U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Retail Food Safety Branch
DRAFT: February 6, 1998
DRAFT: April 24, 2001
DRAFT: June 28, 2001

This document has been superceded by a more recent version.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

Work Sheet Instructions

This Standard applies to all voluntary and regulatory activities used by a jurisdiction to achieve compliance with regulatory requirements. The desired outcome is an effective compliance and enforcement program that consistently follows through on documented violations and achieves compliance. The sequence and type of follow-up activity a particular jurisdiction elects to use may vary. However, when an out-of-control risk factor or intervention is documented on an inspection report, the expectation is that actions taken to correct the violation will also be documented in the establishment file. For the purposes of self-assessment, follow-up actions have been divided into three groups.

• On-site corrective action that occurs at the time of a routinely scheduled inspection,
• Follow-up action that occurs after the routine inspection, such as re-inspections, training, risk control plans, and informal conferences, and
• Enforcement activities such as fines, permit suspension, hearings, mandated training, restriction of operations, embargo, etc.

Step 1. Sample Selection: Randomly select a representative number of establishment inspection files for review. The selection should be made from establishments that have been placed in the medium- to high-risk categories. Establishments must have been in business long enough to have had three routine inspections. Jurisdictions with less than 400 total establishments select at least 20 files for review. Jurisdictions with over 400 establishments select a sample equal to 5% of the total establishments or 70 files which ever is less.

Step 2. Identify the items on the local inspection report that correspond to each of the risk factors and interventions on the work sheet. Record the local item numbers on the "reference key" line of the worksheet. If there is no corresponding local requirement for a particular FDA Code risk factor or intervention, record "NA" for not applicable. You may find the Standard No. 1, Appendix A Worksheets, helpful in making this comparison. [Note: The program is not penalized under Standard No. 6 for sections of the Food Code that have not been adopted.|

Step 3. Open the first establishment inspection file that was randomly selected in Step 1 above. Identify the third oldest routine inspection report in the file, starting at the current date and working back chronologically. This inspection will be the "start point inspection" for the review of this file. Using the reference key line on the worksheet, determine which risk factors and interventions were out of compliance at the time of start point inspection. Place a check under each item that is out of compliance on the horizontal status line.

Step 4. Review all of the documentation in the establishment file from the start point inspection forward to the current date and determine whether follow-up action was taken and documented for each of the out-of-compliance risk factors and interventions that were out of compliance on the start point inspection. Determine whether there was at least one type of follow-up activity for each item that was marked out of compliance. Place "Yes" in the appropriate line and column to indicate that follow up action was documented in the establishment file. Make a notation* below each "Yes" to indicate the type of action taken such as "RH" for Reheat, "WL" for warning letter or "RCP" for risk control plan. If there is no documentation in the establishment file to indicate that follow-up action was taken for each specific risk factor or intervention that was out of compliance, the presumption is that follow up did not occur. Indicate by "yes" or "no" in the last column whether follow-up actions complied with the jurisdiction's written step-by-step procedure for compliance and enforcement.

In order for an individual establishment file to pass, each column marked with a violation at the start point inspection must have a subsequent "yes" answer to indicate that at least one type of follow-up action was taken. Actions must have complied with the jurisdiction's written step-by-step procedure for compliance and enforcement. A single start point violation without a final resolution, either correction or a compliance/enforcement activity causes the file to fail. Circle the appropriate "pass" or "fail" notation at the bottom of the work sheet.

Repeat Steps 2 through 4 with each of the randomly selected establishment files. When all of the files have been reviewed, total the number of files that passed and divide by the total number of files reviewed. To meet Standard No. 6, eighty percent (80%) of the files must pass.

See the example following and blank Worksheet.

EXAMPLE:

Sample Work Sheet

File No 1

Risk Factors and Food Code Interventions
Establishment Name Seafood Palace	Unsafe Source	Inadequate Cooking	Improper holding Temperatures Hot & Cold	Time/Temperature Parameters not met.(Time as a control, date marking, rapid cooling)	Bare hand contact with ready-to-eat PHF	Poor Personal Hygiene	Contaminated Food Contact Surfaces & Equipment	Consumer Advisory (when required)	Demonstration of Knowledge by PIC	Employee Health Control system or policy implemented.	Was the Written Procedure Followed?
Permit Number 339
Inspection Date (start point) 3 May 2000
Reference Key to local inspection items	1	2, 3, 4, 5	6,7	8, 11	13	14	15	NA	NA	16	Circle One YES or NO
Start Point Inspection Violations		X		X	X	X
Was on site corrective action taken?		Yes R H		YES EM	Yes Glove
Was follow up corrective action taken?				Yes      RCP		Yes TR
Was enforcement action taken?		Yes W L
Each column in which a violation is noted must receive a yes response to one of the three questions in order for the file to pass. Additionally, written procedures must have been followed										Circle One Pass / Fail

In this example, the file passes because each of the violations noted on the start point inspection, dated 3 May 2000, has documented follow-up action in the file. The "NA" under Consumer Advisory indicates that the jurisdiction does not have a requirement for this intervention. The "yes" in the last column indicates that the compliance and enforcement procedure of the jurisdiction was followed.

