Quality System Audit Readiness Form (ISO / Customer)

{ "Title": "Quality System Audit Readiness Form (ISO / Customer)", "IntroductionHtml": "

Use this form as a structured spot-check before a customer or ISO audit. Answer each checklist item, add concise evidence references, assign an owner for follow-up, and score the observed risk. This form saves a snapshot of readiness and captures actions so the team can fix gaps before an external inspection. This is a readiness tool, not a substitute for a certified audit or full QMS validation.

", "SubmitLabel": "Save Audit", "SuccessMessage": "Audit saved. You can return to add evidence, update corrective actions, or export the results.", "DataType": "QualitySystemAuditReadiness", "SchemaVersion": "1.0", "Fields": [ { "Key": "audit_date", "FieldType": "text", "Label": "Audit date", "HelpText": "Enter the date of the spot-check (YYYY-MM-DD)." }, { "Key": "auditor_names", "FieldType": "text", "Label": "Auditor(s)", "HelpText": "Who conducted the readiness check? Include names/roles." }, { "Key": "section_doc_ctrl_header", "FieldType": "textarea", "Label": "Section: Documentation & Control Plans — Notes", "HelpText": "Use this space for quick notes about the documentation environment before completing checklist items below." }, { "Key": "doc_qms_manual_current", "FieldType": "radio", "Label": "QMS manual or system documentation up-to-date and accessible", "HelpText": "Does the manual/process documentation reflect current practice and is it available to auditors?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial / some gaps"}, {"Value": "no", "Label": "No"} ] }, { "Key": "doc_control_plans", "FieldType": "radio", "Label": "Control plans (process/product) are defined and placed under change control", "HelpText": "Including key characteristics, control methods, and revision history.", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "doc_record_retention", "FieldType": "radio", "Label": "Records retention and retrieval processes appear adequate", "HelpText": "Can sample records be located quickly for the last 12 months?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "doc_notes", "FieldType": "textarea", "Label": "Documentation — evidence references and notes", "HelpText": "List filenames, folder locations, batch numbers, or other evidence references (no file upload here)." }, { "Key": "doc_owner", "FieldType": "select", "Label": "Owner for documentation follow-up", "HelpText": "Assign someone to fix gaps or collect missing evidence.", "Options": [ {"Value": "quality_manager", "Label": "Quality Manager"}, {"Value": "document_control", "Label": "Document Control"}, {"Value": "production_manager", "Label": "Production Manager"}, {"Value": "other", "Label": "Other (specify in notes)"} ] }, { "Key": "section_trace_header", "FieldType": "textarea", "Label": "Section: Traceability & Genealogy — Notes", "HelpText": "Quick notes before answering the traceability items below." }, { "Key": "trace_lot_genealogy", "FieldType": "radio", "Label": "Lot genealogy and inbound/outbound traceability demonstrable for sampled lots", "HelpText": "Can you trace raw materials to finished product and to customers for sampled lots?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial / some gaps"}, {"Value": "no", "Label": "No"} ] }, { "Key": "trace_serialization", "FieldType": "radio", "Label": "Serialized product or key identifiers are recorded and match system records", "HelpText": "Where serialization or unique IDs are required, are they consistent between label, system, and production records?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "trace_testlink", "FieldType": "radio", "Label": "Test/inspection results are linked to batch/lot records", "HelpText": "Are quality test records (e.g., incoming inspection, in-process checks, final tests) linked to the lot/batch?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "trace_notes", "FieldType": "textarea", "Label": "Traceability — evidence references and notes", "HelpText": "Record lot numbers, sample serials, system screens, or file names showing trace evidence." }, { "Key": "trace_owner", "FieldType": "select", "Label": "Owner for traceability follow-up", "Options": [ {"Value": "supply_chain", "Label": "Supply Chain"}, {"Value": "quality_engineer", "Label": "Quality Engineer"}, {"Value": "warehouse_mgr", "Label": "Warehouse/Receiving"}, {"Value": "other", "Label": "Other"} ] }, { "Key": "section_capa_header", "FieldType": "textarea", "Label": "Section: CAPA Lifecycle & Closure — Notes", "HelpText": "Context notes before completing CAPA checks." }, { "Key": "capa_open_clears", "FieldType": "radio", "Label": "Open CAPAs are documented with root cause analysis and defined corrective actions", "HelpText": "Check a sample of open CAPAs for RCA quality and assigned actions.", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "capa_timely_closure", "FieldType": "radio", "Label": "CAPAs show reasonable timeliness and evidence of effectiveness verification", "HelpText": "Are closures verified and is effectiveness documented?