Manufacturing Competitiveness

Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/52

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1x16 Post Weld Continuity
(Polytechnic University of Puerto Rico, 2021) Martínez Adorno, Valerie; García Sandoval, María
Laser welding is a critical process of medical device used for the manufacturing process of spinal cord stimulation leads that brings different offenders. The highest for 1x16 family is continuity failure with 4% of rejection rate. It intended to improve the process with a new post weld continuity as an early detection point to avoidscrap and recover the unit as RWK. Improvement consists of to change the manual inspection for an automatic that allows to maximize the inspection time with an improvement of 68 seconds. Benefits from improvements include product output, yield, less scrap, process performance and financial area. Process performance is evaluated by the technique of the operator with the automatic check through unit position, time and correct inspection order. A P-chart results demonstrate the improve and control in continuity with a rejection rate of 3.6%. The welding process will continue to be evaluated to reducing the % rejection.Key Terms – Continuity, Laser welding,Medical Devices, Scrap.
5s Techniques to Optimize Classroom Organization
(Polytechnic University of Puerto Rico, 2020) Moreno López, Stephanie L.; González Miranda, Carlos J.
This research project was focused in the 5s methodology for the improvement of an elementary classroom. The 5s is defined as a method of five steps that seeks to improve working space, eliminate waste and improve efficiency within the service industry. This methodology can be utilized to improve any service or space. In this research the 5s tool can be utilized to improve the organization and time management with a small classroom that provides tutoring services for elementary students. An organized space is fundamental for the proper classroom management techniques. In order to optimize space and improve time management in the classroom the 5s methodology was used. The name of the steps is derived from the Japanese language. These are: Seiri, Seiton, Seiso, Seiketsu, Shitsuke. Its beginnings were in the Toyota Corporation in 1960 with the objective of achieving a well-organized and clean working environment that could be sustained permanently. This research seeks to optimize a small classroom, improve lesson plans being carried and time management, promote organization skills and positive habits. This is important for appropriate classroom management techniques such as increased students focus, promote self-awareness of shared space, reduce waste, reduce negative impact in the lesson plan and increase student’s motivation. The 5s methodology brings a structure and tools to improve a process by optimizing and increasing efficiency in the service field. In this case optimized space and organization for the results in an elementary tutoring classroom. Key terms ⎯ classroom, improve, management, optimize
Acceptance Testing for Thermoplastic Injection Molds
(Universidad Politécnica de Puerto Rico, 2020) Arias Geraldo, Pavel; Nieves Castro, Rafael A.
The injection molding process is the most important of all plastics processing processes due to its variety of uses and applications. The primary element of an injection molding process is the mold itself. Molds are expensive pieces of equipment that often cause their share of problems due to improper acceptance procedures. This research was limited to thermoplastic injection molds. The data was collected through interviews by phone. Practices with professionals during the acceptance process of a mold were discussed to gather an insight of the current situation. The results pointed out that many companies should implement and improve their acceptance procedures to avoid delays and money losses due to an improper methodology. A methodology was provided for molders based on scientific molding tests and it was evidenced that an acceptance procedure is needed for new molds. Key Terms ⎯ Acceptance testing, mold, plastic processing, scientific molding.
Analytical Method Technology Transfer From Quality Control Laboratory To Manufacture Area
(Polytechnic University of Puerto Rico, 2021) Pérez Dominicci, Linnette; Nieves Castro, Rafael A.
The project was developed with the intent to document the analytical transfer method to reduce in-process concentration testing cycle time. A reduction of up to 50% turnaround time (TAT) downtime was achieved. Waste reduction due to no sample preparation, gowning cost reduction, since there is no need for the operators to take the sample to the Quality Control (QC) laboratory and transferring the in-process method to the manufacturing area allows more capability to the QC laboratory to perform another testing were other improvements obtained from the project. Technology method transfer tools were applied to generate a successful in process method transfer from the QC laboratories to the manufacturing area. The implementation of this project complying with all the standards required by the company and the different regulatory agencies will improve the capability and competitiveness of the manufacturing area among the company sites. Key Terms ⎯ Analytical Method Transfer, Manufacturing Process, Protein Concentration, Turnaround time (TAT) reduction.
