Sanitation Standard Operating Procedures (SSOP) 

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SANITATION STANDARD OPERATING PROCEDURES 

Objectives 

After completion of this module, the participant will be able to: 

1. Explain the meaning and significance of the following terms: 

a. Sanitation SOP 

b. Responsible person 

c. Regulatory control action 

d. Pre-operational sanitation procedures 

e. Operational sanitation procedures 

f. Sanitation SOP Implementation & Monitoring 

g. Sanitation SOP Maintenance 

h. Sanitation SOP Corrective Actions 

i. Sanitation SOP Recordkeeping 

2. Select from a list the 4 regulatory requirements for Sanitation SOPs. 

3. State the steps taken by IPP to verify Sanitation SOP implementation and 

monitoring, maintenance, recordkeeping, and corrective actions. 

4. Identify the required corrective actions the establishment must take and 

record for noncompliances involving direct contamination or adulteration of 

product. 

5. List the record retention, authentication, data integrity, and daily 

documentation requirements for Sanitation SOP records. 

6. Discuss the enforcement action that could be taken when FSIS observes a 

noncompliance during a pre-operational or operational sanitation inspection. 

7. Given Sanitation SOP corrective and preventive measure examples, 

determine those that meet the regulatory requirements of 9 CFR 416.15(b). 

8. Given an example Sanitation SOP, determine regulatory compliance with 

9 CFR 416.12. 

References: 

1. 9 CFR 416.11-416.17 

2. FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System

3. FSIS Directive 5000.4, Performing the Pre-Operational Sanitation Standard 

Operating Procedures Verification Task 

4. FSIS Directive 5000.5, Verification of Less Than Daily Sanitation Procedures 

in Processing Operations 

5. FSIS Directive 4791.11, Lockout/Tagout Safety Procedures 

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Sanitation Standard Operating Procedures (SSOP) 

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General Rules 

§416.11 General Rules 

Each official establishment shall develop, implement, and maintain written 

standard operating procedures for sanitation (Sanitation SOPs) in accordance 

with the requirements of this part. 

Sanitation Standard Operating Procedures (Sanitation SOPs) are written 

procedures that an establishment develops and implements to prevent direct 

contamination or adulteration of product. The establishment is required to 

maintain these written procedures on file, and they must be available to FSIS 

upon request. It is the establishment’s responsibility to implement the procedures 

as written in the Sanitation SOPs. The establishment must maintain daily records 

sufficient to document the implementation and monitoring of the Sanitation SOPs 

and any corrective action taken. When the establishment or FSIS determines that 

the Sanitation SOPs may have failed to prevent direct contamination or 

adulteration of product, the establishment must implement corrective actions that 

include the appropriate disposition of product, restore sanitary conditions, and 

develop measures to prevent recurrence. 

Development of Sanitation SOPs 

§416.12 Development of Sanitation SOPs 

(a) The Sanitation SOPs shall describe all procedures an official establishment 

will conduct daily, before and during operations, sufficient to prevent direct 

contamination or adulteration of product(s). 

(b) The Sanitation SOPs shall be signed and dated by the individual with overall 

authority on-site or a higher level official of the establishment. This signature 

shall signify that the establishment will implement the Sanitation SOPs as 

specified and will maintain the Sanitation SOPs in accordance with the 

requirements of this part. The Sanitation SOPs shall be signed and dated 

upon initially implementing the Sanitation SOPs and upon any modification to 

the Sanitation SOPs. 

(c) Procedures in the Sanitation SOPs that are to be conducted prior to 

operations shall be identified as such, and shall address, at a minimum, the 

cleaning of food contact surfaces of facilities, equipment, and utensils. 

(d) The Sanitation SOPs shall specify the frequency with which each procedure 

in the Sanitation SOPs is to be conducted and identify the establishment 

employee(s) responsible for the implementation and maintenance of such 

procedure(s). 

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Establishment Responsibilities 

The establishment has the responsibility to develop written Sanitation SOPs that 

clearly describe procedures the establishment will implement to prevent direct 

contamination or adulteration of product. The establishment and inspection 

personnel should understand that there are not separate Sanitation SOPs for 

different operations or different shifts. The Sanitation SOPs cover the entire 

establishment and all shifts of operation. 

These written procedures must: 

 contain all the procedures the establishment will conduct daily, before and 

during operation. 

 identify the procedures to be conducted prior to operations (pre-op) and 

address, at a minimum, the cleaning of food contact surfaces of facilities, 

equipment, and utensils. 

 specify the frequency with which each procedure in the Sanitation SOP is 

to be conducted and identify the establishment employee or position 

responsible for the implementation and maintenance of the procedures. 

 be signed and dated by the individual with overall authority on-site or a 

higher-level official of the establishment. This signature signifies that the 

establishment will implement the Sanitation SOPs as written and will 

maintain the Sanitation SOPs in accordance with the requirements of this 

part. 

Inspection Verification for the Sanitation SOP Design 

All USDA-FSIS inspected establishments must have written Sanitation SOPs that 

meet the development (basic design) requirements listed in §416.12 before a 

Grant of Inspection is given. The FLS, or designee, will ensure that new 

establishments have written Sanitation SOPs in place prior to recommending 

approval for a Grant of Inspection to the District Office. IPP will address basic 

design noncompliance while performing Sanitation SOP verification tasks. 

To effectively verify compliance with the Sanitation SOP regulations, IPP are to 

understand the Sanitation SOP regulations (§416.11 - §416.16), be familiar with 

the establishment’s current written Sanitation SOPs, and perform the verification 

tasks as described in FSIS Directive 5000.1 and FSIS Directive 5000.4. 

NOTE: If IPP find that an establishment has not developed written 

Sanitation SOPs, they should contact their supervisor immediately. 

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WORKSHOP #1- Identifying the Basic Elements of the SSOPs 

Objective: Carefully read the sample Sanitation SOP below. Evaluate the 

Sanitation SOP for compliance with §416.11 and §416.12. After you have 

evaluated the Sanitation SOP, answer the questions listed in the worksheet. 

BEEF SLAUGHTER ESTABLISHMENT M41777—Sanitation SOP 

Owner – Joe Green 

This Sanitation SOP is for Beef Slaughter Establishment M41777 and becomes 

effective on January 28, 2013 

Pre-operational 

All food contact surfaces of the facility, equipment, and utensils on the kill floor 

will be cleaned daily after production by rinsing, soaping, and sanitizing. 

All cleaning will be monitored daily by Joe Green before production begins the 

next day. Records will be kept on Form Pre-Op I by Joe Green. 

Operational 

Every day all equipment and surfaces on the kill floor will be kept as sanitary as 

necessary to prevent contamination or adulteration of the carcasses. 

Every day all employees will follow hygienic practices to keep themselves from 

contaminating or adulterating carcasses. These actions will be monitored by Joe 

Green once each day. Records of this monitoring will be kept on Form Ops I by 

Joe Green. 

Corrective actions taken during pre-operational sanitation inspection or during 

operations will be written on the back of the Form Pre-Op I or Form Ops I as 

necessary. 

(Signature and date of 1/25/13) 

Joe Green 

Modification Log 

1. (signature and date of Joe Green, 12/11/13) 

2. (signature and date of Joe Green, 6/17/14) 

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Sanitation Standard Operating Procedures (SSOP) 

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WORKSHOP #1- Identifying the Basic Elements of the SSOPs 

For Training Purposes Only 

Objective: Verification of compliance with the basic development of SSOPs 

PHIS Task: Pre-operational & Operational SSOP Record Review task 

Relevant Regulatory Question Yes No Student’s comments

Does the establishment have written 

Sanitation SOP’s that describe the

procedures the establishment conducts 

daily to prevent direct contamination or 

adulteration of product(s)? [§416.12 (a)] 

Do the establishment’s SSOPs identify

which of the procedures are preoperational procedures? [§416.12 (c)] 

Do the establishment’s pre-operational 

SSOP procedures address (at a minimum) 

the cleaning of food contact surfaces of 

facilities, equipment, and utensils? 

[§416.12 (c)] 

Do the establishment’s SSOPs specify the 

frequency with which the establishment will 

conduct each procedure? [§416.12(d)] 

Do the establishment’s SSOPs identify the

establishment employee or employees 

responsible for implementing and 

maintaining specified procedures? 

[§416.12 (d) ] 

Does the establishment have records that 

identify the documentation and the 

implementation and monitoring of the 

SSOPs on a daily basis and any corrective 

actions taken? [§416.16 (a)] 

Did the individual with overall authority onsite or a higher level official of the 

establishment sign and date the Sanitation 

SOP's 

(1) Upon initial implementation, or 

(2) Upon modification [§416.12 (b)] 

Are there any failures to comply? 

