Module Title:Validation and Quality
Language of Instruction:English
Credits: 5
NFQ Level:7
Module Delivered In 1 programme(s)
Teaching & Learning Strategies: It is envisaged that this module will prominently take place online using the college VLE Blackboard. Learners will also meet the lecturer face to face at the start of the term and during any planned workshop days during the term. Online class will take place one evening per week. Online lectures will incorporate a mixture of presentations, examples and student exercises/problem-solving, question and answer sessions, group discussions along with online resources.
Module Aim: The aim of this module is to enable the learner to develop their understanding and knowledge of quality and validation in regulated sectors in the context of Measurement, control and automation technology.
Learning Outcomes
On successful completion of this module the learner should be able to:
LO1 Explain terms and concepts relevant to quality and their requirement within regulated industries.
LO2 Explain the principles surrounding quality management systems and how quality management systems are operated, applied, implemented and reviewed.
LO3 Demonstrate knowledge of the principles of validation and regulatory requirements in a regulated industry.
LO4 Develop basic quality/validation documentation, (such as change control, calibration failure protocols, customer complaints and surveillance programmes) for Engineering systems.
Pre-requisite learning
Module Recommendations

This is prior learning (or a practical skill) that is recommended before enrolment in this module.
No recommendations listed
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements
This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed.
No requirements listed
 

Module Content & Assessment

Indicative Content
Introduction to Quality
The meaning of quality. Measuring quality, inspection, quality control and quality assurance. The customer's specification. Quality in design, planning, purchasing, production, service.
Quality Management Systems.
Quality management systems, to develop an understanding of how a regulated company manages compliance to policies procedures and standards, and manages quality and continuous improvement initiatives. Collection of quality data and use of Statistical Process Control and control charts methods to determine product quality. Reporting and communicating quality related issues.
Validation
Documented evidence, the meaning of validation. Validation policy, validation documentation, qualification. Process validation. Cleaning validation. Analytical method validation
Regulatory bodies, Regulations, Standards and Guidance
Structure and content of guidance documents, regulatory bodies and certification / accreditation agencies. The function of audits, internally by quality departments and externally by regulatory agencies such as the FDA, EU, HPRA, ISO and INAB.
Assessment Breakdown%
Continuous Assessment40.00%
End of Module Formal Examination60.00%
Continuous Assessment
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Essay Essay on the role of Quality in regulatory environments. 1,2 10.00 Week 3
Essay Essay on the need for Validated systems and how they are implemented. 1,2,3 10.00 Week 6
Case Studies Case study on implementing a potential engineering change to a validated system outlining the steps required to implement the change. 3,4 20.00 Sem 1 End
No Project
No Practical
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam Written Exam 1,2,3 60.00 End-of-Semester
Continuous Assessment
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Essay Essay on the role of Quality in regulatory environments. 1,2 10.00 Week 3
Essay Essay on the need for Validated systems and how they are implemented. 1,2,3 10.00 Week 6
Case Studies Case study on implementing a potential engineering change to a validated system outlining the steps required to implement the change. 3,4 20.00 Sem 1 End
No Project
No Practical
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam Written Exam 1,2,3 60.00 End-of-Semester

SETU Carlow Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Frequency Average Weekly Learner Workload
Online Learning (Moderated) Every Week 2.00
Independent Learning Time Every Week 7.00
Total Hours 9.00
Workload: Part Time
Workload Type Frequency Average Weekly Learner Workload
Online Learning (Moderated) Every Week 2.00
Independent Learning Time Every Week 7.00
Total Hours 9.00
 

Module Delivered In

Programme Code Programme Semester Delivery
CW_EMIMC_D Batchelor of Science in Industrial Measurement and Control 1 Mandatory