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Creating Multiple Product Issues Related to One Service Request

Only one product issue can be created directly from a service request (using the Create Product Issue button on the Service Requests screen). However, in the Product Issues screen, the quality manager can create additional product issues related to the service request and the original product issue.

Here are some examples where multiple product issue records are needed:

• A medical kit contains a drug and a device. The drug and the device might have caused the event. Separate adverse event and product complaint investigations have to be completed.
• There are several products involved with the adverse event or complaint and the quality manager wants a unique product issue for each product.

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

To create a new 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 Create Related PI.

   This starts a workflow (LS Medical Product Issue Create Related PI), which creates a new product issue record, copying fields from the current product issue.

   For more information about the workflow, see About Configuring Create Related PI and Review Complete Buttons.

4. In the Event Detail applet, modify the fields as required.
5. In the Products applet, create a new record for each product that you want to associate with the issue and complete the necessary fields.