Manufacturing Competitiveness
Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/52
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Item Reduction of the Excessive Use of RODAC and STA Plates in Pharmaceutical Industries(Polytechnic University of Puerto Rico, 2024) Arroyo Garcia, Stephanie Marie; Nieves Castro, Rafael A.This project aims to solve the problem of the pharmaceutical companies' excessive use of RODAC and STA plates, which increases waste production and negatively affects the environment. The study uses a thorough methodology that combines qualitative and quantitative research to find the causes of these plates' excessive use and suggests waste reduction techniques. The technique consists of data gathering to estimate plate usage and related expenses, interviews to understand the current usage, and a literature review to investigate current practices. The results will be used to modify and intervene in pharmaceutical manufacturing processes to minimize plate usage and increase efficiency and sustainability. This initiative aims to promote eco-friendly methods in the pharmaceutical sector, which will enhance resource management and lessen environmental impact. Key Terms - Continuous Improvement, Process Optimization, Sustainability, Waste Reduction.Item Effective Management Models of Pharmaceutical Supply Chain(Polytechnic University of Puerto Rico, 2024) Rivera Encarnación, Liz Y.; Nieves Castro, Rafael A.Through thoroughly examining the literature, this research investigates the potential and problems of managing the pharmaceutical supply chain. By examining current studies, the paper explores how cutting-edge technology, such as blockchain and artificial intelligence, might improve inventory management procedures. The results show how crucial it is to embrace technology, work together, and strategically prepare to overcome inventory management obstacles. Blockchain technology is promising for improving transparency and trust; it also highlights revolutionary forecasting techniques and supply chain agility. Furthermore, recent studies underscore the necessity of collaboration and innovative solutions to enhance operational efficiency. In the end, a comprehensive strategy is put out, focusing on the incorporation of cutting-edge technology and stakeholder cooperation to enhance the effectiveness of the pharmaceutical supply chain and guarantee prompt access to life-saving drugs. Key Terms - Blockchain Technologies, Development Models, Inventory Management, Pharmaceutical Industry.Item Improving Product Changeover in Pharmaceutical Manufacturing Through Lean Six Sigma(Polytechnic University of Puerto Rico, 2024) Barreto Feliciano, Kelly M.; Morales Morales, José A.Pharmaceutical bulk manufacturing is essential for producing important lifesaving drugs, but often faces significant challenges during changeovers that can lead to production delays and increased costs for the company. This study focuses on applying Lean Six Sigma methodologies to streamline complex changeover processes within a pharmaceutical manufacturing facility. With tools such as fishbone diagrams and Pareto analysis, root causes were identified, and solutions were implemented to reduce changeover delays. An Andon board was implemented which reduced operator response times to alarms by 39%, helping to mitigate delays caused by equipment malfunctions. Standardized flowcharts provided consistency which helps in reducing human error and confusion during the process. The 5S initiative reduced wasted time and unnecessary movement during changeovers. The successful application of these methodologies in this study highlights the potential for Lean Six Sigma to drive significant operational improvements in highly regulated environments like pharmaceutical manufacturing. Key Terms - Changeover, Continuous Improvement, DMAIC, Lean Six Sigma, Pharmaceutical Manufacturing.Item Challenges and Effectiveness of Lean Management Implementation in the Manufacturing Sector(Polytechnic University of Puerto Rico, 2024) Mestey Rivera, Keisha; Nieves Castro, RafaelThe aim of Lean practices is to improve the performance of processes by taking away wastage. However, adoption may differ due to management involvement, type of tools, and organizational culture. Consequently, this research employs a case study and literature review in combination. The outcome of the literature review suggests that tools such as JIT, Kaizen, value stream mapping, and 5S give great benefits to the organization, but there are hindrances in culture and resources. Quantitative case studies indicate that the adoption of Lean will yield notable improvements in productivity by 15%, Quality by 20%, a reduction in lead-time by 25%, and cost savings by 10%. However, Lean is not implemented in a vacuum, and other factors, such as the commitment to sustain the drive towards continuous improvement or the strategic fit, impact factors like change management. It is recommended in this research that Lean should be implemented strategically within the organization and makes deems appropriate further studies for Lean integration within automation and artificial intelligence technology and investigation of Lean approach’s viability in the future by longitudinal approach research. Key Terms - Continuous Improvement, Lean Management, Organizational Culture, Toyota Production System.Item Navigating Training Needs: A Study of Medical Devices Industry Laboratories(Polytechnic University of Puerto Rico, 2024) Rivera Jaime, Yaira N.; Nieves Castro, Rafael A.Imparting effective training for laboratory personnel in the medical device industry is crucial for ensuring operational excellence and reducing quality-related incidents. This article, therefore, explores the relationship between the adequacy of training for laboratory personnel and the frequency of quality-related incidents affecting operational excellence. The goal is to identify gaps in existing training programs and propose solutions to enhance them. A mixed-methods approach was employed, combining quantitative survey data with qualitative interviews to assess current training