REGU08001 2021 Introduction to Quality Management Systems
Full Title
Introduction to Quality Management Systems
Transcript Title
Introduction to Quality Manage
Code
REGU08001
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2021 - Full Academic Year 2021-22
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_E08 202100 Certificate in Medical Device Regulatory Affairs and Quality
SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality
Description
This module aims to provide students with an introduction to Quality Management and an understanding of setting up a basic QMS and its implementation. It also aims to provide the students with an understanding of the requirement for a quality management system and how to design this quality system under the 21 CFR 820 or ISO13485 headings.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe the evolution of Quality Management Systems including the Future of Quality; Quality 4.0
2.
Describe a basic QMS and its components as well as Quality Management systems in a digital age
3.
Explain the application and requirements of a QMS as prescribed by 21CFR 820 (and integration of ISO 13485:2016 as consensus standard) and with EN ISO 13485:2016
4.
Explain the application and requirements of ongoing and future regulatory body legislative programs aligned with meeting industry needs for Quality 4.0
5.
Describe the integration of operational excellence methods; Lean and Six Sigma with quality to implement and achieve continuous quality improvement in the MedTech industry”
6.
Illustrate the audit requirements of a QMS and how to deal with auditors.
7.
Understand how to apply ethics and scientific integrity to professional practice.
8.
Describe skillset for the future quality engineers in the smart factory; the barriers, enablers, components, and smart digital technologies involved in Quality 4.0 deployment
Teaching and Learning Strategies
Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used. Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.
Module Assessment Strategies
The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.
Repeat Assessments
Repeat assignments will be given.
Indicative Syllabus
This module aims to provide students with an introduction to and understanding of setting up a basic QMS and its implementation. It also aims to provide the students with an understanding of the requirement for a quality management system and how to design this quality system under the CFR 820 or ISO13485 headings. The principles of quality management and quality systems and quality management in both production and GMP environment will be discussed. The following quality management principles and concepts will be introduced; Quality Management in a digital age, Quality 4.0 and the future of Quality management; statistical process control; the measurement and benchmarking of quality; tools and techniques for quality improvement; organisational and teamwork requirements for quality implementation; strategic issues in quality management and finally current developments in quality management.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Non conformance reports | Coursework Assessment | Written Report/Essay | 20 % | Week 3 | 5,6,8 |
| 2 | Quality Improvement Case Study | Coursework Assessment | Essay | 30 % | Week 6 | 2,3,4,5,6,8 |
| 3 | MCQ/LAQ | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Week 10 | 1,2,3,4 |
| 4 | Document control and SOPS | Coursework Assessment | Written Report/Essay | 20 % | Week 8 | 2,3,4 |
| 5 | Good docn practice review | Coursework Assessment | Assignment | 10 % | Week 13 | 2,3,4,7 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Online Lecture | Online | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | Online | Self directed learning | 5 | Weekly | 5.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Recommended Reading
2016 Quality Management for Organizational Excellence Pearson
2016 Quality Management for Organizational Excellence Pearson
Recommended Reading
2015-04-23 Quality Management for Organizational Excellence: Introduction to Total Quality Pearson
2015-04-23 Quality Management for Organizational Excellence: Introduction to Total Quality Pearson
This is the eBook of the printed book and may not include any media, website access codes, or print supplements that may come packaged with the bound book.
For courses in quality management, quality engineering, quality technology, and continuous process improvement in universities, colleges, community colleges, and corporate environments
A comprehensive, practical look at how to become an effective quality manager and decision maker focused on improving the quality of people, processes, products, and the work environment on a continual basis
Current and future quality managers and decision makers gain the knowledge and skills they need to achieve organizational excellence. With a focus on continually developing the quality of people, processes, products, and the work environment, it covers all pertinent quality-related topics, including: an overview of quality, quality and global competitiveness, strategic alliances, establishing a culture of quality, customer satisfaction and quality, employee empowerment, leadership and change management, team building and teamwork, education and training for quality, overcoming internal politics and conflict, quality tools, problem solving and decision making, quality function deployment, statistical process control, continual improvement methods, such as six sigma, lean, and lean six sigma), benchmarking, just-in-time/lean manufacturing, and implementing quality. The new edition features an improved artwork package; updated critical-thinking activities; and new material on managing quality in the supply chain, change to ISO 9000-2015, Lean, and Lean Six Sigma, QFD, SPC.
Module Resources
Non ISBN Literary Resources
as per book list
URL Resources
Website: https://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfCFR/CFRSearch.cfm
Website: https://www.iso.org/standard/36786.html
Other Resources
as per URLs