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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorMorales, José A.
dc.contributor.authorÁlvarez Rodríguez, Bianca
dc.date.accessioned2022-07-06T17:57:17Z
dc.date.available2022-07-06T17:57:17Z
dc.date.issued2022
dc.identifier.citationÁlvarez Rodríguez, B. (2022). Change Control Routed with Missing Information Delaying Approval and Implementation Date [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1628
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe approval of manufacturing change control for MedDevice Inc., is currently acting lower than target(15 business days). Based on a 12-months data review, the lead time of approval of a change is approximately 36 days. This means that 25.8% of changes were routed for evaluation without the necessary information. The DMAIC methodology was used to determine what is causing the delay. The following possible causes were identified as part of the evaluation: (1) missing information i.e., Manufacturing Plan, Validation documents, and Product affected is not included. (2) Volume of changes being routed. (3) Time for identification and number of required approvers by type of change. During control phase, lead time for four months (Quarter 2) was collected, and results demonstrate a reduction of less or equal to 33 business days. The project goal was to reduce approval lead time process from 36 to 33 days by end of Quarter 2.KeyTerms⎯Change Control, Continuous Improvement, DMAIC, Lead Time.en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesSpring-2022;
dc.relation.haspartSan Juanen_US
dc.subject.lcshSix sigma (Quality control standard)en_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Postersen_US
dc.subject.lcshMedical instruments and apparatus--Time management
dc.titleChange Control Routed with Missing Information Delaying Approval and Implementation Dateen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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