Manufacturing Engineering

Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/53

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Aero Repairs Documentation Cycle Time Reduction By Lean Application
(Polytechnic University of Puerto Rico, 2014) Negrón Rivera, David A.; Torres, Edgar
In our daily life and world, with a diversity of industries and services, from health to manufacturing, all kind of products; many of them care apply Lean concepts or tools to perform important improvements to their service or products. Value Stream Map (VSM) is one of the lean tools than can help to reduce the problem discussed on this article “cycle time reduction. One of the major opportunities of Aero Consulting Company (X) is that the average cycle time of each project is around 280 days. The main goal of this project is to evaluate the current state and develop a future state VSM to reduce the cycle time by 40%. Currently delivery of each project consists of at least three milestones, named as: Early-Milestone (EM), Mid-Milestone (MM), and Final Milestone (FM). Each of these milestones has several delays, once the action items have been implemented the new cycle time will be reduced to 123 calendar days. This represent to an overall cycle time reduction of 56%. Key Terms - Cycle time, Lean, Manufacturing, VSM.
Alternate Raw Material Supplier Validation
(Polytechnic University of Puerto Rico, 2019) Valerín Díaz, Melissa; Nieves Castro, Rafael A.
This article discusses the Process Validation of Over the Counter Pharmaceutical Product using alternate supplier of raw material. The primary ibuprofen drug substance supplier for GSK Ibuprofen family products informed that they have not recovered from a natural disaster that impacted their facilities. As a result of this natural disaster, the supplier shut down production of ibuprofen indefinitely. In order to alleviate ibuprofen drug shortage imposed by primary supplier’s facility shut down, GSK Puerto Rico has identified potential alternate supplier of Ibuprofen for the current Ibuprofen OTC products. To conduct this project, DMAIC methodology was used in order to have a better understanding of the process to increase efficacy and identify areas of opportunity to improve. GSK Puerto Rico is responsible for the 100% of the Ibuprofen family products for US domestic sales and Ibuprofen family represents 58% of GSK 2019 volume plan. The company will be able to supply the expected volume of Ibuprofen family products to the customers and the volume plan will be achieved with the validation of alternate ibuprofen supplier for Ibuprofen family products. Key Terms - DMAIC, Process Validation, Raw Material, Supplier Qualification.
Análisis de Pesos y Optimización del Proceso
(Polytechnic University of Puerto Rico, 2021) Betancourt Díaz, Manuel; González Miranda, Carlos J.
Este proyecto se desarrolló con el objetivo de implementar la metodología DMAIC seis sigmas 5s. Organizando el lugar de trabajo y validando el proceso de confección de pastelillos para reducir la variabilidad en peso, aumentar eficiencia de los empleados, asegurando calidad del producto para el cliente y para el comerciante asegurar ganancias y un aumento en productividad. En el desarrollo del proyecto fue necesario definir los aspectos del proceso que se quiere mejorar y luego medir y recolectar información necesaria para luego analizar los resultados por medio de un diagrama de causa/efecto y analizando los datos de pesos en Minitab. Luego en base a los resultados se recomiendan unas mejoras al proceso para finalmente desarrollar una propuesta para controlar los cambios recomendados. Palabras Claves – DMAIC, Eficiencia, Seis Sigma, Variabilidad
Anti-inflammatory Drug Elution Rate Variability Reduction
(Polytechnic University of Puerto Rico, 2013) Aponte Medina, Edneris; González Miranda, Carlos J.
This project was focused in the Drug Elution Rate Variability of an Anti-inflammatory Drug used in a Medical Device Company. The project is based on the manufacturing and bonding process of a DXA Drug Collar that is a component of a lead manufacturing company. As part of the Lot Acceptance testing for drug collars, elution testing is performed. Results must comply both individual and mean values in order to be considered acceptable. A failure in a drug collar lot could result in a cost of scrapping or a field action. Therefore, there is a need to implement changes that reduce the variability of the elution testing. The methodology selected for this project is DMAIC. A process map will be developed to identify elements that could be providing variability in elution rate and provide recommendations for manufacturing process enhancement. An implementation plan will be create for proposed changes implementation. Key Terms - DMAIC (Define, Measure, Analyze, Implement, Control), DXA (Dexamethasone Acetate), FDA (Federal Drug Administration), Lot Acceptance Test.
