Introduction to Validation and Verification as GFSI requirements
A food safety plan will not be complete without monitoring, verification and validation activities. That is exactly why food safety manuals are usually thick. A complete food safety plan includes hazard identification and plans to control identified hazards along with monitoring, verification, validation and record-keeping activities.
Today, we will focus on clarifying the difference between verification and validation along with a quick example. Let’s get started.
According to SQF Appendix for SQF 9.0 Manufacturing, the term Validation refers to an element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP food safety (or quality) plan is properly implemented, will effectively control the hazards (CODEX).
The goals of validation are to determine the effectiveness of a food safety plan for controlling identified hazards. Validation evidence can come from two main source categories -internal and external sources.
Internal validation sources:
- Food Safety trends and data analysis from in-house data (e.g. GMP trending, Microbial trending analysis etc.)
- Internal validation studies (e.g. allergen cleaning validation, Metal Detector validation)
External validation sources
- Food Safety Critical Limits (typically from local and internationally recognized sources, e.g. government or regulatory website, industry-related guidance documents)
- Validation studies data (from industry-related documents, supplier’s validation report studies)
- Peer-reviewed scientific literature
- Mathematical modelling
Further, in their article titled “Validation and Verification of Food Safety Measures,” the Quality Assurance and Food Safety Magazine suggested that there are six major steps for validating kill-steps.
Determining methods for validation
- Select a surrogate or pathogenic microorganism
- Identify worst-case scenarios
- Conduct validation study by a qualified microbiologist or food safety expert
- Data collection and analysis
- Preparation of validation report
In writing a validation report, the report must include
- Contact information
- Background information
- General Information about the product
- Parameters studied
- Details of equipment (models)
- Microbial strain used
- Date of Validation Study
- Discussion and Significance
The report must be clearly written so that it can be repeated and understood properly.
According to SQF Code 9.0 Food Manufacturing under the Appendix section, the term Verification refers to activities other than monitoring, determine the validity of the HACCP food safety (or quality) plan, and ensuring that the system is operating according to the plan(CODEX).
In other words, verification refers to the activity that we conduct to ensure that our plan operates as intended. Here are few verification activities.”
- HACCP process flow and traffic flow verification
- Document and record review
- Internal Audit
Whenever possible, it is recommended that the person conducting the verification activities be independent of the person conducting the monitoring activities. For example, the QA Manager verifies the temperature records monitoring log while the QA technician records the temperature. This is to prevent confirmational bias.
SQF 9.0 Validation and Verification Requirements
Under the requirements of SQF Food Manufacturing Code 9.0, the following are required:
2.5.1 Validation and Effectiveness (Mandatory)
22.214.171.124 The methods, responsibility, and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented. The methods applied shall validate that:
i. Good Manufacturing Practices are confirmed to ensure they achieve the required results;
ii. Critical food safety limits are reviewed annually and re-validated or justified by regulatory standards when changes occur; and
iii. Changes to the processes or procedures are assessed to ensure the controls are still effective.
Records of all validation activities shall be maintained.
2.5.2 Verification Activities (Mandatory)
126.96.36.199 The methods, responsibility, and criteria for verifying monitoring of Good Manufacturing Practices, critical control points, and other food safety controls, and the legality of certified products shall be documented and implemented. The methods applied shall ensure that personnel with responsibility for verifying monitoring activities authorize each verified record.
A verification schedule outlining the verification activities, their frequency of completion, and the person responsible for each activity shall be prepared and implemented.
Records of verification of activities shall be maintained.
How to Comply with SQF 9 requirements?
Based on the requirements, here are quick tips for ensuring your compliance with SQF 9.0 requirements (also works for most GFSI requirements:
- Record keeping -ensure all records pertaining to validation and verification activities are kept.
- Document your verification and validation procedures. In general, you want to list
- Methods, responsibility, and criteria for verification and validation
- What are you verifying and validating? As a starter, include all SQF requirements (Module 2 and 11) and the food safety plan
- Very important and commonly missed! Verify and validate before you change a process or add a process.
- Build a Visual Verification and Validation Schedule
Channaiah, L. (2015, June 11). Validation and verification of food safety control measures. Retrieved May 02, 2021, from https://www.qualityassurancemag.com/article/aib0615-food-safety-validation-verification-methods/
SQF Code – edition 9 Food Manufacturing code downloads. (2020, November 13). Retrieved May 02, 2021, from https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/