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Standard Operating Procedures (SOP's)
What are SOPs?
Standard Operating Procedures (SOPs) are descriptions of particular tasks undertaken in a food processing operation. A specific SOP should address the following: the purpose and frequency of doing a task, who will do the task, a description of the procedure to be performed that includes all the steps involved, and the corrective actions to be taken if the task is performed incorrectly. SSOP Programs includes an example of an SOP for cleaning an automatic labeling machine.
Are SOPs different from Good Manufacturing Practices (GMPs)?
Yes, SOPs represent a different set of jobs to be performed that may or may not be related to the safety of a food product, while GMPs refer to a set of procedures and measures taken by a plant to ensure that the food is not adulterated: i.e." manufactured under such conditions that it is unfit for food" (Federal Food, Drug and Cosmetic Act section 402 a, 3), or "prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health" (section 402 a, 4). In a plant environment, all SOPs should take GMPs into account when being written and as such SON and GMPs are used in conjunction with each other.
In the SSOP Programs example given above, while the SOP for labeling machine cleaning is being performed, the employee doing the task should stick to GMPs by wearing clean clothing and a hair net, by avoiding contamination of the product with the QUATS solution, and by washing his/her hands after finishing the task and prior to handling food products.
Are SOPs mandated by regulatory agencies?
FDA mandates GMPs but not SOPs. USDA mandated Sanitation Standard Operating Procedures (SSOPs) for Meat and Poultry Operations effective January 27, 1997. The rule calls on plant management to develop SSOPs that address daily routine sanitary procedures, before and during operations to prevent direct product contamination or adulteration. Procedures should be specific for each plant and can be as detailed as the plant wants to make them.
An SSOP program should provide:
1. Descriptions of pre-optional SSOPs, explicitly distinguished from daily sanitation activities, addressing at a minimum the cleaning of food contact surfaces of facilities, equipment and utensils.
2. Descriptions of operational SSOPs that will result in a sanitary environment in accordance with sections 308 and 381 of the Meat and Poultry Inspection Regulations.
Example: SOP 7: Automatic labeling machine
Purpose: Cleaning and sanitizing of labeling machine to reduce microbial contaminants in the packaging room and keep machine in good working condition.
Frequency: Daily for routine cleaning
Who: Packaging line supervisor or his/her designee
For daily cleaning:
For weekly breakdown:
These should describe procedures during operations that include equipment and utensils cleaning, sanitizing, disinfecting during production, at breaks, at midshift and between shifts, employee hygiene and product handling in raw and cooked product areas.
For implementation, the rule calls on the establishment to identify the employee(s), by position(s) rather than by the name(s) of a specific employee, who will be responsible for the SSOPs by monitoring the program and documenting adherence to the SOP and corrective actions taken. Evaluation of the effectiveness of the SSOP can be performed by organoleptic.
(sight, feel, smell), chemical (sanitizer level) or microbiological methods. Records should be maintained for a minimum of 6 months and on-site for 48 hours.
Inspectors will NOT approve SSOPs, but will provide advice and guidance. Inspectors also have the authority to verify adequacy and effectiveness of SSOPs. Verification may include reviewing the SSOPs, reviewing the daily records, direct observation of the SSOPs implementation, or direct observation of sanitary conditions.
Detailed information on the SSOPs regulations can be found in the Federal Register, 61 (144) and 9CFR 416. Appendix A - Guidelines for Developing a Standard Operating Procedure for Sanitation (Sanitation SOPs) in Federally Inspected Meat and Poultry Establishments and Appendix B - A Model of a Standard Operating Procedure for Sanitation from this issue of the Federal Register are included here.
Guidelines for Developing a Standard Operating Procedure for Sanitation (Sanitation SOPs) in Federally Inspected Meat and Poultry Establishments
Foodborne illness is a significant public health problem in the United States. While data on illness associated with meat and poultry products are limited, data from various sources suggest that foodborne microbial pathogens may cause up to 7 million cases of illness each year and 7,000 deaths. Of these, nearly 5 million cases of illness and more than 4,000 deaths may be associated with meat and poultry products.
The Food Safety and Inspection Service (FSIS) is pursuing a broad and long term science-based strategy to improve the safety of meat and poultry products to better protect public health. FSIS is undertaking steps to improve the safety of meat and poultry throughout the food production processing, distribution and marketing chain. The Agency's goal is to reduce the risk to public health of consuming meat and poultry products by reducing pathogenic microbial contamination. The FSIS strategy relies heavily on building the principle of prevention into production processes.
Sections 308.7, 381.57 and 381.58 of the Meat and Poultry Inspection Regulations require that rooms, compartments, equipment and utensils used for processing or handling meat or poultry in a federally inspected establishment must be kept clean and in a sanitary condition. Establishments are responsible for sanitation of facilities, equipment and utensils.
Sanitation maintains or restores a state of cleanliness, and promotes hygiene for the prevention of foodborne illness. Sanitation encompasses many areas and functions of an establishment, even when not in production. However, there are certain sanitary procedures that must be addressed and maintained on a daily basis to prevent direct product contamination or adulteration. Good sanitation is essential in these areas to maintain a safe food production process.
FSIS is requiring meat. and poultry establishments to develop and implement a written Standard Operating Procedure for sanitation (Sanitation SOPs) which addresses these areas. An establishment's adherence to its written SOP for sanitation will demonstrate knowledge of and commitment to sanitation and production of safe meat and poultry products.
New part 416 to the Meat and Poultry Inspection Regulations requires that a written Sanitation SOP contain established procedures to be followed routinely to maintain a sanitary environment for producing safe and unadulterated food products. Plant management must develop a Sanitation SOP that describes daily sanitation procedures to be performed by the establishment. A designated establishment employee(s) must monitor the Sanitation SOP and document adherence to the SOP and any corrective actions taken to prevent direct product contamination or adulteration. This written documentation must be available to HIS program employees.
These HIS guidelines should help federally inspected meat or poultry establishments develop, implement and monitor written Sanitation SOPs.
The Sanitation SOP developed by the establishment must detail daily sanitation procedures it will use before (pre-operational sanitation) and during (operational sanitation) operation to prevent direct product contamination or adulteration. FSIS program employees will verify an establishment's adherence to its Sanitation SOP and will take appropriate action when there is noncompliance.
These guidelines, where applicable, are for:
- livestock slaughter and/or processing establishments;
- poultry slaughter and/or processing establishments;
- import inspection establishments; and
- identification warehouses.
The establishment should update the Sanitation SOP to reflect changes in equipment and facilities, processes, new technology or designated establishment employees.
II. Pre-Operational Sanitation
Established procedures of pre-operational sanitation must result in clean facilities, equipment and utensils prior to starting production. Clean facilities, equipment and utensils are free of any soil, tissue debris, chemical or other injurious substance that could contaminate a meat or poultry food product. Pre-operational sanitation established procedures shall describe the daily, routine sanitary procedures to prevent direct product contamination or adulteration. The sanitary procedures must include the cleaning of product contact surfaces of facilities, equipment and utensils to prevent direct product contamination or adulteration.
The following additional sanitary procedures for preoperational sanitation might include:
- Descriptions of equipment disassembly, reassembly after cleaning, use of acceptable chemicals according to label direction and cleaning techniques.
- The application of sanitizers to product contact surfaces, after cleaning. Sanitizers are used to reduce or destroy bacteria that may have survived the cleaning process.
III. Operational Sanitation
All federally inspected establishments must describe daily, routine sanitary procedures that the establishment will conduct during operations to prevent direct product contamination or adulteration. Established procedures for operational sanitation must result in a sanitary environment for preparing, storing or handling any meat or poultry food product in accordance with sections 308/381 of the Meat and Poultry Inspection
- Regulations. Established procedures during operations might include, where applicable:
- equipment and utensil cleaning-sanitizing-disinfecting during production, as appropriate, at breaks, between shifts and at midshift cleanup;
- employee hygiene: includes personal hygiene, cleanliness of outer garments and gloves, hair restraints, hand washing, health, etc.; and
- product handling in raw and in cooked product areas.
The established sanitary procedures for operational sanitation will vary with the establishment. Establishments with complex processing need additional sanitary procedures to ensure a sanitary environment and to prevent cross contamination. Establishments that do not slaughter or process (such as an Import Inspection facility) should develop established sanitary procedures specific to that facility.
IV. Implementing and Monitoring of the Sanitation SOP
The Sanitation SOP shall identify establishment employee(s) (positions rather than specific names of employees) responsible for the implementation and maintenance of the Sanitation SOP. Employee(s) are to be identified to monitor and evaluate the effectiveness of the Sanitation SOP and make corrections when needed.
