Manufacturing Competitiveness

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

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    Optimizing Efficiency and Employee Satisfaction by Streamlining the Complaint Sample Request SOP of a Manufacturing Company Using Lean Methodology
    (Polytechnic University of Puerto Rico, 2023) Delgado Santos, Johanny; Nieves Castro, Rafael A.
    In the Complaint department of a Manufacturing Company, the redundancy of documentation within the Standard Operating Procedure (SOP) has emerged as a critical challenge. This redundancy is primarily manifested in the duplication of testing requests, which exist in both electronic (LIMS) and paper format (Logbook). These inefficiencies directly impact employees' ability to accurately track activities in a timely manner and have led to a decline in employee satisfaction. This unnecessary duplication of documentation represents an overprocessing waste by Lean Methodology. It consumes valuable resources, elevates the risk of data entry errors, and introduces delays in carrying out essential tasks. Therefore, addressing this issue is imperative to enhance overall departmental efficiency and boost employee satisfaction. Our project aims to eliminate double documentation (overprocessing waste) and, in doing so, eliminate data entry errors. We seek to enhance employee satisfaction by streamlining processes. Key Terms – Complaint, Data Integrity, Employee Satisfaction, Lean Methodology, SOP Improvement.
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    Formulation Process Optimization
    (Polytechnic University of Puerto Rico, 2023) Hernández Lorenzo, Saúl; Pabón González, Miriam
    The field of biologics drugs development continues to grow and is becoming increasingly competitive. The manufacturing of biological medicines is a complex process that consumes a large amount of resources and time resulting in higher manufacturing costs in comparison of small molecules therapies. The lean manufacturing philosophy provides tools to identify areas of opportunity to optimize these processes by eliminating waste as activities that does not add value to the product. Buffer formulation is an inherent step in the biological product formulation process. Using the Value Stream Map tool in our buffer formulation process helped to find areas of opportunity that will allow recommendations to optimize the formulation process. In this way, it is possible to reduce manufacturing costs, increase capacity and have a better allocation of resources. Key Terms - Biologic Drugs, Buffer, Formulation, Lean Manufacturing, Value Stream Map.
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    Standardization Times in a Blending (Flex 2 Unit Operation) Manufacturing Process
    (Polytechnic University of Puerto Rico, 2023) Acevedo Colón, Gabriel; Morales Morales, José Alberto
    The continuous evolution in standardization, digitalization, and changes in the ways of working in manufacturing in the pharmaceutical industry and the increase in production for product X by 2023, has made it necessary to study the work process and standardize the blending production unit of the Flex 2 production area. The Flex 2 area is dedicated to a single product only. For the preparation of the drug, the area of Flex 2 performs 2 different types of API mixing, since the drug in its final stage of compression is a Bi-layer tablet. The blending process requires standardizing the number of operators needed to execute the batches and the number of batches that can be manufactured in the Flex 2 Blending unit. In 2022, a total of 610 batches were processed and the average batch cycle time was 7.0hrs. Key Terms - Blending, Cycle Time, Lean Manufacturing, Standardization Times.
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    Feasibility Study of Proposed Manufacturing Layout Re-design to Improve Process Capacity and Reduce Cycle Time of a Downstream Operation of Product A
    (Polytechnic University of Puerto Rico, 2022) Aponte Santiago, Lyanne M.; Nieves Castro, Rafael A.
    Lean Six Sigma tools and methodologies are widely used in today’s work environments. The use of a Lean Six Sigma approach provides organizations more flexibility and efficiency to improve their competitiveness. At the present time, with the high market changes environment, is crucial for industries to improve their processes to fulfill their customers’ needs. One key area for Manufacturing Operations is their production layout design. This article will discuss the use of DMADV (Define, Measure, Analyze, Design, & Verify) methodology to complete, and evaluate a feasibility study of a manufacturing layout re-design proposal. The project concluded that the proposed manufacturing layout re-design will represent a reduction of approximately 29-36% of the current process cycle time and represent a potential increase in production capacity of approximately 15-25%. These benefits identified during the feasibility study activities can lead to improve the company’s competitiveness and obtain financial benefits. Key Terms ⎯ Cycle time, DMADV, Lean, Process Capacity.
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    Fiber Drums Reduction in Weighing & Dispensing Manufacturing Process
    (Polytechnic University of Puerto Rico, 2022) Rosa, Diangie M.; Morales Morales, José Alberto
    Achieving overall efficiency within the manufacturing processes is the key goal among many organizations. Reducing waste enables manufactures to save money and take production up a notch. LEAN manufacturing and DMAIC are tools that can be helpful to reduce costs by removing waste within an organization, increasing productivity, and addressing environmental impacts. In search of improving the manufacturing PV, opportunities for improvement were identified in the weighing & dispensing process that would bring multiple benefits. Nowadays, companies’ principal goals are focused on costs, waste reduction and reduce production time. By implementing dedicated containers for a specific process manufacturing area has been able to reduce generated waste, reduce yearly costs and improve cycle time of processes. Because less is more. Key terms – Capacity, Continuous'Improvement, Cost Reduction, Waste Reduction.
