Investigate Task


  1. Overview

    • The CAPA shall be investigated at this step of the workflow.
    • The Investigator investigates and documents the root cause and determines an Action Plan to address the root cause.

  1. Sections


  • Optional sections: Audit information, Customers information, Documents information, Equipment information, Processes information, Product information, Suppliers information, Management Review information, Process information and products information, suppliers information are not visible initially, users have to choose sections that are relevant to the CAPA and enable them in scope section. 

Sections

Visible

Editable

Basic Details

Immediate Actions

Scope

Impact Details

Audit Information

Customers Information

 ✔

Documents Information

Equipment Information

Management Review Information

Process Information

Products Information

Suppliers Information

Required Approvals

Approvals

Investigation Outcome

Action Plan

Cost

Decision

Verification



  1. Routing

    • Please refer to the diagram in the Overview section to see an end-to-end workflow.

    • From Investigate step the CAPA can only be routed forward to the Approval step. 


  1. Completing the Investigate Step


    • Submitting Investigate Task will follow the standard routing process. Please refer to the routing process in the introduction module of this guide for more details.
    • Only a single User is required to sign off on the Investigate step