HACCP

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Food Safety & Preventive Controls • GFSI Schemes • FDA/FSMA (21 CFR 117) • Distribution under GDP

HACCP (Hazard Analysis and Critical Control Points) is a structured, science-based method for identifying, evaluating, and controlling hazards that are significant for food safety across the end-to-end value stream—from Goods Receipt through storage and processing to packaging, distribution, and Finished Goods Release. Rooted in seven codified principles, HACCP forces organizations to enumerate biological, chemical (including allergens), and physical hazards; determine where control is critical; establish measurable limits and monitoring; define corrective actions, verification, and recordkeeping; and maintain the plan under formal change control. In modern, digitally connected facilities, HACCP is not a stand-alone binder but the backbone that informs electronic master design, execution interlocks, label content, traceability frameworks, and logistics rules such as FIFO/FEFO selection. A well-engineered plan connects laboratory data, Environmental Monitoring (EM), allergen segregation, hold-time limits, and labeling controls to tangible decisions at line speed, and then preserves the evidence with Data Integrity and audit trails that withstand regulatory inspection or customer audits under GFSI programs.

“HACCP works when the math meets the minute—when your limits and monitoring are tight enough to catch hazards before consumers do.”

1) What HACCP Is

HACCP is a preventive, process-centric approach rather than a product-end test program. It begins with a comprehensive hazard analysis of ingredients, packaging, process steps, environment, people, and equipment to identify where hazards could be introduced, increased, or fail to be controlled. Hazards include pathogens (e.g., Salmonella, Listeria), chemical hazards such as undeclared High-Risk Allergens or cleaning residues, and physical hazards such as metal fragments. From this analysis, the team determines Critical Control Points (CCPs)—steps where control is essential to prevent, eliminate, or reduce a hazard to an acceptable level. For each CCP, measurable critical limits are set (e.g., cook temperature-time, sieving mesh size, metal detector sensitivity, allergen swab thresholds), along with monitoring methods and frequencies, corrective actions if limits are breached, verification activities (calibration checks, independent review, proficiency testing), and robust recordkeeping requirements linked to master documents. Because hazards can emerge outside the core process, the plan also integrates Hold Time Study (HTS) outcomes for in-process holds, cross-contamination control for changeovers, expiration & shelf-life control logic, and supply chain protections such as tamper evidence and temperature control under Good Distribution Practice (GDP).

In the U.S. regulatory context, HACCP dovetails with the Food Safety Plan (FSP) requirements under FSMA (21 CFR 117). While the FSP uses “Preventive Controls” terminology (often called HARPC), its risk logic and documentation expectations align strongly with HACCP. Most high-performing sites harmonize the two so there’s a single source of truth, not competing documents.

Digital maturity matters. Paper HACCP looks fine until you try a real exception. Automated evidence capture, Dual Verification at decision points, Barcode Validation, and electronic records with audit trails determine whether you contain a problem in minutes or bleed margin and reputation for weeks.

2) The Seven HACCP Principles in Practice

1. Conduct a hazard analysis. Map the process (including receiving, storage, process, pack, ship) and list potential hazards for each step. Use EM data, supplier histories, consumer complaints, and recalls to sharpen likelihood and severity. Consider new risks introduced by automation, software, or label variants. Link findings to the Food Safety Plan framework (FSP), and to risk tools like FMEA for component-level analysis. Don’t overlook distribution risks (truck temps, mixed pallets) or information hazards (wrong label template).

2. Determine Critical Control Points (CCPs). Apply decision trees to distinguish CCPs from prerequisite controls. Typical CCPs include thermal lethality, metal detection/x-ray, allergen clean-to-validate between recipes, water activity controls, sieving/filtration, gas flushing, seal integrity, and label control points where an allergen declaration or date code is printed. When in doubt, examine detectability and severity: if failure could reasonably cause injury and you can measure control at that point, it’s a CCP.

