Food Safety: Validation, Sampling/Lotting, and Events

Kerri B. HarrisPresident/CEO, International HACCP AllianceAssociate Director, Center for Food SafetyAssociate Professor, Texas A&M University

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)

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)

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.

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.

Validation often requires:1) Expert advice and scientific

studies2)In-plant observations,

measurements, and evaluations.

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

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

In-plant observations Measurements Microbiological test results Or other information demonstrating the control

measures are being implemented as written in the HACCP plan

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?

Process control reduces riskGoal 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

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

“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

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.

Presented at Beef Safety Summit March 2011

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)

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.

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.

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)

Events are real things that are going to happen

Important to have a program that you can follow in the heat of the moment

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

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

CHARLIE Multiple presumptives at levels where sub-primals may

need to be addressed

DELTASystemic contamination affecting majority of days

production

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

You must critically investigate your process daily Use the small indicators to develop action

plans Don’t wait to implement system wide process

improvements1.Make your process improvement list2.Prioritize3.Implement

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”

[email protected]