Modifying Evaluation Details

Modify Evaluation Details from the Product Evaluations Page

Before you begin: You must be on the Product Evaluations page.

From the Product Evaluations page toolbar, click Edit.

Modify the following details.


Column Name	Description
Severity	Select a severity. You can select High, Low, Medium, or Urgent.
Device Deficiency Confirmed	Select Yes if problem with the device is confirmed. Otherwise, select No.
Problem Corrected	Select Yes if problem with the device is corrected. Otherwise, select No.
Further Investigation Required	Select Yes if further investigation is required. Otherwise, select No.
Completion Date	Click and select the evaluation completion date. You can select today's date or a past date.

Note: If you are a quality manager, you can modify only the Severity and Further Investigation Required fields.

Click Done.
The details of the evaluation are updated.

Modify Evaluation Details from the Product Evaluation Properties Page

You can modify the details of the evaluation such as

Before you begin: You must be on the Product Evaluation Properties page.

From the Product Evaluation Properties page toolbar, click Edit.

Modify the following details.


Field Name	Description
Severity	Select a severity. You can select Low, Medium, High, or Urgent.
Location	Type the name of the required location, or click and select a location from the Search Results page.
Device Deficiency Confirmed	Select Yes if problem with the device is confirmed. Otherwise, select No.
Method	Click and select a method code from the Structure View page.
Results	Click and select a result code from the Structure View page.
Conclusion Code	Click and select a conclusion code from the Structure View page.
Remedial Action Taken	Describe the remedial actions taken to evaluate the event.
Further Investigation Required	Select Yes if further investigation is required. Otherwise, select No.
Rationale	Type the reason for completing the evaluation.
Responsible Investigator	Type the name of the investigator, or click and select an investigator from the Search Results page.
Completion Date	Click and select the evaluation completion date. You can select today's date or a past date.
Risk Analysis Required	Select Yes if risk analysis is required. Otherwise, select No.
Comments	Type the reason for selecting the risk analysis requirement.
Malfunction	Select Yes if the problem occurred due to reported item malfunction. Otherwise, select No.
Packaging/Labeling	Select Yes if the problem occurred due to a packaging or labeling issue. Otherwise, select No.
Use Error	Select Yes if the problem occurred due to wrong usage. Otherwise, select No.
Recommended Actions	Explain the actions recommended.
Summary Details	Type the summary of the evaluation.
Evaluator	Type the name of the external evaluator, if any.
CAPA Number	Type the CAPA number.
Corrective Action Target Date	Click and select the target date to implement the identified actions.
Initial Corrective Actions	Type corrective actions as recommended by the manufacturer
Preliminary Analysis	Type comments from preliminary analysis performed by the manufacturer
Device Analysis Results	Type results of device analysis performed by the manufacturer
Additional Information	Type additional information from the evaluation

Notes:

If you are a quality manager, you can modify only the Severity, Further Investigation Required, and Additional Information fields.
If you are a regulatory user, you can modify only the Recommended Actions and Additional Information fields.

Click Done.
The details of the evaluation are updated.