Module Details
| Module Code: |
CHEM7006 |
| Title: |
QA for Chemists
|
|
Long Title:
|
Quality Assurance for the Chem
|
| NFQ Level: |
Intermediate |
| Valid From: |
Semester 1 - 2019/20 ( September 2019 ) |
| Field of Study: |
4421 - Chemistry
|
| Module Description: |
This course aims to give chemical analysts an understanding of the nature of quality and its role in the chemical industry.
|
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| # |
Learning Outcome Description |
| LO1 |
Explain the role of quality within an organisation |
| LO2 |
Outline how quality applies to manufacturing and testing in the chemical and pharmaceutical industries, including the role of Good Manufacturing Practice (GMP) and Quality Management Systems (QMS). |
| LO3 |
Construct and explain charts designed to aid in the control of variability of processes |
| LO4 |
Describe the elements of quality as they apply to the analytical chemistry laboratory |
| 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 Basics
Identifying and understanding quality. Quality in all areas: marketing, specification, design, purchasing, production, inspection, measurement, packaging, storage, service.
|
|
Quality for Process Industries
The management of quality for chemical, pharmaceutical and related industries. Outline of a quality management system (e.g. ISO 9000). Regulations such as 21CFR 211 and/or ICH Q7 as they relate to: suitability of equipment, SOPs, validation of processes, traceability, laboratory controls, documentation and records, control of nonconforming product etc.
|
|
Understanding variability in processes
Frequency distribution curves and their presentation. Normal distribution and standard deviation. Specification limits vs Process capability. Standardised normal curve and calculation of process capabilities. Process capability indices. Quality control charts, central limit theorem, Shewhart charts. Control charts for variables - Mean and range charts. Control charts for attributes. CUSUM charts.
|
|
Quality for the laboratory
Overview of quality assurance in the analytical chemistry laboratory including such topics as: sampling, statistical principles, validation, documentation, equipment calibration & maintenance, reference materials & their traceability, internal and external QC, Laboratory accreditation, Auditing and Ethics.
|
|
Module Content & Assessment
|
| Assessment Breakdown | % |
|---|
| Coursework | 100.00% |
Assessments
| 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 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 |
Theory and discussion classes |
Every Week |
2.00 |
2 |
| Lab |
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 |
Theory and discussion classes |
Every Week |
2.00 |
2 |
| Lab |
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 |
|---|
-
Donna C. Summers,. (2009), Quality, 6th. Pearson, London, [ISBN: 9780134413273].
-
James Miller. (2018), Statistics and Chemometrics for Analytical Chemistry.
| | Supplementary Book Resources |
|---|
-
Elizabeth Prichard and Vicki Barwick. (2007), Quality assurance in analytical chemistry, [ISBN: 0470012048].
-
NSAI. (2015), IS EN ISO: 9001:2015.
-
D.H. Besterfield. (2009), Quality control, Prentice Hall Ptr, Upper Saddle River, [ISBN: 0135000955].
-
Kehoe D.F.. (1996), The Fundamentals of Quality Management, [ISBN: 041262690X].
-
David Hoyle. (2007), Quality Management Essentials, Routledge, U.s., [ISBN: 9780750667869].
| | This module does not have any article/paper resources |
|---|
| Other Resources |
|---|
-
Website, US Food and Drug Administration (FDA). 21 CFR 210/211,
-
Website, International Conference on
Harmonisation (ICH). GMP Guide for Active Pharmaceutical
Ingredients Q7 and other relevant
documents,
-
Website, Eurachem. Several relevant documents,
|
|
