| Course Unit Code | 617-2027/01 |
|---|
| Number of ECTS Credits Allocated | 5 ECTS credits |
|---|
| Type of Course Unit * | Choice-compulsory type A |
|---|
| Level of Course Unit * | First Cycle |
|---|
| Year of Study * | Third Year |
|---|
| Semester when the Course Unit is delivered | Summer Semester |
|---|
| Mode of Delivery | Face-to-face |
|---|
| Language of Instruction | Czech |
|---|
| Prerequisites and Co-Requisites | Course succeeds to compulsory courses of previous semester |
|---|
| Name of Lecturer(s) | Personal ID | Name |
|---|
| RIT37 | doc. Ing. Michal Ritz, Ph.D. |
| Summary |
|---|
| The course aims to provide a comprehensive overview of the measures, procedures and tools to ensure the quality of data produced by analytical laboratories, and provide a comprehensive overview of the measures, procedures and tools to document the activities carried out to ensure the quality of data; provide students with sufficient information about the management of quality in analytical laboratories. |
| Learning Outcomes of the Course Unit |
|---|
Objectives of subject:
• provide a comprehensive overview of the measures, procedures and tools to ensure the quality of data produced by the analytical laboratories,
• provide a comprehensive overview of the measures, procedures and tools for documentation of the activities carried out to ensure the quality of data,
• provide students with sufficient information about the management of quality in analytical laboratories.
Acquired knowlewdges:
to assess and find an appropriate analytical method; to choose the appropriate calibration and validation procedures; to select appropriate metrological practice; to select appropriate procedures within-and between-laboratory control; grasp of the quality management system.
Acquired skills:
to implement and evaluate calibration procedures; to construct and use control charts; to perform the validation of analytical methods; to carry out metrological analysis laboratories. |
| Course Contents |
|---|
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 |
| Recommended or Required Reading |
|---|
| Required Reading: |
|---|
KLOY, D., LONG, D., BHALLA, S., SEILER, J. (Eds.). Handbook - Good Laboratory Practise (GLP), 2nd edition. World Health Organization, 2009. ISBN: 978-92-4-154755-0.
Dostupné z: http://www.who.int/tdr/publications/documents/glp-handbook.pdf |
PRAUS, P., KLIKA, Z. a DOMBEK, V. Základy analytické chemie. Ostrava: VŠB-TU Ostrava, 2001. ISBN: 80-7078-896-8.
Studijní opora dostupná z: http://katedry.fmmi.vsb.cz/Opory_FMMI/617/617-Eckschlager-Chemometrie.pdf
|
| Recommended Reading: |
|---|
| DALE, B., VAN DER WIELE, T. and VAN IWAARDEN, J. Managing Quality, 5th edition, Oxford: Blackwell Publishing, 2007. ISBN: 978-1-4051-4279-3. |
MILDE, D. a SUCHÁNEK, M. (Eds.). Kvalimetrie 22: Průvodce kvalitou v analytické chemii - Pomůcka pro akreditaci. Praha: Eurachem, 2017. ISBN: 978-80-86322-10-0.
Dostupné z: http://www.eurachem.cz/user-files/files/kvalimetrie-22-final.pdf
SUCHÁNEK, M. a MILDE, D. (Eds.). Kvalimetrie 21: Referenční materiály v chemické analýze. Nastavení a používání cílové nejistoty měření. Praha: Eurachem, 2016. ISBN: 978-80-86322-09-4.
SUCHÁNEK, M. (Ed.). Kvalimetrie 17: Mezilaboratorní porovnávání a zkoušení způsobilosti. Pomůcka k zajišťování kvality v chemických, biochemických a klinických laboratořích. Praha: Eurachem, 2010. ISBN: 80-86322-05-X. |
| Planned learning activities and teaching methods |
|---|
| Lectures, Seminars, Other activities |
| Assesment methods and criteria |
|---|
| Task Title | Task Type | Maximum Number of Points
(Act. for Subtasks) | Minimum Number of Points for Task Passing |
|---|
| Credit and Examination | Credit and Examination | 100 (100) | 51 |
| Credit | Credit | 45 | 20 |
| Examination | Examination | 55 | 6 |