HACCP – STEP 11, PRINCIPLE 6

VALIDATION
AND
VERIFICATION
FAO Good Hygiene Practices (GHP) and
Hazard Analysis and Critical Control Point
(HACCP) Toolbox for Food Safety
HACCP – STEP 11, PRINCIPLE 6

VALIDATION
AND
VERIFICATION
FAO Good Hygiene Practices (GHP) and
Hazard Analysis and Critical Control Point
(HACCP) Toolbox for Food Safety

Food and Agriculture Organization of the United Nations

Rome, 2023
Required citation:

FAO. 2023. Validation and verification – Step 11, Principle 6. FAO Good Hygiene Practices (GHP) and Hazard Analysis and Critical Control Point (HACCP) Toolbox for
Food Safety. Rome. https://doi.org/10.4060/cc6272en

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CONTENTS

INTRODUCTION 1
CONTEXT 2

HACCP STEP 11 3
EXERCISE: FOOD SAFETY FOR THOUGHT 11

KEEP READING 12

iii
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FAO Good Hygiene Practices (GHP) and Hazard Analysis and Critical Control Point (HACCP) Toolbox for Food Safety

VALIDATION
AND
VERIFICATION
INTRODUCTION
12. DOCUMENTATION
PRINCIPLE 7 AND RECORD-KEEPING
This guidance document is part of a toolbox of materials
11. VALIDATION
and has been developed to provide users with a good PRINCIPLE 6 AND VERIFICATION

understanding of food safety management practices,

10. CORRECTIVE ACTIONS
including HACCP systems, based on the Codex General PRINCIPLE 5

Principles of Food Hygiene (CXC 1-1969). 9. MONITORING CRITICAL

PRINCIPLE 4 CONTROL POINTS
You are here
Well established and effective 8. ESTABLISH VALIDATED
Good Hygiene Practices (GHP) PRINCIPLE 3 CRITICAL LIMITS

set the foundation for implementing 7. DETERMINE CRITICAL

PRINCIPLE 2 CONTROL POINTS
a HACCP system.
6. CONDUCT A
PRINCIPLE 1 HAZARD ANALYSIS
This graphic representation
shows the seven principles 5. ON-SITE CONFIRMATION
OF FLOW DIAGRAM
of HACCP along with the
4. CONSTRUCT FLOW
12 successive steps for its DIAGRAM

application. 3. IDENTIFY INTENDED

USE AND USERS

2. DESCRIBE PRODUCT

1. ASSEMBLE HACCP TEAM

AND IDENTIFY SCOPE

GHP 1
VALIDATION AND VERIFICATION

VALIDATION
AND
VERIFICATION
CONTEXT

Before the HACCP plan can be implemented, it should be

validated to confirm that it can ensure consistent control of Learning objectives
the significant hazards relevant to the food business under
production conditions. Validating the HACCP plan could This document provides
include a review of the scientific literature, using mathematical guidance on how to:
models, conducting validation studies, and/or using guidance
developed by authoritative sources. Where HACCP guidance is • establish procedures for
developed by external experts, care should be taken to ensure verifying control at each of
that these critical limits fully apply to the specific operation, the CCPs and for validating
product or groups of products under consideration. the adequacy of the overall
HACCP plan prior to
After the HACCP system has been implemented, procedures implementation; and
should be established to verify that the HACCP plan is being
followed and that it is controlling hazards on an ongoing • document this
basis. There should also be procedures to show that the step as part of
control measures are effectively controlling the hazards as the HACCP plan.
intended. Verification also includes reviewing the adequacy
of the HACCP system periodically and when changes occur, as
appropriate. Any changes having a potential impact on food
safety require a review of the HACCP system, and, when necessary, a revalidation of the HACCP plan.

2
FAO Good Hygiene Practices (GHP) and Hazard Analysis and Critical Control Point (HACCP) Toolbox for Food Safety

VALIDATION
AND
VERIFICATION
HACCP STEP 11
Principle 6: Validate the HACCP plan and then establish procedures for
verification to confirm that the HACCP system is working as intended

Codex definitions:

Validation of control measures: Obtaining evidence that a

control measure or combination of control measures, of properly
implemented, is capable of controlling the hazards to a specified
outcome.