Aplicación de Metodología DMAIC-Seis Sigma para Disminuir el Costo de Inventario del Proceso de Re-trabajo en una Compañía de Dispositivos Médicos
(Polytechnic University of Puerto Rico, 2015) Ojeda Burgos, Luz D.; Morales, José A.
El trabajo se realizó con el fin de solucionar el problema que presentaba el costo de inventario, el cual incrementaba año tras año y no se estaba trabajando a su máxima capacidad por deficiencias en el manejo del mismo. Durante el diagnóstico de la situación se pudo determinar que el costo de inventario del área era excesivo debido a factores como; falta de controles durante el proceso, exceso de personal para trabajar en el área, incremento de rechazos internos, rechazos repetitivos e incremento en las quejas del cliente. Se proponen algunas soluciones como: control del inventario, reducción del personal, control de rechazos internos de tal manera que el incremento en el inventario de productos pendientes por retrabajar fuera disminuyendo eficientemente y con un costo beneficio tanto para la compañía como para los clientes. Palabras Claves — Diagrama de flujo, DMAIC, Instrucciones de trabajo, Lluvia de ideas.
Aplicación de Metodología DMAIC-Seis Sigma para Mejorar el Proceso de Almacenaje de una Compañía Distribuidora de Accesorios de Equipos Electrónicos
(Polytechnic University of Puerto Rico, 2023) Cartagena Rivera, Kevin A.; Nieves Castro, Rafael A.
Este proyecto contiene la propuesta de trabajo para el mejoramiento del área de almacén de una empresa de distribución de accesorios para equipos electrónicos como celulares, tabletas, etc. y el estudio se centrará en la reubicación y organización de la mercancía y estanterías para almacenaje teniendo en cuenta su posición dentro del área, accesibilidad y facilidad para disponer de los materiales en el momento en que se necesiten. La empresa se caracteriza por la búsqueda de nuevos métodos que le permitan implementar un mejor control en sus procesos como la recepción, el almacenamiento y movimiento de materias primas, así como el control de la mercancía existente dentro del almacén. Esto sirve para manejar un inventario real en un tiempo efectivo, permitiendo proyectar y planificar órdenes de producción de un producto determinado anticipándose a la demanda del mercado obteniendo garantía en el cumplimiento hacia los clientes. Con esto se busca organizar, planear, ejecutar y controlar esta tarea aprovechando lo aprendido y generando soluciones efectivas a estas oportunidades de mejora detectadas en esta empresa. Términos claves ⎯ almacén, DMAIC, inventario.
Aplicación del “Right First Time (RFT)” en un Proceso de Documentación para una Industria Farmacéutica
(Polytechnic University of Puerto Rico, 2013) Panell Calo, Jatziry J.; Morales, José A.
La presente investigación se llevó a cabo con el objetivo de evaluar las alternativas para mejorar el proceso de manejo de documentos en la industria farmacéutica. Las regulaciones de la FDA hacen que sea necesario que la documentación de esta industria esté completa y correcta. A los efectos de recopilar los datos se utilizó una muestra de cinco empleados de una planta farmacéutica del área este de Puerto Rico. A estos empleados se les impartió un cuestionario con el objetivo de conocer las razones más comunes por las cuales la documentación es devuelta a los departamentos que la originan. La investigación mostró que existe una deficiencia en el proceso de redacción de lo que se denomina Revision History y que es esta la razón principal para que los documentos tengan que ser devueltos. Palabras claves – Documentación de la Industria Farmacéutica, Lean Manufacturing, Right the First Time, Standard Operating Procedure.
