" %}
***
## Workflow Initiation
An action item can be initiated through either of the following triggers.
{% tabs %}
{% tab title="Triggered by User" %}
A user may manually initiate an action item when an activity requires formal assignment, execution, tracking, and review.
{% endtab %}
{% tab title="Triggered by Another Source" %}
An action item may also be initiated from another application in the system such as:
* **Quality Event**
* **CAPA**
* **Incident**
* **Complaint**
* **Risk**
* **Change Request**
* **Management Review**
* **Vigilance**
In these cases, the action item is linked to the originating record and becomes part of the associated workflow. The action is assigned to an owner and reviewer and progresses through execution, review, and closure at the appropriate stage of the originating workflow.
{% endtab %}
{% endtabs %}
***
## Workflow Stages
This workflow is organized into **six key stages**, each with specific roles and responsibilities.
{% hint style="success" %}
For detailed instructions on any stage, click the corresponding button.
{% endhint %}
{% stepper %}
{% step %}
### Create New Action
> **Performed By:** Action Creator (e.g., Department Manager, Project Manager, Product Owner)
**Responsibilities:**
* Identify the need for an action.
* Provide the necessary details (e.g., name, priority, due date, description).
* Specify the action type and configure the required details.
* Assign the appropriate owner and completion reviewer.
* Submit the action to initiate the workflow.
Create New Action
***
{% endstep %}
{% step %}
### Execute Action
#### :building: Internal Action
> **Performed By:** Assigned Action Owner
This path is used for actions managed internally within the organization.
**Responsibilities:**
* Accept or refuse the assigned action.
* Execute the required internal activities according to instructions and timelines.
* Update the action status and document findings, outcomes, and supporting evidence.
* Evaluate and document the effectiveness of the implemented action.
* Submit the completed action for review.
Execute Action
#### :truck: External or Supplier Action
> **Performed By:** Assigned Action Owner or Supplier Representative
This path is used for actions assigned to external parties or suppliers that do not require a Supplier Corrective Action Request (SCAR).
**Responsibilities:**
* Accept or refuse the assigned action.
* Execute the required external or supplier-related activities.
* Document findings, outcomes, and supporting evidence.
* Evaluate and document the effectiveness of the implemented action.
* Submit the completed action for review.
Execute Action (Not Internal)
#### :triangle-exclamation: Supplier Action with SCAR
> **Performed By:** Assigned Supplier Representative
If the action item involves a SCAR, the standard action execution is bypassed and the workflow integrates with the [SCAR Management](/interfacing-help-files/quality-managers/action-item-application/creating-and-managing-scars.md) workflow.
**Responsibilities:**
* Review the assigned SCAR.
* Investigate the issue.
* Document investigation findings, root causes, and corrective measures.
* Provide supporting evidence and required documentation.
* Submit your results for review.
Execute SCAR Investigation
***
{% endstep %}
{% step %}
### Manage Extension
This stage includes the **Extension Request Management** subprocess, which governs activities required to request, review, and apply additional time for action completion.
{% hint style="warning" %}
This stage is triggered only when additional time is requested to complete the action.
{% endhint %}
This workflow is organized into **two key stages**.
{% stepper %}
{% step %}
#### Request Extension for Action
> **Performed By:** Assigned Action Owner
**Responsibilities:**
* Initiate the extension request.
* Enter a proposed new due date and provide justification.
* Submit the request to initiate the workflow.
Request Extension
***
{% endstep %}
{% step %}
#### Approve or Reject Extension Request
> **Performed By:** Assigned Action Completion Reviewer
**Responsibilities:**
* Review the request and justification.
* Approve or reject the extension.
Approve or Reject Extension Request
***
{% endstep %}
{% endstepper %}
***
{% endstep %}
{% step %}
### Action Refused: Reassign, Send Back, or Close without Completion
> **Performed By:** Action Creator (e.g., Department Manager, Project Manager, Product Owner)
**Responsibilities:**
* Review the refused action and associated feedback.
* Update action details as needed.
* Take appropriate action:
* Reassign the action
* Return the action to the existing owner
* Close the action without completion when further work is not required or feasible
Action Refused: Reassign, Send Back, or Close without Completion
***
{% endstep %}
{% step %}
### Sign Off on Action
> **Performed By:** Assigned Action Completion Reviewer
**Responsibilities:**
* Review the completed action, findings, and supporting evidence.
* Verify that the action was executed correctly and effectively.
* Assess whether the implemented action resolved or mitigated the identified issue.
* Identify any remaining risks, deficiencies, or follow-up needs.
* Approve the action to close the workflow or reject it for re-execution.
Sign Off on Action
***
{% endstep %}
{% step %}
### Action Refused by Reviewer: Re-Execute Action
> **Performed By:** Assigned Action Owner
**Responsibilities:**
* Review reviewer feedback and identified deficiencies.
* Re-execute or revise the action as required.
* Update findings, evidence, effectiveness information, and related documentation.
* Respond to reviewer comments and provide clarifications where necessary.
* Resubmit the action for sign-off and approval.
Action Refused by Reviewer: Re-Execute Action
***
{% endstep %}
{% endstepper %}
***
---
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