How Do I Return a Complaint to the Initiate Complaint step?

When working with Complaints, a best practice is to leave the Initiate Complaint task open until the Complaint is ready to close. Decisions and actions available when initiating the Complaint may be started independently at any time until the task is signed off, and completed actions may be reinitiated as many times as needed. This includes the following actions:

• Edit the Issue/Complaint

• Edit the Complaint Priority

• Assign Process Impact Implementation tasks

• Initiate an investigation or provide justification for no investigation

• Initiate a CAPA Request or provide justification for not opening a CAPA Request

• Initiate Regulatory Reporting or provide justification for no Regulatory Reporting

• Initiate a Field Action Process

Instructions for returning to Initiate Complaint

1. All in-process tasks must be signed off. If the tasks are not complete, there will be an opportunity to finish them later in the process. This includes the following tasks:

   1. Impact Implementation

   2. Investigation

   3. Initiating a CAPA Request

   4. Field Action

   5. Regulatory Reporting
      
      

2. With the above tasks signed off, the Complaint will go to the Review for Closure step. Click “Perform” in the Review for Closure task.

Open

Review for Closure task

3. Click “Return to Initiate Complaint.”

Open

4. Indicate what additional work needs to be completed and click “Return to Initiate Complaint.”

5. The Complaint is back to the Initiate Complaint task, where it may be edited and any necessary actions may be reinitiated.