3.1 to 3.3 Documentation system
Food safety manual (3.1), document control with master list (3.2), records retention shelf life + 12 months (3.3)
Food Safety ManualDocument controlRecords management
3.4 · Internal audits
Fundamental
Program with at least 4 staggered audit dates (3.4.1), competent and independent auditors (3.4.2), reports with objective evidence (3.4.3), separate documented factory inspections, monthly for open product zones (3.4.4)
Internal audit programV9 audit checklistFactory inspection procedure
3.5.1 · Raw material/packaging suppliers
Fundamental
Documented raw material risk assessment updated every 3 years (3.5.1.1), risk-based approval procedure, GFSI certification, audit, or questionnaire (3.5.1.2), continuous performance monitoring (3.5.1.3), supplier database (3.5.1.4), traceability through agents/brokers (3.5.1.5-3.5.1.6)
Raw material risk assessmentSupplier approvalSupplier performanceSupplier database
3.5.2 to 3.5.4 Receiving, services, outsourced processing
Risk-based raw material receiving procedure (3.5.2), service provider management (3.5.3), approved and controlled outsourced processing (3.5.4)
Raw material receivingService providersOutsourced processing
3.6 · Specifications
Up-to-date specifications for raw materials / packaging / finished products, reviewed every 3 years (3.6.4)
Raw material specsFinished product specs
3.7 · Corrective actions
Fundamental
Procedure for management and correction with root cause analysis and preventive actions (3.7.1), documented investigation / evaluation / deadline / responsible / effectiveness verification (3.7.2)
CAPA procedureRoot cause analysis
3.8 · Nonconforming products
Identification, secure storage, documented disposition, traceability of nonconforming products (3.8.1)
Nonconformity control
3.9 · Traceability
Fundamental
Documented procedure (3.9.1), identification at every step (3.9.2), annual mass-balance test, traceability under 4 hours (3.9.3), traceability of rework (3.9.4)
Traceability procedureTraceability test
3.10 to 3.11 Complaints, incidents, withdrawal, recall
Complaints with trend analysis (3.10), incident procedure including cybersecurity (3.11.1), withdrawal/recall procedure (3.11.2), annual recall plan test (3.11.3), CB notification within 3 business days in case of incident (3.11.4)
Complaints managementIncident managementRecall procedureMock recall