U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Retail Food Safety Branch
DRAFT: February 28, 1998
DRAFT: April 24, 2001
DRAFT: June 28, 2001

This document has been superceded by a more recent version. Below is an earlier version.

STANDARD NO. 9

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 8 (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. 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;
2. That a baseline survey and report on the occurrence of 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 baseline information is updated at least once within every 3-year audit interval to measure trends; and
3. That a verification audit is conducted within 36 months of the initial self-assessment and following the initial baseline survey report. Subsequent verification audits are conducted every 36 months thereafter.

Description of Requirement

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) 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, that standard is not met.
2. A baseline survey and report on the occurrence of 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 baseline information is updated at least once in every 3-year audit interval to measure trends. 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 survey tool similar to Appendix I is required.
3. Verification audit: The first verification audit is conducted within 36 months the initial self-assessment and following the initial baseline survey report. 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 survey reports. During the verification audit, the auditor will:
1. 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. Confirm that the baseline data collection procedures and survey tools similar to Appendix J have been used and that the conclusions are supported by the data.
4. Reporting: The FDA National Registry Report will be completed and submitted to the appropriate FDA Regional office within 30 days following completion of the self-assessment, baseline surveys, verification audits, and/or baseline update. The FDA National Registry will be updated using data contained in this report. A current Release and Permission to Publish Form must accompany each FDA National Registry Report

Outcomes

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. Baseline survey report,
3. Verification audit report,
4. FDA National Registry Report, and
5. Affidavit of Permission to Publish.

Last updated by dav/ear/cjm 2006-NOV-14