APIS Automatic Packaging Inspection System
(Polytechnic University of Puerto Rico, 2018) Charles Gómez, Carlos A.; Torres, Edgar
Blister packaging is very common and very popular in the pharmaceutical and medical devices industry. This high increase in the use of this type of packaging provides a large variety of designs for cosmetic appearance and at the same time it has become more important to ensure the integrity of the packaging for the safety and the health of the patients using the products. Quality inspections are one of the most important areas of any manufacturing process and there are many ways to inspect the quality and integrity of these packages to provide and to ensure that the quality complies with the regulation and standards. In the other hand, vision system inspection is improving and very flexible and powerful to perform any kind of visual inspections for quality, measure and even temperature and others. This article focusses on how is the possibility of a vision system to inspect blister packaging to prevent packaging leaks, sealing and damage foil and what type of effectiveness or consistency it would have to be reliable. Key Terms - Blister Packaging, Packaging Inspection, Vision Systems.
Aplicación de Lean Six Sigma a Compañía de Construcción, Mejorando la Imagen y la Estructura
(Polytechnic University of Puerto Rico, 2015) Rosa Torres, Héctor D.; Nieves Castro, Rafael A.
Hoy en día es bien importante mantener la rentabilidad del negocio a niveles competitivos. Si el equipo de trabajo no está motivado, el servicio que ofrecen nunca será completado a tiempo, trayendo consigo descontento de parte de los clientes y por ende, cancelación de contratos y una mala reputación. Este proyecto se basa en como los principios de “Lean Six Sigma”, usando la metodología DMAIC como guía, ayuda a identificar las posibles razones de ausentismo laboral en una compañía de construcción. Siendo esta causa la razón principal de atraso en los proyectos programado por el patrono. Inicialmente 8 de 8 empleados no lograban cumplir con los requerimientos del patrono, teniendo una media de ausentismo de aproximadamente 7 por un periodo de tres meses. Siendo la meta del patrono que el número de ausencias de los empleados estuviera entre un rango de 0 a 3 días laborables por un periodo de tres meses. Se pudo reducir el nivel de ausentismo que presentaba esta compañía. Ya que una vez implementado los cambios, se pudo observar que 6 de 8 empleados estaban cumpliendo con los requisitos establecidos por el patrono, siendo esta una reducción de ausentismo de una media de aproximadamente 3 por un periodo de tres meses. Key Terms - Ausentismo Laboral, Construcción, DMAIC, Six Sigma.
Aplicaciones de la Filosofía Lean para Optimizar la Logística en los Almacenes y Controlar los Periodos de Expiración en Productos Refrigerados
(Polytechnic University of Puerto Rico, 2015) Cuebas Cancel, Sylvette; Torres, Edgar
En el almacenamiento de productos refrigerados se tiene que mantener un alto nivel de los controles de calidad e inocuidad y estos se deben monitorear con mucho más énfasis si los productos son perecederos y van dirigidos al consumo humano. A continuación se presentaran varias aplicaciones utilizadas respecto a la filosofía LEAN para optimizar la logística en los almacenes y controlar los periodos de expiración en productos refrigerados. Para ello se estará utilizando el modelo del Sistema de Producción Toyota, comúnmente conocido por sus siglas en inglés TPS (Toyota Production System). A través del artículo se observará la implementación de varias de las herramientas de la filosofía LEAN como lo son: “Just In Time”, “5S”, Sistema “Pull”, Sistema “Kanban”, Ciclo de Tiempo, “First In, First Out”, entre otras. Todas estas herramientas serán implementadas con el propósito de eliminar o reducir el despilfarro. Precisamente esta es una de las características clave de la filosofía LEAN, la reducción del despilfarro o “MUDA”; comúnmente conocido en inglés como “waste”. Términos Claves - Bebidas de Frutas, Filosofía LEAN, Leche, Periodos de Expiración
Applicability of Lean Concepts in Reducing Change Over Time to Increase Production Capacity
(Polytechnic University of Puerto Rico, 2011) Sécola, Lydianne; Nieves Castro, Rafael A.
