Full Title:Quality Management
Module Code:QUAL S7Z01
 
Credits: 5
Valid From:Semester 1 - 2019/20 ( June 2019 )
Module Delivered in 9 programme(s)
Module Description:To provide the student with the necessary knowledge and understanding of the tools, processes and systems used to implementation and maintain a compliant Quality Management System thus allowing him/her to operated effectively and efficiently in a highly regulated and controlled manufacturing and/or service environment.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Explain the evolution of Quality, the contribution of Quality Guru’s to the systematic and continuous improvement in Quality Systems and Leadership.
  2. Evaluate how the concepts of Right First Time, Zero Defects and other preventative techniques can be used to continually improve quality.
  3. Illustrate the concepts/dynamics underpinning Quality Leadership and using a Kaizan Team based approach to Continuous Improvement (CI).
  4. Evaluate different Traceability formats and design a basic Backward Traceability system..
  5. Discuss how to design, document and assess (audit) a basic hierarchal QMS.
 

Module Content & Assessment

Indicative Content
The Evolution of Quality
The principles behind and differences between Inspection, Quality Control (QC), Quality Assurance (QA) and Quality Management (QM). The philosophy behing the Prevention e.g. Right First Time (RFT) and Zero Defects (ZD). Quality definitions including The Eight Dimensions of Quality.
Quality Gurus
The methodologies developed and applied by Deming e.g. SPC, PDCA, Principle of Transformation etc. Introduction to Variation: types of variation (natural and special), sources of variation. The concepts of In/Out of Control and Capable/Not Capable processes. How to apply a systematic approach to Prevention.
The Seven Quality Improvement Tools (7 QIT)
Introduction to the 7 QIT i.e. Flowcharts, checksheets, paretos, histograms, cause and effect (C&E) or fishbone diagrams, scatter plots and SPC.
Leadership & Empowerment
Designing a Vision and Mission statement. Fundamentals and attributes of effective leadership. How to Transform an Organisation i.e. change management. What is the future role of leaders.
Teams
The philosophy and operational principles underpinning the Kaizan Team approach to CI. Team roles i.e. Leader, Member, facilator etc. How to design team agreements. Hoshin planning.
Basic Quality Management Systems
The basic Quality Management System (QMS) i.e. Quality Manual, Policy, Objectives, Standard Operating Procedures (SOP's), Records and Specifications. Documentn control and obsolescence.
Traceability Systems
Batch definitions, Forwards and Backwards traceability systems. Batch and Component traceability. Product recall process. ISO traceability requirements. How to design batch/traceability number.
Good Manufacturing Practice (GMP)
Regulatory requirements. Evolution of GMP. cGMP and the impact on premis design. Process Validation: IQ,OQ,PQ.
Auditing
Audit definitions. Types of audits i.e. Process Vs Checklist approach. Effective auditor characterists. Auditing methodologies. The corrective action (CA) and preventative action (PA) process.
Assessment Breakdown%
Course Work20.00%
Project30.00%
End of Module Formal Examination50.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Open-book Examination n/a 1,2 20.00 0 0 Week 6 0
Project
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Group Project Will assess at a minimum one of the five learning outcome. 1,2,3,4,5 30.00 0 0 n/a 0
No Practical
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Formal Exam Final Examination will assess at a minimum learning outcomes not assessed in either the Open Book Exam or the Group Project 1,2,3,4,5 50.00 0 0 End-of-Semester 0

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload & Resources

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture No Description 4.00 Every Week 4.00
Tutorial No Description 1.00 Every Week 1.00
Independent Study No Description 2.00 Every Week 2.00
Directed Reading No Description 2.00 Every Week 2.00
Total Weekly Learner Workload 9.00
Total Weekly Contact Hours 5.00
This course has no Part Time workload.
Resources
Recommended Book Resources
  • Deming, W, Edward, Out of the Crisis, 1st Ed., McGrath Hill 1982 [ISBN: 978-0911379013]
  • Orsins, Nilsson, Joyce 2012, The Essential Deming, McGrath-Hill [ISBN: 978-0071790222]
  • Juran, M Joseph & Defeo, Joseph 2010, Jurans handbook on Quality, 6th Ed., McGrath-Hill [ISBN: 978-0071629737]
  • David Hoyle 2009, ISO 9000 Quality System Handbook, 6th Ed., Butterworth-Heinemann [ISBN: 978-1856176842]
  • Tricker, Ray 2013, ISO 9000:2008 for Small Businesses, 5th Ed., Routledge [ISBN: 970-0-4-415-70390-1]
  • Ticker, Ray 2005, ISO 9001:2000 Audit procedures, 2nd Ed., Routledge [ISBN: 978-0-7506-6615-2]
  • Imai, Masaaki 1997, Gemba Kaizan, 1st Ed., McGrath-Hill [ISBN: 978-0070314467]
  • Oakland, John 2004, Oakland on Quality Management, Routledge [ISBN: 9780750657419]
  • Gitlow, H 1995, Tools and Methods for Improvement of Quality 2nd Ed., 2nd Ed., McGrath Hill, Irwin [ISBN: 0256106657]
  • ASQ Quality Management division 2006, ASQ Quality Management division, 2nd Ed., ASQ Quality Press [ISBN: 978-0873896900]
Supplementary Book Resources
  • J.Beckford 2009, Quality: A Critical Introduction, 3nd Ed., Routledge [ISBN: 978-0415259185]
  • Womac P. James, Jones T. Danial, Roos Danial 2007, The Machine that Changed the World, Reprint Ed., Free Press [ISBN: 978-0743299794]
This module does not have any article/paper resources
Other Resources
  • n/a: http://www.excellence-ireland.ie
  • n/a: http://www.iso.ch
  • n/a: http:///www.nsai.ie/
  • n/a: http://www.icbe.ie
  • n/a: http://www.enterprise-ireland.com
  • n/a: http://www.efqm.org
  • n/a: http://www.globalbenchmarking.org
  • n/a: http://www.quality-foundation.co.uk
  • n/a: http://www.niqc.com
  • n/a: http://www.eoq.org
  • n/a: http://www.cqm.org
  • n/a: http://www.european-quality.co.uk

Module Delivered in

Programme Code Programme Semester Delivery
Dk_NLBIO_8 Bachelor of Science (Honours) in Biopharmaceutical Science (2019) 6 Mandatory
DK_SENVI_8 Bachelor of Science (Honours) in Environmental Bioscience 6 Mandatory
DK_NLENV_8 Bachelor of Science (Honours) in Environmental Bioscience (2019) 6 Elective
DK_SAPBI_7 Bachelor of Science in Applied Bioscience 6 Mandatory
DK_NLBIO_7 Bachelor of Science in Bioscience (2019) 6 Mandatory
659 Bachelor of Science in Environmental Bioscience 6 Mandatory
DK_NLPHS_7 Bachelor of Science Pharmaceutical Science (2019) 6 Mandatory
DK_SGMPP_7 Certificate in GMP in Pharmaceutical Manufacturing 2 Mandatory
DK_SBIOP_8a Diploma in Biopharmaceutical Processing 2 Mandatory