Verification: The application of methods, procedures, test

and other evaluations, in addition to monitoring, to determine
whether a control measure is or has been operating as intended.

Validation and verification work together and can be considered a means

of continuous improvement of the HACCP plan.

3
VALIDATION AND VERIFICATION

VALIDATION
AND
VERIFICATION
HACCP STEP 11

Validation of the HACCP plan

Validation of the HACCP plan should occur before implementation and is an essential step to obtain
evidence that the elements of the plan are capable of controlling the significant hazards relevant to
the food business.

HACCP plan validation will ensure that:

• hazards significant for the safety of the product and the process have been identified;

• critical control points (CCPs) have been correctly identified;

• critical limits are defined for CCPs and validated;

• non-CCP control measures are operating effectively;

• the frequency and type of monitoring of CCPs is able to identify when the process is not operating
according to critical limits;

• corrective actions will prevent the release of unsafe food and minimize recurrence;

• the frequency and type of verification is able to confirm compliance with the HACCP plan; and

• the type of information recorded will be sufficient to demonstrate historical proof of compliance with
the HACCP plan.

4
FAO Good Hygiene Practices (GHP) and Hazard Analysis and Critical Control Point (HACCP) Toolbox for Food Safety

VALIDATION
AND
VERIFICATION
HACCP STEP 11

Who can support validation activities?

• the HACCP team;

• staff with specific technical expertise (for example, the person in charge of the maintenance of
electronic equipment); and

• external experts, as needed.

Information needed to validate the HACCP plan often includes:

• collecting and evaluating scientific, technical and observational information (such as, scientific
literature, mathematical models, conducting validation studies, and/or using guidance developed by
authoritative sources); and

• evidence obtained during implementation of the HACCP system.

5
VALIDATION AND VERIFICATION

VALIDATION
AND
VERIFICATION
HACCP STEP 11

Revalidation of the HACCP plan

Any changes in the process that could have an impact on food safety require a review of the HACCP
system and, when necessary, the revalidation of the HACCP plan.

Examples of such changes are:

• new product formulation or new raw materials;

• new scientific information about a hazard (such as, an outbreak of food-borne disease linked to a
novel food source) and new control measures;

• regulatory changes or changes in the requirements of importing countries;

• use of new processing technologies or equipment;

• consumer complaints regarding product safety; and

• recuring deviations or unsatisfactory audit findings.

6
FAO Good Hygiene Practices (GHP) and Hazard Analysis and Critical Control Point (HACCP) Toolbox for Food Safety

VALIDATION
AND
VERIFICATION
HACCP STEP 11

Verification procedure

Verification is more than monitoring. It answers the question: Am I confident that my food safety
system is controlling hazards as intended and that my HACCP plan is being complied with?

Verifying the HACCP system is essential to ensuring that it operates effectively. This includes
ensuring that the HACCP plan is being followed, that hazards are being controlled continuously and
that the control measures are controlling the hazards as intended.

Verification activities include:

• HACCP plan validation

• HACCP system audits

• equipment calibration

• targeted sample collection and testing

Verification is an ongoing activity, which should be initiated once the HACCP system is fully
functional.

7
VALIDATION AND VERIFICATION
HACCP STEP 11
Codex examples of verification activities:
• reviewing monitoring records to confirm that
CCPs are kept under control;
• reviewing corrective action records, including
specific deviations, product disposition and
analysis conducted to determine the root cause
of the deviation;
• calibrating or checking the accuracy of
instruments used for monitoring and
verification;
• observing control measures to determine if they
are being conducted according to the HACCP
plan;
VALIDATION
AND
VERIFICATION
• sampling and testing, for example, for
microorganisms (pathogens or their indicators),
chemical hazards such as mycotoxins, or
physical hazards such as metal fragments, to
verify product safety;
• sampling and testing the environment for
microbial contaminants and their indicators,
such as Listeria spp.; and
• reviewing the HACCP system, including the
hazard analysis and the HACCP plan (for
example, by means of internal and/or third-party
audits).
8
FAO Good Hygiene Practices (GHP) and Hazard Analysis and Critical Control Point (HACCP) Toolbox for Food Safety

VALIDATION
AND
VERIFICATION
HACCP STEP 11

Who can support verification activites?

