Communities in PRCR
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- Colecciones de la Albizu University
- Colecciones digitales de Atenas College
- Colecciones de los Centros Sor Isolina Ferré
- Materiales utilizados para la certificación.
Recent Submissions
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.
Pharmaceutical Expansion: Contractor Coordination and Risk Management
(Polytechnic University of Puerto Rico, 2026) Santiago Mulero, Kevin M.; Pons Fontana, Carlos A.
This study analyzes the execution of a pharmaceutical granulation facility expansion project conducted within an active manufacturing environment. The project aimed to increase production capacity, optimize process flow, and improve material handling while maintaining compliance with Good Manufacturing Practices. Due to the involvement of multiple contractors and critical operational constraints, safety management and coordination were identified as key challenges. Using Define, Measure, Analyze, Improve, Control methodology and Root Cause Analysis, safety observations were evaluated to identify recurring risk patterns, high-risk activities, and root causes. Results indicated that improper use of personal protective equipment, unsafe handling of mobile equipment, and risks associated with working at heights were the most frequent and severe issues. Based on these findings, targeted improvement strategies were developed, including enhanced supervision, stricter safety controls, and improved contractor coordination. The study provides practical recommendations to strengthen safety performance and support more efficient execution of similar industrial projects.
Idle Waiting Time for Patients – Why Does It Happen?
(Polytechnic University of Puerto Rico, 2026) Díaz Quiles, Laura; Nieves Castro, Rafael A.
This study examines the increasing wait times for physician appointments and office visits at a medical practice specializing in endocrinology. The practice operates Monday through Thursday, with hours on Mondays and Wednesdays from 12:00 PM to 5:00 PM, and on Tuesdays and Thursdays from 8:00 AM to 12:00 PM. The current appointment system is outdated and overwhelmed by the growing number of patients. This study suggests that not only does the scheduling system contribute to long wait times, but that factors such as patients with multiple comorbidities, older patients, and those with psychological or mental disorders also play a significant role. Patients experienced wait times for consultations ranging from 33 to 121 minutes, with an average consultation time of 21.17 minutes. Implementing a new appointment scheduling method could reduce physician burnout, minimize errors, and allow for more dedicated time for patient care.
Design of a Lean Capacity Optimization Strategy for Machines Under No Mixing Policies
(Polytechnic University of Puerto Rico, 2026) Pérez Hidalgo, Licelys M.; Pabón González, Miriam
Manufacturing systems operating under fixed batch sizes and strict no-mixing requirements often experience capacity losses due to misalignment between production order quantities and machine cycle capacity. This research examines a three-machine manufacturing system where recurring idle machine cycles lead to underutilized assets, increased lead times, and elevated work-in-process levels. Using the Define, Measure, Analyze, Improve, Control (DMAIC) methodology, the study identifies traceability limitations within machine cycles as the primary root cause of capacity loss. A traceability-based feeding system is developed that enables multiple production orders to be processed within the same cycle while maintaining compliance with quality, process, and documentation requirements. The solution incorporates uniquely identified trays, enhanced documentation, and 5S-based preparation to eliminate idle machine cycles without changing batch sizes or adding equipment. The results demonstrate that hidden capacity can be unlocked through process redesign and improved traceability in constrained manufacturing environments.