Agricultural Marketing Service, Specialty Crops Program, Specialty Crops Inspection Division

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed above. After incorporation into the document listed above this PATCH will 

become obsolete. USDA is an equal opportunity provider, employer, and lender. 

PATCH # 092 Brief description of subject (February 23, 2023) 

SCI Division Inspection Series

Page 1 of 1 

PATCH # 092

DOCUMENT: Sanitation Manual, September 2013 

REMARKS: This PATCH provides updated instructions under Essential Requirements of the 

Survey, section K relating to acceptable water quality certificate provided during a plant survey. 

Updated information will be incorporated into the next revision of the Sanitation Manual. 

Essential Requirements of the Survey

K. The plant must provide SCI Division an acceptable water quality certificate. Samples

tested for water quality must be collected directly from a line within the facility, at the

end of the facility’s water system. Municipal water quality reports will not be accepted

for fulfillment of this requirement. See your immediate supervisor if there is any question

about the documentation provided.
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Agricultural Marketing Service, Specialty Crops Program, Specialty Crops Inspection Division 

PATCH # 058 

DOCUMENT: Sanitation Manual, September 2013 

REMARKS: Plant and Food Defense Surveys are required to be entered into an electronic 

database to facilitate efficient and Specialty Crops Inspection (SCI) Division wide access to the 

survey data. Beginning in October 2020 SCI will retire the obsolete IBM Notes database 

application and begin utilizing an application known as Streebo as a replacement. The following 

procedures provide guidance on completing Surveys, accessing and entering the data into 

Streebo and the running of activity reports. 

Accessing Streebo 

The below instructions describe the process for accessing Streebo. You must use the Google 

Chrome browser to access Streebo. You must also have a valid USDA email address and USDA 

network logon credential that includes a functional LincPass (PIV) card. At the time the 

application was written, a list of users was provided, and these users were granted access. Any 

new users will need to request access. You will be granted permissions for Streebo access by 

SCI management and once your credentials have been added to the access control list for the 

Plant Survey form. 

A. Accessing the Plant Survey is a two-step process:

1. Using Google Chrome, log onto the following site:

https://my.aphis.usda.gov/myportal/myaphis/home

• Login with E-auth credentials.

• After logging in with your pre-approved E-auth credentials, you will be

redirected to the APHIS landing page. (If your computer is set up for

“Single Sign-On” you will be taken to the landing page without the need

to enter your credentials.)

• Do NOT close browser session

2. In same Google Chrome browser session, copy and paste (or type) the following

link into the “web address” bar at the top of the Google Chrome browser:

https://my.aphis.usda.gov/mobileforms/

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed above. After incorporation into the document listed above this PATCH will 

become obsolete. USDA is an equal opportunity provider, employer, and lender. 

PATCH # 058 Streebo Instructions (October 1, 2020) 

SCI Division Inspection Series 

Page 1 of 7 
 

 

 

 

 

 

 

 

• This two-step process will need to be done each time you need to access 

the Plant Survey in Streebo. (TIP: Bookmark both locations in the 

Google Chrome browser so that you will not need to copy, paste, or type 

them again in the future.) 

• Once in Streebo, you will see the screen for the Plant Survey and the DOV 

Audit applications. Choose “Plant Survey” 

• Wait for the logon to complete. The following Home screen for the Plant 

Survey will appear: 

Note: At this screen, you can create a new plant survey or view various 

other surveys/audits that have been previously completed. 

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed on the first page. After incorporation into the document listed above this 

PATCH will become obsolete. 

PATCH #058 Streebo Instructions (October 1, 2020) 

SCI Division Inspection Series 

Page 2 of 7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Entering Data 

To enter information for a new Plant Survey, select “CREATE A NEW PLANT SURVEY” 

A. Enter the survey information into Plant Survey. 

Note: If a facility has been done in the past and the previous Survey is in Streebo, you 

can select “Copy a facility” to automatically enter some information from the old Survey 

into the new one (i.e. company name, address, etc.). 

B. There are several ways that information is entered in the survey/audit application. 

• Typed in: There are many fields that require the information be typed in. Fields 

such as the name of the facility, address, city, etc. These fields appear as a blank 

line in the Survey. 

• Drop-down lists: There are fields that have drop-downs that allow you to select 

an item from a list of choices. These are fields like the state, the status, field 

office, etc. These fields appear as a blank line with a down arrow (▼) at the right

end of the line. To activate the drop-down list, click on the empty field (not the 

▼). When the list appears, click on the item you want entered into the field. If

you need to change the entry, click on the field again and this will activate the list. 

Note: The first item in the list is blank. Selecting this allows you to clear the 

field. 

• Dates: There are fields that are designed specifically for dates. These fields 

appear as a blank line with a calendar icon ( ) at the right end of the line. To 

activate the calendar, click on the empty field (not the ). A calendar will open 

up to allow you to select a date. Click on the date in the calendar and it will be 

entered into the field. If you need to change the entry, click on the field again and 

this will activate the calendar. 

Note: There is no way to clear this field. Clicking on this field will require you to 

select a date. Once a date is entered, it can only be changed and not deleted. 

• Check boxes: There are some items on the Survey that are identified by checking 

a box (such as the “Status of Proprietorship”). These items will have an empty 

box (□) next to them. Clicking on the box once will put a check mark in the box. 

Clicking on the box again will remove the check box. Check boxes are used in 

areas that allow you to select more than one item. 

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed on the first page. After incorporation into the document listed above this 

PATCH will become obsolete. 

PATCH #058 Streebo Instructions (October 1, 2020) 

SCI Division Inspection Series 

Page 3 of 7 
 

 

 

 

 

 

 

 

 

 

 

 

 

• Radio buttons: There are some items on the Survey that are answered by the use 

of a radio buttons (such as the “Overall Sanitation Level”). These items will have 

an empty circle ( ) next to them. Clicking on the circle once will put a dot in 

the circle ( ). Radio boxes are used in areas that have more than one choice but 

only one can be selected. If you select a second item, the dot will be removed 

from the first item and appear in the second. 

• Multiple item areas: There are areas on the Survey that allow you to enter 

multiple items. “Owners or Officers” on the General Info page is one example 

and the page for the “Deficiencies Continuation Sheets” is another. These areas 

appear as boxed in areas with buttons in the lower let corner to add, edit, or delete 

items. 

• Adding items: Clicking the “add” button will open a window that will allow you 

to enter the information. Once entered, clicking “Ok” will save the entry and 

close the window. 

• Editing items: If you need to edit information that has already be entered, first 

click on the item to edit, then double click the “edit” button. This will open a 

window that will allow you to edit the information. Once edited, clicking “Ok” 

will save the entry and close the window. 

• Deleting items: If you need to delete an item that has already be entered, first 

click on the item to delete, then click the “delete” button. WARNING: Deleting 

is a single click operation. Make sure you have selected the item you want 

deleted. Once deleted, the only way to get the information back into the form is 

to re-enter it. 

• Deficiencies boxes: Deficiencies boxes are “multiple item areas” similar to above 

except they don’t have an “add” button. When the answer to a question in the 

Survey indicates a deficiency, an item will be added in the deficiency box area. 

The number of the question will be shown in the first column titled “ITEM” but 

there will be no other information (description and dates). To add the additional 

information, you will need to edit the item. Editing and deleting items are done 

the same way as in “multiple item areas” described above. If there are more than 

one deficiency with the same item number, the additional items are to be entered 

on the page for the “Deficiencies Continuation Sheets.” 

C. All additional documentation relating to the Survey e.g. cover letters, water potability, 

follow-up correspondence will be added as attachments. To add these attachments to the 

Survey: 

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed on the first page. After incorporation into the document listed above this 

PATCH will become obsolete. 

PATCH #058 Streebo Instructions (October 1, 2020) 

SCI Division Inspection Series 

Page 4 of 7 
 

 

 

 

 

 

 

 

• Save the documents to be attached on the local computer. 

• In the Streebo Survey select the “Attachments” tab in the survey you are working 

on in the Plant Survey Form application 

• Under Attachment 1 (or 2 or 3 as applicable), select “Choose File.” This will 

bring up a window to allow you to explore the local computer to pick the file to 

attach. 

• Select the file to attach. 

• Once selected, the file of the attached document will be shown as an attachment. 

D. Some applicants may also request that a Food Defense Survey to be performed in 

addition to the Plant Survey, in this case the Food Defense Survey will be included as 

part of the Plant Survey. While completing the Plant Survey in Streebo, select the tab 

titled “Food Defense – Facility” and answer the questions for the Food Defense audit. 

If the Food Defense Survey is performed as a standalone survey, follow the instructions 

below for a “Standalone Warehouse Food Defense Survey.” 

E. Standalone Warehouse Food Defense Survey 

• Log into Streebo as described in the previous section and select “Plant Survey.” 

• Wait for the logon to complete. The following Home screen for the Plant Survey 

will appear: 

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed on the first page. After incorporation into the document listed above this 

PATCH will become obsolete. 

PATCH #058 Streebo Instructions (October 1, 2020) 

SCI Division Inspection Series 

Page 5 of 7 
 

 

 

 

 

 

• From the menu on the left, select “Food Defense” and you will see a screen 

similar to the following: 

• When this view is first opened, the “Create a Warehouse FD Survey” button is 

greyed out and cannot be selected. In order to create a new Survey, it needs to be 

associated with a “Parent Facility.” The Parent Facility must have a Plant Survey 

that has been entered into the database. 

o To select the Parent Facility, first select the office that performed the Plant 

Survey of the Parent Facility and the year from the drop downs. This will 

populate the table on the page with the facilities that have plant surveys. 

o Scroll down the list and find the Parent Facility. 

o Click on the name of the Parent Facility. This will select the Parent 

facility. 

Note: There is no visible cue when you do this. Nothing is highlighted or 

underlined, etc. If you click more than once, the last Parent Facility you 

click on is the one that will be selected. 

o Scroll back to the top of the screen. The “Create a Warehouse FD 

Survey” button is now blue and can be selected. 

o Select “Create a Warehouse FD Survey” 

o The Food Defense form will open. 

o Enter the information from the warehouse audit. 

o Save the form when complete. 

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed on the first page. After incorporation into the document listed above this 

PATCH will become obsolete. 

PATCH #058 Streebo Instructions (October 1, 2020) 

SCI Division Inspection Series 

Page 6 of 7 
 

 

 

 

 

Saving, Printing and Signing Surveys 

Completed Surveys will be saved so that they can be signed in ink or via an Adobe digital 

signature. Ink signature will require the Survey to be printed. Surveys in Streebo are “Cloud” 

based applications and cannot print directly to a printer. 

• When the print function is selected, the application will generate a “PDF” file with the 

document. The Survey generated can then be printed for an ink signature or opened to 

have a digital signature applied. 

• Surveys that are complete and signed (either in ink or by digital) will be saved in an 

office shared folder on the SCI network share drive. 

Distribution of Surveys 

Distribution of the Plant and Food Defense Surveys shall be in accordance with the instructions 

in the Sanitation Manual. 

This PATCH represents official guidance. This PATCH is scheduled to be incorporated into the 

document listed on the first page. After incorporation into the document listed above this 

PATCH will become obsolete. 

PATCH #058 Streebo Instructions (October 1, 2020) 

SCI Division Inspection Series 

Page 7 of 7 
Marketing and 

Regulatory 

Programs 

Agricultural 

Marketing 

Service 

Fruit and 

Vegetable 

Program 

Specialty 

Crops 

Inspection 

Division 

AIM 

Inspection 

Series 

Sanitation Manual 

September 2013 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SANITATION MANUAL 

Table of Contents 

Introduction......................................................................................................................................1 

Guide for Electronic Usage...............................................................................................................1 

In-Plant Sanitation ............................................................................................................................2 

Reporting Sanitation Conditions.......................................................................................................5 

Sanitation Deficiencies - Examples in Processed Fruit and Vegetable Plants ...............................10 

Plant Survey....................................................................................................................................14 

Essential Requirements of the Survey ............................................................................................16 

SCI Division Sanitation Policy.......................................................................................................19 

Reporting Significant Food Safety Observations to the FDA and USDA FSIS.............................20 

Food and Drug Administration Regulatory Visits..........................................................................26 

Action by Inspectors .......................................................................................................................26 

Action by Supervisors.....................................................................................................................29 

Action by National Office...............................................................................................................29 

Inspection of Products under Seizure by a Regulatory Agency .....................................................29 

MOU Between the AMS and the FDA concerning Inspection and Grading of Food Products.....29 

Sanitation Requirements.................................................................................................................29 

Example of the SCI Division Plant Survey. ...................................................................................29 

Food Defense System Survey.........................................................................................................50 

Rating Elements of the Food Defense System Survey ...................................................................52 

Food Defense System Survey.........................................................................................................53 

Good Manufacturing Practices (GMPs) .........................................................................................54 

Sanitizing Food Contact Surfaces...................................................................................................55 

Compliance Guidelines for HACCP Verification Survey ..............................................................58 

Sanitary Practices for Fresh Produce Inspection ............................................................................60 

Employee Signature of a Firm’s Hygiene, Health and Confidentiality Statements .......................61 

Attachments....................................................................................................63 

i 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 1 of 63 

INTRODUCTION 

This manual is provided to Specialty Crops Inspection (SCI) Division personnel to promote 

uniformity in the performance of sanitation inspection procedures. Sanitation is an integral part 

of Division services. If needed, contact your immediate supervisor for any situation not 

addressed in this manual. 

