions. The audits does not have a rule. One of the suggested improvement was the implementation of a tracking system, which could facilitate the process. Continuous monitoring should be performed to ensure the effectiveness and the reduction of extensions requests. Key Terms - Audit, CAPA, Medical Device, Timeliness.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness
dc.relation.ispartofseriesSpring-2015
dc.relation.haspartSan Juanen_US
dc.subject.lcshSix sigma (Quality control standard)en_US
dc.subject.lcshTotal quality management
dc.subject.lcshMedical instruments and apparatus industry--Management
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleEnhancement of CAPA’s and Audits Responses in a Medical Devices Industryen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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