Guide

Manage a CAPA

A CAPA, corrective and preventive action, removes the root cause of a problem so it does not recur. This guide takes one from its first record to a signed closure: root cause analysis, an approved plan, implementation, and a verified effectiveness check, with the overdue and cancellation paths along the way.

Two approval gates, not one

A deviation or a nonconformity closes with a single signed approval. A CAPA has two. The plan is reviewed and approved in Plan review before implementation starts, and the closure is a separate signed approval in Closure after the effectiveness check. Reject either one and the CAPA drops back a step to be revised, not forward.

A CAPA moves through a fixed set of statuses from record to closure.

IDENTIFICATIONThe starting point once a CAPA is recorded. You can transition back here from any other status.

EVALUATIONCategory, priority, and impact assessment are underway.

ROOT CAUSE ANALYSISInvestigating why the problem happened. A CAPA has no immediate corrective action or disposition status: it comes straight here from evaluation.

PLANCorrective and preventive actions are being defined and linked as tasks.

PLAN REVIEWOut with the plan approvers, awaiting signatures. The first approval gate.

IMPLEMENTATIONThe plan is approved. The actions are being carried out.

EFFECTIVENESS CHECKThe actions are complete. Waiting to confirm the fix held.

CLOSUREOut with the closure approvers, awaiting signatures. The second approval gate.

CLOSURE REJECTA closure approver rejected. Use the Rework closure transition to return to Effectiveness check.

CLOSEDApproved and complete. Read-only. The only way back is to Identification.

CANCELEDWithdrawn by a Quality Events Administrator, from any status. Read-only, and the only way back is to Identification.

New to Quality Events? See Key concepts for the vocabulary used across every guide.

Record a CAPA

Open the CAPA space, click the Quality Events tab, then the CAPA sub-tab, and click + New CAPA.
You can also reach a CAPA from the space All work tab, filtered on the CAPA work type, or from the global view: open the Jira side menu, select Apps, then Quality Events, to see across every Quality Events space at once.
The CAPA space, on the Quality Events tab’s CAPA sub-tab, with summary panels, filters, and the CAPA table.
Select the CAPA (CAPA) space and the CAPA work type, then enter a summary and a description covering what happened, when, where, who was involved, how many units are affected, and how it was discovered.
The CAPA is created in Identification. You can transition back to it from any other status if you need to start over.
The create dialog, with the CAPA (CAPA) space, the CAPA work type, the initial status Identification, and the summary and description fields.
Choose a category such as Product, Process, Material, System, Regulatory, Documentation, Environmental, or Safety.
The category field, with Process already selected and Material being added from the list below it.
Assign the CAPA to the person responsible for it.
Once the CAPA is sufficiently documented, click Evaluate to move it from Identification to Evaluation.
Assignee and description are both required for this transition. A deviation or a nonconformity needs only the description, so a CAPA is stricter here.
The status menu, moving the CAPA from Identification to Evaluation.

Evaluate the CAPA

Frequency and impact are two independent scales, filled in during evaluation. Together they set the priority and the due date.

Frequency	How often this type of issue occurs
`Continuity`	Ongoing and happening all the time. Systemic and persistent.
`Frequently`	Regularly, or several times recently.
`Occasionally`	More than once, but not regularly.
`Rarely`	A first-time or isolated occurrence.

Impact	Severity of the consequence if it is not addressed
`Critical`	Patient safety risk, regulatory non-compliance, potential for a product recall.
`Important`	Significant quality or reliability risk. Could reach the customer. A regulatory finding is likely.
`Minor`	Limited impact, contained internally. No safety concern.
`Negligible`	Cosmetic or administrative. No effect on product quality or compliance.

Set the frequency.
The frequency field, with Continuity, Frequently, Occasionally, and Rarely listed as the options.
Set the impact.
The impact field, with Critical, Important, Minor, and Negligible listed as the options.
Set market surveillance to Pre-Market or Post-Market, then set the priority and the due date from the frequency and the impact together.
Priority and due date sit in the Details panel on the right of the record, not on the field tabs.
Link the trigger that surfaced the CAPA, a nonconformity, a deviation, or an audit finding.
The triggers tab, with a nonconformity already linked, and empty link fields for deviations and audit findings.
Fill in the evaluation with the impact on product quality, patient safety, process integrity, and regulatory compliance, the scope (how many units, and whether they have left the facility), and the severity.
The CAPA’s details tab, with the category set and the evaluation field filled in with the scope, impact, frequency, and patient safety assessment.
Click Analyse to move the CAPA from Evaluation to Root cause analysis.
Evaluation, category, and priority must all be filled in before you can make this move.
The status menu, moving the CAPA from Evaluation to Root cause analysis, with Cancel as the other option.

Analyze the root cause

Go to the Root cause analysis tab and document the investigation method (5-Why, Ishikawa, or another), the findings, and the root cause in the root cause analysis summary field.
You can do the analysis in a controlled document instead. If you do, link it in affected documents and still put the conclusion in root cause analysis summary, because that field is what the transition checks.
The root cause analysis tab, with a 5-Why analysis filled in under root cause analysis summary, and the frequency and impact fields below it.
Click Plan actions to move the CAPA from Root cause analysis to Plan.
Frequency, impact, root cause analysis summary, and priority must all be filled in before you can make this move.
The status menu, moving the CAPA from Root cause analysis to Plan, with Cancel as the other option.

