Manufacturing Competitiveness

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

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    Execution of Lean Techniques for Cost improvement in a Quality Area of a Small Regulated Company established in Puerto Rico
    (Polytechnic University of Puerto Rico, 2022) Ruiz Reyes, Yiaslín; Morales, José A.
    A small regulated company established in Puerto Rico developed a cost improvement project on a Quality Area to stay competitive. The main objective was to reduce the number of samples sampled for X and Y areas. Also, according to the evaluation those samples quantities already stored were reduced and the sample orientation at storage was changed. The implementations were performed with data integrity, high quality, within Regulatory and Quality Management approvement. Plan Phase was used to investigate the situation where the Visual Management5’S was applied. During the data analysis was implemented a solution plan on the Do Phase. Meanwhile on Check Phase it was evaluated that implementation accomplished the project milestones. Though on Act Phase a cost saving of $85,784.82 was met and around 50% of samples sampled were reduced. It was confirmed with a Hypothesis Test for the Mean with alpha 5% and it was found that the reduction was completed. Key Terms⎯ Cost saving, Deming Cycle, Quality, Visual Management 5’S Methodology.
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    Reducing Documentation Errors by Designing a Continuous Workflow for the In-Process of Spinal Needles
    (Polytechnic University of Puerto Rico, 2022) Gomez Mulero, Nerimar; Morales, José A.
    Good Documentation Practices are essential to maintain a robust Quality System. Many documentation errors were constantly found on acceptance records at the Product Release-to-Packaging stage. A Flow Diagram and a Root Cause Analysis were performed to identify deficiencies on the process that were leading to errors. Four different types of wastes were found multiple times in the in-process of spinal needles, constantly interrupting the flow of work and information. A continuous flow is achieved by re-designing the in-process documentation. The new acceptance record avoids most of the documentation mistakes by replacing handwritten forms with electronic forms, ultimately, improving productivity and achieving a leaner process. Key Terms⎯ Continuous Workflow, Good Documentation Practices, Lean Manufacturing, Root Cause Analysis.
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    Process Time Reduction in Manufacturing Areas: Visual Valves Identification on Manufacturing Area specifically on Media Prep Area, Media Preparation tanks to Pursue Agility on the Visual inspections required before, during and after the Media Prep Solution are Prepared
    (Polytechnic University of Puerto Rico, 2022) López, Jaymarie; Morales, José A.
    Time of production process and associate activities were evaluated for Media Prep manufacturing process on Juncos, P.R. The voice of the customer requested reduced time inspection process before, during and after batching preparative activities and process. DMAIC methodology was used to evaluate the production costs. Fishbone, Scatter, Grant Charts, and other tools were used to determine what was the possible cause of highest time associates take to find valves, and equipment in gray area, even though the valves are identified with its proper part number. Equipment and material identification were most probable causes. Improvements in procedures and identification tags were used to perform and established the new color code tags, based on the function and type of addition of the valves. Evaluated process and defined the color code for the valve and established a 5S in the gray area reduced time and cost, also process became more agile and effective. Key Term⎯ Agility, DMAIC, Grant Chart, Lean Manufacturing.
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    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.
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    Monomer’s Residuals Test Elimination for Soft Acrylic Buttons at Polytechnic University of Puerto Rico
    (Polytechnic University of Puerto Rico, 2022) Vargas Lugo, Bethzaily; Morales, José A.
    In the cataract surgery, the natural lens in the eye is replace with an Intraocular Lens. Five monomers (EA/EMA, TFEMA, EGDMA, UV Chr) are mixed to produce the soft acrylic lens. Residual monomer testing measures the amount of monomer and crosslinker not polymerized or removed by annealing process. During the last years residual monomer testing become a high-cost test due to equipment maintenance, chemical purchases, and spare parts cost. Historical data was collected from the residual testing for Optiblue from January 2019 up to May 2020and Opal from June 2018 up to May 2020. DMAIC methodology was used in this analysis. Process Performance Index (Ppk) value varies from 5.62 to 49.52 for Opal and 2.09 to 30.00 for Optiblue, which confirm annealing process is a capable and is in statistically control. Trend analysis was performed, and no negative trend was observed. Therefore, the monomer residual test can be eliminated. KeyTerms⎯ Residual Monomer Testing, Opal, Optiblue, Process Performance Index.
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    Validation and Project Process Improvement Using DMAIC Methodology
    (Polytechnic University of Puerto Rico, 2021) Morales-Ramos, Lisbeika; Morales, José A.
