Selecting a Qualified Individual (QI) for FSVP Compliance

When it comes to import-food safety under the FSVP rule, one of the most important (and sometimes overlooked) elements is the role of the Qualified Individual (QI). Without a suitably trained and documented QI, your FSVP may lack the backbone it needs to meet regulatory expectations and support consistent process standards.

What is a “Qualified Individual”?

Under 21 CFR § 1.503(a):

A qualified individual must develop your FSVP and perform each of the activities required under this subpart. A qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an activity.

This means:

• The QI is responsible for developing your FSVP and ensuring appropriate implementation.
• The QI must have the appropriate background (education, training and/or experience) to carry out those duties.
• The QI must be able to read and understand any records required to be reviewed under the FSVP rule.
• The QI may be an employee of the importer or may be a third-party (such as us).

To ensure that the QI fulfills the regulatory requirement, you should define clear selection criteria. Here are the primary elements:

Education and professional background

• Though there is no specific educational requirement, the QI should have the training and experience needed to review each food safety plan.
• The QI will need to evaluate the foreign supplier’s hazards, performance, and verification activities.  They, therefore, should have strong familiarity with food safety processes such as HACCP.

Practical experience

• The QI (also sometimes referred to as the FSVP agent) should have experience in supplier evaluation, audits, and import operations.
• They must have experience reviewing documentation from foreign suppliers, understanding international operations, reading audit reports, and test results. Ask your potential QI how many years experience they possess and what their previous experience entailed.

Regulatory knowledge

• The QI should have an understanding of the FSVP rule, including the importer responsibilities, supplier verification obligations, record-keeping.
• Awareness of US food-safety regulations (e.g., the Food, Drug, and Cosmetic Act), and how FSVP aligns with the other FSMA rules (Preventive Controls, Produce Safety) so the QI can interpret “equivalent level of public health protection”

Questions to ask a Potential QI:

• What certificates makes you a QI/FSVP Agent?
• Can you send me your certificates?
• How many years experience do you have reviewing food safety plans?

Conclusion

The role of the Qualified Individual is far more than a regulatory checkbox; it’s the linchpin that turns your plan into action and your processes into consistent, auditable standards. By selecting the right person (or persons), you transform FSVP compliance from a burden into a structured, reliable process.

Here at Ken Lehat and Associates, our QI/FSVP Agents meet those standards.  With 60+ years experience complying with FDA standards, possessing multiple PCQI and FSVP certifications and a customs license, and FSVP experience since the law rolled out in 2017, we can help you comply with this law.  We can ensure your shipment reaches its destination with efficiency.

For more information, please contact us: