Supplier Verification (FSVP)

Qualified Individual workflow for evaluating a supplier under 21 CFR 1.505-1.506. Covers the Supplier Evaluations list, the Run Evaluation modal (partner and hazard-analysis pickers), the AI evaluation that runs inside the modal, the recorded decision (Approved / CA Required / Discontinued), approving the partner, downloading a response package, scheduling a reevaluation, and the partner Audit Trail. Any partner with a matching hazard analysis can be evaluated — there is no hardcoded “foreign” requirement.

Who: Qualified Individual (QI) · Regulation: 21 CFR 1.505 (Supplier evaluation) and 21 CFR 1.506 (Verification activities). The QI uses information about the supplier, the hazards in the food, and the controls being applied to determine appropriate verification activities and record an evaluation decision for the supplier.

Open the Supplier Evaluations list

What you should see: The Evaluations list is the hub for FSVP verification activity records. Clicking a row opens that partner’s detail page so you can review the full evaluation.

Open the Run Evaluation modal

What you should see: The modal collects the minimum inputs the AI evaluation needs: which partner, which hazard analysis to match against, and whether this is an initial evaluation or a periodic reevaluation. The hazard analysis list is org-wide — pick the one that matches the partner’s commodity and country.

Run the AI supplier evaluation from the modal

What you should see: The AI checks every hazard from the analysis against the partner’s verified documents and records a decision of Approved, CA Required, or Discontinued. When the run finishes, the modal shows “Supplier evaluation complete.” and the new evaluation appears as a row in the list. If gaps are found, corrective actions are created automatically.

Open the partner’s FSVP tab to review the evaluation

What you should see: The evaluation results render as cards inside the partner’s FSVP tab — there is no separate detail page. Each evaluation card shows a Hazard Verification table (Hazard / Matched Document / Adequacy), a “Gaps Identified” panel for anything missing, and the AI Assessment text. This is the audit-defensibility view of which hazards were verified by which documents.

Read the evaluation decision the AI recorded

What you should see: The decision badge at the top of each evaluation card shows the outcome the AI determined — Approved, CA Required, or Discontinued — based on how the partner’s documents covered the hazards. The decision is read-only on this tab; to act on it, use the Approve Partner control in the partner header. The supporting assessment and gaps are the defensible record an FDA inspector would ask for.

Approve the partner from the partner header

What you should see: The “Change standing” menu offers Approve once the partner is in onboarding. Approving records the partner as approved with a snapshot of its compliance state, giving you the FDA-defensible record that both tracks were satisfied at the time of approval: the Document Requirements checklist and the FSVP evaluation decision.

Download the full FSVP package from the partner header (approved partners)

What you should see: Once a partner is approved, a “Download FSVP Package” button appears in the partner header alongside Suspend / Discontinue. Clicking it downloads a ZIP of the complete FSVP record — Hazard Analysis, Supplier Evaluation, Verification Worksheet, Reevaluation Form, plus the partner’s third-party verification documents — ready to hand to an FDA inspector or keep in the audit binder. Unlike the per-evaluation button on the FSVP tab, this path works directly from an approved partner without first creating an FDA inspection record.

Email the partner via the compose window (response-package attachment is manual)

What you should see: The compose window opens pre-addressed to the partner’s contact email. Attach the downloaded response package and send so the partner has a copy of the FSVP record. The sent email is logged under Emails.

Verify the partner Audit Trail tab renders

What you should see: The Audit Trail tab is the FDA-facing record of activity on this partner. Each entry shows who did what and when, with the compliance state captured at the time, giving you the defensible history of the partner’s evaluation and approval per 21 CFR 1.510.