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Articles on Quality

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How to Implement ISO 13485:2003
This two part series published in Medical Product Outsourcing Magazine discusses how medical device manufacturers are look more at the process of production to improve quality and reminds those who would implement ISO 13485:2003 that they need to do gap analysis before starting their implementation.

Part One: The Arrival of ISO 13485:2003 (PDF file)
Part Two: Implementing ISO 13485:2003 (PDF file)

Global Harmonization of Medical Standards
In this article, originally printed in the Business Briefing: Global Healthcare - Advanced Medical Technologies 2004, three doctors look at the work of the Global Harmonization Task Force (GHTF). (More...)

SPC for Everyday Work Processes - by Greg Gruska and Chad Kymal
Theoretically, statistical process control (SPC) is viewed as useful for economically producing consistently acceptable products and services. In practice, however, SPC isn't being used for continually improving unique industrial processes. The right tools, such as advanced charts, can make SPC effective in these situations. (More...)

Managing the next phase of growth - Lean Six sigma in the Pharmaceutical Industry by Arun Kumar, Vice President of Omnex Asia Operations
How many times during our day to day work have we faced problems where we have to grapple with products delivery issues, high rejections, high machine downtimes, inventory turns are not as per target and of course, my personal favorite- "If the procedure has two signatures and a red stamp that says "Approved", I thought I just had to do it. So if it's bad, ask quality department!" (More...)

Latest update on ISO/TS 16949:2009 by Chad Kymal, Chief Technical Officer & Founder, Omnex
ISO/TS 16949:2009 gets redefined often as the standard evolves over time. Though the technical specification does not change, the definition, interpretation, and audit requirements have changed and/or evolved over time through Sanctioned Interpretations and FAQs. Most of the time the changes are focused on improvements based on required industry change. (More...)

Proof by example - Yes, SPC Does Work - by Greg Gruska, Senior Consultant-Omnex
Why must SPC be periodically revitalized? If it is all that people say it was, wouldn't it be self sustaining? The problem is that SPC is viewed as an approach for the "Economic Control of Quality". This is the way Dr. Shewhart initially described this approach. But if times are good, management does not focus on economic control but volume control. (More...)

Lessons e-learned - Reduce Costs, Improve Effectiveness - by Robert Halsey, President, Omnex
With tight budgets and volumes of rapidly changing information that has to be absorbed by mobile workforces, companies are looking for additional ways to create and sustain organizational knowledge. With the rapid increase in corporate and personal access to high-speed internet connections and a younger workforce that has grown up using computers and playing video games, e-Learning has become a very cost effective and efficient training method. (More...)

Reflections on the future of quality by David K. Watkins - Executive VP and Director of International Operations, Omnex (This article is a condensed version of an article first published in the January 2006 edition of Quality Progress magazine 2007, American Society for Quality.)
This article from Quality Progress discusses how quality management systems lag behind evolving concepts of organizational excellence. The focus must move from 'quality' to 'excellence' and from products & services to the enterprise. (More...)

Juggling Multiple Standards: Save Time and Money by Integrating Your Various Management Systems - By Chad Kymal
This article appeared in the June 2005 Quality Digest magazine Organizations often embrace standards simply to show that certain functional areas - for example, quality, environment or financial reporting - are in compliance with regulatory bodies. (More...)

Semiconductor Quality Initiatives: How to Maintain Quality in this Fast-Changing Industry - Chad Kymal (This article appeared in the April 2006 issue ofQuality Digestmagazine 2007, QCI International.) It is shown here by permission.
In an industry where standards are high and innovations are rapid, Zero Defects are the goal. However, changes to TS 16949 have left many semiconductors searching for new standards. These trends in addition to the move from traditional markets to Asia have left some wondering what is going to happen to quality. (More...)

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