Communities in PRCR
Select a community to browse its collections.
- Colecciones de la Albizu University
- Colecciones digitales de Atenas College
- Colecciones de los Centros Sor Isolina Ferré
- Materiales utilizados para la certificación.
Recent Submissions
El Concepto “Lean” en Laboratorios Industriales: Una Nueva Manera de Pensar
(Polytechnic University of Puerto Rico, 2026) Ayala Monserratte, Nicole; Nieves Castro, Rafael A.
Esta investigación analiza la aplicación de la filosofía Lean Manufacturing en laboratorios industriales, especialmente en áreas de control de calidad donde su implementación aún es limitada. Aunque las metodologías Lean y Six Sigma son ampliamente utilizadas en manufactura, su adopción en laboratorios ha sido poco estudiada. El objetivo principal fue identificar los tipos de desperdicio (waste) y las herramientas Lean más utilizadas mediante una revisión bibliográfica de estudios publicados entre 2015 y 2025. Con base en los hallazgos, se desarrolló una herramienta fundamentada en los principios de las 5S para identificar desperdicios en operaciones de laboratorio. La herramienta se aplicó en un área específica, permitiendo detectar los desperdicios más frecuentes. Los resultados mostraron que los defectos fueron los desperdicios de mayor incidencia, seguidos por el movimiento innecesario y los tiempos de espera. Además, se evidenció que la falta de organización y estandarización contribuye significativamente a las ineficiencias operacionales y limita la mejora continua.
Optimization of Reagent Inventory and Storage in a Chemistry Laboratory
(Polytechnic University of Puerto Rico, 2026) Cartagena Fonseca, Sonia; González Miranda, Carlos J.
This research addresses the challenge of reagent inventory management in a chemistry laboratory that relied on manual tracking systems, physical cards, and basic spreadsheets. The laboratory managed approximately 148 reagents and recorded up to 3 incidents per year involving the use of expired reagents. The study proposes and evaluates a digital inventory system using Microsoft Excel integrated with the VIVA platform, incorporating a four-stage automated expiration alert system combined with Lean Laboratory and ISO 17025 quality standards. Following implementation, expired reagent use was reduced from 3 per year to zero, a 100% improvement, and full traceability was achieved across all 148 reagents. Although manual data entry remains a limitation, the system demonstrates measurable improvements in laboratory efficiency, safety, and regulatory compliance. Future research should explore integration with Laboratory Information Management Systems and barcode or radio-frequency identification technologies.
Clean Room Space Optimization Through Lean-Driven Workstation Redesign and Financial Analysis
(Polytechnic University of Puerto Rico, 2026) Negrón Rivera, Jan L.; Morales Morales, José Alberto
A five-phase Lean methodology was implemented to improve space utilization in a medical device manufacturing cleanroom. The study concentrated on Zone A, comprising 25 workstations and 10 manufacturing processes. Application of 5S principles, workstation table redesign, and enhanced use of vertical space resulted in the release of 304 ft² of cleanroom floor space, representing a 35% reduction from the original 868 ft² baseline. Cycle time was reduced from 15,318 to 14,911 seconds, a statistically significant improvement of 407 seconds (paired t-test, t (9) = 4.48, p = 0.002). The I-MR control chart demonstrated consistent application of the methodology across workstations. Regression analysis indicated that original workstation size was a significant predictor of freed space (R² = 48.3%, p < 0.001). Financial analysis revealed strong economic value, with a net present value (NPV) of $446,568 and a payback period of 5.02 months.
Reducing Appraisal Costs in Computer System Validation (CSV): A Risk-Based Auditing Approach Using DMAIC Methodologies
(Polytechnic University of Puerto Rico, 2026) Vega Quintero, Jenylis; García Sandoval, María
Computer System Validation (CSV) in the pharmaceutical industry often relies on test-everything approaches, resulting in excessive Appraisal Costs. This research applies to the Lean Six Sigma DMAIC framework to optimize the validation lifecycle by transitioning to a risk-based approach aligned with FDA Computer Software Assurance (CSA) and ISPE GAMP 5 R2 guidelines. A retrospective analysis of 11 protocols established a historical baseline of 336.0 hours across 42 execution days, requiring 8.20 hours per identified issue. A 2025-specific dataset of 144.0 baseline hours was used for back-testing. Results demonstrated that the risk-based framework reduces validation effort to 103.7 hours (a 28% reduction), saving $2,015 per project cycle while maintaining a 100% detection rate for all 28 critical defects.
Improving Production Fixture Availability Using Lean and Six Sigma in a Medical Device Manufacturing Line
(Polytechnic University of Puerto Rico, 2026) Figueras Toro, Jorge; Morales Morales, José Alberto
This design project addressed the problem of production fixture unavailability in a medical device manufacturing line, where missing, misplaced, or delayed fixtures generated avoidable downtime and process interruptions. The main objective was to improve fixture availability and reduce fixture-related downtime through the application of Lean and Six Sigma principles. The methodology followed an applied, non-experimental, observational approach using historical downtime records, fixture usage logs, direct observations, process mapping, cause-and-effect analysis, and statistical evaluation of key performance indicators. The results showed that missing fixtures, misplaced fixtures, and waiting for fixture return were the most frequent baseline causes. Comparative analysis between baseline and post-improvement conditions showed a reduction in mean downtime from 37.53 to 13.53 minutes, a reduction in interruptions from 4.40 to 1.73, and an increase in fixture availability from 80.93% to 95.00%. These findings support the conclusion that a structured fixture management strategy can improve operational efficiency and process stability.