Abstract - At this very competitive environment, companies need to do more with less. One way to do this is to maximize the use of the facilities that are already in use instead of building new ones or expanding existing ones. This project applied some of the Lean concepts and tools to reduce change over time for a key equipment during a pharmaceutical manufacturing process, without negatively impacting quality, health, safety or environmental compliance. The main Lean concepts used include: eliminating non-value activities, reducing the time required for business value-added activities and scheduling activities in the most efficient sequence. The Lean tools used include: Cause and Effect Diagram, Brainstorming, Single Minute Exchange of Dies, 5S, Poka Yoke, Standard Work and Risk Analysis. The implemented actions achieved a reduced average change over time (from 19 to 12 hours, for a 37% reduction). With the reduction of the change over time, additional manufacturing can take place within the same time period, and thus, the demand increase can be addressed with no significant investment. Key Terms - Change Over, Increase Production Capacity, Lean, Pharmaceutical Manufacturing Challenges
Application of Design of Experiment to Demonstrate Equivalency of Two Multi Layer Compression Process for an Extended Release Tablets Product
(Polytechnic University of Puerto Rico, 2009) Carrión Vega, Jaime; Nieves Castro, Rafael A.
Abstract ― A design of experiment (DOE) was performed to a multi layer compression process that is going to be transferred from facility A to facility B. This study demonstrates and compared the equivalence of the compression process of a non-validated process site with a validated process from the original site. The relevance of this project is to demonstrate the equivalence of the process to ensure the robustness, and quality of the product. During the compression process, the weight of multiple stages, thickness, and hardness were collected in both machine. The data collected was analyzed using One-Way-ANOVA and Kruskal-Wallis test. Based on the results obtained from the data, it was concluded that both multi layer compression process are equivalent. Key Terms ― Design of Experiment, Extended Release Tablets, Multi Layer Compression Process, One – Way – ANOVA.
Application of DMAIC Methodology to Improve the Utilization of an Industrial Glassware Washer System in a Biopharmaceutical Industry
(Polytechnic University of Puerto Rico, 2009) Colón Santiago, Cindy; Pons Fontana, Carlos A.
Abstract ⎯ This article describe how the problem solving approach of Define, Measure, Analyze, Implement and Control (DMAIC) is applied to increase the utilization of an industrial glassware washer system in a Biopharmaceutical Industry. The application of this methodology results in a deep understanding of the cleaning process. Sources of variation were identified and a root cause analysis conducted allows for the identification of potential solutions as well as selection and implementation of improvements. The implementation of improvements in the control phase reflect reductions in the amount of cleaning loads required to satisfy manufacturing needs on a weekly basis, reducing in 40% the amounts of loads,increasing by 20% the utilization of the cleaning system and providing tools to the support area staff that will allow them to have a better understanding of the logistic involved along the cleaning process. Key Terms ⎯ DMAIC methodology, cleaning system utilization.
Application of Lean Six Sigma Methodology to Optimize Fixation Device Assembly Line in the Medical Devices Industry
(Polytechnic University of Puerto Rico, 2013) López Colón, Elmer A.; Pons Fontana, Carlos A.
The research project was focused in the line optimization of a Fixation Device assembly line in a Medical Devices Industry. The Fixation Device is called ProTack™. The Covidien Company is the manufacturer located in Ponce, Puerto Rico. The medical device has application in endoscopic surgery procedures for fixation of prosthetic material and approximation of tissue for various surgical specialties, such as repair of hernia defects. The Ponce facility of Covidien has identified improvement areas within the assembly process of ProTack™. The Lean Six Sigma (LSS) Philosophy was used to identify Non-Value Added (NVA) activities in order to be eliminated or reduced. The implementation of Lean Six Sigma Philosophy results were line output was optimized as per customer requirements, labor costs were reduced and line performance improved. This research demonstrates that the Lean Six Sigma Philosophy is a robust methodology for continuous improvement and optimization. Key Terms - Lean Manufacturing, Process Optimization, Six Sigma, U-shape Manufacturing Cell.
