- Docente: Stefano Girotti
- Credits: 4
- SSD: CHIM/01
- Language: Italian
- Teaching Mode: Traditional lectures
- Campus: Rimini
- Corso: First cycle degree programme (L) in Quality control of health products (cod. 0913)
Learning outcomes
Course overview and learning objectives: The module of “Quality System Application” the integrated course “Management of the Quality System” intends to provide the fundamental notions, both theoretical and practical, regarding the quality system, quality control, certification, and accreditation according to national and international standards (ISO 9000:2000 and ISO 17025:2000). It provides guidelines for drawing up the operational protocols for implementing good quality laboratory practice standards (GQLP or BPLQ) and the specific laboratory activities for application of the chemical control methods for finished products and for the various production stages as well as for validation studies for drugs and health products. It is also aimed to acquire the cultural knowledge necessary to carry out chemical analyses according to certification, accreditation and quality standards.
Course contents
Analytical Chemistry: An introduction and test on Analytical Chemistry concepts. Aims. Glossary. Certified reference materials. Statistical processing of analytical data. Chemiometry.
History of the Quality System.
Quality System ISO 9000:2000 Series of Standards, necessary for all three modules of the integrated course and introductory to the course itself.
Quality System: compulsory and voluntary requirements; National and European guidelines. Quality management. Certification, advantages for enterprises and authorities. ISO 9000:2000 Series of Standards. ISO 17025 Series of Standards. Quality System and Accreditation. Quantifying Uncertainty in Analytical Measurement (EURACHEM/CITAC Guide CG 4, 2000). Good Quality Laboratory Practice (GQLP or BPLQ). Standard Operative procedures. Usage and maintenance of instrumentation. Quality in Analytical Chemistry, An Aid to Accreditation (CITAC/Eurachem Guide, Edition 2002) The Quality Assurance Program in the laboratory. Quality and safety integration in the laboratory. SINAL and SIT agencies. Sample management and data recording in the laboratory. The Quality Manual. Quality control and inspection. Inspection planning, development and report. Quality and Environment: The ISO 4000 Series of Standards and their application. Social Accountability SA 8000.
The Quality System in a hospital analysis laboratory: Introduction to Quality in a laboratory of Clinical Chemistry. The Quality System in a laboratory of Clinical Chemistry and its peculiarity. Institutional accreditation. Emilia-Romagna Accreditation Law (LEGGE REGIONALE 12 ottobre 1998, n. 34#LR-ER-1998-34#).
Quality Control in the Food and Dietetic products industries. Quality Control instruments. Inspections planning. The evolution of Quality Control and Quality Assurance.
Quality System in a Laboratory of Environmental Analysis: Advantages from the introduction and application of the Quality System. Quality problems. Methodologies to define the costs for the introduction and application of the Quality Service. Experiences of accreditation and certification.
Quality System in a FoodFactory.
Quality System in an Analysis Laboratory of Pharmaceutical Factory.
Readings/Bibliography
Recommended reading
- Transparencies of the lessons can be downloaded from the website: http://bomet.fci.unibo.it/girotti/Socrates/didattica/lucidi.html
- ISO standards downloaded from https://login.ihserc.com/login/erc throught the University agreement and from official PC (agreement by #IP).
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- CITAC guides.
- ACCREDIA (SINAL and SIT) documents.
- Helmut Günzler “Accreditation and Quality Assurance in Analytical Chemistry”, Springer, 1994.
- Elizabeth Prichard “Quality in the Analytical Chemistry Laboratory”, ACOL (university of Greenwich), John Wiley & Sons, 1995.
- Analytical Chemistry: an Introduction, D.A. Skoog, D.M. West, F.J. Holler, EdiSES, 1996.
- Elements of Analytical Chemistry, Daniel C. Harris, Zanichelli Editore, 2005.
Teaching methods
Lessons in which the course topics will be presented and discussed, with explanatory exercises. Practical tests. In-depth seminars. Self-assessment tests.
Assessment methods
Written exam by questionnaire on the entire programme. Assessment is based on the student being able to use and apply the knowledge, information and cultural means provided by the course. The threshold of learning sufficiency is represented in particular by the demonstration of critical understanding and the ability to discuss the course topics. The lecturer is available for further clarification and to asses the level of pre-exam preparation.
Teaching tools
Video projector, PC, beamer
Links to further information
http://bomet.fci.unibo.it/girotti/
Office hours
See the website of Stefano Girotti