617-2009/01 – Quality Control Methods (MKK)

Gurantor departmentDepartment of ChemistryCredits4
Subject guarantordoc. Ing. Michal Ritz, Ph.D.Subject version guarantordoc. Ing. Michal Ritz, Ph.D.
Study levelundergraduate or graduateRequirementCompulsory
Year3Semestersummer
Study languageCzech
Year of introduction2014/2015Year of cancellation
Intended for the facultiesFMTIntended for study typesBachelor
Instruction secured by
LoginNameTuitorTeacher giving lectures
PRA37 prof. Ing. Petr Praus, Ph.D.
RIT37 doc. Ing. Michal Ritz, Ph.D.
Extent of instruction for forms of study
Form of studyWay of compl.Extent
Full-time Credit and Examination 3+1

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

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

Full-time form (validity from: 2017/2018 Winter semester)
Task nameType of taskMax. number of points
(act. for subtasks)
Min. number of points
Exercises evaluation and Examination Credit and Examination 100 (100) 51
        Exercises evaluation Credit 30  15
        Examination Examination 70  20
Mandatory attendence parzicipation:

Show history

Occurrence in study plans

Academic yearProgrammeField of studySpec.ZaměřeníFormStudy language Tut. centreYearWSType of duty
2020/2021 (B3909) Process Engineering (3909R014) Process Engineering and Quality Control Methods P Czech Ostrava 3 Compulsory study plan
2019/2020 (B3909) Process Engineering (3909R014) Process Engineering and Quality Control Methods P Czech Ostrava 3 Compulsory study plan
2018/2019 (B3909) Process Engineering (3909R014) Process Engineering and Quality Control Methods P Czech Ostrava 3 Compulsory study plan
2017/2018 (B3909) Process Engineering (3909R014) Process Engineering and Quality Control Methods P Czech Ostrava 3 Compulsory study plan
2016/2017 (B3909) Process Engineering (3909R014) Process Engineering and Quality Control Methods P Czech Ostrava 3 Compulsory study plan
2015/2016 (B3909) Process Engineering (3909R014) Process Engineering and Quality Control Methods P Czech Ostrava 3 Compulsory study plan
2014/2015 (B3909) Process Engineering (3909R014) Process Engineering and Quality Control Methods P Czech Ostrava 3 Compulsory study plan

Occurrence in special blocks

Block nameAcademic yearForm of studyStudy language YearWSType of blockBlock owner