metadata:
organization: "Precision Manufacturing Corp"
facility: "Plant A - Austin, TX"
certifications:
- "ISO 9001:2015"
- "ISO 13485:2016"
- "IATF 16949:2016"
- "AS9100D"
last_audit: "2023-11-15"
next_audit: "2024-11-15"
product_lines:
medical_devices:
class: "II"
regulatory_body: "FDA"
standard: "ISO 13485"
traceability: "lot_and_serial"
automotive:
tier: 1
customers: ["OEM_A", "OEM_B"]
standard: "IATF 16949"
traceability: "lot_based"
ppap_required: true
aerospace:
standard: "AS9100D"
traceability: "serial_number"
fai_required: true
inspection:
incoming:
sampling_plan: "ANSI/ASQ Z1.4"
aql_critical: 0.065
aql_major: 0.25
aql_minor: 1.0
skip_lot_allowed: false
in_process:
frequency: "per_operation"
statistical_process_control: true
control_chart_type: "xbar_r"
sample_size: 5
final:
inspection_level: "II"
critical_100_percent: true
documentation_required: true
spc:
enabled: true
control_limits:
warning_sigma: 2
action_sigma: 3
rules:
- name: "rule_1"
description: "One point beyond 3-sigma"
action: "stop_production"
- name: "rule_2"
description: "8 points in a row on same side"
action: "investigate"
- name: "rule_3"
description: "6 points trending"
action: "adjust_process"
- name: "rule_4"
description: "2 of 3 points beyond 2-sigma"
action: "investigate"
reaction_plan:
out_of_control:
- stop_production
- quarantine_suspect_parts
- notify_quality_engineer
- root_cause_analysis
- corrective_action
non_conformance:
severity_levels:
critical:
description: "Safety or regulatory violation"
containment_hours: 4
disposition_authority: "quality_director"
customer_notification: true
major:
description: "Does not meet specification"
containment_hours: 24
disposition_authority: "quality_manager"
customer_notification: "if_shipped"
minor:
description: "Cosmetic or documentation"
containment_hours: 72
disposition_authority: "quality_engineer"
customer_notification: false
disposition_options:
- use_as_is
- rework
- repair
- scrap
- return_to_supplier
mrb_review:
required_for: ["critical", "major"]
members:
- quality_manager
- engineering_manager
- production_manager
documentation: "required"
calibration:
schedule:
critical_equipment_months: 6
standard_equipment_months: 12
traceability: "NIST"
out_of_tolerance:
action: "quarantine_and_evaluate"
impact_assessment: "required"
customer_notification: "if_impact_confirmed"
supplier_quality:
approval_process:
- quality_system_audit
- first_article_inspection
- capability_study
- approval_committee_review
monitoring:
scorecard_frequency: "monthly"
metrics:
- ppm_defect_rate
- on_time_delivery
- corrective_action_response
risk_levels:
approved:
audit_frequency_years: 3
incoming_inspection: "reduced"
conditional:
audit_frequency_years: 1
incoming_inspection: "normal"
probation:
audit_frequency_months: 6
incoming_inspection: "tightened"
traceability:
requirements:
medical_device:
level: "unit"
retain_years: "device_life_plus_5"
automotive:
level: "lot"
retain_years: 15
aerospace:
level: "unit"
retain_years: "indefinite"
data_captured:
- raw_material_lot
- supplier_certificate
- operator_id
- machine_id
- process_parameters
- inspection_results
- ship_date
- customer_po
ai_assistance:
enabled: true
allowed_functions:
- defect_detection_vision
- spc_chart_analysis
- trend_prediction
- root_cause_suggestion
- document_verification
prohibited_functions:
- autonomous_disposition
- unsupervised_release
- specification_changes
human_oversight:
always_required_for:
- product_release
- non_conformance_disposition
- process_changes
- specification_deviations
document_control:
approval_matrix:
work_instructions:
author: "engineer"
approver: "manager"
specifications:
author: "engineer"
approver: "director"
quality_manual:
author: "quality_manager"
approver: "plant_manager"
revision_control:
method: "revision_letter"
obsolete_handling: "marked_and_retained"
distribution: "controlled"
training:
initial:
gmp_hours: 8
quality_system_hours: 4
job_specific: "varies"
refresher_frequency_years: 1
documentation:
records_retained_years: "employment_plus_3"
competency_assessment: "required"