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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorAvilés Segundo, Iván M.
dc.contributor.authorRosado Cruz, Janitza
dc.date.accessioned2021-08-17T00:09:20Z
dc.date.available2021-08-17T00:09:20Z
dc.date.issued2021
dc.identifier.citationRosado Cruz, J. (2021). Release by Exception Project Design Optimization [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1125
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractPharmaceutical companies are trying to improve the adverse effects that technology brings with the change in documentation. Going from a paper record to an electronic record is a new challenge that must be absorbed and implemented as a growth projection. The objective of this study is to implement the Release by Exception, analyzing, and obtaining only the critical steps of the process that must be complied according to regulation requirements. At the same time, this study contemplates improving other areas that guarantee the release of as many batches as possible. In other words, optimize the process to make it more efficient and effective without forgetting critical details. The research question is the following: What improvement strategy can be achieved under the implementation? In this context, the use of the Lean manufacturing principles and DMAIC methodology through the analysis of a representative sample of 30 manufacturing lots provides the way to achieves the objectives. The implementation of Release by Exception with DMAIC method indicates that, under a redistribution of the certified assigned personnel, the determination and justification of the critical steps and the reduction of open exceptions, a single batch of Adalimumab currently takes between 51 to 58 days from manufacture to final approval by Quality department as expected. Key Terms ⎯ DMAIC, Electronic Record, Release by Exception, Quality department.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness Program;
dc.relation.ispartofseriesSpring-2021;
dc.relation.haspartSan Juanen_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.lcshSix sigma (Quality control standard)en_US
dc.titleRelease by Exception Project Design Optimizationen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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