Quality Requirements and Standards
There are days I worry we are debating how many angels can dance on the head of a performance specification. Or that we're all blind men feeling different parts of a great elephant of error and uncertainty. But the latest "round" in the debate is depressingly familiar.
In January, we were fortunate to have a guest essay by one of the organizers of the EQA monitoring program, Empower IVD * Globe. More recently, an editorial in Clinical Chemistry and Laboratory Medicine has endorsed this approach. As the Empower IVD project produces more studies and more significant findings, we add our strong encouragement.
As part of the Westgard QC global survey of analytical quality goals, we provided an opportunity for all respondents to make open comments. See the words beyond the survey answers.
In December 2014 and January 2015, we asked laboratory professionals around the world to share their views on analytical goals. Here are the results.
The current (2014) discussion on Quality Goals seems a lot like the debate as it stood nearly 40 years ago. To see why current Quality Goal thinking may only be a "revolution" in the most literal sense, read this flashback to the 1970's