Manufacturing Engineering

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

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Improvement of Contact Lens Field Complaint Rate Using the DMAIC Approach
(Polytechnic University of Puerto Rico, 2009) Pietri, Emil A.; Pesante Santana, José A.
Contact lenses are susceptible to a defect call “tearing”. This is common but seldom condition detected in the field by the customer. The manufacturing process of a contact lens is a very precise method of combining an injection molding processes with a chemically bonded monomer. The liquid monomer is automatically placed between two half’s of plastic injected molds then forming the lens ,subsequent process of curing ,de-molding , hydration and packaging would form the final product for sale. The purpose of this study is to demonstrate that the application of the 6 sigma DMAIC approach to problem solving would provide a methodical and enriched conclusion to the root cause determination of contact lens “tearing” thus reducing the defect rate, subsequently customer complaints. Key Terms - Define, Measure, Analyze, Control
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.
Cycle Time Reduction using Lean Manufacturing Techniques for a Solid Pharmaceutical Product
(Polytechnic University of Puerto Rico, 2009) Ocasio Ortiz, Ángel; Pons Fontana, Carlos A.
Abstract ⎯ The purpose of this project was to demonstrate that the Lean Manufacturing techniques could be applied to a Solid Pharmaceutical Product in order to reduce the cycle time. During the year 2007, the Solid Pharmaceutical Product studied had 52 days of cycle time. The goal is to reduce the cycle time 25% or to 39 days. Lean Manufacturing tools used in this project was the process map to develop the required knowledge of the manufacturing process and the Value Stream Mapping where the values added and non-values added activities were identified. A Multidisciplinary team, essential for creation and implementation of new ideas, a list of improvements was generated and weighted for prioritization. This prioritization matrix is the foundation to start the implementation of improvements. After the Multidisciplinary team implemented the short term improvements in the Manufacturing Area, it was observed that the Product Cycle time decreased to 37 days in the third quarter of the 2008. After completion of the study, it was proved that the Lean Manufacturing techniques can be applied to a Solid Pharmaceutical Product and can radically reduce the cycle time. Key Terms ⎯ Kaizen, Value add (VA), Value Stream Map and Waste (muda).
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.
Lean and Safe Manufacturing for an Antidepressant Tablets Coating Process
(Polytechnic University of Puerto Rico, 2009) Torres Santiago, Meraris; Zárate, Patricia
Abstract - The Lean and Safe Manufacturing Process (6S event) was selected for implementation in an antidepressant tablets coating manufacturing process. The coating process was identified due to the utilization of toxic ingredients and hazardous materials during the coating solution preparation and during the coating application. In addition, lost time and productivity were identified in the process. The tool selected to perform a Lean and Safe Manufacturing Process in this coating process was 6S (Sort, Set in Order, Shine, Schedule, Score and Safety). Contributions, like the creation of a system that will be used to maintain an organized, clean, safe, and efficient setting that enables the highest level of value-added performance, were achieved during the 6S event implementation. In addition, a decrease in cycle time, in operators needed in the process execution, and minimization of injuries risk, were very important contributions achieved. Key Terms - 6S, Coating Process, Lean and Safe Manufacturing, Manufacturing Process.
Quality Improvement in a Medical Device Manufacturing Process Applying Six Sigma Tools
(Polytechnic University of Puerto Rico, 2009) Rondón Nieves, Luis Daniel; Zárate, Patricia
Abstract - The current manufacturing process of a medical device product has great opportunities on scrap percent reduction, which has been impacting the material and labor costs of the product, as well as in defects per million (DPMs) reduction, to improve the quality of this product. The current scrap percent has been affecting the production yield and complaints from clients (surgeons) have been increasing during the last Fiscal Year. The Six Sigma structure DMAIC: Define, Measure, Analyze, Improve, and Control, will be the key for the success of this project. The expected benefits are the evaluation, recommendation, and implementation of any opportunity of quality improvement that results in a positive impact to the clients at a low cost of production for the company. The main research contribution is that this project provides the customers (surgeons and their patients) an instrument that always actuate as established in the specifications to save humans lives. Key Terms  Medical Devices, Process Optimization, Quality Improvement, Six Sigma.
