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
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.validation verification
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: 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
1)Complete the prerequisite steps to validation.
2)Decide the approach or combination of approaches.
3)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.
4)Assemble relevant validation information and conduct the studies if necessary.
5)Analyze the results
6)Document and review the validation
7)Reference all sources of data
8)Results of validation studies will either
9)Indicate that the hazard can be adequately controlled and thus the measure can be
implemented or
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