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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 Process Output
(Polytechnic University of Puerto Rico, 2020)
Haemonetics Puerto Rico, a medical
devices manufacturing site of blood filters,
identified that approximately the 11% of the
monthly plan of the manufacturing line #3 cannot
be made using the available manufacturing ...
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 ...
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 ...
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 ...
Medical Device Assembly Yield Improvement: Application of Quality Foundations
(Polytechnic University of Puerto Rico, 2013)
Quality foundations application is not a
new concept for medical device, manufacturing,
and service industries. The key quality concepts
have origins from the quality pioneers named as
“gurus” Joseph Juran, Deming and ...
A Strategically Systematic Approach to Acquire Improvement Project Prospects in a Medical Device Company
(Polytechnic University of Puerto Rico, 2012)
Abstract - Numerous companies begin their manufacturing improvement journey lacking an overall game plan. This results in a not strategized and structured improvement implementation with results less than optimal and if ...