Quality Creates Perspective

A QMS Resource for Quality Champions: news, perspective and commentary on hot issues in quality and quality management.



Risk Assessment: Creating a Risk Matrix

In this day and age, Risk is the biggest buzzword in the compliance industry.  We've talked about it, you can't go anywhere without hearing about it, and everyone's got a Risk-Based solution. We can no longer rely purely on "gut instinct" to execute on events, whether Quality, Financial, Social or similar areas.  The world moves too fast, and one misstep can make or break you as a business.  Risk provides the objective metric to help the decision-making process.  But, you need to know how to use risk.

By ETQ on March 4, 2011
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HACCP for Medical Device and Pharmaceuticals

I recently was speaking to a group of folks on the different ways to mitigate risk.  While this may not seem like "exciting" dialogue, it actually provoked an interesting thought - while many organizations interpret Risk factors differently, it seems that from one industry to the next, they tend to use a singular method.  One group uses FMEA exclusively, another uses HFACS or some human error risk, another uses HACCP, and so forth.

By ETQ on December 20, 2010
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Making Change: How Quality Management Fits into Change Management

I love my smartphone. I'm not ashamed - I marvel at the concept of having information at my fingertips. And the smartphone companies know I love them, which is why they proceed to launch a new smartphone every six months. As soon as I get the latest technology, the "next big thing" is only a few months away. Companies like Apple seem to introduce a new product version just as soon as the seasons change. This had me wondering about their product lifecycle, and how post-market information makes its way around the company to influence the next release. This is Change Management.

By ETQ on September 23, 2010
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