This manual contains links to various internal and external sources of information. For 

inspection personnel without internet or intranet access, please contact your immediate 

supervisor to obtain hard copies of documents as needed. 

GUIDE FOR ELECTRONIC USAGE 

The Administrative, Inspection, and Management (AIM) System of instructional manuals is 

available electronically in Adobe Acrobat Portable Document Format (PDF) at the following 

intranet address: http://agnis/sites/FV/PPB/AIM/default.aspx. 

When accessed electronically, AIM materials have hyperlinks and hypertext (visible as 

underlined blue text) available to the PDF user. Clicking on a hyperlink takes the reader to a 

web site with information relating to the subject. Hypertext will link the reader to a different 

page within the current manual - or even a different manual - with information relating to the 

subject. For example, the hypertext in the Table of Contents allows a reader to go directly to the 

section of interest in the manual by clicking on the section title within the Table of Contents. 

PDF offers a variety of tools depending on the Adobe version the reader has. The newer the 

version, the more tools available. To learn about the variety of PDF search options available: 

• Click on the “Help” tab on the top of this page, 

• Then click on the “Adobe Acrobat Help” bar, 

• Type the word “Search” in the “Search” box, and click on the “Search” button, 

• A series of options will become available, 

• Click on the “Access Search Features” link and follow the instructions for the type of 

search you are interested in. 

This document format allows a PDF user to easily search for content within a document, or 

within multiple documents. 
 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 2 of 63 

IN-PLANT SANITATION 

In-plant inspection is designed to give a processor the advantage of on-site, timely inspection of 

product quality, condition of raw materials, in-process control, availability of inspection reports, 

and sanitation inspection. These benefits can be realized to the fullest extent when good sanitary 

and good manufacturing procedures are practiced. 

These instructions are designed to help the inspector make sound sanitation decisions, and to 

apply the same sanitary standards uniformly to all plants. Supervisors should be kept informed 

of any problem areas with which the inspector may need assistance. 

Both the plant management and the inspector have specific sanitation responsibilities which 

should not be assumed by the other. Although supervisors and inspectors will work with plant 

management to maintain high standards of sanitation, plant management should not view the 

inspector as an additional foreman or sanitation supervisor. 

A. Plant Management's Role in Sanitation 

The plant management has the responsibility to produce a clean product, 

in a clean plant, under sanitary conditions. 

Each plant or department must have a trained employee responsible for 

sanitation. This responsibility must include an inspection of the plant or 

department to insure proper and effective cleanup prior to the start of 

operations, and procedures to ensure that adequate cleanup is maintained 

throughout the shift. This depends on four things: 

1. An effective cleanup procedure; 

2. Trained, properly supervised personnel; 

3. Appropriate cleanup equipment and materials; and 

4. Time to properly accomplish the work. 

B. Inspector's Role in Sanitation 

Monitoring plant sanitation is one of the most important responsibilities of the 

in-plant inspector. The inspector must see that plant management follows through 

with their responsibilities to produce a clean product in a clean plant. 

Inspectors must always remember that they are dealing with human food 

products. To be effective, inspectors must understand why good sanitation is 

essential; look and be personally clean; and be familiar with the plant and its 

operational procedures, including proper cleaning procedures. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 3 of 63 

Monitoring Plant Sanitation 

The prerequisite for performing an efficient, thorough sanitation inspection is a comprehensive 

knowledge of the plant layout, premises, machinery, equipment, and processes. 

A. General 

Inspectors have the responsibility of evaluating management's plant sanitation 

program to assure that sanitation practices are satisfactory and effective. They 

must continually be on the alert to help management's representatives’ spot 

conditions that might contribute to product contamination. 

Inspectors must take the time necessary to perform thorough sanitation 

inspections, using plant sanitation history as a guide for checking problem areas. 

If other tasks pull the inspector away from this duty, the plant may need to 

contract for an additional inspector. Be sure the plant understands your 

responsibilities, and your supervisor knows your circumstances. If needed, 

schedule a meeting with you, your supervisor and plant management to resolve 

the situation. 

Plants operating on an "around-the-clock" basis may be reluctant to use operating 

time for the purpose of cleanup. Proper sanitation cannot be maintained under 

these conditions. Plants under in-plant inspection must periodically cease 

operations for the length of time necessary to maintain proper sanitation. This 

time will depend on the size and efficiency of the cleanup crew and equipment, 

the size of the plant, the complexity and accessibility of processing equipment, 

and the kind of product being processed. 

Shutdown for cleanup must be supplemented by "sustaining" cleanup during 

operations and production breaks. The "sustaining" cleanup includes emptying 

garbage containers, keeping floors hosed off during operations, and cleaning 

belts, fillers, cutters, and similar equipment and facilities during breaks. 

The plant layout may permit alternate shutdowns on one or more lines for cleanup 

while other lines of the same product continue processing operations. This type 

of cleanup should not be permitted if there is danger of adulterating product lines 

that are still in operation. 

B. Definition of Terms for Rating Conditions 

1. Minor Deficiencies do not result in product contamination, but are not 

desirable. 

2. Major Deficiencies may result in product contamination, or are highly 

objectionable. 

3. Critical Deficiencies result in product contamination. 
 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 4 of 63 

C. Correction of Sanitary Deficiencies 

1. Minor Deficiencies should be corrected within 24 hours, or less if 

specified by the inspector. 

2. Major Deficiencies must be corrected within the time specified by the 

inspector. This is normally between the time the deficiency is discovered 

and the next shift or end of the next cleaning period, depending on the 

probability of product contamination. 

3. Critical Deficiencies must be corrected immediately. Contaminated 

product not immediately disposed of must be placed in a "hold" category 

pending disposition. 

Note: FDA notification may be required in the case of critical deficiencies and 

uncorrected major deficiencies. Please see the Reporting Significant Food Safety 

Observations to the Food and Drug Administration and USDA Food Safety and 

Inspection Service section of this manual for additional instructions. 

D. Coverage of Exempt Product Lines 

Processing lines or facilities producing product not covered by the in-plant 

inspection contract are to be maintained in a clean, sanitary condition. 

Deficiencies in facilities or housekeeping which may pose a hazard to product 

safety must be corrected. The Inspector's concern will primarily be the general 

appearance of the facilities and operations as observed by a walk-through. 

Note: FDA notification may be required in the case of critical deficiencies and 

uncorrected major deficiencies. Please see the Reporting Significant Food Safety 

Observations to the Food and Drug Administration and USDA Food Safety and 

Inspection Service section of this manual for additional instructions. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 5 of 63 

Reporting Sanitation Conditions 

A. Oral Reports 

The inspector will immediately make an oral report to the designated plant 

"sanitarian" on any major or critical deficiencies observed during the tour. 

Inspectors will also promptly notify plant management of situations which are in 

danger of deteriorating to an unsatisfactory condition. Oral reports are followed 

up in writing with appropriate sanitation score sheets. 

Some facilities have the designated sanitarian accompany the inspector during the 

sanitation tour. This allows both people to simultaneously observe and discuss 

any issues of concern. As above, the inspector will follow up in writing with 

appropriate sanitation score sheets after the tour. 

B. Written Reports, Sanitation Score Sheets 

1. Procedure 

Sanitation score sheets are used to record and report to plant management 

the inspector's evaluations of plant sanitation. These evaluations are made 

on a pre-operational basis and during processing operations for each 

production shift covered by an inspector. Sanitation score sheets (and a 

continuation sheet, if needed) clearly explain any deficiencies encountered 

and indicate when and what corrective action was taken. They provide a 

summary of conditions for that production day. These continuing 

evaluations and reports are extremely beneficial for quickly recognizing 

and correcting any troublesome areas. Current versions of approved 

sanitation score sheets may be found on the AMS Forms Catalog at the 

following intranet address: 

http://agnis/AMSFormsCatalog/Forms/AllItems.aspx. 

The correct score sheet for (canned, frozen, citrus, olives, or raisins) is to 

be used in plants using our services. 

As well as noting deficiencies, it is very important to include evaluations 

of a positive nature on sanitation score sheets. This will demonstrate to 

plant management SCI Division recognition of corrective measures, or any 

special efforts to improve the appearance or functionality of the plant. 

2. Recording Deficiencies 

Record deficiencies even when cleaned up immediately. Note on the 

sanitation score sheet that the corrective action was taken promptly. 

Minor Conditions - Report as "MN" on the sanitation score sheet 

opposite the applicable item. If not corrected within the time specified by 
 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 6 of 63 

the inspector (e.g., 24 hours), the condition is considered "Unsatisfactory", 

and shown as "U." 

Major Conditions - Report as "MJ" on the sanitation score sheet opposite 

the applicable item. If corrective action is not taken within the time 

specified by the inspector (e.g., prior to the next shift or at the end of the 

next cleanup period), or it occurs repeatedly, it is considered 

"Unsatisfactory", and shown as "U." 

Critical Conditions - Report as "CR" on the sanitation score sheet 

opposite the applicable item. Note what action is taken on the 

contaminated product. 

3. Distribution of Sanitation Score Sheet 

a. Plant Management — original to the designated plant employee 

responsible for the sanitation program with copy(s) to upper-level 

management, as necessary. 

b. USDA Plant File — one copy. 

c. Area Field office — one copy when conditions are 

"Unsatisfactory" or unusual. 1/ 

d. Regional office — one copy when conditions are "Unsatisfactory" 

or unusual. 1/ 

e. National office — one copy when conditions are "Unsatisfactory" 

or unusual. 1/ 

1/ The Area office will distribute these sanitation score sheets daily. 

Note: FDA notification may be required in the case of critical deficiencies and 

uncorrected major deficiencies. Please see the Reporting Significant Food Safety 

Observations to the Food and Drug Administration and USDA Food Safety and 

Inspection Service section of this manual for additional instructions. 
 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 7 of 63 

Example: Form FV-416-1, "Sanitation Score Sheet for Canned Food Processing Plants." 

PAGE 1 OF 2 

U.S. DEPARTMENT OF AGRICULTURE 

AGRICULTURAL MARKETING SERVICE 

"Unsatisfactory 1st Day" 

SANITATION SCORE SHEET FOR CANNED FOOD PROCESSING PLANT 

NAME OF PLANT DATE 

RATING SYMBOLS 

(√ ) Satisfactory 

MN - Minor MJ - Major 

CR - Critical U - Unsatisfactory 

TIME TIME 

PREM ISES COOK ROOM 

1. Outside Areas 1. Exhaust Box √ √ √

A 2. Waste Disposal √ MN √ √ E 2. Syrupers √ √ √

3. 3. Seamers √ √ √

RECEIVING DEPARTM ENT 4. Floors, Gutters and Walls √ √ √

1. Boxes √ √ √ 5. 

2. Storage √ √ √ SYRUP & EVAPORATION DEPARTM ENT 

3. Dumpers & Conveyors √ √ √ F 1. Tanks and Pipes √ √ √

4. Floors, Gutters and Walls √ √ √ 2. Vacuum Pans √ √ √

5 3. Floors, Gutters and Walls √ √ √

PREPARATION DEPARTMENT 4. 

1. Washers and Flumes MN MJ U WAREHOUSE 

2. Belts and Elevators G 1. General Housekeeping √ √ √

3. Graders and Snippers 2. Stacks √ √ √

4. Cutters and Slicers √ √ √ 3. Condiment Room MN √

5. Blanchers, Hoppers √ √ √ REST ROOM S 

6. Pulpers and Finishers √ √ √ 1. Supplies √ √ √

7. Floors, Gutters and Walls √ √ √ 2. Wash Basins √ √ √

√ √ √ 3. Toilets and Urinals √ √ √

√ √ √ 4. Floors and Walls √ √ √

10. 5. 

CANNING DEPARTM ENT PERSONNEL 

1. Belts √ √ √ √ √ √ I 1. Cleanliness √ √ √

D 2. Fillers and Can Tables √ √ √ √ √ √ 2. Head Covering √ √ MJ 

3. Floors, Gutters and Walls √ √ √ √ √ √ 3. Smoking √ √ √

4. 4. 

5. 5. 

ITEM RATING 

NO. SYMBOL 

A1 1000 MN 

B 1000 

C1 1000 MN 

FV-416-1 

B 

C 

ABC PROCESSING COMPANY 

1700 1700 

D.I.R. NO. 

129 

MN √ √ √

W. Fields, Conner Tibbetts, M. Jared 

W. Fields, Conner Tibbetts, M. Jared 

1000 

PROCESSVILLE, TN 

H 

1300 

TIME SANITATION DEFICIENCIES 

SHOW RATING, ITEM NO. AND DESCRIBE 

LOCATION 

1000 1300 

SIGNATURE OF USDA INSPECTOR (Print and Sign) 

2100 

9. Chutes 

8. De-w aters, Tank s 

2100 0300 0500 0300 0500 

1/28/2011 

TIME 

CORR. 

TIME 

LIMIT 

24 hrs 

Receiving department is much improved since 

1300 

1700 

additional clean-up person was added. 

