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The Quality System: Incorporating Safeguards into the Procedures

The Quality Assurance operating system is a valuable tool for any manufacturing corporation, and can be a real asset in a product liability case. Unfortunately, it can also become a major liability, which I will explain.

From a positive perspective, a manufacturer could not hope to have all the elements under control on a consistent basis that could have a bearing on the quality of the products and services they provide, without documented procedures and processes for all the employees to reference and follow. Believing such things are engrained in the employees, or commonly understood by all, and therefore procedures are not necessary, is fools play. There must be documented procedures in place, they must be kept current and available for all the employees, and they must be periodically audited to assure they are being followed or updated as required.

It should be noted that I have spent most of my professional life in Quality, progressing from a Quality Engineer in the 1970s, to a Quality Manager, to the Quality Director, and ultimately to being VP of Quality and several other corporate areas. I have spent around 30 years in the Quality profession and have been there as the whole profession went through numerous evolutionary changes, and was a Director of Quality developing a quality system for my second large multiplant corporation during the 1980s as American industry fought over which Quality guru had the ...

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