Quality Assurance and Quality Control in the Analytical Chemical Laboratory

LIST OF ABBREVIATIONS

1. BASIC NOTIONS OF STATISTICS

1.1. Introduction

1.2. Distributions of random variables

1.2.1. Characterization of distributions

1.3. Measures of location

1.4. Measures of dispersion

1.5. Measures of asymmetry

1.6. Measures of concentration

1.7. Statistical hypothesis testing

1.8. Statistical tests

1.8.1 Confidence interval method

1.8.2. Critical range method

1.8.3. Dixon's Q test

1.8.4. Chi-Square test

1.8.5. Snedecor's F test

1.8.6. Hartley's Fmax test

1.8.7. Bartlett's test

1.8.8. Morgan's test

1.8.9. Student's t test

1.8.10. Cochran-Cox test

1.8.11. Aspin-Welch test

1.8.12. Cochran's test

1.8.13. Grubbs' test

1.8.14. Hampel's test

1.8.15. Z-Score

1.8.16. En -Score

1.8.17. Mandel's test

1.8.18. Kolmogorov-Smirnov test

1.9. Linear regression

1.10. Significant Digits. Rules of Rounding.

1.11. References

2. QUALITY OF ANALYTICAL RESULTS

2.1. Definitions

2.2. Introduction

2.3. Quality assurance system

2.4. Conclusions

2.5. References

3. INTERNAL QUALITY CONTROL

3.1. Definitions

3.2. Introduction

3.3. Quality control in the laboratory

3.4. Control charts 3.4.1. Shewhart charts

3.4.2. Shewhart chart preparation

3.4.3. Shewhart chart analysis

3.4.4. Types of control charts

3.4.5.Control samples

3.5. Conclusion

3.6. References

4. TRACEABILITY

4.1. Definitions

4.2. Introduction

4.3. The role of traceability in QA/QC system

4.4. Conclusion

4.5. References

5. UNCERTAINTY

5.1. Definitions

5.2. Introduction

5.3. Methods of estimating of measurement uncertainty

5.3.1. Procedure for estimating the measurement uncertainty according to GUM

5.4. Tools used for uncertainty estimation

5.5. Uncertainty and confidence interval

5.6. Calibration uncertainty

5.7. Conclusion

5.8. References

6. REFERENCE MATERIALS

6.1. Definitions

6.2. Introduction

6.3. Parameters which characterize RMs

6.3.1. General information

6.3.2. Representativeness 6.3.3. Homogeneity 6.3.4. Stability 6.3.5. Certified value

6.4. Production of CRMs - requirements (ISO 17034)

6.5. Practical application of CRM

6.6. Conclusion

6.7. References

7. INTERLABORATORY COMPARISIONS

7.1. Definitions

7.2. Introduction

7.3. Classification of interlaboratory studies

7.4. Characteristics and organization of interlaboratory comparisons

7.5. The presentation of interlaboratory comparison results. Statistical analysis in interlaboratory comparisons

7.5.1. Comparisons of results obtained using various procedures

7.5.2. 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. Conclusions

7.8. References

8. CALIBRATION

8.1. Introduction

8.2. Types of calibration

8.3. Calibration techniques

8.3.1. Single standard technique

8.3.2. Bracketing solutions technique

8.3.3. Calibration curve technique

8.3.4. Standard addition technique

8.3.5. Multiple standard addition technique

8.3.6. Internal standard technique

8.3.6.1. Isotope Dilution Mass Spectrometry (IDMS) technique

8.4. Conclusions

8.5. References

9. METHOD VALIDATION

9.1. Introduction

9.2. Characterization of validation parameters

9.2.1. Selectivity

9.2.2. Linearity

9.2.3. Limit of Detection and Limit of Quantitation

9.2.4. Range

9.2.5. Sensitivity

9.2.6. Precision

9.2.6.1. Manners of estimating the standard deviation

9.2.7. Accuracy and Trueness

9.2.7.1. Measurement Errors

9.2.8. Robustness and ruggedness

9.2.9. Uncertainty

9.3. Conclusions

9.4. References

10. METHOD EQUIVALENCE

10.1. Introduction

10.2. Ways of equivalence demonstration

10.2.1. Difference testing

10.2.2. Equivalence testing

10.2.3. Regression analysis testing

10.3. Conclusions

10.4. References

APPENDIX