Application of Lean Manufacturing and Lean Six Sigma Tools to Improve Back to Back Activities in the Compression Process
(Polytechnic University of Puerto Rico, 2019) Calzada Vázquez, Omar; Nigaglioni, Rolando
A recent opportunity regarding a product ramp up in the production schedule due to a potential product transfer requires the manufacturing area to look for creative ways to improve in order to comply with expected demand. By applying Lean Six Sigma concepts, the current process was defined, a baseline was established, and improvements were identified and executed. The results achieved due to these improvements were: average back to back cycle time in the compression area was reduced from an average of 3.7 hours to 2.87 hours for a 22% reduction and a standard deviation reduction of 91% (1.44 to 0.131 hours). These results were achieved by implementing parallel activities as well as eliminating constraints (redundant documentation and availability of tools) throughout the process. The improvements were also instrumental in achieving a potential capacity increase of an additional 1.33 lots for a work week due to additional time available. Key Terms ⎯ Baseline Establishment, Cycle Time, Improvements, Lean Manufacturing.
Application of Lean Manufacturing Principle to Construction Industry
(Polytechnic University of Puerto Rico, 2016) Márquez Pagán, Pedro E.; González Miranda, Carlos J.
Waste in the construction industry has been the subject of several research projects around the world in recent years because of inefficiency. Researchers and professionals implement different methods to reduce the amount of waste in the construction industry. One of the efficient methods for reducing waste is the application of lean approaches. Lean construction is a result of the introduction of a new form of production management on the field. Although lean construction is still evolving, its generic principles, techniques and tools can already be applied. The construction projects include various risk factors which have various impacts on time objective that may lead to time-overrun. This study suggests and applies a new technique for minimizing wastes and risk factors effect on time using lean construction principles. The lean construction is implemented in this study using the last planner system through execution of an industrial project in Puerto Rico. This is due to minimizing and mitigating the effect of most of the risk and debris factors in this project due to the implementation of lean manufacturing techniques. Key Terms - Lean Construction, Process Flow, Risk Management, Waste.
The Application of Lean Tools Using the Plan-Do-Check-Act Cycle
(Polytechnic University of Puerto Rico, 2011) Rodriguez Muñoz, Felix R.; Nieves Castro, Rafael A.
Abstract - This kaizen event is going to illustrated how to apply Lean principles and tool using the PLAN-DO-CHECK-ACT methodology. Throughout the project it will be demonstrated how important the Lean principles are for the medical device industry in general. The labor cost, efficiency and the quality of the product are the most important aspects of production. This project was design to targets this areas of the manufacturing environment. The Next Generation Balloon cell was set up to produce certain quantity of units with the require demand at the time of it develop. At this moment the demand has change and some changes need to be made. After a team was build and all the data was recollected a new Takt Time was calculated and from that result many changes were executed. It will be demonstrated that not only the pre determined goals are achievable but how new goals were developed throughout the event. The benefits of this project will help the company to maintain it cost in control and to be more competitive in the market of the medical devices. The result will show how the PDCA help the implementation of Lean techniques. Key Terms - Lean manufacturing, Medical Device, PDCA, Space Maker Balloon.
Application of Quality Improvement Tools to a Perishables Food Distribution Center to Reduce Product Return and Improve Customer Satisfaction
(Polytechnic University of Puerto Rico, 2015) Pérez Rosario, Alexandra; Morales, José A.
Product Return and Customer Satisfaction have a high impact on the financial, customer service and quality aspects of the food distribution and storage in the perishables food industry. A Lean Six Sigma approach was used to reduce the product return impact and improve the customer satisfaction overall. A significant improvement at the financial and operational aspects was revealed using more than one Quality Improvement tool, including statistical control measure and taking into account the FDA 21 CFR 101.10, USDA and PACA standards that regulates the industry. The implementation of recommendations had a positive outcome after only a week of the execution but needed to be controlled for a consistent change. Key Terms - Customer Satisfaction, Lean, Product Return, Quality Improvement and Six Sigma.
