Quality Management in Chemical Laboratory

COURSE CURRICULUM

1.

Course title

QUALITY MANAGEMENT IN CHEMICAL LABORATORY

2.

Code

HM-719

3.

Study curriculum

All study courses at the Institute of Chemistry

4.

Organizer of the curriculum (institute, department)

Institute of Chemistry

5.

Degree (BSc, MSc, PhD)

BSc

6.

Academic year/semester

IV/VII

7.

ECTS points

4

8.

Lecturer

Prof. Dr. Goran Stojkovikj

9.

Prerequisites

Application of computers in chemistry, Instrumental analytical methods

10.

Course objectives (competences):
This course will acquaint the student with quality management in a chemical testing laboratory. The student will learn about the fundamentals of good laboratory practice, traceability in metrology, introduction and validation of analytical methods, quality control in chemical testing laboratories through the use of various tools (use of control samples, Shewhart control charts). The knowledge gained in this subject enables the student to understand the philosophy of good quality management, leading to the accreditation of the testing laboratory according to the standard MKS EN ISO/IEC 17025:2018.

11.

Course content:
Lectures:

1. Introduction to metrology. Traceability in metrology.
2. Traceability and calibration. Calibration/verification of analytical equipment and volumetric apparatus. Proper handling of analytical balances.
3. Analytical process - method (objectives, requirements and classification, development of a new analytical method).
4. Validation of analytical methods. Basic principles. Parameters for method validation.
5. Types of validation. Screening and confirmatory methods.
6. Screening methods.
7. Measurement uncertainty. Causes, types, and assessment of measurement uncertainty.
8. General principles of good laboratory practice (GLP).
9. Quality system in analytical chemical laboratory (or chemical testing laboratory) - quality assurance and quality control.
10. Quality control tools in laboratory. Control charts.
11. MKS EN ISO/IEC 17025:2018.

Exercises:
- (using Excel) - determination of statistical parameters: linearity, residual analysis, limit of detection, limit of quantification, accuracy (standard addition method), precision, determination of analyte content through calibration curves, construction of Shewhart control charts, assessment of standard measurement uncertainty, Type A and B uncertainty, combined and expanded uncertainty.

12.

Teaching methods: lectures, exercises

13.

Total available time

120

14.

Time distribution

3+1+0 hours/week
Lectures 45 hours
Lab classes 15 hours

15.

Teaching methods distribution

15.1.

Teaching – lectures

45 hours

15.2.

Practicals (laboratory, problem solving), seminars, team work

15 hours

16.

Other activities

16.1.

Projects

0 hours

16.2.

Independent work

20 hours

16.3.

Homework

40 hours

17.

Grading methods

17.1.

Tests

90 points

17.2.

Seminars/projects (written/oral presentation)

0 points

17.3.

Activity

10 points

18.

Grading scale (points/mark)

< 50 points

5 (five) (F)

51 to 60 points

6 (six) (E)

61 to 70 points

7 (seven) (D)

71 to 80 points

8 (eight) (C)

81 to 90 points

9 (nine) (B)

91 to 100 points

10 (ten) (A)

19.

Criteria for taking the final exam

Attendance at lectures and completed lab classes

20.

Course language

Macedonian

21.

Teaching quality control

Anonymous surveys, discussions with students

22.

Literature

22.1.

Compulsory

No.

Author

Title

Publisher

Year

1.

Goran Stojkovikj,

Elizabeta Dimitrieska-Stojkovikj

Quality Management in Chemical Laboratory, Internal script

2022

2.

3.

22.2.

Additional

No.

Author

Title

Publisher

Year

1.

Werner Funk, Vera Dammann, Gerhild Donnevert

Quality Assurance in Analytical Chemistry

WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany

2007

2.

D. Brynn Hibbert

Quality assurance for the analytical chemistry laboratory,

Oxford University Press, Inc., New York, New York, USA,

2007

3.

4.