Production Line Improvement Using DMAIC Tool in an Electrical Production Plant
(Polytechnic University of Puerto Rico, 2010) Díaz Marrero, Jessuelly E.; Nieves Castro, Rafael A.
Today, there is much competition between the manufacturers of electronics products. This creates a need for the manufacturers to develop processes that can supply the client demand within a required time and a specified quality. The studied production line had productivity problems, since it was never able to reach the 95% productivity level established by the company, and had a backorder cost of $26K. These factors affected the availability of products required by the customer. Using the DMAIC tool the main factors that affected the production output were properly identified to correct the problem of a production line that did not meet adequately the client demand. The initials stand for: Define Measurement, Analyze, Improve and Control. As a result of working with causes affecting the productivity problems of the studied area, the productivity was increased from 85% to 96.7% and Backorder costs were reduced to $4,300. Key Terms: DMAIC, Sub. assemblies, Molding Parts, 5’S.
Reliability of Operators performing the Visual Inspection of Parenteral Drug Products
(Polytechnic University of Puerto Rico, 2010) Adams Monell, Glorynette; Morales, José A.
The visual inspection of parenteral product filled vials is performed to assure that any damaged or defective unit is detected and removed prior to packaging. This investigation evaluated the visual inspection process of parenteral products with manual handling to enhance actual process and reduce regulatory exposure. It challenged the probabilistic inspection results due to variability within operators and inspection time. A total of three (3) different standard sets of 100 vials each were evaluated by three (3) inspectors of high, medium and low experience level. The study concluded with a 95% confidence level that there is no significant difference between the results obtained at forty (40) and fifty (50) seconds inspection time neither between the interaction of inspectors and inspection time but that there is significant difference between operators. Consequently, initial and continuous training are essential elements for the quality assurance of the visual inspection process. Key Terms – analysis of variance, operators reliability, parenteral products, visual inspection
Design of a Cleaning Change Over Reduction Strategy for a High Volume Product in a Packaging Line
(Polytechnic University of Puerto Rico, 2010) Alvelo Ortiz, Grisel; Torres, Edgar
Currently packaging operations are trying to reduce the downtime and operational cost among others activities to enhance efficiency and overall process performance. Based on this objective, pharmaceutical packaging operations defined, proved and validated a process that allowed to use five released bulk lots be combined into one packaging lot. The strategy proved to be efficient for operational cost, unproductive time reduction and cross contamination. An identified disadvantage was that if a quality event was noticed in the release product, no bulk segregation could be done. Once each bulk lot is added into the filler machine or product bottle, it was mixed with previous bulk lots and it cannot be determined which tablet belongs to a specific bulk. Redesigned batch record includes a table to estimate the bulk traceability when it is packaged as Combolot. A project to develop a sub-lot numbering system was identified as future wok for this research. Key Terms ⎯ Cleaning validation, campaign, change over, combined lots, packaging lots, process improvements.
Structured Approach for Compliance Determination of FDA Regulated Tablet Compression Process
(Polytechnic University of Puerto Rico, 2010) Madera, Juan Carlos; González Miranda, Carlos J.
Tablets are the most popular unit dosage form used by the Pharmaceutical Industry to provide health treatment to patients in the United States. It is important to control process critical parameters (variables) such as weight, thickness and hardness of the unit dosage form to provide the patient with the same drug levels obtained during clinical studies. There are also quality attributes that are inherent to product quality such as shape, color, texture, and general appearance. Without robust in-process controls, it is very likely to have undesired effects such as manufacturing yield issues, rework or re-processing, customer complaints, and possible observations from regulatory agencies that may affect not only economically but also the company quality reputation. For this reason it was developed a comprehensive method, structured to help as a guideline to understand the current level of compliance for pharmaceutical tablet compression facilities regulated by the FDA. Key Terms - cGMP, process controls, recall, tablet compression.
Electronic Report Improvement Using Six Sigma DMAIC Tools
(Polytechnic University of Puerto Rico, 2011) Pérez Acosta, Javier A.; Nieves Castro, Rafael A.
