Quality Requirements and Standards
It's becoming something of a trend in Europe: lowering standards, postponing implementation of standards, and inventing new reasons why the rules don't apply.
Another year, another new model. Almost regularly as the planet circles the sun does a new model emerge in the literature. The latest is called "Precision QC." Have we been practicing "Imprecision QC" for the last 60 years? Do we need to recreate the QC wheel again?
There's a race to develop new adjectives for Quality Control. Statistical Quality Control is out. So is Process-Focused. Patient-Focused Real-Time, and Risk-Based are the latest terms in vogue. But what does any of this actually mean to the laboratory?
A concluding note on the ongoing debate between the metrological measurement uncertainty approach to quality, and the allowable total error / sigma metric approach. While there is ultimately room for both, when one attempts to abolish the other, there is no alternative but vigorous struggle.