617-2009/01 – Quality Control Methods (MKK)
| Gurantor department | Department of Chemistry | Credits | 4 |
| Subject guarantor | doc. Ing. Michal Ritz, Ph.D. | Subject version guarantor | doc. Ing. Michal Ritz, Ph.D. |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 3 | Semester | summer |
| | Study language | Czech |
| Year of introduction | 2014/2015 | Year of cancellation | 2021/2022 |
| Intended for the faculties | FMT | Intended for study types | Bachelor |
Subject aims expressed by acquired skills and competences
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.
Teaching methods
Lectures
Seminars
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.
Compulsory literature:
Handbook: Good Laboratory Practise (GLP): Quality Practices for Regulated Non-clinical Research and Development. World Health Organization. Book is avaiable in Google Library
Recommended literature:
Dale B.G., van der Wiele A., van Iwaanden: managing Quality. Blackwell, 5th ed.,2007
Additional study materials
Way of continuous check of knowledge in the course of semester
E-learning
Other requirements
Attendance at seminars.
Elaboration and submission of seminar papers.
Prerequisities
Subject has no prerequisities.
Co-requisities
Subject has no co-requisities.
Subject syllabus:
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
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction