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Chapter 7. Establish Critical Limits. Objective. In this module, you will learn: How to define critical limits How to set critical limits for a CCP How to find sources of critical limit information How to determine the relationship between critical limits and operating limits. Principle 3.
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Chapter 7 Establish Critical Limits
Objective In this module, you will learn: • How to define critical limits • How to set critical limits for a CCP • How to find sources of critical limit information • How to determine the relationship between critical limits and operating limits
Principle 3 • Establish critical limits
Critical Limit • A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food-safety hazard
Examples of Critical Limits Hazard CCP Critical Limit bacterial pasteurizer ≥161oF for ≥15 pathogens seconds (biological) for elimination of pathogens from milk
Examples of Critical Limits Hazard CCP Critical Limit bacterial drying drying schedule: pathogens oven oven temperature: 200oF (biological) drying time: 120 min. air flow rate: 2 ft3/min. product thickness: 0.5 inches (to achieve aw0.85 to control pathogens in dried foods)
Examples of Critical Limits Hazard CCP Critical Limit bacterial acidification Batch schedule: pathogens product weight: 100 lbs. (biological) soak time: 8 hours acetic acid concentration: 3.5% volume: 50 gallons (to achieve maximum pH of 4.6 to control Clostridium botulinum in pickled foods)
Sources of Information on Critical Limits General Source Examples scientific publications journal articles, food science texts, microbiology texts regulatory guidelines state and local guidelines, tolerances and action levels; USDA guidelines, tolerances and action levels; FDA guidelines, tolerances and action levels
Sources of Information on Critical Limits General Source Examples FDA FDA Fish and Fisheries Products Hazards and Controls Guidance Manual (referenced in Chapter 13)
Sources of Information on Critical Limits General Source Examples experts NACMCF (National Advisory Committee on Microbiological Criteria for Foods), thermal process authorities; consultants, food scientists/ microbiologists, equipment manufacturers, sanitarians, university extension, trade associations experimental studies In-house experiments; contract labs
Options for Controlling Hazards • Often a variety of options exist for controlling a particular hazard • The selection of the best control option and critical limit is often driven by practicality and experience
Monitoring for Pathogens at a Cook StepOption No. 1: Monitoring for Pathogens • Hazard • presence of pathogens (microbiological) • CCP • fryer • Critical Limit • no pathogens detected (Not typically the best option)
Monitoring for Pathogens at a Cook Step Option No. 2: Monitoring Internal Temperature • Hazard • presence of pathogens (microbiological) • CCP • fryer • Critical Limit • minimum internal temperature of 150oF for 1 minute
Monitoring for Pathogens at a Cook Step Option No. 3: Monitoring Factors That Affect Internal Temp. • Hazard • presence of pathogens (microbiological) • CCP • fryer • Critical Limits • minimum fryer oil temperature of 350oF • maximum patty thickness of 1/4 inch • minimum cook time in the oil of 1 minute
Operating Limits • Criteria that are more stringent than critical limits and that are used by an operator to reduce the risk of a deviation • Operating limits may be selected for various reasons: • For quality reasons • To avoid exceeding a critical limit • To account for normal variability
Process Adjustment • An action taken by the firm to bring the process back within operating limits
Operating Limit/Process Adjustment Example Cooker Temperature Operating Limit Process Adjustment Needed DegreesF Corrective Action Required Critical Limit Lot 1
Operating Limit/Process Adjustment Example Cooker Temperature Operating Limit Process Adjustment Needed DegreesF Corrective Action Required Critical Limit Lot 1 Lot 2 Lot 3 Lot 4 Lot 5
Establishment of Critical Limits Critical Control Point Critical Limits CCP Cooker Cook at 212oF for 3 minutes CCP - Weigh/Pack/Label All product containing sulfiting agent must declare presence
HACCP Plan Form: Critical Limits 1. CCP 2. Hazard 3. Critical Limits 4. 5. 6. 7. 8. Corrective Action(s) 9. Verification 10. Records What How Frequency Who Monitoring
HACCP Plan Form: Cooked Shrimp • Page 80