CAPA intake, investigation & closure form

{"Title":"CAPA intake, investigation & closure form","IntroductionHtml":"

Purpose: Use this form as the single canonical CAPA record for each quality escape. Capture detection details, immediate containment, evidence, a structured root-cause investigation, corrective & preventive actions with owners and dates, verification evidence, and final closure sign-off. Complete required fields and attach supporting files where your site stores evidence. This record is intended to stop repeats, preserve traceability, and provide feedstock for audits and improvement metrics.

Tip: Be factual and link to objective evidence (measurements, images, test results, production records). If you need more action rows, create additional CAPA action entries or attach a supporting action plan document.

","SubmitLabel":"Submit CAPA","SuccessMessage":"CAPA submitted. The record will be used for traceability, assignment, and verification. You may update this record as actions progress.","DataType":"CAPARecord","SchemaVersion":1,"Fields":[{"Key":"issue_id","Label":"CAPA ID (if assigned)","FieldType":"text","Required":false,"HelpText":"Enter existing CAPA number if this is an update. Leave blank to auto-generate if your system assigns IDs."},{"Key":"date_reported","Label":"Date reported","FieldType":"text","Required":true,"HelpText":"Enter date in YYYY-MM-DD format."},{"Key":"reported_by","Label":"Reported by (name & role)","FieldType":"text","Required":true,"HelpText":"Person who detected or reported the issue."},{"Key":"location_process","Label":"Location / Process / Line","FieldType":"text","Required":true,"HelpText":"Where the defect or nonconformance occurred."},{"Key":"issue_summary","Label":"Issue summary (what happened)","FieldType":"textarea","Required":true,"HelpText":"Brief, objective summary describing the nonconformance, defect, or escape, including product/part numbers and batch/lot/serial if applicable."},{"Key":"immediate_containment_actions","Label":"Immediate containment actions taken","FieldType":"textarea","Required":true,"HelpText":"Describe steps taken to contain impact (stop line, quarantine material, notify customer, rework, hold shipments). Include who performed the action and when."},{"Key":"containment_effectiveness","Label":"Containment effectiveness","FieldType":"select","Required":true,"Options":[{"Value":"effective","Label":"Effective (stopped further escapes)"},{"Value":"partial","Label":"Partial (reduced impact but not fully stopped)"},{"Value":"ineffective","Label":"Ineffective (did not stop escapes)"}],"HelpText":"Select how well containment worked; this influences priority and verification needs."},{"Key":"customers_impacted","Label":"Customers impacted (if any)","FieldType":"text","Required":false,"HelpText":"List customer names, order numbers, or 'internal' if contained before shipping."},{"Key":"evidence_links_and_files","Label":"Evidence & data attachments (list links or filenames)","FieldType":"textarea","Required":false,"HelpText":"Specify filenames, shared-drive paths, or links to photos, test results, logs, or MES records. Use your organization's attachment workflow to store files and list them here for traceability."},{"Key":"rca_method","Label":"RCA method used","FieldType":"radio","Required":true,"Options":[{"Value":"5why","Label":"5 Whys"},{"Value":"fishbone","Label":"Fishbone / Ishikawa"},{"Value":"fault_tree","Label":"Fault tree analysis"},{"Value":"other","Label":"Other (describe below)"}],"HelpText":"Choose the investigation method you used."},{"Key":"rca_details","Label":"Root cause analysis details and evidence links","FieldType":"textarea","Required":true,"HelpText":"Record the evidence, timeline, and reasoning that led to the root cause statement(s). Link to specific data where possible (measurements, logs, sample analysis)."},{"Key":"root_cause_statement","Label":"Root cause statement (concise)","FieldType":"textarea","Required":true,"HelpText":"One or two sentences that state the proximate root cause(s) your investigation supports."},{"Key":"corrective_action_priority","Label":"Corrective / Preventive action priority","FieldType":"select","Required":true,"Options":[{"Value":"low","Label":"Low"},{"Value":"medium","Label":"Medium"},{"Value":"high","Label":"High"},{"Value":"critical","Label":"Critical"}],"HelpText":"Use your site's risk/priority criteria (safety, regulatory, customer impact, cost, repeatability)."