A 'qualified individual' for FSVP tasks must have what qualifications?

• A. Education, training, or experience necessary to perform the activity and ability to read and understand the language of any records reviewed
• B. A high school diploma only
• C. FDA employment status
• D. Unrestricted access to facility

Answer: (A)

A qualified individual must have education, training, or experience necessary to perform the activity and the ability to read and understand the language of any records reviewed. This ensures the person can competently assess supplier compliance, evaluate verification activities, and interpret records such as audits, certificates, and shipment documents, even when those records are in another language. Having only a high school diploma doesn’t guarantee the specific skills or literacy needed to perform FSVP tasks; FDA employment status isn’t the criterion for qualification, and unrestricted facility access isn’t what defines a qualified person. The emphasis is on demonstrating the capability to carry out the required tasks and comprehend the relevant records.