SubjectsSubjects(version: 953)
Course, academic year 2023/2024
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Analytical Laboratory and Factors Affecting the Quality of Results - MC230P41
Title: Faktory ovlivňující kvalitu výsledků analytické laboratoře
Czech title: Faktory ovlivňující kvalitu výsledků analytické laboratoře
Guaranteed by: Department of Analytical Chemistry (31-230)
Faculty: Faculty of Science
Actual: from 2016 to 2023
Semester: winter
E-Credits: 3
Examination process: winter s.:
Hours per week, examination: winter s.:2/0, Ex [HT]
Capacity: unlimited
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
State of the course: taught
Language: Czech
Note: enabled for web enrollment
Guarantor: RNDr. Václav Červený, Ph.D.
Teacher(s): RNDr. Václav Červený, Ph.D.
doc. Ing. Zbyněk Plzák, CSc.
Annotation -
Principles and basic methodology of management of chemical measurements in analytical laboratories, metrology in chemistry, standardization, testing, accreditation and certification. Approaches for estimation of measurement uncertainty.
Last update: Červený Václav, RNDr., Ph.D. (18.09.2019)
Literature -

Analytical Chemistry: A Modern Approach to Analytical Science, 2nd Edition, Kellner R., Mermet J.- M., Otto M., Valcárcel M., Widmer H. M. Eds., Wiley-VCH Weinheim 2004.

Quality in Chemical Measurements, Neidhardt B., Wegscheider W. Eds., Springer-Verlag Berlin 2001.

Guide to Quality in Analytical Chemistry, An Aid to Accreditation. EURACHEM/CITAC 2016 (www.eurachem.org).

Last update: Červený Václav, RNDr., Ph.D. (26.09.2022)
Requirements to the exam -
Students register for the exam via SIS for one of the 3 announced dates. Students can arrange another term with the examiner.

The exam will consist of elaboration of four individual tasks assigned during the semester and final oral examination. Assignments must be submitted in paper form to the specified extent not later than the oral examination. In addition to the discussion of two drawn topics, the test will also evaluate the correctness and performance of these tasks.

THEMATIC CIRCUITS FOR THE TEST:

1. Main elements applied by analytical and medical laboratories to ensure the quality of analysis results (QA / QC).

2. Quality management systems in the laboratory. Accreditation according to EN ISO / IEC 17025, EN ISO 15189 ed. 2; certification according to ČSN EN ISO 9001; good laboratory practice and good manufacturing practice; their comparison and position in analytical and medical laboratory. The role of quality manager. Risk management. Controlled documentation.

3. Development and standardization of analytical method (procedure), use of standard procedure for routine analysis.

4. Validation - validated parameters, design of validation study. Verification.

5. Traceability of results of analytical measurements - measurement of substance quantities, primary methods, primary reference materials, specifics of metrological traceability in chemistry and biochemistry.

6. Reference materials (RM), types, RM certificate, use for individual types of analytical methods. Working RM, primary RM. Information security - international database RM. Commutability RM. Comparison of measured and certified CRM value.

7. Quality management, its goal. Series, quality management tools, control sample requirements.

8. Control charts. Purpose, principle, types. Construction of limits. Method of use.

9. Interlaboratory experiment. Types, purpose. Proficiency testing, PT program selection (database) and frequency of laboratory participation. Method of assessing proficiency testing.

10. Uncertainty of analytical results. Intended use. Error and uncertainty. Evaluation in A and B. Two basic approaches to estimating uncertainty of determination. Methodological procedure. Presentation of results.

11. Fundamentals of legal metrology. Categorization of gauges. Working gauges specified. Specifics of metrology in chemistry.

12. Instrumentation. Instrumentation calibration, instrumentation qualification. Metrological confirmation. Metrological support of analytical laboratory, metrological order.
Last update: Červený Václav, RNDr., Ph.D. (26.09.2022)
Syllabus -

1st        Introduction: A brief overview of the development of quality assurance, basic terms of quality management concepts, principles and tools of quality management in an analytical or medical laboratory.

2nd       Quality management systems: basic terms, accreditation, certification, accreditation system for testing and medical laboratories – procedure for accreditation according to ISO/IEC 17025 and ISO 15189 in Czech Republic. Principles of document control. Standard operation procedure (SOP). Risk management. Tasks of quality manager.

3rd        Quality management systems: The OECD Good Laboratory Practice, Good Manufacturing Practice, certification according to ISO 9001, their main features, compared with the accreditation and applications in the analytical or medical laboratory, inclusion in the international framework.

4th        Development and standardization of analytical methods (chemical measurement procedures), using of the standard procedures for routine analyses.

5th        Validation of analytical methods (procedures), validation of instrumentation and software. Verification.

6th        Quality control: aims, tools, types of control samples, proficiency testing, risks.

7th        Control charts: purpose, types, construction, method of use, statistical process control.

8th        Metrology in chemistry, legal metrology, metrological traceability and its specifics in chemistry.

9th        Reference materials (RM), types of RM, usage of RM, comparing the measured and certified values of CRM, commutability of RM.

10th      Instrumentation, confirmation, calibration and qualification of instrumentation. Categorization of measuring devices. Metrological assurance of analytical laboratory.

11th      Uncertainty of the results of analytical measurements: purpose, use, relationship of an error and uncertainty, evaluation ways, presentation of results, the impact of uncertainty on the comparison of a result with limits.

Last update: Červený Václav, RNDr., Ph.D. (06.10.2020)
 
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