Risk assessment is now mandated by the regulation focusing on Preventive Controls for Human Foods. The regulation mirrors the ISO 22000 standard, Food Safety Management Systems—Requirements for any Organization in the Food Chain, in that it states that risk assessment should include likelihood of occurrence and severity of occurrence. Risk assessment really should not have been treated as a new concept, but, in reality, very few companies were actually doing comprehensive assessments on ingredients and the process.
Way back in 1994, Dr. Russell Cross of the United States Department of Agriculture emphasized the importance of risk assessment as part of HACCP. “We believe that the HACCP system, coupled with strong risk assessment programs, is the food safety system of the future … and the future is now.”
There are different tools for assessing risk currently in use. Perhaps the most common is a system in which the company assigns a value to likelihood of occurrence and severity, and multiples them together to get a risk rating. The higher the final value, the greater the risk. In addition, the United States Food and Drug Administration (FDA) has developed a draft document entitled, “Hazard Analysis and Risk-Based Controls for Human Food: Draft Guidance for Industry.” This document summarizes the current thinking of the Agency when it comes to hazards associated with different foods and ingredients (Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food - Appendix 1 Tables (fda.gov) ). It is an invaluable tool for processors looking to better understand potential risks with their ingredients, products and processes. Processors need to fully document the risk assessments that they have conducted as they will be challenged on the subject by third party auditors and regulators.
Validation has been an integral element of the basic HACCP principle of verification for over 30 years going back to when the seven HACCP principles were first proposed back in 1989. In 21 CFR Part 117.3, Definitions, validation is defined as “obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.” In other words, validation ensures that the preventive controls that a company establishes will ensure that hazards are properly controlled and that safety is ensured.
Lastly, let’s touch on supplier controls. Any processor that does not have a validated kill step in their processes is usually going to have to rely on supplier verification and in-plant programs to ensure that products are not contaminated during process operations. The word “usually” is used because there are products that are not only inhibitory to microorganisms (bacteriostatic) but lethal. Processors that manufacture such products should conduct challenge studies to validate that the products are inhibitory or lethal to pathogens. Supplier management involves a number of steps: identification of the supplier; supplier approval, which usually includes a supplier questionnaire; first- or third-party audits; detailed evaluation of the material being purchased; and ongoing supplier assessment. The passage of the Foreign Supplier Verification Program underscores the importance that the FDA places on supplier quality and safety especially materials coming from overseas suppliers. FE