Sustainable Quality Improvements for Isotope Dilution in Molecular Ultratrace Analyses: Fitness for Purpose, Performance-Based Criteria, and Measurement Uncertainty uses a novel Sustainable Quality Improvement (SQI) framework with the aim of helping to re-introduce much needed flexibility and restore accountability and integrity necessary for developing confidence in products obtained with these specialty assays. The book can also be used as a comprehensive reference text for data and information on matrix-specific target analytes detection/quantitation limits, and measurement of uncertainties for planning purposes, congeners profiles, multi-phasic, multi-component and multi-analyte samples processing flow charts, and useful definitions of the underlying technology-relevant terminologies.
The SQI framework around which the book is constructed paves the way for the innovative technological solutions described in the book and is powered by three key elements: Fitness for Purpose (Data Quality Objectives), Performance-Based Measurement System (flexibility, latitude), and Measurement Uncertainty (accountability). Together, they facilitate the development and validation of advanced methodologies to resolve many of the contemporary issues associated with continuously evolving and demanding regulatory requirements. A stronger focus on effective performance feedback is demonstrated to help laboratories rethink their own approach to quality improvements.
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Table of Contents
1. Spotlight on the Issues2. The Path to Current Reality
3. Quality Improvement Movements
4 Self-referential principle and enfolded performance concept
5. Quality-Generating Assays
6. Batch Control Spike
7. Performance-Based Criteria Analysis
8. Innovation Platform
9. Revisiting Traditions
10. The right, legal, and correct answers
Appendices
A: Guideposts for core steps
B: Limits of detection (LOD) and quantitation (LOQ)
C: Measurement of uncertainty
D: What’s our focus?
E: Audit samples Method 301 PLQ Method 23 final rule
F: Method 1668 validation study
G: New formation mechanism in secondary aluminum smelter
H: Insights into the origin of dioxins in ancient tertiary clays
I: Performance assessment-A vision
J: Method detection limits
K: Artifact and vigilance
L: LOQ validation
M: Percent valley
N: SQI-relevant definitions
O: SQI charts
P: Reference values
References
Reflections pool
