08 Sanitation Standard Operating Procedures (SSOP) 

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. 

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). 

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. 

(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. 

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. 

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 

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

specified therein. 

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. 

(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. 

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. 

IPP will verify that establishments meet all four of the following regulatory requirements during 

the performance of each SSOP task: 

a. Implementation and monitoring 

b. Maintenance 

c. Corrective actions 

d. Recordkeeping 

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The following table lists the 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. 

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 PreOperational 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 preoperational or operational sanitation procedures. 

2) Verify that the SSOP continues to meet the design requirements of §416.1. 

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 pre3 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

operational inspection, IPP verify that the establishment documented that the 

contaminated surface was re-cleaned, 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. 

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. 

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. 

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

should have: 

• 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. 

Note: Recommend having a good flashlight to check dark areas or inside pipes/equipment. 

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Pre-Op Sanitation SOP Review and Observation Task 

• 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. 

• After establishment management informs IPP that an area is ready for FSIS pre-op 

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 contaminants to product (e.g., direct food contact 

surfaces that are difficult to clean or may serve as microbial harborage sites). 

• 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: 

o Reject the affected equipment by placing a reject tag; 

o Notify the establishment, and 

o Document the noncompliance on NR. 

• 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 U.S. Rejected tag until the establishment has 

restored sanitary conditions. 

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. 

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

contamination is not occurring during operation. 

• 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. 

• 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. 

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• 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. 

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WORKSHOP #1- Identifying the Basic Elements of the SSOPs 

Examples of Pre-Op and Operations SSOPs Training Purposes Only 

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, 1998 

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 1/25/98) Joe Green 

Modification Log 

1. (signature and date of Joe Green, 12/11/2018) 

2. (signature and date of Joe Green, 6/17/2019) 

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WORKSHOP #1- Identifying the Basic Elements 

Objective: Verification of compliance with the basic development of SSOPs 

For Training Purposes Only 

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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