Establishing Critical Limits for Each CCP
Aligned with HACCP Principle – Codex Alimentarius / 21 CFR 117.135(c)(3)
Requirement Overview
HACCP Principle 3 requires that critical limits be established for each Critical Control Point (CCP). A critical limit is a measurable value (e.g., time, temperature, pH) that must be met to ensure that a hazard is controlled at that CCP.
Failure to stay within a critical limit signals a loss of control, requiring immediate corrective action to protect food safety.
Critical limits are validated boundaries—not target values—that distinguish safe from unsafe conditions.
Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3
Requirement Overview
BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.
Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”
Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.
Key Compliance Objectives
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✓ Identify measurable limits that effectively control hazards
✓ Ensure each CCP has a scientifically validated critical limit
✓ Document the basis for each limit and the method of monitoring
✓ Maintain records of limit verification, deviation, and correction
Step-by-Step Compliance Implementation
1. Identify the Hazard at Each CCP
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Clarify what hazard (biological, chemical, physical) the CCP controls.
Example: Pathogen survival during cooking; allergen cross-contact.
Evidence to Maintain:
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• CCP decision tree documentation
• Hazard analysis summary
- • CCP decision tree documentation • Hazard analysis summary
2. Determine the Appropriate Critical Limit
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Define a specific measurable value or range that ensures control of the hazard.
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Types of Limits May Include:
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• Time/Temperature (e.g., 165°F for 15 seconds)
• pH or Water Activity (Aw)
• Concentration (e.g., sanitizer levels)
• Physical Parameters (e.g., metal detection sensitivity)
Evidence to Maintain:
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• Scientific or regulatory references (e.g., USDA, FDA, NACMCF)
• In-house validation studies
- • Time/Temperature (e.g., 165°F for 15 seconds) • pH or Water Activity (Aw) • Concentration (e.g., sanitizer levels) • Physical Parameters (e.g., metal detection sensitivity)
- • Scientific or regulatory references (e.g., USDA, FDA, NACMCF) • In-house validation studies
3. Document the Monitoring Method
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Clearly outline how each critical limit will be monitored in real-time or at a set frequency.
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Monitoring Details to Include:
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• What parameter is being measured
• Who is responsible for monitoring
• When and how monitoring will occur
• Tools used (e.g., thermometer, pH meter, test strips)
Evidence to Maintain:
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• Monitoring log sheets
• Equipment calibration records
- • What parameter is being measured • Who is responsible for monitoring • When and how monitoring will occur • Tools used (e.g., thermometer, pH meter, test strips)
- • Monitoring log sheets • Equipment calibration records
4. Set Acceptable Limits and Tolerances
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Ensure the limit leaves no room for ambiguity.
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Examples:
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• Acceptable: “Product must reach an internal temperature of ≥165°F for ≥15 seconds.”
• Unacceptable: “Product must be adequately cooked.”
Evidence to Maintain:
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• Signed CCP summaries
• Calibration SOPs
• CCP-specific work instructions
- • Acceptable: “Product must reach an internal temperature of ≥165°F for ≥15 seconds.” • Unacceptable: “Product must be adequately cooked.”
- • Signed CCP summaries • Calibration SOPs • CCP-specific work instructions
5. Link to Corrective Action and Verification
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Every critical limit must tie directly to the corrective action plan if the limit is not met.
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Evidence to Maintain:
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• Critical limits integrated into HACCP plan
• Corrective action procedures per CCP
• Verification records showing limits are consistently met
- • Critical limits integrated into HACCP plan • Corrective action procedures per CCP • Verification records showing limits are consistently met
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| Vague or undefined critical limits | Specify measurable values with units and duration |
| Critical limit not scientifically based | Reference validated sources or conduct internal validation |
| Monitoring lacks frequency or person | Assign responsibility and monitoring schedule |
| Limit not linked to corrective action | Connect every CCP limit to an appropriate correction response |