Siebel Life Sciences Guide > Investigating Adverse Events and Complaints >

Assessing If a Product Issue Is Reportable

Assessments allow end users to calculate a single numerical value based on their answers to questions about the product issue. An quality manager can then use the assessment score to decide how to proceed with the investigation.

These are some example assessment questions used to determine if a product needs to be reported:

• Was there any patient injury? {No, Mild, Moderate, Severe}
• Was there a labeling problem? {No, Yes}
• Did the product function according to specification? {No, Yes}

This task is a step in Process of Adverse Events and Complaints Investigation.

To assess a product issue

1. Navigate to Product Issues screen, then the Product Issue List view.
2. Drill down on a product issue.
3. Click the Assessments view tab.
4. In the Assessments list, create a new record.
5. In the Template Name field, select the assessment template that has been prepared for you.

   The application fills in other fields in the record when the record is saved.

6. In the Assessment Attributes list, enter a value for each attribute.

   The assessment score and percentage are calculated and shown in the Assessments list.