CAPA: Corrective Action Preventative Action

The AODocs for Life Sciences Grow package lets you manage CAPAs, Quality Events and Audits. Use the Grow package to enrich and expand your quality management system with automated workflows and processes. Learn more about the AODocs for Life Sciences packages.

A CAPA is defined as a Corrective Action or a Preventative Action.

Typically, a Corrective Action is used to identify a specific problem that already exists, and create a process to correct it. In contrast, a Preventative Action is used to identify a potential problem that hasn’t yet occurred, and create a process to prevent it happening.

This article explains how to create CAPAs. You can also find information about the CAPA workflow and properties.

How do CAPAs integrate with other AODocs for Life Sciences processes?  
Create a CAPA
          New CAPA
          Routing
          Containment (CA only)
          Implementation plan
          Implementation review
          Implementation escalated 
          Pending change request
          Pending effectiveness review 
          Effectiveness review 
          Effectiveness escalated
          CAPA signoff
          Closed
The CAPA workflow
CAPA properties

How do CAPAs integrate with other AODocs for Life Sciences processes? 

Usually CAPAs are initiated from Audit Findings or a standalone Quality Events such as Customer Complaints or Incidents. For example, when you create an Audit Finding as a related item in an Audit, you can create a CAPA from the workflow within your Audit Finding, during the Investigation or Investigation review state. Information is pulled over from the Audit Finding directly into your CAPA.

Note: CAPAs are never related directly to Audits, only to Audit Findings.

You can also create standalone CAPAs.


Create a CAPA

Below is a description of how to create a CAPA. Each section corresponds to a different state in the workflow, corresponding to the lifecycle of a CAPA. Learn more: The CAPA workflow. You need to fill in properties throughout the workflow. You can consult the full list of CAPA properties.

Some properties are optional throughout the workflow. Others become mandatory during particular workflow states. You can fill in optional properties at any point. For example, when you create your CAPA, you may want to fill in all the properties that will become mandatory throughout the workflow.

In this description of how to create a CAPA, we assume you haven’t filled in properties in advance; we indicate whenever optional properties become mandatory as the document progresses through the CAPA workflow.

Note: Properties that are mandatory in a given workflow state are usually used during the following workflow state.

New CAPA

1. To create a standalone CAPA: as a member of the Collaborators group, on your library homepage, press New and select CAPA. An unsaved CAPA document opens.

Learn more from AODocs: Create documents from a template.

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To create a CAPA from an Audit Finding: select Create CAPA in the Investigation or Investigation review workflow state of your Audit Finding. An unsaved CAPA document opens.

2. In the unsaved CAPA document, fill in the mandatory property CAPA Title.

Learn more from AODocs: Edit custom properties.

3. Save your CAPA document.

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When you save your CAPA document:

  • it transitions to the Routing workflow state (if you haven’t yet defined the CAPA type)
  • the CAPA # property is filled in automatically with a reference number used to populate the title of your CAPA, along with the CAPA Title property
  • the Document Owner property is filled in automatically with the email address of the person who created the CAPA – learn more: CAPA properties

Routing

Your CAPA is in the Routing workflow state if you created your CAPA without defining the CAPA type property. Learn more: The CAPA workflow.

If you defined the CAPA type when you created your CAPA, you skip the Routing workflow state and transition directly to:

Note: If you created your CAPA using the workflow in an Audit Finding, the CAPA passes directly into the Routing workflow state and the following properties are filled in automatically:
CAPA title defaults to title of the Audit Finding
– The Audit team property in your CAPA is filled in with values from the Audit Team (if filled in) and the Lead Auditor properties in the Audit.

In the Routing workflow state, the CAPA type property is mandatory. Contributors see an orange warning sign indicating that there is at least one mandatory property that isn’t filled in.

Learn more from AODocs: Mandatory properties haven’t been filled in.

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1. Press the Edit button.

2. Click in the CAPA Type field and select either Corrective Action or Preventative Action.

3. Save your CAPA. It transitions to:

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Containment (CA only)

Your CAPA is in the Containment workflow state if you selected Corrective Action as the CAPA Type. Learn more: The CAPA workflow.

While your document is in the Containment workflow state, take the required actions to contain the issue identified by the CA. 

If Documents with attachments are added as related items, anyone with edit access can copy the attachments from the Documents into the Quality Event. To do this, open the custom action menu and select Copy related document attachments

Note: All attachments from all related Documents are copied. If you run the copy command again, all documents from all documents are copied again, which may create duplicates. 

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When the issue has been contained, use the workflow menu to indicate that the containment step is complete.

1. Press Containment and select Containment step complete.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.
The workflow transitions to the Implementation plan workflow state.

Learn more from AODocs: Perform workflow actions in a document.

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Implementation plan

Your CAPA is now in the Implementation plan workflow state. Learn more: The CAPA workflow.

 

Fill in the mandatory properties

In the Implementation plan workflow state, these properties are mandatory:

  • Reviewers
  • Implementation review due date

Learn more: CAPA properties.

Contributors see an orange warning sign indicating that there is at least one mandatory property that isn’t filled in.

