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Decommissioning of Retain Samples and GMP Documentation at a Manufacturing Site
(Polytechnic University of Puerto Rico, 2015)
During the past couple of years Elkay
Corporation has been pushing to consolidate the
product supply of its Hallo™ brands on a global
scale. Elkay’s Skin Care business which operates
one of its plants in Puerto Rico, ...
Enhancement of Batch Review Report for Annual Product Reviews in the Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2015)
The pharmaceutical industry is required
to comply with various regulatory agencies which
determine the industry capabilities for compliance
and allow the marketing of their products.
Regardless the regulatory agency ...
Implementation of a 5S Project to Improve Office Layout and Functionality in a Small Consulting Firm
(Polytechnic University of Puerto Rico, 2015)
Planning is key to improve and
maintain daily operations on an office environment,
making it a challenge sometimes for small
companies to accustom to this. Lack of organization
and planning leads to poor usage of time, ...
Improvement on Machine Products Output, by Optimizing the Use of the Resources
(Polytechnic University of Puerto Rico, 2015)
Today’s globalized world presents
major challenges to maintain the competitiveness of
the companies, the manufacturing industry is not
the exception. Over times companies debated what
will be their best strategy to ...
Design of methodology to uncontrolled documents assessments for quality department
(Polytechnic University of Puerto Rico, 2015)
A medical device company embarked
on the journey of developing a program of control
of possible human errors that can be applied in any
place of manufacture. The project is based on the
creation of a methodology to ...
Measuring and Improving the Quality of Service from the Customer's Perspective in an Emergency Room using Lean Thinking
(Polytechnic University of Puerto Rico, 2015)
Lean is a philosophy and a powerful
set of tools designed for process improvement by
eliminating waste from processes. It also focuses
on what adds value in processes from a customer's
perspective. The quality of a ...
Enhancement of a Distribution Center Process using Lean Six Sigma
(Polytechnic University of Puerto Rico, 2015)
The competition between manufacturing
& distribution companies increases every day, in the
present world of competitive business, cost
minimization and efficient management of
manufacturing unit is not an easy task. ...
Enhancement of CAPA’s and Audits Responses in a Medical Devices Industry
(Polytechnic University of Puerto Rico, 2015)
In the regulated industry of medical
devices, different issues can compromise regulatory
certifications. The CAPA and Audit system were
presenting a situation regarding the submission of
responses; Timeliness. One of ...
Quality Risk Management (QRM) Considerations for Introduction of New Products
(Polytechnic University of Puerto Rico, 2015)
Quality Risk Management (QRM) is an
optional tool to improve product effectiveness and
safety by assuring that the recognized risk is at a
desired level. Also risk management tools provide a
methodology to evaluate ...
Optimizing Inventory Levels in a Medical Device Company
(Polytechnic University of Puerto Rico, 2015)
Having material shortages can be
dangerous to production since it can cause lack of
product availability for sale therefore making the
company unprofitable. Only measuring the weeks of
inventory and inventory turns can ...