Approval


  1. Overview

    • During the Approval step, each Approver (if there are multiple Approvers assigned), shall have the opportunity to document their decision in relation to the CAPA information and the proposed Action Plan.
    • The outcome of this step shall determine whether the CAPA shall proceed to Implementation, rejected (and hence closed) or returned for more changes/information (back to Initiate).

  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.
  • Each Approver shall complete their respective Approval section by documenting their decision and comments. 
  • The last Approver shall have the responsibility for determining the next available step for the CAPA by selecting from the following options in the Approval Decision field of the Decision section: 

    • Proceed: The CAPA shall be routed to Implement.

    • Rejected: The CAPA shall be routed to Closed.

    • Return for more changes/information: The CAPA shall be routed to Initiate.


  1. Completing the Approval Task


    • Submitting Approval Task will follow the standard routing process. Please refer to the routing process in the introduction module of this guide for more details.
    • If there are multiple approvers, ALL approvers have to sign the change.