The Issue that you selected is shown below. If you click on "Word Document File with Tracking," you will open a Word document version of the Issue. Because the document you will be opening is in Word format, you will need to use Word functions to save or print the Issue. When you view or use this Word version, the internal html functions will no longer work. Closing the screen will return you to the Start icon.

Issue Number: Council II 025

Title

Recommendations from Uniform Inspection Program Audit Pilot Project

Issue you would like the Conference to consider

Based on a review of the findings and feedback from the Uniform Inspection Program Audit Pilot Project (conducted July 2010 through June 2011), the CFP Certification of Food Safety Regulation Professionals Work Group has identified specific criteria contained in the Voluntary National Retail Food Regulatory Program Standards, Standard 4 - Uniform Inspection Program criteria that should be reviewed and revised, as necessary, to facilitate the implementation of quality assurance assessments within regulatory retail food protection programs. The CFSRP Work Group is recommending that the FDA, with input from the CFP Program Standard Committee, review the pilot project recommendations impacting Standard 4 - Uniform Inspection Program, to determine if the suggested revisions to the criteria are appropriate and in keeping with the intent and scope of the FDA Voluntary National Retail Food Regulatory Program Standards.

The Work Group's Uniform Inspection Program Audit Pilot Project Report was submitted as an attachment to the Issue titled: Report - CFSRP Part B - Uniform Inspection Program Audit Pilot Project.

Public Health Significance

Standard 4 applies to a regulatory 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. It requires that a review of each Food Safety Inspection Officer's (FSIO) work be made during at least two joint inspections, with a corresponding file review of at least the three most recent inspection reports. These quality assurance assessments provide important feedback that will assist the regulatory jurisdiction in identifying existing strengths and potential areas for improvement within their existing retail food training program or administrative policies.

The Uniform Inspection Program Audit Pilot Project provided an opportunity to garner important feedback from a limited number of jurisdictions enrolled in the FDA Voluntary National Retail Food Regulatory Program Standards on the practical application of the criteria contained in Standard 4. The subsequent pilot project report contains a number of recommendations for enhancing the effectiveness of the Standard that include, but are not limited to:

  • Aligning the 10 Program Elements described in Standard 4 with the Performance Elements and Competencies contained in the Standard 2 - CFP Field Training Plan for new hires or staff newly assigned to the retail food protection program.
  • Providing a linear listing of the Program Elements in Standard 4 to reflect an organized flow to the inspection process.
  • Providing an assessment system that differentiates between the complexity and importance of the 10 Program Elements, particularly as they are assessed during the inspection review process.
  • Clarifying the Standard 4 criteria to include qualifications for an individual charged with assessing the performance of field staff and what type of establishments should be selected for the file and field review.
  • Re-evaluating the system currently in place for determining compliance with the Standard 4 criteria. The Standards are intended to apply to the operation and management of regulatory retail food programs, NOT as assessments of practitioners in the field. The current system weighted on a practitioner's ability to demonstrate the 10 Program Elements during field inspections seems to be skewed more toward an assessment of the individual rather than an evaluation of the regulatory retail food inspection program.

Recommended Solution: The Conference recommends...

that a letter be sent to FDA requesting that they:

1. Work in collaboration with the Program Standards Committee to revise Standard 4, Uniform Inspection Program, to address the pilot project comments and to assess the criteria in Standard 4 to make it more program focused rather than focused on the individual.

2. Review for potential revisions to the Standard 4 Uniform Inspection Program criteria and field inspection review process, the following recommendations contained in the CFP CFSRP Uniform Inspection Program Audit Pilot Project Report.

  • Revise the Guide to Conducting a Uniform Inspection Program Audit. Some changes that should be considered include:
    a) Developing a more comprehensive guidance document similar to the CFP Field Training Manual contained in Standard 2 that explains the criteria for each component of the audit process;
    b) Clarifying the process for selecting the establishments that are to be used for the file and field review;
    c) Clarifying the parameters for what is to be included as part of the establishment file review;
    d) Providing expanded guidance on the auditor's qualifications, role, and responsibilities.
  • Align the 10 Program Elements contained in Standard 4 with the Performance Elements and competencies identified in the Standard 2 - CFP Field Training Plan. This alignment would necessitate revisions to the Guide to Conducting a Uniform Inspection Program Audit, Audit Worksheet, and Audit Reference Guide.
  • Present the 10 Program Elements contained in the Standard 4 criteria, the Guide to Conducting a Uniform Inspection Program Audit, and Audit Worksheet in a linear format to reflect a logical sequence to the inspection process.
  • Incorporate the information contained in the Audit Reference Guide into the Guide to Conducting a Uniform Inspection Audit to eliminate the need for multiple documents.
  • Ensure consistency in the weighting/assessing of each of the 10 Program Elements. Some Program Elements, such as the one that relates to assessing risk factors, are much more complex than others, such as the timely filing of reports and documents. A more equitable, objective assessment system should be established for the audit process.
  • Design the audit process and worksheet to allow jurisdictions the flexibility for assessing inspection Program Elements that are specific to their retail food protection program. The Standard 2 - CFP Field Training Plan builds in the flexibility for a jurisdiction to include performance elements / competencies that are important to their program. The Standard 4 criteria and associated audit worksheet and guides are more rigid in their format.
  • Re-evaluate the assessment protocol for Performance Elements and provide better guidance as to what constitutes an effective performance measurement. The field inspection assessment conducted as part of Standard 4 seems to take an all or nothing approach. Item 1 for example pertains to an assessment of observations of risk factors and public health interventions - eleven different categories. If an inspector fails to make an observation of just one item in this category, this Program Element is not met. This level of performance is higher than what is used for FDA Food Code Standardizations.
  • Provide defined performance measurements that are quantifiable within the Program Elements contained in Standard 4. Some of the Program Elements are very subjective in nature and do not contain definitive performance measurements, such as producing legible reports.
  • Include a comment section within the Audit Worksheet so that a more detailed description can be provided as to the observations made of an inspector's performance of any one of the 10 Program Elements.

3. Obtain input and feedback from the CFP Program Standards Committee to assist FDA in the review of the recommendations contained in the CFP CFSRP pilot project report.

Reference:

The Uniform Inspection Program Audit Pilot Project Report was submitted as an attachment to the Issue titled: Report - CFSRP Part B - Uniform Inspection Program Audit Pilot Project.

Submitter Information

Name Susan Kendrick, Co-Chair
Organization Certification of Food Safety Regulation Professionals Work Group
Address Oregon Department of Agriculture
635 Capitol Street NE
Salem, OR 97301
Telephone 503-533-0835
Fax 503-986-4729
Email skendrick@oda.state.or.us
Word File
Printing Options