3. Establish critical limits. Limits must be specific, validated, and measurable—time/temperature curves, detector settings with test pieces, ATP or ELISA thresholds for allergen verification, moisture/water activity bands, oxygen residual limits, maximum hold times from HTS, or label checksum rules bound to approved templates. For distribution, include temperature ranges and excursion durations. Link the limit to verification assets (calibration certs, Temperature Mapping studies) so auditors see the chain of logic.

4. Establish monitoring procedures. Define continuous or frequent checks using instruments, software events, or operator observations. Examples: PLC-captured thermal profiles, automated metal detector challenge frequencies, barcode scan-backs to confirm GS1/GTIN and lot alignment, vision systems for allergen statements (see Machine Vision Inspection), or warehouse rules enforcing FEFO. Monitoring records must be attributable and contemporaneous per ALCOA+.

5. Establish corrective actions. Pre-define actions for loss of control: hold affected lots, segregate product, rework or destroy, sanitize and re-validate, retrain, and investigate. Tie triggers to Hold & Release status transitions with documented authority and disposition logic. Ensure traceability to upstream components and downstream customers for rapid, targeted response. Prove readiness with scheduled Mock Recall events.

6. Establish verification procedures. Verify the plan design and its effective operation: validate thermal models and detector performance, conduct challenge studies, run proficiency tests, audit records, trend exceptions, and review EM and complaint data. Use independent QA review and internal audits to confirm control is sustained. Tie verification to CPV, Process Validation, and—when appropriate—Test Method Validation (TMV) for lab methods supporting decision points.

7. Establish recordkeeping and documentation. Define master templates, e-records, signatures, and retention. Connect CCP records to batch genealogy, label versions, equipment states, and calibration certificates, ensuring inspectors can find “who, what, when, why” quickly. Maintain version history under formal Document Control and route revisions through Change Control with CAPA linkages where nonconformances are systemic. If software is involved, treat it under CSV and Part 11 expectations.

3) HACCP vs. Prerequisite Programs

HACCP sits atop foundational programs that reduce baseline risk so that relatively few steps require CCP designation. These include supplier approval (Vendor Qualification, SQM), sanitation and Cleaning Validation, pest control, water/air quality, equipment maintenance and Qualification (IQ/OQ/PQ), calibration, personnel hygiene, allergen & cross-contamination control, EM, and labeling governance (see Label Verification). In digital operations, label accuracy and traceability are further supported by EPCIS event capture and standardized identifiers such as GTIN. Prerequisites should be risk-assessed and periodically verified; where a prerequisite alone cannot guarantee control of a significant hazard, promote the step to a CCP with explicit limits and monitoring.

4) Typical HACCP Hazards and CCP Examples

Biological. Pathogen reduction via validated cook/kill steps; prevention of post-lethality contamination using EM-informed zoning, airflow, and sanitation; control of growth through cooling, aw, pH, and time limits (HTS). Chemical. Undeclared allergens due to mis-labeling or changeover carryover; cleaning chemical residues; mycotoxins or heavy metals in raw materials; migration from packaging. Physical. Metal, glass, plastic fragments controlled by sieving, magnets, x-ray/metal detection with frequent challenge pieces; container/closure integrity and seal checks. Information hazards. While not traditional, label content and date codes represent a direct consumer risk; therefore, treat label template selection, variable data population, and scan-back as CCP-like controls where allergens or shelf life are safety-critical.

GFSI schemes (e.g., SQF and BRCGS) align with HACCP’s core logic and raise the bar on traceability outcomes. See SQF Edition 9 Traceability & Mass Balance and BRCGS Clause 3.9 Traceability for program expectations that directly influence hazard analysis and CCP selection.

5) Traceability, Labeling, and Distribution Interfaces

Rapid containment depends on precise genealogy and label accuracy. Use standardized keys (GTIN, lot, serial/SSCC) and event capture per EPCIS to connect ingredients to work-in-progress and finished goods. Enforce FIFO and FEFO at picking to reduce aging and spoilage risk. Treat label printing as an engineered step: bind approved templates to the product master, populate variables from controlled sources, verify via vision or barcode validation, and restrict reprints with audit trails. Distribution risks—temperature, tamper, mix-ups—are managed through GDP-aligned controls, scan points, and shipping QA checks, culminating in documented criteria for release.

