COURSE OBJECTIVE: The aim of the course is to acquaint students with the establishment, development and application of quality systems and quality control.
COURSE PROGRAM:
Week 1: Concept, development and price of quality. Quality management systems. Principles of quality management. Quality improvement. Risk-based thinking.
Week 2: Norms and standardization. Laboratory quality management systems. Chemical analysis as a system.
Week 3: Quality of analytical result. Seminar: Errors and statistical processing of results
Week 4: Presentation of individual seminars
Week 5: Validation of analytical methods: Objective of validation. Scope of validation. Performance characteristics. Validation criteria. Selectivity and specificity
Week 6: Validation of analytical methods: Linearity. Sensitivity. Limits of detection and quantification. Accuracy (trueness and precision). Working range. Robustness of the method. Stability. Seminar: Validation of analytical methods.
Week 7: First test
Week 8: Measurement uncertainty. Ishikawa diagram. Standard uncertainty. Combined measurement uncertainty. Extended measurement uncertainty. Pareto diagram.
Week 9: Seminar: Method validation and estimation of measurement uncertainty of test results.
Week 10: Traceability of measurement results. Reference materials. Selection and evaluation of methods.
Week 11: Ensuring the validity of test results: internal and external measures. Control diagrams. Seminar: Control diagrams
Week 12: Sampling planning. Sampling validation. Estimation of sampling uncertainty.
Week 13: Reporting results. Decision rules. Accreditation.
Week 14: Presentations of group seminars
Week 15: Second test
A visit to the accredited laboratory was organized as part of the seminar.
PREREQUISITES FOR COURSE ENROLLMENT:
Regular class attendance (lectures and seminars), successful participation in continuous short tests, submitted individual and presented group seminar papers.
PREREQUISITES FOR TAKING THE EXAM
Regular class attendance (lectures and seminars), successful participation in continuous short tests, submitted individual and presented group seminar papers.
DEVELOPMENT OF GENERAL AND SPECIFIC COMPETENCIES OF STUDENTS:
General knowledge related to the quality management system and specific knowledge related to the quality system in the chemical laboratory are being developed.
STUDENTS OBLIGATIONS:
Regular attendance at lectures and seminars.
Participation in continuous short knowledge tests.
Preparation of an individual seminar paper (short seminar paper on a selected topic).
Presentation of group seminar paper (work assignment within which a validation plan should be proposed for a certain method and data given in the task should be calculated, measurement uncertainty of results should be assessed, method acceptability should be concluded, validation of test results should be proposed) and quality control results should be processed.
TEACHING METHODS:
Lectures
Seminars
Fieldwork: visit to an accredited laboratory
Consultations as needed
METHODS OF KNOWLEDGE ASSESSMENT:
Continuous short knowledge tests (6 during the semester)
Continuous assessment (2 partial tests)
Preparation of individual seminar paper
Presentation of group seminar paper
All these activities are scored and, depending on the success achieved, it is possible to be exempted from taking the exam.
Written Exam
Oral exam
METHOD OF MONITORING THE QUALITY AND PERFORMANCE OF COURSES:
Student survey
COURSE LEARNING OUTCOMES
1. Argue the role, development and application of quality management systems
2. Argue the role of standardization
3. Argue basic metrological concepts (traceability, measurement uncertainty) and procedures (validation, use of reference materials, interlaboratory tests) relevant for chemical analysis
4. Assess the suitability of the method for a specific purpose based on the results of validation and measurement uncertainty assessment
5. Select appropriate procedures to ensure the validity of test results
6. Valorize the appropriateness of measurement results using statistical methods
LEARNING OUTCOMES AT THE LEVEL OF THE PROGRAM TO WHICH THE COURSE CONTRIBUTES
1. Apply the more complex principles of chemistry built upon the foundations of the Bachelor degree
2. Integrate knowledge to handle complex ideas
3. Objectively evaluate research results for their presentation
4. Independently plan experiments while being self-critical in the evaluation of experimental procedures and results
5. Organise laboratory work in responsible manner
6. Evaluate the limits of accuracy of experimental data to inform the planning of future work
7. Show capability to work autonomously with minimal supervision
REQUIRED LITERATURE:
1. M. Kaštelan-Macan, Kemijska analiza u sustavu kvalitete, Školska knjiga, Zagreb 2003.
2. E. Protchard, V. Barwick, Quality assurance in analytical chemistry, John Wiley & Sons, Chichester 2007.
3. P. Konieczka, J. Namiśnik, Quality assurance and quality control in the analytical chemical laboratory, CRC Press Taylor & Francis Group, Boca Raton 2009.
4. J. N. Miller, J. C. Miller, Statistics and chemometrics for analytical chemistry, Pearson Education Limited, Harlow, 2005.
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Kemijska analiza u sustavu kvalitete, M. Kaštelan-Macan, Školska knjiga, Zagreb, 2003.
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Quality Assurance in Analytical Chemistry, E. Protchard, V. Barwick, ohn Wiley & Sons, Chichester, 2007.
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P. Konieczka, J. Namiśnik, Quality Assurance and Quality Control in the Analytical Chemical Laboratory, CRC Press Taylor & Francis Group, Boca Raton 2009., P. Konieczka, J. Namiśnik, CRC Press Taylor & Francis Group, Boca Raton, 2009.
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Statistics and chemometrics for analytical chemistry, J. N. Miller, J. C. Miller, Pearson Education Limited, Harlow, 2005.
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