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This document has been superceded by a more recent version.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. 4

This standard applies to the jurisdiction's internal policies and procedures established to ensure uniformity among regulatory staff in the interpretation of regulatory requirements, program policies and compliance / enforcement procedures.

Requirement Summary

Program management has established a quality assurance program to ensure uniformity among regulatory staff in the interpretation and application of laws, regulations, policies, and procedures.

Description of Requirement

1. Program Management implements an on-going quality assurance program that evaluates inspection uniformity to ensure inspection quality, inspection frequency and uniformity among the regulatory staff. The quality assurance program shall:
1. Be an on-going program.
2. Assure that each inspector:
1. Determines and documents the compliance status of each risk factor and intervention through observation and investigation;
2. Completes an inspection report that is clear, legible, concise, and accurately records findings, observations and discussions with establishment management;
3. Interprets and applies laws, regulations, policies and procedures correctly;
4. Cites the proper local code provisions for CDC-identified risk factors and Food Code interventions;
5. Reviews past inspection findings and acts on repeated or unresolved violations;
6. Follows through with compliance and enforcement;
7. Obtains and documents on-site corrective action for out-of-control risk factors at the time of inspection as appropriate to the type of violation;
8. Documents that options for the long-term control of risk factors were discussed with establishment managers when the same out-of control risk factor occurred on consecutive inspections. Options may include but are not limited to risk control plans, standard operating procedures, equipment and/or facility modification, menu modification, buyer specifications, remedial training, or HACCP plans;
9. Verifies that the establishment is in the proper risk category and that the required inspection frequency is being met; and
10. Files reports and other documentation in a timely manner.
3. Describe the actions that will be implemented when the program analysis identifies deficiencies in quality or consistency in any program aspect listed in 1)B.

2. The quality assurance program must achieve an overall inspection program performance rating for each of the ten measured aspects [Items1-10| of at least 75% using the following self-assessment procedure and the appropriate Table in Appendix D.

An assessment review of each inspector's work shall be made during at least two joint on-site inspections, with a corresponding file review of at least the three most recent inspection reports of the same inspected establishments, during every self-assessment period.

Outcome

A quality assurance program exists that ensures uniform, high quality inspections.

Documentation

The quality records needed for this standard include:

1. A written procedure that describes the jurisdiction's quality assurance program, including corrective actions for deficiencies, and
2. Documentation that the program achieves a 75 percent performance rating on each aspect using the self-assessment procedures described above and in Appendix D.

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