The terms validation and verification are often confused. During validation, you determine if your HACCP system is designed and capable to eliminate hazards or reduce 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. In some cases, you may also need to collect microbial data to demonstrate that pathogens of interest are being controlled.
But first, how do you determine what critical operating parameters are effective? You certainly cannot select them out of a hat and hope for the best. For example, you wouldn’t just say that you are going to cook meat for 15 minutes at 250oF without a scientific basis for choosing those limits. Any such parameters used in processing must be based on scientific support to demonstrate that they can eliminate or satisfactorily control your risks.
So, where can you find the scientific support to determine your processing parameters (e.g. time, temperature, pH, pressure, conveyor speed, humidity, concentration)? Good places to look include:
- Peer-reviewed scientific journals
- Technical documents from processing authorities and trade associations
- Regulatory guidance documents
These documents should inform you 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 your product and process are consistent with the scientific support documentation you have. For example, 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. Neither will it be a good idea to assume the same critical limits if your sausage product is made from chicken instead of beef.
The scientific support should be for the same pathogen that you are intending to control. Don’t assume that since the validated process you would like to use control E. coli O157:H7, that it will also control the pathogens in your process. It is true that in some cases the presence of one type of pathogen is an indicator for the presence of another. Therefore, if you control the indicator-pathogen you control the others. However, have adequate validated scientific support for this on file.
It is also recognized that some pathogens are more heat-resistant than others. Therefore, destruction of the heat-resistant type will indicate destruction of those that are less heat-resistant. For example, Salmonella is more heat-resistant than E. coli O157:H7. So, if you eliminate Salmonella, you essentially take care of E. coli O157:H7 as well. Just make sure that you have the scientific support to justify targeting an indicator organism instead of the actual hazard you are concerned with.
Validation in a HACCP program is focused on the HACCP plan rather than 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 becomes a part of the HACCP plan. Therefore, you will have to prove that the hazard is effectively controlled in the prerequisite program by providing scientific support.
If your process is consistent with the validated process on file, then you will only need to demonstrate that you are able to consistently execute the required operating parameters. That means for example, that you will have to show that you are able to cook at the determined temperature and time, maintain the correct pH, apply the right level of antimicrobial treatment, or whatever parameter that is effective in controlling the hazard.
Microbial data does not have to be collected if you are strictly following the validated process. You will only need to demonstrate that you can maintain the operating parameters. 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.
Your initial HACCP in-plant validation records should include:
- HACCP records
- Record showing that operating parameters (time, temperature, pH, etc.) are met
- Methods for gathering critical operating parameters
- Documentation showing how you decided 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.
An important point to mention is that you do not have to validate every single product in your plant. You may only validate one product in each HACCP category. So, which one should you validate? The general principle is to take a worse-case-scenario approach. Which one of the products in the category represents the worst case? For example, is one product slightly larger in size than the others? This may impact heat penetration rate, so you may want to run the validation on that product.