Supplier Qualification Initial Risk Assessment

This form documents the initial, risk-based supplier qualification assessment. Risk classification and related controls are determined in accordance with the Supplier Qualification Program and are used to define qualification, testing, and approval requirements prior to inclusion on the Approved Supplier List (ASL).

Section A — Supplier Identification Legal Supplier Name * DBA (if applicable)

Country *

City / State *

Primary Contact Name * Primary Contact Email * Primary Contact Phone * Supplier Operating Profile

Section B — Supply Scope Type of Supplier * Description of Materials or Services Supplied * Does the supplier impact product quality or GMP compliance? *

Section C — Quality & Regulatory Status Applicable Certifications Quality Management System Description * Date of Most Recent Audit Critical observations (last 3 years)

Section D — Initial Supplier Risk Assessment Risk Drivers

Direct product contact Identity-critical material New or limited history supplier Single-source supply History of quality issues

Initial Risk Classification * Risk Assessment Rationale *

Section E — Documentation Reviewed Documents Reviewed *

Section F — Supplier Attestation

Name *

Title *

Signature *

Date *