SubjectsSubjects(version: 863)
Course, academic year 2019/2020
  
Quality in Laboratory and Control Practice - N323030
Title: Jakost v laboratorní a kontrolní praxi
Guaranteed by: Department of Food Analysis and Nutrition (323)
Actual: from 2019
Semester: summer
Points: summer s.:3
E-Credits: summer s.:3
Examination process: summer s.:
Hours per week, examination: summer s.:1/1 C+Ex [hours/week]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Level:  
Is provided by: M323013
For type:  
Additional information: http://web.vscht.cz/kocourev/study.html
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: Kocourek Vladimír prof. Ing. CSc.
Tomaniová Monika Ing. Ph.D.
Z//Is interchangeable with: M323013
Annotation -
Last update: Kocourek Vladimír prof. Ing. CSc. (29.07.2016)
Quality is an essential prerequisite for the credibility and success of producer or provider of service, such as laboratory testing. The quality management system where a laboratory needs to demonstrate its ability to provide services that fulfill customer and regulatory requirements are explained. Students shall understand the fundamentals of quality management systems and the relevant terminology used in (food) testing laboratories involved either in food/water quality and safety control or environmental monitoring. Good Laboratory Practice (GLP), quality control (QC) and Quality assurance (QA) rules are explained, students shall be able to assess the uncertainty of their analytical results and to use this information to decide on compliance with limits. Validation of analytical methods, traceability of measurement, sampling strategy and the participation in proficiency testing are also substantial part of general requirements for the competence of testing and calibration laboratories as defined by the international standards.
Aim of the course -
Last update: Kocourek Vladimír prof. Ing. CSc. (29.07.2016)

Students will be able to:

  • understand basic principles of the quality management systems in the testing laboratories and food/environmental sampling.
  • document and validate (chemical) analytical methods and to assess the uncertainty of test results.
  • understand, design and perform procedures used for quality control in analytical / testing laboratories and manufacturing (including statistical process control procedures).
  • assess compliance of test results with specifications and to take advantage of proficiency testing for quality assurance and improvement.
Literature -
Last update: Kocourek Vladimír prof. Ing. CSc. (12.02.2016)

R: Kvalimetrie 9. Vhodnost analytických metod pro daný účel. Laboratorní příručka pro validaci. M. Suchánek Ed., EURACHEM-ČR, Praha 1999. ISBN 80-901868-7-4.

R: EN ISO/IEC 17025:2005 Conformity assessment - General reguirements for the competence of testing and calibration laboratories (CEN Brussels, www.iso.org).

A: ISO 3534-1:2010 Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability(www.iso.org).

A: International vocabulary of metrology - Basic and general concepts and associated terms (VIM), 3rd edition, JCGM 200:2012, BIPM, Paris, 2012 (http://www.bipm.org/en/publications/guides/vim.html).

R: Method validation and quality control procedures for pesticide residues analysis in food and feed. Document DG SANTE/11945/2015.

A: Statistical Quality Control for the Food Industry, 3rd Edition (Merton R. Hubbard Ed.), Kluwer Academic/Plenum Publishers, New York, 2003. ISBN 0-306-47728-9.

Learning resources -
Last update: Kocourek Vladimír prof. Ing. CSc. (06.10.2015)

http://kocourev.bluefile.cz/kvalita-v-laboratorni-a-kontrolni-praxi/

http://www.cai.cz

http://www.eurachem.org/index.php/publications/

Syllabus -
Last update: Kocourek Vladimír prof. Ing. CSc. (29.07.2016)

1. Requirements on testing laboratories in food and pharmaceuticals control; quality in research laboratories.

2. Terms and definitions used in analytical chemistry, assessment of test results.

3. Calibration, traceability and reference materials in chemical laboratory.

4. Uncertainty of measurement results and its use in food control.

5. Analytical method selection, validation and documentation; performance criteria; verification.

6. Quality control procedures, statistical tools in quality control, control charts.

7. Quality management system in production and testing facilities; Standards ISO 9001, 14001 and 2200x,GLP,ISO 17025.

8. International standardization and certification, inspection, producer's responsibility, REACH regulation.

9. Accreditation of testing laboratories - policy, prerequisites and procedures, validity.

10. Quality audit, documentation and records, corrective action, preventive measures, improvement.

11. Interlaboratory comparison, proficiency testing, transfer and implementation of analytical methods.

12. Reporting of test results, compliance with specification assessment; disputing of results.

13. Laboratory information system, protection of data and samples, GALP.

14. Sampling plans and procedures for food control, protocols, sampling uncertainty.

Registration requirements -
Last update: Kocourek Vladimír prof. Ing. CSc. (26.06.2013)

Analytical chemistry I and II, Analysis of food and natural products. Statistics.

Teaching methods
Activity Credits Hours
Účast na přednáškách 0,5 14
Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi 1 28
Příprava na zkoušku a její absolvování 1 28
Účast na seminářích 0,5 14
3 / 3 84 / 84
Coursework assessment
Form Significance
Regular attendance 10
Examination test 40
Oral examination 50

 
VŠCHT Praha