*Define the acronyms and notations used to reflect follow-up action. RH= Reheat to safe temperature, RCP= risk control plan successfully completed, WL= warning letter sent, EM =embargo, TR = training required

File No._____

Risk Factors and Food Code Interventions
Establishment Name	Unsafe Source	Inadequate Cooking	Improper holding Temperatures Hot & Cold	Time/Temperature Parameters not met.(Time as a control, date marking, rapid cooling)	Bare hand contact with ready-to-eat PHF	Poor Personal Hygiene	Contaminated Food Contact Surfaces & Equipment	Consumer Advisory (when required)	Demonstration of Knowledge by PIC	Employee Health Control system or policy implemented.	Was the Written Procedure Followed?
Permit Number
Inspection Date (Start Point)
Reference Key to local inspection items											Circle One YES or N0
Start Point Inspection Violations
Was on site corrective action taken?
Was follow up corrective action taken?
Was enforcement action taken?
Each column in which a violation is noted must receive a yes response to one of the three questions in order for the file to pass. Additionally, written procedures must have been followed.										Circle One Pass / Fail

*Define the acronyms and notations used to reflect follow up action.

SELECTING THE SAMPLE

The method used to select the sample will be uniformly applied and will provide a sample that is representative of the total number of retail food establishments in the community. A method of simple random sampling will be used on the principle that all retail food establishments in the inventory are equally exposed to selection. Two sample selection techniques suitable for retail food program self-assessments are:

1. The first technique requires that each establishment be identified by a card or strip of paper having the establishment's name and address, permit number, file number, or other means of positive identification. These identifying cards or slips of paper are thoroughly mixed and the establishment files to be reviewed are drawn one at a time until the required number is obtained. (Jurisdictions with less than 400 establishments draw at least 20. Jurisdictions with over 400 establishments, draw 5 percent up to a maximum of 70.)
2. The second technique utilizes a card file, ledger, list or data processing record system. When this procedure is used, all the establishments in the program must be subject to sampling. The frequency interval may be determined by dividing the total number of retail food establishments by the number of files needed in the sample. (For example, if there were 800 establishments within the jurisdiction, a sample of 40 would be needed. The frequency interval would be 800 divided by 40, or 20. Thus every 20th establishment shall be selected to make up the sample.) In order to maintain the desired random quality of the sample, the card file, ledger, list or data processing record system should be entered in a random fashion. To establish a starting point when using a frequency interval of 20, write numbers 1 - 20, inclusive, on separate strips of paper and draw one slip at random. The number appearing on that strip of paper represents the first establishment to be drawn. If a ledger or list is being used for sampling and the number drawn is 7, then the seventh entry in the ledger or list would be the first establishment in the sample. The second establishment would be the 27th entry, the third would be the 47th entry and so forth, until the sample of 40 is drawn. A table of random numbers may also be used to select establishments from a card file, ledger, list or data processing record system.

SUPPLEMENTAL SAMPLING

Deletion of an establishment from the sample of files to be reviewed will be limited to those establishments which have not been in business long enough to have three regularly scheduled inspections. When an establishment is eliminated, a pre-selected alternate establishment file will be reviewed. Alternate files will be drawn in a similar manner as the original sample and at the same time as the original sample selection. Alternate files will be selected on the basis of 20 percent of the original sample size.

When method 1 is used for the random selection, the alternate files will be the last files drawn. For example, if the sample size is 20, then 24 files will be selected and the last 4 drawn will be designated as alternate.

When method 2 is used for the random selection, a separate drawing of the alternates will be made using an interval determined as follows: number of establishments in the inventory, minus the number of files in the original sample, divided by the number of alternate files needed. Using our example from method 2 above, 800 - 40 / 8 or 95. To establish a starting point for the new interval 95, write the numbers 1 - 95 inclusively on separate slips of paper and draw one at random. The number drawn will be the first file selected for the alternate sample and every 95th file afterward until 8 files are drawn.

The list of alternate files shall be kept separate from the original sample list. When selected files cannot be reviewed because they have not been in business long enough to have received three routine inspections, pre-selected alternates will be reviewed in the order in which they were selected.

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