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Corrective and Preventive Actions address identified root causes and reduce the chance that quality problems recur. CAPA records connect accountable action planning with effectiveness review.

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CAPA Register

All CAPAs are shown with type (Corrective or Preventive), status, priority, linked deviations, and assigned owners. Focus on overdue CAPAs and work awaiting effectiveness verification, and preserve the source-deviation relationship where applicable.

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Action Planning

CAPA detail pages show the action plan, responsible owner, due dates, status, and linked deviation context. Write actions so their completion can be verified, assign clear owners, and align due dates with risk and product impact. Each new action needs an Action owner and a Due date. Use Edit owner / due date with a reason for change to update them; on a completed action, only missing values can be filled. Completing an action requires an evidence note, and the change is recorded in the audit trail.

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Effectiveness and Closure

Effectiveness dates identify when QA should verify whether the implemented action achieved its intended result. Effectiveness verification requires an independent approver and is blocked until the actions are complete. Final closure is also signed and is blocked until effectiveness is verified. The signed effectiveness step records a result of Effective or Not effective. Not effective returns the CAPA to In Progress without recording a passed result. An independent QA signer can also use Return to in progress on a Done CAPA. A linked CAPA cannot be created from a closed deviation.
A completed CAPA can be reopened for correction only with an independent signer and a reason for change. Preserve the original decision trail when adding corrective follow-up.

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Risk score (RPN) (where enabled)

Where CAPA risk scoring is enabled, the Risk score (RPN) section records Severity, Occurrence and Detectability, each from 1 to 10. Invariant calculates the RPN (severity × occurrence × detectability, 1 to 1000).
  • An Initial score records the risk before action.
  • A Residual score records the risk after action. It is available once the CAPA is Done and an initial score exists. The section then shows the risk reduction, or that risk went up.
Administrators, QA Managers and Reviewers can select Record assessment with a reason. Scores are append-only: a new score supersedes the previous one, and Assessment history keeps every score with its time, the CAPA status at scoring and the reason. Scoring is closed on a closed CAPA and after effectiveness is verified. A missing residual score does not block effectiveness verification.

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Scheduled effectiveness checks (where enabled)

Where scheduled effectiveness checks are enabled, moving a CAPA to Done asks Schedule a later effectiveness check? Choose a check date from tomorrow up to one year ahead, in your organization’s time zone, or verify effectiveness now. A scheduled CAPA shows Awaiting effectiveness check with its due date, marked Overdue once the date passes. Filter the CAPA list with Awaiting effectiveness check, or turn on Show CAPA effectiveness checks on the Quality Calendar. Where in-app notifications are enabled, the CAPA owner gets a reminder. Record the result through the usual signed effectiveness step. After a Not effective result, Raise a follow-on CAPA starts a new CAPA. The schedule is a reminder only. It does not change the closure and signature rules. For the end-to-end procedure, see Manage a CAPA.