| Title: | Quality Systems, LIMS and SQC |
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| Long Title: | Quaity Systems, LIMS and SQC |
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| Field of Study: |
Chemistry
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| Valid From: |
Semester 1 - 2020/21 ( September 2020 ) |
| Module Coordinator: |
Donagh OMahony |
| Module Author: |
Mary Lehane |
| Module Description: |
This module aims to provide learners with a sound understanding of the principles, practices and protocols relating to quality measurement, control, assurance, management and the LIMS system, training them in the use of quality tools for problem solving and quality improvement, in the PharmaChem, Biotechnology, Medical device and regulated sectors. |
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| LO1 |
Review and analyse, in-depth, current knowledge, and best practices in Quality Systems. |
| LO2 |
Examine and apply management strategies to the complex interrelationships (vendors, materials, processes inputs and final outputs, and inspection/testing/analysis, personnel, management) that exist within a production facility that are necessary to assure quality. |
| LO3 |
Apply descriptive statistics to appraise the variability data and to investigate and solve quality problems/anomalies in the manufacturing process. |
| LO4 |
Discuss quality cost models and resource requirements to enable the management of the QMS. |
| LO5 |
Describe the current good documentation practice, usage, design and control of quality documentation within a QMS. |
| LO6 |
Outline the role, advantages, limitations and control of the LIMS in the highly regulated area of product testing. |
| Pre-requisite learning |
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).
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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
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| 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.
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| No requirements listed |
Module Content & Assessment
| Indicative Content |
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Quality Principles
The meaning of Quality, Inspection, Quality Control, Quality Assurance, Total Quality Management (TQM), Quality Principles, Quality Criteria and Specifications, Process Approach, Continuous Improvement, Lean-Sigma, Regulatory bodies and their roles. Control of the conditions of manufacture and testing.
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Descriptive statistics
Calculation of mean, median, mode, standard deviation, missing data, outliers and types of error, accuracy and precision. Histograms/density plots.
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Quality Tools
Brainstorming, Check sheets, Flowcharting, Box Plots, Dot Plots, Scatter Diagrams, Linearity, Pareto Analysis, Ishakawa Diagrams, Root Cause Analysis.
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The Human Element of Quality
The role of the human in the achievement of quality. A people based philosophy. Motivation, ethics, behaviour, inclusion, problem solving in teams. Empowerment.
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Documentation for quality assurance
Why document? Different types of document and their roles. Document control and change. Elements of a documentation system.
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Managing quality assurance systems
Elements and principles of quality management systems, role of the quality manager. Quality costing methods.
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Process Control Data
Variables chart-range and mean, attributes chart-outer control Limits-Specification limits-Variance, % failing to meet specification limits-(Cp, Cpk, Cpm, Cpu, Cpl).
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LIMS
Overview of laboratory processes and data/information workflow in quality control, analytical services and pharmaceutical laboratories, in a regulated environment, security protocols, sample chain of custody, instrument automation and robotic systems. Analytical data including control, security and traceability, audit and review. Q. risk management, Review of Q. Sys. Deviation management, Change Control, CAPA, OOS, and complaints handling.
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| Assessment Breakdown | % |
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| Course Work | 100.00% |
| Course Work |
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| Assessment Type |
Assessment Description |
Outcome addressed |
% of total |
Assessment Date |
| Open-book Examination |
Short Answer Questions and/or MCQ |
1,2,4 |
20.0 |
Week 5 |
| Practical/Skills Evaluation |
Integrated problem solving, quality risk analysis, portfolio of teamwork exercises, and a reflective journal. |
1,2,3,6 |
50.0 |
Week 8 |
| Other |
Written assessment based on project work and teamwork assignments |
4,5,6 |
30.0 |
Week 12 |
| No End of Module Formal 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.
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The institute reserves the right to alter the nature and timings of assessment
Module Workload
| Workload: Full Time |
| Workload Type |
Workload Description |
Hours |
Frequency |
Average Weekly Learner Workload |
| Lecture |
Quality Theory |
1.0 |
Every Week |
1.00 |
| Tutorial |
Tutorial sessions - Application of theory and principles, teamwork problem solving |
1.0 |
Every Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Revision of theory and problem solving and performing teamwork tasks via lecturer directed study |
5.0 |
Every Week |
5.00 |
| Total Hours |
7.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
2.00 |
| Workload: Part Time |
| Workload Type |
Workload Description |
Hours |
Frequency |
Average Weekly Learner Workload |
| Lecture |
Quality Theory |
1.0 |
Every Week |
1.00 |
| Tutorial |
Tutorial sessions |
1.0 |
Every Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Revision of theory and problem solving |
5.0 |
Every Week |
5.00 |
| Total Hours |
7.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
2.00 |
Module Resources
| Recommended Book Resources |
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- Besterfield, D. H. 2014, Quality Control, 9th Ed., Pearson Education Ltd. Essex, UK [ISBN: 0132624419]
- Sarker, D. K. 2008, Quality Systems and Control for Pharmaceuticals, 1st Ed., John Wiley & Sons, Inc., Chichester, UK [ISBN: 9780470056936]
- Summers, D.C. 2018, Quality, 6th Ed., Pearson [ISBN: 978-013441327]
- Sartor, M., and Orzes,G., 2019, Quality Management: Tools, Methods and Standards, 1st Ed., Emerald Publishing Ltd. UK [ISBN: 13 9781787698]
| | Supplementary Book Resources |
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- Goetsch, D. L., and Davis, S. B. 2013, Quality Management for Organisational Excellence,, 7th Ed., Pearson, USA [ISBN: 9780133791853]
| | This module does not have any article/paper resources |
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| Other Resources |
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- Website: FDA - Us Food and Drug Administration
- Website: International Organization for
Standardization
- Website: Council Of Europe Quality Documents
- Website: Health Products Regulatory Authority
(HPRA)
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Module Delivered in
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