Quality and Product Safety
Kvalitet och produktsäkerhet

KMBF10, 7.5 credits, G2 (First Cycle)

Valid for: 2024/25
Faculty: Faculty of Engineering LTH
Decided by: PLED B/K
Date of Decision: 2024-04-17
Effective: 2024-05-08

General Information

Depth of study relative to the degree requirements: First cycle, in-depth level of the course cannot be classified
Elective mandatory for: MLAK1, MLIV1, MLSA1
Elective for: B4-l, B4-mb, B4-lm, B4-pt, K4-l, MBIO1, R4
Language of instruction: The course will be given in English

Aim

The course aims to introduce and train the students to use various quality assurance methods such as HACCP, GMP and hygienic process design, standardised quality management systems such as ISO 9000, 14000 and FSSC 22000 as well as relevant legislation.

Learning outcomes

Knowledge and understanding
For a passing grade the student must

• comprehend the principles of and the need for industrial quality assurance and product safety
• independently account for and apply the most common quality assurance methods, quality management systems and relevant legislation

Competences and skills
For a passing grade the student must

• independently, both in written and oral forms, present a risk- and quality assessment of a process in accordance with the guidelines for different quality assurance methods, quality management systems and relevant legislation

Judgement and approach
For a passing grade the student must

• show an understanding for the need of quality assurance methods, quality management systems and legislation in order to ensure that processes and products meet the requirements of authorities, society, individuals and companies on product quality, safety, efficacy, sustainability and environmental consideration as well as ethics

Contents

• tools for quality assurance and product safety in primarily pharmaceutical and food industries, but also in medical device industries and for materials are included
• the course is given in close collaboration with representatives from the mentioned industry branches. The lectures include hygienic process design, aseptic processing, clean rooms, methods for cleaning and disinfection in food and pharamceutical industries, CIP- and SIP- procedures, good hygienic practice (GHP), HACCP, good manufacturing practice (GMP and cGMP) and validation, legislation and standards, ISO 9000 (quality management), ISO 14000 (environmental management ), ISO 22000/FSSC 22000 (food safety management), ISO14971 (risk management) and ISO13485 (medical device).

Examination details

Grading scale: TH - (U, 3, 4, 5) - (Fail, Three, Four, Five)
Assessment:

Written report, oral presentation and defence, and opposition on project assignment. Written examination. The final grade is based on the total amount of points from the written report, oral presentation and defence, oral opposition on project assignment and written examination.

The examiner, in consultation with Disability Support Services, may deviate from the regular form of examination in order to provide a permanently disabled student with a form of examination equivalent to that of a student without a disability.

Modules
Code: 0119. Name: Project.
Credits: 5.0. Grading scale: UG - (U, G). Assessment: Written report, oral presentation and opposition. Grades pass or fail.
Code: 0219. Name: Written Examination.
Credits: 2.5. Grading scale: UG - (U, G). Assessment: Written examination with grades pass or fail.

Admission

The number of participants is limited to: No
Kursen överlappar följande kurser: KMB031

Reading list

• Adams, M.R., Moss, M.O. and McClure P.J: Food Microbiology - Fourth Edition. The Royal Society of Chemistry, 2016, ISBN: 978-1-84973-960-3.
• Compendium.
• Hand-outs from lectures.
• Relevant information from scientific literature and official websites.

Contact

Course coordinator: Jenny Schelin, jenny.schelin@tmb.lth.se
Course homepage: https://www.tmb.lth.se