The evaluation can be performed by using one or more of the following methods:
1. organoleptic (sensory-e.g., sight, feel, smell);
2. chemical (e.g., checking the chlorine level); and
3. microbiological (e.g., microbial swabbing and culturing of product contact surfaces of equipment or utensils).
Establishments might specify the method, frequency and recordkeeping processes associated with monitoring. Pre-operational sanitation monitoring should, at a minimum, evaluate and document the effective cleaning of all direct product contact facilities, equipment and/or utensils that are to be used at the start of the production. Operational sanitation monitoring should, at a minimum, document adherence to the SOP, including actions that identify and correct instances or circumstances of direct product contamination which occur from environmental sources (facilities, equipment, pests, etc.) or employee practices (personal hygiene, product handling, etc.) All establishment records of pre-operational and operational sanitation monitoring, including corrective actions to prevent direct product contamination or adulteration, must be maintained by the establishment for at least six months, and be made available to FSIS program employees. After 48 hours, they may be maintained off-site.
V. Corrective Actions
When deviations occur from the established sanitary procedures within the Sanitation SOP, the establishment must take corrective actions to prevent direct product contamination or adulteration. Instructions should be provided to employees and management officials for documenting corrective actions. The actions must be recorded.
Model of a Standard Operating Procedure for Sanitation
Hill-Top Meats has prepared a written Standard Operating Procedure (SOP) for Sanitation. Let's look at the Sanitation SOP and discuss its attributes (guidance and advice are in italics).
Hill-Top Meats, Est. 38 Any town, U.S.A. is a slaughter and medium processing establishment. This plant receives live cattle for slaughter and dressing and processes the carcasses into chubs of ground beef, roast beef, and ready to eat beef products. This introductory information is not a regulatory requirement but identifies the type of establishment and its production. The information will help FSIS personnel, who are not familiar with the Sanitation SOP.
Management structure is as follows:
Slaughter Manager-Ken Smith
Processing Manager-Susan Jones
Quality Control (QC) Manager-Gwen Summers
Sanitation Manager--Carl Anderson
The QC Manager is responsible for implementing and daily monitoring of the Sanitation SOP and recording the findings and any corrective actions. The Slaughter, Processing and Sanitation Managers are responsible for training and assigning specific duties to other employees and monitoring their performance within the Sanitation SOP.
All records, data, checklists and other information pertaining to the Sanitation SOP will be maintained on file and made available to FSIS program employees.
The identification of establishment personnel (positions rather than specific names of employees) responsible for implementing, maintaining, monitoring and records associated with the Sanitation SOP is a regulatory requirement.All records pertaining to the Sanitation SOP must be kept on file and made available to FSIS personnel, but it is not necessary to make that statement.
Sanitation SOP for EST. 38
I. Pre-operational Sanitation-Equipment and Facility Cleaning Objective
All equipment will be cleaned and sanitized prior to starting production.
A. General Equipment Cleaning.
(Simple equipment and hand tools are cleaned and sanitized in the same manner but they do not require disassembly and reassembly.)
1. Established Sanitary Procedures for Cleaning and Sanitizing Equipment:
a. The equipment is disassembled. Parts are placed in the designated tubs, racks, etc.
b. Product debris is removed.
c. Equipment parts are rinsed with water to remove remaining debris.
d. An approved cleaner is applied to parts and they are cleaned according to manufacturers' directions.
e. Equipment parts are rinsed with potable water.
f. Equipment is sanitized with an approved sanitizer, and rinsed with potable water if required.
g. The equipment is reassembled.
h. The equipment is resanitized with an approved sanitizer, and rinsed with potable water if required.
The established sanitary procedures are daily routine sanitary procedures to prevent direct product contamination or adulteration. Daily routine sanitary procedures to prevent direct product contamination or adulteration are required in the Sanitation SOP; FSIS personnel use them to verify compliance with the Sanitation SOP. The procedures shall be specific for each establishment; however, they can be as detailed as the establishment wants to make them.
2. Implementing, Monitoring and Recordkeeping. The QC Manager performs daily organoleptic sanitation inspection after pre-operational equipment cleaning and sanitizing. The results of the inspection are recorded on Establishment Form E
a. If everything is acceptable, the appropriate box is initialed. If corrective actions are needed, such actions are to be documented (see below).
