Draft Voluntary National
Retail Food Regulatory Program Standards

standard 9
program assessment

This standard applies to the process used to measure the success of jurisdictions in meeting the Voluntary National Retail Food Regulatory Program Standards 1 through 9 (hereafter referred to as the National Standards) and their progress in reducing the occurrence of foodborne illness risk factors. Additionally, it applies to the requirements for recognition by the Food and Drug Administration of those jurisdictions meeting the National Standards.

Requirement Summary

1. For listing on the FDA Roll of Participating Jurisdictions, a jurisdiction must assure:
   1. That the program manager conducts an initial self-assessment within 12 months of the date of enrollment in the National Registry and every 36 months thereafter; and,
   2. That a verification audit is conducted within 36 months of the initial self-assessment. Subsequent verification audits are conducted every 36 months thereafter.
2. For achievement of Standard 9, a jurisdiction must assure:
   1. That a survey and report on the occurrence of foodborne illness risk factors and the use of Food Code interventions is completed within the 36-month period between the self-assessment and the verification audit; and
   2. A survey on the occurrence of risk factors and Food Code interventions is conducted at least once every five years thereafter to measure trends specific to the occurrence of the risk factors and interventions.
3. Reporting by means of the FDA National Registry Report form.

Description of Requirement

For Listing on the FDA Roll of Participating Jurisdictions, a jurisdiction must assure that:

1. Self-Assessment:
   The program manager, or a designated representative, conducts an initial self-assessment of the retail food safety program within 12 months of the date of enrollment in the National Registry and every 36 months thereafter. The self-assessment will determine:
   1. The compliance status with each of the National Standards by completing the Appendix documents (hereafter referred to as the worksheets) or documents containing equivalent summary information for each Standard, and
   2. Whether the quality records specified as requirements in each of the National Standards have been established, identified, and maintained. If the quality records for a specific program element are incomplete or provide inadequate information upon which to make a determination or to enable a verification audit, that standard is not met.
2. Verification Audit:
   The first verification audit is conducted within 36 months the initial self-assessment. An individual as defined in the definitions shall complete the verification audit. Subsequent verification audits are conducted every 36 months thereafter. Verification audits confirm and report on the accuracy of the self-assessment and the occurrence of risk factors and Food Code interventions survey reports. During the verification audit, the auditor will:
   1. A. Review the quality records and confirm that the self-assessment accurately reflects the current program compliance status in each of the program elements, and
   2. B. Confirm that the occurrence of risk factors survey collection procedures and survey tools similar to Appendix J have been used and that the conclusions are supported by the data.
3. Achievement of Standard 9,
   A jurisdiction must assure that a baseline survey and report on the occurrence of foodborne illness risk factors and the use of Food Code interventions is completed within the 36-month period between the self-assessment and the verification audit. The survey information is updated at least once in every 5 years to measure trends specific to the occurrence of the risk factors and Food Code interventions. The subsequent surveys and reports will determine whether there has been a net change in the occurrence of the risk factors and use Food Code interventions.

   A data collection instrument similar to the FDA model form referenced in 2.B., using the IN, OUT, NA, and NO convention, is required. Failure to use this convention skews the data toward either IN compliance or OUT of compliance. The FDA data collection instrument is not intended as an inspection form. However, jurisdictions that have developed an inspection form using the IN, OUT, NA and NO convention may use that inspection form as a survey instrument. Refer to the Data Collection Manual to understand the statistical limitations and restrictions if using an inspection form or a data collection form different from the FDA data collection instrument. If the jurisdiction uses a different form, the data may be difficult to compare with the data from the FDA national foodborne illness risk factor study or with data from other jurisdictions.

4. Reporting:
   The FDA National Registry Report (Standards Appendix I) will be completed and submitted to the appropriate FDA Regional office within 30 days following completion of the self-assessment, survey report on the occurrence of foodborne illness risk factors and Food Code interventions, verification audits, and/or survey of risk factor occurrence updates. The FDA National Registry listing will be updated using data contained in this report. A current Release and Permission to Publish Form must accompany each FDA National Registry Report.

Outcome

The desired outcome of this Standard is to enable managers to measure their program against national criteria. The process identifies program elements that may require improvement or be deserving of recognition.

Documentation

The quality records required for this standard include:

1. The completed Appendices (worksheets) for each Standard and supporting records,
2. Survey reports on the occurrence of risk factors and Food Code interventions,
3. Verification audit report,
4. FDA National Registry Report, and
5. Affidavit of Permission to Publish.