Module Database Search
| MODULE DESCRIPTOR | |||
|---|---|---|---|
| Module Title | |||
| Quality Assurance & Regulations For Industry | |||
| Reference | PL3147 | Version | 1 |
| Created | October 2022 | SCQF Level | SCQF 9 |
| Approved | June 2023 | SCQF Points | 15 |
| Amended | August 2021 | ECTS Points | 7.5 |
| Aims of Module | |||
|---|---|---|---|
| To provide the student with the ability to understand the importance of quality assurance and quality regulations within organisations, and explore approaches to the assurance and improvement of quality. | |||
| Learning Outcomes for Module | |
|---|---|
| On completion of this module, students are expected to be able to: | |
| 1 | Discuss the role of quality, quality systems, and their relevance in bioindustry. |
| 2 | Discuss quality tools and techniques which are employed to assess and improve quality in an organisation. |
| 3 | Define the purpose of audit, and evaluate the different types of audit. |
| Indicative Module Content |
|---|
| Definitions of Quality; The role of Quality in industry; Cost of poor quality; Reliable results; Calibration; Quality control; Quality assurance; Quality system; Reference materials and method of validation; Traceability; Measurement of uncertainty; Good laboratory practice; Standard operating procedures; Measuring and monitoring Quality; Quality systems; Laboratory accreditation; ISO 9000/9001; ISO 15189; ISO 13845; Cultures of quality; Audit; Continuous quality improvement; External Quality assessment; Corrective action plan; Understanding and complying with FDA and CE marking requirements; Lifecycle of a medical device/pharmaceutical product. |
| Module Delivery |
|---|
| A combined approach utilising formal lectures, seminars, directed reading and tutorials. |
| Indicative Student Workload | Full Time | Part Time |
|---|---|---|
| Contact Hours | 30 | N/A |
| Non-Contact Hours | 120 | N/A |
| Placement/Work-Based Learning Experience [Notional] Hours | N/A | N/A |
| TOTAL | 150 | N/A |
| Actual Placement hours for professional, statutory or regulatory body |
| ASSESSMENT PLAN | |||||
|---|---|---|---|---|---|
| If a major/minor model is used and box is ticked, % weightings below are indicative only. | |||||
| Component 1 | |||||
| Type: | Coursework | Weighting: | 100% | Outcomes Assessed: | 1, 2, 3 |
| Description: | The module will be assessed by a coursework evaluating the outcome of an audit. | ||||
| MODULE PERFORMANCE DESCRIPTOR | |
|---|---|
| Explanatory Text | |
| Component 1 (CW1) comprises 100% of the module grade. A minimum of a Grade D is required to pass the module. | |
| Module Grade | Minimum Requirements to achieve Module Grade: |
| A | A |
| B | B |
| C | C |
| D | D |
| E | E |
| F | F |
| NS | Non-submission of work by published deadline or non-attendance for examination |
| Module Requirements | |
|---|---|
| Prerequisites for Module | None, in addition to SCQF level 9 entry requirements or equivalent. |
| Corequisites for module | None. |
| Precluded Modules | None. |
| INDICATIVE BIBLIOGRAPHY | |
|---|---|
| 1 | HOYLE, D. 2017. ISO 9000 Quality Systems Handbook - updated for the ISO 9001: 2015 Standard. 7th Edition. Routledge. |
| 2 | Beckford, J. 2016. Quality: a critical introduction. 4th Edition. Routledge. |
| 3 | OAKLAND, J.S. 2020. Total quality management and operational excellence. 5th Edition. Routledge. |