Quality Requirements and Standards
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.
In the debate over new models for QC, keep your eyes wide open. Sometimes the desire for something new and different blinds you from seeing the strength of the present.
A key part of the ongoing debate about measurement uncertainty and allowable total error hinges on how we talk about bias. Is bias just another uncertainty like imprecision? Or is it truly a shift, a linear change that cannot be included in uncertainty calculations? Recent metrological approaches have attempted to fudge the answer to this question. But it's time to tackle it head on.
Part 3 of a continuing disucssion about of the current debate on quality, performance specifications, measurement uncertainty, and the meaning of life.