Fields
| Column Name | Field Name | Description |
|---|---|---|
| Event | Name of the derived event associated with the evaluation | |
| Evaluation Required | Yes: evaluation is required No: evaluation is not required |
|
| Severity | Severity of the evaluation. Possible values are Low, Medium, High, and Urgent. | |
| Location | Name of the location where the evaluation was performed | |
| Device Deficiency Confirmed | Yes: problem with the device is confirmed No: problem with the device not confirmed | |
| Method | Evaluation method code | |
| Results | Evaluation result code | |
| Conclusion Code | Evaluation conclusion code | |
| Remedial Action Taken | Details of remedial actions taken to evaluate the event | |
| Further Investigation Required | Yes: further investigation is required No: further investigation is not required | |
| Rationale | Reason provided for completing the evaluation | |
| Approval Sign-off | Responsible Investigator | Name of the investigator who performed the evaluation |
| Completion Date | Date on which the evaluation was completed | |
| Risk Analysis | Risk Analysis Required | Yes: risk analysis is required No: risk analysis is not required |
| Comments | Reason for selecting the risk analysis requirement | |
| Conclusion | Malfunction | Yes: problem occurred due to product model malfunction No: problem did not occur due to product model malfunction |
| Packaging/Labeling | Yes: problem occurred due to packaging or labeling issue No: problem did not occur due to packaging or labeling issue | |
| Use Error | Yes: problem occurred due to wrong usage No: problem did not occur due to wrong usage | |
| Recommended Actions | Recommendations provided by the evaluator | |
| Summary Details | Summary of the evaluation | |
| External Evaluation | Evaluator | Name of the external evaluator, if any |
| Notified Date | Date when the external evaluator was notified | |
| Manufacturer's Evaluation Details | CAPA Number | CAPA number provided by the investigator |
| Corrective Action Target Date | Date by which the identified actions must be implemented | |
| Initial Corrective Actions | Corrective actions recommended by the manufacturer | |
| Preliminary Analysis | Comments from preliminary analysis performed by the manufacturer | |
| Device Analysis Results | Results of device analysis performed by the manufacturer | |
| Additional Information | Additional information from the evaluation | |
| Transfer Owner Rationale | Reason why the evaluation was transferred | |
| Reopen Rationale | Reason why the evaluation was reopened |