Course syllabus
Kvalitet och produktsäkerhet
Quality and Product Safety
KMBF10, 7,5 credits, G2 (First Cycle)
Valid for: 2023/24
Faculty: Faculty of Engineering, LTH
Decided by: PLED B/K
Date of Decision: 2023-04-18
General Information
Elective Compulsory for: MLIV1, MLAK1, 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 in
different quality assurance methods such as HACCP, GMP
and hygienic process design as well as standardised management
systems such as ISO 9000, 14000 and FSSC 22000.
Learning outcomes
Knowledge and understanding
For a passing grade the student must
- comprehend the principles for industrial quality assurance and
product safety
- know to the most common quality assurance methods and quality
management systems
Competences and skills
For a passing grade the student must
- be able to both in written form and as an oral presentation
present a risk- and quality assessment of a process in accordance
with the guidelines for different quality assurance methods and
quality management systems
Judgement and approach
For a passing grade the student must
- show an understanding for the need of quality assurance methods
and quality management systems in order to ensure that processes
and products meet the authorities', society's and companies'
requirements on product quality, safety, effectiveness,
sustainability and environmental consideration
Contents
- tools for quality assurance and product safety in primarily
pharmaceutical and food industries, but also packaging and medical
device industries 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, 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 and oral presentation including opposition on project assignment. Written examination. The final grade is based on the total amount of points from the written report, oral presentation, 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.
Parts
Code: 0119. Name: Project.
Credits: 5. Grading scale: UG. Assessment: Written report, oral presentation and opposition.
Grades pass or fail.
Code: 0219. Name: Written Examination.
Credits: 2,5. Grading scale: UG. Assessment: Written examination with grades pass or fail.
Admission
The number of participants is limited to: No
The course overlaps following course/s: 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 and other information
Course coordinator: Jenny Schelin, jenny.schelin@tmb.lth.se
Course homepage: http://www.tmb.lth.se