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    HACCPHazard Analysis and Critical Control Points

    Definition

    Hazard Analysis and Critical Control Points — a structured approach to identifying, controlling and recording food-safety hazards.

    Editorial definition: The QHSE Standard, updated 3 October 2026 · https://qhsetech.com/glossary/haccp

    Scope: Specific legal requirements vary by jurisdiction, product and activity. A HACCP software label does not establish compliance.

    Sources checked: . Examples are editorial illustrations.

    What Regulation 852/2004 and FDA say about HACCP

    Hazard Analysis and Critical Control Points is a management system for food safety. FDA describes it as addressing biological, chemical and physical hazards from raw material production, procurement and handling through manufacturing, distribution and consumption of the finished product. FDA lists seven principles: conduct a hazard analysis, determine the critical control points, establish critical limits, establish monitoring procedures, establish corrective actions, establish verification procedures, and establish record-keeping and documentation procedures. Before applying them, its guidelines set five preliminary steps: assemble the team, describe the product, define its intended use, develop a flow diagram of the steps under the company's control, and verify the diagram on site.

    In the European Union, Article 5 of Regulation (EC) No 852/2004 requires food business operators to put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles, and lists the same seven in its own words. The last asks for documents and records commensurate with the nature and size of the business, and the operator reviews the procedure whenever the product, process or any step is modified. Article 5 applies to operators after primary production and the associated operations in Annex I. Operators give the competent authority evidence of compliance in the manner it requires, keep documents describing the procedures up to date and retain other records for an appropriate period. Article 5 also allows detailed arrangements that may include the use of guides on applying the principles. The Commission says the 2004 hygiene rules were adopted in April 2004 and became applicable on 1 January 2006.

    In the United States, FDA's HACCP page lists seafood and juice HACCP guidance, a voluntary programme for Grade A dairy and guidance for retail and food service. Verification goes beyond routine monitoring: FDA's guidelines describe initial validation of the plan, further validation after significant changes and periodic reviews. Which rules apply to a food business depends on the product, the activity and the jurisdiction, and a HACCP label on software does not establish compliance. This page is general information, not legal advice.

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    What a HACCP record holds in software

    • The team, product description, intended use and verified flow diagram, kept as versions.
    • A hazard analysis per step, with the hazard, whether it is significant and the control measure.
    • Critical control points with their critical limits, the monitoring method, the frequency and the responsible person.
    • Monitoring entries captured at the time of the check, with the reading, the person and the time.
    • Corrective actions linked to the deviation that caused them, including what happened to the affected product.
    • Verification and validation records, including the review made after any change to a product, process or step.
    • Document control for the plan and retention dates for the records.

    HACCP, a HACCP plan and the records that show it works

    A HACCP plan is a document, while Article 5 asks for a procedure that is put in place, implemented and maintained. The difference shows in the records: monitoring entries, corrective actions and verification show that the plan is in use. A certificate from a private scheme or a customer audit is a separate matter from the evidence an operator gives its competent authority.

    A hypothetical example: a cooking step with a new cut

    This scenario is invented and describes no real business. A small caterer prepares cooked chicken for chilled sandwiches. The team holds a product description, an intended use and a verified flow diagram. The hazard analysis marks survival of pathogens as significant at the cooking step, which is a critical control point with a critical limit set from the team's own validation, and monitoring is a probe reading on every batch, entered by the cook.

    When the caterer changes to a larger cut, the change record reopens the plan, because Article 5 asks for the procedure to be reviewed when the product, process or a step is modified. The team revisits the hazard analysis, repeats the validation of the cooking time and limit and updates the flow diagram. A later batch misses the limit. The cook records the deviation and holds the batch, and the record links the decision on the product to the corrective action and to the verification that the cause was dealt with.

    Common misunderstandings about HACCP

    • HACCP is not general cleanliness. It is hazard-specific: hazards, control points, limits, monitoring and corrective actions.
    • More control points are not better. The principles ask for control at the steps where it is essential, so a long list can hide the few that matter.
    • A plan is not enough. Article 5 asks for procedures to be put in place, implemented and maintained, with records commensurate with the business.
    • The rules are not identical everywhere. FDA lists separate seafood, juice, dairy and retail HACCP pages, while Article 5 applies to operators after primary production.
    • Verification is not monitoring. FDA's guidelines describe validation, validation after significant change and periodic review as work beyond routine monitoring.

    How HACCP relates to other glossary terms

    HACCP applies the general logic of hazard control to food.

    • SOP: the written instructions that sit under a control point.
    • FMEA: a failure mode method for designs and processes, while HACCP is specific to food safety hazards.
    • CAPA: the corrective action loop that deviations from a critical limit feed.
    • HIRA: the general idea of hazard identification and risk assessment that HACCP applies to food.

    Records and evidence that usually exist for HACCP

    • The HACCP plan with its team, product description and flow diagram.
    • The hazard analysis and the reasoning behind each control point.
    • Monitoring records for each critical control point.
    • Deviation and corrective action records, including product decisions.
    • Validation and verification records with dates.
    • Review records made after a change to a product, process or step.
    • Any guide on applying the principles that the operator relied on.

    What a software tool needs to capture for HACCP

    • A versioned plan with team, product description and flow diagram.
    • A hazard analysis table linked to process steps, with control measures and a control point flag.
    • Monitoring forms that show the critical limit and give a time-stamped pass or fail entry.
    • A deviation workflow that holds product and links the corrective action.
    • Review prompts when a product, process or step is changed.
    • Verification and validation records with dates and the person responsible.
    • Retention rules by record type and an export for the competent authority.

    Catalog profiles documenting HACCP or food safety workflows

    The list follows the HACCP or food safety rule. It does not show that a product models critical control points with limits and alarms, or meets any national food law, which should be tested with a real flow diagram.

    Same rule for every product: tagged “Food Safety”, “Quality Management”, “Audits & Inspections” or “Quality Inspection”, with a sourced HACCP or food safety capability in its record, or one the vendor stated to us, labelled as vendor-stated. Documented and conditional capabilities qualify; check the linked scope before treating a module as included.

    Tekmon pays for a sponsored placement (above); its place in this list follows the same rule as every entry. How lists are ordered

    All 4 matching profiles are shown. Documentation review, not hands-on testing or a claim of compliance.

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    Frequently asked questions

    Is HACCP legally required?

    It depends on the product and the place. Article 5 of EU Regulation 852/2004 requires operators after primary production to have procedures based on the principles, FDA's HACCP page lists separate seafood, juice, dairy and retail pages, and other products and jurisdictions differ.

    How many HACCP principles are there?

    Seven, in both the FDA list and Article 5: hazard analysis, critical control points, critical limits, monitoring, corrective actions, verification, and records and documentation.

    Does a small business need the same paperwork?

    Article 5 asks for documents and records commensurate with the nature and size of the food business, and allows guides on applying the principles. What a competent authority accepts is for that authority to say.

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