The QC Manager performs daily microbial monitoring for Total Plate Counts (TPCs) after pre-operational equipment cleaning and sanitizing. The QC Manager swabs one square inch of a food contact surface on a piece of equipment or hand tool within one hour prior to production. The samples are plated and incubated at 35'C. for 48 hours. Colonies are counted and recorded as number of colony forming units (CFU) per square inch of surface swabbed. Daily microbial counts are documented on Establishment Form M-1.
3. Corrective Actions.
a. When the QC Manager determines that the equipment or hand tools do not pass organoleptic examination, the cleaning procedure and reinspection are repeated. The Sanitation Manager monitors the cleaning of the equipment or hand tools and retrains sanitation crew employees, if necessary. Corrective actions are recorded on Establishment Form E-1.
b. If microbial counts exceed CFUs/sq. in., (plant specific based on national recommendations) the QC Manager notifies the Sanitation Manager and attempts to determine the cause of the high count (for example, cleaning procedures varied, new people cleaned the equipment, sanitizer not applied). If microbial counts remain high for several days, the QC Manager will confer with the Sanitation Manager. The Sanitation Manager notifies sanitation crew employees and reviews all cleaning and sanitizing procedures and personal hygiene. Microbial counts are recorded on Establishment for M-1. Corrective actions to prevent direct product contamination or adulteration are documented on Establishment Form E-1.
The establishment is required to monitor daily routine sanitation activities as described in the Sanitation SOP, the establishment determines the methods and frequency of monitoring. Microbiological sampling is not required, but Hill-Top Meats wants to monitor the effectiveness of the cleaning by daily microbial sampling, in addition to organoleptic monitoring, and has set limits to enable them to take appropriate action when those limits are exceeded. Establishment Forms E-1 and M-I are used only as examples; no specific forms or form numbers are required. However, establishments must record the daily completion or adherence to the established procedures in the Sanitation SOP, and deviations from regulatory requirements and corrective actions.
B. Cleaning of Facilities-including floors, walls and ceiling.
1. Cleaning Procedures.
a. Debris is swept up and discarded.
b. Facilities are rinsed with potable water.
c. Facilities are cleaned with an approved cleaner, according to manufacturer's directions.
d. Facilities are rinsed with potable water.
2. Cleaning Frequency
a. Floors and walls are cleaned at the end of each production day.
b. Ceilings are cleaned as needed, but at least once a week.
There is no specific requirement to include facility cleaning in the Sanitation SOP, unless part of the facility could directly contaminate or adulterate product.
3. Establishment Monitoring.
The QC Manager performs daily organoleptic inspection prior to the start of operations. Results are recorded on Establishment Form E-1.
4. Corrective Actions.
When the QC Manager determines that the facilities do not pass organoleptic inspection, the cleaning procedure and reinspection are repeated. The Sanitation Manager monitors the cleaning of facilities and retrains sanitation crew employees if necessary. Corrective actions to prevent direct product contamination or adulteration are recorded on Establishment Form E-1.
II. Operational Sanitation Objective:
Carcass dressing will be performed under sanitary conditions and in a manner to prevent contamination of the carcass.
A. Slaughter Operations.
1. Established Methods for Carcass Dressing.
a. Employees will clean hands, arms, gloves, aprons, boots, etc., as often as necessary during the dressing procedures.
b. Employees will clean and then sanitize with 180°F. water, knives and other hand tools, saws and other equipment, as often as necessary during the dressing procedures to prevent contamination of the skinned carcass.
c. The brisket saw is sanitized between carcasses using 180°F. water.
d. Eviscerating employees will maintain clean hands, arms, clothes, aprons, boots and knives during the evisceration process. If contamination occurs, the employee is required to step away from the evisceration table onto a side platform to clean and sanitize apron, boots and knives. It may be necessary to clean hands and arms with soap and water. In cases of contamination from an abscess or other extensive contamination, the employee may need to shower and change clothes before resuming work.
e. The carcass splitting saw is sanitized with 180°F. water after each carcass.
The above methods for carcass dressing are specific for Hill-Top Meats. The establishment considers them to be Good Manufacturing Practices for their type of operation, to prevent direct contamination or adulteration of carcasses. Each establishment determines the sanitary procedures and any requirements they want to detail in their Sanitation SOP.
