*Editor's note: this post is the first in an ongoing HACCP series.
The concept of HACCP validation has long been a mysterious and confusing topic for many people. Since it is included as a part of HACCP principle number 6 for verification, the validation requirement is often misunderstood.
There are many advocates, myself included, that feel like the National Advisory Committee for Microbiological Criteria for Foods should revise the standards to clarify the topic and give it the attention it deserves. Until then, I hope to help you learn the elements of validation and how you can prepare for the new Food Safety Inspection Service (FSIS) requirements before enforcement begins in 2016.
What is HACCP Validation Anyway?
In the simplest form, verification asks the question, “Are you following your HACCP plan the way it is written?”
Validation asks an entirely different question, “Is your HACCP plan written accurately?”
Proper validation assesses if the correct hazards have been identified in the hazard analysis. It also demonstrates whether or not the control measures cited in your HACCP plan address those hazards assuring a safe, unadulterated product is produced.
1st Element of Validation - Proper Design
The first element of proper HACCP validation under FSIS is scientific or technical support that confirms proper design. This includes published support documents that closely match the plant’s processes to control identified hazards.
Major types of support include:
- scientific or technical data
- regulatory performance standard and guidelines
- pathogen modeling programs
- processing authority advice
- challenge studies
- data gathered from plant operations
The best place to start is to assemble this type of information from your HACCP plan supporting documentation.
Be prepared to also identify the critical operational parameters that are relevant to processes. This will be necessary when comparing the critical controls cited in scientific or technical support. It will also help to determine if the studies referenced reflect the same conditions that are used in plant processes.
2nd Element of Validation - In Plant Validation
Next, the initial in-Plant validation confirms proper execution of the HACCP system. This requires your operation’s critical controls to match the criteria cited in support documents.
Methods of in-plant validation may include:
- plant observations
- microbiological test results
- other measured control information
The bottom line is, the plant must produce defensible documentation of adequate hazard controls.
Preparing to Comply
The industry has its work cut out when it comes to compliance, no doubt.
Begin by choosing at least one product from each HACCP plan category and collect in-plant data. Analyze the data and demonstrate effective implementation of the critical operational parameters for the product.
Under FSIS, large establishments must review a minimum of 90 calendar days’ records as part of this process. Small and very small establishments must review data from a minimum of 13 production runs.
It will take time for establishments to define how to approach these new requirements. Even though the enforcement deadlines seem far away, it is important for the industry to begin preparing now!
Give your operations team time for developing validation protocols, time to complete required microbiological testing, and time to review production day records well ahead of the enforcement dates. Additionally, be sure to regularly reassess your HACCP plans.
So, as a final thought for HACCP validation, are you doing it right?