HACCP, USDA, FDA FSMA & GFSI (SQF/BRCGS) Quality Compliance
Preventive Controls Protocol: This audit form must be executed across every processing shift. Out-of-Specification (OOS) critical control point limits, metal detector failures, or sanitation breaches require immediate product hold, quarantine, and corrective action logging.
1. FACILITY & PROCESSING LINE METADATA FDA FSMA / USDA 9 CFR
Plant / Processing Facility Name
Processing Line / Zone ID
Audit Date
Shift
Lead FSQA Auditor Name
Plant Sanitation Manager
HACCP Plan Version
2. SANITATION STANDARD OPERATING PROCEDURES (SSOP) & HYGIENE FDA 21 CFR 117.135
Item # | Audit Parameter & Compliance Standard | Field Reading / Limits | Pass | Fail | N/A | Ref ID | ||
|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | ||
1 | 2.1 | Pre-Operational ATP Surface Swabbing: Contact surfaces verified < 30 RLU prior to line startup. | ||||||
2 | 2.2 | Environmental Listeria / Salmonella Swabs: Zone 1-3 environmental monitoring sampling executed per schedule. | ||||||
3 | 2.3 | Drain Sanitation & Backflow Prevention: Drains free-flowing, disinfected, with intact air gaps and traps. | ||||||
4 | 2.4 | Integrated Pest Management (IPM): Traps, bait stations, and insect light traps intact; zero activity recorded. |
3. RECEIVING, COLD CHAIN & ALLERGEN SEGREGATION USDA / SQF Ed. 9
Item # | Audit Parameter & Compliance Standard | Target Standard | Pass | Fail | N/A | Ref ID | ||
|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | ||
1 | 3.1 | Raw Material Cold Chain Receiving: Perishable refrigerated ingredients received at or below 4.0°C (40°F). | ||||||
2 | 3.2 | Major Allergen Storage Segregation: Milk, soy, peanuts, wheat, eggs, sesame stored in color-coded racks. | ||||||
3 | 3.3 | Packaging Integrity & COA Verification: Food contact packaging sealed; Certificate of Analysis attached. |
4. CRITICAL CONTROL POINTS (CCP): THERMAL & FOREIGN MATERIAL Mandatory HACCP Checks
Item # | Audit Parameter & Compliance Standard | Logged Value | Pass | Fail | N/A | Ref ID | ||
|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | ||
1 | 4.1 | CCP 1 - Thermal Pasteurization / Cooking: Product core temp maintained ≥ 74.0°C (165°F) for 15+ seconds. | ||||||
2 | 4.2 | CCP 2 - Metal Detector Sensitivity Challenge: Rejection arm tested with Fe (1.5mm), Non-Fe (2.0mm), SS (2.5mm) test wands. | ||||||
3 | 4.3 | CCP 3 - X-Ray Foreign Object Inspection: High-density glass and bone particulate rejection verified every 2 hours. | ||||||
4 | 4.4 | Rapid Chilling / Blast Freezing: Internal product temp reduced from 60°C to 4°C within 6 hours. |
5. CLEAN-IN-PLACE (CIP) & POTABLE WATER INTEGRITY EPA / FDA 21 CFR 129
Item # | Audit Parameter & Compliance Standard | Recorded Value | Pass | Fail | N/A | Ref ID | ||
|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | ||
1 | 5.1 | CIP Caustic Wash Wash Temperature & Conc.: Sodium hydroxide solution maintained at 1.8-2.2% conc @ 75°C. | ||||||
2 | 5.2 | Sanitizer Contact & Final Rinse Clearance: Peracetic acid (PAA) 150-200 ppm; zero caustic residue post-rinse. | ||||||
3 | 5.3 | Potable Water Chlorination / UV Disinfection: Process water residual free chlorine 0.5 - 2.0 mg/L or UV dose > 40 mJ/cm². |
6. PERSONNEL HYGIENE, PPE & HEALTH CONTROLS FDA 21 CFR 117.10
Item # | Audit Parameter & Compliance Standard | Verification Method | Pass | Fail | N/A | Ref ID | ||
|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | ||
1 | 6.1 | Handwashing Station Compliance: Automated hands-free sinks equipped with soap, 50°C water, paper towels, and sanitizer. | ||||||
2 | 6.2 | Personal Dress Code & Jewelry Restrictions: Hairnets, beard covers, frock coats worn; zero watches or rings present. |
7. CHEMICAL CONTROL & HAZARDOUS MATERIAL STORAGE OSHA / BRCGS Section 4.9
Item # | Audit Parameter & Compliance Standard | Inspection Finding | Pass | Fail | N/A | Ref ID | ||
|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | ||
1 | 7.1 | Approved Food-Grade Lubricants (NSF H1): All production line greases and hydraulic fluids food-grade certified. | ||||||
2 | 7.2 | Sanitation Chemical Storage Cage: Concentrated acids/alkalis locked separately with SDS charts posted. |
8. DEFICIENCY LOG & CORRECTIVE / PREVENTIVE ACTION (CAPA) Mandatory Remediation
Ref ID | Deficiency / Food Safety Non-Conformance | Required CAPA Plan | Assigned Lead | Target Date | ||
|---|---|---|---|---|---|---|
A | B | C | D | E | ||
1 | ||||||
2 | ||||||
3 | ||||||
4 |
9. QUANTITATIVE AUDIT TALLY & COMPLIANCE MATRIX GFSI Scoring System
AUDIT SCORE CALCULATIONS
Total Food Safety Checkpoints Evaluated
Full Compliance Score (Pass)
Identified Non-Compliances (Fail)
Calculated Food Safety Compliance Score
Audit Approval Status
LEAD FSQA AUDITOR
I verify that I have inspected this processing facility in accordance with USDA, FDA FSMA, and internal HACCP food safety standards.
Signature
PLANT OPERATIONS MANAGER
I approve the findings, acknowledge the provisional status, and confirm initiation of the assigned CAPA containment items.
Signature
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