• an individual within the food business who is not responsible for performing the monitoring and
corrective actions; and/or

• external experts or qualified third-party auditors.

Frequency of verification activities

Verification activities should be performed:

• as a routine operation; or

• according to a pre-established schedule described in the HACPP plan; or

• whenever changes that can affect food safety occur.

9
VALIDATION AND VERIFICATION

VALIDATION
AND
VERIFICATION
HACCP STEP 11

Documenting verification activities

Verification procedures should be documented as part of the HACCP plan, and the results of all
verification activities should be recorded. Records of verification activities should include methods
used, date of the activity, individuals or organizations responsible, results or findings and actions
taken. (See Supporting documents for templates and examples.)

i For additional information, please consult the Further reading

section accessible from the SECTION LANDING PAGE.

10
FAO Good Hygiene Practices (GHP) and Hazard Analysis and Critical Control Point (HACCP) Toolbox for Food Safety

VALIDATION
AND
VERIFICATION
EXERCISE: FOOD SAFETY FOR THOUGHT

This is the little “game” we GHP PROGRAMMES Please explain your choices.
created. This will apply to all
1. INTRODUCTION AND
HACCP steps, except the intro. CONTROL OF FOOD HAZARDS

2. PRIMARY PRODUCTION

11. VALIDATION AND

3. ESTABLISHMENT - DESIGN
VERIFICATION OF FACILITIES AND EQUIPMENT

4. TRAINING AND
COMPETENCE

GHP are fundamental 5. ESTABLISHMENT MAINTENANCE,

DISINFECTION, AND PEST CONTROL
to the sucessful application
of HACCP. 6. PERSONAL
HYGIENE

Think of a food operation

that you are familiar with, 7. CONTROL
OF OPERATION
and select those GHP
elements that you feel 8. PRODUCT INFORMATION

are most relevant for the AND CONSUMER AWARENESS

application of HACCP step 11.

9. TRANSPORTATION

11
VALIDATION AND VERIFICATION

VALIDATION
AND
VERIFICATION
KEEP READING
12. DOCUMENTATION
PRINCIPLE 7 AND RECORD-KEEPING
You have completed the eleventh step to create a HACCP
system. PRINCIPLE 6
11. VALIDATION
AND VERIFICATION
The next step will be Documentation and record-keeping.
10. CORRECTIVE ACTIONS
To continue reading, click on the highlighted card. PRINCIPLE 5
Click here for
PRINCIPLE 4
9. MONITORING CRITICAL
CONTROL POINTS
the next step
8. ESTABLISH VALIDATED
PRINCIPLE 3 CRITICAL LIMITS

7. DETERMINE CRITICAL
FEEDBACK ON THIS PRINCIPLE 2 CONTROL POINTS

GUIDANCE MATERIAL IS 6. CONDUCT A

PRINCIPLE 1
ALWAYS WELCOMED! HAZARD ANALYSIS

5. ON-SITE CONFIRMATION
OF FLOW DIAGRAM
Please contact us at:
food-quality@fao.org 4. CONSTRUCT FLOW
DIAGRAM

3. IDENTIFY INTENDED
USE AND USERS

2. DESCRIBE PRODUCT

1. ASSEMBLE HACCP TEAM

AND IDENTIFY SCOPE

GHP 12
 KEEP READING

GHP and HACCP Toolbox for Food Safety

www.fao.org/good-hygiene-practices-haccp-toolbox

FOOD SYSTEMS AND FOOD SAFETY –

ECONOMIC AND SOCIAL DEVELOPMENT
www.fao.org/food-safety

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

ROME, ITALY

CC6272EN/1/06.23