Ground area below ingredient hoist ---spilled spices, etc. 

on floor. Notified R. Benett. 

Product residue on underside of long wire grate on 

whole peel line - between shift clean-up not effective -

will need attention prior to next shift. Notified R. Benett. 

Example 
 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 8 of 63 

Example: Form FV-416-5, "Sanitation Score Sheet for Processing Plants (Continuation Sheet)." 

PAGE 2 OF 2 

U.S. DEPARTMENT OF AGRICULTURE 

AGRICULTURAL MARKETING SERVICE 

SANITATION SCORE SHEET FOR PROCESSING PLANTS (Continuation Sheet ) 

NAME OF PLANT 

ABC PROCESSING COMPANY 

LOCATION 

PROCESSVILLE, TN 

DATE 

10/10/2010 

D.I.R. NO. 

129 

RATING SYMBOLS 

(√ ) Satisfactory 

MN - Minor MJ - Major 

CR - Critical U - unsatisfactory W. Fields, Conner Tibbetts, M. Jared 

SIGNATURE OF USDA INSPECTOR (Print and Sign) 

W. Fields, Conner Tibbetts, M. Jared 

ITEM 

NO. TIME RATING SYMBOL SHOW RATING, ITEM NO. AND DESCRIBE 

SANITATION DEFICIENCIES TIME 

LIMIT 

TIME 

CORR. 

G3 1000 MN Condiment room - spilled spices, etc. 24 hrs 1700 

A2 1700 MN Offensive odor around cull hopper - Notified B. Stevens. 24 hrs 2100 

C1 1700 MJ Slime on underside of long wire grate on whole peel 0030 

line - Notified B.Stevens. See C1 @ 1000. 

C1 0030 U Same condition as 1700 - J. Byron stated that they are 

going down for general clean-up at 0700. 

H ─ ─ Dockside men's room looks good since painting. 

I2 0030 MJ Two graders on line 6 without hairnets- Notified J. Byron. Immediately Immediately 

Overall sanitation rating 

UNSAT ISFACT ORY 

account inadequate follow-up on 

Major deficiency (See C1) 

William Fields 

Inspector-in Charge 

FV-416-5 Example 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 9 of 63 

C. Problem Situations 

The Inspector is responsible for informing the Officer-in-Charge, (OIC) 

of any sanitation problem situations in the plant, including instances of 

"no corrective action" or repeated occurrences of a sanitation deficiency. 

The OIC is responsible for informing the Regional Section Head of any 

plant that has a definite or potential sanitation problem. The OIC will also 

initiate recommendations for withdrawal of service if the problem(s) 

cannot be resolved after discussion with plant management. 

If the Regional Section Head concurs with the OIC, he or she will submit the 

recommendation of withdrawal to the Inspection Branch Chief. The withdrawal 

will proceed in accordance with 7 CFR, Part 50, "Rules of Practice Governing 

Withdrawal of Inspection and Grading Service under the Agricultural Marketing 

Act of 1946," which may be found at the following internet address: 

http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR. 

Note: FDA notification may be required in the case of critical deficiencies and 

uncorrected major deficiencies. Please see the Reporting Significant Food Safety 

Observations to the Food and Drug Administration and USDA Food Safety and 

Inspection Service section of this manual for additional instructions. 

D. Recommendations for Handling Unsatisfactory Sanitation Conditions 

1. The inspector should be certain that all sanitation score sheets are 

distributed to the plant person(s) responsible for the sanitation 

program. The lines of communication must be kept open and clear 

to allow any unsatisfactory rating to be discussed in detail. 

2. If there are unsatisfactory sanitation reports for three 

successive days, or three within one week, the inspector 

shall contact their immediate supervisor. The supervisor 

shall contact the appropriate plant management either by 

telephone or personal visit, and discuss arrangements for 

corrective action of the unsatisfactory plant conditions. 

Pertinent points of all discussions are to be confirmed in 

writing. Distribute confirmation to the responsible 

plant personnel, the Regional Section Head, and the 

Inspection Branch Chief. 

3. If it is not possible to gain cooperation in correcting a definite 

sanitation problem, the OIC should contact the Regional Section 

Head. Together they should arrange for a meeting with top plant 

management, and thoroughly review all previous conversations 

and actions. During this meeting, plant management should be 

warned that further unsatisfactory reports will require a 
 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 10 of 63 

recommendation for withdrawal of service. Confirm the warning 

to management in writing, with a copy to the Inspection 

Branch Chief. 

4. If the Regional Section Head is unsuccessful in making progress, 

the Regional Section Head should discuss the situation with the 

Inspection Branch Chief. A memorandum should be prepared 

showing the efforts made to resolve the problem(s), including all 

necessary supporting documents. This memorandum should 

contain a recommendation to the Inspection Branch Chief for 

withdrawal of service. 

Note: FDA notification may be required in the case of critical deficiencies and 

uncorrected major deficiencies. Please see the Reporting Significant Food Safety 

Observations to the Food and Drug Administration and USDA Food Safety and 

Inspection Service section of this manual for additional instructions. 

Sanitation Deficiencies - Examples in Processed Fruit and Vegetable Plants 

A. Premises-Waste or Garbage Areas-Receiving Areas-Dumping Areas 

1. Minor Conditions 

a. Overflow or spillage that adversely affects operations 

b. Accumulation of freshly spilled product 

c. Dusty roads or muddy areas 

d. Insect "concentration" and/or harborage 

e. Waste not removed in a timely manner 

f. Litter, or paper and trash 

g. Dirty raw product containers 

h. Overflow or backup of waste disposal 

i. Improperly handled old, decaying, or moldy products 

j. Offensive, odorous conditions 

k. Evidence of rodents and/or harborage conditions (grass, weeds, old 

equipment, junk, and other similar materials) 

l. Slime on equipment, floors, or paving 
 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

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B. Preparation and Processing Areas 

1. Minor Conditions 

a. Overflow or excessive water on floors 

b. Product on floor after cleaning 

c. A few insects in area 

d. Fresh product, or product residue, on equipment after cleaning 

e. Dirty walls, windows, ledges 

f. Excessive product on floors during operations 

2. Major Conditions 

a. Dirty, decaying, or discolored product on parts of equipment that 

may contaminate the product 

b. Slime on equipment 

c. Insects in areas near vulnerable product 

d. Loose rust, flaking paint, dust, cobwebs, or mold on overhead 

areas, or dirt on part of equipment that may come in contact with 

or contaminate the product while it is vulnerable. This includes 

overhead areas, underside of drip pans, motor mounts, walkways, 

and crossovers 

e. Offensive, odorous conditions 

f. Product containers that are rusty, dirty, or that contain cleanup 

water or sediment 

g. Product holding containers (bins, tubs, pans) nested after having 

been in contact with unsanitary situations 

h. Container cleaners not operating properly 

i. Misuse of empty product containers such as drinking cups, waste 

receptacles 
 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

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3. Critical Conditions during Operations 

a. Vulnerable product that has been in contact with an insanitary 

condition (such as floors) returned to line or packaged for use 

b. Dirty containers or equipment brought in contact with product 

c. Insects in or on product or product contact surfaces 

d. Condensate from dirty surfaces dripping on product 

e. Filled, open containers stacked in such a manner as to contaminate 

the product 

f. Dirty ice in product 

g. Maintenance or repair work done in such a manner as to 

contaminate the product 

h. Sediment or foreign material in packing media, fillers, or holding 

tanks 

C. Warehouse and Shop Areas 

1. Minor Conditions 

a. Litter, trash, cigarette butts, and other materials on floor 

b. Untidy, dirty, or wet storage conditions for containers, and/or other 

materials and supplies 

2. Major Conditions 

Overall storage conditions that are attracting insects, birds, rodents, and/or 

animals which may contaminate the product 

D. Rest Rooms 

1. Minor Conditions 

a. Room not clean; presents a poor general appearance 

b. Toilets or sinks not properly cleaned 

c. Excessive water on floor 
 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

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2. Major Conditions 

a. Absence of toilet tissue, suitable hand-cleaning soap or detergents, 

paper towels, and any other essential supplies 

b. Very dirty or non- functional toilet or sinks 

c. No hot water available for washing hands 

d. No hand washing signs (bilingual as appropriate) 

E. Personal Hygiene 1/ 

1. Minor Conditions 

a. Wearing unsecured jewelry 

b. Chewing gum or eating except in authorized areas 

c. Wearing improper clothes for work, such as sleeveless shirts 

d. Personal items on unused equipment 

1/ Although it will be monitored by USDA, this part of the plant sanitation program 

should be controlled by management. For it to be effective, management must 

provide adequate training on good personal hygiene practices. These practices 

and rules should be conspicuously posted throughout the plant. 

2. Major Conditions 

a. Smoking or spitting in plant processing area 

b. Uncovered, or improperly covered hair (no hat, hairnet, or beard 

cover) 

c. Wearing very dirty clothes 

d. Starting or returning to work without washing or sanitizing hands 

and/or gloves 

e. Using unhygienic practices 

3. Critical Conditions 

a. Production line employees having uncovered infections or cuts 

b. Direct contamination of product by sneezing or coughing 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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F. Lunchroom Area 

1. Minor Conditions 

a. Untidy areas and facilities 

b. Presence of a few flies 

G. Freezer Facilities 

1. Minor Conditions 

a. Buildup of frozen spilled product from broken or leaking product 

containers 

2. Major and/or Critical Conditions 

a. Grease, oil, or dirt contamination of product on belts in freezing 

tunnels 

PLANT SURVEY 

The plant sanitation survey form includes the following: 

A. Plant organization, management; 

B. Plant facilities, equipment, and environmental factors; 

C. Plant operational conditions; and 

D. Survey evaluation and review. 

The plant survey is a facility assessment to determine compliance with government and/or 

private buyer sanitation requirements and current Good Manufacturing Practices (GMPs). For 

processors who have contracts on a continuing basis, a plant survey is performed annually, prior 

to the anniversary date of the previous survey ensuring a continuous record of GMP compliance. 

For new applicants - processors that have never had a contract service agreement, or those 

without a contract for the previous processing season - a plant survey is performed prior to 

starting inspection. 

Prior to implementing any inspection service, plant survey items A, B, and D above must be 

completed. Item C (the operational portion of the survey) may also be evaluated at this time if 

the plant is operating. When survey requirements are considered acceptable, the applicable 

contract service form will be completed and distributed according to Division instructions. 

When it is not possible to evaluate the operational part of the survey before granting service, the 

survey form will be held until this is done. However, this will not delay distribution of the 
 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 15 of 63 

application and contract of agreement for inspection/grading service. The contract form is 

accompanied by a memo stating that the plant is approved for service and that operational 

conditions will be evaluated within ten days after processing begins. When the survey is 

completed, an e-mail notification will be promptly sent to the appropriate regional office. 

For other than new applicants, plants should be surveyed at least once a year. This applies to 

both seasonal and year-round plant contracts. For in-plant assignments, an experienced inspector 

may assist the supervisor by completing a "preliminary survey" which must be approved by the 

supervisor. All final surveys shall be completed by the OIC, Assistant OIC, sub-area supervisor, 

or approved inspection staff as soon as practical after a plant begins processing, normally within 

a period of ten days. The plant survey shall be distributed as follows: 

1. Original to plant management, optional electronic delivery is acceptable if 

requested by the applicant; 

2. Enter survey into Plant Survey database in Lotus Notes; 

a. All additional documentation relating to the survey e.g. cover 

letters, water potability, follow-up correspondence shall be added as 

attachments in Lotus Notes. Save the documents in a manner 

enabling retrieval as follows: 

i. Save the survey documents on your computer; 

ii. Select the “Attachment” tab in the survey you are working 

on in Lotus Notes; 

iii. Select the down arrow “v” on the right of the T. 

iv. Select “Attachments”; 

v. Select the “paperclip” icon. That will open “My 

Documents” on your computer; 

vi. Highlight the document to attach; and 

vii. Select “Create” and your document will be listed. 

3. Copy to plant inspector's file; and 

4. Copy maintained at the area field office. Hard copy delivery to the 

National office and Regions is no longer required. 

For plants under consideration for continuous inspection approval, follow the survey procedures 

for this type of agreement. (See the AIM Management Site at the following intranet address: 

http://agnis/sites/FV/PPB/AIM/Manage/default.aspx.) The actual survey is performed and 

distributed in the same way as other types of contracts and agreements. 
 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 16 of 63 

All plant survey reports and attachments shall be legible. Each section shall be completed in 

detail, particularly the evaluation and review section. Recommendations should be definite and 

understandable. Documents shall be dated and signed in the appropriate places. 

On the front page of all plant surveys and related attachments, indicate the type of contract or 

service involved, i.e., Continuous, Pack Certification, Letter Agreement, request from applicants 

for potential government contracts. Also indicate the products being processed at the time of the 

survey. The plant should be evaluated as acceptable, conditionally acceptable, or unacceptable 

based on the results of the survey. Conditional approval is assigned if corrections are mandatory 

in order to approve the plant. The plant is unacceptable if conditions are present which would 

result in product contamination, or the plant is unwilling or unable to meet the essential 

requirements. Indicate if the plant is approved, not approved, or conditionally approved at the 

bottom of the survey front page. 

