While the terms verification and validation come from HACCP, the concepts can be applied to all plant programs. Once the concept of verification and validation is understood, implemented, and yields favorable results, plant personnel can be confident that the established programs and the documentation are being carried out and are meeting the desired objectives.
Verification includes a records review that is completed as tasks are carried out. Some records that may be reviewed as part of a food safety verification include:
- cleaning schedules
- allergen changeover sheets
- pesticide application logs
- chemical concentration checks
- shipping and receiving inspection reports
- time and temperature logs
- metal detector logs
The review determines if frequencies are in compliance with the program, if results are in compliance with the program, and if corrective action has been taken for any results that fall outside acceptable limits. For example, if ingredients arrive on a dirty truck or a chemical concentration check shows an established concentration limit has not been met, the results fall outside acceptable limits.
Verification also includes calibration of measuring devices, such as thermometers and pH meters. Calibration helps to ensure that the recorded results are accurate. If these devices are not calibrated, the results can be misleading and are useless.
Validation may also include a review of records. Records that would be reviewed to determine if existing programs are valid include equipment and environmental testing results, customer or consumer complaints, and results of finished product testing. Testing of equipment, product, and environment can be used to determine the effectiveness of control measures for microorganisms and allergens. For example, acceptable baseline limits should be established for air and water quality. If test results exceed these limits, you can assume that the current measures are not meeting the program objectives and corrective action must be taken. Customer or consumer complaints related to product safety are a clear indicator that there may be a program gap or failure. While the absence of complaints is a good indicator, it alone is not proof of an effective program.
External resources also can be used as part of validation. External resources to consider include suppliers (equipment, ingredients and chemicals), scientific literature, universities and industry associations. Equipment suppliers can provide key information about preventive maintenance requirements, calibration and equipment capabilities. For example, a metal detector manufacturer can help establish the capabilities of the unit to determine which test pieces should be used to test and/or calibrate the unit. Ingredient suppliers can provide key information about refrigeration requirements for micro-sensitive ingredients, allergens present, etc. Scientific literature may be used to determine if microbiological controls or kill steps meet established limits for time/temperature, chemical concentration, etc.
A combination of both verification and validation is essential for a successful audit program. Using both tools can determine if established procedures are appropriate and implemented. Here are some sample verification and validation questions that may be incorporated into the internal audit program.
- Do written procedures exist?
- Do records exist?
- Do records exist for each appropriate occasion (ingredient receiving, allergen changeover)?
- Do records show compliance with the written program?
- Are frequency requirements met?
- Are results in agreement with established limits?
- Was corrective action taken for any results that fell outside of established limits?
- Do employees know the procedure requirements?
- Does scientific data support the established limits?
- Are procedures in compliance with manufacturer or supplier recommendations?
- What are the self-inspection results?
- Are objectives of procedures met?
- Are corrective actions effective?
- Are deficiencies recurring?
- Are there customer or consumer complaints?