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}

Tip: An alternate way to assess product issues is by using a SmartScript which guides the quality manager through a series of questions using a decision tree. For more information about SmartScripts, see Siebel SmartScript Administration Guide.

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. In the Product Issues list, drill down on a product issue.

3. Click the Assessments tab.

4. In the Assessments list, create a new record and complete the necessary fields.

   For example, 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.

5. In the Assessment Attributes applet, enter a value for each attribute.

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