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
DMAIC-Based Optimization of In-Process Monitoring for Scrap Reduction in a Regulated Industry
(Polytechnic University of Puerto Rico, 2025) Jackson Rodríguez, Yaritza; Nieves Castro, Rafael A.
Process monitoring and control are critical for quality assurance in the regulated medical device industry, supporting ongoing verification of processes and confirming they remain capable and in control. Many in-process monitoring activities require destructive testing, thereby increasing scrap costs. This project focuses on Line X, where in-process monitoring scrap significantly increased scrap costs, totaling $0.279 per unit over six months. Production volume growth forecasts and new product introductions suggest that the current monitoring strategy will further affect manufacturing efficiency. DMAIC methodology was applied to evaluate and optimize the in-process monitoring strategy. The project objective was to reduce monthly scrap costs associated with monitoring samples in Line X, focusing on destructive tests such as mechanical integrity and leak testing. All modifications were required to maintain product quality and
regulatory compliance, and to prevent nonconforming units from reaching the customer. The optimized sampling strategy reduced costs and implemented controls to sustain improvements. Keywords ⎯ DMAIC, In-Process Monitoring, Sampling Strategy, Scrap Reduction.
Center Thickness Optimization for Product A
(Polytechnic University of Puerto Rico, 2025) Arzola Rodríguez, Luis A.; Morales Morales, José Alberto
Every organization wants to increase its production and reduce the possibility of having scraps. Having to scrap products increases production costs, reduces cost savings, reduces volume output, and therefore reduces confidence in the manufacturing process. For a product to be released into the market, quality approval must be obtained. This quality approval considers compliance with critical to quality dimensions (CTQ) where no error or deviation must be found.
Having a deviation on the CTQ triggers a Non Conformance Investigation (NCR) that normally is resolved by scrapping the batch and product because there is nothing that can be done to fix it. Using DMAIC methodology, an investigation exercise will be conducted to understand the root cause of why this CTQ fails and how it can be solved and improved. Improving this CTQ will result in the reduction of NCR and make the manufacturing process more reliable, steady by
reducing scrapped products and therefore increasing volume output. Keywords ⎯ CAPA, Center Thickness, DMAIC Method, Tooling Design, SPC.
Reducing Defects in Garage Door Panels Through PDCA-Based Process Improvement
(Polytechnic University of Puerto Rico, 2025) Barriera Rodríguez, Heriberto; Morales Morales, José Alberto
This design project applies the Plan–Do–Check–Act (PDCA) methodology to analyze and reduce defects in garage door panel manufacturing. A dataset of 30 nonconforming panels was examined to identify defect types, severity levels, locations, and dispositions. Pareto analysis, defect severity evaluation, heat mapping, and a cause-and-effect diagram were used to identify dominant defect patterns and likely root causes. Based on the findings, corrective and preventive improvement actions were developed targeting handling practices, equipment contact, material protection, inspection standardization, and workplace layout. The effectiveness of these actions was evaluated using a simulated post-improvement dataset reflecting realistic first-cycle PDCA results. The simulation showed a reduction in total defects from 30 to 17, representing a 43% improvement. Both customer-perceived quality (fraction defective) and internal process performance (defects per unit) showed measurable improvement. The results demonstrate that PDCA provides a structured, data-driven approach for diagnosing quality problems and guiding sustainable defect reduction in manufacturing environments. Keywords ⎯ Continuous Improvement, Defect Reduction, Manufacturing Quality, PDCA.
Implementation of Digital Documentation System as a Replacement for Current Physical Documentation Process
(Polytechnic University of Puerto Rico, 2025) Espinosa Vázquez, Gabriel; Nieves Castro, Rafael A.
The purpose of this project was to establish a digital documentation system for the site’s form execution processes. Physical printing incurs cost for paper and toner, along with slow monitoring of data. The main objective of this project was to convert physical executable forms into electronic forms by creating a digital documentation platform while complying with regulatory governing bodies and standards organizations. By employing a PDCA methodology, the planning and execution of the project was a success by successfully converting 42 forms from physical to digital in the span of two phases, with the remaining 17 forms tied to Phase 3 scheduled to conclude by February 2026. Finally, future projects should finalize the last Phase 3 of the project to further accomplish the site’s paperless
agenda. Key Terms ⎯ ALCOA+, Digital Documentation Platform, Good Documentation Practices, Physical Documentation.
Implementing Lean Six Sigma Practices for Process Improvement in the Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2025) López Medina, Claudia Sofia; Nieves Castro, Rafael A.
The pharmaceutical industry operates in a highly regulated environment where operational efficiency, product quality, and regulatory compliance are critical. This research examines the application of Lean Six Sigma methodologies as a systematic approach to process improvement in pharmaceutical manufacturing.
Through the analysis of existing processes and the evaluation of Lean and Six Sigma tools, this study identifies opportunities to reduce waste, minimize
variability, and improve overall operational performance. The research highlights how structured methodologies such as DMAIC and DMADV can support compliance with Good Manufacturing Practices while enhancing product quality and patient safety. The findings demonstrate that Lean Six Sigma contributes to measurable improvements in efficiency, defect reduction, and process consistency. This study provides practical insights and recommendations for pharmaceutical organizations seeking to adopt continuous improvement strategies in a competitive and highly regulated industry. Key Terms ⎯ Lean Six Sigma, Pharmaceutical Manufacturing, Process Improvement, Quality Management, Regulatory Compliance.