Sustainable Quality Improvements for Isotope Dilution in Molecular Ultratrace Analyses
Fitness for Purpose, Performance-Based Criteria, and Measurement Uncertainty
- 1st Edition - April 26, 2024
- Imprint: Elsevier Science
- Author: Yves Tondeur
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 2 9 0 3 4 - 3
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 2 9 0 3 5 - 0
Sustainable Quality Improvements for Isotope Dilution in Molecular Ultratrace Analyses: Fitness for Purpose, Performance-Based Criteria, and Measurement Uncertainty uses a novel… Read more
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Request a sales quoteSustainable 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.
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.
- Aims to bring back a more scientific approach and critical thinking in the use of crucial isotope dilution techniques in analytical labs
- Provides an extensive introduction of Sustainable Quality Improvements (SQI) frameworks as a new paradigm to chemical analysis challenges
- Pushes the reader to think outside the box by presenting creative and innovative ways to handle QA/QC in a challenging environment where analytical laboratory results have a huge impact on decision-makers
Researchers or technicians at advanced students and researchers/teaching staff in the field of analytical chemistry departments, as well as industry technicians at government research facilities (including environment, food and drug, Centers for Disease Control), pharmaceutical research laboratories, and antidoping research laboratories
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- Synopses
- Epigraphs
- Descriptive keywords
- About the author
- Foreword
- Acknowledgments
- List of abbreviations and acronyms
- Chapter 1. Spotlight on the issues
- It is possible that we may be wrong!
- A steward for the future
- Chapter 2. The path to current reality
- Nature of the relationships
- In the name of maintaining stability
- Fear factor
- Deceitful method or thinking?
- USEPA office of solid waste and emergency response PBMS implementation
- Purpose, tactic, and hurdles
- Chapter 3. Quality improvement movements
- Realigning our thinking
- Discovering the boundaries
- Structural conflicts
- NELAC challenges
- Improving quality
- Methods innovation rule
- Methods update rule
- Now what?
- To sum up
- Chapter 4. Self-referential principle and enfolded performance concept
- Commitment-based method
- Coherence and continuity
- Identity of methods: Core principles
- Identity of methods: Pattern of organization and structure
- Core principles: Application to procedural steps
- Chapter 5. Quality-generating assays
- Emergent quality
- Alternative strategy
- Achieving a state of sustainable quality improvements
- The sustainable quality improvements platform (Fig. 5.5)
- Pertinent questions
- The gate to sustainable quality improvements
- Fitness for purpose
- User's bill of rights
- Barriers to SQI
- Performance-based criteria
- Circling back
- Chapter 6. Batch control spike
- Traditional misgivings
- Random coincidence?
- Structure drives behavior
- Transparency and responsibility
- Function of the labeled standards
- Benefits of the batch control spike
- Performance assessment under the BCS system
- Batch control spike
- The thinking method
- Additional thoughts
- More perspectives
- Chapter 7. Performance-based criteria analysis
- Recorder of the truth
- PBCA process
- Closing thoughts
- Chapter 8. Platform for innovation
- dfa technology [dioxin-furan array]
- Equalizer
- Defragmenter
- Chapter 9. Revisiting traditions
- Method Detection Limits
- Expanded uncertainty
- Initial calibration
- The truth about estimated maximum possible concentration (EMPC)
- Reporting analytical results
- Method validation
- Documentation of capability
- Laboratory audits
- Professionalism
- Standard operating procedures
- Organizational charts
- Holding times and sample preservation
- Leaps of abstraction
- Perspectives on the 2,3,7,8-TCDF confirmation
- Standards expiration dates
- On the purpose of a reporting limit calibration run
- Irrelevant criteria
- Performance-based measurement system
- The MACT cycle
- Recoveries and accuracy
- Chapter 10. The right, legal, and correct answers
- Not right-legal-incorrect
- Intricacies
- Legal standing
- Essential elements
- A change of heart?
- Apples and oranges
- It is all about integrity
- Appendix A: Guideposts for core steps
- Appendix B: Limits of detection (LOD) and quantitation (LOQ)
- Appendix C: Measurement of uncertainty
- Appendix D: What is our focus?
- Appendix E: Audit samples—Method 301 PLQ—Method 23 final rule
- Appendix F: Method 1668 Validation Study
- Appendix G: New formation mechanism in secondary aluminum smelter
- Appendix H: Insights into the origin of dioxins in ancient tertiary clays
- Appendix I: Assessing performance—A vision
- Appendix J: Method detection limits
- Appendix K: Artifact and vigilance
- Appendix L: LOQ validation
- Appendix M: Percent valley
- Appendix N: SQI-relevant definitions
- Appendix O: SQI charts
- Appendix P: Reference values
- Reflections pool
- Index
- Edition: 1
- Published: April 26, 2024
- Imprint: Elsevier Science
- No. of pages: 808
- Language: English
- Paperback ISBN: 9780443290343
- eBook ISBN: 9780443290350
YT
Yves Tondeur
Yves Tondeur is the Founder and CEO of It’s About Purpose, LLC, based in the USA. He graduated from the Free University of Brussels with a Ph.D. in Chemistry. Post-doctoral research work in the field of analytical organic mass spectrometry entailed the applications of negative chemical ionization mass spectrometry to trace analyses of chlorinated aromatic compounds, interfacing the sample preparation and mass spectrometry laboratories while developing and optimizing analytical procedures for substances of concern. He developed the original version of USEPA Method 8290 in support of the Superfund Program before rejoining a group of former scientists and colleagues who founded a commercial laboratory. He consistently and determinatively promoted the benefits of isotope dilution for measuring trace levels of toxic compounds, refined the original version of Method 8290 leading to the analytical portion of Method 23 for stack emissions, and Method 1613. During his tenure at Analytical Perspectives, efforts toward improvements in methodologies continued with a special emphasis on understanding the technology, how it differentiates itself from older methods and other technologies, and how a genuine performance-based approach could be materialized.
Affiliations and expertise
Founder and CEO, It’s About Purpose, LLC, USARead Sustainable Quality Improvements for Isotope Dilution in Molecular Ultratrace Analyses on ScienceDirect