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FSMA & Accreditation of Third-Party Auditors

Some of the most talked about aspects of FSMA have to do with Produce Safety & Preventative Controls. But what some may not be aware of is that this law even touches upon the validity of 3rd party audits to foreign food facilities.

Check Out the link on the FDA website:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm

The proposed rule would require accreditation bodies to:

  • Assess third-party auditors for accreditation;
  • Monitor performance of the third-party auditors it accredits and notify the FDA of any change in, or denial of, accreditation;
  • Assess and correct any problems in its own performance;
  • Submit reports and other notifications to the FDA;
  • Protect against conflicts of interest; and
  • Maintain and provide the FDA access to records.

Requirements for Third-Party Auditors

The proposed rule sets eligibility requirements for accreditation as a third-party auditor. A third-party auditor can be a foreign government, foreign cooperative, or other third-party. It must also meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance, and records procedures.

Accredited third-party auditors would audit and issue certifications for foreign facilities and food.

The FDA would require accredited auditors to:

  • Ensure their audit agents are competent and objective;
  • Conduct rigorous audits;
  • Submit reports of audits used for certification purposes (called regulatory audits) to the FDA;
  • Notify the FDA upon finding any condition posing a serious risk to the public health;
  • Assess and correct any problems in its own performance;
  • Protect against conflicts of interest; and
  • Maintain and provide the FDA access to records.

The FDA would be closely monitoring these systems and could revoke an accreditation body’s recognition or withdraw an auditor’s accreditation for good cause.

The final rule has not yet been issued on this portion of FSMA.

As we all know, 3rd party audits can be a great tool to help companies adjust processes and procedures to ensure the safest possible product. However, in recent years, there is ample evidence to demonstrate that audits are not a cure all. They are simply a snap shot of a point in time and can be highly subjective based on the auditor experience and perspective. At the end of the day, the goal is safer food and the 3rd party audit is one mechanism. Daily production controls, verification steps, education and training are also extremely important to help all the hands on deck succeed in their daily functions.

 

 

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