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CAPAs

Introduction

The CAPA process outlines the actions that will be taken in order to prevent or correct an issue.
CAPAs can either be created as children of Quality Events or as a standalone.
In this guide we will focus on standalone CAPAs.

Creating a CAPA

Follow along the instructions and let’s learn how to use the CAPA object!

CAPA
  • Click on the CAPA Process tab or search the process name from the 9 dots on the left.

  • Create a New CAPA record.

  • Fill in the Title and Type.

  • Click Save.

CAPA Workflow

Before we start learning how the process works, it is important to understand that each process has its own flow called “Workflow”.

What is a Workflow?

Each record has its own workflow which displays the record’s current state. In each status there could be one or more users responsible for the CAPA such as the owner, action plan approver(s) and final approver(s) that need to complete certain tasks in the record. By completing these tasks (using workflow buttons), those participants allow the workflow to move on to the next status. These tasks are also known as “Workflow Tasks” discussed in the Tasks section.

This is the out of the box flow of the CAPA that we will go over:

  • These are all the statuses the record can go through.

  • These are the workflow buttons that will allow us to move between statuses.

Fields

The Details tab presents the fields captured on the record.
There are multiple field types such as: text, date, number, picklist (drop- down) and checkbox.

The fields are used to document the details of the CAPA. 

  • The fields are presented in the page layout in the Details tab.

  •  Make a change in one of the fields (e.g. Responsible Department). Click Save.

Audit Trail

Captures the record’s changes as required by Part 11. 

Scroll down and see the change you made captured in the Audit Trail.  

  • Who made the change?

  • When the changed occurred?

  • What changed? – old and new value.

Right Side Component

  • Files- you can upload a file to the record.

  • Participants- assign reviewers and approvers.

  • Task- each status has its own task that opens automatically (Workflow Tasks) and you can also create tasks to your needs.

  • Related Items- add new related items or link existing ones. For instance, link other relevant CAPAs or create a CC out of a CAPA.

    *in Quality Events a CAPA is typically created as a related item. 

  • Prints- allows us to print the record information. We can create several prints for a record.

Controlled Document
  • Check-in/out- allows us to upload the document file.

  • Participants- assign reviewers and approvers.

  • Tasks- create tasks related to the record (will be explained in a later stage).

  • Related Items- add new related items or link existing ones. For instance, link other relevant documents to the record.

  • Prints- print the record information. Different prints could be created for an object.

Attach a File

Follow along the video and upload a file to the record.

Action Plan Status

Move to the Action Plan status by clicking on the Submit button.
When moving to this status in standalone CAPAs the system pops up a required field in order to move to the next status.
 

Add Action Plans

In the Action Plan status we add the actions to be taken in order to correct or prevent the issue.

The actions will initially be created in draft status, when the CAPA reaches the Action Plan Execution status the actions will be executed.

Add Risks

You can link existing risks from your risk registry or add new risks.
The risks are added from the related items component and will appear in the risk matrix.

Action Plan Approval Status

Click on Action Planning Completed and choose user(s) for the Action Plan Approval and Final Approver.

The Action Plan Approver approves the action plan before it moves into the execution phase.

Electronic Signature and Comment

  • Each button could be configured to require an electronic signature and/or required comment in order to move to the next status. Typically the approval actions require a signature and when sending the record backwards or cancelling it a comment.

Let’s move to the Action Plan Execution status and see how the electronic signature works:

Action Plan Execution Status

In the Action Plan Execution status the actions are executed and the status changes from Draft to Not Started. When all the actions are completed the record will move automatically to the Final Approval status.
Take Ownership- The Take Ownership button allows the user to control the workflow statuses. When pressing this button the workflow buttons will appear.
 
  • In the Action Plan Execution status the actions are executed and the status changes from Draft to Not Started.

  • Click on the name of the action in order to open and complete it. When all the actions are completed the record will automatically move to the Final Approval status.

  • Take Ownership- this button allows the user to control the current workflow status. Pressing this button will display the workflow buttons.
    To move the record to the Final Approval status manually click on the Take Ownership button and move the

Final Approval Status

The Final Approver approves the record and needs to decide if an Effectiveness Check is required, if Yes, a task will be created based on the Due Date, it’ll be assigned to the record owner.

Fantastic! You completed your first CAPA record.

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