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Validation Procedure: 1. Purpose

This document outlines a food company's validation procedure. It defines validation and describes the company's responsibilities and methods for validating control measures to control food safety hazards. The validation procedure involves identifying hazards, prioritizing validations, deciding validation approaches, defining validation criteria, conducting validation studies, analyzing results, and documenting validations. The company will validate that control measures are capable of consistently controlling hazards to intended levels.

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Abhishek Kumar Singh
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420 views

Validation Procedure: 1. Purpose

This document outlines a food company's validation procedure. It defines validation and describes the company's responsibilities and methods for validating control measures to control food safety hazards. The validation procedure involves identifying hazards, prioritizing validations, deciding validation approaches, defining validation criteria, conducting validation studies, analyzing results, and documenting validations. The company will validate that control measures are capable of consistently controlling hazards to intended levels.

Uploaded by

Abhishek Kumar Singh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 7

[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]
LOGO Doc No: Page 2 of 7
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


[COMPANY NAME]
LOGO Doc No: Page 4 of 7
Food Safety Management System

Subject: Validation Procedure

Compiled by: Approved by: Date: Rev no: 00

INTENTIONALLY LEFT BLANK

For the complete FSSC 22000 documents toolkit visit:


https://ascconsultants.co.za/fsms-templates/fssc-22000-
document-templates
[COMPANY NAME]
LOGO Doc No: Page 5 of 7
Food Safety Management System

Subject: Validation Procedure

Compiled by: Approved by: Date: Rev no: 00

INTENTIONALLY LEFT BLANK

For the complete FSSC 22000 documents toolkit visit:


https://ascconsultants.co.za/fsms-templates/fssc-22000-
document-templates
[COMPANY NAME]
LOGO Doc No: Page 6 of 7
Food Safety Management System

Subject: Validation Procedure

Compiled by: Approved by: Date: Rev no: 00

INTENTIONALLY LEFT BLANK

For the complete FSSC 22000 documents toolkit visit:


https://ascconsultants.co.za/fsms-templates/fssc-22000-
document-templates
[COMPANY NAME]
LOGO Doc No: Page 7 of 7
Food Safety Management System

Subject: Validation Procedure

Compiled by: Approved by: Date: Rev no: 00

INTENTIONALLY LEFT BLANK

For the complete FSSC 22000 documents toolkit visit:


https://ascconsultants.co.za/fsms-templates/fssc-22000-
document-templates

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