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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Appendix F Summary of Contract Audit Findings: Feed Establishments

ORA FIELD MANAGEMENT DIRECTIVE No. 76
Appendix F

Subject:
State Contracts-Evaluation of Inspectional Performance
Area:
State Program Management
Date:
1/24/14 Revised

Printer Friendly Version:  PDF


 

Appendix F

Summary of Contract Audit Findings - Feed Establishment Inspections

The summary of the performance factor ratings for all contract audits allows the District, State agency, and Office of Partnerships (OP) to recognize trends in inspectional coverage and identify specific areas in the State agency’s inspection program that may need improvement. A corrective action plan is required when an overall rating is below 90 percent for the contract period of performance or a single performance factor is rated as “needs improvement” in four or more audits. If fewer than four audits are conducted, a performance deficiency may be considered for a single performance factor at the discretion of the District and State agency.

Workbook F is used to report audit findings, calculate an overall rating for the contract period of performance, and identify single performance factors rated as “needs improvement” in multiple audits. The performance factors are found in Appendix C, BSE/Feed Establishment Audit Form. The workbook contains six worksheets labeled as:

  1. Contract Dates
  2. Tracking Sheet
  3. Feed Audit Records-Quarter 1
  4. Feed Audit Records-Quarter 2
  5. Feed Audit Records-Quarter 3
  6. Feed Audit Records-Quarter 4

 

The workbook may be used to track multiple State contracts when the contract start dates are very close.

INSTRUCTIONS FOR COMPLETING THE WORKSHEETS

The following instructions are provided for completing the worksheets.

Worksheet 1. Contract Dates

Data entered on this worksheet will populate the Tracking Sheet and the Feed Audit Record worksheets.

  1. Enter the name of the FDA reviewer.
  2. Select the District from the drop down list.
  3. Select the State from the drop down list.
  4. Enter the number of required audits for the contract period of performance.
  5. Enter the start date of the contract period of performance (MM/DD/YYYY).

 

Worksheet 2. Tracking Sheet

Data is not entered on this worksheet. This sheet automatically counts and calculates data reported on the Feed Audit Record worksheets. The Tracking Sheet has two tables.

Table 1, Audit and Joint Inspections Performed, Audit and Joint Inspections Performed, counts the number of audits and joint inspections and calculates the running total and the percentage of completed audits and joint inspections for the contract period of performance.

Table 2, Number of “NI” Ratings per Performance Factor, counts the number of NI ratings for each performance factor and calculates the overall rating for the contract period of performance.

Worksheets 3-6. Feed Audit Records (Quarters 1-4)

Record the number of audits and joint inspections on the sheet designated for the quarter. The header is automatically filled with the information entered on worksheet 1.
Column A displays the entry numbers 1-100 for each sheet.
Data must be entered in columns B-AB. The instructions are provided here.

Column BSelect the State from the drop down list in Column B.
Column CEnter the name of the firm.
Column DEnter the firm FEI/CFN number.
Column ESelect the type of inspection from the drop down list.
Column FEnter the start date of the audit.
Column GEnter the auditor’s initials.
Columns H-ABSelect the rating from the drop down list for each performance factor listed in BSE/Feed Establishment Audit Form. If a joint inspection was conducted, select “J” for all performance factors.
Column ACThe rating for each performance factor is automatically counted and the overall rating for the audit automatically populates the field. To ensure accuracy, compare the ratings on the BSE/Feed Establishment Audit Form to the data entered on the worksheet.
Column ADUse this space for notes about the audit.

 

INSTRUCTIONS FOR NAMING THE WORKBOOK

When naming the Workbook F, the following document-naming convention must be use. The standard document name will help distinguish the contents of the workbook simply by name and ensures that the workbook can be located quickly and easily.

The name of the Workbook F contains four elements. The name of the workbook begins with the 3-digit district abbreviation, for example, CIN for the Cincinnati District, followed by the State agency abbreviation, for example, UKRS for University of Kentucky/Division of Regulatory Services. The next element of the workbook name is the inspection program, which is Feed. The final element of the workbook name is the beginning year of the contract period of performance.

Here is a sample workbook name showing the four elements explained above.

CIN-UKRS-Feed-2012

If the workbook is used to reporting audit findings for multiple State programs, the workbook name will contain the State agency abbreviations for each State program.

If the naming convention is not followed, the workbook will be returned to the District for correction.

INSTRUCTIONS FOR SUBMITTING AUDIT FINDINGS

Quarterly reports are due 10 working days after the end of each quarter of the contract period of performance. Report the number of audits and joint inspections on the sheet designated for the quarter. The District must save and email the complete workbook to the OP audit mailbox ContractAudits@fda.hhs.gov