61431 - Quality and Safety in Laboratory

Learning outcomes

At the end of the training course, the student will have a proper knowledge of the basic elements for safety management on laboratory activity: from laboratory methods and good laboratory practices, to safety standards and techniques, applied both to research and to a company context, particularly regarding to the various risk factors at work. The course aims to provide the knowledge bases of the main rules and regulations of the Quality Management System of products / services in analysis laboratories (chemical and biological, etc.), and to supply operational tools for the simplified application of a laboratory Quality Management System for the accreditation process.

Course contents

PROGRAMME

Module A - 8 hours

Legislative and safety aspects in occupational hygiene and medicine will be taken up. In particular, regulatory framework and evolution up to Italian Legislative Decree 81/2008 and subsequent amendments: introduction and regulatory framework.

Risk assessment - Risk identification: chemical, physical and biological risk management.

Exposure assessment and epidemiological data on risks in the laboratory.

Factors that can affect the occurrence of an injury / accident in the laboratory.

The “main actors” of the prevention system: employer, directors and supervisors, workers, Health & Safety Manager - HSE, competent doctor, qualified expert and safety workers’ representative.

The basic concepts of the prevention and safety system: danger, probability, damage / magnitude, risk and safety of workers. The damage generation process.

Biological risk: biological agents, classification, exposure. Biohazard prevention, measures and containment level in laboratories; laboratory equipment: precautions and recommendations, containment measures.

Collective and personal protective equipments (CPE – PPE): protection of the body, eyes, hands and face, respiratory tract. Classification, choice and correct management of PPE.

Good laboratory practices. Disinfection and sterilization. Waste management.

Environmental monitoring for exposure to chemical, physical and biological substances.

 

Module B - 12 hours

BBS topic (1^st lesson)

• Behaviour Based Safety. Risk perception induced by experiences, external factors and indoor simulations.

Physical risk topic (2^nd lesson)

• Physical risk factors in the laboratory: noise, ionizing and non-ionizing radiation, artificial optical radiation, lighting, exposure to computer terminals, microclimate, load handling and risk of biomechanical overload.
• Laboratory environments and storage, control, order, labeling, pouring, fume hoods, work-table operations. Glassware, vacuum and underpressure operations, hot and cold operations.
• Types and mechanisms of injury and accidents (statistics for the specific sector – Italian National Institute for Insurance against Accidents at Work - INAIL).

Chemical risk topic (3^rd lesson)

• Chemical risk: definitions, interactions and risks, dose / effect curve contamination mechanisms, toxicological characteristics. The exposure limit (Threshold Limit Value – TLV, short-term exposure limit - STEL, time-weighted average – TWA, and ceiling).

  Registration, Evaluation, Authorisation and Restriction of Chemicals – REACH, and Classification, Labelling and Packaging - CLP: labeling of substances and preparations; hazard symbols, risk phrases “R” and safety advices “S”.

• Dangerous chemicals and their cataloguing. Safety data sheets: analysis and interpretative reading.

Transversal and ubiquitous risks topic (4^th lesson)

• Workplace risk: fire risk, escape routes, safe places, emergency lighting, alarms and safety signs. Emergency plans and procedures, behaviours in emergency management. Psychosocial risks: classification and prevention measures.

Risk assessment document topic (5^th lesson)

• Criteria and assessment methods, risk identification, prevention measures and improvement interventions. Analysis and critical reading of a risk assessment document (DVR) of an analysis laboratory. Health surveillance in the management of chemical, physical and biological risk. The role of training and information.

Quality Management System topic (QMS) (6^th lesson)

• Basic principles, aspects and application examples relating to the Quality System Documentation: quality manual; management, technical and operational procedures; recordings; management reviews.
• Notes and definitions regarding laboratory accreditation: test accreditation in accordance with UNI CEI EN ISO / IEC 17025; Accreditation process and its meaning - basic features and principles. National and international legislation and guidelines for chemical, physical and biological risk.

Readings/Bibliography

The acquisition of specific texts is not necessary.

Regulations and sector guidelines, articles, reports and handouts related to the topics covered will be available in digital format.

Teaching methods

The course is organized in two modules: 8-hour “Module A” held by Professor Maria Antonietta Bucci Sabattini, and a 12-hour “Module B” held by Professor Vincenzo Marcotrigiano.

Assessment methods

Learning verification takes place through an oral exam which will ensure the acquisition of knowledge and skills expected on the topics developed in the two Modules.

Teaching tools

Material: the material presented in class will be made available to the student in electronic format via the Internet .

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 Vincenzo Marcotrigiano