Abstract - The purpose of this project is to evaluate the application and benefits of Six Sigma tools to electronic reporting. In this particular case the DMAIC (Define, Measure, Analyze, Implement and Control) method is applied to a repetitive quality electronic report. It is of great importance to reduce the report compilation time, reduce variations and errors and at the same time increase the quality of the report. It is in the best interest of service companies to have their clients satisfied by delivering a competitive product. Previous studies show a relation between productivity and the quality of a product. Utilizing the DMAIC method, the areas of opportunities were identified and determined that automating the report will resolve these areas of opportunities. The automation represented a 75% time reduction, minimized the variability within the report and a cost reduction of $9,758 per year. This automation principle will be implemented on other similar reports in order to increase quality and reduce costs. Key Terms - automatic database report creation, DMAIC, electronic reporting, service companies.
Implementing Lean Manufacturing to the Breaker X Final Assembly Line
(Polytechnic University of Puerto Rico, 2011) Quiles Sosa, Johnny; Nieves Castro, Rafael A.
Abstract - Lean manufacturing is a practice based on preserving the value of a product or service, with the minimum work and materials required to complete it. It is derived from the Toyota Production System and concentrates in eliminating waste and non-value added work while maintaining high standards of quality and customer satisfaction. The implementation of lean manufacturing on any service or production line, can help minimize scrap or idle time, increase productivity, increase sales and returns, maximize infrastructure and time, and produce a quality product that can compete in today’s market. Our company launched a new product into production, but the assembly line wasn’t keeping up with the production needed. The implementation of this practice results in minimal inventory, minimum employee overtime, and higher production while maintaining the standards of quality. The two main outcomes from Lean Manufacturing was 150% increase in production and over $128K in overtime savings. Key Terms - Just-in-Time, Kanban, Lean Manufacturing, Value Stream Map
Quality Management Applied on a Food Industry
(Polytechnic University of Puerto Rico, 2011) Rodríguez Molina, Christian Miguel; González Miranda, Carlos J.
Abstract – The research project was focused in transforming the quality engineering perspective from one that solves problems directed to engineers to one that solves routine problems that affects the entire society. Therefore, the implementation of quality techniques into a future state business based on the Sushi food was analyzed. The proposal intent is to change the perception of this particular food that often is presented on formal restaurants. The sushi process was evaluated as the production of a product required by a customer and must be completed in a specific range of time considering and maintaining the quality standards pre-established by the customer. The sushi food process was analyzed in their regular basis preparation and the methodology was rearranged using Lean Manufacturing techniques; in order to transform the process into one faster achieving in all instances the voice of the customer that reacts as the quality input. A production line layout was implemented by benchmarking the business against a commerce that shares an equal way to deliver a product. More quality techniques were implanted to glimpse this business as one prosperous and effective. Key Terms – Fast Food, Lean Manufacturing, Process Improvement, Sushi.
Services Repair Optimization in a Subcontractor Company Applying Lean- 6 Sigma
(Polytechnic University of Puerto Rico, 2011) Souchet Aponte, Shayli; Pons Fontana, Carlos A.
Abstract ⎯ Increasing competition between industries forced their services to expand to other countries out of their territorial limits. Job cost, planning and quality are the keys to success. This project measured, identified and analyzed the offered services of a subcontractor company to understand and minimize the errors in their process. Also, it includes the control of the margin of profits in each of the different services that it realizes. Also, new procedures will be recommended. The critical incident technique is particularly well-suited to measure perceived service quality because of characteristics common to all services. Services are basically intangible. Thus, the use of Lean Manufacturing in the service departments to obtain: potential for tremendous improvement, improved quality, shorter lead time, Lower cost, higher flexibility and higher degree of job satisfaction. Lean Six Sigma methodologies were applied in the service repair process to identify the wastes, and increased the yield of the process. Key Terms ⎯ Lean Six Sigma Methodology Continues Improvement Process, Service Quality, and Service Industry.
Time Cycle Reduction of the Scrap Process in a Medical Device Company
(Polytechnic University of Puerto Rico, 2011) González Martínez, Aurelix; Morales, José A.