Application of Six Sigma and Lean Tools to Facilitate use of an Electronic Health Record System in a Medical Office in a Sub-Urban Area of Puerto Rico
(Polytechnic University of Puerto Rico, 2012) Iramain Acevedo, Jorge A.; Torres, Edgar
Abstract - The study was conducted within a primary medical care office with the goal of determining how the implementation of an Electronic Health Record (EHR) system affected the attendance and patient wait time in said workplace. Using some Six Sigma and Lean manufacturing tools and techniques, it was determined that both the attendance and patient wait time were affected. The attendance was determined to have decreased by approximately 33% on average during the sampled time period, while the patient wait time increased by approximately 15 minutes, which accounts for a 33% increase. Thus, it was determined that the implementation strategy utilized during the integration of the EHR system was suboptimal, and in need of revision in order to increase both parameters. Key Terms - EHR, DMAIC, Six Sigma, Wait Time.
Applying a Quality Risk Management Approach to a Cleaning Validation System
(Polytechnic University of Puerto Rico, 2014) Medina, Jesús M.; Torres, Edgar
Cleaning Validation is a crucial step on assuring product effectiveness and safety by assuring that the equipment to be used has the appropriate condition to manufacture a new product without any foreign substances that could endanger the patient to ingest this product. A quality risk management approach was used to see possible risks on a cleaning validation system and give recommendations in order to mitigate and control those the risks by seeking options to access does risks in an effective and reliable manner. FDA 21 CFR 210-211 was used as a guide for regulations regards cleaning validation systems. Key Terms - Cleaning Validation, FMEA, PAT, Quality Risk Management.
Applying International Organization Standardization Guideline for Quality System Management (ISO 9001:2008) in the Aerospace Industry
(Polytechnic University of Puerto Rico, 2012) Ortiz, Eric X.; Nieves Castro, Rafael A.
Abstract - The aerospace industry is based on the continuous improvement on processes and product within a high quality. Many companies are working with outsourcing companies to design most of the components that will be used in the final product. These companies should comply with the same quality standards. International Organization Standardization, ISO 9001: 2008 is a standardization system that works with the quality system in the company to achieve a standardized process. This project evaluated each norm that the ISO standard includes and recommended how the system should be implemented to an outsourcing aerospace company and describes some of the result that will be obtained by implementing it. Key Terms - Aerospace, ISO 9001:2008, Outsourcing, Standardization.
Applying Lean Manufacturing to Minimize Inspection Time in a Medical Device Company
(Polytechnic University of Puerto Rico, 2012) Feliciano, Denise; Morales, José A.
Abstract - This research is conducted in medical devices manufacturing company that makes a product to be used on the treatment of female stress urinary incontinence resulting from urethral hyper mobility and intrinsic sphincter deficiency. The product consist of a family of products which and the device is commonly referred to as tension free, pub urethral sling. This research is the result of the initiatives of the Continues Improvement Department. It was identified waste time caused by off-line quality inspections in the product-assembly process and it is intended to reduce the waiting time in the manufacturing of the product. Lean Manufacturing tools were used in this project. The main objectives of this research were to reduce waiting time at least 20% and improve efficiency at least 10%. Some tools used to obtain the results were: balancing the production line, evaluating the line layout, implementing 5S to the sub assembly station. Key Terms - Improvement, Lean Manufacturing, Inspections, Waste time.
Applying of Lean Manufacturing Concepts to Improve Process Flow in a Needlework Industry
(Polytechnic University of Puerto Rico, 2014) Vázquez Candelario, Lydiana; González Miranda, Carlos J.
The needlework industry is one of the oldest and most important industries for the economy of many countries. In Puerto Rico it is a source of jobs since 1940 for many regions as: Lares, Las Marias, Cabo Rojo, Camuy, Arecibo, Mayaguez and Añasco. Currently, it is unstable and constantly decreasing. Unlike other industries it cannot replace the ability of its employees by the evolution of technology. Improved process flow through the implementation of Lean Manufacturing can help conserve the needlework industries. Lean Manufacturing is a methodology that eliminates waste, which is defined as activities that do not add value to a product. Lean Manufacturing is derived from the Japanese manufacturing industry and can be used in any industries. Key Terms - Lean Manufacturing, Needlework Industry, Standardized Work Flow, Waste.
