Module Details

Module Code: CHEM8007
Title: Quality Management Systems
Long Title: Quality Management Systems for
NFQ Level: Advanced
Valid From: Semester 1 - 2019/20 ( September 2019 )
Duration: 1 Semester
Credits: 5
Field of Study: 4421 - Chemistry
Module Delivered in: 1 programme(s)
Module Description: This course aims to bring the learner to a professional level understanding of quality as it applies in chemical and pharmaceutical industries.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Discuss quality management philosopies & frameworks
LO2 Explain and discuss the elements of a quality management system
LO3 Assess the various quality standards and select appropriate standards for use
LO4 Research and critically evaluate quality information sources and extract relevant information as required.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
13363 CHEM7006 QA for Chemists
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
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. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
Quality Management Philosophies and Frameworks
The foundations of quality: Deming, Juran, Ishikawa, Crosby, etc., concept of the internal customer, continual improvement, leadership, commitment, the quality culture, total quality, six sigma.
Establishing a Quality Management System
Policy statement, objectives, process approach, quality manual, writing SOPs, documentation control, responsibility and authority, training. Implementation and Auditing. The role of auditing, preparation and planning, risk based approach, performance of and reporting on audits, practical examples.
Elements of a Quality Management System
Management commitment, planning, customer related processes, design and development, resource management, purchasing, process control, validation, control of nonconforming product, monitoring and measurement, change control, corrective and preventive actions, internal auditing.
Quality Standards and Awards
Certification and regulatory bodies relevant to the analyst. External Audit and Assessment. Reference to relevant standards e.g. ISO 9000, ICHQ10 Pharmaceutical Quality System, ISO17025.
Module Content & Assessment
Assessment Breakdown%
Coursework30.00%
End of Module Formal Examination70.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 15
Timing Week 8 Learning Outcomes 1,2,3
Assessment Description
Test of course material
Assessment Type Project % of Total Mark 15
Timing Week 10 Learning Outcomes 1,4
Assessment Description
Research-based exercises on assigned topics to be completed late in the semester
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 70
Timing End-of-Semester Learning Outcomes 1,2,3,4
Assessment Description
End-of-Semester Final Examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Small group lecturing Every Week 2.00 2
Lecturer-Supervised Learning (Contact) Contact Practical skills development Every Week 1.00 1
Independent & Directed Learning (Non-contact) Non Contact Personal study Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Small group lecturing Every Week 2.00 2
Lecturer-Supervised Learning (Contact) Contact Practical skills development Every Week 1.00 1
Independent & Directed Learning (Non-contact) Non Contact Personal study Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • David Hoyle. (2009), ISO 9000 Quality Systems Handbook-updated for ISO 9000:2008, [ISBN: 1856176842].
  • John S. Oakland. (2004), Oakland on Quality, 3rd. [ISBN: 978070657413].
  • National Standards Authority of Ireland. (2015), IS EN ISO 9000:2015 Series.
  • D.L. Goetsch & S. Davis. (2014), Quality Management for Organisational Excellence, Pearson, U.s., [ISBN: 9781292022338].
Supplementary Book Resources
  • NSAI. (2017), ISO 17025:2017 General requirements for the competence of testing and calibration laboratories.
  • Lionel Stebbing. (1993), Quality assurance, 3rd. Ellis Horwood, New York, [ISBN: 0131097539].
  • W. Edwards Deming. (2000), Out of the crisis, 2nd. Massachusetts Institute of Technology, Cambridge, Mass, [ISBN: 0262541157].
  • Elizabeth Prichard, Vicki Barwick. (2007), Quality in Analytical Chemistry, Wiley, U.K., [ISBN: 9780470012031].
  • Peter Bedson, Trevor J. Farrant, Stephen L.R. Ellison, Vicki J. Barwick, William A. Hardcastle, Sue Upton,. (2009), Practical Statististics for Analytical Scientists, 2nd. Royal Society of Chemistry, U.K., [ISBN: 9780854041312].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_SCHQA_8 Bachelor of Science (Honours) in Analytical Chemistry with Quality Assurance 7 Mandatory