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Sanitation SOP Verification Tasks 

The following table lists four tasks used to verify compliance with Sanitation SOP 

requirements. 

Inspection Tasks General Description 

Pre-Operational Sanitation 

SOP Record Review 

Use the Recordkeeping verification activity to 

verify that the establishment implements the 

procedures in the Sanitation SOP effectively to 

prevent contamination of food contact surfaces 

or adulteration of products prior to operations. 

Pre-Operational Sanitation 

SOP Review and 

Observation 

Use the Review and Observation verification 

activity and the Recordkeeping verification 

activity to verify that the establishment 

implements the procedures in the Sanitation 

SOP effectively to prevent contamination of food 

contact surfaces or adulteration of products prior 

to operations. In PHIS, IPP should select the 

“Both” option on the Activity tab. 

Operational Sanitation 

SOP Record Review 

Use the Recordkeeping verification activity to 

verify that the establishment implements the 

procedures in the Sanitation SOP effectively to 

prevent contamination of food contact surfaces 

or adulteration of products during operations. 

Operational Sanitation 

SOP Review and 

Observation 

Use the Review and Observation verification 

activity and the Recordkeeping verification 

activity to verify that the establishment 

implements the procedures in the Sanitation 

SOP effectively to prevent contamination of food 

contact surfaces or adulteration of products 

during operations. In PHIS, IPP should select 

the “Both” option on the Activity tab. 

Regardless of which Sanitation SOP task is performed, IPP will verify that 

establishments meet all four of the following regulatory requirements in addition 

to the design requirements §416.12: 

a. Implementation and monitoring of Sanitation SOP (§416.13); 

b. Maintenance of Sanitation SOP (ensuring its effectiveness) (§416.14); 

c. Sanitation SOP corrective actions (§416.15); and 

d. Sanitation SOP recordkeeping (§416.16). 

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The Record Review Tasks: Pre-Operational and Operational 

IPP use the recordkeeping verification activity to verify all four Sanitation SOP 

requirements (implementation, maintenance, corrective actions, and 

recordkeeping) while performing the Pre-Operational and Operational Sanitation 

SOP Record Review tasks. 

During the Sanitation SOP record review tasks, IPP perform the following: 

1) Review the written Sanitation SOP to be familiar with the establishment’s 

current pre-operational or operational sanitation procedures. 

2) Verify that the SSOP continues to meet the design requirements of 

§416.12. 

3) Verify that the establishment has maintained daily records that 

demonstrate that the establishment has implemented the pre-operational 

and operational procedures as written, monitored those procedures at 

least daily or at the specified frequency, and taken immediate or corrective 

action when necessary. 

For instance, IPP verify that the records indicate that the establishment 

conducted monitoring daily prior to the start of operations. If the 

establishment observed a contaminated food contact surface (residue 

from previous day’s product) during pre-operational inspection, IPP verify 

that the establishment documented that the contaminated surface was recleaned, re-inspected and released before product passed over the 

surface. Similarly, if the establishment has documented the finding of 

contaminated product or food contact surfaces during operations, IPP 

verify that the documented corrective actions meet regulatory 

requirements. 

NOTE: In most cases, product does not contact equipment surfaces prior 

to the start of operations. However, if the establishment found 

contaminated product during pre-operational inspection, IPP will verify that 

the establishment has documented corrective actions that meet the 

requirements of §416.15(b). 

4) Verify all the recordkeeping requirements of §416.16. 

For instance, IPP verify that the establishment employee responsible for 

the implementation and monitoring of the procedure has authenticated the 

records with their initials and date. 

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Sanitation Standard Operating Procedures (SSOP) 

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The Review and Observation Tasks: Pre-Operational and 

Operational 

IPP use both the review and observation verification activity and the 

recordkeeping verification activity when performing the Pre-Operational and 

Operational Sanitation SOP Review and Observation tasks. IPP are to verify that 

all four Sanitation SOP requirements (implementation, maintenance, corrective 

actions, and recordkeeping). 

Each time IPP perform the review and observation tasks, they: 

1) should review the written Sanitation SOP so they are familiar with the 

establishment’s current pre-operational or operational sanitation 

procedures, 

2) verify that the SSOP continues to meet the requirements of §416.12, 

3) observe the establishment conducting its monitoring activities and 

implementing corrective action when they find that the pre-operational or 

operational procedures have failed to effectively clean and sanitize food 

contact surfaces, 

4) inspect one or more areas and perform an organoleptic examination of 

some of the establishment’s facilities, equipment, and utensils to assess 

sanitary conditions (sometimes referred to as “hands-on” inspection), 

5) compare their findings with the establishment records/findings, (which may 

not be documented until the start of the next production day for that 

specific shift), and 

6) verify that the establishment meets the corrective action requirement of 9 

CFR 416.15 when they find that the establishment’s Sanitation SOP has 

failed to prevent product contamination or adulteration. 

Selecting Production Areas and Equipment for Pre-Op Sanitation SOP 

Review and Observation Verification Task (FSIS Directive 5000.4) 

In both slaughter and processing establishments, IPP follow the same 

methodology or thought process to plan their Pre-Op Sanitation SOP verification. 

IPP are to select the production area(s) and equipment to examine using a riskbased approach. The area(s) and equipment selected are those that present the 

highest risk of becoming insanitary or causing product contamination. 

The following factors indicate a higher risk to public health: 

1) Equipment that will contact exposed product. 

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2) Equipment that will contact RTE product post-lethality. 

3) Equipment that is difficult to clean. 

4) Equipment that FSIS has not verified recently. 

5) Equipment/area(s) with a history of noncompliance; and 

6) Testing results that suggest that specific pieces of equipment may present 

a risk to public health. 

IPP review test results and other records relevant to the food safety system 

weekly per FSIS Directive 5000.2. Based on information gathered from test 

results, establishment sanitation records or other records, establishment pre-op 

sanitation findings, or repetitive noncompliances, IPP are to consider whether to 

increase the extent of pre-op sanitation verification activities (i.e. how much 

equipment and how many areas). 

IPP are encouraged to discuss their thought processes for making their 

selections on an on-going basis with their IIC or FLS. They are not expected to 

put their thought process in writing, nor to share it with establishment 

management. 

Pre-Op Sanitation SOP Review and Observation Task 

To perform the Pre-Op Sanitation SOP Review and Observation task, IPP should 

have: 

 A functional flashlight. 

 A pen or pencil. 

 U.S. Rejected/U.S. Retained tags and some means (tape, string, rubber 

bands) of affixing these tags to equipment, departments, product, etc. 

 A notepad to record their pre-operational findings. 

IPP not trained in lockout/tagout (FSIS Directive 4791.11) methodology shall not 

perform pre-op sanitation inspection on any piece of equipment requiring lock 

out. If IPP select a ready-to-eat (RTE) production area for pre-operational 

inspection, they should start in the RTE department first to prevent introduction of 

microorganisms from the raw product areas. 

After establishment management informs IPP that an area is ready for FSIS preop inspection, IPP perform the review component of Pre-Op Sanitation SOP 

Review and Observation verification task. They are to inspect areas in the 

establishment, equipment and utensils, and places on equipment that, if 

insanitary, would present the greatest risk of transferring pathogens or other 

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contaminants to product (e.g., direct food contact surfaces that are difficult to 

clean or may serve as microbial harborage sites). Establishments can elect to 

reassemble equipment after they complete their monitoring and implementation 

of the Sanitation SOPs. However, IPP can request that the establishment 

disassemble the piece of equipment so that the IPP will be able to perform their 

pre-op sanitation verification. 

IPP perform “hands-on” inspection to verify that direct food contact surfaces are 

organoleptically clean. This means that the surfaces look clean, feel clean, and 

smell clean. IPP visually examine the food contact surfaces for product residues 

from previous days’ operations. They feel the contact surfaces to determine if

there are residues or foreign materials (e.g. grit, dust, etc.) present from previous 

days’ operations that are not visible. IPP detect any odors in these area(s) that 

may indicate insanitary conditions. 

If direct food contact surfaces are contaminated with residues from previous 

days’ operations, it is likely that these conditions will harbor microorganisms 

and/or have a chemical residue present. The surfaces should be free of foreign 

material such as fat, blood, hair, rust, dust, grease, and cleaning chemicals. 

IPP are to focus on food contact surfaces and not on surfaces or areas that do 

not directly contact product. They are to look at selected pieces of equipment 

rather than all equipment. When there are large numbers of simple equipment 

such as pans, buckets, trays, or hand tools, IPP are to select a representative 

sample (e.g. one or two each). 

