Heat Treated but Not Fully Cooked – Not Shelf Stable HACCP Process Category

Aligned with USDA-FSIS HACCP Requirements – 9 CFR Part 417

Requirement Overview

The HACCP Heat Treated but Not Fully Cooked – Not Shelf Stable Process Category applies to establishments producing products that are partially cooked, par-cooked, or heat-treated but require refrigeration or further cooking by the consumer, such as partially cooked sausages, hams, or poultry products. Under 9 CFR Part 417, establishments must implement CCPs to control hazards from pathogens like Salmonella, Listeria monocytogenes, and Clostridium perfringens.

Partial cooking reduces pathogen levels but does not eliminate all risks. Proper heat treatment, cold chain management, and handling procedures are critical to ensure product safety until final consumption.

Disclaimer: This content is for educational and compliance support purposes only and is not affiliated with or endorsed by USDA or FSIS. For official guidance, refer to the USDA FSIS website.

Key Compliance Objectives

  • ✓ Identify hazards specific to partially cooked, refrigerated products (Salmonella, Listeria, spoilage organisms)
  • ✓ Validate partial heat treatment and cooling procedures as CCPs
  • ✓ Monitor temperature, cross-contamination, and storage conditions
  • ✓ Maintain documentation for regulatory and third-party audits

Step-by-Step Compliance Implementation

1. Develop Partial-Cook HACCP Strategy

  • Core Hazard Areas:
  • • Insufficient heat treatment leading to survival of pathogens in partially cooked products
  • • Post-process contamination during handling, cooling, or packaging
  • • Improper cooling or temperature abuse during storage and distribution
  • Intervention Examples:
  • • Partial cooking validation using time–temperature verification to ensure safe internal temperatures are reached
  • • Rapid cooling protocols to suppress pathogen growth after partial heat treatment
  • • Physical separation of raw, partially cooked, and fully cooked areas to prevent cross-contamination
  • • Continuous monitoring of cold storage and transportation temperatures
  • Evidence to Maintain:
  • • Hazard analysis and CCP determination for partial cooking operations
  • • Process flow diagrams covering partial cooking, cooling, storage, and handling stages
  • • Cooking and cooling validation records demonstrating compliance with critical limits

  • Testing Frequency by Risk Level:

Risk Level Verification Method Recommended Frequency
High (e.g., peanut lines) ELISA + ATP testing After every cleaning cycle
Medium (shared lines) Visual + ATP Weekly
Low (dedicated equipment) Visual inspection only Monthly

  • Intervention Examples:
  • • Steam vacuum applications for localized removal of visible contamination on carcass surfaces
  • • Organic acid sprays (e.g., lactic or acetic acid) applied to reduce microbial load post-dressing
  • • Hot water pasteurization cabinets for whole-carcass thermal intervention prior to chilling

  • Evidence to Maintain:
  • • Hazard analysis documents detailing biological, chemical, and physical risks by product and process
  • • Process flow diagrams and decision trees showing CCP identification and control logic
  • • Scientific, regulatory, and industry supporting documents for intervention effectiveness and CCP selection

2. Validate Heat Treatment CCPs

  • Validation Protocol Should Include:
  • • Worst-case product sizes, thicknesses, and load conditions to determine the slowest heating profile
  • • Verification of internal temperatures and holding times to reach validated lethality targets
  • • Cooling rate verification to ensure products reach safe temperatures within defined critical time limits
  • • Calibration of thermometers, probes, and monitoring devices prior to validation runs
  • Evidence to Maintain:
  • • Partial cooking and cooling validation reports including time–temperature curves and supporting data
  • • CCP monitoring logs documenting processing conditions and compliance with critical limits
  • • Equipment calibration certificates for thermometers, probes, sensors, and monitoring devices
  • • Corrective action documentation detailing deviations, investigations, and preventive measures

3. Implement Routine Monitoring

  • Monitoring Program Components:
  • • Internal temperature checks during partial cooking to verify product reaches validated time–temperature targets
  • • Verification of rapid cooling to critical temperatures to prevent pathogen proliferation and ensure food safety
  • • Sanitation and separation verification to control cross-contamination between raw, partially cooked, and cooked areas
  • • Documentation of deviations and corrective actions taken to restore control when critical limits are not met
  • Evidence to Maintain:
  • • Monitoring logs including batch numbers, operators, time–temperature data, and validated results
  • • Corrective action records documenting deviations, root cause analysis, product disposition, and resolution
  • • Trend reports identifying recurring deviations and insights for continuous process improvement

