HACCP Validation

Validation of a HACCP system involves two separate elements

1) design and 2) execution.

major types of scientific and technical support documents used to satisfy the design element of HACCP Systems Validation

1. Published processing guidelines that achieve a stated reduction of a pathogen are examples of scientific support. The time-temperature guidelines in Appendix A of the final rule "Performance Standards for the Production of Certain Meat and Poultry Products" (64 FR 746-748) is an example of a guideline that addresses process lethality. The guidelines in Appendix B, Compliance Guidelines for Cooling HeatTreated Meat and Poultry Products (Stabilization), address product stabilization to meet the requirements of 9 CFR 318.17(a)(2), 9 CFR 318.23(c)(1), and 9 CFR 381.150(a)(2) Published guidelines from other agencies, trade organizations, or universities can also be used as scientific support. Extension publications may also be cited as scientific support; however, extension publications often reference the original journal articles that were used to develop the support and would be required

Under 9 CFR 417.4(a)(1) establishments are required to assemble two types of supporting documentation to demonstrate these elements are met:

1. The scientific or technical support for the HACCP system design (design 2. The in-plant validation data (execution)

The HACCP requirements that establishments must meet are set out in

9 CFR Part 417

Theoretical

All decisions base on sound science NOT customer or practice Controls are CAPABLE of achieving safety at a CCP All info gathered needs to be retained

These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the ____________ __________ to be taken if a critical limit is not met. ___________ ____________are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce.

CORRECTIVE ACTIONS

Practically Challenging Controls

Challenge controls to understand what would happen in the event of a failure Investigate all possible failure modes, contributory causes and the outcome Consider current controls and any additional controls required to give more confidence and increase effectiveness of the HACCP system

Plants determine the food safety hazards AND identify the preventive measures the plant can apply to control these hazards.

HAZARD ANALYSIS

Seven Principles

Hazard analysis

The HACCP regulation requires that all plants maintain certain documents, including

Its hazard analysis written HACCP plan, documenting the monitoring of critical control points, critical limits, verification activities handling of processing deviations.

are necessary to ensure that the process is under control at each critical control point. FSIS is requiring that each monitoring procedure and its frequency be listed in the HACCP plan.

Monitoring activities

(NACMCF)

National Advisory Committee on Microbiological Criteria for Foods

The Seven HACCP Principles

Principle 1: CONDUCT HAZARD ANALYSIS Plants determine the food safety hazards identify the preventive measures the plant can apply to control these hazards. Principle 2: IDENTIFY CRITICAL CONTROL POINTS Principle 3: . ESTABLISH CRITICAL LIMITS FOR EACH CCP Principle 4: ESTABLISH CRITICAL CONTROL POINT MONITORING REQUIREMENTS. Principle 5: ESTABLISH CORRECTIVE ACTIONS Principle 6: Establish record keeping procedures. Principle 7: Establish procedures for verifying the HACCP system is working as intended.

Statistical verification of a process to establish the probability (Confidence) of its ability to stay within specified limits.

Process Capability

Validation During/end of Design

Theoretical Checking that the hazards will be controlled: *control measures are suitable *Correct CCP's have been ID'd *Critical limits set correctly *Process will achieve the Critical limits *Monitoring will detect loss of control if it happens *Corrective action will prevent the potentially unsafe food from being consumed

Process of Validation

Theoretical and Practical/Experiment

Obtaining and evaluating scientific and technical evidence that control ameasure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

Validation

The element of verification that focuses on collecting and evaluating scientific and technical informatoin to determine if the HACCP plan, when properly implemented, will effectively control the hazards (NACMCF)-

Validation Is it technically valid, If we do this will it work, i.e. will it be effective? Verification..are we doing what we say we are doing and is it working

The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

Verification

A critical control point (CCP) is

a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.

A food safety hazard is any

biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

This means that establishments must maintain scientific or technical support for the

design of those prerequisite programs used to support decisions in the hazard analysis (Element 1 of validation) and must collect in-plant validation data to support that the programs are implemented as designed (Element 2)

Validation ensures that the plans

do what they were designed to do; that is, they are successful in ensuring the production of safe product.

Verification ensures the HACCP plan

is adequate, that is, working as intended.

verification tasks would also be performed by FSIS inspectors. Both FSIS and industry will undertake _________testing

microbial ____________as one of several verification activities. the occurrence of the identified food safety hazard. divider

When an establishment determines that a potential hazard is not reasonably likely to occur because the implementation of a prerequisite program (e.g., Sanitation SOP, written sanitary procedures incorporated into prerequisite programs, purchase specifications, antimicrobial interventions) prevents conditions that make the potential hazard likely, that prerequisite program then becomes

part of the HACCP system and as a result, must be validated.

FSIS is requiring that the HACCP plan include verification tasks to be performed by .

plant personnel

RAC

raw agricultural commodity

Verification procedures may include such activities as

review of HACCP plans, CCP records, critical limits and microbial sampling and analysis.

2. The in-plant validation data (execution) -

the in-plant observations, measurements, microbiological test results, or other information demonstrating the control measures in the HACCP system can perform as expected within a particular establishment to achieve the intended food safety objective. Identifies at leas one product from each HACCP category to gather in-plant validation data and analyzes that data against critical operational parameters

Under 9 CFR 417.5(a)(1) and 9 CFR 417.5(a)(2), these supporting documents must be kept for

the life of the plan

A critical limit is

the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce HAZARD to an acceptable level.

1. The scientific or technical support for the HACCP system design (design) - •Closely matches the actual process and consist of:

the theoretical principles, expert advice from processing authorities, scientific or technical data, peer-reviewed journal articles, challenge studies. pathogen modeling programs, other information demonstrating that particular process control measures can adequately prevent, reduce, or eliminate specific hazards identified in Hazard Analysis

Establishments need information on all the critical operational parameters in order to determine

whether the process in the publication matches their actual process.