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 oncollecting and evaluating scientific andtechnical information to determine whetherthe HACCP plan, when properlyimplemented, will effectively control thehazards. (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 completionof the hazard analysis and development of the HACCP plan,the establishment shall conduct activities designed todetermine that the HACCP plan is functioning as intended.During this validation period, the establishment shallrepeatedly test the adequacy of the CCP’s, critical limits,monitoring, and recordkeeping procedures, and correctiveactions set forth in the HACCP plan. Validation alsoencompasses reviews of the records themselves, routinelygenerated by the HACCP system, in the context of othervalidation activities.
Validation often requires: 1) Expert advice and scientific studies 2) In-plant observations, measurements, and evaluations.
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 risk Goal is to monitor process ▪ Detect trends ▪ Respond before loss of control ▪ Possible with pathogen testing?? 12
Sanitation verification Environmental for RTE Incoming ingredients Within HACCP plan Validate pathogen control at CCP Verify process control 13
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
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
“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.”
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.
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 DELTA Systemic 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 improvements 1. Make your process improvement list 2.Prioritize 3.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”