Although the focus is on food contact surfaces, IPP should remain aware of 

other insanitary conditions such as unclean non-food contact surfaces; 

condensation; peeling paint; and scaling rust from overhead fixtures in areas 

where products are processed, handled, or stored. 

When IPP have completed their examination of the selected area(s) and 

equipment, IPP should compare their findings to the establishment’s sanitation

findings. If the written records are not yet completed, IPP may ask the 

establishment about its pre-operational findings and any actions taken. However, 

IPP must verify the recordkeeping requirements before completing the task. 

When IPP observe contaminated direct food contact surfaces during the pre-op 

sanitation verification, they are to reject the affected equipment. The 

establishment has the responsibility to restore sanitary conditions (clean the 

contaminated food contact surface) and document the restoration of sanitary 

conditions under §416.16(a). Preventive measures do not need to be 

developed and documented unless product has been contaminated or 

adulterated by the unclean surface. IPP should not remove the USDA reject 

tag until the establishment has restored sanitary conditions. 

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In rare situations in which product has been contaminated or adulterated before 

the start of operations, the establishment must take corrective actions that meet 

the requirements in §416.15(b). Furthermore, IPP should not remove the 

regulatory control action until the establishment has proposed corrective actions, 

either verbally or in writing, that meet these requirements. 

In some cases, the establishment might conduct monitoring of the 

implementation of the Sanitation SOP procedures before inspection personnel 

arrive at the establishment. In these situations, the FLS or IIC will decide how 

frequently IPP will directly observe the establishment conducting their monitoring 

procedures. The supervisor will consider several factors when making this 

decision: 1) establishment compliance history, 2) documentation in the FSIS file, 

and 3) information from Sanitation SOP records. 

Operational Sanitation SOP Review and Observation Task 

IPP should select area(s) of the establishment and equipment that presents the 

highest risk for insanitary conditions or product contamination. If a RTE 

production area is selected, IPP should start in the RTE area to prevent 

introducing microorganisms from the raw product areas into the RTE area. 

IPP are to have: 

 a functional flashlight. 

 a pen or pencil. 

 U.S. Rejected/U.S. Retained tags and some means (tape, string, rubber 

bands) of affixing these tags to equipment, departments, product, etc. 

 a notepad to record their operational findings. 

IPP should observe the equipment, employees, and facilities to verify that 

product contamination is not occurring during operation. For example, employees 

might contact contaminated surfaces with their hands and/or clothing and return 

to handling product without first cleaning their hands or changing their outer 

clothing. If IPP observe contaminated direct food contact surfaces or 

contaminated product, there is Sanitation SOP noncompliance whether there is a 

procedure written in the establishment’s Sanitation SOP to cover that situation or 

not. 

IPP should inspect direct food contact surfaces of equipment, facilities, and 

utensils. Although the task focuses on verifying product and food contact 

surfaces are not contaminated during operation, IPP should be aware of other 

potential sources of product contamination such as condensation, peeling paint, 

dead-end pipes and scaling rust from overhead fixtures where products are 

processed, handled, or stored can contaminate products. 

When possible, IPP should also observe the establishment conducting its 

monitoring activity. Some establishments conduct the monitoring of operational 

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sanitation at a frequency of once or twice daily. Therefore it might be difficult for 

the IPP to observe this activity 

When IPP have completed their assessment of the sanitation in one or more 

areas of the establishment, they should compare their findings with the 

establishment’s sanitation findings. If the records are not complete at the time, 

IPP might ask the establishment if it has conducted monitoring and what 

observations were made. However, IPP must verify the recordkeeping 

requirements prior to completion of the task. 

IPP should be aware that there are times the responsible establishment 

employee might not be able to propose permanent preventive measures 

immediately. However, in these situations, the establishment should propose a 

tentative preventative measure of what they will do until they determine a 

permanent solution. 

Frequencies for Performing the Sanitation SOP Verification Tasks 

IPP are to perform pre-operational and operational Sanitation SOP verification 

tasks at frequencies scheduled by PHIS or an adjusted frequency based on 

relevant information (e.g. a developing trend of noncompliance). IPP are to: 

1. perform two pre-operational Sanitation SOP verifications per week at each 

establishment in an assignment, including one Pre-Op SSOP Review and 

Observation and one Pre-Op SSOP Record Review task. These two preoperational tasks are to be performed at an approximately equal amount; 

2. perform one operational Sanitation SOP verification task at each 

establishment in an assignment during each shift – either an Operational SSOP 

Review and Observation or Operational SSOP Records Review task. These two 

operational tasks are to be performed at an approximately equal amount; and 

3. perform “inspector directed” Sanitation SOP verification tasks as warranted by

conditions observed at the establishment. For example: During the performance 

of other verification tasks unrelated to sanitation, if inspection personnel observe 

insanitary conditions, they are to perform an Operational SSOP Review and 

Observation verification task. IPP are also to perform Sanitation SOP tasks as 

directed by their supervisor. 

In patrol assignments, there are times when inspection personnel cannot perform 

the Pre-Op SSOP Review and Observation task in each establishment once per 

week due to simultaneous start times or having more than five establishments on 

the patrol. In such cases, IPP are to use good judgment and their knowledge of 

the establishments’ compliance histories with sanitation requirements to decide

where and when to do Pre-Op Sanitation SOP verification tasks. 

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When an establishment operates on Saturdays, Sundays, and holidays, IPP are 

to conduct pre-operational and operational sanitation tasks in the same manner 

and frequency as they do during the week. Whenever IPP performed a task on 

reimbursable overtime, IPP are to check the appropriate box on the task’s 

Activity tab to document this fact. 

We will now cover each of the Sanitation SOP regulatory requirements in more 

detail. 

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IMPLEMENTATION AND MONITORING 

§416.13 Implementation (Monitoring) Requirement 

a) Each official establishment shall conduct the pre-operational procedures in 

the Sanitation SOPs before the start of operations. 

b) Each official establishment shall conduct all other procedures in the 

Sanitation SOPs at the frequencies specified. 

c) Each official establishment shall monitor daily the implementation of the 

procedures in the Sanitation SOPs. 

1. Establishment Responsibilities 

The establishment is responsible for developing written procedures that are 

sufficient to prevent direct contamination or adulteration of product. The 

establishment also has the responsibility for implementing the procedures in the 

written Sanitation SOPs. If the establishment writes a procedure in its Sanitation 

SOP, it must implement that procedure and monitor it daily. In other words, the 

establishment is responsible for doing what it said it would do. 

2. Inspection Verification 

IPP should verify that the establishment is meeting these regulatory requirements 

by performing the recordkeeping, and the review and observation task. 

When verifying the implementation requirement while performing the preoperational Sanitation SOP task, IPP are verifying that the establishment is 

meeting the regulatory requirements for implementation of the procedures that 

will be conducted before the start of operations. When verifying the 

implementation requirement while performing the operational Sanitation SOP 

task, IPP are verifying that the establishment is implementing the procedures that 

will be conducted during operations. 

When verifying compliance with §416.13, IPP should seek answers to the 

following type of questions: 

 Is the establishment implementing the pre-operational procedures in the 

Sanitation SOP prior to the start of operations? 

 Is direct contamination or adulteration of product, or unclean direct food 

contact surfaces observed by FSIS or the establishment? 

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Sanitation Standard Operating Procedures (SSOP) 

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 Is the establishment conducting the procedures in the Sanitation SOP as 

written? 

 Does the Sanitation SOP contain monitoring frequencies? 

 If the Sanitation SOP does not contain monitoring frequencies, is the 

establishment monitoring the implementation of the procedures in the 

Sanitation SOP daily? 

3. Environmental Sampling 

There are no regulatory requirements to include environmental sampling in an 

establishment’s Sanitation SOP. However, if environmental sampling is included 

in the Sanitation SOP, IPP should verify that the establishment is following those 

procedures. IPP should observe the establishment collecting samples, review 

sample results, and verify that the corrective actions specified in the Sanitation 

SOP are taken when necessary. The verification should be completed as part of 

the Sanitation SOP review & observation task. If the establishment is conducting 

environmental testing but the procedures are not included in the Sanitation SOP, 

IPP will review the establishment’s testing results weekly as described in FSIS

Directive 5000.2. Information gathered from such testing results should be used 

in the IPP’s thought process for selecting the areas and equipment examined 

and the extent of inspection (i.e., how much equipment and several areas) during 

the Operational Sanitation SOP review and observation task in establishments 

that process meat and poultry products. 