Deficiencies are rated as minor, major, or critical. Each deficiency will be described, and the 

date the plant intends to correct the deficiency noted. 

Survey results are to be discussed with responsible plant management. The inspector on duty 

should be present, if available. There should be complete understanding regarding the correction 

of all deficiencies. 

Essential Requirements of the Survey 

Many of the questions and statements on the plant survey are points of information and/or 

recommendation. They become a requirement only when an incident becomes serious enough to 

cause an unsanitary condition. 

There are, however, certain essential requirements included in the plant survey. Unless these 

requirements are satisfied, the plant will not be approved and the Division will not enter into a 

contract for in-plant inspection. The requirements are as follows: 

A. Parking lots and drives are to be surfaced or treated to control dust and dirt; 

B. All exterior openings of the preparation and packaging rooms are to be enclosed 

or screened (metal or effective air screens) to protect finished product from birds, 

insects, rodents, and other vermin; 

C. Screened, vented toilet facilities are to be designed so they do not open directly 

into rooms where products are handled; 

D. Can cleaners (steam, air, or water) are to be installed on each line for glass, tin 

and semi rigid containers; 

E. Non-wood, non-corrosive material is to be used on all product contact surfaces 

where the product is exposed, i.e. when the product has been pitted, peeled, cut, 

during and after blanching, or is in such a form as to be subject to contamination. 
 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

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The surfaces of corrosive material must be kept clean, free of rust or flaking paint 

and other foreign material in order to avoid product contamination; 

F. Lights above all product lines are to be shielded or shatterproof; 

G. Floors and gutters are to be constructed to drain well, and be free of pitting or 

cracks which prevent proper cleaning. Wide, deep cracks and extremely rough 

sections that are difficult to clean must be repaired or replaced; 

H. The cleanup program uses the proper equipment and adequate time to effectively 

sanitize - rather than rinse - processing lines during and between shifts; 

I. Manufacturing practices that prevent product contamination shall be followed. 

This includes but is not limited to keeping overhead areas free from flaking paint, 

dust, condensate, mold, dirt; 

J. Waste material is removed frequently, and on a timely basis; and 

K. The plant provides SCI Division an acceptable water quality certificate. See your 

immediate supervisor if there is any question about the documentation provided. 

Survey Follow-up 

If conditional approval was granted, required changes will be listed on the final page of the 

survey. Deficiencies such as manufacturing practices are to be corrected immediately and noted 

in the date corrected column. 

Other deficiencies should be corrected in accordance with realistic and reasonable timetables 

reached in agreement with the processor. The area OIC will confirm these dates in writing, 

listing each deficiency along with the correction dateline. Copies of this confirmation letter shall 

be sent to the Regional Section Head and the Division Director. If deficiencies are not corrected 

within the specified time, the area supervisor will contact the processor in writing, stating what 

action will be taken if the deficiencies are not corrected. 

As corrective action is taken on each deficiency, the correction date is noted in the appropriate 

column of the follow-up summary sheet for deficiencies. Assisted by the plant inspector, the 

area supervisor is responsible for keeping this sheet up to date and checked against agreed 

correction datelines. Distribution of the follow-up summary sheet for deficiencies is the same as 

for the plant survey. 
 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 18 of 63 

Example of Plant Survey Confirmation Letter 

(Current Official Letterhead) 

(Date) 

(Plant Contact Information 

Name, Title 

Address 

City, State Zip Code) 

Dear (Insert Name): 

It is the policy of the United States Department of Agriculture (USDA) to conduct an annual 

Plant Survey to ensure compliance with good commercial manufacturing practices. This year the 

survey for your facility located in (Insert facility location) was completed on (Insert date of 

survey). 

The following deficiencies were noted during the plant survey: 

(List deficiencies and agreed correction dates, if available) 

(Insert food defense survey results as appropriate. i.e. The Food Defense System Survey is 

included. No deficiencies were found, etc.) 

I would like to thank you for the cooperation given to us by you and your staff. If you have any 

questions or if there is any way we can improve our service to you to further meet your needs, 

please contact me at (insert appropriate SCI telephone number). 

A copy of the Plant Survey and Food Defense System Survey is enclosed for your records. 

(As appropriate) 

Sincerely, 

Signature 

Name 

Title 

Enclosure 

CC: 

(Insert Name), Division Director 

(Insert Name), Regional Section Head 

(Insert Name), Officer-in-Charge 

USDA Inspector (If appropriate) 

File 
 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 19 of 63 

SCI DIVISION SANITATION POLICY 

It is SCI Division policy to encourage essential sanitation requirements, seek positive 

alternatives with regard to problem areas, and advocate a continuing cooperative effort and 

working relationship with the industry. 

In plant inspectors should strive to create and maintain a good working relationship with plant 

management. To support their efforts to achieve high sanitation standards and establish effective 

lines of communication, meeting with the processor prior to the packing season and again shortly 

after the season is over is recommended. 

A. Pre-Season Meeting 

1. Review in detail any sanitation problems which persisted throughout the 

previous season; 

2. Recommend that a competent plant employee be assigned the 

responsibility for sanitation; 

3. Define USDA and plant management sanitation responsibilities. Review 

our sanitation policies and procedures so that there is a complete 

understanding of our requirements and inspection coverage; 

4. Determine that all necessary corrections of deficiencies in plant facilities 

and equipment have been made by the agreed date(s). Verify if the plant 

is ready to begin operation; and 

5. Solicit comments and suggestions from plant management regarding 

improvements in the program. 

B. Post-Season Meeting 

1. Review the effectiveness of the overall sanitation program during the past 

season; 

2. Discuss in detail all sanitation problem situations of the past year or 

season. Use the sanitation score sheets as a basis for discussion; 

3. Make a list of the plant facilities and equipment that will need 

improvement. A reasonable corrective action date should be agreed upon. 

Most of the corrections can be made during the "off-season." 

4. Often processors using our services make many improvements to plant 

facilities. During the meeting, be sure to recognize any effective 

sanitation improvements added over the course of the season. 
 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

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Reporting Significant Food Safety Observations to the Food and Drug Administration and 

USDA Food Safety and Inspection Service 

The purpose of this procedure is to facilitate the uniform reporting of significant food safety 

observations made by Specialty Crops Inspection (SCI) Division inspectors during the course of 

their normal duties (e.g., inspection, daily sanitation, Plant Surveys, etc.) to the Food and Drug 

Administration (FDA) or to USDA’s Food Safety and Inspection Service (FSIS), as applicable. 

This procedure implements a component of USDA’s commitment to continually improve 

procedures to notify FDA regarding potential food safety issues as outlined in a September 2010 

letter from Agriculture Secretary Vilsack to Health and Human Services Secretary Sebelius and 

FDA Commissioner Hamburg. In addition, this procedure implements FDA-USDA guidance on 

reporting significant food safety observations as distributed on DVD in August 2011. 

These guidelines apply to the SCI Division procedure for reporting significant food safety 

observations to FDA and FSIS. All applicable Division employees are responsible for ensuring 

the uniform application of these reporting procedures. 

Reporting Procedure 

A. When SCI is at a facility less than once a week: 

This covers observations made during SCI Division inspection activities including 

Lot Sampling and Inspection, Plant Surveys, Plant Systems Audits (PSA), 

Qualified Through Verification (QTV) audits, and Domestic Origin Verification 

(DOV) audits. The steps in the process are as follows: 

1. Inspector observes significant food safety observation (see Attachment 1), 

and documents the observation on Plant Survey, PSA, QTV checklist, or 

other appropriate document. If applicable, the inspector establishes and 

records a time frame for the facility to take corrective action. 

2. Inspector reports significant food safety observation to the Officer-InCharge (OIC). 

3. OIC notifies the Regional Office. With the Regional Office’s 

concurrence, the OIC (or the IIC, if designated by the OIC) informs the 

facility that FDA or FSIS will be notified. The OIC contacts the local 

FDA office or FSIS representative and reports the observation verbally, 

with supplemental e-mail, fax, or written correspondence if needed. 

4. OIC inputs information about the observation into their Regional Office’s 

SharePoint FDA Notification template at one of the following SharePoint 

sites: 

For Eastern Region: http://agnis/sites/FV/PPB/East/Lists/FDANotifications/AllItems.aspx 

For Western Region: http://agnis/sites/FV/PPB/West/Lists/FDANotifications/AllItems.aspx 
 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 21 of 63 

5. The OIC alerts the Regional Office once the information about the 

observation has been entered into the SharePoint FDA Notification 

template. 

6. The Regional Office reviews the information entered into the SharePoint 

FDA Notification template, makes editorial changes as needed, and alerts 

the National Office reviewer that the information is ready for review. 

7. The National Office reviewer makes editorial changes as needed and 

finalizes the text. The National Office reviewer transfers the contents of 

the SharePoint template to the Interagency Referral Report internet 

website at: http://www.accessdata.fda.gov/scripts/IRF/. (In this report, the 

OIC will be the “Employee Reporting the Incident,” and the National 

Office reviewer will be the “Employee Completing the Report.”) The 

report includes the following in the “Additional Emails for the Report to 

be Sent” block: 

• Erin.morris@ams.usda.gov 

• KerryR.smith@ams.usda.gov 

• Regional Section Head 

• Assistant Regional Section Head 

• Officer-in-Charge 

• National Office reviewer 

8. The National Office reviewer submits the report to the Interagency 

Referral Report internet website. 

9. FDA or FSIS provides feedback to SCI regarding any FDA or FSIS 

actions and recommendations for SCI Division actions. 

10. SCI Division follows-up as necessary. 

B. When SCI Division is at the facility at least once a week 

This covers observations made during SCI Division inspection activities including 

in-plant inspection duties or observations made at facilities visited frequently (i.e., 

at least once a week). These procedures apply to FDA-regulated products. For 

FSIS-regulated products covered under in-plant services, such as in Operational 

Rations plants, inspectors and OICs should continue to use existing channels of 

communication for reporting observations to FSIS. The steps in the process for 

reporting to FDA are as follows: 

1. In-plant inspector makes a significant food safety observation (see 

Attachment 1), and documents the observation on the SCI Division 

sanitation score sheet. Inspector establishes and records a time frame for 

facility’s corrective action. 
 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 22 of 63 

2. In-plant Inspector-in-Charge (IIC) reports significant food safety 

observation to OIC. 

3. OIC evaluates severity of the violation to determine whether it requires 

immediate reporting to FDA or FSIS (see Attachment 1). 

4. If violation severity does not require immediate reporting to FDA: 

a. In-plant inspector monitors condition and facility’s corrective 

action. 

b. If plant executes effective corrective action within the time frame 

required, the inspector documents the corrective action, time, and 

date on sanitation score sheet. No further SCI Division action is 

required. 

c. If plant does not execute effective corrective action within the time 

frame required, inspector documents status, and time and date on 

the sanitation score sheet and the IIC reports the uncorrected 

sanitation deficiency to the OIC. The OIC evaluates the 

observation to determine whether FDA should be notified (See 

Attachment 1). If yes, OIC follows step 5 below. If no, OIC takes 

no further steps to notify FDA, and stays in communication with 

IIC to monitor situation. 

5. If violation severity does require immediate reporting to FDA: 

a. The OIC notifies the Regional Office. With the Regional Office’s 

concurrence, the OIC (or IIC, if designated by the OIC) informs 

the plant that FDA will be notified. OIC calls local FDA office 

and reports observation verbally, with supplemental e-mail, fax, or 

written correspondence if needed. 

b. The OIC inputs information about the observation into their 

Regional Office’s SharePoint FDA Notification template at one of 

the following SharePoint sites: 

For Eastern Region: http://agnis/sites/FV/PPB/East/Lists/FDANotifications/AllItems.aspx 

For Western Region: http://agnis/sites/FV/PPB/West/Lists/FDANotifications/AllItems.aspx 

c. The OIC alerts the Regional Office once the information about the 

observation has been entered into the SharePoint FDA Notification 

template. 

d. The Regional Office reviews the information entered into the 

SharePoint FDA Notification template, makes editorial changes as 

needed, and alerts the National Office reviewer that the 

information is ready for review. 
 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 23 of 63 

e. The National Office reviewer makes editorial changes as needed 

and finalizes the text. The National Office reviewer transfers the 

contents of the SharePoint template to the Interagency Referral 

Report internet website at: 

http://www.accessdata.fda.gov/scripts/IRF/. (In this report, the 

OIC will be the “Employee Reporting the Incident,” and the 

National Office reviewer will be the “Employee Completing the 

Report.”) The report includes the following in the “Additional 

Emails for the Report to be Sent” block: 

• Erin.morris@ams.usda.gov 

• KerryR.smith@ams.usda.gov 

• Regional Section Head 

• Assistant Regional Section Head 

• Officer-in-Charge 

• National Office reviewer 

f. The National Office reviewer submits the report to the Interagency 

Referral Report internet website. 

g. FDA provides feedback to SCI regarding any FDA actions and 

recommendations for SCI actions. 

h. SCI Division takes steps as appropriate. 

