Run Corrective and Preventive Action (CAPA) Management Inspection — Free

CAPA Record Intake and Scope

CAPA record has a unique identifier and open date critical (required)

Yes No N/A

Issue source is documented critical (required)

Confirm the trigger is identified, such as non-conformance, audit finding, complaint, deviation, trend, or management review input.

Note (optional)

Problem statement is specific and measurable critical (required)

The issue description should define what happened, where it occurred, and the observed impact or risk.

Yes No N/A

Containment or immediate correction documented critical (required)

Verify interim controls were implemented to protect product, service, customer, or process integrity while root cause analysis was underway.

Yes No N/A

Risk or impact assessment completed

Confirm the record includes an assessment of product quality, patient/customer impact, safety, regulatory, or business risk as applicable.

Root Cause Analysis and Action Planning

Root cause analysis is documented critical (required)

Yes No N/A

Root cause is supported by objective evidence critical (required)

Evidence may include data review, process records, interviews, testing, trend analysis, or verification of contributing factors.

Yes No N/A

Contributing causes are identified where applicable

Check whether secondary causes, process gaps, human factors, equipment issues, or supplier inputs were evaluated.

Yes No N/A

Note (optional)

Corrective and preventive actions are defined separately critical (required)

Verify the plan distinguishes actions that fix the current issue from actions that prevent recurrence or similar issues elsewhere.

Yes No N/A

Action owners and due dates are assigned critical (required)

Each action should have a responsible owner and a realistic completion date.

Yes No N/A

Implementation and Verification of Completion

Corrective actions are completed on or before due date critical (required)

Yes No N/A

Preventive actions are completed on or before due date critical (required)

Yes No N/A

Implementation evidence is attached

Evidence may include revised procedures, training records, inspection results, calibration records, maintenance logs, or updated controls.

Note (optional)

Affected personnel were trained or informed where required

Verify training, communication, or competency updates were completed for impacted roles.

Yes No N/A

Implementation status is current and accurate

The CAPA record should reflect completed, in-progress, overdue, or canceled status with no unexplained gaps.

Effectiveness Verification

Effectiveness criteria are defined before closure critical (required)

Yes No N/A

Effectiveness check was performed after implementation critical (required)

Confirm the review occurred after enough time or production cycles to meaningfully assess the change.

Yes No N/A

Effectiveness evidence shows the issue did not recur critical (required)

Use objective evidence such as reduced defects, no repeat complaints, stable process metrics, or audit confirmation.

Residual risk is acceptable critical (required)

Confirm any remaining risk has been evaluated and accepted by the appropriate owner or authority.

Yes No N/A

Follow-up monitoring period is defined

If ongoing monitoring is needed, verify the duration, metric, and review owner are documented.

Note (optional)

Closure, Approval, and Record Control

Closure justification is documented critical (required)

The record should explain why the CAPA can be closed and reference the effectiveness evidence.

Yes No N/A

Closure approval obtained from authorized reviewer critical (required)

Verify the closure was approved by the designated quality owner, manager, or other authorized approver.

Note (optional)

CAPA status is updated to closed in the system critical (required)

Yes No N/A

Related documents and records are linked

Check that supporting records such as deviations, complaints, audits, training, and revised procedures are cross-referenced.

Note (optional)

Record retention and traceability requirements are met critical (required)

Verify the CAPA file is complete, legible, and retained per the applicable document control procedure.

Yes No N/A

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Run: Corrective and Preventive Action (CAPA) Management Inspection

CAPA Record Intake and Scope

Root Cause Analysis and Action Planning

Implementation and Verification of Completion

Effectiveness Verification

Closure, Approval, and Record Control

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