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Examples of Implementation and Monitoring Noncompliance: 

An establishment has a Sanitation SOP that lists the following procedures: 

 The trash and debris will be removed from the production area. All equipment 

in the production areas will be rinsed with warm water. The equipment will 

then be foamed and scrubbed as necessary to remove product residues. The 

equipment will then be rinsed with potable water and a sanitizer applied to all 

food contact surfaces. These procedures will be conducted daily prior to 

operation. QA personnel will monitor all equipment with food contact surfaces 

for acceptability daily prior to operations. 

-If the establishment does not conduct the procedures for cleaning the 

production areas prior to operation daily, there is noncompliance with 

§416.13(a). 

-If the IPP finds a contaminated food contact surface during pre-op 

inspection, there is noncompliance with §416.13(a) 

 If product incidentally drops on the floor in the raw product area, the utility 

person will promptly remove the product from the floor, trim the contaminated 

surfaces, wash the product at the product wash station, and re-inspect it for 

any contamination before placing it back into production. QA personnel will 

monitor the product reconditioning procedure twice a day. 

-If the IPP finds that product is not promptly removed from the floor and 

properly reconditioned, there is noncompliance with §416.13(b). 

-If the establishment is not monitoring the product reconditioning procedure 

twice during the day, there is noncompliance with §416.13(c). 

 A production employee will observe all overheads in product storage areas 

and remove condensation as necessary during operation. QA personnel will 

monitor the procedure designed to prevent condensation from contaminating 

product. 

-If the IPP finds condensate dripping on product, there is noncompliance with 

§416.13(b). 

-If the production employee is not performing the procedure to prevent 

condensation from directly contaminating or adulterating product, there is 

noncompliance with §416.13(b). 

-If the establishment is not monitoring the procedure designed to control 

condensation daily, there is noncompliance with §416.13(c) 

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WORKSHOP #2: Monitoring 

Objective: Given a scenario, identify any noncompliance, the relevant 

regulations, and the actions you would take in response to your findings. 

In-plant scenario 

You are performing a Pre-Operational Sanitation SOP Review and Observation 

task. You have chosen to observe the monitor, Ms. Mary Jones (the sanitation 

manager), during her pre-operational sanitation inspection. You accompany Ms. 

Jones to the fabrication floor. Several members of the cleaning crew also 

accompany you. Four of the fabrication lines will be operating today. Ms. Jones 

walks down the aisle between lines 1 and 2 and then down the aisle between 

lines 3 and 4. Ms. Jones inspects the visible portion of the band saw blade. You 

notice that Ms. Jones does not open the door to the band saw cabinet. After she 

releases the area for operation, you perform the review portion of the task by 

going back to the band saw and opening the door to the cabinet. You observe 

that the rest of the saw blade, as well as the inside of the cabinet, has meat and 

fat particles, and bone dust, adhering to the direct and indirect food contact 

surfaces. 

1.) Based on your observations, list your concerns? 

2.) List the actions that you would take? 

3.) Is there a Sanitation SOP noncompliance? If yes, describe the 

noncompliance(s) and the relevant regulation(s). 

4.) Would you issue an NR? If so, what specific language would you include 

in the noncompliance description? 

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Sanitation Standard Operating Procedures (SSOP) 

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MAINTENANCE 

§416.14 Maintenance Requirement 

Each official establishment shall routinely evaluate the effectiveness of the 

Sanitation SOPs and the procedures therein in preventing direct contamination or 

adulteration of product(s) and shall revise both as necessary to keep them 

effective and current with respect to changes in facilities, equipment, utensils, 

operations, or personnel. 

1. Establishment Responsibilities 

Before federally inspected meat or poultry establishments are permitted to 

operate, they must develop Sanitation SOPs that prescribe sanitation measures 

to prevent product adulteration or contamination. This means establishments can 

only speculate about which sanitation measures should be included in their 

Sanitation SOPs to prevent the occurrence of insanitary conditions in their 

production process. The effectiveness of these measures is unknown initially. 

Therefore, it is necessary for establishments to evaluate the effectiveness of their 

Sanitation SOPs once they are implemented. 

Each establishment must meet two primary obligations to comply with the 

requirements for the Sanitation SOP maintenance regulation. The first 

responsibility requires establishments to evaluate the effectiveness of all 

Sanitation SOPs that have been implemented in their production operations and 

the second requires that the establishment to revise the Sanitation SOP as 

needed in order to ensure that it is reflective of the operation and that the 

Sanitation SOP is effective. This regulatory requirement encourages 

establishments to develop a system for the evaluation of their written Sanitation 

SOPs in order to prevent direct contamination or adulteration of product. 

Although establishments must identify the members of their management team 

who will be responsible for implementation and evaluation of their Sanitation 

SOPs, they are not required to identify the method the individuals employ to 

perform the evaluations. The regulation only requires that establishments 

perform an evaluation of the effectiveness of their Sanitation SOPs; it does not 

dictate how establishments should perform this evaluation. The establishment 

must sign and date the Sanitation SOPs any time modifications are made. 

However, there is no regulatory requirement that the establishment personnel 

should notify FSIS inspection personnel of the change. 

It is also a responsibility of the establishments to revise their Sanitation SOPs to 

keep them effective and current with respect to changes in facilities, equipment, 

utensils, operations, or personnel. These regulations list examples of changes 

that may occur within an establishment that could alter the effectiveness of an 

established Sanitation SOP. However, the methodologies used to evaluate their 

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Sanitation Standard Operating Procedures (SSOP) 

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Sanitation SOPs and to determine their effectiveness do not need to be 

recorded. If the establishment determines the Sanitation SOPs are no longer 

effective and current, the Sanitation SOPs must be revised. 

2. Inspection Verification 

FSIS is responsible for verifying the establishment meets the maintenance 

regulatory requirements. IPP should verify this requirement while performing the 

Pre-Operational and Operational Sanitation SOP tasks. When verifying this 

requirement, IPP must understand that IPP should review the establishment’s 

Sanitation SOP records and NRs over a period of time to determine whether this 

requirement is met. Just because IPP find an unclean food contact surface while 

performing the review and observation task for pre-operational sanitation does 

not mean that the establishment needs to evaluate the effectiveness of the 

Sanitation SOPs. 

However, if IPP look at several weeks of Sanitation SOP records, IPP might see 

that the Sanitation SOPs have repeatedly been ineffective in preventing direct 

contamination or adulteration of product. During this same period of time IPP 

might also find that there have been several NRs documenting the 

ineffectiveness of the Sanitation SOPs in preventing direct contamination or 

adulteration of product. IPP will have to use their professional knowledge and 

good judgment to determine whether the Sanitation SOP is meeting the 

maintenance regulatory requirement. IPP should discuss and document their 

concerns with the establishment. If the establishment does not modify the 

Sanitation SOP and IPP observe contaminated product, IPP should take a 

regulatory control action. IPP might not accept preventive measures that do not 

include re-evaluation of the Sanitation SOP as an effective means of preventing 

direct contamination or adulteration of product. 

When verifying compliance with §416.14, IPP should seek answers to questions 

similar to the following: 

 Has the establishment routinely evaluated the effectiveness of the Sanitation 

SOPs in preventing direct contamination or adulteration? 

 If changes were made in the facilities, equipment, utensils, operations, or 

personnel, have the Sanitation SOPs been revised to keep them effective? 

 Does the establishment routinely review the Sanitation SOP records to 

determine if there are trends occurring indicating that the Sanitation SOP 

needs revising? 

NOTE: In addition to determining if the establishment has met the maintenance 

requirement, information gathered from reviewing the establishment’s Sanitation 

SOP records and NRs may be used in the thought process for selecting the 

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Sanitation Standard Operating Procedures (SSOP) 

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areas and equipment examined and the extent of inspection (i.e., how much 

equipment and how many areas) during the Pre-Operational Review and 

Observation task in establishments that process meat and poultry products. For 

instance, IPP could determine from the Sanitation SOP records and NRs which 

processing areas or rooms and equipment are typically found to be unclean and 

if noncompliances are increasing during pre-op verification. 

Keep in mind, the establishment needs to revise the procedures as necessary to 

keep them current and effective. The Sanitation SOP may be changed 

frequently. The establishment is not obligated to notify FSIS when it revises its 

written Sanitation SOPs since FSIS does not approve the Sanitation SOP or 

Sanitation SOP revisions. However, the Sanitation SOP must be signed and 

dated when any modification is made. 

Example of Maintenance Compliance 

The establishment-appointed persons would conduct the evaluation as 

prescribed by the establishment. The establishment evaluation system may 

require the plant representatives to gather all of the data that pertains to the 

Sanitation SOP. Data used in this evaluation may consist of the different 

Sanitation SOP records, such as the monitoring checks and corrective action 

log. It may also include noncompliance records (NRs) issued to the 

establishment by the FSIS inspection team. These records may include records 

that reflect clean-up procedures, or product handling training programs for their 

employees. The representatives would examine the results recorded on the 

sanitation documents that pertain to product or direct food contact zones 

addressed by the Sanitation SOP. They will identify instances within these 

documents where the implementation of the Sanitation SOP failed to prevent 

direct contamination or adulteration of product and review the establishment’s 

copies of NRs documenting noncompliances in this area. The representatives 

may use this information to determine the effectiveness of the Sanitation SOP. 