Workflow participants see a message indicating that the workflow action is disabled until the mandatory properties are filled in.

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1. Press the Edit button.

2. Enter one or more people in the Reviewers field. Learn more: CAPA properties.

3. Enter a value in the Implementation review due date field. Learn more: CAPA properties.

4. Press Save. The workflow action is now available.

 

Create a Change Request from your CAPA

If you want to create a Change Request (CR) from your CAPA, activate the switch Create CR on implementation approval

Note: You can do this during the Implementation plan or any previous workflow state.

If required, add one or more effective Documents as related items in your CAPA. These are existing Documents that need to be updated.

Note: You can’t create new Documents as related items in your CAPA because you can only relate effective Documents to your CAPA. If you want to use your CR to create one or more new Documents, you can create them as related items from the CR once it has been created.

When you transition your CAPA from Implementation review to Pending change request, a related Change Request is created in your CAPA.

 

Send your implementation plan for review

While your CAPA document is in the Implementation plan workflow state, you need to develop a plan to deal with the issue raised by the CAPA. 

During the implementation plan, anyone with edit access can copy the attachments from related Documents into the CAPA.

When your implementation plan is complete, send it for review.

Learn more from AODocs: Add attachments.

1. Press Implementation plan and select Send for review.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit. The workflow transitions to the Implementation review workflow state.

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Implementation review

Your CAPA is now in the Implementation review workflow state. Learn more: The CAPA workflow.

 

Fill in the mandatory properties

In the Implementation review workflow state, the Effectiveness review due date property is mandatory. Learn more: CAPA properties.

Contributors see an orange warning sign indicating that there is at least one mandatory property that isn’t filled in.

Workflow participants see a message indicating that the workflow action is disabled until a contributor fills in the mandatory property.

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1. As a contributor, press the Edit button.

2. Enter a value in the Effectiveness review due date field. Learn more: CAPA properties.

3. Press Save. The workflow action is now available.

 

Review the implementation plan

During the implementation review, anyone with edit access can copy the attachments from related Documents into the CAPA.

1. As a reviewer, press Implementation review and select an option from the drop-down menu:

Notes:
– If you select Escalate, the property Escalation team must be filled in.
– If you select Reject, you must leave a comment in the Perform Workflow Action pop-up.
– If there are several reviewers defined, the CAPA transitions as soon as any one of the reviewers accepts, rejects or escalates the implementation plan.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.

image10.png

Implementation escalated

Your CAPA is in the Implementation escalated workflow state if you selected Escalate during the Implementation review. Learn more: The CAPA workflow.

During the implementation escalated workflow state, anyone with edit access can copy the attachments from related Documents into the CAPA.

Note: The Escalation team property must be filled in.

image11.png

As a member of the escalation team:

1. Handle the issue raised by the escalation.

2. Select Implementation review and then Send for review.

3. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.
The CAPA transitions back to the Implementation review workflow state.

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Pending change request

Your CAPA is in the Pending change request workflow state if the switch Create CR on implementation approval was active when the implementation review was approved. Learn more: Create a Change Request from your CAPA.

A related Change Request is automatically created in your CAPA during the transition to Pending change request. Any Documents you added as related items in your CAPA become related to the Change Request in your CAPA and draft versions of your related Documents are created so you can update them while the published versions remain visible to users. 

Learn more:

During the Pending change request workflow state:

1. Optionally, add one or more effective Documents as related items in your CAPA. These are existing Documents that need to be updated.

Note: You can’t create new Documents as related items in your CAPA because you can only relate effective Documents to your CAPA. If you want to use your CR to create one or more new Documents, you can create them as related items from the CR once it has been created.

2. Approve the change request: press Pending Change request and select Approve. Your CAPA transitions to the Pending effectiveness review workflow state.

 

Pending effectiveness review

Your CAPA is in the Pending effectiveness review workflow state if you selected:

Learn more: The CAPA workflow.

The Effectiveness review due date property defines the date at which you assess whether the actions defined in the implementation plan are effective. Your CAPA document stays in the Pending effectiveness review date until one day before the effectiveness review due date. At this point, it transitions to the Effectiveness review workflow state.

Effectiveness review

Your CAPA transitions to the Effectiveness review workflow state one day before the effectiveness review due date. Learn more: The CAPA workflow.

 

Fill in the mandatory properties

In the Effectiveness review workflow state, the Approvers property is mandatory. Learn more: CAPA properties.

Contributors see an orange warning sign indicating that there is at least one mandatory property that isn’t filled in.

Workflow participants see a message indicating that the workflow action is disabled until you fill in the mandatory property.

image13.png

1. Press the Edit button.

2. Enter one or more people in the Approvers field. Learn more: CAPA properties.

Note: You can only add users who are members of the Approval group in your library. Contact your library administrator if needed.

Important: You must define all approvers during or before the Effectiveness review workflow state. If you add approvers when your CAPA document has transitioned to CAPA signoff, they are not copied to the Pending approvers property, so they can’t perform CAPA signoff.