practices. The results indicate that, although training is generally perceived as effective, recurring incidents-such as documentation errors and testing inaccuracies reveal gaps in the depth of the training. This research highlights the need for tailored training solutions that address technical and soft skills, fostering continuous improvement and minimizing costly quality-related errors. Future work will focus on refining training programs and assessing their effectiveness in reducing incidents and improving overall operational performance. Key Terms - ISO 17025, Laboratory Personnel, Medical Device Industry Quality Assurance, Training Program.Item Optimizing the Engineering Configuration Control Board Process(Polytechnic University of Puerto Rico, 2024) Rosado Cardona, Angeliz; Morales Morales, José A.This article provides a detailed review and improvement of a missiles and defense company’s Engineering Configuration Control Board (CCB) process. This project was intended to study and explore the main bottlenecks in the CN processing system that slow down engineering processes and may affect contractual delivery dates. Utilizing a business process improvement approach that encompasses process mapping, identification of stakeholders, data gathering, analysis, and the application of corrective actions, the project successfully achieved efficiency enhancements. The derived outcomes include a 39% reduction in check review time, a 67% reduction in CC time, a 37% reduction in Concept Screening Board time, and a 43% reduction in the average time spent on the CCB cycle. Key Terms - change notice, change request, configuration control board, process optimization.Item Metodología 5S como Estrategia de Optimización y Aprendizaje Experiencial en los Salones del Colegio Miglen Learning School, Sabana Grande, Puerto Rico(Universidad Politécnica de Puerto Rico, 2024) Pérez Roche, Natalia B.; Pabón González, MiriamLa metodología 5S se caracteriza por optimizar y emplear un enfoque de calidad a los diferentes entornos en los que se puede aplicar, por tanto, desde el entorno educativo se convierte en una experiencia de evolución y aprendizaje. Como objetivo, en el presente trabajo se plantea implementar la metodología 5S (Clasificar, Ordenar, Limpiar, Estandarizar y Mantener) en los salones del Colegio Miglen Learning School, Sabana Grande, Puerto Rico, para mejorar el rendimiento escolar y crear un ambiente más adecuado para el aprendizaje. Desde un proceso dinámico y participativo en la implementación, así como un 53% en el rendimiento de la aplicación, una mejor organización y aprovechamiento de los espacios. Por último, se resalta la importancia de la disciplina y el orden en el proceso educativo a partir de esta experiencia, además, de fomentar valores de responsabilidad y cuidado entre los estudiantes, preparándolos mejor para enfrentar los desafíos académicos y personales. Términos Claves - 5S, Distribución, Espacio, Experiencia, Optimización.Item Design and Implementation of Buffer Multi-batch in the Biopharmaceutical Industry(Polytechnic University of Puerto Rico, 2024) Figueroa Rosario, Nariet; Nieves Castro, Rafael A.In this research, an analysis of buffer consumption was performed throughout buffer and FBP manufacturing processes to determine if the current buffer batch size of 200 kg or 600kg is enough to prepare more than one FBP batch or if the buffer batch size should be increased. Also, if the proposed multi-batch buffer is a viable option for the manufacturing processes in the studied biopharmaceutical industry. To execute the design and implementation of the buffer multi-batch strategy for the industry, the DMAIC methodology was used, resulting in a reduction of 18 hours per batch of cycle time. Key Terms - Buffer, Consumption, DMAIC, Multi-batch.Item Upstream Fermentation and Research Laboratory Design, Safety, and Validation(Polytechnic University of Puerto Rico, 2024) Pierantoni Núñez, Michelle M.; González Miranda, Carlos J.The fermentation process plays an essential role in biotechnology and biopharmaceutical research, serving as a foundation for the production of various valuable compounds. This abstract provides an overview of recent advancements in fermentation laboratory design and equipment selection aimed at enhancing research efficiency and safety. Key considerations in facility design, including spatial organization, and safety implementations, are discussed in the context of meeting specific research and production needs. Moreover, the importance of equipment selection, ranging from fermenters and bioreactors to ancillary systems, is highlighted, emphasizing factors such as control capabilities and regulatory compliance. Furthermore, the significance of integrating advanced technologies and rigorous operational protocols to drive innovation and scientific discovery in the field of biotechnology and biopharmaceuticals. Key Terms - fermentation, laboratory, safety, validation.Item Optimización de la Eficiencia: Un Enfoque 5S/DMAIC para la Gestión del Inventario de Reactivos en un Laboratorio Químico(Universidad Politécnica de Puerto Rico, 2024) Portalatín Mouliert, Michael A.; González Miranda, Carlos J.Este proyecto ataca el problema de la pobre gestión de inventario en el laboratorio de control de calidad de una farmacéutica situada en el área sureste de Puerto Rico. Para abordar los problemas que encontramos en el manejo de inventario se estuvo utilizando las reconocidas metodologías DMAIC y 5S en paralelo. Al trabajar con ambas de estas dos metodologías en paralelo se obtuvieron mejores resultados, ya que ambas de estas metodologías se complementan. Con la implementación de este proyecto se obtuvo como resultado una mejor organización en el área del cuarto reactivos y junto con esto se logró una disminución del tiempo de búsqueda de los analistas en encontrar un reactivo dentro del área. Con la implementación de estas mejoras en el manejo del inventario del laboratorio podemos mejorar la eficacia del laboratorio y junto con esto logramos un lugar de trabajo más fluido. Palabras Claves ⎯ 5S, DMAIC, Inventario, Lean Six Sigma.