Additionally, TPA requires accredited third-party certification bodies to:
- Ensure their audit agents are competent and objective
- Verify the effectiveness of corrective actions taken by audited facilities to address identified deficiencies
- Self-evaluate and correct any problems in their own performance
- Maintain and provide the FDA access to records required to be kept under TPA
Accredited third-party certification bodies can perform two kinds of audits under TPA, consultative and regulatory. In both kinds, auditors will examine compliance with applicable federal food safety requirements. The difference is who gets the report.
A consultative audit is conducted to prepare for a regulatory audit and is for internal use by the audited facility. A consultative audit may also consider how the facility meets industry and other food safety standards and practices.
A regulatory audit report is seen by FDA. Only a regulatory audit can be the basis for certification that the facility complies with FDA regulations. All reports submitted to FDA must be in English.
An accredited third-party certification body could be a foreign government or other third-party entity or individual. Accreditation of third-party certification bodies is granted for up to four years.
The TPA rule exempts:
- Alcoholic beverages manufactured by foreign facilities
- Meat, poultry and egg products that are subject to U.S. Department of Agriculture oversight at the time of import
Safeguards are built into the criteria for accreditation and certification to avoid conflict of interest, an issue that has plagued the credibility of third-party auditing from the beginning. FDA has committed to closely monitoring participants in the program. It may revoke an accreditation body’s recognition and withdraw a certification body’s accreditation for cause. The rule describes FDA’s procedures for monitoring and oversight of participating accreditation bodies and certification bodies. FDA’s intends these requirements to help ensure the competence and independence of accreditation bodies and third-party certification bodies.