Manufacturing Engineering
Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/53
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Item Lean Transformation in Medical Device Manufacturing: Improving the Thermal Bond Process to Reduce Defects(Polytechnic University of Puerto Rico, 2024) González Aponte, GénesisThis research assessed the application of Lean manufacturing principles in the thermal bonding process of catheter production to reduce defects and improve operational efficiency. An analysis of the current state identified the root causes of the “Overflow” defect and established a foundation for process improvements. The implemented redesign allowed the transition from batch production to a single-piece flow system. Specifically for the thermal bonding process, applying Lean methodology allowed for the re-sequencing of process steps, which facilitated an optimal workload balance. Post-implementation results demonstrated a significant reduction in defect rates, from 1.91% to 0.24%, reflecting a statistical difference with a p-value of 1.59E-12. Additionally, scrap costs decreased substantially in the three months following Lean implementation, resulting in financial savings of $292K. However, despite time constraints, this study highlights the tangible benefits of process optimization through the Lean application methodologies by providing a clear example of its impact on improving operational efficiency. Keywords - Lean Principles, Medical Device Manufacturing, Operational Excellence, Thermal Bond Process.Item Enhancing Operational Efficiency Through Workflow Standardization: A Comprehensive Process Map for Managing Engineering Drawing Releases(Polytechnic University of Puerto Rico, 2024) De León Colón, YariannThis research addresses inefficiencies in managing engineering drawing releases within the Engineering team, stemming from the lack of a standardized process map and adequate training. These challenges result in frequent turnbacks, inconsistent workflows, and delays, negatively impacting productivity and project timelines. To resolve these issues, the study develops a comprehensive process map that standardizes workflows by defining key stages, responsibilities, and dependencies, enhancing clarity and reducing errors. Additionally, tailored training programs equip team members with the skills and knowledge needed to navigate the updated processes, fostering engagement and operational alignment. The study employs performance metrics such as turnback rates, resolution times, and delivery timelines to monitor improvements. Initial results indicate significant reductions in turnbacks and enhanced delivery efficiency, validating the effectiveness of the interventions. Beyond addressing immediate challenges, this research establishes a scalable framework for long-term success, transforming engineering operations into a more efficient and collaborative environment. Keywords - CCDoc, New Drawings, Process Map, Turnbacks.Item Improve Vision System Seal Presence Inspection(Polytechnic University of Puerto Rico, 2024) Luciano González, Anaisha I.; Nieves Castro, Rafael A.The sterile packaging of implantable medical devices is crucial for ensuring patient safety, preventing post-operative infections, and maintaining the integrity of the device until implantation. Given that these devices are placed within the body, contamination with harmful microorganisms can lead to serious complications, including implant failure and life-threatening infections. Sterile packaging acts as a barrier against pathogens, maintaining the sterility of the device during storage and transportation. Vision systems play a critical role in the sterile barrier inspection of implantable medical device packaging by ensuring the integrity and quality of the packaging, which is essential to maintaining sterility. In the manufacturing plant, inefficiencies in the packaging process, particularly in seal inspection, result in compromised product quality and potential contamination risks. Manual inspections and outdated quality control systems are prone to human error, leading to undetected seal defects, rework, and product recalls. In addition to the sterility issue, in the specific case being studied through this project, the sealing inspection inefficiencies create a productivity burden and operators’ burnout due to the extensive inspections. Key Terms - DMADV Method, Seal Inspection, Vision Systems.Item Revitalizing A Small Restaurant through Lean Manufacturing Practices(Polytechnic University of Puerto Rico, 2024) Morales Lugo, Gabriel A.; Morales Morales, José AlbertoThis project aims to improve the structural integrity of hamburger patties in a food truck setting. Several preparation methods were tested to determine their impact on patty cohesion, including refrigerated vs. frozen storage, liquid ingredient proportions, the timing of salt addition, and the use of cheese as a topping. The Mann-Whitney U test and Kruskal-Wallis test were used to analyze the results, with effect size calculations providing further insight into practical significance. While some differences were not statistically significant, effect size analysis showed meaningful variations, particularly in the timing of ingredient addition and storage methods. The findings offer practical recommendations for optimizing patty preparation processes to improve product quality. Key Terms - Effect Size, Food Truck, Hamburger Patty, Structural Integrity.Item Warehouse Design and Usage, Inventory Control System, and Material Handling Logisticsfor a Vertical Transportation Company(Polytechnic University of Puerto Rico, 2024) Vázquez Díaz, Brian A.; González Miranda, Carlos J.When it comes to delivering an ideal service based on quickness and effectiveness, the main or only focus does not only depend on the customer service, but also, on what, when, where, why, and how background operations work to ensure the availability to provide a service of excellence. In some particular cases, service problems might arise due to misuse of warehouse space, a lack of an inventory control system, and a blurred vision of an opportunity for material handling improvements. Executing a complete analysis where concepts of lean manufacturing, and six sigma are implemented to facilitate the performance of the warehouse and inventory logistics with the appropriate