Which statement about onsite audits is true?

Which statement about onsite audits is true?

• A. They must be conducted by a qualified auditor
• B. They must be conducted by the supplier's internal staff
• C. They do not require review of HACCP plans
• D. They can be skipped for low-risk ingredients

Answer: (A)

Onsite audits are a verification activity under FSMA to confirm that a supplier’s preventive controls and HACCP plan are properly designed and implemented. Because audits evaluate complex processes, they must be performed by a qualified auditor—someone with appropriate training in auditing and knowledge of HACCP/PRPs and the ability to assess facility operations, records, and control measures. This qualification ensures the audit is credible and objective, whether the auditor is an external party or an internal staff member who meets the qualification criteria. Auditing a supplier always involves reviewing the HACCP plan and its implementation, so the idea that HACCP reviews aren’t required is incorrect. And verification isn’t optional for low-risk ingredients—the rule requires appropriate verification across suppliers, not skipped based on perceived risk.

Onsite audits are a verification activity under FSMA to confirm that a supplier’s preventive controls and HACCP plan are properly designed and implemented. Because audits evaluate complex processes, they must be performed by a qualified auditor—someone with appropriate training in auditing and knowledge of HACCP/PRPs and the ability to assess facility operations, records, and control measures. This qualification ensures the audit is credible and objective, whether the auditor is an external party or an internal staff member who meets the qualification criteria.

Auditing a supplier always involves reviewing the HACCP plan and its implementation, so the idea that HACCP reviews aren’t required is incorrect. And verification isn’t optional for low-risk ingredients—the rule requires appropriate verification across suppliers, not skipped based on perceived risk.