With a couple of words, the FDA drastically altered the expectations of food processors. Those words were: “shifts accountability.” The impact of the FSMA for major companies largely comes down to this transfer as food processors are now responsible for every supplier along the line of bringing products from the farm to the table.
One major aspect is the extensive verification now required, a process that includes compliance status review, hazard analysis, verification activities, corrective actions, periodic reassessment of the Foreign Supplier Verification Program (FSVP), importer identification, and record-keeping (citation).
Sound like a lot? Multiply that process by hundreds or thousands of suppliers scattered across the world and the implications are dizzying. The monetary investment is significant in itself, but the time necessary for such a feat compounds the demand.
What if there was a way to systematically approach this task to target risk and minimize expenditure? There is, and it is possible to enact the approach in 30 days with these 3 steps.
Step #1: Tier the risk based on the food.
By designating risk in 3 tiers (high, moderate, or low), supplier verification can take on a categorical, organized nature. This risk is based on the hazards associated with the specific foods and the accompanying processes.
Each food item inevitably comes with its own inherent risk, whether it is poultry at risk for Salmonella or seafood at risk for Vibrio vulnificus. Biological factors should be considered on the basis of their potential in a certain area. This information can be ascertained through the history of prevalent viruses or parasites in connection to determined foods.
Other components should be similarly analyzed, including chemical risks. These could arise from the pesticides in use, color additives, sanitation chemicals, allergens, or other chemical processes involved in the production of the food in question.
Physical hazards, of which foreign material is the most significant, could contribute to a higher level of risk. If a foreign material control program is employed, this risk can be appropriately mitigated through GMPs or GAPs.
After the known or anticipated safety hazards for each food is taken into account, the processes are the next thing to enter the equation of defining risk. From storage to packaging to transportation, each stage involves a level of risk for the supplier. It is the company’s job to decide which level of risk their supplier(s) fits in to. Combining this information with the biological, chemical, and physical hazards, each supplier should now fit within one of the initial 3 risk-tiers.
Step #2: Tier the risk based on the suppliers.
Like food, each supplier has its own unique set of risks to go along with it. When looked at in the context of FDA inspections, it can be relatively simple to finalize which tier each belongs in. Past history of inspection can be a large guiding factor; how often they have been inspected, what the results of the inspections were, and the focus of those inspections.
FDAzilla provides a method to track FDA inspections across the globe, identifying the low or high-risk suppliers to prioritize your efforts. With the data portal, you have a way to save suppliers and cut the information for easy access. Taken as a whole, the analytics monitor and manage risk, ultimately doing much of the risk tiering on your behalf. Knowing where each supplier is on the spectrum either minimizes or exemplifies the perceived risk-level defined in Step 1. From this, high, moderate, and low risk should be evident to move into developing an adequate plan of action.
(NOTE: Want to see how to do this for your specific group of suppliers? Get your FREE Supplier Assessment by clicking here.)
Step #3: Develop program based on risk analysis.
The 80/20 rule is probably one that you are familiar with. It focuses 80% of the efforts on the riskiest 20% of the suppliers in your system. With the FSVP, more efforts would translate to more in-depth involvement with the supplier. This is where the risk-tiering comes in handy, dictating the action that will be taken for each individual supplier. Here is what that would look like for each tier:
- High-risk: Annual on-site audit to ensure the safety of the food and that it will not result in serious adverse health consequences or death to humans or animals (called a SAHCODHA hazard).
- Moderate-risk: Sampling and/or testing the food product or environment.
- Low-risk: Periodically collecting and reviewing food safety records from the supplier (hazard control and ongoing safety plan).
This method of tiering and consecutive verification activities simplifies the requirements under FSMA and ensures that importations are safe. Splitting it up into 3 different categories eliminates unnecessary efforts and puts the proper program into place on an individual basis.
It is possible to follow these steps in 30 days, so act now. Being prepared on the front end will put you ahead of the competition, giving you a chance to anticipate potential outcomes instead of reacting to unexpected consequences. 30 days from now you can be fully FSVP ready.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
About The Authors
Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.
Paul Brooks is the lead FSMA/Food Business Development Representative at FDAzilla.