About CAPA

Corrective Action Preventive Action (CAPA) is a method that allows companies to fix problems using corrective and preventive actions. A corrective action helps to prevent the recurrence of an existing problem. A preventive action helps to avoid the occurrence of a potential problem.

This page discusses:

CAPA

A CAPA is an object that is used to plan and implement the corrective or preventive action, as required. A CAPA is created from a CAPA request, and the CAPA request is created from different sources that describe a problem.

A CAPA contains the following:

  • Details about the problem
  • CAPA request from which it is created
  • Members assigned to the project
  • Phases that define the schedule
  • Tasks that are assigned to members from different departments

A user having a project lead role can create a CAPA from a CAPA request.

The project lead can perform the following actions on a CAPA.

  • Add team members
  • Create phases and tasks
  • Assign phases and tasks to members

When the task assignees complete all the tasks in a phase, the phase is completed. When all phases are completed, the CAPA is verified and completed.

Lifecycle

The lifecycle of a CAPA consists of six states.

  • Preliminary: In this state a project owner or a project lead can add team members, create phases and tasks, and assign them to members.
  • Ready: When the CAPA is promoted to this state, the assigned tasks are made available to the assignees.
  • In Work: When the task assignees start working on the tasks, the CAPA is promoted to this state.
  • In Review: When all phases are completed, the CAPA is promoted to this state.

    When a CAPA is promoted to the Review state, an approval route is automatically created between the Review and Complete states. A task is assigned to the CAPA owner for approving the CAPA . If the CAPA is demoted back to the Review state, a new route is created between the Review and complete states.

    Note: You cannot manually promote a CAPA from the Review state to the Complete state.

  • Complete: Once CAPA owner approves the route in between the Review and Complete states, the CAPA is automatically promoted to the Complete state.
  • Archived: The project owner can move the unused, completed CAPAs to this state.