Example Noncompliance with the Maintenance Regulatory Requirement 

Changes were made in the facilities, equipment, utensils, operations, or 

personnel, and the Sanitation SOP is no longer effective in preventing direct 

contamination or adulteration of product. 

Inspection Methods 13-20 
 

 

 

 

 

 

Sanitation Standard Operating Procedures (SSOP) 

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CORRECTIVE ACTION 

§416.15 Corrective Action Requirement 

(a) Each official establishment shall take appropriate corrective action(s) when 

either the establishment or FSIS determines that the establishment’s Sanitation

SOPs or the procedures specified therein, or the implementation or maintenance 

of the Sanitation SOPs, may have failed to prevent direct contamination or 

adulteration of product(s). 

(b) Corrective actions include procedures to ensure appropriate disposition of 

product(s) that may be contaminated, restore sanitary conditions, and prevent 

the recurrence of direct contamination or adulteration of product(s), including 

appropriate reevaluation and modification of the Sanitation SOPs and the 

procedures specified therein or appropriate improvements in the execution of the 

Sanitation SOPs or the procedures specified therein. 

1. Establishment Responsibilities 

These regulations require the establishment to take corrective actions when 

either the establishment OR FSIS determines the Sanitation SOPs fail to 

prevent direct contamination or adulteration of product. Regardless of the 

type or cause of the failure, corrective actions must be taken. There are three 

parts to corrective action and all three of these requirements must be met and 

recorded each time product contamination occurs. The corrective actions also 

include appropriate disposition of product. 

NOTE: Most of the time product will not be involved during pre-operational 

sanitation monitoring. When the establishment finds direct food contact surfaces 

that are unclean during its monitoring of pre-operational sanitation and cleans the 

surfaces before product passes over that surface, this is compliance. In these 

situations, FSIS believes the establishment’s Sanitation SOP has worked as 

intended. Implementing and documenting preventative measures are not 

required. 

The establishment is not required to notify inspection personnel when product 

contamination occurs, but has the responsibility to implement corrective actions 

that will meet the requirements of §416.15(b). The establishment should take full 

responsibility for the corrective actions meeting the three requirements of the 

regulation. Those regulatory requirements are: 

 Appropriate disposition of products that may be contaminated; 

 Restoration of sanitary conditions; and 

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Sanitation Standard Operating Procedures (SSOP) 

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 Prevention of recurrence of direct contamination or adulteration of 

products. 

Reconditioning Product 

Although there is no regulatory requirement, establishments may have a 

procedure in its Sanitation SOPs for reconditioning product that incidentally 

comes in contact with a non-food contact surface (such as the floor). The 

procedure usually consists of the following steps; an establishment employee will 

remove product from the floor in a timely manner, trim contaminants from the 

surface area, wash the product at a product wash station, and inspect it before 

returning it to production. This procedure is used for occasional instances of 

product contamination. If the establishment is following its written procedures and 

monitoring these procedures, the establishment would not be required to take 

corrective action that meets the requirements of §416.15 every time product falls 

on the floor. If the establishment does not have a reconditioning procedure in its 

Sanitation SOP, it would be required to take and document corrective actions 

that meet the requirements of §416.15 each time product falls on the floor. 

2. Inspection Verification 

IPP should verify this regulatory requirement when performing the Sanitation 

SOP verification tasks. Every time the establishment implements corrective 

actions due to product contamination, IPP should verify that the regulatory 

requirements in §416.15 are met. IPP can verify this requirement by performing 

any of the verification tasks. When performing the Pre-Operational Sanitation 

SOP Record Review task, IPP should request the daily pre-operational sanitation 

records that they want to review. IPP should review the monitoring records to 

determine if the establishment documented occasions in which product was 

contaminated. If there is documentation showing the establishment had found 

product contamination during pre-operational monitoring, there should also be 

documentation of the corrective actions taken for these situations. IPP should 

review these corrective actions and compare them to the regulatory requirements 

to verify that they have been met. Did the establishment have adequate 

documentation to demonstrate appropriate disposition of the affected product? 

Did the establishment document corrective actions that were adequate to restore 

sanitary conditions? Did the establishment document corrective actions to 

prevent recurrence of direct contamination or adulteration of product? 

When performing the Operational Sanitation SOP Record Review task, IPP 

should request from the establishment the daily operational sanitation records 

that they want to review. IPP should review the monitoring records to determine if 

there were instances of direct food contact surfaces or product being 

contaminated. If there is documentation showing the establishment had found a 

contaminated food contact surface that had contacted product or product 

contamination during the operational monitoring, there should also be 

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Sanitation Standard Operating Procedures (SSOP) 

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documentation of the corrective actions taken for these situations. IPP should 

review these corrective actions and compare them to the regulatory requirements 

to verify that they have been met. Did the establishment have adequate 

documentation to demonstrate appropriate disposition of the affected product? 

Did the establishment document corrective actions that were adequate to restore 

sanitary conditions? Did the establishment document corrective actions to 

prevent recurrence of direct contamination or adulteration of product? 

When IPP are performing the Pre-Operational Sanitation SOP Review and 

Observation task and find direct food contact surfaces that are contaminated, IPP 

should take a regulatory control action on the piece or pieces of equipment. 

There is an insanitary condition which is noncompliance with §416.13(a). In most 

cases product is not coming into contact with equipment surfaces during preoperational sanitation inspection. The establishment must clean the surface (reestablish sanitary conditions) and document the restoration of sanitary conditions 

according to §416.16(a). FSIS would expect the establishment to consider how to 

make appropriate improvements in the execution of its pre-operational 

procedures because the establishment must be operated and maintained in a 

manner sufficient to prevent the creation of insanitary conditions as stated in 

§416.1. However, establishing and documenting preventive measures are not 

required. 

If IPP are observing the establishment performing the monitoring as part of the 

Pre-Operational Sanitation SOP Review and Observation task and the monitor 

finds a contaminated food contact surface, this provides an opportunity for IPP to 

observe the establishment implementing actions to restore sanitary conditions. 

When IPP are performing the Operational Sanitation SOP Review and 

Observation task and find direct food contact surfaces or product that is 

contaminated, IPP should take a regulatory control action of that equipment or 

product. IPP should keep that control action in place until the establishment has 

given IPP the corrective actions and preventive measures they plan to implement 

to restore sanitary operations and prevent recurrence. They must also implement 

corrective actions to ensure the appropriate disposition of affected product. If 

what they are proposing does not meet these regulatory requirements, the 

regulatory control action should be left in place until the establishment proposes 

corrective actions that will meet these requirements. This also provides IPP the 

opportunity to verify that the establishment implements the corrective actions that 

they proposed. IPP should also verify that the corrective actions they document 

are the same as those they implemented. 

If IPP are observing the establishment performing the monitoring as part of the 

Operational Sanitation SOP Review and Observation task and the monitor finds 

a food contact surface or product contaminated, this provides an opportunity for 

IPP to observe the establishment implementing the corrective actions. IPP can 

observe the establishment taking actions that restore sanitary conditions. IPP 

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Sanitation Standard Operating Procedures (SSOP) 

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can observe the establishment to verify that they make appropriate disposition of 

product. If they put preventive measures in place immediately, IPP can verify 

these preventive measures. 

NOTE: IPP should realize that many times the establishment might not be able to 

propose preventive measures until later because decisions might involve others 

in the establishment. For example, if IPP have identified a problem and the 

person in that area cannot propose the preventive measures because of the 

amount of capital involved, they should inform IPP that they will have a meeting 

with top management. This should be documented on the Sanitation SOP 

records. After the meeting, when the preventive measures have been decided, 

the establishment needs to document those preventive measures in the 

Sanitation SOP records. 

Example: 

For example, you identify a condensation problem in an area of the 

establishment that is contaminating product. You retain the product in the area 

and reject that area for use. When you notify the responsible establishment 

employee of the problem, he tells you that there is a structural problem in that 

area that will cost several thousand dollars to repair. He further explains that he 

does not have the authority to have the structure repaired. He states he will bring 

it to the attention of the establishment owner and will inform you of the preventive 

measures that the owner proposes. You agree this is logical and when the 

appropriate disposition is made on the product and sanitary conditions in that 

area are restored, you relinquish the regulatory control actions. All of these 

corrective actions should be recorded in the establishment records. You should 

keep notes of your findings while performing this verification task so that you can 

accurately document them on the NR. 