The following Attachments are included for use and reference for these procedures: 

Attachment 1: General guidance for assessing a food safety-related observation and determining 

whether it should be reported to FDA or FSIS 

Attachment 2: Example of a completed Interagency Referral Report 

Attachment 3: September 15, 2010, letter from USDA Secretary Vilsack to HHS Secretary 

Sebelius and FDA Commissioner Hamburg 

Attachment 4: June 30, 2011, memorandum from Acting Branch Chief Randle Macon regarding 

Reporting Significant Food Safety Deficiencies 

Attachment 5: September 28, 2011, memorandum from Acting Division Director Randle Macon 

regarding Guidance on Reporting Significant Food Safety Deficiencies 

Attachment 6: September 22, 2011, Notice to the Trade regarding SCI Reporting Significant 

Food Safety Deficiencies 
 

 

 

 

 

 

 

 

 

 

 

Fruit & Vegetable Programs 

Original (Revision 1) – Nov. 2011 

Reporting Significant Food Safety Observations to the Food and Drug Administration 

(FDA) and USDA Food Safety and Inspection Service (FSIS) 

ATTACHMENT 1 

The following provides general guidance for assessing a food safety-related observation and 

determining whether it should be reported to FDA or FSIS using this reporting protocol. 

I. Reporting to FDA 

A. An observation that Specialty Crops Inspection Division (SCI) procedures would 

classify as a Critical (CR) Sanitation Deficiency (i.e., a condition which results in 

product contamination) should be reported to FDA upon first occurrence, 

regardless of any corrective action the facility may take. This reporting of CR 

deficiencies is applicable to in-plant situations (e.g., continuous, year-round, less 

than year round, Quality Assurance Program (QAP), etc.) and non in-plant 

situations (e.g., Plant Survey, Plant Systems Audit (PSA), Qualified Through 

Verification (QTV) audit, Domestic Origin Verification (DOV) audit, or lot 

sampling, etc.). 

B. In addition, FDA has identified certain additional conditions that if observed, 

should be reported upon first occurrence regardless of any corrective action the 

facility may take. Examples of these conditions include: 

• Failure to protect ready-to-eat foods, such as fresh-cut produce from 

contamination; 

• Obvious signs of pest damage to food; 

• Obvious and significant pest infestation; 

• Improper handling or labeling of food allergens (i.e., peanuts, soy, milk 

ingredients, eggs, fish, crustacean shellfish, tree nuts, wheat); 

• Indication of possible problem(s) with contamination by gases (e.g., ammonia 

system leak); 

• Improper cooling of potentially hazardous foods; 

• Temperature of foods in refrigerators or freezers maintained above 41 degrees 

F or 10 degrees F, respectively; and 

• Exposure of food to human blood. 

C. For an observation that SCI procedures would classify as a Major (MJ) Sanitation 

Deficiency (i.e., a condition which may result in product contamination or is 

highly objectionable), the following guidelines apply: 

1. If the MJ is observed while SCI is providing service at a facility that SCI 

visits less than once a week (such as during a Plant Survey, PSA audit, 

QTV audit, DOV audit, or lot sampling, etc.), the observation should be 

reported on first occurrence, regardless of any corrective action taken by 

the facility. 

24 
 

 

 

 

 

 

 

 

Fruit & Vegetable Programs 

Original (Revision 1) – Nov. 2011 

Reporting Significant Food Safety Observations to the Food and Drug Administration 

(FDA) and USDA Food Safety and Inspection Service (FSIS) 

ATTACHMENT 1 

(Continued) 

2. If the MJ is observed while SCI is providing service at a facility that SCI 

visits once a week or more frequently (such as an in-plant assignment), the 

observation should only be reported if the facility does not take effective 

corrective action within the required time frame. (For example, a MJ 

observation should be reported if SCI observes the condition uncorrected 

after informing the facility of the condition, and after the established time 

frame for correction has passed). In addition, if a particular MJ deficiency 

is observed repeatedly, even if it is corrected effectively by the facility 

each time within the required time frame, the observation should be 

reported to FDA. 

II. Reporting to FSIS 

A. If a significant observation is made during in-plant inspection of an FSISregulated product (such as a meat entrée at an Operational Rations plant), 

inspectors and OICs should continue to use existing channels of communication 

for reporting observations to FSIS. 

B. If a CR or MJ observation is made regarding an FSIS-regulated product at a 

facility that SCI visits less than weekly (such as during a Plant Systems Audit), 

the deficiency should be reported to FSIS using the process described on page one 

of the “Reporting Significant Food Safety Observations to the Food and Drug 

Administration and USDA Food Safety and Inspection Service” section of the 

AIM Inspection Series, Sanitation and Safety manual under “Reporting 

Procedure, A. When SCI is at a facility less than once a week. 

25 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 26 of 63 

FOOD AND DRUG ADMINISTRATION REGULATORY VISITS 

A. Purpose 

Food and Drug Administration (FDA) inspectors visit processing plants for 

various reasons in connection with their overall regulatory responsibilities. 

Ordinarily, the purpose of these visits is as follows: 

1. To perform a sanitation inspection, including the condition of raw 

materials; 

2. To collect a routine sample, e.g., pesticide analyses; or 

3. To check a processing compliance procedure for low acid products. 

Our primary interest is in the sanitation inspection aspects of the FDA review. 

Action by Inspectors 

A. Agreement with Federal Food and Drug Administration 

The March 4, 2011, Memorandum of Understanding (MOU) between AMS and 

FDA Concerning Information Sharing and Other Activities Related to the 

Auditing, Inspection, and Grading of Food Products, is an agreement between the 

Agricultural Marketing Service (AMS) and the FDA outlines the authority or 

basis for cooperative efforts between these two agencies. Inspectors should 

carefully review this agreement. 

Although this instruction deals directly with FDA–USDA relationships under the 

agreement, the same basic philosophy applies to state, county, and other 

regulatory agencies. Whenever possible we cooperate with such agencies. 

However, since we have no agreement with them, they are not obligated to 

cooperate with us. 

B. Plant Visits 

The inspector should notify his/her supervisor as soon as the inspector becomes 

aware that FDA will be, or is, making a plant visit. FDA inspectors must always 

contact plant management and announce the intended purpose of their visit when 

they enter the plant, so the plant is aware of their presence and can accompany 

FDA on the tour. 

If not contacted in the early stages of the visit, the SCI Division inspector may 

introduce him or herself to the FDA inspector and tactfully ask to be present 

during the tour. However, SCI Division inspectors should not spend more time 

on the tour than they can spare. If the FDA visit extends over a considerable 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 27 of 63 

length of time, ask to be advised at the end of the visit to take the opportunity to 

review and receive a copy of the FDA report documenting their visit. 

In many instances, the FDA inspector's purpose is to gather information 

concerning the condition of the raw and finished products, and observe packing 

practices and facilities. If encountered, unsanitary conditions or practices may 

later be associated with analyses of samples drawn at the time of inspection, or 

from trade channels before any seizure action is taken. During the inspection 

tour, the FDA inspector may or may not comment on conditions that might lead to 

seizures at some later date. 

As indicated in the MOU between FDA and AMS, AMS will “when requested by 

FDA, provide assistance necessary to facilitate investigations required to ensure 

public health;” and “furnish to FDA upon request any pertinent reports AMS 

generates that include general information on deficiencies in current good 

manufacturing practice or good agricultural practice.” 

The SCI Division inspector should create and encourage a relationship of 

cooperation with the FDA inspectors. If FDA seeks plant documents, these can 

be provided by the plant or, if necessary from the SCI Division inspector, if in 

SCI Division possession for the execution of our services. 

1. SCI Division Responsibilities 

a. If invited by FDA, the SCI Division inspector will make every 

effort to join in for at least part of the tour; 

b. When asked by the FDA inspector, the SCI Division inspector will 

comment only on the facts of any particular sanitation deficiency 

about which the SCI Division inspector is knowledgeable; 

c. SCI Division inspectors shall document the FDA inspector's visit 

on form FV-425. This form is to be used to document visits by all 

regulatory agencies, such as Occupational Safety and Health 

Administration, Environmental Protection Agency, state, county, 

or city health agencies, and may be found on the AMS Forms 

Catalog at the following intranet address: 

http://agnis/AMSFormsCatalog/Forms/AllItems.aspx. 

Any discrepancies noted between the SCI Division inspector’s 

assessments and those of the Regulatory inspector should be fully 

explained in the "Remarks" section of the form, with enough detail 

to allow supervisory personnel to accurately evaluate the 

conditions. Retain one copy with the daily inspection report or 

sanitation score sheet. Send the original with a copy of the 

sanitation score sheet, and Food and Drug Form 483 or other 

documentation issued by FDA regarding the visit to the area field 

office, and the regional office for distribution to the Division 

Director. 
 

 

 

 

 

 

 

SCI Division Inspection Series 

Effective Date: September 2013 

Sanitation Manual 

Page 28 of 63 

Example of FV-425 

Reproduce Locally. Include form number and edition date of all reproductions. 

Fruit and Vegetable Program 

Specialty Crops Inspection Division 

NAME OF PLANT DIR NO. 

LOCATION OF PLANT (City and State) 

PLANT TOUR BY REGULATORY INSPECTOR(S) 

REPORT OF 

REGULATORY AGENCY INSPECTION 

BEGINNING DATE AND HOUR ENDING DATE AND HOUR 

INSTRUCTIONS: Complete in triplicate. Retain copy. Send original to Washington and copy to Regional 

Office. Attach copy of sanitation scoresheet(s) and copy of regulatory agency report. 

NAME(S) OF REGULATORY INSPECTOR(S) 

AGENCY REPRESENTED 

FEDERAL 

FOOD AND DRUG 

STATE 

FOOD AND DRUG OTHER (Specify) 

PRODUCTS BEING PROCESSED 

Did USDA inspector accompany regulatory inspector(s) on tour? 

(If “No” explain under “Remarks”) 

YES NO 

Were the comments (oral or written) of the regulatory inspector(s) in substantial agreement with USDA 

reports or opinions? (If “No” indicate discrepancies under “Remarks”) 

Did plant management make required or recommended corrections? 

(Give details under “Remarks”) 

REMARKS 

DATE OF REPORT INSPECTOR IN CHARGE (Signature) 

FV-425 (Example) 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 29 of 63 

Action by Supervisors 

If substantial disagreements are reported between the FDA and SCI Division inspectors in 

evaluating conditions of the plant, raw materials, or other pertinent factors, and the SCI 

supervisor is unable to resolve these differences, or there are numerous deficiencies, a report 

shall be made at once to the Regional Section Head and the National office concerning further 

steps to take. The OIC will report to the local FDA office as required in the Memorandum of 

Understanding, paragraph 5, under "The Agricultural Marketing Service will:” 

Action by National Office 

All actions under the agreement other than that specified above will be handled by the National 

office. This includes supplying information with respect to lots of product being considered for 

regulatory action by FDA. 

Inspection of products under seizure by a Regulatory Agency 

Refer to AIM Inspection Series, Sampling Manual, “Inspection of Products under Seizure by 

Regulatory Agencies" section for Division policy regarding products under seizure or quarantine 

by regulatory agencies on Federal, State, County, or City levels, or in an instance in which it may 

not be to the best interest of the government to perform such inspection. 

Memorandum of Understanding between the Agricultural Marketing Service and the Food 

and Drug Administration concerning the inspection and grading of food products 

MOU 225-72-2009 may be found at the following internet address: 

http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/ 

DomesticMOUs/default.htm 

SANITATION REQUIREMENTS 

General 

Although the Division refers specifically to the Food and Drug Administration regulations as our 

sanitary requirements, this does not excuse plant management from complying with any state, 

local, or contract requirements that also apply. 

Regulations applying to plant sanitation requirements are issued under section 402 (a) (4) 

and 701 (a) of the Federal Food, Drug, and Cosmetic Act and now appear in Title 21, Part 

110 of the Code of Federal Regulations published by the Food and Drug Administration, 

Department of Health and Human Services which may be found at the following internet 

address: http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR. 

The following pages contain an example of the SCI Division Plant Survey. 
 

 

 

 

EXAMPLE 

APPENDIX A 

United States Department of Agriculture 

Agricultural Marketing Service 

Fruit and Vegetable Program 

Specialty Crops Inspection Division 

PLANT SURVEY 

PLANT FACILITIES, EQUIPMENT, ENVIRONMENT, 

MANAGEMENT AND OPERATIONS 

NAME OF PLANT 

LOCATION OF PLANT 

AREA FIELD OFFICE 

TYPE OF CONTRACT OR SERVICE 

PRODUCT(S) PACKED DURING SURVEY 

ANNUAL SURVEY (FINAL) COMPLETED BY DATE 

OVERALL SANITATION LEVEL ACCEPTABLE UNACCEPTABLE 

RECOMMENDED APPROVAL YES NO CONDITIONAL 
 

LOCATION OF MAIN OFFICE (Complete mailing address, 

including Zip Code) 

, 

STATUS OF PROPRIETORSHIP 

INDIVIDUALLY OWNED PARTNERSHIP 

CORPORATION COOPERATIVE 

LOCATION OF PLANT COVERED BY THIS REPORT 

(Complete mailing address including Zip Code) 

, 

OTHER 

OWNERS OR OFFICERS 

NAME TITLE 

EXAMPLE

MANAGERS, SUPERINTENDENT, OR RESPONSIBLE FOREMAN 

NAME TITLE 

AUTHORIZED PERSON RESPONSIBLE FOR SANITATION 

NAME TITLE 

TO WHOM DO THEY REPORT? 

