Deep Dive into FSMA Foreign Supplier Verification: 5 Pitfalls to Avoid

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Deep Dive into FSMA Foreign Supplier Verification: 5 Pitfalls to Avoid

By | 2018-04-02T16:54:09+00:00 April 2nd, 2018|cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, Food, FSMA|

FSMA (which was signed into law in 2011) laid out many new demands for food processors in the United States. One aspect of FSMA was shifting the responsibility of food safety onto importers by requiring a Foreign Supplier Verification Program (FSVP) to monitor all foreign suppliers. With this complex system in place, it is important to avoid the pitfalls that others have already experienced. Below are 5 major pitfalls along with practical ways to avoid them.

1. Taking on the process alone.

Since the FSVP emerged, an abundance of research and aid has been developed for importers. To ignore the resources that are offered would be problematic. By keeping things insular and targeting the FSVP with workers and technologies that were previously within a company, it is easy to overlook issues in the development of a program.

One simple way to institute some outside aid is by sending qualified individuals to additional training in preparation for FSVP. Incorporating this new information into the workforce will result in a better program. FDA approved curriculum training like that of Professional Food Safety could be instrumental in preparing staff involved in FSVP.

Another type of support can come from third-party organizations or companies that come alongside suppliers in the creation of an FSVP. It can be useful to have these experts for recommendations and instruction. One example is Assistance by Decofruit — a service that helps with the implementation of FSVP at every level.

Other aid includes technological and electronic platforms for monitoring, tracking, or storing information on suppliers. Small or medium businesses might consider a system like Safefood360° to manage compliance and perform many time-consuming tasks on their behalf.

(NOTE: Want to know what enforcement actions are happening in your supply chain? Get your FREE SUPPLIER ASSESSMENT.)

2. Meeting requirements without proper documentation.

Correctly abiding by the rules of FSVP is only half of the requirement. Without evidence (proper documentation), all implementations are void. Hazard analysis, controls, verification activities, corrective actions, and any other operation must be recorded as per FSMA specifications and kept for a period of 2 years. A complete reassessment of plans must take place every 3 years to replace prior records.

The requirements for documentation are outlined in-depth here for your reference.

3. Treating all suppliers the same.

Not all suppliers are identical, so it would be a mistake to treat them as such. Depending on the type of food that they supply, they might fit under different conditions or exceptions to begin with. Even disregarding the variation in requirements, to employ the same program for every supplier would be a waste of both money and time.

Efforts should be focused on the riskiest suppliers to ensure food safety across the entire system in the most efficient way. Tiering based on the processes that each supplier is involved in (as well as their history and current compliance) can separate those that belong in high, moderate, or low risk categories. A tool that provides data and risk analytics by tracking FDA compliance for suppliers around the world is FDAzilla.

Once risk is identified, the appropriate course of action can be tailored to individual suppliers in an effort to reduce the risk that is present. For example, it would be an astronomical investment to order annual audits for 1000+ suppliers. By simply assigning other verification activities like review of documentation or sampling/testing for lower risk tiers, a limited number of annual audits is more manageable. With this method, the risk is limited, avoiding unnecessary costs.

4. Missing important deadlines.

A large source of confusion for foreign supplier is when exactly they must be fully compliant with FSVP. There’s confusion regarding the many dates floating around for separate classifications, whether suppliers are subject to the PC or produce safety rules, the size of the suppliers, whether suppliers are dealing with human or animal food, etc. As if this weren’t enough to sift through, modifications and exceptions are scattered around the industry. Companies can find the exact dates that they must note here to avoid the confusion that many are facing.

5. Delaying the implementation of an FSVP.

Even once the dates for compliance are nailed down, steps towards an FSVP should be taken immediately. The assumption that a group of suppliers already fit the requirements will likely leave importers with heavy fines and possibly criminal charges. To stay ahead of the competition, a hazard analysis paired with tiering to asses the state of suppliers should be enacted today for guidance. Knowing the pitfalls to avoid will launch importers into the process that awaits them — a process that can only be effectively tackled with urgency.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

(RELATED: Shine a light on your supply chain with a FREE FOOD SUPPLIER ASSESSMENT.)

About the Author

Paul Brooks

Paul Brooks is the lead FSMA/Food Business Development Representative at FDAzilla.

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