1. Life Sciences Guide
  2. Escalating Adverse Events and Complaints as Product Issues

Escalating Adverse Events and Complaints as Product Issues

A valid adverse event or complaint that is first recorded as a service request should be transferred to a product issue record. As a product issue, it can be investigated by the quality manager. This allows the Call Center to retain ownership of the service request and the Quality team to manage the investigation and processing of the complaint.

Note: Only one product issue can be created from a given service request using the Create Product Issue button. Additional product issues for a service request can be created using the Create Related PI button in the Product Issues screen.

This procedure describes creating a product issue from the Service Requests screen. Product issue records can also be created in the Product Issues screen and the Site Management screen.

Tip: To aid call center agents with information gathering and problem diagnosis associated with adverse events and complaints, you can set up SmartScripts. For more information about SmartScripts, see Siebel SmartScript Administration Guide.

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

To create a product issue from a service request

  1. Navigate to the Service Requests screen, then the Service Request List view.

  2. In the Service Request list, select the record for which you want to create a product issue.

  3. Click Create Product Issue.

    This starts the Create a Product Issue from a Service Request workflow that:

    • Makes these fields in the Service Request read-only: Account, Last Name, First Name, and Product.

    • Creates a product issue record from a Service Request.

    • Copies the following fields from the service request to the new product issue: Account, Summary, Last Name, First Name, Description, Type, Area, Sub Area, Priority, Severity, Product, Codes, Asset #, and Lot#.

    • Takes you to the Product Issues screen.

      For more information about the workflow, see About Configuring Adverse Events and Complaints Capture.

  4. Complete the necessary fields in the product issue record.

    Typically, call center agents enter data such as the event date, the outcome, and whether the product was returned. If more than one product is involved with the adverse event or complaint, it is entered in the product issue record. (Only one product can be associated with a service request record.)