CAPAs

Overview

A CAPA (Corrective and Preventive Action) is the controlled record you use to fix a problem and stop it coming back. Each CAPA captures what happened, who owns it, a workflow of review steps to investigate and act on the issue, and a follow-up effectiveness check to confirm the fix actually worked. CAPAs can be raised on their own or spawned automatically from a Nonconformance, which carries over the title, site, department, and supplier so you do not have to retype them.

The CAPAs list page gives you at-a-glance stat cards (Open CAPAs, Overdue, Critical open, Closed this month), a search box, status/priority/type filters, and quick filter pills such as All open, My CAPAs, Critical, High, Overdue, Closed, and Cancelled.

Key concepts

Statuses

Status	What it means
Draft	Being set up. Editable, deletable, and not yet a permanent record.
Pending	Opened and active — the workflow is running and the CAPA is a controlled record.
Closed	Work is complete, signed off, and an effectiveness check is scheduled.
Cancelled	Stopped before completion, with a recorded reason.

Type, source, and priority

Field	Examples / values	Notes
CAPA Type	Corrective, Preventive (your configured types)	A corrective action fixes a problem that already happened; a preventive action stops a potential problem before it occurs.
Source	Nonconformance, Internal Audit, and other configured sources	Where the issue came from. A CAPA raised from a Nonconformance links back to it.
Priority	Low, Medium, High, Critical	Drives the Critical and High filters and stat cards.

Effectiveness check outcomes

Outcome	Meaning
Effective	The corrective and preventive actions are preventing the issue from recurring.
Not Effective	The fix did not hold; further action or a renewed check may be needed.

How to create a CAPA

1. On the CAPAs page, click Create CAPA.
2. Under Basic information, enter a Title and an optional rich-text Description. The panel shows similar existing records so you can avoid duplicates.
3. Under Classification, set the required fields: Site, Department, CAPA Type, Source, Priority, Initiated date, and Owner. Add an optional Due date.
4. To route review steps to an external party, pick a Supplier and tick Supplier-facing CAPA. (This is locked once the CAPA is opened.)
5. Under Workflow, choose the workflow version that will drive the review and action steps, then pick the reviewer for each step when prompted.
6. Click Submit. The CAPA is created in Draft with its own CAPA number.

tip

If you start a CAPA from a Nonconformance, the title, site, department, root cause category, and supplier details are pre-filled from that record.

How to open a CAPA

A Draft CAPA is a worksheet — nothing is running yet. To activate it:

1. Open the CAPA. As the owner, click Open CAPA.
2. Review the confirmation: opening starts the workflow, makes the CAPA a permanent audit record, and means it can no longer be deleted — only closed or cancelled.
3. Click Open CAPA to confirm. The status changes to Pending, the first workflow step becomes active, and reviewers receive their tasks.

To discard a CAPA you no longer need, use Delete while it is still in Draft.

How to investigate and complete actions

The workflow section on the CAPA page is where the investigation and actions happen.

1. Each workflow step represents a stage of the CAPA — for example investigation, root cause, corrective action, or preventive action — and is assigned to a reviewer.
2. Reviewers open their step, fill in any required form fields and comments, and submit it. Steps requiring a signature prompt for e-signature confirmation.
3. Stages can contain sub-tasks. The owner or step assignee can add a child task with its own name, description, due window, assignee, and form fields to break the work down further.
4. A step can be reassigned, skipped, or sent back for rework as needed.
5. The CAPA stays editable (title, description, dates) until it is closed.

note

A CAPA cannot be closed while any workflow step or sub-task is still open. The Close dialog tells you how many remain so you can complete, skip, or cancel them first.

How to close a CAPA

1. Open the CAPA and click Close CAPA (available to the owner while the CAPA is Pending).
2. The dialog confirms all workflow steps are complete. If any are open, finish them first.
3. Set the Effectiveness Check Date — choose a preset (30, 60, 90, 180, or 365 days from close) or pick a specific date. The industry default is 90 days.
4. Add optional Closure Comments summarising the action taken.
5. Click Sign & Close CAPA and confirm your identity with an e-signature. The status becomes Closed and a follow-up effectiveness check is scheduled.

How to verify effectiveness

After closure, the Effectiveness Check section tracks whether the fix worked. On the due date, a verification task is created for the CAPA owner.

1. Open the closed CAPA and, on the active check, click Verify.
2. Choose an Outcome — Effective or Not Effective.
3. Enter required Verification Notes describing what you checked.
4. Click Mark Complete and confirm with an e-signature.

If a check needs more time or another round of monitoring, it can be renewed with a new due date, and completed checks remain visible under History.

tip

Before closing, you can set the planned check interval directly in the Effectiveness Check section. This becomes the default preset in the Close dialog.

How to cancel a CAPA

If a Pending CAPA should not continue, click Cancel CAPA, enter a Reason, then Sign & Cancel CAPA and confirm with an e-signature. This aborts any in-progress workflow, records the reason, and sets the status to Cancelled.

Tips

• Use Print for a controlled copy and Audit Log to see the full timeline of the CAPA, its workflow steps, and its effectiveness checks in one place.
• From an open CAPA you can also start a linked Change Request when the fix requires a controlled change.