CAPA Investigation & Verification Form

{ "Title": "CAPA Investigation & Verification Form", "IntroductionHtml": "

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.

", "SubmitLabel": "Submit CAPA", "SuccessMessage": "Thank you — your CAPA submission has been saved. A CAPA record will be assigned and owners notified where configured.", "DataType": "CAPAFormSubmission", "SchemaVersion": "1.0", "Fields": [ { "Key": "capa_id", "FieldType": "text", "Label": "CAPA ID (optional)", "HelpText": "Enter an existing CAPA number if this is an update. Leave blank to auto-assign.", "Required": false }, { "Key": "reported_by", "FieldType": "text", "Label": "Reported by (name)", "HelpText": "Who detected or reported the issue? Include name and role.", "Required": true }, { "Key": "detection_date", "FieldType": "text", "Label": "Date detected", "HelpText": "Use YYYY-MM-DD. If time is important, append HH:MM.", "Required": true }, { "Key": "detection_summary", "FieldType": "textarea", "Label": "Detection summary", "HelpText": "Brief description of the defect/nonconformance, where it occurred, and how it was discovered.", "Required": true }, { "Key": "immediate_containment", "FieldType": "textarea", "Label": "Immediate containment actions taken", "HelpText": "Describe actions taken to stop shipment/use, quarantine material, notify stakeholders, and any temporary controls. Include who executed containment and when.", "Required": true }, { "Key": "containment_complete", "FieldType": "yesno", "Label": "Is containment complete?", "HelpText": "Has the immediate containment been implemented and confirmed?", "Required": true }, { "Key": "containment_evidence", "FieldType": "textarea", "Label": "Containment evidence / references", "HelpText": "Reference photos, inspection records, quarantine tag IDs, or links to attachments stored elsewhere.", "Required": false }, { "Key": "rca_method", "FieldType": "select", "Label": "Root cause analysis method", "HelpText": "Choose the approach used for this investigation. Use supporting evidence in the RCA fields.", "Required": true, "Options": [ { "Value": "5whys", "Label": "5-Whys" }, { "Value": "fishbone", "Label": "Fishbone (Ishikawa)" }, { "Value": "fault_tree", "Label": "Fault Tree" }, { "Value": "other", "Label": "Other" } ] }, { "Key": "5why_why1", "FieldType": "textarea", "Label": "5-Whys: Why #1", "HelpText": "Start with the immediate cause. Use successive 'Why' fields to go deeper. If not using 5-Whys, leave blank.", "Required": false }, { "Key": "5why_why2", "FieldType": "textarea", "Label": "5-Whys: Why #2", "HelpText": "Second-level cause.", "Required": false }, { "Key": "5why_why3", "FieldType": "textarea", "Label": "5-Whys: Why #3", "HelpText": "Third-level cause.", "Required": false }, { "Key": "5why_why4", "FieldType": "textarea", "Label": "5-Whys: Why #4", "HelpText": "Fourth-level cause.", "Required": false }, { "Key": "5why_why5", "FieldType": "textarea", "Label": "5-Whys: Why #5", "HelpText": "Fifth-level (root) cause.", "Required": false }, { "Key": "fishbone_categories", "FieldType": "checkbox", "Label": "Fishbone categories considered", "HelpText": "Select applicable categories and add notes below.", "Required": false, "Options": [ { "Value": "man", "Label": "Man (People)" }, { "Value": "machine", "Label": "Machine (Equipment)" }, { "Value": "method", "Label": "Method (Process)" }, { "Value": "material", "Label": "Material" }, { "Value": "measurement", "Label": "Measurement (Inspection)" }, { "Value": "mother_nature", "Label": "Environment" } ] }, { "Key": "fishbone_notes", "FieldType": "textarea", "Label": "Fishbone analysis notes", "HelpText": "Summarize contributing causes found for selected categories.", "Required": false }, { "Key": "root_cause_summary", "FieldType": "textarea", "Label": "Root cause summary (evidence-based)", "HelpText": "Summarize the root cause(s) you concluded and cite evidence (test records, measurements, witness statements, logs).", "Required": true }, { "Key": "corrective_actions", "FieldType": "textarea", "Label": "Corrective / Preventive Action Plan (describe each action)", "HelpText": "Be specific: action, objective, what will change, and how it addresses the root cause. Use separate lines for multiple actions.", "Required": true }, { "Key": "action_owner", "FieldType": "text", "Label": "Owner(s) for corrective actions", "HelpText": "Name or role responsible for implementing the actions. If multiple, separate with commas.", "Required": true }, { "Key": "action_due_date", "FieldType": "text", "Label": "Target due date for actions", "HelpText": "Use YYYY-MM-DD. Ensure dates are realistic and prioritized by risk.", "Required": true }, { "Key": "verification_criteria", "FieldType": "textarea", "Label": "Verification criteria (how will you know the action worked?)", "HelpText": "Define objective, measurable evidence that will demonstrate the action prevented recurrence (e.g., test result thresholds, inspection frequency, KPI change).", "Required": true }, { "Key": "verification_method", "FieldType": "select", "Label": "Verification method", "HelpText": "Choose how verification will be performed.", "Required": true, "Options": [ { "Value": "inspection", "Label": "Inspection / Audit" }, { "Value": "test", "Label": "Test / Measurement" }, { "Value": "process_monitoring", "Label": "Process monitoring / SPC" }, { "Value": "training_check", "Label": "Training / competency check" }, { "Value": "other", "Label": "Other" } ] }, { "Key": "verification_due_date", "FieldType": "text", "Label": "Verification target date", "HelpText": "Use YYYY-MM-DD. Verification should be scheduled after actions are implemented.", "Required": true }, { "Key": "verification_result", "FieldType": "textarea", "Label": "Verification result / evidence", "HelpText": "After verification, summarize results and reference evidence (photos, inspection logs, SPC charts, test reports, names of verifiers).", "Required": false }, { "Key": "impact_scope", "FieldType": "textarea", "Label": "Impact assessment (scope of affected product/process/customers)", "HelpText": "Estimate affected lots, orders, customers, regulatory impact, or safety risk.", "Required": false }, { "Key": "severity", "FieldType": "scale", "Label": "Severity (1 = minor, 5 = critical)", "HelpText": "Assess the potential impact on safety, compliance, or customer use.", "Required": true }, { "Key": "final_closure_by", "FieldType": "text", "Label": "Prepared by (name) / Date", "HelpText": "Name of the person preparing this CAPA and date (YYYY-MM-DD).", "Required": true }, { "Key": "qa_signoff", "FieldType": "yesno", "Label": "QA verification complete (QA sign-off)", "HelpText": "QA should confirm that corrective actions were implemented and verification criteria met before closure.", "Required": true }, { "Key": "management_signoff", "FieldType": "yesno", "Label": "Management approval for closure", "HelpText": "Final approval that closes the CAPA and confirms no further action required.", "Required": true }, { "Key": "closure_notes", "FieldType": "textarea", "Label": "Closure notes / lessons learned", "HelpText": "Summarize what changed, what was learned, and any follow-up monitoring required.", "Required": false } ] }