Hi mmg.fs15,
Welcome to the IFSQN forums.
Validation can be conducted by different methods including references to:
Legislation
Scientific/Technical literature
External Validation studies
Historical site results demonstrating control measure effectiveness
Site process/production trials
Mathematical modelling
Industry Codes of Practice
Verification methods include:
Internal & External Audits
Inspections
Sampling and Testing
Review of results/records
Trend Analysis
For the FSSC 22000 Certification Scheme the key requirements for Validation and Verification are prescribed in International ISO Standard 22000 2018 Food safety management systems — Requirements for any organization in the food chain. As shown below, ISO 22000 isn’t particularly specific in what validation and verification is required, so I refer to CODEX Codes of Practices and Guidelines (The Codex Alimentarius website is referenced in ISO 22000:2018)
ISO 22000 8.5.3 Validation of control measure(s) and combinations of control measures
The food safety team shall validate that the selected control measures are capable of achieving the intended control of the significant food safety hazard(s). This validation shall be done prior to implementation of control measure(s) and combinations of control measures to be included in the hazard control plan (see 8.5.4) and after any change therein (see 7.4.2, 7.4.3, 10.2 and 10.3).
…..
The food safety team shall maintain the validation methodology and evidence of capability of the control measure(s) to achieve the intended control as documented information.
ISO 22000 8.8 Verification related to PRPs and the hazard control plan
8.8.1 Verification
The organization shall establish, implement and maintain verification activities. The verification planning shall define purpose, methods, frequencies and responsibilities for the verification activities.
The verification activities shall confirm that:
a) the PRP(s) are implemented and effective;
b) the hazard control plan is implemented and effective;
c) hazard levels are within identified acceptable levels;
d) input to the hazard analysis is updated;
e) other actions determined by the organization are implemented and effective.
…….
Have a look at the following CODEX documents which I think will help you gain further understanding of what should be included in your procedures
CODEX Guidelines for The Validation of Food Safety Control Measures CAC/GL 69 – 2008
The guideline also explains the Interrelationships among Validation, Monitoring and Verification: Verification is an ongoing activity used to determine that the control measures have been implemented as intended. Verification occurs during or after operation of a control measure through a variety of activities, including observation of monitoring activities and review of records to confirm that implementation of control measures is according to design.
CODEX General Principles of Food Hygiene (CXC 1-1969) Revised 2022 Part two Hazard analysis and critical control point (HACCP) system and guidelines for its application. Note: this is referenced in ISO 22000.
Validation 19.8 Establish validated critical limits for each CCP (Step 8/ Principle 3)/19.11.1 Validation of the HACCP plan:
Critical limits for control measures at each CCP should be specified and scientifically validated to obtain evidence that they are capable of controlling hazards to an acceptable level if properly implemented. Validation of critical limits may include conducting studies (i.e. microbiological inactivation studies). FBOs may not always need to conduct or commission studies themselves to validate critical limits. Critical limits could be based on existing literature, regulations or guidance from competent authorities, or studies carried out by a third party, e.g. studies conducted by an equipment manufacturer to determine the appropriate time, temperature and bed depth for dry roasting tree nuts.
19.11.2 Verification procedures:
Verification activities should be performed on an ongoing basis to ensure the HACCP system functions as intended and continues to operate effectively. Verification, which includes observations, auditing (internal and external), calibration, sampling and testing, and records review, can be used to determine if the HACCP system is working correctly and as planned. Examples of verification activities include:
• reviewing monitoring records to confirm that CCPs are kept under control;
• reviewing corrective action records, including specific deviations, product disposition and any analysis to determine the root cause of the deviation;
• calibrating or checking the accuracy of instruments used for monitoring and/ or verification;
• observing that control measures are being conducted in accordance with the HACCP plan;
• sampling and testing, e.g. for microorganisms4 (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; and
• reviewing the HACCP system, including the hazard analysis and the HACCP plan (e.g. internal and/or third-party audits).
Finally, with regards to templates, IFSQN offers a FSSC 22000 Food Safety Management System for Food Manufacturers Implementation Package.
Customer reviews can be seen here.
Kind regards,
Tony