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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorLópez Morales, Perla M.
dc.date.accessioned2024-01-11T16:18:42Z
dc.date.available2024-01-11T16:18:42Z
dc.date.issued2023
dc.identifier.citationLópez Morales, P. M. (2023). Reduction in Dye Test Failures Incidence for Cartridges Manufacturing Process in the Medical Device Industry [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/2011
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe medical device industry is known to be regulated by regulatory agencies across the world. Every year, a significant number of Non Conformances (NCs) and Corrective Actions Preventive Actions (CAPA’s) are generated to investigate the incidences where the product specifications are not aligned with company requirements. In coated cartridge manufacturing process, 63 Non-conformances were generated from January 2022 to October 2022 in where 22 non-conformances correspond to Dye Test Failures. This incidence of Dye Test Failures triggers the generation of one CAPA to investigate and identify actions to reduce the incidence of Dye Test Failures associated to human errors, equipment malfunctions and method. Kaizen Methodology and 6M’s Tool were applied for the investigation and implementation phases. A total of 5 actions were successfully implemented. An Effectiveness Monitoring (EM) was established for a 9-month period where a maximum of 9 Non conformances will be permitted to declare successful the reduction as part this Dye Test CAPA. Key Terms  Cartridges, Dye Test, Coating, Non-conformance.en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesFall-2023;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshMedical instruments and apparatus industry--Waste minimizationen_US
dc.subject.lcshCartridges
dc.subject.otherKaizen
dc.titleReduction in Dye Test Failures Incidence for Cartridges Manufacturing Process in the Medical Device Industryen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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