    Lean Six Sigma Methodology impacts positively the efficiency, customer satisfaction and quality for manufacturing and systematics process. This article provides a successful example of how the Sig Sigma methodologycan improvethe lead time associated to project/validation documents in the LMR company by 15%. In addition to the reduction in the lead time, a cost saving of one million was identify. This was achieved by the elimination of non-value-added activities, creation of approval matrix and development a system for the execution of minimum changes and First Articles Inspections avoiding the protocol generation. As consequence of this streamline process, the company have a capacity incrementation to absorb more projects that will contributed in the continuous improved in product quality and customer services. KeyTerms⎯DMAIC, Lead Time, Value Stream Map.
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    Soap-Making Process Improvement by Using Ingredient X in the Formulation and Laboratory Validation of His Use
    (Polytechnic University of Puerto Rico, 2021) Rivera Del Cueto, Kathia; Morales, José A.
    Soaps are one of the major elements which we use in our everyday life and is produced by the saponification of a triglyceride (fat or oil). The ingredient X oil, a non-psychoactive compound that has long been used for its therapeutic benefits, which include soothing skin, treating joint injuries and easing chronic pain, and for those properties the ingredient X is used in the formulation of this soap to validate that can be a useful ingredient. The analysis chart of the tests made to the soap made with a mixture of a few oils, sodium hydroxide, water and Ingredient X demonstrate a few components presents in the soap. A chromatograph evaluated by HPLC showed presence of Ingredient X in it.The validation that the soap contains Ingredient X in it certifies that soaps can be made with Ingredient X and that can be beneficial for the health of the skin.Key Terms -Natural ingredients, Natural Soap, Oils, Soap
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    Quality in the Pharmaceutical Industries
    (Polytechnic University of Puerto Rico, 2021) Ilarraza Marzán, Vithya; Morales, José A.
    There are various techniques to measure the productivity of a certain economic activity, which is one that generates a profit from three phases: production, distribution, and consumption. One restriction in choosing the ideal method is the availability of statistical information. In some localities, there is still insufficient data to measure total factor productivity systematically and periodically. However, there is information that allows calculating productivity for the labor factor in economic activities, notably the pharmaceutical industry. The simplest measurement of labor productivity occurs when there is a company or an industry with a single product. In this case, labor productivity is expressed in units of that single product, either per man hours or per worker. This is an exceptional situation, since it is usually necessary to measure the productivity of a company, or a sector of activity where different products are produced or where the labor platform in the production lines. KeyTerms – DMAIC, Methodology, SMED, SIPOC.
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    Proceso de Mejora de Solicitud de Ventanas para Muestreo de Gases y Agua en Cuartos Asépticos en Edificios de Manufactura
    (Polytechnic University of Puerto Rico, 2021) Ramos Rosado, Rafael; Morales, José A.
    En este análisis se encontró la causa raíz de la problemática que se tiene en cuartos asépticos de manufactura, el obtener ventanas para la toma de muestras de agua y gases con facilidad. Con la utilización de la metodología “Six Sigma”, utilizamos el método DMAIC (Definir, Medir, Analizar, Mejorar y Controlar), que, con el uso de esta herramienta, pudimos encontrar la situación real del problema a mejorar y poder ganar un 100% en productividad comprobado en este proyecto con una Prueba de Hipótesis. Ya mejorando la comunicación y con un sistema electrónico, llamado “Smatsheet Request Form”, que fue creado para poder solicitar las ventanas para monitoreo de agua y gases en cuartos aséptico de manufactura, determinó y mejoró la productividad y se ganó eficiencia en el proceso. Palabras Clave ⎯ DMAIC, Manufactura, Productividad, Prueba de Hipótesis, “Six Sigma”
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    Process Improvement and Cost Reduction Opportunities by a Change in the Packaging Material of Human Thrombin Component Coming in Vials
    (Polytechnic University of Puerto Rico, 2021) Quiñones Díaz, Mariely; Morales, José A.
    Human Thrombin is a bleeding control agent that is formulated, filled into a glass vial, and lyophilized to maintain stability. In order to be shipped, the vials are packaged in a container made from cardboard material. Particulate matter coming from the packaging is transferred to the vials which results in the addition of a cleaning step prior to subsequent processing. An alternate plastic packaging material consisting of Polyethylene Terephthalate and Polypropylene was evaluated. Assessment of the cleaning process showed that a change in the current packaging represents an improvement in terms of the elimination of a non-value- added step and the associated labor cost. Additional evaluation demonstrates that this change also implies a reduction in scrap and in the costs applied for shipping. By identifying and implementing an alternate packaging material, product quality is improved, and non-value-added process steps and associated costs are eliminated, which will result in costs savings. Key Terms ⎯ Cleaning Process, Cost Reduction, Packaging Container, Particle Matter