VALIDATION OF

HACCP SYSTEMS

Mindy Brashears, PhD

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

• Who?
 Plant Employee
 Independent Consultant/Scientist

• 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?

• SSOP • Corrective Actions

• Hazard Analysis • Validation Procedures
• CCPs • Verification Procedures
• Critical Limits • Record Keeping
• Monitoring Procedures • Reassessment
Review of Hazard Analysis

• Is Hazard Analysis Complete?

 All Hazards Identified and Controlled

• Do Hazards Meet “Reasonably Likely to

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