Training activity information
Details
Investigate a questionable laboratory result or out of trend result
Type
Entrustable training activity (ETA)
Evidence requirements
Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion.
Reflection at multiple timepoints on the trainee learning journey for this activity.
Considerations
- Procedure
- Analyst self-check
- Supervisor check
- Hypothesis testing
- Repeat testing
- Resampling
- Notifying customers
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Perform a range of chemical analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| # 2 |
Outcome
Perform a range of microbiological analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| # 3 |
Outcome
Apply physical and environmental monitoring tests to provide evidence of facility compliance and ascertain compliance with requirements. |
| # 4 |
Outcome
Write specifications for routine quality control and stability assessment based on relevant standards and guidance. |
| # 5 |
Outcome
Investigate questionable laboratory results or out of trend results following quality system requirements, liaising with analysts, supervisor and customers where appropriate. |
| # 7 |
Outcome
Describe the requirements of data integrity related to quality control systems. |