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CHEM8011 - Quality Systems, LIMS and SQC

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Title:Quality Systems, LIMS and SQC
Long Title:Quaity Systems, LIMS and SQC
Module Code:CHEM8011
 
Duration:1 Semester
Credits: 5
NFQ Level:Advanced
Field of Study: Chemistry
Valid From: Semester 1 - 2020/21 ( September 2020 )
Module Delivered in 1 programme(s)
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 CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
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
 

Module Content & Assessment

Indicative Content
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.
Descriptive statistics
Calculation of mean, median, mode, standard deviation, missing data, outliers and types of error, accuracy and precision. Histograms/density plots.
Quality Tools
Brainstorming, Check sheets, Flowcharting, Box Plots, Dot Plots, Scatter Diagrams, Linearity, Pareto Analysis, Ishakawa Diagrams, Root Cause Analysis.
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.
Documentation for quality assurance
Why document? Different types of document and their roles. Document control and change. Elements of a documentation system.
Managing quality assurance systems
Elements and principles of quality management systems, role of the quality manager. Quality costing methods.
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).
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.
Assessment Breakdown%
Course Work100.00%
Course Work
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.

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
  • 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
  • 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
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_SQSDA_8 Higher Diploma in Science in Quality Systems Validation with Data Analytics 1 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie