Audit

The Multi-Step Process of Third-Party Accreditation

By Charles Breen
No Comments
Audit

Before the initial third-party inspection, several administrative steps must be taken.

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.

Related Articles

  • Which GFSI Standard is Right for Me, and How Do I Prepare For The Audit?

    So your company has decided to pursue certification against a GFSI benchmarked standard. How do you go about choosing the right standard for you, and how can you prepare for your first audit? This article offers some advice.

  • SCS Global's Sr. Technical Director and Auditor Heena Patel

    From the auditor's point of view, what’s most important when it comes to auditing your food safety plans and programs? What do they consider best practices for passing audits? What are the biggest no-no’s leading to deductions? SCS Global's Sr.…

  • What Constitutes a Successful FDA Audit?

    From the proposed third party accreditation rule, to GFSI audits, and needing more trained and experienced auditors, the process of auditing food facilities is undergoing a sea-change. What is the impact going to be on food companies, auditors, and the…

  • Top 5 Reasons Organizations Fail Audits and How to Not Be One of Them

    When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. To help shed light on some of the reasons companies fail audits and to help prevent future failure, here's our top…

  • Ask the Expert : Root Cause Analysis - Responding to Audit Non-Conformances

    A food manufacturer’s food safety program must encourage continual improvement to their existing program in order to be successful and to comply with their food safety standard. And root cause analysis is a great tool for problem solving when a…

  • 5 Tips for Conducting a Successful Internal Audit

    A strong internal audit program will help drive continuous improvement, promote a food safety culture within the organization, and help improve the external audit score.

About The Author

Charles Breen, EAS

Leave a Reply

Your email address will not be published. Required fields are marked *

For security, use of Google's reCAPTCHA service is required which is subject to the Google Privacy Policy and Terms of Use.

I agree to these terms.