As part of an assessment performed for continuous improvement it was identified that the Nonconformance (NC) Timeline metric shows 23% over the goal of 30 days closure. From the list of NC Reports (NCR) impacting this metric, 31% were classified with scrap disposition. This project focused in the improvement of the overall SCRAP process. This process include product under an NCR which disposition is SCRAP and for material to be SCRAPPED for any other reason. The main objective of the project was to reduce the cycle time for product to be SCRAPPED. Improvements considered eliminating those non-value added activities that were being performed and that were impacting the timeline of the NC Process and the SCRAP process. This project reduced the NC timeline by 56.75% in average for NCRs with SCRAP disposition. In addition this project brought a labor cost reduction of 74%. Key Terms - Methodology DMAIC, Nonconformance, Timeliness metric
Output Improvement for a Blister Packaging Line using Lean/Six Sigma
(Polytechnic University of Puerto Rico, 2011) Feliciano Machado, Omar; Nieves Castro, Rafael A.
Abstract - With the pass of the years industries are looking to reduce costs associated to packaging process. In the packaging line analyzed for this project product is packed in blister cells at primary packaging by two blistering machines. Since January 2010, Product A packaging process average output is 44 blisters per minute. The objective of this project is to improve the packaging output and consistently achieve a takt rate of 46 blisters per minute with one blistering machine. Lean Six Sigma Methodology and tools were used to drive the project, analyze data, document results and establish the controls to sustain the improvements. Some of the tools used were: SIPOC, Voice of the Customer, Cause & Effect Diagrams, Control Charts and Analysis of Variance. As project results, objectives were met by increasing packaging takt rate from 44 to 46 blisters per minute and reducing process variability by 45% with one blistering machine. Key Words – Blister Packaging, Primary Packaging, Secondary Packaging, Six Sigma.
Packaging Preventive Maintenance Rationalization and Lean Pilot at a Pharmaceutical Company
(Polytechnic University of Puerto Rico, 2011) Cuadrado Torres, Juan L.; Torres, Edgar
Abstract - The downtime developed by the poor maintenance scheduling techniques used in a manufacturing plant produces a huge amount of loses, financially and timely speaking. This project looks to use DMAIC methodology to attack the problem, and eliminate the waste existing on the preventive maintenance itself. Using the mentioned aids, the planning and scheduling steps are clear and easy to follow. Several techniques (ex. routes) were applied to the maintenance to perform it in the least amount of time with greater results. Key Terms - Lean, DMAIC, Preventive Maintenance
Generic Methodology for the Implementation of Automated Device Management Systems
(Polytechnic University of Puerto Rico, 2011) Ocasio, Wendell; Nieves Castro, Rafael A.
Abstract - Organizations establish maintenance programs to ensure instruments and other devices are maintained, properly configured, and periodic calibrations are performed. Typically, a combination of computerized maintenance system and manual data collection and entry are used. The whole process is prone to errors as it depends on individuals manually performing each step. The generic methodology presented in this article can be followed to implement an automated device management system in any manufacturing organization. The methodology may be employed in new installations as well as retrofits in existing operations, as long as compatible devices are used Key Terms - Automation, Calibration, Device Management, Maintenance
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
Creation of a Library for a Religious Organization Using the Lean Six Sigma Methodology
(Polytechnic University of Puerto Rico, 2011) Torres, Ivette; Nieves Castro, Rafael A.
Abstract - Due to the economic situation during this 21th century, each individual, corporation, industry, service, and any kind of business, is looking for better ideas to improve their day to day jobs. It is not a surprise then that a Church is also exploring new ways of opportunity to facilitate their community services. One of these aspects is the way that the church team leaders prepare themselves to be able to provide the best quality service to the community where they had been established. One important way is the creation of a library that includes relevant information about how to understand the Bible in a way that the quality of their life improves as a result of a better understanding of it. This is what this project is about. It is related to Church that has over 500 books that need to be organized in such a way that they are easy to retrieve and manage. This project was developed using the Lean Six Sigma tool, specifically the DMAIC concept. As a result of this project, a Book Library with it specific data base was created as a community service to this church. Key Terms - DMAIC, Six Sigma, 5S, Lean.