Perform a range of manufacturing tasks in compliance with quality standards.
The purpose of this QQI Quality Level 5 award is to equip the learner with the knowledge, skill and competence to perform a range of manufacturing tasks in compliance with quality standards and good manufacturing practice.
Learners attending this QQI Quality programme must meet RPL criteria. Your entry to this course is not guaranteed until The Cpl Institute training team can confirm your RPL eligibility.
If you are unsure of your eligibility contact us on 01 895 5755.
Click on the links below for information on RPL & Exemptions
Course Duration – 4 Days
On course completion learners will be able to:
-
Outline the regulatory framework applicable to the life sciences sector including the range of regulatory bodies and key legislative requirements
-
Explain the principles of quality and good manufacturing practice compliance systems, as applicable to the life sciences sector
-
Explain key elements of a quality management system in the context of organisational structure, responsibilities, procedures, processes, and resources
-
Analyse the relationship between quality systems, good manufacturing practice and manufacturing operations
-
Distinguish between conforming and non-conforming products and work practices
-
Complete required documentation in accordance with quality practices and procedures in the workplace
-
Implement current good manufacturing practice in relation to appropriate dress code and or personal protective equipment in accordance with regulatory requirements
-
Apply standard operating procedures demonstrating an appreciation for their significance and the processes required to follow them
-
Implement appropriate corrective action, preventative action (CAPA) in line with standard operating procedures
-
Carry out a range of operational or manufacturing tasks in accordance with appropriate procedures and regulations
All learning outcomes must be assessed:
-
Portfolio / Collection of Work 50% – A portfolio or collection of work is a collection and/or selection of pieces of work produced by the learner over a period of time that demonstrates achievement of a range of learning outcomes. The collection may be self-generated or may be generated in response to a particular brief or tasks/activities devised by the assessor.
-
Examination – Theory 50% – An examination provides a means of assessing a learner’s ability to recall and apply knowledge, skills and understanding within a set period of time and under clearly specified conditions. A theory-based examination assesses the ability to recall, apply and understand specific theory and knowledge.
Grading:
-
Pass 50% – 64%
-
Merit 65% – 79%
- Distinction 80% – 100%
Transfer
Successful completion of this component award enables the learner to transfer to programmes leading to other certificates where this component is a mandatory or an elective requirement.