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

Module I (Sandra Cristino)

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.

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

Factors that can affect the occurrence of an injury / accident during the work and in  laboratory: "professional diseases".

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

Risk assessment - the elaboration of risk assessment plan for biological risk (matrix of risk). 

Quality Management System topic (QMS)

• 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.

 

Module II (Dott.ssa Michela Carlotti)

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

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.

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).

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

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”.

 

 

Readings/Bibliography

Power point presentations, connection to the main network regarding the diseases and events on work

Teaching methods

Lectures and pratical experience through classroom exercises.

Assessment methods

Oral exame

Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students ) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.

Teaching tools

Connection to the main network based on quality, accreditation and certification 

Office hours

See the website of Sandra Cristino

See the website of Michela Carlotti