This document discusses validation and verification of HACCP systems. It defines validation as establishing the validity of a HACCP plan through factual proof that it is controlling food safety hazards. Verification ensures that the HACCP plan is being properly implemented. The document outlines initial validation activities after a HACCP plan is first implemented as well as ongoing validation when changes occur. It provides examples of appropriate data to collect and analyze to validate CCPs, critical limits, and monitoring procedures. In-depth verification reviews conducted by regulatory agencies are also summarized.
This document discusses validation and verification of HACCP systems. It defines validation as establishing the validity of a HACCP plan through factual proof that it is controlling food safety hazards. Verification ensures that the HACCP plan is being properly implemented. The document outlines initial validation activities after a HACCP plan is first implemented as well as ongoing validation when changes occur. It provides examples of appropriate data to collect and analyze to validate CCPs, critical limits, and monitoring procedures. In-depth verification reviews conducted by regulatory agencies are also summarized.
This document discusses validation and verification of HACCP systems. It defines validation as establishing the validity of a HACCP plan through factual proof that it is controlling food safety hazards. Verification ensures that the HACCP plan is being properly implemented. The document outlines initial validation activities after a HACCP plan is first implemented as well as ongoing validation when changes occur. It provides examples of appropriate data to collect and analyze to validate CCPs, critical limits, and monitoring procedures. In-depth verification reviews conducted by regulatory agencies are also summarized.
This document discusses validation and verification of HACCP systems. It defines validation as establishing the validity of a HACCP plan through factual proof that it is controlling food safety hazards. Verification ensures that the HACCP plan is being properly implemented. The document outlines initial validation activities after a HACCP plan is first implemented as well as ongoing validation when changes occur. It provides examples of appropriate data to collect and analyze to validate CCPs, critical limits, and monitoring procedures. In-depth verification reviews conducted by regulatory agencies are also summarized.
Director-International Center for Food Industry Excellence Department of Animal and Food Sciences Texas Tech University Requirements for Validation
• 417.4 a • “Every establishment shall validate the HACCP Plan’s adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented” Validation
• “To Support or Corroborate on a Sound or
Authoritative Basis”
• Establish Validity of HACCP Plan by
Supplying Factual Proof.
• Merriam Webster Validation and Verification
• Verification “Do we say what we do and do we do what we say?”
• Validation “Is it the right thing to do?”
Verification of HACCP Systems-An Advanced HACCP Workshop-Food
Processors Institute Validation
• The Element of Verification focused on
collecting and Evaluating Scientific and Technical Information to Determine if the HACCP Plan, When Properly Implemented, will Effectively Control the Hazards • NACFMF Initial Validation
• Is the HACCP Plan Valid?
Does it control hazards? Can the Plan be implemented as Written? Performed During Initial Implementation of Plan • FSIS Regulations Require that Initial Validation Be Conducted Repeatedly test adequacy of CCPs, CL, Monitoring and Recordkeeping Procedures Review of Records Associated with Plan Initial Validation
• After first few weeks
Review Hazard Analysis for validity • Are Significant Hazards Identified and Controlled CCPs, CLs and Monitoring Activities • Adequate Control of the Hazards • May Include Scientific Studies In-Plant Observations and Measurements (data Collection) When to Validate
• Initially • When Changes in Process Occur • If CCP, CL, or Monitoring Method is Changed Must Provide Evidence that New Methods/Limits are Comparable to Previous Methods/Limits • If new Food Safety Information Becomes Available What Should be Validated
• Lethality and Stabilization (Cook and Chill)
Processes that Differ from “Safe Harbors” • Processing room Temperatures that may be too high (above 50 F). • Do NOT have to validate “Safe Harbors” • Change CL/CCP’s. Validation Experiments
• Research “A systematic quest for undiscovered truth”
Generate: New Information/Data Search Literature to Find Answers Validation Research
• Must Consider: • Population – All of the Product in the Universe that you will produce • Experimental Unit – Portion of Population you will test to ensure that your process is safe Statement of Problem
• What do you want to know?