FSMA 204 amplifies the urgency: define, capture, and retrieve Key Data Elements (KDEs) at Critical Tracking Events (CTEs). Map your HACCP flow to KDEs using FSMA 204 KDE; if you touch fresh produce, align with PTI labeling; for Canadian distribution, check CFIA SFCR linkage. For outbound logistics, include ASN data quality and case/pallet labels (see GS1-128 Case Label).

6) Governance, Data Integrity, and Review

HACCP effectiveness depends on governance as much as science. Plans must exist as controlled masters, with clear ownership, versioning, and training under Document Control. Monitoring records and decisions must satisfy ALCOA+ and be attributable to named individuals with e-signatures; computer-generated audit trails should capture creation, modification, and reason-for-change. Periodic review analyzes trends (EM excursions, detector failures, allergen near-misses, temperature excursions, complaint categories) to determine whether limits, CCPs, or prerequisites need revision. Revisions flow through Change Control with risk assessment and, where required, verification/validation before becoming effective. Systemic gaps—e.g., recurring mis-labels or persistent EM hot spots—progress to formal CAPA with effectiveness checks. Tie digital controls into GAMP 5 and Part 11 expectations for audit-ready records.

7) Metrics That Prove HACCP Works

Track right-first-time runs and CCP nonconformance rates per 10,000 units; time-to-containment for CCP failures; allergen mis-labeling near-misses; EM trend stability post-CAPA; detector challenge pass rates and missed challenge investigations; temperature excursion frequency and response time in storage/transport; review-by-exception workload (proportion of lots that trigger holds); and inspection retrieval time to present a complete package (HACCP plan version, CCP records, label scans, genealogy). Use SPC with appropriate control limits (e.g., X‑bar/R) to track CCP stability, and monitor process capability (Cp/Cpk) where measurement variation matters.

8) How HACCP Fits with V5

V5 by SG Systems Global embeds HACCP so that risk controls are executed automatically and evidence is created as a by-product of doing the work. In V5 MES, CCP logic is encoded in the eMMR and executed in the eBMR with device capture, timers, interlocks, and Dual Verification for critical decisions. In V5 WMS, FEFO/FIFO, Bin / Location segregation, and Hold & Release are enforced at scan points; Barcode Validation prevents wrong-item/lot/label; temperature and status checks block risky issues and shipments. Label control ties to approved templates with scan-back confirmation of GTIN, allergen statements, and date codes. In V5 QMS, HACCP masters live under Document Control; plan changes route via Change Control; exceptions open Deviations/NC with photos and reason codes; systemic issues become CAPA with effectiveness checks. EPCIS events and unit-level or lot-level identifiers provide fast, surgical tracebacks and targeted notifications in the rare event of a recall.

9) HACCP FAQ

Q1. How does HACCP relate to an FSMA Food Safety Plan (FSP)?
HACCP is the process-hazard backbone; the FSP expands it with Preventive Controls requirements (allergen, sanitation, supplier, process, recall) and supply-chain program elements. The two should be harmonized so controls are not duplicated or contradictory.

Q2. Are label controls part of HACCP?
If undeclared allergens or incorrect use instructions present a significant hazard, label control steps may be designated as CCPs or managed as rigorously verified prerequisites. Bind templates to masters and require scan-back and vision checks to prevent mis-labeling (see Label Verification and Machine Vision Inspection).

Q3. How often should we review the HACCP plan?
At least annually, and whenever there are significant changes: new formulations, equipment, suppliers, complaint trends, EM drifts, or recurring deviations. Changes should follow Change Control with verification before release. Tie major changes to validation or CPV as needed.

Q4. What evidence convinces auditors that HACCP is effective?
A clear line from plan to practice: calibrated instruments; CCP records with signatures and audit trails; rapid retrieval of genealogy and label scans; trend charts for challenges, EM, excursions, and corrective actions; closure evidence for related CAPAs; and demonstrated Mock Recall performance.

