Validation in a HACCP plan is the process of obtaining and evaluating scientific and technical evidence to confirm that control measures, when properly implemented, are capable of effectively controlling identified food safety hazards. Under FSMA’s Preventive Controls for Human Food rule (21 CFR Part 117), validation applies not only to individual control measures but also to the food safety plan as a whole. It is a design confirmation step, establishing that the plan is scientifically sound before relying on it to protect consumers. It is a critical step in the development of a HACCP system because it ensures that the system is properly designed and that all necessary controls have been included.
Validation starts with an assessment of the program, which is conducted by an individual or team that has no prior knowledge of the program. This group or person evaluates the plan for inconsistencies and omissions, ensuring that all critical parameters have been identified and addressed. While a formal processing authority is a regulatory requirement specifically for manufacturers of acidified foods (21 CFR Part 114) and low-acid canned foods (21 CFR Part 113), validation is a broader requirement under FSMA for any facility with process preventive controls. Under 21 CFR Part 117, validation activities must be conducted by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI). For complex thermal, pressure, or chemical process controls, engaging a food process authority remains a strongly recommended best practice even when not strictly mandated.
A common source of confusion in food safety management is the distinction between validation and verification. Validation is conducted before or at the start of operating a control measure to confirm, using scientific and technical evidence, that the measure is capable of controlling the identified hazard. Verification is the ongoing activity that confirms the control measure is actually being implemented correctly and consistently in practice. In simple terms: validation proves the plan will work; verification proves the plan is working.
A Food Process Authority Can Help With Validation and Validation Protocols
A food process authority can partner with you to evaluate the worst-case parameters of your processing equipment. They can determine where the cold spots are. They can tell you which part of the product is exposed to the shortest time of processing. They can measure temperature drift over the duration of a long shift. They can scientifically determine the longest run time for your equipment. There are so many variables to assess, and a food process authority will make sure you are addressing all the variables.
A food process authority is often a food engineer or chemical engineer. You want to hire someone who has been in a lot of food facilities with a variety of processing equipment. With experience like that, they will have applied their knowledge in many operations and may have seen a setup like yours or worked with the same equipment at a different facility.
Validation Protocols Test Each Component
The next step is designing validation protocols, which will be used to test each component of the program. These protocols should include information about how each control measure will be tested (what methods will be used) as well as when and how often they will be tested during normal operations.
Validation protocols must also include details about what happens if a problem is found after testing has occurred. Incorrectly calibrated equipment or improperly trained staff can lead to serious food safety issues, so it’s important to know how these issues will be resolved if they’re discovered before or after validation testing has been completed.
It is worth noting that the foundational international HACCP document, the Codex Alimentarius General Principles of Food Hygiene (CXC 1-1969), was revised in 2020 and further updated in 2022 and 2023. The revised version formally requires that control measures be scientifically sound, elevates food safety culture to a structured requirement, and strengthens allergen management guidance within the HACCP framework. Facilities operating under GFSI-benchmarked certifications such as SQF or BRCGS should ensure their validation programs align with the current Codex version.
Facilities subject to FSMA Preventive Controls requirements should be aware that the FDA’s multi chapter guidance document supporting 21 CFR Part 117 validation remains in draft form as of early 2026. A GAO report released in January 2026 recommended that FDA establish a clear timeline for finalizing this guidance. Until the guidance is finalized, facilities should use the published draft chapters alongside peer reviewed scientific literature and process authority expertise to support their validation documentation.
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Validation Under FSMA
For food manufacturers subject to the FDA’s Food Safety Modernization Act (FSMA), validation is not just a HACCP best practice. It is a legal requirement embedded in the Preventive Controls for Human Food rule (21 CFR Part 117). Understanding what FSMA adds to traditional HACCP validation helps facilities avoid gaps between their HACCP-based practices and their regulatory obligations.
Who must validate under FSMA? Facilities subject to 21 CFR Part 117 Subpart C must validate process preventive controls — those control measures that rely on specific parameters (such as time, temperature, pressure, or water activity) to control a hazard. Validation is required before implementing the control measure, and must be repeated whenever changes are made to the process or product that could affect the effectiveness of the control.
Who must conduct validation? Under 21 CFR Part 117, validation must be conducted by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI). A PCQI is a person who has successfully completed training in the development and application of risk-based preventive controls through a curriculum recognized by FDA, such as the FSPCA Preventive Controls for Human Food course, or who is otherwise qualified through relevant job experience.
What counts as validation evidence? The FSMA rule requires scientific and technical evidence. Acceptable forms of validation evidence include peer-reviewed scientific literature, challenge studies, regulatory guidelines from agencies such as the USDA or FDA, data from similar processes at other facilities, or data generated through in-house studies. Documentation of all validation activities and the evidence on which they are based must be retained as records under the food safety plan.
Validation is distinct from ongoing verification. Validation establishes that a control measure is designed correctly and capable of controlling the hazard. Verification, which is a separate ongoing activity, confirms that the control measure is being implemented correctly in practice. Both are required under 21 CFR Part 117, but they serve different purposes and must not be conflated in records or procedures.
For facilities operating under both HACCP-based programs and FSMA Preventive Controls, maintaining a single integrated validation framework that satisfies both sets of requirements is the most efficient approach. Working with a PCQI or a food process authority to design and document this framework reduces audit risk and ensures the scientific basis for all process controls is clearly established.
FAQs
Validation and verification are both critical components of a HACCP plan, but they serve different purposes. Validation, as described in the article, involves confirming that the control measures and the HACCP plan as a whole are scientifically and technically sound to control the hazards effectively. It is about ensuring the design of the HACCP plan is capable of achieving its objectives. Verification, on the other hand, is the ongoing activity confirming that the HACCP plan is being implemented correctly according to its design. Verification activities can include regular checks of CCPs (Critical Control Points), calibration of monitoring equipment, and review of records to ensure compliance with the HACCP plan.
The frequency of HACCP plan validation can depend on several factors, including changes in the process, equipment, ingredients, or product formulation. It is also advisable to conduct validation activities whenever there is a reason to believe that the existing control measures may no longer be effective. Generally, it is a good practice to review and validate the HACCP plan annually to ensure it remains effective and up-to-date with any changes in the production process, regulatory requirements, or industry standards.
Yes, a HACCP plan can have too many control measures, which may not only be inefficient but can also dilute the focus on measures that are truly critical to food safety. Validation helps by ensuring that each control measure is both necessary and effective for its intended purpose. Through the validation process, unnecessary control measures can be identified and eliminated, allowing the focus to remain on critical points that significantly impact food safety.
Yes. Under FSMA’s Preventive Controls for Human Food rule (21 CFR Part 117), process preventive controls must be validated using scientific and technical evidence, and this validation must be conducted by or under the oversight of a Preventive Controls Qualified Individual. Having an existing HACCP plan does not automatically satisfy the FSMA validation requirement.
