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October 2010


George L. Harris

19 Key Elements to Review for Effective Audits

 by Dr. George L. Harris
 DBA, CPM, CPCM, President, Calyptus Group

Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination of business, production, service, and quality factors to provide a holistic impression of the supplier's organization. These factors play a critical role in providing excellent customer service.

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Quality Basics Simplify Complex Engineering Document Management Challenge

by Ted Shaar
Freelance Writer on Quality Topics

In the spring of 2006, Ray Wilson, an internal business systems analyst for an investor-owned utility company, faced a monumental challenge: how to go about transferring the management of approximately 750,000 documents on paper, Mylar, microfiche, and other media from more than 150 different facilities to one centralized location.

He was also responsible for helping to determine which documents should be retained, creating a searchable database, and maintaining the data files that resulted from the effort.

Although the scope may have been once-in-a-lifetime, at the heart of the task was a common problem for engineers everywhere—content management for engineering drawings.

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Did you know that a single FDA device reclassification could save the medical device industry millions of dollars? All medical device manufacturers are aware of the implications of the Class I, II and III device categories. If a device falls in the Class I category then the probable mantra is "Full steam ahead! Piece of cake!" But what about Class III devices that require a PMA and significant expenditure on the part of the manufacturer?
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