equipment to improve the service offered. From identifying and organizing inventory, to designating areas in the warehouse floor space, to appropriate equipment for handling materials, everything is for a continuous and consistent business where the values of reliability, security, and efficiency are pillars in the company’s vision. Key Terms — Inventory Control System, Lean Thinking, Material Handling Automation, Six Sigma.Item Implementation of a Change Control Process in a Pharmaceutical Industry(Polytechnic University of Puerto Rico, 2024) Ramos Feliciano, Paola C.; Nieves Castro, Rafael A.The pharmaceutical industry is monitored by the highest regulatory bodies such as the Food and Drug Administration (FDA) and other agencies to ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). The quality of the product is demonstrated through data generated within the process and supporting documentation. The data should demonstrate consistency, accuracy and completeness for data integrity. At the same time the equipment, process and systems should be validated for the intended use. This project focuses on the implementation of a change control in a validated system emphasizing in the required documentation to demonstrate the system has the capacity to function as it is intended and continues to meet regulatory standards. Additionally, the project provides a solution to a problem that has the potential to have data integrity issues. Key Terms ⎯ Change Control, Computer System Validation, Pharmaceutical Industry.Item Reducción de Costos con Impacto Ambiental Positivo: Un Enfoque Sostenible en la Industria Manufacturera(Polytechnic University of Puerto Rico, 2024) Hernández Rosado, Manuel C.; Nieves Castro, Rafael A.Esta investigación se centra en la implementación de prácticas sostenibles para optimizar la eficiencia energética y reducir costos en una industria manufacturera. El objetivo principal es explorar estrategias innovadoras que mejoren la optimización de procesos, incorporen tecnologías verdes, gestionen eficientemente los residuos y utilicen los recursos naturales de manera responsable. Además, el estudio examina la viabilidad de iniciativas de energía renovable, como la integración de fuentes de energía limpias y sistemas avanzados de reciclaje, orientadas a mejorar tanto la sostenibilidad económica como la ambiental dentro de la operación manufacturera. El enfoque no solo busca lograr una reducción de costos a largo plazo, sino también reforzar la responsabilidad social corporativa y contribuir al desarrollo de modelos de producción más amigables con el medio ambiente. Al emplear tecnologías y procesos sostenibles, la investigación demuestra cómo las industrias manufactureras pueden disminuir significativamente los gastos operativos mientras mejoran su huella ecológica, lo que lleva, en última instancia, a una práctica industrial más responsable y sostenible. Palabras Claves - Eficiencia Energética, Energía Renovable, Gestión de Residuos, Industria Manufacturera, Optimización de Recursos, Prácticas Sostenibles, Reducción de Costos, Responsabilidad Social Corporativa, Sostenibilidad Ambiental, Tecnologías Verdes.Item Qualification of the Cold Chain System in Drug Logistics(Polytechnic University of Puerto Rico, 2024) Otero Torres, Yailyn; Nieves Castro, Rafael A.Distributions Centers for pharmaceutical products have experienced significant changes in recent years in terms of the cold chain, adapting to new social, economic, and technological structures. The main objective of this process is to maintain a constant cold temperature of refrigerated pharmaceutical products, which requires maintaining a refrigeration specification of 2°C to 8°C. This article aims to use DMAIC tools to help us ensure that deliveries from more distant routes to different customers consistently meet the required temperatures from their departure from the distribution center to delivery to the customer. Key Terms - Cold Chain System, Distribution Centers, DMAIC Method, Pharmaceutical Products.Item Improvement and Standardization of the Remuneration Process of Engineering Lecturer Professors(Polytechnic University of Puerto Rico, 2024) Samó Velázquez, Yahira M.; Nieves Castro, Rafael A.Human beings invest plenty of time carrying out various tasks for an employer or company to generate a salary. Salaries must satisfy the personnel who provide services to earn income [1]. After conducting a study on the remuneration processes of lecturers at a post-secondary institution using the DMAIC methodology, it was determined that the personnel in charge of the processes need to standardize it to satisfy professors’ needs, such as counting a highly efficient. This standardization should come into force for the semester from August to December 2024 and will take 30 days to 3 months to be fully implemented. According to the research, the time taken by the remuneration process will decrease from 4 weeks and five days to 14 days, and the receipt of the salary will go from one month after the professors sign the contract to 15 days after signing the contract. Key Terms - DMAIC method, Improvement Remuneration, Standardization.Item Optimization of Shear Testing(Polytechnic University of Puerto Rico, 2024) Acevedo Liceaga, Wilfredo; González Miranda, Carlos J.This research project focused on improving shear testing processes. This project aims to implement a new system that performs shear testing without destroying the piece, thus reducing the scrap percentage. The DMAIC methodology was used to enhance the shear testing process. DMAIC is a concept that measures defects in business processes and improves profitability. DMAIC stands for the process's five main steps: Define, Measure, Analyze, Improve, and Control. This research seeks to improve the measurement process of shear tests. This is important for the process because it will reduce scrap, decrease the error percentage when measuring shear in each piece that undergoes welding processes, and provide a more accurate value, thus improving quality. The DMAIC methodology provides a structure and tools to enhance a process by optimizing and stabilizing the business process. In this case, it would involve eliminating destructive tests and reducing scrap percentage due to shear tests. Key Terms — Optimization, Residential Breakers; Shear Test; Welding Process.