Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

ORA FIELD MANAGEMENT DIRECTIVE No. 76
Appendix E

Subject:
State Contracts-Evaluation of Inspectional Performance		 Area:
State Program Management		 Date:
8/22/6 Revised

Printer Friendly Version: Word Size 36 kb


Appendix E

Food Inspections: Summary of Contract Audit Findings

The summary of the performance factor ratings for all contract audits allows the District, State agency, and DFSR to recognize trends in inspectional coverage and identify specific areas in the State agency’s inspection program that may need improvement.

Worksheet E is used to calculate an overall rating for the contract performance period and identify single performance factors rated as “needs improvement” in multiple audits. The performance factors are described in Appendix B, FDA Form 3610. A rating below

80 percent indicates a need for improvement and requires corrective action.

INSTRUCTIONS:

  1. For each food firm audited, record the auditor’s initials and date of audit in the box.

  2. For each food firm audited, record the rating for each performance factor listed in Appendix B.
    “A” = acceptable; “NI” = needs improvement.

  3. Record the At and NIt for each performance factor.
    At = horizontal total of acceptable ratings.
    NIt = horizontal total of needs improvement ratings.

  4. Calculate the overall rating for the food contract audits.
    Record the rating in the space provided in the box located at the top of Worksheet E.

    FORMULA:

    Food contract audit performance rating
    [ Σ At / ( Σ At + Σ NIt ) x 100 ]

    NOTE: Σ is the statistical symbol for the sum of all numbers.

    Σ At = vertical sum of acceptable ratings.
    Σ NIt = vertical sum of needs improvement ratings.

  5. Evaluate audit ratings for a single performance factor. Use the space at the bottom of Worksheet E to identify and make notes about single performance factors rated as “needs improvement” in multiple audits.

This page was last updated on: 08/16/06.