[COMPANY NAME]
LOGO Doc No: Page 1 of 7
Food Safety Management System
Subject: Validation Procedure
Compiled by: Approved by: Date: Rev no: 00
VALIDATION PROCEDURE
1. PURPOSE
To determine and demonstrate whether control measures are capable of controlling food safety hazards to
intended appropriate levels and these levels of control can be achieved consistently.
2. SCOPE
This procedure covers all validations of control measures used to control microbiological, chemical, physical
and allergen hazards in the processing of starch and glucose products.
3. REFERENCES
ISO 22000:2018
4. RESPONSIBILITY
QA MANAGER Ensuring that validation exercises are done
Recording results from validation exercises
Maintain records for validation exercises
Assist the QA Manager with conducting validation exercises whenever assistance
HACCP TEAM
is sought
4.1. Definitions
Control Measure – Any action and activity that can be used to prevent or eliminate a food safety hazard to an
acceptable level.
Food Safety Control System – The combination of control measures that when taken as a whole, ensures
that food is safe for its intended use.
Monitoring – The act of conducting a planned sequence of observations or measurements of control
parameters to assess whether a control measure is under control.
Validation – Obtaining evidence that a control measure or combination of control measures if properly
implemented is capable of controlling the hazard to a specified outcome.
Verification – The application of methods, procedures, tests, and other evaluations in addition to monitoring to
determine whether a control measure is or has been operating as intended.
5. METHODS
5.1 Prerequisite Steps to Validation
Identification of the hazards that are intended to be controlled (relevant information including risk assessment
to be utilized.
Factors that should be considered includes:
[COMPANY NAME]
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Food Safety Management System
Subject: Validation Procedure
Compiled by: Approved by: Date: Rev no: 00
The importance of the control measure as it relates to achieving the expected outcome for the control of the
hazard.
Whether a control measure can be validated by itself or whether combination of control measures should be
validated together.
5.2. Priority Of Validation Takes into Account
Adverse health effect
Historical experience
Ability to monitor and verify the control measure
Scientific and technical feasibility
Resources
Identification of the food safety outcome required
Approaches for Validating control measures
Reference to scientific and technical literature, previous validation studies or historical knowledge
of the performance of the control measure(s).
Scientifically valid experimental data that demonstrate the adequacy of the control measure (s).
Collection of data during normal operating conditions in the food operation.
Mathematical Modelling
Surveys
5.3 Steps Involved in The Validation Process
Complete the prerequisite steps to validation.
Decide the approach or combination of approaches.
Define the parameters and decision criteria that would demonstrate that a control measure or
combination of control measures if properly implemented is capable of consistently controlling the
hazard to the specified outcome.
Assemble relevant validation information and conduct the studies if necessary.
Analyze the results
Document and review the validation
Reference all sources of data
Results of validation studies will either
Indicate that the hazard can be adequately controlled and thus the measure can be implemented
or
Indicate that the measure is not adequate to achieve the necessary level of control and should not
be implemented. This may lead to re-evaluation of process parameters, control measures or
product formulation.
[COMPANY NAME]
LOGO Doc No: Page 3 of 7
Food Safety Management System
Subject: Validation Procedure
Compiled by: Approved by: Date: Rev no: 00
5.4 Need for Re-Validation
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Food Safety Management System
Subject: Validation Procedure
Compiled by: Approved by: Date: Rev no: 00
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[Link]
document-templates
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Food Safety Management System
Subject: Validation Procedure
Compiled by: Approved by: Date: Rev no: 00
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Food Safety Management System
Subject: Validation Procedure
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document-templates
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Food Safety Management System
Subject: Validation Procedure
Compiled by: Approved by: Date: Rev no: 00
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