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Workflow Management in the Batch Record Review Process
(Polytechnic University of Puerto Rico, 2022)
The review of Batch Records creates a story of the materials, manufacturing, and packaging involved in the production of
biopharmaceuticals. The Master Batch Record details who, when, where, and how each process stage is ...
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)
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 ...
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)
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 ...
Product Mix Analysis in Manufacturing Line
(Polytechnic University of Puerto Rico, 2023)
This research project was focused on the Product Mix Analysis of a Medical Device manufacturing line due to a customer complaint. A product mix is a manufacturing defect and is defined as a mix of components/ assembly ...
Manufacturing Process Coordination through Visual Analytics Tools
(Polytechnic University of Puerto Rico, 2022)
This research project was focused on the identification of requirements and the design of a software application toolset, which facilitates and improve the coordination of pharmaceutical manufacturing production steps. The ...
Reducing the amount of "turnback" on the classification center
(Polytechnic University of Puerto Rico, 2022)
The research Reducing the Amount of “Turnback” on the Classification Center consists in the large amount of turnbacks that occur on the database system on a daily basis these turnbacks are errors that affect the time service ...
Redesign of a Space in the Autopsy Room Assigned for the Preparation of Biological Samples for Toxicological Analysis by Using DMADV Technique
(Polytechnic University of Puerto Rico, 2022)
The government agency of the Institute of Forensic Sciences recently received the necessary accreditations to be able to provide the essential service it offers to the citizens of Puerto Rico. The objective of this project ...
Using Six Sigma in a Computer System Validation Project in a GMP environment
(Polytechnic University of Puerto Rico, 2022)
Computer Systems Validation is a process used to test, validate, and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, ...
Using Six Sigma Methodology and Technology to Improve Quality Audit Process Cycle Time
(Polytechnic University of Puerto Rico, 2022)
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 ...
Designing a Standardized Process Flow for Regulatory R&D Service Center: A Design for Lean Six Sigma DMADV Case Study
(Polytechnic University of Puerto Rico, 2022)
Lean Six Sigma has great impact in the removal of non-value-adding activities and improving business performance. It does so by
applying tools and techniques to eliminate waste, and focus on implementing strategies to ...