4. Monitor, Analyze & Improve

  • Data Management Best Practices:
  • • Analyze trends in cooking, cooling, and storage temperature data to identify deviations and performance gaps
  • • Review CCP monitoring records and corrective actions routinely to verify ongoing process control
  • • Reassess the HACCP plan annually or when process, formulation, equipment, or facility changes occur
  • Evidence to Maintain:
  • • Monthly trend and deviation reports summarizing temperature controls, CCP performance, and identified risks
  • • Root cause investigation records documenting systematic analysis and preventive measures
  • • Updated SOPs and staff training records reflecting changes derived from process reviews or deviations

Common Audit Findings & Recommended Fixes

Audit Finding Recommended Solution
No partial-cook validation Conduct thermal validation for worst-case product sizes
Cooling not monitored Implement time-temperature logs for rapid chilling
Post-process contamination risk Enforce separation of raw, partially cooked, and cooked areas
Temperature monitoring gaps Use automated or manual monitoring devices
Outdated hazard analysis Update annually or after process/equipment changes

Auditor Verification Checklist

  • Auditors will expect to review:
  • • Hazard analysis and CCP determination specific to partially cooked, refrigerated products
  • • Validation studies supporting partial cooking and rapid cooling controls, including time–temperature verification
  • • CCP monitoring logs and deviation records demonstrating compliance and corrective actions taken
  • • Corrective action documentation detailing investigation findings, root cause, and preventive measures
  • • Equipment calibration and maintenance records validating reliability of thermometers, chillers, and monitoring devices

Implementation Roadmap

Build Your Program

  • ✓ Identify hazards and CCPs for partially cooked, refrigerated products
  • ✓ Map process flow diagrams for cooking, cooling, and storage
  • ✓ Develop monitoring and corrective action procedures

Train and Validate

  • ✓ Train staff on partial cooking, rapid chilling, and cold chain management
  • ✓ Validate worst-case product scenarios
  • ✓ Verify calibration and competency of monitoring equipment

Operate and Monitor

  • ✓ Conduct routine CCP monitoring for cooking, cooling, and cold storage
  • ✓ Track deviations and corrective actions
  • ✓ Maintain logs and records

Improve Continuously

  • ✓ Perform annual HACCP reassessment
  • ✓ Revalidate CCPs after process, formulation, or equipment changes
  • ✓ Conduct monthly trend analysis

Why This Matters?

Effective HACCP for partially cooked, non-shelf-stable products:

  • ✓ Ensures safety until final consumer cooking
  • ✓ Reduces the risk of foodborne illness and recalls
  • ✓ Demonstrates compliance with FSIS regulations
  • ✓ Protects consumer health and brand reputation
  • ✓ Supports audit readiness and due diligence

Heat Treated but Not Fully Cooked – Not Shelf Stable HACCP Services & Pricing

HACCP Service Description Price Action
Partial-Cook HACCP Assessment Comprehensive hazard analysis and CCP identification for products only partially heat-treated prior to storage, chilling, or further processing. Includes process mapping for pre-cook, cook-to-target, cooling, and hold steps aligned with FSIS, FDA, and Codex requirements. $599 / session Get Started
Partial Cooking & Cooling Validation Validation of sub-lethality targets for partial-cook products using internal temperature endpoints, surface kill distributions, cooling curves, airflow capacity, batch size, and time-to-refrigeration compliance to minimize pathogen survival risk. $899 / project Get Started
CCP Monitoring Setup Implementation of monitoring controls for partial cooking and chilling, including endpoint temperatures, batch time logs, step-dependent hold windows, temperature recovery validation, and cross-contact controls with operator verification. $499 / module Get Started
Corrective Action Program Structured deviation response for under-cook, delayed cooling, extended ambient exposure, or recontamination events. Includes root-cause analysis, segregation and reprocessing protocols, disposition decisions, and documented traceability. $699 / project Get Started
Verification & Review Routine performance review of partial-cook monitoring records, thermometer calibration, cold-hold compliance, validation data, trend analysis, and regulatory readiness for FSIS verification or third-party inspections. $999 / site / month Get Started
HACCP Toolkit Industry-ready documentation tailored for partial-cook workflows: flow diagrams, step-specific monitoring sheets, lethality deviation logs, cooling validation forms, and audit-aligned verification templates. $1,299 one-time Get Started
Implementation Support Remote or on-site technical coaching for partial-cook CCP execution, workforce training, validation record organization, SOP deployment, and FSIS-compliant documentation tailored to hybrid heat-treated product lines. $699 / project Get Started

Need Help Developing or Validating Your Heat-Treated but Not Fully Cooked HACCP Program?

Consultare Inc. Group provides:

  • ✓ HACCP plan development for partially cooked, refrigerated products
  • ✓ CCP validation and intervention support
  • ✓ Monitoring and training materials
  • ✓ Audit preparation and documentation templates

GET STARTED NOW

This document is for internal training and compliance use only and is not affiliated with USDA or FSIS.

Please refer to official USDA FSIS guidelines for regulatory requirements.