Application of Six Sigma DMAIC methodology in a Merchandise Receiving Process at Burlington Store
(Polytechnic University of Puerto Rico, 2021) Marrero-Santiago, Wilmarie; García Sandoval, María
With the intent of decreasing the cycle time of the merchandise process receiving, the unloading and scanning step and the sorting step were identified as a labor cost opportunity. Through 3 kaizen events done across site, it was determined a requirement of 15% total cycle time reduction for receiving merchandise process. DMAIC methodology and Lean manufacturing principles was used to develop this project and successfully decreased the receiving process cycle time. With the reassignment of employee’s positions in the different steps and the identification of the work areas, the improvement on the process was significantly noted. This project achieved an improvement of 75.27 minutes per pallet down to 52.46 minutes per pallet, which represents a 30.30% decrease of cycle time on this process, which at the same time, represent a reduction of approximately $10,927.42 on payroll cost for the company. Key Terms ⎯ DMAIC, Lean manufacturing, Retail store, Receiving process.
Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant
(Polytechnic University of Puerto Rico, 2008) Arizmendi Figueroa, Rose Mary; Rivera, José Orlando
The cleaning procedure process validation has generated considerable discussion when executing a US Food and Drug Administration (FDA) inspection at Pharmaceutical Plants. In general, the FDA requires the equipment to be clean prior to its use for manufacturing, processing, packing, holding of a drug product and/ or when sampling a raw material. Currently, some pharmaceutical plants have failed to design a good manual cleaning process. In regards to this, the Management Theory is crucial to manage effectively a cleaning procedure with the optimization of the Cleaning Process Validation. The application of the management functions contributed on the development of a guide to correct these faults and/or prevent further occurrence. By implementing the Administrative Management Theory a cleaning validation program is without a doubt optimized. Key Terms — Administrative Management Theory, Cleaning validation, crucial, optimization
Audit Process Optimization in the Manufacturing Area
(Polytechnic University of Puerto Rico, 2021) Ortiz Martinez, Alexander; Nieves Castro, Rafael A.
This project was developed to demonstrate a viable audit process optimization in the manufacturing area. The AbbVie site ubicated in Barceloneta, Puerto Rico,started with only one product back in 2003; by the end of 2021, the site has become a multidrug facility with six products. This increase in production has a higher requirement in the audit. The implementation of Release by exception will help mitigate the audit time and keep the production running as business needs. This project is a recommendation to accommodate the reality of the site. The use of a manufacturing execution system (MES) is expected in the pharmaceutical and biotechnological industries to perform the activities related to the manufacturing of a product. This tool, MES, have the potential to benefit the audit of the process, reducing the time to achieve a faster lot release. Using the DMADV framework on this project can improve the audit cycle time. KeyTerms⎯Audit, DMADV, MES, Release by Exception.
Automatización Y Optimización Del Garaje Rivera
(Polytechnic University of Puerto Rico, 2020) Torres Soto, Dorian E.; Nieves Castro, Rafael A.
Este trabajo consiste en el desarrollo de un mecanismo que pueda ser utilizado con fines de documentación. Se efectuará en un taller de mecánica en el cual se busca automatizar y optimizar diferentes partes del proceso. El problema que enfrentaba el taller estaba marcado en la documentación sobre el trabajo que se le realizaban a los automóviles una vez llegados al taller y durante su estadía en este. También, se busca poder identificar posibles defectos o faltas físicas que tengan los automóviles en el momento de su llegada al taller. Para poder identificarlas áreas de mejora, se realizó un DMAIC en el cual se analizó detalladamente el proceso y se entrevistó al dueño y personal del taller para poder conseguir información detallada sobre el proceso. Se trabajó en una hoja de cotejo y una hoja de registro. Estas como efecto tienden hacer el proceso de documentación uno más fácil de realizar y archivar. Palabras claves — automatización, documentación, optimización.
Buffer Formulation Vent Filter Re-Use at Parenteral Manufacturing Plant
(Polytechnic University of Puerto Rico, 2020) Figueroa-Rodríguez, Jorge; Morales, José A.
