Verification and the Preventive Controls Rule

Contributed by Anne Sherod, The Acheson Group 

I previously gave an overview and background on FSMA and the Preventive Controls Rule and the Rule’s intent to give U.S. Food and Drug Administration (FDA) the authority to require that companies build food safety into their processes so that issues could be prevented from occurring – more specifically, “preventative controls”.

Today we will address the two types of verification: validation and evaluation.

There are two overarching aspects of verification: one is the initial validation and the other is the evaluation that the system is performing as expected. Both of these aspects are directed at the effectiveness of the control for each significant hazard. They establish that the control is scientifically valid for controlling the hazard and verify that the control process or procedures are accomplishing the intended purpose to prevent, eliminate, or significantly reduce the likelihood of the hazard.

There has been quite a bit of confusion in the past about verification and validations, especially since the U.S. National Advisory Commission on Microbiological Criteria for Foods (NACMCF) definition for verification includes validation and excludes monitoring, and the Codex Alimentarius Commission (Codex) definition includes monitoring and does not specifically mention validation.

The Codex Alimentarius Commission (according to its website), was established by FAO and WHO in 1963 and develops harmonized international food standards, guidelines and codes of practice to protect the health of the consumers and ensure fair practices in the food trade. The Commission also promotes coordination of all food standards work undertaken by international governmental and non-governmental organizations.

As a result of differing opinions from major authorities in the industry, food safety employees may ask “Why are these different?” and “ What is a verification activity and what is a validation activity?”

Validation

Validation is the initial determination that the controls are scientifically and technically sound to prevent the hazard. This initial validation will answer the question, “How do I know that what I’m doing is working so that I have achieved the reduction in the hazard that I’ve specified to achieve (e.g., 100% inspection for metal greater than 4mm in size)?” The information to support the initial validation can be peer-reviewed public literature, regulatory guidance, trade association publications, manufacturer’s technical information, company knowledge, and initial in-plant data collection. Validation happens prior to putting the control or the plan into place.

Evaluation and Verification

Verification involves evaluating that all hazards — as determined by a hazard analysis to be significant — have been identified, as well as determining that if the food safety plan is properly implemented these hazards will be effectively controlled. Another aspect of verification is evaluating whether the facility’s HACCP system is functioning according to the HACCP plan (HACCP Principle 6: “Establishing Verification Procedures” NACMCF). In other words, “Am I doing what I’ve said I am going to do in the plan?”

Regulatory Requirements for Verification

Verification, as it is known today in Principle 6, was originally published in NACMCF HACCP in 1989 and adopted by the Federal regulatory agencies as a required part of HACCP (D.A. Corlett, 1998). Currently, there are three regulated HACCP programs:

• FDA Juice HACCP (21 CFR 120)
• FDA Seafood HACCP (21 CFR 123)
• USDA – FSIS meat and poultry HACCP regulations (9 CFR 417)

There is one difference to note as it relates to verification. In NACMCF, verification is Principle 6 and records is Principle 7, and these are used for the basis of the FDA Juice and Seafood HACCP regulations. In Codex, these two principles are transposed and this is the basis for the USDA-FSIS Meat and Poultry HACCP. For the purposes of these articles, verification is noted as HACCP Principle 6.

As mentioned previously, verification will be a critical component of your food safety plan, because it demonstrates that you’re keeping tabs on your food safety system.To see a brief summary table of Required HACCP Verification Activities, see the White Paper written in cooperation with The Acheson Group: Verification: Can Your Food Safety Plan Meet the Rigors of FSMA’s Proposed Preventive Controls?