PERSON WITH WHOM THE USDA INSPECTOR IS TO DEAL 

NAME TITLE 
 

CODING SYSTEM - CODE MARKING SYSTEM INCORPORATES 

COMMODITY TYPE GRADE OTHER (SPECIFY) 

DATE STYLE SYRUP 

SHIFT SIZE PLANT 

PERIOD 

INSPECTION SERVICE 

WHAT IS THE REASON FOR THIS COMPANY APPLYING FOR INSPECTION SERVICE? 

DOES THIS COMPANY INTEND TO USE SHIELDED LABELS OR OTHER APPROVED IDENTIFICATION OF CONTAINERS? 

NONE LIMITED EXTENSIVELY 

EXAMPLE

FILL IN THE FOLLOWING INFORMATION REGARDING PRODUCTS PACKED BY THIS PLANT 

COMMODITY SEASON COMMODITY SEASON 

DEFICIENCIES 

DEFINITION OF TERMS 

RATING 

MINOR (MN) - Do not result in product contamination but are not desirable . 

MAJOR (MJ) - May result in product contamination or are highly objectionable . 

CRITICAL (CR) - Result in product contamination . 

ACCEPTABLE 

UNACCEPTABLE 

OVERALL SANITATION LEVEL 

- No critical or major defects that would have a significant impact on 

product contamination . 

- Plant practices or operations present that result in product 

contamination or potential product contamination . 
 

A. SANITATION CONTROLS 

YES NO RATING

1. Is there a planned sanitation program that includes an educational training program for 

personnel hygiene and plant sanitation? 

2. Does the plant have an authorized person charged with the responsibility to administer 

an effective sanitation program? 

3. Does the plant maintain or utilize a bacteriological laboratory? 

4. Does the plant maintain or utilize a pesticide residue laboratory? 

5. Is there an adequate program to prevent rodents, birds or animals on the premises, in 

the receiving area, and/or warehouse? * 

6. Is there an adequate program to control insects on the premises, in the receiving area, 

processing area, and/or warehouse? * 

7. Does the plant contract for a commercial exterminator? 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation' 
 

B. PREMISES

 Parking Lot and Yard Surfaces PAVED BLACKTOP DIRT GRAVEL 

YES NO RATING

1. Are there significant deficiencies in the general appearance of the premises? 

2. Are weeds, trash, rubbish, unused machinery or "junk" a problem? 

3. Are there conditions on adjacent properties that could cause sanitation problems? 

4. Is there evidence of rodent/insect harborage? 

5. Are there offensive odors? * 

6. Is there a dust or soot problem? * 

7. Is there a drainage problem? * 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 
C. RECEIVING AREA 

YES NO RATING 

1. Is the general appearance satisfactory? 

2. Is the area designed to facilitate cleanup? 

3. Does there appear to be adequate cleanup equipment available? 

4. Is the area free from offensive odors? * 

5. Is debris and product refuse removed on a timely basis? * 

6. Are there sufficient facilities for handling raw materials in an efficient and expeditious 

manner? * 

7. Do raw material storage and handling practices preclude contamination by 

environmental hazards such as rodents, birds and insects? * 

8. Are raw product containers cleaned and stored satisfactorily? * 

9. Are holding tanks, holding bins, conveying equipment and devices adequately 

cleaned? * 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 
D. PLANT CONSTRUCTION AND DESIGN 

YES NO RATING 

1. Is the general appearance, construction and condition of the buildings satisfactory? 

2. Are all exterior openings (including doors, windows, and wall openings) equipped 

with screens in good condition or otherwise protected? 

3. Are exterior screen doors self-closing and/or air screens operating satisfactorily? 

4. Are floors constructed of materials which can be well cleaned? 

5. Are walls and ceilings in good condition and of the type that can be kept clean? 

6. Are lights shatterproof or equipped with protective shields? 

7. Is there an in-line chlorination or other sanitizing system? 

8. Are there sufficient facilities including steam and water outlets throughout the plant 

for cleanup? 

9. Is there a rodent-proof storage area for salt, sugar, and other product ingredients? 

10. Is there proper locked storage for chemicals, cleaning compounds, and similar 

materials separate from product ingredients and container storage? 

11. Is there sufficient lighting to permit efficient operations and cleaning? * 

12. Do floors, gutters or drains have sufficient slope and outlets to drain adequately? * 

13. Are buildings adequately ventilated so that all areas are kept reasonably free from 

excessive heat, steam, condensation, vapors, smoke, or fumes? * 

14. Are there leaks in the roof? * 

15. Are there leaking pipes or valves? * 

16. Is the tool shop neat, orderly and well maintained? * 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 
 

 

 

E. PROCESSING AREA, EQUIPMENT AND FACILITIES 

YES NO RATING 

1. Is the general appearance satisfactory? 

2. Are the equipment and area structures free from flaking paint and rust? 

3. Are all product contact surfaces of equipment, containers and utensils made of 

non-absorbent corrosion resistant material that will not affect the product by chemical 

or physical contact? 

4. Is the equipment constructed and located so that product contact surfaces are 

accessible for cleaning, maintenance and inspection? 

5. Are equipment, containers, and utensils in good condition? 

6. Is idle or unused processing equipment clean and located or arranged so as not 

interfere with cleanup? 

7. Are equipment, containers and utensils constructed of wood? (If so, for what 

purpose and what is the condition. Show in Remarks.) 

8. Are product contact brushes in good condition? 

9. Are motors, conveyor belts and drive mechanisms located and protected so that oil 

or grease will not contaminate the product? 

10. Are cross belts adequately protected? 

11. Are catwalks and stiles properly constructed and located to prevent product 

contamination? 

12. Is the area free from offensive odors? * 

13. Are containers and utensils used in handling the product cleaned, stored, and 

utilized in such a manner as to preclude an insanitary condition? * 

14. Are can cleaners (steam, air or water) on each line for glass, tin and semirigid 

containers? 

15. Is the can cleaning system adequate for cleaning containers? 

16. Are product belts clean and in good condition? * 

17. Are gutters and drains in good repair, functioning satisfactorily, and properly fitted 

with grates and screens? 

18. Are plant facilities and equipment satisfactory with respect to absence of slime 

and/or mold buildup? * 

19. Are cleanup procedures adequate and supported by: * 

a. proper equipment and materials? 

b. trained and well supervised personnel? 

c. sufficient time to accomplish the work? 

20. Are blending tanks, product ingredient pipelines, pumps, and valves cleaned 

frequently (including dismantling if necessary)? * 

21. When overflow sirup and brine are used, are they properly handled to avoid 

contaminating the products? * 

22. Are window ledges, wall plates, beams, equipment, etc., free from lunch boxes, 

tools, and personal gear? * 

EXAMPLE * Answer when plant is in operation 
E. PROCESSING AREA, EQUIPMENT AND FACILITIES (continued) 

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 

EXAMPLE
F. WATER SUPPLY 

MUNICIPAL PRIVATE BOTH 

YES NO RATING 

1. Is the plant's water supply approved by a state, municipal or private authority? 

2. If yes, name the authority. 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 
G. TOILET FACILITIES 

YES NO RATING 

1. Is there an adequate number of toilet facilities? 

2. Do toilet rooms have independent outside ventilation? 

3. Are toilet rooms designed so that they do not open directly into rooms or 

compartments in which processed products are being handled? 

4. Are toilet rooms equipped with self-closing doors? 

5. Are toilet rooms well lighted? 

6. Are there sufficient and proper waste receptacles? 

7. Are there signs posted indicating the importance of hand washing (multilingual if 

appropriate)? 

8. Do hand washing facilities include hot and cold water, soap, and individual towels or 

forced air hand dryers? 

9. Are toilet rooms clean, dry and of good general appearance? * 

10. Are all toilets, sinks, and faucets in good working condition? * 

11. Are waste receptacles emptied as necessary? * 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when the plant is in operation 
H. WAREHOUSE AND STORAGE FACILITIES 

YES NO RATING 

1. Is the warehouse in good repair? 

2. Are the packaging, labeling, and storage areas neat and orderly? 

3. Are empty containers protected from dust and other sources of contamination? 

4. Are materials and supplies stacked in a manner to permit sanitation inspection? 

5. Is the condition of storage areas adequate to protect the finished product, materials, 

and supplies from the elements? 

6. Are there adequate facilities to cool and maintain the raw product when necessary? 

7. Are there adequate facilities to refrigerate or freeze the finished product as required? 

8. Are there temperature-recording devices located in the freezer facilities? 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when the plant is in operation 
I. WASTE DISPOSAL 

(refers to waste areas in the plant and on plant premises ) 

YES NO RATING 

1. Is there an adequate number of waste disposal containers and are they made of 

materials suitable for the intended use? 

2. Are waste containers in good condition? 

3. Is the general appearance of collecting area satisfactory? * 

4. Is the frequency or removal of the waste timely? * 

5. Is drainage suitable in all area(s) * 

6. Are waste disposal containers cleaned regularly? * 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 
J. LABORATORY FACILITIES 

YES NO RATING 

1. Is the location, size, heating, cooling, and ventilation of the laboratory sufficient to 

provide a good working environment for the inspectors? 

2. Is the USDA-approved lighting available for color scoring? 

3. Is adequate space and inspection equipment available (including microscope and 

other appropriate specialized equipment)? 

4. Does the laboratory meet basic safety requirements? 

5. Are properly equipped grading stations available for line checks? 

6. Is the laboratory used only by USDA and quality control personnel? 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 
 

 

 

K. PERSONNEL 

YES NO RATING 

1. Do employees wear suitable clothing, including effective head coverage? * 

2. Are employees working in the processing area free from unsecured jewelry 

(bracelets, dangling earrings, etc.)? * 

3. Are employees working in direct contact with food, free from infected lesions or 

skin diseases? * 

4. Is gum chewing and all uses of tobacco limited to designated areas away from the 

processing areas? * 

5. Are other personal habits such that they will preclude contamination of the food? * 

6. Does plant management provide for personal comfort and assistance, such as: * 

a. A lunchroom? 

b. A first-aid station? 

c. Suitable working condition of temperature and humidity? 

EXAMPLE

DEFICIENCIES 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

* Answer when plant is in operation 
DEFICIENCIES (CONTINUATION SHEET ) 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

EXAMPLE

This continuation sheet may be used for any section of the plant survey. 
MANDATORY CHANGES REQUIRED IF CONDITIONAL APPROVAL WAS GRANTED 

ITEM DEFICIENCIES 

Letter and 

Number 

EXAMPLE

CONTINUATION SHEET FOR : 

MANDATORY CHANGES REQUIRED IF CONDITIONAL APPROVAL WAS GRANTED 

ITEM DEFICIENCIES 

Letter and 

Number 
 

 

EXAMPLE

ANNUAL SURVEY (Preliminary) 

CONDUCTED BY: APPROVED BY: 

INSPECTOR'S SIGNATURE DATE SUPERVISOR'S SIGNATURE DATE 

ANNUAL SURVEY (Final) 

CONDUCTED BY: APPROVED BY: 

SUPERVISOR'S SIGNATURE 

Auditor 

DATE OFFICER'S-IN-CHARGE SIGNATURE DATE 
FOLLOW-UP SUMMARY SHEET FOR DEFICIENCIES 

(List deficiencies noted on previous survey. If corrected, note date corrected) 

ITEM 

Letter and 

Number 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 

EXAMPLE

CONTINUATION SHEET FOR : 

FOLLOW-UP SUMMARY SHEET FOR DEFICIENCIES 

(List deficiencies noted on previous survey. If corrected, note date corrected) 

ITEM DESCRIPTION PROPOSED DATE 

Letter and CORRECTIVE CORRECTED 
Number ACTION DATE 

EXAMPLE
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 50 of 63 

FOOD DEFENSE SYSTEM SURVEY 

This survey is optional and can be used in conjunction with the plant survey to address Food 

Defense issues as identified in the FDA publication Guidance for Industry, Food Producers, 

Processors, and Transporters: Food Security Preventative Measures Guidance. This Food 

Defense survey meets the requirements of the Fruit and Vegetable Programs, Commodity 

Procurement Division, USDA Purchase Programs, and other programs requiring a Plant Survey 

and Food Defense System Survey. This survey may be used for any processing facility, storage, 

or offsite warehouse facility. The guidelines and rating elements listed should be used to 

determine facility ratings. A copy of this survey can also be found at the Fruit and Vegetable 

Programs, Specialty Crops Inspection Division website at the following internet address: 

http://www.ams.usda.gov/AMSv1.0/SCIHome. Under the “SCI Division Processed Services” 

block click on the “Audit Services” link, then under “Available Services” click on the “Food 

Defense System Survey” link. 

Guidelines For Evaluation Elements 

Evaluation Elements Guidance 

1. 

Does management have a Food Defense 

Plan that is implemented, and reassessed 

by management to assure it remains 

relevant to the operation? 

 Procedures documented defining a food defense 

program. Food defense plan does not need to be 

formal (i.e., elements of a food defense plan may 

exist and be written in other company 

documentation; e.g., a recall plan). 

 There is evidence that the Food Defense Plan is 

being followed. 

 Plan identifies management responsibilities and 

frequency of review. 

 Food Defense Plan is reassessed at least annually 

to assure it remains relevant to the operation. 

2. 

Does the Food Defense Plan address 

preventive measures relative to product 

tampering and deliberate contamination at 

the facility and during transport in 

commerce? 

 Includes description of policy and preventive 

measures to reduce the risk of product tampering. 

 Measures separately address food defense issues 

for product whether at the facility or in transport 

(both incoming and outgoing). 

3. 

Do written defense practices list 

management contacts and procedures for 

notifying appropriate authorities in the 

case of an emergency or security issue? 

 Plan identifies management names and telephone 

numbers. 

 Contacts for local authorities (police, fire, and 

rescue) are provided. 

 Procedures describe steps involved in the 

notification process. These procedures may be 

verified in a documented recall program – if one 

exists. 

4. 

Do company personnel hiring practices 

include screening all potential 

employees? 

 Review personnel files to verify security 

screening. Acceptable screening includes at least 

one of the following: 

1. Employee references obtained and verified. 

2. Employee immigration status checked 

(INS Form I-9). 

3. Criminal background checks for employees, 

as needed (FBI Investigation watch list). 
 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 51 of 63 

5. 

After hiring, are photo identification or 

other measures employed to restrict 

access to the facility? 

 Verify identification practices through 

observations. 

 Verify measures used to restrict access. 

6. 

Have employees received training in Food 

Defense, and is the Food Defense training 

documented? 



 Verify food defense training records for 

employees. 

7. 

Do supplier delivery personnel, contract 

workers, and visitors have restricted 

access to vulnerable product areas of the 

facility, and are they accompanied by a 

company representative? 

 Security policy defines restricted access areas. 

 Verify policy practices and procedures through 

observation. 

8. 

Are the outside premises of the facility 

secure with limited access to vulnerable 

areas? 

The following guidance is for questions 8-10: 

 Restricted access points to grounds and facility are 

defined and identified. 

 Security monitored manually or mechanically as 

demonstrated by documentation. 

 Verify the presence of posted signs or other 

measures used to secure and limit access to 

vulnerable areas. 

 Policy describes procedures/frequency and 

responsibility. 

9. 

Are the grounds and facility monitored 

for suspicious activity and unauthorized 

entry? 

10. 

Are “No Trespassing” signs visible along 

the perimeter of the facility, or are other 

measures being taken to secure and limit 

access to vulnerable areas? 

11. 

Are assurances concerning food defense 

practices provided by suppliers of direct 

or indirect ingredients, product and 

equipment cleaning and sanitizing 

compounds, and packaging materials? 

This may include the use of tamper 

evident packaging for raw materials, 

sealing of trailers, and locking of bulk 

ingredient receiving ports. 

 Review written assurances from suppliers. 

 When possible, verify described assurances 

through observation. 

12. 

Is the security of water and utilities within 

the facility’s control addressed in the 

Food Defense Plan, and does the plan 

define limited access by designated 

company representatives? 

 Review plan for procedures, management 

responsibilities, and designated personnel. 

 When applicable (company well or water reservoir 

included), verify limited access through 

observation. 

13. 

Does the processing plant have a 

manufacturer processor registration 

number (MPN), a Food and Drug 

Administration (FDA) food facility 

registration number issued to the 

manufacturer/processor by FDA? 

 Affidavit or FDA correspondence verifies 

registration under the FDA Public Health Security 

and Bioterrorism and Response A of 2002. 

 Verify company documents demonstrate 

registration of the facility with FDA. 
 

 

 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 52 of 63 

Rating Elements Of The Food Defense System Survey 

Question Rating Objective Evidence 

1 Critical If the facility does not have a documented food defense plan. 

1 Critical If the facility has a documented food defense plan but it is not implemented. 

1 Minor If the facility has a documented food defense plan but it has not been reviewed and 

verified, annually. 

2 Major If the plan does not include preventive measures relative to product tampering and 

deliberate contamination at the processing facility and during transport in commerce. 

3 Major If the plan does not include written defense practices listing management contacts and 

procedures for notifying appropriate authorities in the case of an emergency or security 

issue. 

4 Major If the plan does not include practices to include screening all potential employees. 

5 Major If after discussing this section with management, you find that they do not have 

adequate procedures according to their plan (No Identification Method or Restrictions) 

and/or you get an agreement that they need to improve this area. 

6 Major If the facility states they have not trained their employees in food defense and/ or cannot 

provide any documentation of training their employees in food defense. 

6 Major If employees of the facility have received training in food defense and/or documentation 

of this training cannot be provided. 

7 Major If you find that supplier delivery personnel, contract workers, and visitors are not 

restricted access to vulnerable product areas of processing and storage. 

8 Major If the plan states that the outside public has restricted access but you find the facility is 

not following their procedures which restrict access. 

9 Major After walking around the grounds and processing facility you find them not monitored 

for suspicious activity or unauthorized entry. 

10 Major If you find that the outside premises is secure, but areas inside the processing facility 

and/or off-site warehouse facility are not secure, or measures are not being taken to 

secure and limit access to vulnerable areas. 

11 Major If the plan does not include procedures for assurances concerning food defense practices 

from suppliers of direct or indirect ingredients, product and equipment cleaning and 

sanitizing compounds, and packaging materials. 

11 Major If you look at the operations section of the plan and it indicates that all raw materials, 

incoming vehicles, containers, or rail cars must be sealed, but you observe one that is 

not sealed. 

12 Major If the water and utilities that are under the control of the facility are not addressed in the 

plan to have limited access. 

13 Critical If the facility has not registered with FDA to obtain a manufacturer processor 

registration number. 

ACCEPTABLE - No critical or major deficiencies. 

UNACCEPTABLE – One or more major or critical deficiencies, practices or operations present 

that result in critical Food Defense Issues. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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FOOD DEFENSE SYSTEM SURVEY 

Food Defense questions listed below are to be evaluated at the processing and offsite warehousing

facilities using the following key and column below: (P) Processing Facility (B) Both Processing and 

Warehousing Facility. Numbers 1-11 are applicable if evaluating the (W) Warehousing Facility only. 

YES NO RATING 

1. B Does management have a Food Defense Plan that is implemented, and reassessed 

by management to assure it remains relevant to the operation? 

2. B 

Does the Food Defense Plan address preventive measures relative to product 

tampering and deliberate contamination at the facility and during transport in 

commerce? 

3. B Do written defense practices list management contacts and procedures for 

notifying appropriate authorities in the case of an emergency or security issue? 

4. B Do company personnel hiring practices include screening all potential

employees? 

5. B After hiring, are photo identification or other measures employed to restrict 

access to the facility? 

6. B Have employees received training in Food Defense, and is the Food Defense 

training documented? 

7. B 

Do supplier delivery personnel, contract workers, and visitors have restricted 

access to vulnerable product areas of the facility and are they accompanied by a 

company representative? 

8. B Are the outside premises of the facility secure with limited access to vulnerable 

areas? 

9. B Are the grounds and facility monitored for suspicious activity and unauthorized 

entry? 

10. B Are “No Trespassing” signs visible along the perimeter of the facility, or are 

other measures being taken to secure and limit access to vulnerable areas? 

11. B 

Are assurances concerning food defense practices provided by suppliers of direct 

or indirect ingredients, product and equipment cleaning and sanitizing

compounds, and packaging materials? This may include the use of tamper 

evident packaging for raw materials, sealing of trailers, and locking of bulk 

ingredient receiving ports. 

12. P 

Is the security of water and utilities within the facility’s control addressed in the 

Food Security Plan, and does the plan define limited access by designated 

company representatives? 

13. P 

Does the processing plant have a manufacturer processor registration number

(MPN), a Food and Drug Administration (FDA) food facility registration number 

issued to the manufacturer/processor by FDA? 

DEFICIENCIES 

ITEM 

NUMBER 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 
 

 

 

 

 

 

 

 

 

 

 

 

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GOOD MANUFACTURING PRACTICES (GMPs) 

SCI Division policy for sanitary procedures are the same as the Food and Drug Administration’s 

(FDA) Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human 

Food, 21 CFR 110. These regulations are published by Food and Drug Administration, 

Department of Health and Human Services, and amended under the authority of the Federal 

Food, Drug, and Cosmetic Act and the Public Health Service Act. SCI Division employees are 

instructed to use these health, safety and sanitation guidelines whenever and wherever they are 

performing official Division business. These regulations may be found at the following internet 

address: http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR. 

Food safety concerns have increased the request for inspection staff to read, fill out, and certify 

visitor hygiene, health and confidentiality agreements before being allowed to enter an 

applicant’s facilities. Generally these policy statements cover visitor food safety policies that we 

must abide by while on-site. However, some visitor policy statements include health and/or 

confidentiality statements which we cannot sign. See the AIM General Procedures manual for 

instructions on employee signature of a firm’s hygiene, health and confidentiality statements. 

SCI Division employees must practice Division and FDA GMPs at all times while performing 

official duties. This includes ensuring that personal hygiene, safe work habits, personal 

appearance, equipment upkeep, and workstation housekeeping are maintained. 

When performing inspection services other than in-plant inspection (such as lot inspection, 

checkloading, case stamping, etc...), SCI Division employees shall document and report any 

noted sanitation deficiency that may lead to product contamination. 

SCI Division employees performing inspection services at public or private work sites shall also 

meet or exceed sanitation practices established by the company’s health and safety policies. To 

meet GMPs, the assignment may require that a particular piece of equipment be brought from the 

field office in clean, sanitary condition. Before leaving for the assignment, consult your 

supervisor if there is any question about equipment needs specific to the inspection. 

Above all, SCI Division employees should use common sense when dealing with health, safety 

and sanitation issues on the job. All employees should be concerned for the safety and health of 

their co-workers, industry counterparts, and others around them. Each employee’s work habits 

and personal hygiene should reflect this concern. All employees shall take reasonable measures 

and precautions to ensure the following: 

A. Sampling and Grading Equipment and Utensils 

Any equipment, utensils, and/or tools used in the sampling, grading, or handling 

of the food product must be designed and constructed so that it can be easily taken 

apart for regular cleaning and inspection. All food contact surfaces for these 

items must be kept in good repair. If the contact surface cannot be repaired, then 

the item should be removed from service. Food contact surfaces must be cleaned 

to remove dirt and debris, and then sanitized prior to use and storage. Sanitizing 

without cleaning is insufficient. Equipment and utensils must be cleaned and 

sanitized during use as needed to prevent product contamination. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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B. Laboratories and Grading Facilities 

An effective cleaning and sanitizing operation is vital to plant operations. Food 

contact surfaces are the first priority, but improper cleaning of non-food contact 

surfaces can cause adulteration or contamination through indirect means. Good 

housekeeping of all areas is necessary, including locker rooms and restrooms. 

Food contact surfaces (such as counters and containers) must be properly 

cleaned and sanitized before use. Sanitizing without cleaning is insufficient. 

Non-product contact areas (such as walls, ceilings, floors, and other room areas 

as well as equipment) must also be cleaned regularly. Sanitizing is not required. 

Note: Employees must take care to use cleaning and sanitization methods that will not 

adulterate or contaminate the food product. 

Sanitizing Food Contact Surfaces 

When sampling or grading product, it is necessary to clean and sanitize equipment. A 

sanitizing solution can be made from ordinary household bleach (sodium hypochlorite). Mix one 

tablespoon (one-half fluid ounce) of liquid bleach with one gallon of water to make the solution. 

To ensure that all surfaces of the equipment are sanitized, the equipment must be kept in contact 

with the sanitizing solution for a minimum of 2 minutes, and left to air dry without rinsing. 

Note: Do not make the solution weaker or stronger than indicated. A solution that is too 

weak will not have the proper sanitizing effect, and a solution that is too strong 

will be no more effective, and could introduce excess chlorine to the product. 

The sanitizing solution must be used on sampling equipment after cleaning but prior to use, prior 

to storage, and as necessary while sampling. Apply the solution to all surfaces of the equipment 

that may come in contact with the product, such as thermometers, chisels, scoops, honey thiefs, 

etc. After sanitizing, the equipment must be stored to prevent contamination, for example in a 

sealed plastic bag. Keep all sampling equipment as clean as possible between samples by resting 

equipment on a clean surface such as a plastic bag. If the equipment becomes contaminated 

during the sampling process, it must be cleaned and sanitized again prior to further use. After 

sampling completion, the equipment must again be cleaned and sanitized prior to storage. 

Grading equipment and other food contact surfaces (such as grading tables) must also be 

cleaned and sanitized. If product that is graded is to be donated to a charitable organization or 

returned to the applicant, grading trays, screens, spoons, thermometers, etc. must be sanitized 

prior to use. If this equipment has not been cleaned and sanitized before use, the product must be 

destroyed after grading. Additionally, at the end of the day or the end of a shift, all grading 

equipment and other food contact surfaces must be cleaned and sanitized, then left to air dry. 

Hazard Analysis and Critical Control Point (HACCP) Verification Survey 

This is an optional survey used to assess if a facility has a HACCP food safety plan in place. It is 

not intended to assess the effectiveness of the plan. See compliance guidelines for key points to 

check. A YES response to all survey questions verifies the use of a HACCP plan at the facility. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)

VERIFICATION SURVEY 

The questions on HACCP listed below are to be evaluated based on the facility’s

HACCP plan. For a facility to pass this survey, all questions must have a “YES” 

response. Any “NO” response results in a “Critical” rating. 

