What's New on Westgard Web: September 2012
Posted by Sten Westgard, MS
Here are two articles from Westgard Web, new in September:
Risk Analysis by FMEA: Reliable?
Risk Analysis is looming larger and larger in US regulations. EQC is
going to be eliminated and replaced by Risk Analysis techniques. The
most common Risk Analysis technique, FMEA, has been used in healthcare
for years outside the US. Unfortunately, recent papers suggest that the
use of FMEA in healthcare has mixed results, at best.
What's the risk of using FMEA for Risk Analysis?
What's the Right Goal - An Example
Here's a recent example proving the importance of the choice of quality requirement. A laboratory was reviewing the performance of a cholesterol method. By one local standard, the performance was not acceptable. By another standard (CLIA), it was. So is the method good or not? Which quality requirements are right? This case study looks at a number of quality requirements and compares them.
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