The terms validation and verification are often confused. During validation of your HACCP plan, you determine if your HACCP system is capable of eliminating hazards or reducing them to a safe level. Verification on the other hand consist of ongoing activities to determine if the HACCP system is working effectively. HACCP validation should be done during the first 90 days of a new or revised HACCP plan. During this time your responsibility will be to collect the data needed to demonstrate that all critical operating parameters are met and hazards are kept under control. But how do you determine what critical operating parameters are effective in the first place? You certainly cannot select them out of a hat and hope for the best. All processing conditions must be based on scientific support. This support may come from peer-reviewed scientific journals, processing authorities, trade associations and regulatory guidelines. These sources should provide technical information on:
- The target pathogen
- The processing parameters required to control the pathogen
- The degree of pathogen reduction when the process is applied
- The processing steps that control the pathogen, and
- How to monitor the processing steps
Make sure that whatever process you are using for your operation, that it has the appropriate scientific support to meet safety and regulatory requirements. A validated study showing critical limits to control Salmonella in half-inch diameter beef sausages, is unlikely to be suitable for your process if your sausage diameter is one inch. Further the scientific support should be for the same pathogen that you are intending to control. Don’t assume that because the validated process controls E. coli O157:H7, that it will also control Salmonella in your process. This will not guarantee safety since Salmonella bacteria is more heat-resistant than E. coli O157:H7.
Assuming that you are using a process that was previously scientifically validated, you must demonstrate that your operation is able to maintain the required processing conditions to control the hazards of interest. Microbial data does not have to be collected if you are strictly following the validated process. However, if the pathogen reduction is not provided in the scientific support documents, or if you are using a modified process, you must also collect microbial data to demonstrate that hazards are effectively controlled. Note that the validation process is mainly focused on the HACCP plan rather than the prerequisite programs. However, if you determine that a hazard is not likely to occur because it is controlled in a prerequisite program, then that prerequisite program must be validated to ensure that it is actually controlling the hazard. Your initial HACCP in-plant validation records should include:
- HACCP records
- Record showing that operating parameters (time, temperature, pH, etc.) are met
- Methods for measuring critical operating parameters
- Process used to decide on your CCPs
- Sampling methods
- Records relating to initial operational setup that may have an impact on the HACCP plan e.g. equipment type and product formulation
After your initial 90-day HACCP validation, then you should conduct ongoing verification activities to prove that the HACCP plan is being consistently followed. Verification activities may include calibration, direct observation, testing, and review of records. Be also prepared to reassess/revalidate the HACCP plan if anything changes that will compromise the ability of the process to control the hazards of interest e.g. changing equipment, changing suppliers, removing or adding a new step to the process etc. You do not have to validate every single product in your plant. However every HACCP plan must be validated.
Reference: USDA – FSIS. (2015). Compliance guideline HACCP systems validation
