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Workmanship Error at Assembly Line in a Medical Device Company
(Polytechnic University of Puerto Rico, 2012)
Abstract — In a Medical Device Company a production line had an increase of non-conformances in 2011. The category for the increase was workmanship error. These failures result in cost of poor quality due to quality holds. ...
Improve Material Flow at Supplier
(Polytechnic University of Puerto Rico, 2012)
Abstract ⎯ This project will be focused in reducing the high lead time that characterizes one of the suppliers in a Medical Device Organization. By reducing the lead time of this supplier, the organization expects to have ...
Machining Process Characterization for Breakoff Torque on Spinal Implants
(Polytechnic University of Puerto Rico, 2012)
Abstract - Breakoff torque value on Spinal Implants is critical to ensure proper fixation of the
system to the human vertebrae. Testing of manufacturing samples involves destructive testing
which leads to scrap cost. The ...
Quality Improvement Process for Software Controls in Regulated Industry using Six Sigma Methodology
(Polytechnic University of Puerto Rico, 2013)
A regulated industry at medical
devices company, Software Control practices on
Automated Processes are weak and not
systematized. Several findings were found in past
internal audits related to software revision
changes. ...
Improving Steroid Out Of Specification (OOS) Trending on Pacemaker Lead
(Polytechnic University of Puerto Rico, 2013)
The purpose of this project is to
identify a roots cause and potential factors that
influencing Steroid Out Of Specification Results
(OOS) on pacemaker lead model XYZ. Project
involves Define, Measure, Analyze, Improve ...
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 ...
Finished Goods Failure Reduction in a Wound Closure Medical Device Product Family
(Polytechnic University of Puerto Rico, 2013)
A corrective action and preventive
action plan was developed to address the increase
of Finished Goods failures in a wound closure
medical device product family. Following a DefineMeasure-Analyze-Improve-Control Six ...
The Increase of Machine Utilization, using SMED, a Lean Manufacturing Tool
(Polytechnic University of Puerto Rico, 2013)
In this project we will see the
application of SMED (Single Minute Exchange
Dye) a Lean Manufacturing tool in the Medical
Device Industry, and how it helps to reduce the
time of changeover in a machine. One of the
benefits ...
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 ...