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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)
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. ...
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 ...
PPAP Process and Correlation Study for Vision Systems
(Polytechnic University of Puerto Rico, 2021)
The Production Part Approval Process (PPAP) is being adopted by Medical Device companies to qualify raw material. To standardized qualification processes between multiple supplies and help ...
Anti-inflammatory Drug Elution Rate Variability Reduction
(Polytechnic University of Puerto Rico, 2013)
This project was focused in the Drug
Elution Rate Variability of an Anti-inflammatory
Drug used in a Medical Device Company. The
project is based on the manufacturing and bonding
process of a DXA Drug Collar that is a ...
Labeling and Packaging Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2022)
Medical Device Companies must ensure that each unit of product has unique identification and that it is labeled correctly. Labeling requirements include having the appropriate data on the label, not ...
Quality Improvement in a Medical Device Manufacturing Process Applying Six Sigma Tools
(Polytechnic University of Puerto Rico, 2009)
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 ...
Reduction of Cosmetic Defects Due to Criteria Misalignment at a Medical Device Manufacturing Line Using DMAIC Methodology
(2013)
For the last few years, the economy of
Puerto Rico has been negatively affected,
increasing the operational cost of the industries in
the Island. The Pharma / Medical Device industry
is not excluded of this situation. ...
Increase of Manufacturing Line Capacity using Lean Manufacturing on a Medical Device Company
(Polytechnic University of Puerto Rico, 2013)
The competition between Medical
Devices companies is increases every day. Many
medical devices companies are marketing products
that compete between each other. They challenged
to obtain long term contracts to supply ...
Application of Lean Six Sigma Methodology to Optimize Fixation Device Assembly Line in the Medical Devices Industry
(Polytechnic University of Puerto Rico, 2013)
The research project was focused in the
line optimization of a Fixation Device assembly line
in a Medical Devices Industry. The Fixation Device
is called ProTack™. The Covidien Company is the
manufacturer located in ...
Manufacturing Expert System Development Guidelines in a Medical Device Manufacturing Company
(Polytechnic University of Puerto Rico, 2012)
Abstract - The medical device manufacturing company as well as other regulated industries can only perform manufacturing activities in a strictly controlled environment working area controlled by complex systems that ...