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Ukončeno v akademickém roce 2021/2022

Quality Control Methods

Type of study Bachelor
Language of instruction Czech
Code 617-2009/01
Abbreviation MKK
Course title Quality Control Methods
Credits 4
Coordinating department Department of Chemistry
Course coordinator doc. Ing. Michal Ritz, Ph.D.

Osnova předmětu

Lectures:
1. Introduction: Basic concepts of quality management. The concept, principles and tools of quality management in the analytical laboratory.
2. Quality management: goals, tools, control mechanisms.
3. Development of analytical methods: selection of appropriate methods, work practices, standard operating procedures (SOP).
4. Calibration of analytical methods: calibration procedures, selection and frequency of calibration procedures.
5. Validation of analytical methods : validation tools and strategies of their choice.
6. Reference materials : types of reference materials , methods and frequency of use.
7. Control charts : purpose, types, structure, method of use, statistical process control.
8. Uncertainty of analytical measurements: the types of mistakes relationship mistakes and uncertainty assessment methods, presentation of results, the effect of uncertainty in comparing the results to the limits.
9. Interlaboratory comparison: species comparison strategy and frequency of participation, organization of interlaboratory comparison.
10. Metrology in the Analytical Laboratory: legislation, gauges, relation gauges and its specifics in analytical laboratories.
11. Quality Management Systems: accreditation, authorization, certification.
12. Quality management systems : ISO 9000 +, MS ISO 17025, GLP, ISO 15189.
13. National Accreditation System: Czech Accreditation Institute (CAI), the procedure for accreditation of laboratories.
14. Accreditation of analytical laboratories: decision making strategy, quality manual, management principles, documentation, standard operating procedures (SOP).

Seminars:
1. The design of control charts
2. Uncertainity of analytical measurements
3. Validation of analytical methods
4. Evaluation of seminar papers

Povinná literatura

Handbook: Good Laboratory Practise (GLP): Quality Practices for Regulated Non-clinical Research and Development. World Health Organization. Book is avaiable in Google Library

Doporučená literatura

Dale B.G., van der Wiele A., van Iwaanden: managing Quality. Blackwell, 5th ed.,2007