Skip to content

Corrective Actions (CAPA)

A CAPA in Qualio is a long-term action that addresses an NCR’s root cause. Every CAPA is bound to exactly one NCR and to one assignee inside your organisation. CAPAs map to ISO 9001:2015 clause 10.2 — Nonconformity and corrective action.

Qualio supports two action types on the same capa_actions table:

  • corrective — you fix a problem that already happened. Use this for the standard “supplier shipped wrong lot, change incoming inspection” case.
  • preventive — you act on a near-miss or trend before it produces a non-conformance. Use this when an NCR investigation surfaces a wider risk.

The type is a free choice at creation time. Both flow through the same lifecycle and timeline.

  1. Open the parent NCR and click + Add CAPA, or go to CAPA → New and pick the NCR from the picker. The NCR must belong to your organisation.

  2. Enter a title (≥3 chars) and an optional description and root cause. Root cause shows in the audit .docx, so capture the 5-Why or fishbone outcome here.

  3. Pick the action type (corrective or preventive).

  4. Assign an owner via the typeahead. The list is scoped to active members of your organisation; the selected user gets an email when you publish.

  5. Set a due date. CAPAs past their due date count toward your supplier risk score (15 points each, capped at 30).

  6. Click Publish CAPA. Status flips from draft to open and the assignee is notified.

draft ─► open ─► inProgress ─► pendingVerification ─► closed
  • draft — saved but not published. Excluded from quotas, dashboards, and analytics. See Drafts.
  • open — published; assignee has been notified.
  • inProgress — work has started; root cause analysis or change implementation underway.
  • pendingVerification — the assignee believes the action is complete and a reviewer must confirm.
  • closed — verified complete. closed_at is stamped automatically and starts the 30-day effectiveness clock.

Every status change is an audit event. The capa_updates table records the user, the old status, the new status, and a mandatory comment between 3 and 4000 characters. The check is enforced at the database level — the UI rejects empty comments and so does Postgres.

This means there is no silent “edit” of a CAPA’s state. Auditors get a clean, chronological story per CAPA: who moved it, when, why.

The CAPA detail page renders capa_updates in reverse chronological order. Each entry shows:

  • Author (email).
  • Status transition, e.g. inProgress → pendingVerification.
  • The comment.
  • Timestamp.

Comment-only entries (no status change) are allowed — use them to log a finding or a question without forcing a state move.

ISO 9001 clause 10.2.1 (e) asks you to review the effectiveness of corrective action. Qualio enforces this automatically:

  1. When a CAPA reaches closed, a trigger sets effectiveness_check_due_at = closed_at + 30 days.
  2. After that date, admins and editors see the CAPA in the Effectiveness queue.
  3. The verify_capa_effectiveness RPC records a rating and optional notes:
RatingMeaning
effectiveThe action resolved the root cause; no recurrence.
partially_effectiveImprovement seen, but residual risk remains. Open a follow-up CAPA.
ineffectiveProblem recurred or the action did not address the cause. Reopen or escalate.

Only closed CAPAs can be verified, and only by users with admin or editor role. Verifying stamps effectiveness_verified_at and effectiveness_verified_by for the audit trail.