SubjectsSubjects(version: 949)
Course, academic year 2023/2024
  
Quality in Laboratory and Manufacturing Practice - M323013
Title: Jakost v laboratorní a výrobní praxi
Guaranteed by: Department of Food Analysis and Nutrition (323)
Faculty: Faculty of Food and Biochemical Technology
Actual: from 2023
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 [HT]
Capacity: unlimited / unlimited (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Teaching methods: full-time
Level:  
For type: Master's (post-Bachelor)
Additional information: http://kocourev.bluefile.cz/studijni-materialy/
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: Tomaniová Monika Ing. Ph.D.
Kocourek Vladimír prof. Ing. CSc.
Interchangeability : N323030
This subject contains the following additional online materials
Annotation -
Last update: Kocourek Vladimír prof. Ing. CSc. (29.01.2018)
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. Moreover, lectures are aimed at strategies and procedures used for food quality and food safety management. Both model and real-life examples are used to explain professional attitude and tools for solution of typical needs in food production.
Aim of the course -
Last update: Kocourek Vladimír prof. Ing. CSc. (13.09.2023)

Students will be able to:

  • understand basic principles of the quality assurance and quality control tools (QA/QC) in the testing laboratories and food/environmental sampling,
  • document and validate (chemical) analytical methods and to calculate 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 - limits, tolerances, etc.,
  • understand principles of Good Hygienic and Good Manufacturing Practice, understand HACCP system and to be able to project, perform and validate effective measures,
  • consider the risks and opportunities associated with the laboratory / production activities (SWOT, FMEA),
  • understand requirements on the competence of testing laboratories as essential prerequisite for their accreditation; requirements on certification of products and management systems,
  • understand principles of food quality and food safety management and food inspection.

Literature -
Last update: Kocourek Vladimír prof. Ing. CSc. (13.09.2023)

R: Relevant EU legal acts (https://eur-lex.europa.eu/), and technical standards (EN, ISO) recommended in lectures,

R: General Guidelines on sampling. CAC/GL 50-2004. available from https://www.fao.org/uploads/media/Codex_2004_sampling_CAC_GL_50.pdf.

A: B. Magnusson and U. Örnemark (eds.) Eurachem Guide: The Fitness for Purpose of Analytical Methods – A Laboratory Guide to Method Validation and Related Topics, (2nd ed. 2014). ISBN 978-91-87461-59-0. Available from www.eurachem.org.

A: Guide to the Expression of Uncertainty in Measurement. ISO, Geneva (1993). (ISBN 92-67-10188-9) (Reprinted 1995: Reissued as ISO Guide 98-3 (2008), also available from http://www.bipm.org as JCGM 100:2008)

D: Analytical quality control and method validation procedures for pesticide residues analysis in food and feed. Guidance document SANTE/11312/2021. Available from www.eurl-pesticides.eu/docs/public/N

D: IFS Standard for auditing product and process compliance in relation to food safety and quality (version 8), IFS Berlin 2023. Available from www.ifs-certification.com.

Learning resources -
Last update: Kocourek Vladimír prof. Ing. CSc. (13.09.2023)

https://e-learning.vscht.cz/

http://www.cai.cz

http://www.eurachem.cz/metodicke-listy.php

http://eur-lex.europa.eu/

http://www.szpi.gov.cz/

Requirements to the exam -
Last update: Vlčková Martina Ing. (30.01.2018)

Within the extent of the syllabus.

Syllabus -
Last update: Kocourek Vladimír prof. Ing. CSc. (29.01.2018)

1. Quality management system in production and testing facilities; general principles (ISO 9001, and 22000, ISO 17025, GLP).

2. Internationally-recognized requirements for accreditation and certification; producer's responsibility.

3. Terms and definitions used in analytical chemistry, accuracy of test results.

4. Selection, verification and validation of methods, performance criteria, standardization.

5. Calibration, metrological traceability and reference materials in laboratory; uncertainty of measurement results.

6. Quality control procedures in analytical laboratory, statistical tools in quality control (SPC).

7. Quality / food safety system audit, control of records, corrective measures, improvement.

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

9. Reporting and interpretation of test results, compliance with specification assessment.

10. Laboratory information system, protection of data and samples, confidentiality.

11. Sampling plans and procedures for food control, environmental sampling, sampling uncertainty, acceptance sampling procedures.

12. Good Manufacturing and Good Hygienic Practice; risk analysis, Critical Control Points system (HACCP).

13. Integrity in food production and testing results reporting; food authentication, fraud.

14. Official food control, food safety inspection.

Registration requirements -
Last update: Kocourek Vladimír prof. Ing. CSc. (13.09.2023)

Analytical chemistry. Analysis of food and natural products. Statistics. Food legislation.

Course completion requirements -
Last update: Kocourek Vladimír prof. Ing. CSc. (31.01.2018)

Seminar case study and its presentation.

Successful completion of written and oral exams.

Teaching methods
Activity Credits Hours
Konzultace s vyučujícími 0.1 3
Účast v laboratořích (na exkurzi nebo praxi) 0 0
Obhajoba individuálního projektu 0.1 3
Účast na přednáškách 0.5 14
Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi 0.6 16
Práce na individuálním projektu 0.6 16
Příprava na zkoušku a její absolvování 0.6 18
Účast na seminářích 0.5 14
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