When verifying compliance with §416.15, IPP should seek answers to the 

following: 

 When FSIS or the establishment determines that the Sanitation SOPs fail 

to prevent the direct contamination or other adulteration of product during 

operation, does the establishment implement corrective actions that 

ensure appropriate disposition is made of any product that may be 

contaminated? 

 When FSIS or the establishment determines that the Sanitation SOPs fail 

to prevent the direct contamination or other adulteration of product during 

operation, does the establishment implement corrective actions that 

restore sanitary conditions? 

 When FSIS or the establishment determines that the Sanitation SOPs fail 

to prevent the direct contamination or other adulteration of product during 

Inspection Methods 13-24 
 

 

 

 

 

 

 

 

 

Sanitation Standard Operating Procedures (SSOP) 

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operation, does the establishment implement corrective actions that 

prevent recurrence? 

 Do the corrective actions include the reevaluation and modification of the 

Sanitation SOPs or improvements in the execution of the procedures 

when trends are occurring? 

NOTE: If the establishment is monitoring the pre-operational sanitation 

procedures, finding unclean food contact surfaces, and taking actions to restore 

sanitary conditions, and IPP are not finding direct food contact surfaces 

unacceptable, the establishment is in compliance with the regulations. Now, IPP 

should focus on whether the establishment is making improvements to the 

execution of its pre-operational sanitation procedures sufficient to prevent the 

creation of insanitary conditions and preventing direct contamination or 

adulteration of product. The requirement for preventive measures only applies 

when the Sanitation SOP fails to prevent direct contamination or adulteration of 

product. However, when IPP find unclean food contact surfaces during preoperational sanitation inspection or direct contamination or adulteration of 

product during operations, IPP should take a regulatory control action. The 

regulatory control action should not be relinquished until the establishment has 

cleaned the food contact surface or taken corrective actions in §416.15 for 

contaminated product including proposing an acceptable preventive measure. 

The IPP should not accept the same preventive measures previously proposed 

by the establishment, if those preventative measures were ineffective in 

preventing recurrence. 

NOTE: If the establishment finds direct contamination or adulteration of product 

and takes appropriate corrective actions as per §416.15(b), then there is no need 

to initiate a regulatory control action or document an NR. These corrective 

actions include restoring sanitary conditions, making appropriate disposition of 

product, and implementing measures to prevent recurrence. If the establishment 

finds a contaminated food contact surface during preoperational sanitation 

inspection and cleans and sanitizes the surface before product goes across that 

surface, then there is no need to initiate a regulatory control action or document 

an NR. 

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Sanitation Standard Operating Procedures (SSOP) 

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Examples of Noncompliance 

 You are performing an Operational Sanitation SOP review and 

observation task on Friday morning. At 8:00 a.m., you observe an 

entry on the operational sanitation monitoring record. At 7:30 a.m., 

the monitor documented that he observed rail dust from the overhead 

rails on carcasses hanging in the cooler #1. You decide that this may 

be a good opportunity to verify the corrective action requirement by 

actually observing the establishment’s corrective actions. You proceed

to cooler #1. You observe two employees examining carcasses on the 

rail in the hallway outside of cooler #1. You remain in the area and 

observe the establishment’s reconditioning of a few carcasses. After 

examining and trimming the contamination off the carcasses, the 

employees placed the trimmed carcasses in cooler #2. You notice an 

establishment hold tag on the door to cooler #1. You open the door to 

the cooler and see that there are no carcasses stored in the cooler. 

Monday morning you review the establishment’s corrective action

record. You find the following information documented. 

“Establishment employees examined all carcasses in cooler #1 and

trimmed any visible contamination off the affected carcasses. We 

moved the carcasses that were not contaminated and the trimmed 

carcasses to cooler #2”. In the preventive measure section, you find

the following documented. “We cleaned the rails over the weekend”. 

This is noncompliance with §416.15(b) because the establishment did 

not implement measures that would prevent product contamination 

from recurring. 

 In another example, you are performing the Operational Sanitation 

SOP record review task by reviewing the operational sanitation records 

from the previous day. You observe an entry on the record of 

condensation dripping into a vat of beef trimmings. The corrective 

actions documented that the product was removed from the area, the 

condensation was removed from the overhead, and a ceiling fan will be 

installed after production is completed. You are aware the fan has 

been installed. 

This is noncompliance with §416.15(b) because the establishment did 

not take measures to ensure appropriate disposition of the product. 

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Sanitation Standard Operating Procedures (SSOP) 

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WORKSHOP #3: Corrective Actions 

Objective: To verify and evaluate the establishment’s corrective actions 

PHIS Task: Routine Operational SSOP Review & Observation Task 

A. FSIS finding: In the second processing department, you observed two 

establishment employees pick up five poultry carcasses off the floor and 

place them onto the moving sizing belt which is a food contact surface. 

The contaminated carcasses were placed on top of other poultry 

carcasses that were present on the sizing belt. You initiated a regulatory 

control action due to the cross contamination of all poultry carcasses on 

the sizing belt. You issue an NR for a monitoring noncompliance using an 

Operational Sanitation SOP Review and Observation task. 

Establishment’s corrective action: Stopped the sizing belt and removed 

the affected product. Will retrain and certify all sizing belt personnel on 

product handling procedures. Three additional Sanitation SOP monitoring 

checks will be performed for the next two months to assure that the 

training for sizing belt personnel is effective. 

1) Did the establishment restore sanitary conditions? If yes, please briefly 

describe what the establishment did. 

2) Did the establishment put measures in place to prevent recurrence of 

direct contamination or adulteration of product? If yes, please list. 

3) Did the establishment appropriately disposition the product? 

4) Do these corrective actions meet the regulatory requirements? 

If not, what regulation should be cited on the NR? 

B. FSIS finding: The Sanitation SOP for product reconditioning requires that 

fabricated meat pieces which have incidentally fallen on the floor to be 

picked up immediately and be placed in a meat wash sink. The procedure 

also details trimming and washing these pieces of meat before they can 

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Sanitation Standard Operating Procedures (SSOP) 

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be returned to production. You are in the processing area performing the 

Operational Sanitation SOP Review and Observation task and you note 

that several pieces of meat have fallen on the floor. All pieces of product 

were picked up immediately by an establishment employee and placed in 

the bottom of the meat wash sink. You continue to observe and there are 

no activities being conducted at the meat wash sink. You proceed to the 

meat wash sink and you observe approximately a dozen pieces of meat 

sitting in the bottom of the sink. You initiate a regulatory control action due 

to the cross contamination of product occurring in the meat wash sink. 

You write an NR for monitoring noncompliance. 

Establishment’s corrective action: All pieces of meat were removed 

from the meat wash sink and placed on an adjacent table. The sink was 

thoroughly cleaned and sanitized. The surfaces of all affected product 

were trimmed and washed before being returned to production. The 

adjacent table was cleaned and sanitized. A written copy of the Sanitation 

SOP procedure for product reconditioning was laminated and posted next 

to each sink. All supervisors in the areas with meat wash sinks were 

trained in the procedure. 

5) Did the establishment restore sanitary conditions? If yes, please briefly 

describe what the establishment did. 

6) Did the establishment put measures in place to prevent recurrence of 

direct contamination or adulteration of product? If yes, please list. 

7) Did the establishment appropriately disposition the product? 

8) Do these corrective actions meet the regulatory requirements? 

If not, what regulation should be cited on the NR? 

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Sanitation Standard Operating Procedures (SSOP) 

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RECORDKEEPING 

§416.16 Recordkeeping Requirement 

(a) Each official establishment shall maintain daily records sufficient to document 

the implementation and monitoring of the Sanitation SOPs and any corrective 

actions taken. The establishment employee(s) specified in the Sanitation SOPs 

as being responsible for the implementation and monitoring of the procedure(s) 

specified in the Sanitation SOPs shall authenticate these records with his or her 

initials and the date. 

(b) Records required by this part may be maintained on computers provided the 

establishment implements appropriate controls to ensure the integrity of the 

electronic data. 

(c) Records required by this part shall be maintained for at least 6 months and 

made available to FSIS. All such records shall be maintained at the official 

establishment for 48 hours following completion, after which they may be 

maintained off-site provided such records can be made available to FSIS within 

24 hours of request. 

