HACCP Workflow

Codex Alimentarius HACCP  |  21 CFR Part 123 (Seafood)  |  21 CFR Part 120 (Juice)
21 CFR 123.6  ·  123.7  ·  123.8
21 CFR 120.8  ·  120.10  ·  120.11
A critical limit turns a significant hazard
into a measurable, enforceable control
Phase 1 - Preliminary Steps and Hazard Analysis
Phase 2 - Critical Control Points and Limits
Phase 3 - Plan Development and Validation
Phase 4 - Verification and Reassessment
Decision point
GMPify Procedural Map Series
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HACCP - A Systematic, Seven-Principle Approach to Controlling Food Safety Hazards

Hazard Analysis and Critical Control Points (HACCP) is a preventive system that identifies the hazards reasonably likely to occur in a food process and controls each significant one at a critical control point with a measurable critical limit. HACCP is mandatory under FDA regulation for seafood and juice processors, and it is the foundation for many customer, retailer, and GFSI scheme requirements. This map follows the Codex preliminary steps and seven principles from team formation through verification and reassessment.

Codex HACCP  ·  21 CFR Part 123  ·  21 CFR Part 120
21 CFR 123 Seafood
21 CFR 120 Juice
Codex HACCP

Critical Control Point

A step where control can be applied and is essential to prevent, eliminate, or reduce a significant hazard to an acceptable level.

Basis: Hazard analysis

Critical Limit

The maximum or minimum value, such as time, temperature, or pH, at which a hazard must be controlled at a CCP.

Basis: Scientific evidence

Prerequisite Programs

Foundational practices such as sanitation, pest control, and hygiene that support HACCP and control hazards not managed at a CCP.

Basis: Good manufacturing practice

Verification

Activities beyond monitoring that confirm the plan is valid, is being followed, and is controlling the hazards.

Basis: Evidence and review
Phase 1
Preliminary Steps and Hazard Analysis
1Assemble the HACCP team and confirm training
Multidisciplinary team formed with the product and process knowledge needed, and with the plan overseen by a trained individual.
Codex Step 1 · 21 CFR 123.10 · 120.13
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2Describe the product, intended use, and consumers
Product characteristics, packaging, storage, shelf life, and intended consumers documented, including vulnerable groups.
Codex Steps 2 and 3
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3Build and confirm the process flow diagram on site
Every step from receiving to shipping diagrammed, then walked on the floor to confirm it matches actual operation.
Codex Steps 4 and 5
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4Conduct the hazard analysis
Food safety hazards reasonably likely to occur identified at each step, with control measures listed for each (Principle 1).
21 CFR 123.6(a) · 120.7
Phase 2
Critical Control Points and Limits
Is control at this step essential for a significant hazard?
YES → Designate a CCP NO → Control by prerequisite program
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5Determine the critical control points
Each step where a significant hazard can be controlled, and where no later step will control it, identified as a CCP (Principle 2).
21 CFR 123.6(c)(2)
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6Establish critical limits for each CCP
Measurable limits, such as time, temperature, pH, or water activity, set from scientific evidence for every CCP (Principle 3).
21 CFR 123.6(c)(3)
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7Establish monitoring procedures
What is measured, how, how often, and by whom defined so a loss of control is detected in time to act (Principle 4).
21 CFR 123.6(c)(4)
Phase 3
Plan Development and Validation
8Establish corrective actions
Predefined responses to a deviation covering product disposition, cause correction, and a record of what was done (Principle 5).
21 CFR 123.7 · 120.10
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9Write the HACCP plan and recordkeeping system
Hazards, CCPs, critical limits, monitoring, corrective actions, verification, and records compiled in one signed plan (Principle 7).
21 CFR 123.6(c) · 123.9
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10Validate the HACCP plan
Scientific and technical evidence gathered showing the plan, as written, is capable of controlling the identified hazards.
Codex validation · 21 CFR 123.8 · 120.11
Phase 4
Verification and Reassessment
11Implement and verify ongoing performance
Calibration of monitoring instruments, product or in-process testing, and direct observation confirm the plan works (Principle 6).
21 CFR 123.8 · 120.11
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12Review monitoring and corrective action records
Records reviewed promptly, within one week under the seafood rule, and signed by a person who did not make them where practical.
21 CFR 123.8 · 123.9
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13Reassess the HACCP plan
Plan reassessed at least annually, and whenever a change, new hazard information, or a control failure could affect it.
21 CFR 123.8 · 120.11
The Seven HACCP Principles (Overview)