YES NO RATING: 

If “No” rate 

as Critical. 

1. Does management have a written HACCP plan? 

1a. Is the HACCP plan implemented? 

1b. Is there evidence of management commitment and are the appropriate 

personnel aware of their responsibilities for the implementation and 

maintenance of the company’s HACCP plan? 

2. 

Does the HACCP plan have a written hazard analysis which lists and

evaluates the hazards associated with the commodity and process under

consideration by this survey? 

3. 

Does the HACCP plan address the application of one or more critical 

control point(s) (CCP) which is/are essential to prevent, eliminate, or

reduce each identified potential food safety hazard? 

4. 

Does the HACCP plan address the establishment of critical limits

within which CCP(s) must be controlled to prevent, eliminate, or

reduce each identified potential food safety hazard? 

5. 

Does the HACCP plan address the application of monitoring 

procedures to assess whether CCP(s) is/are under control to prevent, 

eliminate, or reduce each identified potential food safety hazard? 

5a. Are monitoring procedures followed? 

6. Does the HACCP plan address the establishment of corrective

action(s)? 

6a. Are corrective actions taken when there is a deviation from established 

critical limits? 

7. 

Does the HACCP plan address the application of verification 

procedures to confirm that the systems are operating according to the

plan? 

7a. Are verification procedures followed? 

8. Does the HACCP plan address the establishment of record-keeping and 

documentation procedures for the HACCP plan? 

9. Are applicable “Good Manufacturing Practices” (GMP) and

prerequisite programs addressed by management? 

9a. Are documented Standard Sanitation Operating Procedures (SSOPs)

addressed? 

9b. Are documented supplier control procedures addressed? 

9c. Are documented specifications for ingredients, products, and 

packaging materials addressed? 

9d. Are documented receiving, storage, and shipping procedures

addressed? 

9e. Are documented pest control program and procedures addressed? 

9f. Are documented traceability and recall procedures addressed? 

9g. Are documented chemical control procedures addressed? 

9h. Are documented personal hygiene procedures addressed? 

9i. Are documented employee training program for GMPs, HACCP, and 

sanitation addressed? 
 

 

 

 

 

 

 

 

 

 

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DEFICIENCIES 

QUESTION 

NUMBER 

DESCRIPTION PROPOSED 

CORRECTIVE 

ACTION DATE 

DATE 

CORRECTED 
 

 

 

 

 

 

 

 

 

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Compliance Guidelines for Hazard Analysis and Critical Control Point 

(HACCP) Verification Survey 

NOTE – Apply compliance guidelines to determine appropriate response to the questions. 

Reference 

Number 

Questions Compliance Guidelines 

1. Does management have a written HACCP 

plan? 

Review HACCP plan documentation which should, at least, 

include the following: 

 Organizational chart with assigned responsibilities; 

 Summary of hazard analysis; 

 Description of product, its distribution, intended use, etc.; 

 Product flow diagram; 

 HACCP plan which identifies hazard(s), and describes the 

critical control points, critical limits, monitoring procedures, 

corrective actions, verification procedures, record-keeping 

and documentation procedures; 

 HACCP plan summary table; 

 Support documentation such as validation records; and 

 Records generated by implementation of the HACCP plan. 

1a. Has the HACCP plan been implemented? Implementation involves the continual application of the 

monitoring, record-keeping, corrective action, verification 

procedures, and other activities described in the HACCP plan. 

Observe plant activity and review records for evidence of this. 

1b. Is there evidence of management 

commitment and are the appropriate 

personnel aware of their responsibilities for 

the implementation and maintenance of the 

company’s HACCP plan? 

HACCP plan implementation is facilitated by commitment from 

top management. This commitment provides facility personnel 

with a sense of the importance of producing safe product. 

Observe plant activity and review records for evidence of this. 

Interviewing certain plant personnel may be necessary. 

2. Does the HACCP plan have a written 

hazard analysis which lists and evaluates 

the hazards associated with the commodity 

and process under consideration by this 

survey? 

Review the written hazard analysis to determine if it addresses 

the product and process designated for consideration by this 

survey. 

3. Does the HACCP plan address the 

application of one or more critical control 

point(s) (CCP) which is/are essential to 

prevent, eliminate, or reduce each 

identified potential food safety hazard? 

Review written HACCP plan to determine if CCPs are identified. 

4. Does the HACCP plan address the 

application of critical limits which must be 

controlled at a CCP(s) to prevent, 

eliminate, or reduce each potential food 

safety hazard? 

Review written HACCP plan to determine if critical limits are 

established. 

5. Does the HACCP plan address the 

application of monitoring procedures to 

assess whether CCP(s) is/are under control 

to prevent, eliminate, or reduce each 

potential food safety hazard? 

Review written HACCP plan to determine if monitoring 

procedures for each CCP are identified and described. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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5a. Are monitoring procedures followed? Review written HACCP plan and the appropriate records to 

determine if monitoring procedures are followed. Also observe 

plant activity for evidence of this. 

6. Does the HACCP plan address the 

establishment of corrective actions? 

Review written HACCP plan to determine if corrective actions 

are established and described. 

6a. Are corrective actions taken when there is 

a deviation from established critical limits? 

Review written HACCP plan and the appropriate records to 

determine if corrective actions were taken as described in the 

plan. Also observe plant activity for evidence of this. 

7. Does the HACCP plan address the 

application of verification procedures to 

confirm that the systems are operating 

according to the plan? 

Review written HACCP plan to determine if verification 

procedures are identified and described. 

7a. Are verification procedures followed? Review written HACCP plan and the appropriate records to 

determine if verification procedures are followed. 

8. Does the HACCP plan address the 

establishment of record-keeping and 

documentation procedures for the HACCP 

plan? 

Review written HACCP plan to determine if record-keeping and 

documentation procedures are identified and described. 

9. Are applicable “Good manufacturing 

Practices” (GMP) and prerequisite 

programs addressed by management? 

Obtain information from management, review appropriate 

documents, and observe operations to assess whether the GMPs 

and prerequisite programs are addressed by management. 

9a. Are documented Standard Sanitation 

Operating Procedures (SSOPs) addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if SSOPs are identified and 

described. 

9b. Are documented Supplier Control

Procedures (SCPs) addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if SCPs are identified and described. 

9c. Are documented specifications for

ingredients, products, and packaging

materials addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if applicable specifications for 

ingredients, products, and packaging materials are identified and 

described. 

9d. Are documented receiving, storage, and 

shipping procedures addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if procedures are identified and 

described for receiving, storage, and shipping procedures. 

9e. Are documented pest control program and 

procedures addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if applicable pest control program 

and procedures are identified and described. 

9f. 

Are documented traceability and recall

procedures addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if traceability and recall procedures 

are identified and described. 

9g. Are documented chemical control 

procedures addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if chemical control procedures are 

identified and described. 

9h. Are documented personal hygiene

procedures addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if personal hygiene procedures are 

identified and described. 

9i. Are documented employee training

programs for GMPs, HACCP, and 

sanitation addressed? 

Review written applicable HACCP plan and facility 

documentation to determine if the applicable training programs 

are identified and described. 
 

 

 

 

 

 

 

 

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Sanitary Practices for Fresh Produce Inspection 

Protecting the safety of the U. S. food supply requires a coordinated effort throughout food 

production, distribution, transportation, marketing, and consumption channels. The 

responsibility to safeguard our food supply is shared by everyone, from the grower to the 

consumer. It is important that everyone handling fresh produce understand the importance of 

personnel cleanliness and sanitary practices with respect to food safety. Individuals at each step 

along the farm-to-table chain have a responsibility to help ensure the safety of our food supply 

and prevent food safety hazards. As USDA representatives we must lead by example. 

These guidelines provide practices that Specialty Crops Inspection (SCI) Division employees 

and Federal-State Inspection Program (FSIP) cooperators must use while performing fresh 

produce inspection and related activities. 

Employee Responsibilities 

SCI Division employees and FSIP cooperators shall follow sanitary practices when they are 

performing SCI Division business. All employees should take appropriate measures and 

precautions to prevent food safety hazards, including the following steps: 

• Wash hands thoroughly: 

o Before starting work; 

o Before and after eating; 

o Before and after treating a cut or wound; 

o After using the rest room; 

o After touching an animal, animal feed, or animal waste; and 

o After contact with a source that could cause contamination. 

Hand washing is one of the most effective ways to prevent the spread of many types of infection 

and illness. Hand washing is the act of thoroughly cleansing hands by applying soap and water, 

rubbing them together vigorously for at least 20 seconds, then rinsing them with clean water, and 

thoroughly drying using single use towels or forced air. The use of gloves in no way lessens the 

need or importance of hand washing and proper hygienic practices. If gloves are used, they must 

also be maintained in a sanitary manner. 

• The use of hand sanitizers is not a substitute for hand washing. If hand 

sanitizers are used they MUST be used as a supplement, not a substitute, for 

hand washing. 

• Maintain adequate personal cleanliness including clean clothes and hair. 

• Inspection equipment including, but not limited to, knives, thermometers, 

scales, sizing rings, inspection tables, clip boards, and laptops, etc., should be 

clean prior to use on any given day. 

• Writing instruments should not be placed behind an ear. 
 

 

 

 

 

 

 

 

 

 

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• Eating food, chewing gum, drinking beverages, or using tobacco are confined 

to designated areas separate from where produce is handled while performing 

official SCI Division business. 

• No spitting where inspections and/or audit activities are conducted. 

• Product and/or product packaging/cartons/bags should not be placed directly 

on the floor or ground, or other surfaces which result in similar exposure to 

contamination. 

• Inspection samples and specimens probed with a thermometer or cut open 

should not be returned to the lot. Disposition of these samples should be 

coordinated with the applicant such that they do not return to product destined 

for consumption. 

• Comply with firm’s employee and visitor hygiene/sanitation policies (i.e., use 

of hair, beard or head coverings, no jewelry, and wear coveralls, protective 

clothing and boots). 

SCI Division employees and FSIP cooperators should practice food safety procedures and take 

appropriate steps to prevent food safety hazards. Thank you for staying alert and vigilant 

regarding food safety issues and concerns. 

Employee Signature of a Firm’s Hygiene, Health and Confidentiality Statements 

SCI Division employees and FSIP cooperators while performing inspection and audit activities 

must comply with a firm’s employee and visitor hygiene/sanitation policies (i.e., use of hair, 

beard or head coverings, no jewelry, and wear coveralls or protective clothing and boots as 

required). If required, you may read, fill out, and certify a firm’s visitor 

hygiene/sanitation/safety policy statement. 

We have been informed through our general counsel that we are not to complete questionnaires 

or sign releases for health information. SCI Division policy regarding personnel is in accordance 

with the Food and Drug Administration, current Good Manufacturing Practices, 21 CFR 110: 

Disease Control 

Any person who by medical examination or supervisory observation is shown to have, or appears 

to have, an illness, open lesion, including boils, sores, or infected wounds, or any abnormal 

source of microbial contamination by which there is a reasonable possibility of food, foodcontact surfaces, or food packaging material becoming contaminated shall be excluded from any 

operations which may be expected to result in such contamination until the condition is 

corrected. Personnel shall be instructed to report such health conditions to their supervisors. 

SCI Division employees should not sign confidentiality statements from applicants. We are not 

in a position to commit the government to confidentiality statements. SCI Division has an 
 

SCI Division Inspection Series Sanitation Manual 

Effective Date: September 2013 Page 62 of 63 

established history of providing inspection service and audit programs that have maintained the 

confidentiality of an applicant’s information. Federal employees are generally prohibited from 

disclosing confidential information by “United States Code: Title 18 – Crimes and Criminal 

Procedure: Part 1 – Crimes; Chapter 93-Public Officers and Employees; Section 1905, 

Disclosure of Confidential Information Generally. The penalties for not adhering to this 

regulation are imprisonment, monetary fines and removal from service.” 

SCI Division policy is that company plans and relevant company documents reviewed during the 

audit will not be removed from the facility. Also documents sent to SCI Division for review are 

to be stamped as "CONFIDENTIAL" and remain the property of the company. When the stated 

purpose of the document has been fulfilled, the company can request that the documents be 

returned or destroyed. 
 

 

 

 

 

 

 

 

 

 

SCI Division Inspection Series Sanitation Manual 

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Attachments Version Date 

(Printed for distribution) 

7 CFR 52.50: __________ 

http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR. 

21 CFR 110: __________ 

http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 

29 CFR 1910.146: __________ 

http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 

Optional Plant Safety Manual: __________ 

http://agnis/sites/FV/PPB/Safety/default.aspx. 

FDA AMS MOU 225-72-2009: __________ 

http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/Dom 

esticMOUs/default.htm. 

Report of Regulatory Agency Inspection, FV-425: __________ 

http://agnis/AMSFormsCatalog/Forms/AllItems.aspx. 

Sanitation Score Sheets, FV- 416-1, 2, 3, 5, 6, 7, 8, 9: __________ 

http://agnis/AMSFormsCatalog/Forms/AllItems.aspx. 

Checked Materials have been printed from the links in this Manual and included for 

reference.