2. Monitoring and Recordkeeping.
a. The Slaughter Manager is responsible for ensuring that employee hygiene practices, sanitary conditions and cleaning procedures and maintained during a production shift. The QC Manager monitors the sanitation procedures twice during a production shift. Results are recorded on Establishment Form E-1.
b. A Microbiological Control and Monitoring Program is used to determine the level of bacteria on product contact surfaces of equipment (e.g., knives, hand tools, evisceration table, etc.) and outer garments (such as aprons and gloves) during production. The QC Manager performs daily microbial monitoring for Total Plate Counts (TPCs). The samples are plated and incubated at 35°C. for 48 hours. Colonies are counted and recorded as number of colony forming units (CFUs) per square inch of surface swabbed. Daily microbial counts are documented on Establishment Form M-1.
3. Corrective Actions.
a. When equipment is visibly contaminated, contaminants are removed cleaning and sanitizing equipment prior to resuming production. The Slaughter Manager attempts to determine the cause of the contamination and takes corrective action. This may require adjusting equipment, retraining employees, temporarily stopping or slowing the line speed, etc. Corrective actions are recorded on Establishment Form E-1.
b. If microbial counts from equipment swabbing exceed the action level set, the QC Manager notifies the Slaughter Manager. The Slaughter Manager attempts to determine the cause (for example, new people not adequately trained, equipment not adjusted properly) and takes corrective action. If microbial counts remain above established limits for several days, the QC Manager confers with the Slaughter Manager and all slaughter operations are reviewed. The Slaughter Manager notifies the slaughter employees and reviews personal hygiene, equipment adjustment, and sanitary handling procedures. Corrective actions to prevent direct product contamination or adulteration are recorded on Establishment Form E-1.
The establishment is required to monitor the regulatory daily sanitation activities as described in its Sanitation SOP, but each establishment determines its own methods for monitoring, the frequency of monitoring, and the corrective actions to include in the Sanitation SOP. Records must be kept on daily completion of the established procedures, deviations, and corrective actions.
B. Processing Operations.
Objective: Processing is performed under sanitary conditions to prevent direct and cross contamination of food products.
1. Established Sanitary Procedures for Processing.
a. Employees clean and sanitize hands, gloves, knives, wizard knives, other hand tools, cutting boards, etc., as necessary during processing to prevent contamination of food products.
b. All equipment, belt conveyors, tables, and other product contact surfaces are cleaned and sanitized throughout the day as needed.
c. Employees take appropriate precautions when going from a raw product area to a cooked product area, to prevent cross contamination of cooked products. Employees change outer garments, wash hands and sanitize hands with an approved hand sanitizer (sanitizer is equivalent to 50 ppm chlorine), put on clean gloves for that room and step into a boot sanitizing bath on leaving and entering the respective rooms.
d. Raw and cooked processing areas are separate. There is no cross utilization of equipment between raw and cooked products.
e. Outer garments, such as aprons, smocks and gloves, are identified and designated specifically for either the raw processing rooms or the cooked processing rooms. Blue is designated for raw processing rooms and orange for cooked processing rooms. The outer garments are hung in designated locations when an employee leaves each room. Outer garments are maintained in a clean and sanitary manner and are changed at least daily and, if necessary, more often.
Establishments with processing will determine their own establishment sanitary procedures in the Sanitation SOP and any establishment requirements. Hill-Top Meats considers its established procedures for processing to be Good Manufacturing Practices.
2. Monitoring and Recordkeeping.
a. The Processing Manager is responsible for ensuring that employee hygiene practices, employee and product traffic patterns, sanitary product handling procedures, and cleaning procedures are maintained during a production shift. The QC Manager monitors the sanitation procedures twice during a production shift. Results are recorded on Establishment Form P-1.
b. A Microbiological Control and Monitoring Program is used to determine and control the level of bacteria on both raw and cooked product contact surfaces during production. Once a day, the QC Manager performs Microbial Monitoring for Total Plate Counts (TPCs). The QC Manager swabs one square inch on a product contact surface from each of three randomly selected pieces of equipment in each raw product room and cooked product room.
Note: The samples are taken from the cooked product rooms first and then from the raw product rooms. The samples are plated and incubated at 35°C. for 48 hours. Colonies are counted and recorded as number of colony forming units (CFUs) per square inch of surface swabbed, Microbial counts are documented on Establishment Form M-1.
3. Corrective Actions.
a. When the QC Manager identifies sanitation problems, the QC Manager notifies the Processing Manager. The Processing Manager stops production, if necessary, and notifies processing employees to take appropriate action to correct the sanitation problems. If necessary, processing employees are retrained. Corrective actions are recorded on Establishment Form P-1.