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Six Sigma
Six Sigma, like Lean, is used to improve the quality and efficiency of operational processes. During the past decade, these process improvement techniques increasingly have been applied outside of the manufacturing sector, for example, in healthcare.
While Lean focuses on identifying ways to streamline processes and reduce waste, Six Sigma aims predominantly to make processes, such as those used in clinical laboratories and pathology group labs, more uniform and precise through the application of statistical methods.
Along with Lean, this process improvement technique has become popular with labs as a way to streamline laboratory processes, reduce costs, increase productivity, and improve quality in a time when labs are increasingly pressured by downward price trends for lab tests. At the same time, labs are able to increase value offered to “customers,” that is, patients.
The principles of a Six Sigma-based system were originally developed by Bill Smith of Motorola in 1986 as a way of eliminating defects in manufacturing, where a defect is understood to be a product or process that fails to meet customers’ expectations and requirements. The name refers to a quality level defined as the near-perfect defect rate of 3.4 defects per million opportunities. As a process improvement strategy, it gained much attention through its association with General Electric and its former CEO Jack Welsh.
Six Sigma also involves the training and certification of designated process specialists (called black belts, green belts, or other similar titles) within organizations to help guide Six Sigma improvement efforts. Other distinctive features include the expectation that process quality improvements be translated into financial metrics to assess value and the active involvement of top management in all initiatives.
Six Sigma is often combined with Lean management techniques to produce a methodology that relies on a collaborative team effort to improve performance by systematically removing waste (Lean) as well as defects, overproduction, waiting, non-utilized talent, transportation, inventory, motion and extra-processing (Six Sigma).
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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