Form

CAPA Investigation & Verification Form

A structured, interactive CAPA form to record detection, containment, evidence-based root cause analysis (5-Whys and fishbone prompts), corrective/preventive actions with owners and timelines, verification criteria and evidence, impact assessment, and formal closure sign-off.

Interactive Tool

CAPA Investigation & Verification Form

This form helps you capture a complete CAPA from detection through verified closure. Use it to record immediate containment, evidence-supported root cause analysis, corrective and preventive actions with clear owners and due dates, verification criteria and results, and final sign-off. Good CAPAs prevent repeat escapes — avoid paperwork-only entries by supplying evidence, owners, timelines, and verification steps.

Enter an existing CAPA number if this is an update. Leave blank to auto-assign.
Who detected or reported the issue? Include name and role.
Use YYYY-MM-DD. If time is important, append HH:MM.
Brief description of the defect/nonconformance, where it occurred, and how it was discovered.
Describe actions taken to stop shipment/use, quarantine material, notify stakeholders, and any temporary controls. Include who executed containment and when.
Has the immediate containment been implemented and confirmed?
Reference photos, inspection records, quarantine tag IDs, or links to attachments stored elsewhere.
Choose the approach used for this investigation. Use supporting evidence in the RCA fields.
Start with the immediate cause. Use successive 'Why' fields to go deeper. If not using 5-Whys, leave blank.
Second-level cause.
Third-level cause.
Fourth-level cause.
Fifth-level (root) cause.
Select applicable categories and add notes below.
Summarize contributing causes found for selected categories.
Summarize the root cause(s) you concluded and cite evidence (test records, measurements, witness statements, logs).
Be specific: action, objective, what will change, and how it addresses the root cause. Use separate lines for multiple actions.
Name or role responsible for implementing the actions. If multiple, separate with commas.
Use YYYY-MM-DD. Ensure dates are realistic and prioritized by risk.
Define objective, measurable evidence that will demonstrate the action prevented recurrence (e.g., test result thresholds, inspection frequency, KPI change).
Choose how verification will be performed.
Use YYYY-MM-DD. Verification should be scheduled after actions are implemented.
After verification, summarize results and reference evidence (photos, inspection logs, SPC charts, test reports, names of verifiers).
Estimate affected lots, orders, customers, regulatory impact, or safety risk.
Assess the potential impact on safety, compliance, or customer use.
1.0 10.0
Name of the person preparing this CAPA and date (YYYY-MM-DD).
QA should confirm that corrective actions were implemented and verification criteria met before closure.
Final approval that closes the CAPA and confirms no further action required.
Summarize what changed, what was learned, and any follow-up monitoring required.
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