This document discusses validation and verification procedures for Hazard Analysis and Critical Control Point (HACCP) plans. It provides definitions and guidelines for validation from regulatory sources to establish that a HACCP plan is functioning properly. Validation involves collecting scientific and technical information to determine if the HACCP plan will effectively control hazards when implemented. Verification activities ensure the HACCP plan is being followed correctly. The document outlines approaches for initial validation and ongoing verification including in-plant observations, measurements, and microbiological testing. It emphasizes using various tools to prove ongoing process control rather than relying solely on end-product testing.

1. Kerri B. Harris
President/CEO, International HACCP Alliance
Associate Director, Center for Food Safety
Associate Professor, Texas A&M University

3. Establish verification procedures.
Verification – Those activities, other than
monitoring, that determine the validity of the
HACCP plan and that the system is operating
according to the plan.
(NACMCF, 1998)

4. That element of verification focused on
collecting and evaluating scientific and
technical information to determine whether
the HACCP plan, when properly
implemented, will effectively control the
hazards.
(NACMCF, 1998)

5. 417.4 Validation, Verification, Reassessment
(a) Every establishment shall validate the
HACCP plan’s adequacy in controlling the
food safety hazards identified during the
hazard analysis, and shall verify the plan is
being effectively implemented.

6. 417.4 (a)(1) Initial Validation: Upon completion
of the hazard analysis and development of the HACCP plan,
the establishment shall conduct activities designed to
determine that the HACCP plan is functioning as intended.
During this validation period, the establishment shall
repeatedly test the adequacy of the CCP’s, critical limits,
monitoring, and recordkeeping procedures, and corrective
actions set forth in the HACCP plan. Validation also
encompasses reviews of the records themselves, routinely
generated by the HACCP system, in the context of other
validation activities.

7. Validation often requires:
1) Expert advice and scientific
studies
2) In-plant observations,
measurements, and evaluations.

8.  Theoretical principles
 Expert advice from processing authorities
 Scientific data
 Peer-reviewed journal articles
 Documented challenge study
 In-house data
 Agency issuances
 Risk assessments

9.  Identify hazard and pathogen
 Level of reduction
 Identify critical parameters
 Sufficient relationship to hazard
 Implemented in the plant as documented;
 Otherwise additional research data needed

10.  In-plant observations
 Measurements
 Microbiological test results
 Or other information demonstrating the control
measures are being implemented as written in
the HACCP plan

11.  Based on the critical parameters identified in the
scientific support
 Intensified data collection during the first 90 days
“repeatedly testing” not recreating the entire
scientific support
 Microbial before/after testing at control steps to
demonstrate log reductions documented in
scientific support
 Indicators
 Pathogen of concern?

12. Process control reduces risk
Goal is to monitor process
▪ Detect trends
▪ Respond before loss of control
▪ Possible with pathogen testing??
12

13.  Sanitation verification
 Environmental for RTE
 Incoming ingredients
 Within HACCP plan
 Validate pathogen control at CCP
 Verify process control
13

14. End-product sampling for pathogens,
regardless of the objective…
Positive samples will occur by chance
▪ Must be careful of message sent to public
regarding safety
▪ May fail to accomplish greater goal
14

15. There are many tools available for verifying
process control in a HACCP system
 Take advantage of all the tools
 Spend energy understanding and challenging
the system
 Develop an complete knowledge of the
microbial ecology of facility
 Focus on more on proving process control, and
less on detection of pathogens in end-products
15

16. “An effective HACCP system requires little end-
product testing, because sufficient validated
safeguards are built in early in the process.
Therefore, rather than relying on end-
product testing, firms should rely on frequent
reviews of their HACCP plan, verification that
the HACCP plan is being correctly followed,
and review of CCP monitoring and corrective
action records.”

17. 17

20. Must understand the key terms:
Lot — the amount of product that is
represented by a sample. This can be
determined by time, weight, container
(combo or boxes) or number of units that
make it independent from other lots.
Sample — a portion of product that
represents the given lot.

21. Presented at Beef Safety Summit March 2011

22.  Carcass – Individual Carcass
 Primal – Individual Subprimal
 Trim Combo – 1 to 5 Combos
 Trim Box – ~10,000 lb Max
 Offal – Shift of Production
 Ground Beef – Dependent on System (batch
or continuous)

23.  Positive: Any test result that is non-negative.
A test result may be suspect, presumptive
positive, or confirmed positive.
 Rework: Product that is rejected from the
process during a single production run.

24.  Always know the materials and product that
will be implicated prior to taking a sample.
 Place the appropriate product on hold prior
to taking the sample.

25.  Microbiological sampling of food to detect
presence of pathogens is very difficult
 Most bacterial pathogens are not
homogenously distributed in our food
 Enteric pathogens like Salmonella and
Escherichia coli O157:H7 are most often
present in very low numbers in raw foods of
animal origin, when they are there at all
(Beef Industry Food Safety Council, Guidance Document for Sampling and Lotting)

26.  Events are real things that are
going to happen
 Important to have a program
that you can follow in the heat of
the moment

27.  There is more than one way to effectively
manage an Event
 Main objective is to identify and control affected products
 Not all Events are created equal
 Situation dependent
 Levels of Severity

28.  Normal
 All clear, all negative results
 ALPHA
 Single presumptive events
• Glitch in the system
• Typically isolate the presumptive product and release
the negative tested product
 BRAVO
 Multiple sporadic presumptive events
• May have “associated” negative tested products sent
to lethality

29.  CHARLIE
 Multiple presumptives at levels where sub-primals may
need to be addressed
DELTA
Systemic contamination affecting majority of days
production

30.  Companies need to have plans to
address Event days
 Not all Event days are created equal
 Determine the severity of the Event day
and control affected products quickly
 Throw the “net wide” and narrow the
scope as data is analyzed

31.  You must critically investigate your process
daily
 Use the small indicators to develop action
plans
 Don’t wait to implement system wide process
improvements
1. Make your process improvement list
2.Prioritize
3.Implement

32.  As further processors, you need to
understand how “Events” can impact you and
the steps that your suppliers are taking to
protect you and the consumers.
 Communication and cooperation are
important factors in successful control of
“Events”

33. kharris@tamu.edu
979-862-3643