For sterilization-in-place cycles that used vent filters as a redundant non-contact product, the filter membranes could be re-used several times without impacting their integrity neither compromising the sterilization cycle. At a parenteral manufacturing plant in Puerto Rico, the vent filter is discarded after exposed to a one-single sterilization-in-place cycle. With the implementation of this project, the vent filter used during the sterilization-in-place as part of the buffer formulation at Manufacturing Plant can be re-used up to 50 times. With DMAIC (Define, Measure, Analysis, Improve and Control) quality strategy, the use of vent filters during buffer formulation at Manufacturing Plant was improved. Under DMAIC, the sterilization conditions of the filter’s manufacturers was identified as the worstcase sterilization scenario. Also, validation activities were executed to confirm no moisture residual particles were found in the vent filter membrane after multiples consecutives sterilization cycles. At the end, this project implementation will provide better manufacturing flexibility and costsavings for up to USD 105,000 yearly. Key Terms ⎯ reuse filter, steaming, sterilization-in-place, vent filter
Carnauba Dispenser to Improve Coated Tablets Elegance
(Polytechnic University of Puerto Rico, 2021) Negrón Romero, Mara Liz; Morales, José A.
This study describes the implementation of Six Sigma for improvement of the addition process of carnauba wax on coated tablets in a pharmaceutical industry. Due to the frequent complaints received from costumers for covered engraving on tablets with carnauba wax, the company carried out a Six Sigma project. The Six Sigma methodology provides an organized structure for problem analysis and problem solving. Using DMAIC phases the problem was defined; the variables influencing the process were measured; the causes for the tablet elegance defect were analyzed; improvements were scheduled and made until level of customer satisfaction were reached. A new tool was implemented for the addition of carnauba wax during coating drying step. The project implementation achieved to increase productivity and allowed process standardization, improving customer service and quality. Key Terms ⎯ carnauba wax, coated tablets, coating, customer.
Catheter bonding Process Improvements with High-intensity Ultraviolet Curing Systems
(Polytechnic University of Puerto Rico, 2021) Ortega Meléndez, María del Mar; Avilés Segundo, Iván M.
Ultraviolet (UV) curing is a common process used in medical devices manufacturing for bonding operations. Light-curable adhesives provide rapid cure, great adhesion, and good chemical resistance for sterilization processes. This project studies the effect of the implementation of a new UV curing technology for manifold catheters manufacturing. The upgrade consists of moving from the current mercury light bulb UV to an LED bulb. Benefits from improvements include energy savings, improved process performance, and reduction of maintenance activities. Process performance is evaluated by its capability of meeting the tensile force design spec of 3.38lbf. Key Process Inputs (KPI) that affect the tensile strength output are UV Intensity and Process Cure Time. A Design of Experiments explored the lower and upper limits of adhesive curing time and intensity parameters, and their impact on tensile values. Key Terms ⎯ Adhesives; LED; UV Cure; Catheters; Medical Devices.
Challenges and Effectiveness of Lean Management Implementation in the Manufacturing Sector
(Polytechnic University of Puerto Rico, 2024) Mestey Rivera, Keisha; Nieves Castro, Rafael
The 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.
Change Control Routed with Missing Information Delaying Approval and Implementation Date
(Polytechnic University of Puerto Rico, 2022) Álvarez Rodríguez, Bianca; Morales, José A.
The approval of manufacturing change control for MedDevice Inc., is currently acting lower than target(15 business days). Based on a 12-months data review, the lead time of approval of a change is approximately 36 days. This means that 25.8% of changes were routed for evaluation without the necessary information. The DMAIC methodology was used to determine what is causing the delay. The following possible causes were identified as part of the evaluation: (1) missing information i.e., Manufacturing Plan, Validation documents, and Product affected is not included. (2) Volume of changes being routed. (3) Time for identification and number of required approvers by type of change. During control phase, lead time for four months (Quarter 2) was collected, and results demonstrate a reduction of less or equal to 33 business days. The project goal was to reduce approval lead time process from 36 to 33 days by end of Quarter 2.KeyTerms⎯Change Control, Continuous Improvement, DMAIC, Lead Time.