Quality Assurance and Quality Control in the Analytical Chemical Laboratory

Piotr Konieczka is Professor at Gdańsk University of Technology, where he is Head of the Department of Analytical Chemistry. He has co-authored 113 publications, 8 books and holds 1 patent. His research interests are environmental pollution analysis, trace analysis, in particular analysis of heavy metal content using spectroscopic techniques, as well as chemical statistics and metrology, as well as control and quality assurance of analytical measurement results, including aspects related to the production and use of certified reference materials (CRM) and the organization and development of proficiency test results (PT).

• LIST OF ABBREVIATIONS1. BASIC NOTIONS OF STATISTICS1.1. Introduction1.2. Distributions of random variables1.2.1. Characterization of distributions1.3. Measures of location1.4. Measures of dispersion1.5. Measures of asymmetry1.6. Measures of concentration1.7. Statistical hypothesis testing1.8. Statistical tests1.8.1 Confidence interval method1.8.2. Critical range method1.8.3. Dixon’s Q test1.8.4. Chi-Square test1.8.5. Snedecor’s F test1.8.6. Hartley’s Fmax test1.8.7. Bartlett’s test1.8.8. Morgan’s test1.8.9. Student’s t test1.8.10. Cochran-Cox test1.8.11. Aspin-Welch test1.8.12. Cochran’s test1.8.13. Grubbs’ test1.8.14. Hampel’s test1.8.15. Z-Score1.8.16. En –Score1.8.17. Mandel’s test1.8.18. Kolmogorov-Smirnov test1.9. Linear regression1.10. Significant Digits. Rules of Rounding.1.11. References2. QUALITY OF ANALYTICAL RESULTS2.1. Definitions2.2. Introduction2.3. Quality assurance system2.4. Conclusions2.5. References3. INTERNAL QUALITY CONTROL3.1. Definitions3.2. Introduction3.3. Quality control in the laboratory3.4. Control charts 3.4.1. Shewhart charts3.4.2. Shewhart chart preparation3.4.3. Shewhart chart analysis3.4.4. Types of control charts3.4.5.Control samples3.5. Conclusion3.6. References4. TRACEABILITY4.1. Definitions4.2. Introduction4.3. The role of traceability in QA/QC system4.4. Conclusion4.5. References5. UNCERTAINTY5.1. Definitions5.2. Introduction5.3. Methods of estimating of measurement uncertainty5.3.1. Procedure for estimating the measurement uncertainty according to GUM5.4. Tools used for uncertainty estimation5.5. Uncertainty and confidence interval5.6. Calibration uncertainty5.7. Conclusion5.8. References6. REFERENCE MATERIALS6.1. Definitions6.2. Introduction6.3. Parameters which characterize RMs6.3.1. General information6.3.2. Representativeness 6.3.3. Homogeneity 6.3.4. Stability 6.3.5. Certified value6.4. Production of CRMs – requirements (ISO 17034)6.5. Practical application of CRM6.6. Conclusion6.7. References7. INTERLABORATORY COMPARISIONS7.1. Definitions7.2. Introduction7.3. Classification of interlaboratory studies7.4. Characteristics and organization of interlaboratory comparisons7.5. The presentation of interlaboratory comparison results. Statistical analysis in interlaboratory comparisons7.5.1. Comparisons of results obtained using various procedures7.5.2. Comparison of the measurement results obtained in a two-level study (for two samples with various analyte concentrations)7.6. Organisation of PTs – requirements (ISO 17043)7.7. Conclusions7.8. References8. CALIBRATION8.1. Introduction8.2. Types of calibration8.3. Calibration techniques8.3.1. Single standard technique8.3.2. Bracketing solutions technique8.3.3. Calibration curve technique8.3.4. Standard addition technique8.3.5. Multiple standard addition technique8.3.6. Internal standard technique8.3.6.1. Isotope Dilution Mass Spectrometry (IDMS) technique8.4. Conclusions8.5. References9. METHOD VALIDATION9.1. Introduction9.2. Characterization of validation parameters9.2.1. Selectivity9.2.2. Linearity9.2.3. Limit of Detection and Limit of Quantitation9.2.4. Range9.2.5. Sensitivity9.2.6. Precision9.2.6.1. Manners of estimating the standard deviation9.2.7. Accuracy and Trueness9.2.7.1. Measurement Errors9.2.8. Robustness and ruggedness9.2.9. Uncertainty9.3. Conclusions9.4. References10. METHOD EQUIVALENCE10.1. Introduction10.2. Ways of equivalence demonstration10.2.1. Difference testing10.2.2. Equivalence testing10.2.3. Regression analysis testing10.3. Conclusions10.4. ReferencesAPPENDIX