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Articles on Quality

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AIAG to Drive Implementation of Lean

Taken from Actionline , March/April 2007

AIAG will soon begin offering Lean Workshops. The format is simple. Up to five companies sign up for workshops that include two days of training in Lean concepts at AIAG for up to 5 participants from each of the five companies. This is then followed by a 3-day workshop, at each company's facility. More…

Auditing the Process Focus

Taken from The Auditor March/April 2007

An organization's processes must be measured, monitored and improved. Organizations tend to draw artificial boundaries between what they do and don't want audited. Be sure your organization hasn't just repackaged ISO 9001 or ISO/TS 16949 procedures. More...

Happy (Audit) Trails - by Chad Kymal

This article originally appeared in Quality Digest Magazine, March 2007 (© 2007 QCI International)

Three basic audit trails are: business planning and management (BPM) review, new product development (NPD), provision and production and service provision. Completing these audit trails will allow the auditor to discover if the organization has a process-driven system. Click here for 1MB PDF.

Breakaway Lean® - 50/50/20 in six months by Chad Kymal, Chief Technical Officer - Omnex

Omnex's Lean approach is a highly structured results oriented process that guarantees results in the relatively short time frame of six months. What does 50/50/20 mean? It means that an organization practicing Breakaway Lean® can achieve a 50% reduction in inventory, a 50% increase in throughput and a 20% reduction in operational cost in six months. More...

Excelerated Six Sigma® training - GET RESULTS BY FOCUSED TRAINING by David A. Lalain - President Omnex Quality Culture and Executive Vice President Omnex - Quality Solutions

Many organizations, especially Automotive, Electronics or companies that have practiced ISO/TS 16949 and QS-9000 quality management systems have gained knowledge and skills in techniques like SPC, MSA, and FMEA. Omnex Excelerated Six Sigma® leverages these skills and knowledge in applying them to the DMAIC Breakthrough Strategy. More...

FMEA's missing link is found in AQuA - LOOKING AT EXISTING CAUSES BEFORE BRAINSTORMING by Greg Gruska, Senior Consultant-Omnex

One step that is in all logical problem solving approaches is "Determine the Root Cause(s)". If you have read a book on problem solving or taken a class, the chances are extremely good that you have been told to use one or more of the various "brainstorming" techniques which are available. More...

Excellence in Auditor Training - THE VALUE OF TRAINING FROM OMNEX

Omnex instructor-led courses are taught and delivered by experts in the field who draw upon realworld experience to provide relevant course content. These courses are in-depth and draw on realistic examples and demonstrations. The practical, hands-on instruction lets you apply new skills and knowledge as soon as you return to your organization. More...

Quality Management Systems for the Production Worker

(Taken from an article in November 2006 issue of Quality Digest © 2006 QCI International)

When viewed from the perspective of a production worker, the quality improvement system at most factories could be, well, improved. One method for achieving this would by a truly enterprise software that contains analysis for top management and input from the production worker. Don Cherry and Greg Gruska examine the subject. Click here to download this PDF.

Enterprise Wide Integrated Management Systems - What Are They?

(Originally printed in the November 2006 issue of Quality Magazine © 2006 BNP Media)

Having once correctly identified that quality software was going enterprise, quality visionary Chad Kymal predicts the future of quality software. The enterprise must be integrated, and quality systems must be integrated in a single software package. Click here to download this PDF.

Semiconductor Quality Initiatives

(Originally printed in the April 2006 issue of Quality Digest magazine © 2006 QCI International)

Semiconductor companies have no choice but maintain high levels of quality: technological innovations come quick, and the market is moving from North America to Asia. Semiconductor expert Chad Kymal looks at the road to zero defects. Click here to download this PDF.

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). Click here to download this PDF.

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. Click here to download this 5 MB PDF file.

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!"Read more...

Latest update on ISO/TS 16949:2002 by Chad Kymal, Chief Technical Officer & Founder, Omnex

ISO/TS 16949:2002 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. Click here to read it.

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. Click here to read it.

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. Click here to read it.

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 ofQuality Progressmagazine © 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. Click here to read it.

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. Click here to download this 1MB PDF.

ISO/TS 16949 Audits - How Effective Are They? - Chad Kymal

(This article appeared in the February 2006 issue ofQualitymagazine © 2007, BNP Media). It is shown here by permission.

This article from Quality magazine discusses how the need for better auditors in the automotive industry led to ISO/TS 16949:2002 and the latest auditor competency criteria from the IATF. Click here to download this 2.5MB PDF file.

Reflections on the Future of Quality – Dave Watkins

(This article appeared in the January 2006 issue ofQuality Progress© 2007, ASQ). It is shown here by permission.

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. Click here to download this 737KB PDF

Conducting Effective ISO/TS 16949:2002 Audits - Advanced Auditing – Chad Kymal

Author of a new book on ISO/TS 16949:2002 Audits, Chad Kymal explains what’s wrong with TS internal audits and how the new competency criteria from the IATF can bring about the needed changes. More…

An Integrated Management Model for Sustainable Excellence – Greg Gruska

Quality Guru Greg Gruska shares how sustainable excellence is constantly evolving as technologies, people, industries and understanding change. How can and organization using sustainable performance excellence techniques adapt to changing times and needs? More…

Release of New PPAP and SPC Editions

What are the highlights of these new editions, and how can you find out about them quickly and easily? Why, Webinars of course. Discover how Omnex got the word out quickly on these updates during Fall 2005. More…

Zero Defects in Manufacturing and Design

The Zero Defects movement of today is very different from the "zero defects" movement in the 1980s, where it was just a buzzword to motivate top management. Today, the requirements of business and customers are more demanding. What was accepted earlier as good quality is increasingly unacceptable today. More…

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