61431 - Quality and Safety in Laboratory

Learning outcomes

The aim of the course is to gain understanding of the main health and safety risks occuring in the laboratory, and to describe the precautions to be taken to reduce hazards.

To this end, the current legislation on the prevention of risks arising from the use of chemical, physical and biological agents in the laboratory will be described, as well as the risk assessment, the use of individual and collective protection devices, laboratory waste and emergencies management.

The lessons will also provide both the basic knowledge of the main rules and regulations on Quality Management System in analytical laboratories (chemical and biological products/services etc..), and working practices for a simplified application of a Quality System into a general manufacture (laboratory or food company).

Course contents

Didactics Unit A

Health and safety regulations about hygiene and occupational medicine. Italian Law81/2008 and amendments: introduction and summary of the relevant international and national regulations and guidelines for the chemical, physical and biological risk, for the contained use of Genetically Modified Microorganisms (GMOs), for the deliberate release of GMOs. Italian Law630/95 and amendments.Hazardous chemicals and their classification; biological agents and levels of bio-security; monitors; physical agents; ionizing and non-ionizing radiation. Risk assessment. Identification of risks: handling of chemical, physical and biological risk. Exposure assessment and epidemiological data on laboratory risks.Factors that may affect the occurrence of an accident / incident in the laboratory.
Environmental/biological monitoring to chemical, physical and biological agents exposure. Good Laboratory Practice. Disinfection and sterilization. Waste Management. Individual and collective protection devices. Emergency Procedures Plans.
Health surveillance in chemical, physical and biological risk management. The role of detailed knowledge of occupational health and safety practices.

Fundamentals: the hazard, the risk and the safety of individual. The possible consequences or damage. The process of generation of the damage. Safety measures: security managements: knowledge, assessment and control of risk factors. Examples of dangerous situations.Risk factors in the laboratory: noise, ionizing and non-ionizing radiation, lighting, monitors, microclimate and load handling.Laboratory environments and storage, control, order, labeling, decanting, hoods, laboratory bench practices.
Electricity power system, gas, water, compressed air. The main laboratory devices and equipments (tanks, stirrers, autoclaves, centrifuges and ultra-centrifuges, cryogenic storage dewars, rotary evaporators). The glassware, vacuum-pressure operations, hot-cold operations. Accidents and risks of accident: types and mechanisms of work related injury.
Overview of legislation on the security framework and regulatory developments up to Italian law 81/2008. The subjects of the prevention system: employer, management and supervisors, the safety officer (RSPP), institutional occupational health advisor, qualified expert, workers' health and safety representative (RLS). The risk assessment statement (DVR): criteria and methods for hazard's evaluation, risk assessment, precautions and improvement of safety measures.
The chemical risk: definitions, interactions and risks, mechanisms of contamination, dose-response relationship, toxicology. The Threshold Limit Value (TLV). Labeling of substances and preparations: hazard symbols, Risk (R) and Safety (S) Statements/Phrases. The safety data sheets.
Biological agents: containment level measures for laboratories. Biological agents hazard group 2, group 3. Group 4. Laboratory equipment: Biohazard hoods. Prevention of biological risk: precautions and recommendations, containment level measures. Disinfection and sterilization. Collective protection equipment (DPC) and Individual protection equipment (DPI): protective clothing. Classification, selection and proper management of DPI.
Workplace risk: emergency escape, places of safety, emergency escape lighting, alarms, and safety signs. Emergency procedures management.

Didactics Unit B.

The lessons will provide both the basic knowledge of the main rules and regulations on Quality Management System in analytical laboratories (chemical and biological products/services etc..), and working practices for a simplified application of a Quality System into a general manufacture (laboratory or food company).

The main contents of the current regulations will be discussed (UNI EN ISO 9001 regulation and the related technical standards): the basic principles, issues and pratical examples will be described together with the Quality System Documents: Quality Manual, managerial,  technical and operating procedures, records; management reviews.

A summary of UNI EN ISO 9001 regulation will be considered (the customer in the quality system, test methods in the quality system, human resources in the quality system, the test sample in the quality system, results' quality assurance, reporting of test results in the quality system, control of the quality system, implementation of corrective and preventive actions in the quality system, improvement and conduction of internal audits to verify the quality management system of the testing laboratory in accordance with the requirements of EN ISO 19011:2003). Indicators of Quality (effectiveness and efficiency).

Brief description of “Laboratory Accreditation”: accreditation of testing in compliance with UNI CEI EN ISO / IEC 17025:2005, procedure for accreditation and its meaning - characteristics and basic principles
for accreditation of testing Laboratories - preparation of the quality system documents in the test laboratory for accreditation in compliance with UNI CEI EN ISO / IEC 17025:2005 and ACCREDIA.
Brief description of the management systems aimed at ensuring the safety of food - mandatory standards. General operating procedures and aims.
Food Safety: the HACCP system, the HACCP-based self-control systems and its applications.
The Hygiene Package: the legislation called the "Hygiene Package" consists essentially of the four EU regulations 852, 853, 854 and 882, adopted in 2004.
Brief description of voluntary certification systems in organic agriculture, Protected Designation of Origin (DOP), and Protected Geographical Indications (IGP).
The role of laboratory tests in food hygiene: environmental analysis and analysis of food matrices.

Readings/Bibliography

It is not necessary to purchase specific texts . Articles and reports about the subjects treated will be made available in electronic format.

Teaching methods

The course is divided into three teaching units draw each consisting of 8 hours of lectures including 8 hours of the Module A taught by Prof. Wolfgang Horn and 8 hours of Module B held by Prof. Maddalena Pelà .
The course also includes 12 hours of laboratory exercises on the topics of the lectures .

Assessment methods

The exam takes place only through the final exam , which ensures the acquisition of knowledge and skills expected by conducting a written test lasting 2 hours, without the aid of notes or books, followed by an oral .
The written test consists of 10 questions: 6 exercises are related to the application of methods learned during the theoretical course , 4 refer to the enforcement procedures of the laboratory experiments.
Each question allows for a maximum of 3 points. To be eligible to take the oral exam must be obtained in the written test a minimum score of 18 points.
Students who have earned at least 18 points support the oral test. The final grade is calculated as an arithmetic average of the written test and the oral test.

 

Teaching tools

Material: the material presented in class will be made available to the student in electronic format via the Internet .
To get educational materials : http://campus.unibo.it/
Username and password are reserved for students enrolled at the University of Bologna. 

Office hours

See the website of Maria Antonietta Bucci

See the website of Wolfango Horn

See the website of Maddalena Pelà