Assay Report Documentation and Storage Process Improvement Using DMADV Methodology
(Polytechnic University of Puerto Rico, 2021) Cartagena Méndez, Manuel J.; Nieves Castro, Rafael A.
As part of the Process Engineering team, one of our goals is to identify areas with opportunities in our current manufacturing processes. It was identified an opportunity to improve the assay hard copy documentation generated in the Analytical Laboratory area because the reports are printed in hardcopy, and the audit process requires 3 signs in every paper. The assay hardcopy documentation and audit trail process will be changed to a paperless process following the Design for Six Sigma (DFSS) systematic approach and DMADV to reduce costs of the process, transforming the documentation repository in an electronic data base for the client convenience. Key Terms ⎯ DMADV, Lean, Process Improvement, Six Sigma.
Attribute Data Treatment of Automated Inspection Vision System For Product Mix-Up Detection
(Polytechnic University of Puerto Rico, 2012) Nieves Santiago, Jorge L; Nieves, Edgar
The pharmaceutical industry continues to grow at an exponential pace, with number of medications being mixed, molded, stamped, and packaged every day in the millions. Regardless of the amount, the margin for error never changes. To prevent any mistakes, the human factor has been reduced and replaced by high speed vision inspection systems. This paper presents a statistical evaluation of product mix-up detection confidence levels, confidence intervals and sample size considerations for a filler vision system (i.e., Optel Vision Inspection) in bottle packaging line using executed engineering studies of “XYZ” Pharmaceutical Industry located at Puerto Rico. An Attribute Agreement Analysis will be used to investigate whether this system can be used for detect different tablet’s defects as broken, different shapes or colors presentations to assess the consistency of responses of appraisers vs. standard reference for the inspection system. Key Terms: Appraiser, Attribute Agreement Analysis, Confidence Intervals, Confidence Level.
Authorized Medical Allowance Lists (AMAL) and the Authorized Dental Allowance List (ADAL) Review Process in the Department of the NAVY
(Polytechnic University of Puerto Rico, 2024) Rodríguez Rivera, Pedro O.; González Miranda, Carlos J.
The AMAL and ADAL are clinically driven documents that specify the minimum quantity of equipment and consumable items required by the U.S. Navy’s operating forces Health Services Departments. These lists ensure that the necessary medical capability and capacity are met based on Required Operational Capabilities (ROC) and Projected Operating Environment (POE). To enhance the AMAL/ADAL Review process, the study employed the Define Measure Analyze Improve Control (DMAIC) methodology. Process Mapping was used to visualize the steps in the current process, identify areas with limited value, and understand the flow of materials and information. The goal is to create an improved process flow, establish roles and responsibilities, and align with the National Defense Authorization Act (NDAA) requirements. In summary, DMAIC provides a structured approach to optimize and stabilize business processes, ultimately enhancing medical and dental readiness for Navy forces. Key Terms — Department of Defense Instruction (DODINST); Distributed Maritime Operations (DMO); Joint Capability and Integration Development System (JCIDS); Required Operational Capability and Projected Operational Environment (ROC/POE).
Automate Palletization Process in a Manufacturing Company
(Polytechnic University of Puerto Rico, 2021) Rivera Morales, Nelson Jr.; González Miranda, Carlos J.
For the last 20 years, the manufacturing industry company has been revolutionized with process improvements, many methodologies like continues manufacturing, and among many others, the revolution of the automatization. This research project pursues the analyze, design and recommend an automated option for a palletization manufacturing process. The manufacturing process to be discussed is one where an associate performs the task stand and repeat the process in many instances, for the long of a shift. Repetitive and stand tasks are ones ideal to automatize. The process under evaluation in X Manufacturing Company consist of placing a predetermined quantity of tubs inside a box, record the quantity in each tub and consequently the quantity in the box and pallet in the manufacturing execution system. The methodology used in the research project is the six-sigma methodology Define, Measure, Analyze, Design and Verify (DMADV) and will be conducted till Design/Recommendation phase. Key Terms ⎯ DMADV, DOF, FDA, OSHA