Principles 1 and 2 - Analyze

Conduct a hazard analysis, then determine the critical control points where significant hazards must be controlled.

Codex HACCP

Principles 3, 4 and 5 - Control

Establish critical limits, monitor each CCP against them, and define corrective actions for any deviation.

Codex HACCP

Principles 6 and 7 - Prove and Record

Verify that the system works as intended, and keep the documentation and records that demonstrate it.

Codex HACCP

Critical Limit Deviation Response (Overview)

Detect and stop A reading outside the critical limit is a deviation. Production at the CCP is stopped or the affected product is segregated.
Control the product Affected product is held and evaluated for safety, then released, reprocessed, diverted, or destroyed as the plan or evaluation dictates.
Correct the cause The reason for the deviation is found and fixed, and the CCP is confirmed back under control before production resumes.
Record and review The deviation, the product decision, and the corrective action are documented, and the plan is reviewed if the failure points to a design gap.

Key HACCP Plan Outputs (Overview)

Hazard analysis worksheet Hazards considered at each step, whether each is significant, the reasoning, and the control measure applied.
HACCP plan summary For each CCP: the hazard, critical limit, monitoring, corrective action, verification, and records in one view.
Monitoring and corrective action records Signed and dated evidence that each CCP was monitored and that deviations were handled as planned.
Verification and reassessment records Calibration, record review, testing results, and the documented reassessment of the plan.

HACCP Quality Elements

Team Competence Team members trained in HACCP principles and able to speak to the real product, process, and equipment.
Accurate Flow Diagram Process diagram confirmed on the floor, including rework loops, hold points, and all inputs and outputs.
Defensible Hazard Analysis Every hazard decision, significant or not, recorded with reasoning that an auditor can follow.
Justified CCP Selection CCPs chosen where control is essential and not duplicated by a later step, with the logic documented.
Science-Based Critical Limits Limits that are measurable, tied to published or validated evidence, and clearly stated for operators.
Reliable Monitoring Monitoring that is continuous or frequent enough, performed by trained people with calibrated instruments.
Predefined Corrective Actions Written responses covering product disposition, cause, and prevention so no one improvises under pressure.
Verification and Reassessment Discipline Scheduled calibration, record review, testing, and reassessment that actually happen and are documented.

Never do this

Draw the flow diagram from a desk without walking the line. Set a critical limit with no scientific basis. Pre-sign or back-fill monitoring records. Release product from a deviation without a documented safety evaluation. Skip reassessment after a process or ingredient change.

CCP vs prerequisite program

A CCP controls a significant hazard at a step with a critical limit that is monitored continuously or frequently. A prerequisite program, such as sanitation or pest control, creates the conditions for safe food and is managed by SOPs, not critical limits. Too many CCPs dilute attention from the few that truly matter.

Critical limit vs operating limit

A critical limit is the boundary where a deviation occurs and corrective action is mandatory. An operating limit is set tighter, inside the critical limit, so operators can adjust before a deviation happens. Operating limits are a good practice, but they are not a substitute for the critical limit.

Key regulations

Codex General Principles of Food Hygiene, HACCP Annex - the seven principles. 21 CFR Part 123 - seafood HACCP. 21 CFR Part 120 - juice HACCP. 9 CFR Part 417 - meat and poultry HACCP under USDA FSIS. 21 CFR Part 117 - preventive controls for other foods.

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