Training activity information
Details
Write a deviation report of an equipment failure and carry out an investigation into this failure
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee​.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Examples of equipment failures might include:
- Leak test failure
- Failure of sessional isolator checks
- Fridge out of temperature range
- AHU failure
- National guidance and local SOPs
- Documentation of deviation
- Investigation of deviation
- Root cause analysis – methods and outcome
- Appropriate corrective actions
- Change control
- Risk assessment
- Impact assessment
- Prioritisation of actions
- Limits of practice
- Appropriate escalation
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Interpret monitoring results and trends and take appropriate action to correct out of specification results. |
| # 4 |
Outcome
Critically evaluate the design, installation and PPM of an aseptic unit and LAFCs/Isolators. |
| # 6 |
Outcome
Apply risk management techniques in the context of aseptic medicines. |