PH3S112 - From URS to PQ - A Practical Validation Strategy 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH3S112 | ||
|---|---|---|---|
| Module Title: | From URS to PQ - A Practical Validation Strategy | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Applied Sciences | ||
| Faculty Sub Group: | Chemistry and Pharmaceutical Science | ||
| Module Leader: | Suzanna Kean | ||
| Module Team: | |||
| First Intended Intake: | Final Year of Intake: | ||
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 6 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100078 - business and management | 100144 - pharmaceutical engineering | |
| HECOS Code Weighting: | 50 | 50 | |
Document Version Information
| Version | 1 |
|---|---|
| Valid From | 01 Jan 2022 |
| Valid To | 31 Aug 2028 |
Module Aims
The aim of this module is to give students an understanding of how to ensure that all user requirements are tested and verified from the beginning to the end of a typical project lifecycle. Students will also learn where in the project lifecycle that various testing should occur for the various equipment systems, with a view to optimizing resources and minimizing reworks / repeat testing, as well as practical ways to make these systems fit for handover to operations and maintenance
Content Summary
Indicative Syllabus:
• Planning the validation strategy
• Approaches for the qualification and commissioning for equipment systems
• Developing the traceability matrices
• Planning the protocol development and execution for multiple equipment systems
• Leveraging vendor testing activities both at the factory and on-site
• Post-construction and pre-commissioning tests
• Planning for handover of the project to plant operation and maintenance
• Preparing for the regulatory audit
This module is delivered through open/distance learning resource packs, pre-recorded lectures, problem-solving exercises and case studies.
Learning and Teaching Methods
| Activity Type | Hours |
|---|---|
| Independent Study | 100 |
| Directed Study | 86 |
| Formative Assessment - Independent | 14 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Plan, schedule and manage a validation strategy over the entire lifecycle of a project, including the project handover to operations and preparation for the regulatory audit. |
| LO2 | Generate the necessary URS and apply a range of risk-management tools to make regulatory based decisions about which equipment systems require commissioning and which require qualification, for the Facility and Equipment protocols. |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Asynchronous Assessment | Report 1 | Develop the documents from P&IDs to PQ protocol for validating a multiple equipment system project | 0 | 3000 | 100 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | ||
| Report 1 | ✔ | ✔ | |