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April - June 2010

Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

Mike Micklewright

It's pretty obvious (within many companies) that based on their actions and behaviors, CEOs and other top managers just don't get it when it comes to ISO 9001 and all the derivative standards. The following 10 signs that your CEO still has no idea about ISO 9001 and Lean are written in no particular order. You'll need to be the judge as to which ones are most prevalent within your own organization. How many can you relate to?

After reading this article, you may also wish to forward it to someone who should probably read this, like maybe...oh, I don't know...your CEO...or ummmm...some other top executive? Directions for how to do so without getting into trouble are at the end of this article.

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Designing a Winning CAPA System

Larry Mager

CAPA is a critical Quality System subsystem that, when executed correctly, can provide your organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. So what is required of a CAPA system to make it compliant, effective and efficient in the United States, Europe, Canada or Japan?

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Avoiding the CAPA Calamity

Ken Peterson

Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let's examine two key distinguishing features of a good approach to CAPA management.

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Did you know that ISO committees are available to provide your company with consultation and relevant documentation? An online article published on the ISO.org website makes it clear that companies that are seeking to become ISO certified can receive assistance regarding "horizontal" topics. This consultative assistance can be helpful for a wide range of companies participating in a variety of vertical markets.
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