},{"Key":"capa_owner","Label":"CAPA owner (overall)","FieldType":"text","Required":true,"HelpText":"Person accountable for coordinating actions, verification, and closure."},{"Key":"containment_owner","Label":"Containment owner","FieldType":"text","Required":true,"HelpText":"Person who owned the immediate containment activities."},{"Key":"action_1_description","Label":"Corrective/Preventive action #1 - description","FieldType":"textarea","Required":false,"HelpText":"Describe the action that will address the root cause."},{"Key":"action_1_owner","Label":"Action #1 owner","FieldType":"text","Required":false,"HelpText":"Who is responsible for completing this action."},{"Key":"action_1_target_date","Label":"Action #1 target date","FieldType":"text","Required":false,"HelpText":"YYYY-MM-DD"},{"Key":"action_1_verification","Label":"Action #1 verification method and acceptance criteria","FieldType":"textarea","Required":false,"HelpText":"How will you verify the action was effective? Define measurements, sampling plans, tests, or observation criteria."},{"Key":"action_2_description","Label":"Corrective/Preventive action #2 - description","FieldType":"textarea","Required":false,"HelpText":"Optional additional action."},{"Key":"action_2_owner","Label":"Action #2 owner","FieldType":"text","Required":false,"HelpText":""},{"Key":"action_2_target_date","Label":"Action #2 target date","FieldType":"text","Required":false,"HelpText":"YYYY-MM-DD"},{"Key":"action_2_verification","Label":"Action #2 verification method and acceptance criteria","FieldType":"textarea","Required":false,"HelpText":""},{"Key":"action_3_description","Label":"Corrective/Preventive action #3 - description","FieldType":"textarea","Required":false,"HelpText":"Optional additional action."},{"Key":"action_3_owner","Label":"Action #3 owner","FieldType":"text","Required":false,"HelpText":""},{"Key":"action_3_target_date","Label":"Action #3 target date","FieldType":"text","Required":false,"HelpText":"YYYY-MM-DD"},{"Key":"action_3_verification","Label":"Action #3 verification method and acceptance criteria","FieldType":"textarea","Required":false,"HelpText":""},{"Key":"verification_plan","Label":"Overall verification plan and monitoring (how will you confirm problem does not recur)","FieldType":"textarea","Required":true,"HelpText":"Define who will verify, what evidence will be collected, over what timeframe, and what success looks like."},{"Key":"verification_completed_date","Label":"Verification completion date","FieldType":"text","Required":false,"HelpText":"YYYY-MM-DD - date when verification was completed and accepted."},{"Key":"closure_checklist","Label":"Closure checklist (select items completed)","FieldType":"checkbox","Required":true,"Options":[{"Value":"containment_verified","Label":"Containment verified"},{"Value":"root_cause_confirmed","Label":"Root cause confirmed with evidence"},{"Value":"actions_completed","Label":"Corrective/preventive actions completed"},{"Value":"verification_passed","Label":"Verification passed to acceptance criteria"},{"Value":"documentation_updated","Label":"Process/work instructions updated as needed"},{"Value":"training_completed","Label":"Training or awareness activities completed"}],"HelpText":"All applicable items should be checked before sign-off."},{"Key":"closure_signoff_name","Label":"Closure sign-off (name & role)","FieldType":"text","Required":true,"HelpText":"Person authorized to accept closure evidence (e.g., QA manager)."},{"Key":"closure_signoff_date","Label":"Closure sign-off date","FieldType":"text","Required":true,"HelpText":"YYYY-MM-DD"},{"Key":"lessons_learned","Label":"Lessons learned and prevention opportunities","FieldType":"textarea","Required":false,"HelpText":"What changes will be shared to prevent similar issues? Consider process, supplier, design, inspection, or training changes."},{"Key":"related_nonconformances","Label":"Related nonconformances or CAPAs","FieldType":"text","Required":false,"HelpText":"List related CAPA IDs, NCRs, or audit findings."},{"Key":"follow_up_monitoring_required","Label":"Is follow-up monitoring required?","FieldType":"yesno","Required":true,"HelpText":"If yes, describe cadence and metrics in 'verification_plan' or attach a monitoring plan."},{"Key":"additional_comments","Label":"Additional comments","FieldType":"textarea","Required":false,"HelpText":"Any other relevant notes."}],"SubmitMethod":"POST","SubmitEndpoint":"/content/2616/submit"}