CAPA Process Steps

The Process Steps category provides a graphical view of the sequential process steps of a CAPA. In this page, you can view the current status of a CAPA and can perform the steps or tasks required to complete it.

The process steps are displayed as a sequence of colored circles with step numbers. A title and description is given for each circle. You can click the circles and the tasks for the step are displayed in a table. You can use the slider buttons to navigate to the left or right direction.

This page discusses:

Color Coding for Step Circles

Color Description
Green Completed steps.
Blue Current or active steps. You can perform actions on this step.
Grey Future steps.
Red Stopped steps. These are steps where the process flow is blocked.

Process Steps

As you hover the pointer over the step circle, the border color of the circle becomes bold and it can be clicked. You can also use the Expand option to view the details of steps.

Process Steps Step Description CAPA State
Prepare CAPA Describe problem and add supporting evidences. Preliminary
Planning Organize team, plan activities and assign tasks Preliminary
Analyze Risks Identify and analyze risks Ready
Investigate Root Causes Identify and investigate root causes In Work, In Review
Implement Solution Implement action plan to fix problem In Work
Measure of Effectiveness Validate that implemented solution is effective

This step is visible only if MOE phase or MOE tasks have been created.

 In Work, In Review
Complete CAPA CAPA request and CAPA closed In Review, Complete

Tasks for Process Steps

When the step circle is clicked, the tasks for the step are loaded in a table below. You can initiate and complete CAPA process from this table. You can perform required tasks under the Actions column based on your role. After completing the action, the task is validated as true and the task icon turns green.

An icon shows the status of each process step task:

Icon Process Step Task Status


Status shows that the tasks are optional.


Status shows that the tasks are mandatory and are not yet completed.


Status shows that the tasks are completed and are validated as true.

Tasks for Prepare CAPA Step

Task Title Task Type Role Owner Actions Related Data
Add Data Sources Mandatory Project Lead CAPA Owner Click icon to add data sources Click icon to open data sources table.
Add CAPA Requests Optional Project Lead CAPA Owner Click icon to add CAPA requests. Click icon to open CAPA requests table.
Add Related CAPA Optional Project Lead CAPA Owner Click icon to add related CAPAs. Click icon to open related CAPA table.
Add Supporting Documents Optional Project Lead CAPA Owner Click icon to add supporting documents. The Bookmark table is opened and you can add, remove, and perform other actions for bookmarks and documents.

Tasks for Planning Step

Task Title Task Type Role Owner Actions Related Data
Add Project Team Members Mandatory Project Lead CAPA Owner Click icon to add members Click icon to open CAPA members table
Define Preliminary Plan & activities Mandatory Project Lead CAPA Owner Click icon to add task/phase/gate/milestone. The Schedule table views opened. If any task, phase, gate, or milestone (any Task Management subtype) is added, the task is validated as true.
Assign Tasks to Team Members Mandatory Project Lead CAPA Owner Click icon to assign tasks to CAPA team. The Schedule page is opened in the Assignment view, and you can assign members to the tasks.
Start Risk Analysis Mandatory Project Lead CAPA Owner Click icon to promote CAPA to the Ready state. CAPA is promoted to the Ready state.

Tasks for Analyze Risks Step

Task Title Task Type Role Owner Actions Related Data
Capture Risks Mandatory Project Lead CAPA Owner Click icon to create risks. Click icon to open CAPA Risks table.
Assign Initial Severity & Occurrence

This task becomes visible only if any risk is created for the CAPA.

 Mandatory Project Lead CAPA Owner Click icon to edit severity and occurrence of risks. After all the CAPA risks have some severity and occurrence assigned, the task gets completed.
Define Action Plan to Migrate Risks Optional Project Lead CAPA Owner Click icon to define action plan to migrate risks. The Schedule table is opened.
Assign Tasks to Team Members

This task becomes visible only if any risk is created for the CAPA.

 Optional Project Lead CAPA Owner Click icon to assign tasks to team members. The Schedule page in the Assignment view is opened. You can assign members to the tasks.
Associate Tasks, which Migrate Risks Optional Project Lead CAPA Owner Click icon to associate tasks, which migrate risks created for the CAPA. The Risks page is opened in which you can access individual risk associated to a task.
Start Root Cause Analysis Mandatory Project Lead CAPA Owner Click icon to root cause analysis. CAPA is promoted to the In Work state and this task is validated as true.

Tasks for Investigate Root Causes Step

Task Title Task Type Role Owner Actions Related Data
Identify Root Cause

This task becomes visible once any defect cause is created for the CAPA.

 Mandatory Project Lead CAPA Owner Click icon to identify and navigate to root causes. The CAPA Defect Causes table is opened, where you can navigate to individual properties page by clicking the defect cause name hyperlink to edit the Primary field.
Define Investigate Plan Optional Project Lead CAPA Owner Click the Add task icon to open Schedule page in the table view. The Schedule page is opened in the table view.
Assign Investigation Tasks to Team Members

This task becomes visible once any defect cause is created for the CAPA.

