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February 2010

Better Innovation for Product Development and Process Improvement

Ellen Domb Joe Miller

What is a problem-solving method based on logic and data, not intuition? What is a problem-solving method that accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems? The answer is TRIZ. TRIZ provides repeatability, predictability, and reliability due to its structure and algorithmic approach. "TRIZ" is the (Russian) acronym for the "Theory of Inventive Problem Solving." G.S. Altshuller and his colleagues in the former U.S.S.R. developed the basic method between 1946 and 1985, and it has been greatly enhanced by international researchers from 1985 to now.

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The Challenges of Change Control

Kenneth Christie

The term "change" is something that we all experience both in life and in our business. While some of us might embrace it and seek the challenges, there are more often those that do not like it and are resistant to the implications that change may have. The big difference between the two attitudes is that in life, we face the change, accept it and move on. We do not formalize the event by a series of documents, reviews, evaluations and approvals. In regulated industries, such as pharmaceuticals, biotechnology, and medical devices, the opposite is required and therein are the challenges.

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Did you know that CAPA problems aren't just a quality problem but a business problem that can reduce your ability to compete and innovate? Inside the organization CAPA problems become everyone's problem and they often result from an "open-looped" CAPA system.
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