3. Press Save. The workflow action becomes available to the approvers.

 

Review the effectiveness review

1. As a reviewer, press Effectiveness review and select an option from the drop-down menu:

Notes:
– If you select Accept, the names of all the approvers are copied into the Pending approvers property when the CAPA transitions to CAPA signoff. Learn more: CAPA properties.
– If you select Escalate, the property Escalation team must be filled in.
– If you select Reject, you must leave a comment in the Perform Workflow Action pop-up
– If there are several reviewers defined, the CAPA transitions as soon as any one of the reviewers accepts, rejects or escalates the effectiveness review.

2. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit.

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Effectiveness escalated

Your CAPA is in the Effectiveness escalated workflow state if you selected Escalate during the Effectiveness review. Learn more: The CAPA workflow.

Note: The Escalation team property must be filled in.image15.png

 

When the CAPA has been escalated, as a member of the escalation team:

1. Handle the issue raised by the escalation.

2. Select Effectiveness escalated and then select:

3. If required, leave a comment in the Perform Workflow action pop-up. Then press Submit. The workflow transitions to the CAPA signoff workflow state.

 

CAPA signoff

Your CAPA is now in the CAPA signoff workflow state. Learn more: The CAPA workflow.

1. As an approver, open the custom action menu and select:

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  • Approve CAPA signoff to transition the CAPA to the Closed workflow state
  • Reject CAPA signoff to transition the CAPA to the Effectiveness review workflow state

Important: To approve or reject CAPA signoff, you must perform two-factor authentication via Duo.

Note: If there’s more than one approver defined, the CAPA:
– transitions to Closed only when all approvers have approved the CAPA signoff
– transitions to the Effectiveness review workflow state as soon as one reviewer rejects the CAPA signoff

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Closed

When all pending approvers have signed off the CAPA, it transitions to the Closed workflow state. The workflow for your CAPA is complete.


The CAPA workflow

The workflow below shows the states involved in creating a CAPA.
Learn more about the properties that need to be filled in at each state.

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CAPA properties

Below is a list of the properties available throughout the process of creating a CAPA.

Section Property Description Mandatory at which state in the CAPA workflow?
Top level of list of properties CAPA Title

Populates the title of your document when you save your document (along with the value of CAPA #).

If you initiated a CAPA from an Audit Finding, the CAPA Title property is automatically filled in with the title of the Audit Finding. Otherwise, fill in a value manually.

New CAPA
  CAPA #

Incremental reference number that is automatically generated and filled in. It’s used to populate the title of your CAPA (along with the value of CAPA Title) when you save it.

Note: If you change its value, it is overwritten with the automatically generated value.

N/A
  CAPA Type Select Corrective Action or Preventative Action from the drop-down list.

Routing

  Create CR on implementation approval Activate this switch to create a Change Request (CR) when the implementation review is approved. The CR is created as a related item in your CAPA. Always optional
  Audit Id

Filled in automatically when you initiate a CAPA from an Audit Finding (which is related to an Audit).

This property is hidden and read-only in your CAPA. Learn more from AODocs Configure custom property settings.

N/A
CAPA details Summary Summary of the CA or PA Always optional
  Containment details Description of the work that has been done or needs to be done to contain the issue. Always optional
Personnel Document Owner

Owner of the process.

You can define one or more people.

Filled in automatically with the email of the person who created the CAPA.

If you enter a different name during the CAPA creation phase (New CAPA), it is replaced with your name when you save the CAPA. However, you can choose a different name or add other names once the CAPA has been created.

Mandatory throughout the process. You can’t save a CAPA without the Document Owner property filled in.
  Implementation team The team that will work on the CA or PA.
You can define one or more people or groups.
Always optional
  Reviewers The names of the people who will review the work done by the implementation team.
You can define one or more reviewers.
Containment
  Approvers The names of the people who perform CAPA signoff.
You can define one or more approvers.
Effectiveness review
  Pending approvers

Filled in automatically during the transition from Effectiveness review to CAPA signoff.

Note: If you add approvers once the CAPA has transitioned to CAPA signoff, they aren’t transferred to the Pending approvers property and can’t perform CAPA signoff.

N/A
  Completed Approvals Filled in automatically when approvers accept the CAPA signoff, with the approver’s name and a timestamp. N/A
  Audit Team

Filled in automatically when you initiate a CAPA from an Audit Finding (which is related to an Audit). It is populated with the values of the Audit Team (if filled in) and Lead Auditor properties from the Audit.
You can’t edit this property manually.

Learn more: Quality Events.

N/A
  Escalation Team The CAPA can be escalated to this team for resolution. Mandatory only if a reviewer selects Escalated during the implementation review or the effectiveness review
Timeline Implementation review due date The date at which you assess whether the actions defined in the implementation plan are effective. Implementation plan
  Implementation review completed Filled in automatically with the date a reviewer approved the implementation review. N/A
  Effectiveness review due date

The date on which you assess whether the actions defined in the implementation plan are effective.

Fill in manually.

Implementation review
  CAPA closed Filled in automatically with the date the last approver signs off the CAPA.  

 

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