Accredited Third-Party Certification Program: Voluntary Audit Templates

Under the FSMA Accredited Third-Party Certification (Third-Party Program) regulation (21 CFR part 1 subpart M), accreditation bodies (AB) are recognized for designated scopes for evaluating third-party certification bodies (CBs) seeking accreditation for these designated scopes under the Third-Party Program. A recognized AB must ensure that certification bodies can adequately evaluate compliance with applicable food safety requirements of the FD&C Act and FDA regulations.

We are providing templates that may be used to help ABs develop evaluation criteria to ensure that CBs will conduct audits to adequately evaluate FDA food safety requirements.  These templates present certain food safety requirements in a table format, which can be used to more easily compare third-party food safety audit standards to these food safety requirements. These templates are not required to be used. ABs and CBs may use other means to determine that audits meet the requirements of the FDA Third-Party Program.

Please note: Included below is the template for the Preventive Controls for Human Food Rule (21 CFR part 117), which includes certain requirements for CGMPs, record keeping, and preventive controls, among other requirements.  Some of the requirements in part 117(e.g., the current good manufacturing requirements in 21 CFR part 117 subpart B) are referenced in the other templates included on this page and are relevant to Third-Party audits.

In addition to 21 CFR 117, other templates that may help determine if third-party audit standards align with FSMA food safety standards are available on our website.


Page Last Updated: 11/16/2018
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