1. Establishment Responsibilities 

§416.16(a) requires the establishment to maintain daily records sufficient to 

document the implementation and monitoring of the Sanitation SOPs and any 

corrective actions taken. The establishment must have records documenting that 

monitoring has been conducted daily for each of the procedures specified in the 

Sanitation SOPs. If the establishment has specified a monitoring frequency in the 

Sanitation SOP that is more frequent than daily, the documentation would have 

to reflect that the monitoring activities had been conducted at the specified 

frequencies. The establishment employee specified in the Sanitation SOPs as 

being responsible for the implementation and monitoring of the procedures shall 

authenticate these records with initials or signature and the date. 

There must also be a written record of any corrective actions required by 

§416.15. These records must be maintained daily. 

Note: The establishment has until the beginning of the same shift the next 

business day to complete SSOP records. 

§416.16(b) provides the establishment the flexibility to maintain these records on 

a computer system provided the establishment implements appropriate controls 

to ensure the integrity of the electronic data. 

§416.16(c) states that the records must be kept on-site for 48 hours and must be 

maintained for at least 6 months. After the initial 48 hours, the records may be 

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Sanitation Standard Operating Procedures (SSOP) 

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kept off-site as long as they can be retrieved for a program employee within 24 

hours of the request. 

2. Inspection Verification 

IPP should perform the Pre-Operational Sanitation SOP Record Review task 

when verifying compliance with the pre-operational sanitation recordkeeping 

requirements and Operational Sanitation SOP Record Review task when 

verifying compliance with the operational sanitation recordkeeping requirements. 

IPP should verify that these daily records contain: 

 Documentation of the monitoring of the Sanitation SOPs; 

 Documentation of any corrective actions taken; and 

 Authentication (initials or signature of responsible person and the date). 

IPP should also verify that: 

 The establishment has appropriate controls to ensure the integrity of 

electronic data maintained on computers; 

 The Sanitation SOP records are accessible to FSIS; 

 The Sanitation SOP records are maintained for at least 6 months; 

 The Sanitation SOP records are maintained on-site for 48 hours after 

Completion; and 

 The Sanitation SOP records are available to FSIS with 24 hours of request, if 

they are maintained off-site. 

Some of the questions that IPP need to consider when evaluating the 

establishment’s records are listed below. As in all the other evaluations of the 

establishment’s Sanitation SOP system, IPP will need to be very familiar with 

exactly what the Sanitation SOP says in relation to the records they are keeping. 

In addition to knowing what is in the Sanitation SOP, IPP will also need to 

understand the regulatory aspect of recordkeeping. 

 Are the Sanitation SOP records available to FSIS upon request? 

 Are the records completed prior to the start of the same shift the next operating 

day? 

 Are the records completed in the manner specified in the Sanitation SOP? 

 Are the records’ entries legible?

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Sanitation Standard Operating Procedures (SSOP) 

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 Was all monitoring done and recorded at the prescribed frequency? 

 Are the records initialed or signed and dated? 

WORKSHOP #4: Recordkeeping 

Objective: Verification of compliance with Recordkeeping 

PHIS Task: Operational SSOP Record Review task 

A. You elect to perform Operational Sanitation SOP Record Review task in the 

QC office at the beginning of your shift. You ask the QC manager for the 

Sanitation SOP records from yesterday. The QC manager tells you that the 

records are completed but not available. 

1.) What regulation applies to this situation? 

2.) What does this regulation state about records availability? 

3.) What actions should you now take? 

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Sanitation Standard Operating Procedures (SSOP) 

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Documentation and Enforcement 

After completing a SSOP verification task, IPP are to use PHIS to document 

findings of compliance or noncompliance. 

If the establishment is in compliance with all Sanitation SOP regulatory 

requirements, IPP will mark the regulations that were verified and check the 

“Inspection Completed” box. 

When IPP determine that an establishment does not meet one of the regulatory 

requirements in 9 CFR §416.11 through §416.16, IPP should immediately notify 

the establishment’s management about the Sanitation SOP noncompliance and

take a regulatory control action, if one is necessary. IPP will need to document 

the findings of the Sanitation SOP noncompliance on a Noncompliance Record 

(NR), FSIS Form 5400-4. 

When IPP become aware that an establishment was required to take corrective 

actions per 9 CFR 416.15, IPP must verify that the establishment met the 

requirement and document in PHIS that they verified the requirements. 

When IPP observe contamination of product or direct food contact surfaces 

during an Operational Sanitation SOP verification task, they are to take a 

regulatory control action on the affected equipment or product. IPP are to 

remove the regulatory control action only after the establishment has taken 

corrective actions that 1) ensure appropriate disposition of products, and 2) 

restore sanitary conditions, and at least proposed 3) prevent recurrence of direct 

contamination or adulteration of products. 

When IPP observe contamination of direct food contact surfaces during a PreOperational Sanitation SOP verification task, they are to take a regulatory control 

action on the affected equipment. During pre-operational sanitation, there should 

be no affected product. IPP are to remove the regulatory control action only after 

the establishment has restored sanitary conditions 

If the establishment has found the contaminated contact surface or product and 

taken the corrective actions required, there is no noncompliance. IPP are to 

verify that the establishment is implementing the corrective actions specified in 9 

CFR 416.15 when the establishment finds direct contamination or adulteration of 

products or contact surfaces. 

When IPP observe Sanitation SOP noncompliance that does not result in 

contamination of product or food contact surfaces (e.g. failure to initial records), 

they are not to take a regulatory control action. 

If IPP observe both Sanitation SOP and SPS noncompliance while performing a 

Sanitation SOP verification task, they document both noncompliances on a single 

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Sanitation SOP NR by recording a result of noncompliance for each applicable 

regulatory citation. 

EXAMPLE: While performing the Pre-Op Sanitation SOP Review and 

Observation verification task in the fabrication department, IPP observe product 

residue and grease on several meat hooks, in addition to fat particles and hog 

hair from the previous days’ production on the wall behind the dehairing machine. 

IPP are to document each noncompliance and cite §416.13(a) and §416.2(b) 

under the Pre-Op Sanitation SOP Review and Observation verification task and 

record the result on a single NR. 

If IPP observe only SPS noncompliance while performing a Pre-Op Sanitation 

SOP verification task, record the noncompliance under the task being performed 

at the time of the observation. In this example, the noncompliance would be 

documented under a Pre-Op Sanitation SOP task even though the regulatory 

citation is an SPS regulation. 

NOTE: If IPP determine that a Sanitation SOP noncompliance represents a 

systematic or repetitive failure by the establishment to prevent product 

contamination or maintain sanitary conditions, they are to document 

noncompliance with 9 CFR 416.1 in addition to the applicable Sanitation SOP 

regulation. 

Application of the Rules of Practice 

The Rules of Practice regulations describe the enforcement actions that can be 

taken if establishments do not meet regulatory requirements. Sections 500.3 and 

500.4 of the Rules of Practice regulations describe the enforcement actions that 

can be imposed on an establishment when the Sanitation SOP regulatory 

requirements are not met. 

§500.3(a)(1) states that FSIS may take a withholding action or impose a 

suspension without providing the establishment prior notification if 1) The 

establishment produced and shipped adulterated or misbranded product as 

defined in 21 U.S.C. 453 or 21 U.S.C. 602, or 2) The establishment does not 

have Sanitation Standard Operating Procedures as specified in §416.11-416.12 

of this chapter. 

1. Shipping contaminated or adulterated product 

If the Sanitation SOP does not prevent contaminated or adulterated product 

from being produced and shipped, IPP should impose a withholding action as 

described in §500.3. 

Since contaminated or adulterated product was shipped, there is an imminent 

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threat to the public health and IPP should take an immediate withholding 

action. When contaminated or adulterated product has been produced and 

shipped, IPP are not required to notify the establishment in advance that IPP 

are taking the withholding action. FSIS will provide the establishment written 

notification later. An NR is written documentation of the noncompliance. The 

District Office will review the circumstances and advise the FLS or IIC on how 

to proceed when further enforcement actions are necessary. 

2. Failure to meet the design regulatory requirements 

Before inspection is granted, the establishment must have developed a 

written Sanitation SOP that meets the requirements of §416.11-416.12. 

However, if an existing establishment modifies its Sanitation SOP or fails to 

maintain the Sanitation SOP such that it no longer meets the basic design 

requirements, IPP should notify the establishment about the noncompliance 

and contact their supervisor regarding possible enforcement specified in 

§500.3. 

Section 500.4 of the Rules of Practice states: FSIS may take a withholding action 

or impose a suspension after an establishment is provided prior notification and 

the opportunity to demonstrate or achieve compliance because: the Sanitation 

Standard Operating Procedures have not been properly implemented or 

maintained as specified in §§416.13 through 416.16 of this chapter. 

