| Step 1 |
HACCP team formation: multidisciplinary skills, training, responsibilities |
Team formation
Composition sheet
Team training
Meeting register
Leader appointment
|
| Step 2 |
Product description: composition, physical-chemical and microbiological characteristics, shelf life, storage |
Product description
Physical-chemical
Microbiology
Use-by / Best-by dates
Packaging
|
| Step 3 |
Identification of intended use: target consumer, vulnerable populations, declared allergens |
Intended use
Vulnerable populations
Consumer instructions
Allergens
|
| Step 4 |
Process flow diagram development: all process steps, flows, zoning |
Flow diagram
Flow scheme
Zoning plan
Flow construction guide
|
| Step 5 |
On-site flow diagram verification: consistency between theory and field practice |
Verification procedure
Validation form
Deviation register
|
| Principle 1 |
Hazard analysis: biological, chemical, physical, allergens; severity × likelihood; control measures |
Hazard analysis
Step-by-step grid
Severity × likelihood
Significant hazards
Control measures
|
| Principle 2 |
CCP determination: application of the Codex decision tree, distinction between CCP / oPRP / PRP |
CCP determination
Decision tree
CCP / oPRP / PRP
CCP justification
CCP register
|
| Principle 3 |
Critical limits: measurable thresholds, scientific basis, regulatory references |
Critical limits
Per-CCP limit sheet
Scientific justification
Regulatory references
|
| Principle 4 |
CCP monitoring: monitoring plan, records, calibration of measurement instruments |
CCP monitoring
Record sheet
Monitoring schedule
Temperature register
Instrument calibration
|
| Principle 5 |
Corrective actions: critical limit deviation, product disposition, root cause analysis |
Corrective actions
Corrective action form
NC product disposition
Deviation register
Root cause analysis
|
| Principle 6 |
Verification: internal audit, control plan, annual review, HACCP plan reassessment |
HACCP verification
Internal audit plan
Audit checklist
Control plan
Annual review
|
| Principle 7 |
Documentation and records: documentation structure, records traceability, archiving |
HACCP manual
Document control
Master list
Records management
Archiving
|
| PRPs |
Hygiene prerequisite programs: premises, personnel, cleaning, pests, maintenance, water, waste |
Cleaning & sanitization plan
Personnel hygiene
Pest control
Maintenance
Waste management
Water potability
|
| Traceability |
Upstream / downstream traceability (FSMA 204 Food Traceability Rule), recall and withdrawal procedure, FDA Reportable Food Registry notification |
Lot traceability
Raw material receiving
Supplier specifications
Recall / withdrawal
Crisis communication
Mock recall
|
| Allergens |
Major allergen management (FDA Big 9 + EU 14 if exporting): cross-contact prevention, labeling, reinforced cleaning |
Allergen management
Per-product matrix
Cross-contact prevention
Labeling
Reinforced cleaning
|
| FSMA & FDA |
Additional US regulatory obligations: FDA facility registration (21 CFR 1.225), Food Safety Plan structure (21 CFR 117 Subpart C), applicable best practice guides, mandatory food safety manager certification |
FDA registration
Food Safety Plan
Reportable Food Registry
Food handler training
HACCP ↔ FSMA mapping
|
| Not included |
Site- and product-specific documents — which must be drafted case by case by your HACCP team according to your actual operation |
Final HACCP plan (per product / process)
Filled-in hazard analysis (per actual step)
CCPs identified on your real process
Product recipes and technical sheets
Site facility plans (specific to each site)
Filed and approved FDA registration
Results of your release analyses
|