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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorRodríguez Vázquez, Luis Adnel
dc.date.accessioned2020-09-09T15:11:20Z
dc.date.available2020-09-09T15:11:20Z
dc.date.issued2016
dc.identifier.citationRodríguez Vázquez, L. A. (2016). Validation machine process of “crosslink, low profile break-off” on tornos deco 20 [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/532
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe United States (U.S.) medical device manufacturing sector is a highly diversified industry that produces a range of products designed to diagnose and treat patients in healthcare systems worldwide. Process validation is an essential part of medical device manufacturing. As an objective of this project there should be the completion of an operational qualification (OQ) to tests the process produces a consistent product that meet with the design specs and the qualification protocol (PQ) examines the capabilities of the current process in producing a safe, high-quality product under simulated conditions of Crosslink Low Profile Break-off. After the qualifications runs the data will be gather to analyze if the data follows a Normal Distribution, then will be calculate the Tolerance Intervals, the ANOVA’s, Capabilities, Sampling Size and the Control Limits for each of the critical dimensions. Key Terms - Control Limits, Operational Qualification, Performance Qualification, Validation, Low Profile Crosslink, Spinal.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2016;
dc.relation.haspartSan Juanen_US
dc.subject.lcshSpinal implants
dc.subject.lcshMedical instruments and apparatus industry--Quality control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleValidation Machine Process of “Crosslink, Low Profile Break-off” On Tornos Deco 20en_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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