Plan the actions

From the Implementation (CA/PA) tab, create or link the corrective actions and preventive actions the CAPA needs, as tasks.
A task has its own lifecycle, covered later in this guide, and every one of them must be completed before the CAPA can be closed.
The implementation tab, with one corrective action and two preventive actions linked, and search fields to link or create more.
Where it applies, link out: resulting changes to create or link a change, affected documents for a document revision, affected training requirements for a training requirement, affected risks for a risk assessment, and resulting concessions for a concession granted as a result of this CAPA.
The implementation tab’s link fields for resulting changes, affected documents, affected training requirements, affected risks, and resulting concessions, each still empty.
Fill in the verification, confirming that the tasks and actions were carried out: trainings scheduled or delivered, documents updated, and so on.
The verification field, filled in with confirmation that the tasks were completed and the documents and agreements updated.
Set the plan approvers, the users who will review and approve the plan.
The plan approvers field, with one approver set.
Click Proceed to Plan Review to move the CAPA from Plan to Plan review.
Verification, due date, and plan approvers must all be filled in before you can make this move.
The status menu, moving the CAPA from Plan to Plan review.

Review the plan

Every plan approver gets an email. Each of them approves separately.
As a plan approver, click Reject or Approve on the Approvals field, and add a comment if needed.
The approvals field, with an approval required label, a comment box, and Reject and Approve buttons.
Enter the one-time password sent to your email.
The one-time password is what records the signature, not the button click.
The signature dialog, prompting for the passcode received by email.
When every plan approver approves, the CAPA moves to Implementation on its own. If any one of them rejects, it drops back to Plan instead, where you revise the actions and re-route the plan for approval.

Check effectiveness

A hard gate before the effectiveness check

You can only move from Implementation to Effectiveness check once all actions are complete, including any linked changes, and every linked concession is approved. A linked change runs its own lifecycle and has to finish first.

Once every action, change, and concession clears, click Proceed to Effectiveness Check.
The status menu, moving the CAPA from Implementation to Effectiveness check, with Cancel as the other option.
Fill in the effectiveness check field.
An effectiveness check can take a long time, and the CAPA stays open while it runs. Set a due date for when it should be performed.
The closure tab, with the effectiveness check filled in against a four-week monitoring period, and the closure remarks still empty.
Set the closure approvers, the users who will approve the closure.
The closure approvers field, with one approver set.

Close the CAPA

Once the fields above are complete, click Close to move the CAPA from Effectiveness check to Closure.
Effectiveness check and closure approvers must both be filled in before you can make this move.
The status menu on a CAPA in Effectiveness check, with Close, Overdue, Revise plan, and Cancel as the options.
Fill in the closure remarks, summarizing the overall CAPA, any lessons learned, or a residual risk you are accepting.
The closure remarks field, filled in with a summary of the root cause fix and the effectiveness result.
Every closure approver gets an email and approves the same way as a plan approver: click Reject or Approve, add a comment if needed, then enter the one-time password sent to your email.
When every closure approver approves, the CAPA moves to Closed on its own.
A closed CAPA can no longer be edited. If it has to be reopened, the only route is back to Identification.
If any closure approver rejects, the CAPA moves to Closure reject instead. From there, use the Rework closure transition to return to Effectiveness check, revise the content or the actions, and re-route for approval.
This differs from a deviation or a nonconformity, where a rejected closure returns all the way to Identification.

Closed and Canceled both stop editing, though either can still be moved back to Identification, which is the only way back in.

Resume an overdue CAPA

Overdue applies at three separate points on a CAPA: Plan review, Effectiveness check, and Closure each have their own overdue status. When an approval runs past the configured period, an automated transition moves the CAPA to the matching overdue status and notifies whoever is configured to hear about it.

Open the CAPA once it has moved to Plan review overdue, Effectiveness check overdue, or Closure overdue.
The period, and who gets notified, are configured per project. See Set up Quality Events.
Investigate why the approval was not completed in time (an approver was unavailable, more information was needed, or an action is still outstanding), then document it in the overdue justification field.
The overdue justification field, filled in with the reason for the delay and a revised target completion date.
Check the due date. It resets automatically, so change it if the new date does not fit.
Click Justify & resume to return the CAPA to whichever status it came from and restart the approval cycle.
Overdue justification is required for this transition.
The status menu on a CAPA in Closure overdue, with Justify & resume moving it back to Closure.

Cancel a CAPA

Open the CAPA, in any status.
Click Cancel.
Only a user with the Quality Events Administrator role can do this. A canceled CAPA cannot be edited, and the only route back is to Identification.
The status menu on a CAPA in Root cause analysis, with Cancel available alongside Plan actions.

Track the actions with tasks

Open a task from the Tasks sub-tab on the space’s Quality Events tab, or click through from the CAPA’s corrective actions or preventive actions field.
The Tasks sub-tab on the Quality Events tab, with summary panels and a table listing each task and its status.
Assign the task, set a due date, set the type (Root cause analysis, Corrective action, or Preventive action), fill in the description with the scope and acceptance criteria, and set the approvers.
The task’s type field, with Corrective action, Preventive action, and Root cause analysis as the options, plus the corrects and prevents CAPA links and the approvers field.
The assignee clicks Start to move the task from To do to In progress.
The status menu on a task, with Start moving it from To do to In progress.
Once the work is done, fill in the verification field with the work performed and the outcome, then click Review.
Type and approvers are both required for this transition.
Each reviewer approves the same way as a CAPA closure: click Reject or Approve, then enter the one-time password sent by email.
Done is read-only. If rework is needed, the reviewer clicks Reject, which sends the task to Reopened. The assignee then clicks Restart to return it to In progress.
If a review sits too long, an automated transition moves the task to Overdue. Fill in overdue justification and click Justify & resume to return it to In review.
Canceling a task follows the same rule as canceling a CAPA: only a Quality Events Administrator can do it, from any status.