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Improvement in the Visibility of Nonconforming Product Inventory and Reduction
(Polytechnic University of Puerto Rico, 2022)
One of the major problems reported in a company is the Nonconforming product inventory, reducing the availability to use space for new production lines and storage of conforming product. Company wants to understand why the ...
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 ...
Optimization, Standardization and Revision of the Label Review Policies and Procedures Manual using Lean Six Sigma at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2022)
The Label Review Department focuses on reviewing other companies label for compliance with FDA regulations by providing a one-on-one service accompanied with a report with recommended changes and a print-ready graphic file. ...
Unidirectional Flow Gasket
(Polytechnic University of Puerto Rico, 2022)
To reduce the number of deviations that occur annually in the plant, through a design, it is expected to reduce this problem taking into consideration the cost factor, lead time and the quality of the products made. Using ...
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, ...
Optimization in the Account Registration Process in Automated Equipment
(Polytechnic University of Puerto Rico, 2022)
Over the years technology has increased in the manufacturing areas. Companies have moved to obtain automated equipment for the manufacture of their products. In the pharmaceutical industry, this equipment has been implemented ...
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 ...
Validation and Project Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2021)
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 ...