Is my process safe? Can I change my CCP and still produce a safe product? Is my HACCP plan controlling hazards? Etc….. What Can I Measure to Answer Question/Solve Problem
• Many Variables Can be Measured:
pH Temperature • Product Temperature • Room Temperature Microbial Data Visual Observations • Visible Fecal Contamination Data Colletion
• How Often? Must Base on Statistical Soundness Must Be Random
• Data must be Subject to Statistical Analysis
Sample Sizes
• Generally 30 Samples are Adequate
Depending on Amount of Product Produced More Product = More Samples
• Samples should not all be taken on same day
of production Spread over at least 3 days
• If data is not consistent (large standard
deviation) more samples may be needed. Data Interpretation
• Assistance from University Specialists is
Recommended • Make Sound Decisions Based on Data: May have to modify processes. Could Simplify Monitoring • Don’t Be Overwhelmed Rely on Outside Sources of Expertise for Assistance • In-Depth Verification Reviews- IDV In-Depth Verification Reviews
• IDVs • Conducted by a “Team” Tech Center, Compliance Officer, Microbiologist, District Coordinator, Representative from D.C., “observer” • Determine the Adequacy of the HACCP plan and the SSOP program • A series of 10 “checklists” are used When Will Reviews be Conducted?
• “For Cause” Recurring Problems • NRs • Unacceptable Generic E. coli/Salmonella • Following a Product Recall • Random Plants will be Randomly Selected for IDVs Phase II of HACCP Implementation Use of Results
• Enforcement Actions • Future Policies • Evaluate Data on Particular Topic What will be Reviewed?
Occur” Standard, 417.2 Historical/Scientific Data Support Decisions Other Data Generated through Validation Studies Review of CCPs
• Are hazards identified in hazard analysis
addressed by a CCP • Are CCPs practical • Are controls practical Review of Critical Limits
• Record Review Are Critical Limits Implemented as Planned? Are deviations recorded/implemented as planned? Review of Monitoring Procedures
• Is continuous monitoring used when feasible?
• If not continuous, are monitoring intervals appropriate? • Are monitoring instruments used appropriately? • Do results of monitoring indicate control of hazard? • Are procedures specific and conducted? Review of Corrective Actions
• Records indicate that CA are completed to
prevent adulterated product from entering commerce • Do Corrective Actions Records Include: ID and Elimination of Problem Evidence that CCP under control after CA Measures to Prevent Recurrence Evidence that NO adulterated product has entered commerce Review of Verification
• Is there evidence of on-going verification
activities/verification schedule Employee audits Record review Calibration
• Does HACCP plan specify frequency
• Do records indicate that verification activities are performed Review of Verification
• Has there been an initial validation to confirm
plan’s adequacy? • Do documents include or site SCIENTIFIC EVIDENCE and/or TECHNICAL studies to support CCPs Review of Records
• Do Records indicate that Process is in control
• Regular analysis of records? • Do records indicate that HACCP plan is followed as written Review of Reassessment Activities
• Has Reassessment occurred at least
annually and at other specified times • Were plan modifications made after reassessment (if necessary) Considerations
• HAZARD ANALYSIS Are all decisions/justifications based on scientific evidence? • Make sure Hazard Analysis correlates with Flow Diagram • Make sure that CCPs include 4 elements specified in hazard analysis • Make sure verification includes all 3 elements specified in regulations Preparation for IDV
• Be ORGANIZED • Do NOT be confrontational • Provide a comfortable meeting place for team Do not allow team to take documents off site if possible Preparation for IDV
• Assemble All HACCP/SSOP plans and
records Include E. coli and Salmonella test results (if Applicable) GMPs SSOPs NRs Lab Methods and Results Preparations for IDV
• Prepare plant employees to answer questions
• Assign a technical person to answer most questions • Make copies of EVERYTHING • Alert EVERYONE of the IDV • Make Sure Team Follows “visitors policy” • Make sure personnel responsible for monitoring are “well versed” in duties and responsibilities • Ask for an Exit meeting Reference
• In-Depth Verification Workshop
National Association of Meat Processors Summary
• Verification and Validation activities ensure
that the HACCP plan is controlling hazards • Activities may be internal or conducted by FSIS • Employee’s have a responsibility to collect sound data to provide accurate data for validation International Center for Food Industry Excellence
