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Sentinel Initiative: Improving Patient Safety and Quality of Medical Care

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(HHS: Washington, D.C.) -- Efforts are underway at the U.S.

Final FDA Rule on Dietary Supplements

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In June 2007, the U.S.

Outsourcing the Quality Function

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Nicolette Dalpino

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What is quality? An academic definition of quality as it relates to business might be that quality is a product or service that consistently has zero defects, conforms to particular specifications, and is satisfactorily received by the customer. Another aspect of quality is that it is a thought process sought out by organizations to create an overall drive toward efficiency, the reduction of waste, and the continual creation of more streamlined management processes.

While We Are Sleeping

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William H. Denney, Ph.D.

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“We are going to win, and the industrial West is going to lose: There’s nothing much you can do about it because the reasons for your failure are within yourselves.”

--Konosuke Matsushita  

Standards for 3-D Imaging Systems

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Geraldine S. Cheok, Alan M. Lytle, and Kamel S. Saidi, Ph.D.

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A Practical Approach to Lean Six Sigma

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S. Bala

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In its optimum form, Six Sigma is anything but simple or practical. Given its considerable upfront cost and ongoing complexity, it’s best viewed as a results-driven expedition of Homeric scope, one where the final destination is 3.4 defects per million opportunities. It’s not a journey for the faint-hearted. You must be seriously committed to pursuing it for the long term, or you’ll never recoup your sizable upfront investment, let alone enjoy a net return.

CMSC Preview

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Cover Story

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The quality industry offers a number of terrific events during the course of the year, but none is more informative, entertaining, and intimate than the Coordinate Metrology Systems Conference. This year’s CMSC occurs in Charlotte, North Carolina, July 21 through July 25. As always, the event is packed with activity, including a bustling exhibition hall, unique off-site events (a tour of Richard Childress Racing is included this year), and white paper presentations demonstrating the latest advances in portable coordinate metrology.

Scan It, Build It

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Nick Moffitt

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When Gabe Draguicevich was asked to help fabricate a titanium hip implant based on CT (computed tomography, also known as CAT) scan data, he had to coordinate numerous technologies to complete the project. Because the CT data consisted of 2-D cross-sections, Draguicevich had to stack and align the individual scans to create a 3-D model, which he used to create a polygonal mesh in the form of a stereolithography (STL) file. After creating a prototype, he had to verify it against the original scan data, which was no mean feat considering that software capable of providing deviation analysis of the model surface to the STL file did not exist. Finally, Draguicevich created a wireframe model from the STL mesh to machine the final product. The entire process took approximately two weeks to complete.

That was 20 years ago. According to Draguicevich, “If I had the tools that are available today, I could have simply taken the CT scan data and created the STL mesh in one step, and then machined directly from the mesh. The data-processing capabilities of modern software have made the entire process painless compared to years past. Furthermore, I could have taken the finished piece and inspected it for accuracy using the original scan data as the reference. Any deviations could have been addressed by modifying the finished part in coordination with the inspection process.”

Baldrige Improvement Day(s) Call for Comments

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(NIST: Gaithersburg, Maryland) -- The Baldrige National Quality Program strives to continuously improve all aspects of the program to deliver greater value to its customers and stakeholders and to improve the effectiveness of our processes.

Standards Enhance Musical Performances

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(ANSI: New York) -- In auto-tune programs, notes are altered to match the nearest exact pitch. If a singer hits a note that’s just a little flat, or a little sharp, auto-tune will pull that note into the accurate pitch with the touch of a button.

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