 Optional Project Lead CAPA Owner Click icon to assign investigation tasks. The Schedule page is opened in the assignment view.
Associate Investigation Tasks for Root Causes Mandatory Project Lead CAPA Owner Click icon to open Defect Causes table. The CAPA Defect Causes table is opened, where user can access the individual cause created for the tasks. Click the Name of defect cause to add one or more CAPA tasks to the defect cause.
Identify Items Impacted by Change Optional Project Lead CAPA Owner Click icon to add impacted items. Click icon to open related items table.
Define Implementation Phase Mandatory Project Lead CAPA Owner Click icon to create a phase. The phase is created with the name as Implementation Phase and listed in the Schedule page of a CAPA.
Complete Investigation Tasks Mandatory Project Lead CAPA Owner Click icon to complete the tasks. The Schedule table is opened in which you can complete the tasks assigned to you.

When all the tasks are completed, except the implementation phase, MOE phases, and MOE tasks, the Complete Investigation Tasks process step is completed.

Tasks for Implement Solution Step

Task Title Task Type Role Owner Actions Related Data
Define Implementation Plan & Activities Mandatory Project Lead CAPA Owner Click icon to define implementation plan and activities.

The Schedule table is opened.

 It is validated as true once the implementation phase was defined using the Define Implementation Phase task of the step number 4.
Assign Implementation Tasks to Team Members Mandatory Project Lead CAPA Owner Click icon to assign tasks to the team members. The Schedule page is opened in the assignment view. You can assign members to the tasks.
Define Measure of Effectiveness Phase Optional Project Lead CAPA Owner Click icon to define MOE phases and tasks. The schedule table is opened. You can create MOE phases and MOE tasks.
Complete Implementation Plan Mandatory Project Lead CAPA Owner Click icon to complete implementation tasks. The Schedule page is opened. You can complete the tasks. After all the tasks except the MOE Phases and MOE tasks are completed, this step task is validated as true.

Tasks for Measure of Effectiveness Step

Task Title Task Type Role Owner Actions Related Data
Define Measure of Effectiveness Schedule Optional Project Lead CAPA Owner Click icon to open the Schedule table view.

You can create MOE phases and MOE tasks.

 The Schedule page is opened in the table view.
Define Review Metrics & Acceptance Criteria

This task becomes visible only if any MOE task is created.

 Mandatory Project Lead CAPA Owner Click icon to edit the criteria of acceptance from the Effectiveness Check table.

You can edit the review metrics from the Properties page of a MOE. You can click the Name of a MOE to access the Properties page of the MOE.

 _
Assign MOE Tasks to Team Members

This task becomes visible only if any MOE task is created.

 Mandatory Project Lead CAPA Owner Click the icon to open the Schedule page in the Assignment view in which you can assign the members to a task. The Schedule page is opened in the assignment view.
Execute Measure of Effectiveness Tasks and update Results

This task becomes visible only if any MOE task is created.

 Mandatory Project Lead CAPA Owner Click the Edit option to edit the value of Results column in the Effectiveness Checks page. The Effectiveness Checks table is opened.
Complete Effectiveness Checks

This task becomes visible only if any MOE task is created.

 Mandatory Project Lead CAPA Owner Click to open the Schedule table view and complete MOE phases and MOE tasks. The Schedule page is opened in the table view.

Tasks for Complete CAPA Step

Task Title Task Type Role Owner Actions Related Data
Finalize Risks Severity & Occurrence

This task becomes visible only if any risk is created for the CAPA.

 Optional Project Lead CAPA Owner Click the Risk icon to open the CAPA Risks table with the Risk Matrix Grid view. The CAPA Risks table with the Risk Matrix Grid view is opened.
All the Route tasks will be displayed in the Review state. Mandatory - Owner of the Inbox Task Add comment to complete the route task. The Route icon is displayed and the Properties page of a route is opened.
CAPA Closed Mandatory Project Lead CAPA Owner No action required. After all the tasks are completed, CAPA is automatically promoted to the Complete state and the task is validated as true. _
CAPA Request fulfilled Dependency _ CAPA Owner

No action required. After the associated CAPA requests are fulfilled, the task is validate as true.

 Click icon to the view the CAPA Requests table.

Process Steps for On Hold CAPA

The On Hold CAPA has below process steps.

Process Steps Step Description CAPA State
On Hold CAPA is on hold On Hold

Tasks for On Hold Step

Task Title Task Type Role Owner Actions Related Data
Resume or Cancel CAPA Mandatory Project Lead CAPA Owner Click the Resume icon to resume the CAPA.

Click the Cancel icon to cancel the CAPA.

 Click the CAPA icon to open the CAPA PowerView page.

Process Steps for Cancelled CAPA

The cancelled CAPA has below process steps.

Process Steps Step Description CAPA State
Cancelled CAPA is cancelled Cancelled

The color of the cancelled step is red.

Tasks for Cancelled Step

Task Title Task Type Role Owner Actions Related Data
CAPA is Cancelled Mandatory - CAPA Owner No actions. -

Impacted Items Panel

This panel is visible only if the CAPA is connected to at least one related item.

Column Title Description
Name Name of the object. Hyperlink is provided to navigate to the object.
Type Type of the object.
Status Current lifecycle state of the object.
Revision Revision of the object.
Related Change Change objects associated with the object.
Description Description on the object.

Input Data Sources Panel

This panel is visible only if the CAPA or its connected CAPA requests have at least one data source.

Column Title Description
Name Name of the data source. Hyperlink provided to navigate to the data source.
Type Type of the data source.
Status Current lifecycle state of the data source.
Impacted Items Data source impacted items.
CAPA Request CAPA Requests associated to the data source and CAPA.
Description Description on the data source.