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    Lean Wastes Caused by Using Hard Copy Paper Forms on Manufacturing Processes
    (Polytechnic University of Puerto Rico, 2022) Almodóvar Rodríguez, Carlos; Morales Morales, José Alberto
    The waste caused by using paper in manufacturing is a project to identify waste costs and possible solutions. In many ublications, the objective is to demonstrate how using an electronic tool instead of printed reports has good effects. On the other hand, the researcher concentrated on locating the lean wastes connected to paper operations in the industrial sector. The project can be used as a proof of concept for companies exploring a digital transformation, by moving from a legacy paper system to electronic paperless systems. The main objective is to identify and quantify all the waste caused by using hard paper copies instead of a proper system. With the results, the project provided options and guidance on using cost savings to implement a manufacturing system.Key Terms ⎯ ERP (Enterprise resource planning), Lean Manufacturing, (NC) Non Conformance, QMS (Quality management system).
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    Reducing Downtime Due to Glove Breakage in Manufacturing Areas
    (Polytechnic University of Puerto Rico, 2022) Ortiz de Jesús, Carilin; Morales Morales, José Alberto
    Lean manufacturing was developed for maximizing resource utilization through the minimization of waste. During certain tasks in the Manufacturing Area, gloves tended to break. I propose that we need to reduce the walk distance by installing glove stations in different parts of the factory. This could reduce the time of unnecessary skin exposure and prevention of the product to be compromised. Gowning rooms should be equipped with glove stations for easy replacement if gloves are broken during or after the gowning process. Gloves need to be replaced quickly in case an employee needs to enter for an urgent task. Key Terms- Lean Manufacturing, Manufacturing Area, Time Reduction, Waste Reduction.
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    Improving the flow of Sampling Analysis of Manufacturing Batches to reduce time and Increase the Capacity of the Process
    (Polytechnic University of Puerto Rico, 2022) Colón Torres, Vilmaris; Nieves Castro, Rafael A.
    This research will focus on analyzing the flow of sample analysis of manufacturing batches to reduce time and increase the capacity of the process in the laboratories. A laboratory in the pharmaceutical industry receives many samples from manufacturing daily. This research aims to find how to mitigate waste time factors in the flow of sample analysis in laboratories. With the incorporation of the new software, the laboratory can analyze many samples and use the equipment at a higher capacity and in less time. A significant improvement in the "takt time" of the process was observed from 50 minutes to 30 minutes. In turn, the flow of analysis of laboratory tests had a 47% increase. Regarding the annual cost of licenses, $3,777 were saved. Keyterms ⎯ data integrity, laboratory analysis, lean manufacturing, sample flow.
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    Using Six Sigma Methodology and Technology to Improve Quality Audit Process Cycle Time
    (Polytechnic University of Puerto Rico, 2022) Morales Tudela, Melisa I.; García Sandoval, María
    Currently, at the “Pharmaceutical Company Y”, the cycle for launching a product can take an average of 46.7 days. The proposal for this study seeks to reduce this cycle time to 30 days. This project illustrates the improvements that can be achieved when a company understands and applies Six Sigma tools and methodologies to reduce the cycle time between product manufacturing and product approval for shipment. The company must have quality control that ensures that the final product meets the acceptance parameters, but at the same time that the release time is reduced so that the product is shipped in less time. The application of the Six Sigma concepts, the DMAIC methodology and the development of an electronic checklist optimizes the quality audit process and the final approval, provided that the audits are carried out with the manufacturing process in parallel. Key Terms ⎯ Cycle Time, DMAIC, Improvements, Lean Manufacturing.
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    New flow route for the delivery of the to be cleaned filling equipment for the lot-to-lot changeover optimization using the lean manufacturing methodology
    (Polytechnic University of Puerto Rico, 2022) Cruz Martínez, Karina Y.; Nieves Castro, Rafael
    Management demand to reduce downtime in manufacturing had increased in recent years. This led manufacturing to use the Lean Methodology and Six Sigma tools to optimize the process. Focused on process improvement and down time reduction an initiative started to reduce the lot-to-lot changeover for filling areas. A new flow route was added to the Standard Operating Procedure to deliver the used filling equipment. This new flow route resulted in a reduction of 33% in movement waste and a 58% benefit of time spent on task for the Syringe Filling Line, and a 43% in movement waste and 67% time spent on task benefit for the Vial Filling Line. The ergonomic risk was calculated for the task, and it was lowered from a Moderate to a Low Risk after implementing administrative ergonomic controls in the Job Hazard Analysis. These results yielded a positive impact in time reduction for both filling lines. Key Terms ⎯ Flow Route, Lean Manufacturing, Lot-to-Lot Changeover, Process Improvement.