With all of the new requirements of FSMA, it can be difficult to know where to focus with your FSVP. Would you be ready for an FDA inspection tomorrow? Here are 10 important questions to ask yourself to ensure that your foreign suppliers are on the right track:
1. Does FSMA’s Foreign Supplier Verification Program apply to me?
If you are importing food into the US for processing, then the answer is mostly likely “yes.” There are a few exceptions, however, that might get you and your foreign suppliers off the hook. Well, at least somewhat off the hook. If you are importing juice or seafood, then you must defer to the HACCP management system. Alcoholic imports remain under the jurisdiction of ATTB. Meat, poultry, or egg products under regulation by the USDA often aren’t subject to the FSVP. Imports solely for research use or personal consumption are also exempt from FSVP, along with low acid canned foods and transshipped foods. It might be worth your while to look into which category your products belong in.
2. Do I have the proper identification to import my suppliers’ products?
Under the FSMA, specific identification is required of importers. A Dun and Bradstreet Universal Numbering System (DUNS) must be obtained by each organization. When filing for entry with Customs and Border Protection, this information must be available to verify electronically, along with your name.
3. Which hazards are associated with the type of food imported and the corresponding processes?
Much of FSVP centers around hazard analysis, and this begins with the type of food subject to importation. Initial hazards to anticipate generally fit into one of three categories: biological, chemical, or physical. Biological hazards include viruses or parasites associated with the food — from salmonella to cyclospora cayetanensis. Chemical hazards emerge from the processes involved, often from pesticides or additives. Physical hazards, mainly foreign objects (glass, plastic, etc.) that might enter the process, should also be assessed. Each of these hazards is the starting point for your FSVP and correctly identifying them is vital for subsequent planning.
4. Which risk-tier do each of my suppliers fit under?
Another step in the tiering process is looking into the history of your suppliers and their compliance with the FDA. FDAZilla is a tool that can do much of the tiering for you. It tracks suppliers and FDA action through a single portal. These analytics, paired with the inherent hazards for the food type, should place each supplier into a tier of high, moderate, or low risk.
(RELATED: Shine a light on your supply chain with a FREE FOOD SUPPLIER ASSESSMENT.)
5. What actions have been taken to mitigate hazards?
Based on the tiers each supplier is placed in, the appropriate measures should be relatively straightforward. An individual safety plan is needed for each supplier, with proper verification activities to ensure that this plan is consistently enforced. Efforts should be focused foremost on high-risk suppliers, then moderate and low-risk tiers. This would entail annual on-site audits, sampling and testing, or reviewing safety records, respectively.
6. Is my FSVP up to date?
Under the new requirements of FSMA, the FSVP must be reassessed every 3 years, at a minimum. If new potential hazards arise, however, then the program must be altered immediately.
7. Does each supplier have adequate record-keeping for the FDA?
Record-keeping is arguably one of the most stringent requirements under FSMA and can make or break your FSVP. Each component must be tracked diligently to provide proof of preventative measures and verification activities. Supplier approval, audits, sampling and testing, food safety records, procedure, qualification, and hazard controls are just a small portion of necessary records. An in-depth description of what the FDA is looking for can be found here.
8. Are my personnel sufficiently qualified?
“Personnel” referenced for the FSVP mainly includes two groups – preventative control plan workers and auditors. FSMA vaguely dictates that preventative control plan workers need appropriate education and experience. Although it is left up to interpretation as to what is deemed “appropriate,” an FDA approved training class is a way to cover all of your bases. Classes approved by Food Safety Preventive Controls Alliance (FSPCA) can bring your personnel up to speed.
Many companies opt to use third-party auditors, and these simply must possess certification under the FDA. Individuals involved in auditing for your FSVP have to be competent for the task they are performing. If you have proof of the skills and ability of the individual to carry out auditing activities, that is sufficient approval for them to take on that role.
9. Do my foreign suppliers have food safety programs that meet the required level of preventive controls for human and animal food?
Preventative controls are impacted by recent updates to Good Manufacturing Practices and should be noted. A food safety plan is the backbone of the requirements. These plans must have a hazard analysis that goes hand-in-hand with questions 3 and 5 above. Preventative controls (including process, food allergen, sanitation, and others) make up another part of the plan. Oversight and management of the controls (verification activities), a supply chain program, and a recall plan comprise the rest of the plan you should follow.
10. Is produce safety suitably incorporated in my plans and processes?
Produce safety is largely targeted with the FSMA and, consequently, must be incorporated in your FSVP. All produce used in the food you are dealing with must be subjected to specific measures to confirm safety on many fronts. Even if there are already controls in place, this must be documented in your FSVP. Here is a general checklist that includes the major focal points of food safety, each of which must be met with appropriate measures:
- Soil amendments
- Worker training
- Health and hygiene
- Equipment and building
- Holding activities
Once these questions are answered in the context of your foreign suppliers, the areas that demand more of your attention should be clear. With all the new policies thrown your way, don’t hesitate to analyze your company and consolidate efforts where they are needed. Staying ahead of the competition with relevant action is key, so get started now.
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 Author
Michael de la Torre is the CEO of FDAzilla.