In risk assessment, it’s always important to ask the right questions.

The Food Safety Modernization Act (FSMA) requires that bakers and snack producers upgrade their existing risk assessment from Hazard Analysis and Critical Control Points (HACCP) to Hazard Analysis and Risk-based Preventative Controls (HARPC). Don’t let the acronyms or hype scare you — HARPC is exactly what it says — a food safety risk assessment.

Although the HARPC has been called “HACCP on steroids,” the assessment should essentially identify controls to prevent failure and corrective actions to take in the event of a failure. Keep in mind that you are probably already doing much of what is required in your HACCP, prerequisite programs and training programs. Under FSMA, these need to be integrated and documented in a food safety plan to ensure risks are identified, controlled and managed and prevent harm to a consumer in the case of a failure.

Start with a comprehensive food safety risk assessment of your process, including incoming ingredients, storage, processing, employee practices, packaging, shipping, distribution and use of the finished product by customers and consumers. Establish a team of knowledgeable people to perform the risk assessment. Use it as an opportunity to educate the team and build awareness of the risks that exist. Don’t expect the assessment to be a “once and done” activity. A team will get better at identifying risks with some experience. Conditions will change, meaning risks will change. Unexpected failures will occur, creating awareness of different types of risks. Vendors, crops, people, process, equipment and more will change. The question that the risk assessment process will ask is: “What can go wrong?”

Consider each situation and rate it for the factors that will determine the magnitude of the loss should a failure occur. The question to ask here is: “How bad would it be if it went wrong?” The factors to rate include severity, probability, complexity, scope, speed, consumer outrage and uncertainty. A team can assign a numeric value to rate the relative importance of each factor. Then add up the scores and rank them accordingly.

This exercise will focus on the most important risks. You will need to put controls in place based on feasibility, not importance. Discuss what can be done to prevent failure. At first, be open to all ideas, regardless of feasibility or cost. Then, answer the question: “What could we do if there were no constraints on time, resources or cost?” Consider what steps are feasible and affordable.

Next, put in place the identified controls. Assess whether the execution has been adequate to control the risk. Understand that perfection is neither possible nor the goal. We need to implement the best controls that we can afford given reasonable constraints of time, money and resources. However, failures will occur despite our best controls.

The goal is to be diligent, not negligent or ignorant. Ignorance means not being aware of a risk or the potential failures that can occur; this is an indefensible position. Negligence means that we are aware of a risk, and the potential failures that can occur, and we choose not to address them by effective controls; this is an illegal position. Use the risk assessment process to go from ignorance to awareness. Identify and implement effective controls to go from negligence to diligence.

Establish procedures to detect failure at the control points. Train your employees to report a failure quickly and to enable effective corrective actions that can prevent the failure from resulting in loss or harm to a consumer. Like it or not, failure will occur, even in the best systems. Expecting no failures creates complacency and creates a new risk; namely, that failure will go undetected because it “cannot” happen.

Finally, document the risk assessment process, the identified risks, the ranking of importance, the controls implemented, the corrective actions to take in case of a failure and the training program to ensure that the necessary employees are aware. These steps should be outlined in your food safety plan, reserving the details for accompanying documents, procedures and prerequisite programs.