3. Repetitive Sanitation SOP failures 

This means that IPP must have adequate documentation to support the 

determination that the Sanitation SOPs have repeatedly not been 

implemented and maintained to be effective in preventing direct 

contamination or adulteration of product. It is not necessary for IPP to 

determine that contaminated or adulterated product has been shipped to 

impose the enforcement actions described in §500.4. It is necessary that IPP 

have adequate documentation to demonstrate that the establishment is 

unable to prevent repeated failures of the Sanitation SOPs. There are two 

reasons why Sanitation SOP failures can occur. (1) Either the Sanitation SOP 

is not designed adequately to prevent contamination or adulteration of 

product, or (2) the Sanitation SOPs are not properly implemented. 

IPP must associate the Sanitation SOP failures to the same cause identified 

within the NRs generated at the establishment. For this reason, accurate 

documentation is very important. Each associated NR should reference the 

previous NR number, the NR date, and list the specific preventive measures 

that were not implemented or were ineffective in preventing the recurrence of 

the Sanitation SOP failures. 

When IPP determine there is adequate documentation to support an 

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enforcement action as specified in §500.4, IPP should contact the District 

Office, via supervisory channels, and request the assistance of an EIAO for 

the issuance of a Notice of Intended Enforcement action (NOIE). There is no 

specific number of NRs required for the issuance of an NOIE, but their 

documentation should support their requested enforcement action. Based on 

the EIAO’s recommendations, the District Office will issue the Notice of 

Intended Enforcement action to the establishment. 

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Noncompliance Documentation Summary Exercise 

Read each scenario. Identify the appropriate PHIS task under which the 

noncompliance(s) would be documented and the noncompliant regulations. 

1. Before the start of operations, two inoperable sets of lights over the blender 

prevent you from being able to verify that food contact surfaces are sanitary. 

The quality of the lighting is not of sufficient intensity to conduct inspection 

activities. These are the only lights in the blender area. You reject the area 

until the establishment repairs the lights. Then you observe product residue 

from previous days’ production on the mixing arms of the blender. You reject 

the blender until sanitary conditions are restored. 

2. During operations, you observe condensation dripping on carcasses in the 

carcass cooler. You reject the cooler, retain affected carcasses, and notify 

establishment management. The establishment is able to demonstrate there 

is no food safety hazard associated with the contamination. 

3. While performing the Pre-Operational Review and Observation task, you 

observe a rough, uneven weld with crevices that connects one of the agitating 

paddles to the shaft of a vertical mixer ready for use in the sausage room. 

Upon further examination, you also find an accumulation of product residue 

stuck in the crevices in the weld. You reject the mixer and notify 

management. The establishment is able to demonstrate there is no food 

safety hazard associated with the contamination. 

4. While passing through the fabrication department to perform an SPS task, 

you observe 5 specks of a black substance on a piece of meat on the cutting 

table and 20 more specks on the table surface. Further inspection revealed a 

very heavy accumulation of grease and dust on an overhead pipe. You reject 

the area, retain the product, and notify management. The establishment is 

able to demonstrate there is no food safety hazard associated with the black 

substance. 

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5. While performing a routine Operational SSOP Review and Observation task in 

the carcass cooler, you observe a rail with an accumulation of rust on it. Beef 

sides are stored directly under the rusted area on the rail. You examine the 

hock and round area of several sides of beef. You find numerous black 

specks on four sides of beef. 

6. While performing a HACCP verification task, you observe an employee 

prepare a pickle solution by adding salt from 50 pound bags to a vat of water. 

You note that he did not strip the outer layer of the bag before placing the bag 

over the edge of the vat, and you decide to examine the solution. You find 

extraneous material (lint, dust, debris, etc.) floating on top of the pickle 

solution. You reject the pickle solution tank and notify management. 

7. While passing through a processing area to conduct a HACCP verification 

task, you observe an employee lift cartons of frozen beef trimmings from the 

floor, open them, and touch exposed surfaces of the beef trimmings without 

washing his hands. You retain the product and notify management. The 

establishment is able to demonstrate that there is no food safety hazard 

associated with the contamination. After management proposes adequate 

corrective actions, you remove the tag, and verify corrective actions. 

8. Before operations, you observe an employee using a pesticide to fog the 

processing area. The processing area also has equipment with food contact 

surfaces and packaging materials that are exposed to the pesticide. You 

determine the pesticide used and examine the label which states the 

pesticide is not approved for use in food processing areas. You immediately 

notify establishment management and verify their corrective actions. 

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Sanitation Standard Operating Procedures (SSOP) 

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Code of Federal Regulations 

TITLE 9--ANIMALS AND ANIMAL PRODUCTS 

CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, 

DEPARTMENT OF AGRICULTURE 

PART 416--SANITATION 

Sec. 416.11 General rules. 

Each official establishment shall develop, implement, and maintain written 

standard operating procedures for sanitation (Sanitation SOP's) in accordance 

with the requirements of this part. 

Sec. 416.12 Development of Sanitation SOP's. 

(a) The Sanitation SOP's shall describe all procedures an official 

establishment will conduct daily, before and during operations, sufficient to 

prevent direct contamination or adulteration of product(s). 

(b) The Sanitation SOP's shall be signed and dated by the individual with 

overall authority on-site or a higher level official of the establishment. This 

signature shall signify that the establishment will implement the Sanitation 

SOP's as specified and will maintain the Sanitation SOP's in accordance 

with the requirements of this part. The Sanitation SOP's shall be signed 

and dated upon initially implementing the Sanitation SOP's and upon any 

modification to the Sanitation SOP's. 

(c) Procedures in the Sanitation SOP's that are to be conducted prior to 

operations shall be identified as such, and shall address, at a minimum, 

the cleaning of food contact surfaces of facilities, equipment, and utensils. 

(d) The Sanitation SOP's shall specify the frequency with which each 

procedure in the Sanitation SOP's is to be conducted and identify the 

establishment employee(s) responsible for the implementation and 

maintenance of such procedure(s). 

Sec. 416.13 Implementation of SOP's. 

(a) Each official establishment shall conduct the pre-operational procedures in 

the Sanitation SOP's before the start of operations. 

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(b) Each official establishment shall conduct all other procedures in the 

Sanitation SOP's at the frequencies specified. 

(c) Each official establishment shall monitor daily the implementation of the 

procedures in the Sanitation SOP's. 

Sec. 416.14 Maintenance of Sanitation SOP's. 

Each official establishment shall routinely evaluate the effectiveness of the 

Sanitation SOP's and the procedures therein in preventing direct contamination 

or adulteration of product(s) and shall revise both as necessary to keep them 

effective and current with respect to changes in facilities, equipment, utensils, 

operations, or personnel. 

Sec. 416.15 Corrective Actions. 

(a) Each official establishment shall take appropriate corrective action(s) 

when either the establishment or FSIS determines that the establishment's 

Sanitation SOP's or the procedures specified therein, or the 

implementation or maintenance of the Sanitation SOP's, may have failed 

to prevent direct contamination or adulteration of product(s). 

(b) Corrective actions include procedures to ensure appropriate disposition of 

product(s) that may be contaminated, restore sanitary conditions, and 

prevent the recurrence of direct contamination or adulteration of 

product(s), including appropriate reevaluation and modification of the 

Sanitation SOP's and the procedures specified therein or appropriate 

improvements in the execution of the Sanitation SOP's or the procedures 

specified therein. 

Sec. 416.16 Recordkeeping requirements. 

(a) Each official establishment shall maintain daily records sufficient to 

document the implementation and monitoring of the Sanitation SOP's and 

any corrective actions taken. The establishment employee(s) specified in 

the Sanitation SOP's as being responsible for the implementation and 

monitoring of the procedure(s) specified in the Sanitation SOP's shall 

authenticate these records with his or her initials and the date. 

(b) Records required by this part may be maintained on computers provided 

the establishment implements appropriate controls to ensure the integrity 

of the electronic data. 

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(c) Records required by this part shall be maintained for at least 6 months 

and made available to FSIS. All such records shall be maintained at the 

official establishment for 48 hours following completion, after which they 

may be maintained off-site provided such records can be made available 

to FSIS within 24 hours of request. 

Sec. 416.17 Agency verification. 

FSIS shall verify the adequacy and effectiveness of the Sanitation SOP's and the 

procedures specified therein by determining that they meet the requirements of 

this part. Such verification may include: 

(a) Reviewing the Sanitation SOP's; 

(b) Reviewing the daily records documenting the implementation of the 

Sanitation SOP's and the procedures specified therein and any corrective 

actions taken or required to be taken; 

(c) Direct observation of the implementation of the Sanitation SOP's and the 

procedures specified therein and any corrective actions taken or required 

to be taken; and 

(d) Direct observation or testing to assess the sanitary conditions in the 

establishment. 

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