Q5. Where do distribution and transport fit?
Distribution risks are addressed via GDP-aligned controls and may be included as CCPs (e.g., cold-chain temperatures) or as verified logistics prerequisites. Use FEFO, temperature monitoring, tamper evidence, Temperature Mapping, and EPCIS event capture to keep risk low after the dock door. Leverage ASN and SSCC for outbound visibility.

10) HACCP Pitfalls and No‑BS Fixes

• Too many CCPs, not enough capability: If everything is a CCP, nothing is. Push routine hygiene and maintenance back into prerequisites, then prove CCP capability with Cp/Cpk or SPC evidence.
• Label chaos: Uncontrolled templates and reprints are how allergen recalls happen. Lock templates to masters, scan-back to item/lot, and use vision/barcode verification.
• EM fatigue: Trending without action is theater. Use EM trends to change sanitation frequencies, zoning, or airflow—then verify via CAPA effectiveness.
• Cold chain blind spots: Map routes, put loggers where it hurts, and define ≤ excursions per shipment with response times. See Temperature Mapping.
• Paper bottlenecks: If retrieval > 5 minutes, you’re not audit-ready. Move to e-records with audit trails and search by lot/CCP/event.
• Supplier drift: Re-approve on schedule. Tie quality agreements and VQ performance to incoming inspection frequency and Approval Workflow.
• Recall rehearsal gaps: Quarterly Mock Recalls with timed KDE pulls. If you can’t identify shipped lots and customers in 2 hours, fix EPCIS and labeling now.

11) HACCP vs. HARPC (FSMA 21 CFR 117) — Practical Alignment

HACCP language (hazard analysis, CCPs, critical limits) and FSMA’s Preventive Controls language (process, allergen, sanitation, supply-chain, recall) are 90% compatible. Keep a single integrated risk register; identify CCPs explicitly; mark other Preventive Controls as verified prerequisites with monitoring and corrective actions. Anchor terminology to your SOPs, Training Matrix, and master data. For Canada, add SFCR record elements; for produce, add PTI case/GTIN logic; and for cross-border distribution, ensure your EPCIS/ASN messages carry the right KDEs.

12) HACCP Implementation Checklist (Audit‑Ready)

• Process map with inputs/outputs, risks tied to VSM steps and work centers.
• Hazard analysis & risk ratings, linked to FMEA where component-level control is needed.
• Designated CCPs with validated limits (detector settings, lethality curves, aw/pH, label checks).
• Monitoring plan: frequencies, roles, devices, and GS1 scan points; define alert/action limits.
• Corrective action playbooks mapped to Hold & Release states and RCA.
• Verification plan: TMV, calibrations, CPV, and independent QA review cadence.
• Record model: e-signatures, audit trail, retention/archival, and retrieval SLAs.
• Traceability: EPCIS events, SSCC, ASN, and Recall Readiness drills.
• GFSI overlays: SQF & BRCGS clauses mapped to plan artifacts.

Related Reading
• Foundations & Programs: GFSI | Food Safety Plan (FSP) | Environmental Monitoring (EM) | High‑Risk Allergen | Cross‑Contamination Control | Cleaning Validation
• Execution & Records: eMMR | eBMR | Hold Time Study (HTS) | Hold & Release | Audit Trail (GxP) | Data Integrity (ALCOA+)
• Materials, Labels & Movement: Goods Receipt | FIFO | FEFO | GS1/GTIN | GS1-128 Case Label | EPCIS Traceability Standard | ASN | SSCC
• Governance & Integrity: Document Control | Change Control | CAPA | CSV | 21 CFR Part 11 | SOP | Training Matrix
• FSMA, GFSI & National Requirements: 21 CFR 117 | FSMA 204 KDE | PTI | CFIA SFCR | SQF Edition 9 | BRCGS Clause 3.9 | Food Defense (IA Rule)
• Risk & Validation: Process Validation | PPQ | TMV | SPC | Control Limits | X‑bar/R Charts
• Readiness & Response: Recall Readiness | Mock Recall | Finished Goods Release