HACCP Establishment of Critical Limits Procedure
Part of Food Industry Hub’s FSQMS Policies and Procedures Suite.
The HACCP Establishment of Critical Limits Procedure forms part of the Food Industry Hub FSQMS Policies and Procedures Suite.
It defines how the HACCP Food Safety Team establishes, justifies, validates, reviews and updates critical limits for each Critical Control Point (CCP) identified within the HACCP food safety plan.
The procedure connects each CCP with measurable or objectively verifiable parameters, documented scientific or technical justification and validation evidence, providing a controlled basis for determining whether the CCP is under control.
Define measurable limits for each CCP
For each CCP, the HACCP Food Safety Team identifies the parameter or parameters that require control to ensure product safety. These may include time, temperature, pH, water activity, concentration, physical properties or other measurable criteria associated with effective hazard control.
Selected parameters must be measurable or otherwise objectively verifiable, directly linked to the significant hazard at the CCP, and consistent with process capability, product design and applicable legal or customer requirements. A specific critical limit is then defined in terms that are measurable, unambiguous and practical for production use.
Base critical limits on recognised evidence
Each critical limit requires documented justification showing that the selected value or criterion provides effective control of the identified significant hazard. Where a safe limit cannot be determined from direct internal data, the procedure provides for recognised sources such as scientific or technical publications, regulatory or legal limits, industry guidance, process authority documentation, customer specifications where appropriate, and historical process capability data.
The justification may also draw on process validation studies, expert opinion, equipment capability and validated processing conditions. This keeps the selected limit tied to evidence relevant to the hazard and the operating process rather than relying on convention alone.
Validate that the limit controls the identified hazard
The HACCP Food Safety Team is required to conduct or commission validation to confirm that each critical limit is effective in controlling the identified hazard. Depending on the CCP and process, validation may include challenge studies, heat penetration or thermal validation studies, laboratory analysis or modelling, controlled trials, confirmation of equipment performance, or review of authoritative references and regulatory data.
Validation is documented and retained as part of the HACCP documentation, creating a traceable basis for the critical limit and the evidence used to support it.
Keep critical limits valid when conditions change
Critical limits are reviewed at planned intervals and sooner where change may affect their validity. Review triggers include changes to products, recipes or raw materials; processing steps, equipment or layouts; legal or regulatory requirements; new scientific, technical or customer requirements; and findings from verification, validation or incident investigations.
Where a critical limit is updated, the change is controlled through the document control procedure. This maintains the relationship between the current HACCP plan, its critical limits and the supporting justification and validation evidence.
Allocate responsibility for establishment, approval and review
Technical or Quality Management leads the process for establishing, justifying and validating critical limits, ensures that the limits are based on appropriate scientific, technical, legislative or authoritative industry guidance, maintains the supporting controlled records, and initiates review when changes may affect validity.
The HACCP Food Safety Team identifies the parameters requiring critical limits, establishes measurable and objective limits, provides the supporting justification, conducts or commissions validation and reviews the limits when food-safety-relevant changes occur. Senior Management provides the necessary resources and technical support, ensures validated limits are implemented within the FSQMS and approves changes following formal review and validation.
Maintain the evidence behind critical-limit decisions
The procedure provides for records including CCP summary tables or HACCP worksheets, validation reports and supporting evidence, scientific or technical literature, regulatory references, change-control documentation and HACCP Food Safety Team review records.
Together, these records show the basis on which critical limits were selected, validated and subsequently reviewed, supporting technical oversight of one of the key control decisions within the HACCP plan.