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "capa_trending", "FieldType": "radio", "Label": "Is there evidence CAPA outcomes are used in trending and preventive actions?", "HelpText": "Do CAPA results feed process improvements or risk mitigation?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "capa_notes", "FieldType": "textarea", "Label": "CAPA — evidence references and notes", "HelpText": "List CAPA IDs, system links, or supporting evidence." }, { "Key": "capa_owner", "FieldType": "select", "Label": "Owner for CAPA follow-up", "Options": [ {"Value": "quality_manager", "Label": "Quality Manager"}, {"Value": "continuous_improvement", "Label": "CI / Process Improvement"}, {"Value": "operations_manager", "Label": "Operations Manager"}, {"Value": "other", "Label": "Other"} ] }, { "Key": "section_training_header", "FieldType": "textarea", "Label": "Section: Training & Competency — Notes", "HelpText": "Quick context before answering training checks." }, { "Key": "training_matrix", "FieldType": "radio", "Label": "Training matrix exists and is current for sampled roles", "HelpText": "Is required training defined and assigned for key roles?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "training_records", "FieldType": "radio", "Label": "Training records for sampled employees are complete and signed", "HelpText": "Can you locate training completion records for recent hires and role changes?", "Options": [ {"Value": "yes", "Label": "Yes"}, {"Value": "partial", "Label": "Partial"}, {"Value": "no", "Label": "No"} ] }, { "Key": "training_notes", "FieldType": "textarea", "Label": "Training — evidence references and notes", "HelpText": "List training record IDs, locations, or who to contact for copies." }, { "Key": "training_owner", "FieldType": "select", "Label": "Owner for training follow-up", "Options": [ {"Value": "hr", "Label": "HR / Training"}, {"Value": "supervisor", "Label": "Supervisor / Shift Lead"}, {"Value": "quality", "Label": "Quality"}, {"Value": "other", "Label": "Other"} ] }, { "Key": "section_evidence_header", "FieldType": "textarea", "Label": "Section: Evidence Collection — Checklist", "HelpText": "Mark which core evidence items you were able to locate during the spot-check." }, { "Key": "evidence_qms_manual", "FieldType": "checkbox", "Label": "Found: QMS Manual or system home page", "Options": [ {"Value": "found", "Label": "Found"} ] }, { "Key": "evidence_control_plans", "FieldType": "checkbox", "Label": "Found: Control plans (sampled products)", "Options": [ {"Value": "found", "Label": "Found"} ] }, { "Key": "evidence_trace_records", "FieldType": "checkbox", "Label": "Found: Traceability records (sampled lots)", "Options": [ {"Value": "found", "Label": "Found"} ] }, { "Key": "evidence_capa_ids", "FieldType": "checkbox", "Label": "Found: CAPA records / closure evidence", "Options": [ {"Value": "found", "Label": "Found"} ] }, { "Key": "evidence_training_records", "FieldType": "checkbox", "Label": "Found: Training records for sampled staff", "Options": [ {"Value": "found", "Label": "Found"} ] }, { "Key": "evidence_other", "FieldType": "textarea", "Label": "Other evidence references", "HelpText": "List any other documents, screen shots, or file names you found." }, { "Key": "observed_overall_readiness", "FieldType": "scale", "Label": "Overall readiness score", "HelpText": "Rate overall readiness for a customer/ISO audit (1 = Not ready, 5 = Ready to host audit now).", "Scale": {"Min": 1, "Max": 5} }, { "Key": "top_findings", "FieldType": "textarea", "Label": "Top findings (concise list)", "HelpText": "Briefly list the highest priority observations that need action. Use bullets or numbered items." }, { "Key": "recommended_actions", "FieldType": "textarea", "Label": "Recommended immediate actions", "HelpText": "What should be done in the next 48–72 hours to reduce audit risk? Include owner and due date where possible." }, { "Key": "action_owner", "FieldType": "select", "Label": "Primary owner for recommended actions", "Options": [ {"Value": "quality_manager", "Label": "Quality Manager"}, {"Value": "plant_manager", "Label": "Plant/Operations Manager"}, {"Value": "document_control", "Label": "Document Control"}, {"Value": "training", "Label": "Training / HR"}, {"Value": "other", "Label": "Other"} ] }, { "Key": "follow_up_due", "FieldType": "text", "Label": "Follow-up target date", "HelpText": "Enter the date by which the owner should address the top findings (YYYY-MM-DD)." }, { "Key": "audit_signoff", "FieldType": "text", "Label": "Audit sign-off (name and role)", "HelpText": "Person who reviewed and accepted the readiness snapshot." } ] }