CAPA Investigation & Containment Form

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

Use this form to record containment, investigation, root-cause analysis (RCA), corrective and preventive actions (CAPA), verification steps, and closure evidence. Provide clear owners, target dates, and verification criteria for every action. When adding actions, use the Actions template: Action | Owner | Due Date | Verification Criteria | Status.

", "SubmitLabel": "Save CAPA", "SuccessMessage": "CAPA submitted. A record has been saved for follow-up.", "DataType": "CAPARecord", "SchemaVersion": "1.0", "Fields": [ { "Key": "report_id", "FieldType": "text", "Label": "CAPA ID", "HelpText": "Unique identifier (or leave blank to auto-generate).", "Required": false }, { "Key": "report_date", "FieldType": "text", "Label": "Report date", "HelpText": "YYYY-MM-DD", "Required": true }, { "Key": "reported_by", "FieldType": "text", "Label": "Reported by", "HelpText": "Name and role of person reporting the issue.", "Required": true }, { "Key": "department", "FieldType": "text", "Label": "Department / Area", "Required": true }, { "Key": "location", "FieldType": "text", "Label": "Plant / Line / Workcell", "Required": false }, { "Key": "affected_product", "FieldType": "text", "Label": "Affected product / part", "Required": true }, { "Key": "impacted_lots", "FieldType": "textarea", "Label": "Impacted lots / serial numbers", "HelpText": "List lot numbers, serials, or batch identifiers separated by commas.", "Required": false }, { "Key": "defect_description", "FieldType": "textarea", "Label": "Defect / Nonconformance description", "HelpText": "Describe the defect, what happened, and immediate observations.", "Required": true }, { "Key": "initial_containment_actions", "FieldType": "textarea", "Label": "Initial containment actions taken", "HelpText": "What was done immediately to contain impact (e.g., quarantine, stop line, hold shipments). Include timestamps.", "Required": true }, { "Key": "containment_owner", "FieldType": "text", "Label": "Containment owner", "HelpText": "Name and role responsible for containment actions.", "Required": true }, { "Key": "containment_date", "FieldType": "text", "Label": "Containment date / time", "HelpText": "YYYY-MM-DD HH:MM (local time)", "Required": false }, { "Key": "impact_assessment", "FieldType": "select", "Label": "Impact assessment", "HelpText": "Select the best description of impact.", "Options": [ { "Label": "Customer affecting (shipment or safety)", "Value": "customer_affecting" }, { "Label": "Internal process impact only", "Value": "internal_only" }, { "Label": "Minor / Documentation", "Value": "minor" } ], "Required": true }, { "Key": "estimated_quantity", "FieldType": "number", "Label": "Estimated quantity impacted", "HelpText": "Number of units, pieces, or batches suspected to be affected.", "Required": false }, { "Key": "stop_shipment", "FieldType": "yesno", "Label": "Is shipment on hold?", "HelpText": "Yes if affected product shipments were stopped.", "Required": true }, { "Key": "quarantine_location", "FieldType": "text", "Label": "Quarantine location", "Required": false }, { "Key": "samples_taken", "FieldType": "yesno", "Label": "Were samples taken for analysis?", "Required": false }, { "Key": "sample_ids", "FieldType": "text", "Label": "Sample IDs", "HelpText": "Reference lab/sample identifiers if available.", "Required": false }, { "Key": "cross_functional_team", "FieldType": "textarea", "Label": "Investigation team / stakeholders", "HelpText": "Names and roles involved in the investigation.", "Required": true }, { "Key": "investigation_start_date", "FieldType": "text", "Label": "Investigation start date", "HelpText": "YYYY-MM-DD", "Required": true }, { "Key": "rca_method", "FieldType": "select", "Label": "Root-cause method", "Options": [ { "Label": "5-Whys", "Value": "5whys" }, { "Label": "Fishbone (Ishikawa)", "Value": "fishbone" }, { "Label": "FMEA", "Value": "fmea" }, { "Label": "Other", "Value": "other" } ], "Required": true }, { "Key": "rca_summary", "FieldType": "textarea", "Label": "Root cause analysis summary", "HelpText": "Concise summary of evidence, analysis steps, and findings.", "Required": true }, { "Key": "root_causes", "FieldType": "textarea", "Label": "Identified root causes", "HelpText": "List root causes and be specific about process, people, materials, equipment, environment, or system causes.", "Required": true }, { "Key": "corrective_actions", "FieldType": "textarea", "Label": "Corrective actions (to fix the problem)", "HelpText": "Use the Actions template: Action | Owner | Due Date | Verification Criteria | Status. Add one action per line.", "Required": true }, { "Key": "preventive_actions", "FieldType": "textarea", "Label": "Preventive actions (to prevent recurrence)", "HelpText": "Use the Actions template: Action | Owner | Due Date | Verification Criteria | Status.", "Required": true }, { "Key": "verification_plan", "FieldType": "textarea", "Label": "Verification plan", "HelpText": "How will you verify each action is completed and effective? Include metrics, sampling plan, or test methods.", "Required": true }, { "Key": "verification_owner", "FieldType": "text", "Label": "Verification owner", "Required": true }, { "Key": "verification_target_date", "FieldType": "text", "Label": "Verification target date", "HelpText": "YYYY-MM-DD", "Required": true }, { "Key": "closure_evidence", "FieldType": "textarea", "Label": "Closure evidence", "HelpText": "List documents, inspection reports, photos, test results, or records that demonstrate closure.", "Required": true }, { "Key": "lessons_learned", "FieldType": "textarea", "Label": "Lessons learned", "HelpText": "What should change in process, training, or controls to reduce recurrence and how will knowledge be shared?", "Required": false }, { "Key": "follow_up_audit", "FieldType": "yesno", "Label": "Schedule follow-up / audit?", "Required": false }, { "Key": "follow_up_audit_date", "FieldType": "text", "Label": "Follow-up audit date", "HelpText": "YYYY-MM-DD", "Required": false }, { "Key": "capa_status", "FieldType": "select", "Label": "CAPA status", "Options": [ { "Label": "Open", "Value": "open" }, { "Label": "In Progress", "Value": "in_progress" }, { "Label": "Verified", "Value": "verified" }, { "Label": "Closed", "Value": "closed" } ], "Required": true }, { "Key": "final_closure_date", "FieldType": "text", "Label": "Final closure date", "HelpText": "YYYY-MM-DD (populate when CAPA is closed)", "Required": false }, { "Key": "final_reviewer", "FieldType": "text", "Label": "Final reviewer / approver", "Required": false }, { "Key": "attachments_note", "FieldType": "textarea", "Label": "Attachments guidance", "HelpText": "Attach or reference evidence files in your system. If attachments are supported, include file IDs or links here.", "Required": false } ] }