The Listeria Control Program

The Listeria Control Program© (LCP) has been designed for the frozen food
industry by subject matter experts and food safety professionals with experience
in food manufacturing. First, it represents an ambitious effort to advance the
science and understanding around Listeria monocytogenes (Lm) prevention.
Second, it is a commitment to continuous improvement in food safety practices.
The LCP© is intended to build knowledge, disseminate and implement best
manufacturing practices across a broad spectrum of frozen food manufacturers.
The information within the LCP© should be used to train individuals representing
various functions, including engineers, sanitation and quality professionals,
management, contractors, suppliers and temporary personnel. The diagram
below represents the basic program requirements recommended to establish
effective Listeria control in a frozen processing manufacturing facility.

#1 Hygienic Zoning
Previous experience indicates there is a greater likelihood of finding spoilage
organisms or pathogens in uncontrolled or raw manufacturing areas than in
controlled production or ready-to-eat (RTE) areas. Designing and managing
the flow of traffic as it relates to personnel, supplies, and equipment significantly
reduces the potential for cross-contamination.

#2 Good Manufacturing Practices

Following good manufacturing practices (GMPs) is a fundamental expectation in
the food industry. Not following these practices could lead to product contamination.
GMPs apply to both personnel practices and, equally important, production
practices. For example, surfaces in a frozen food production facility can be wet
from manufacturing conditions; this moisture can support microbial harborage
and growth. Floors and other surfaces should be dry, well maintained, and free
of cracks.

AFFIFoodSafety.org
1
 #3 Hygienic Facility and Equipment Design
Hygienic design of equipment and facilities is one of the most important Lm control
components. Surfaces which are difficult to clean can be challenging and/or
overlooked in a sanitation cycle, resulting in microbial harborage and growth.
To fully assess cleanability and identify improvements, quality, food safety, and
engineering professionals should spend time observing and possibly performing
cleaning duties during the sanitation process.

#4 Sanitation Controls
Cleaning and sanitation must be effective. Effective sanitation is core to maintaining
a clean plant environment. Enhanced cleaning procedures have been proven to
compensate for weaknesses in facility or equipment design until improvements
can be implemented.

#5 Environmental Monitoring
Environmental monitoring measures the success of a frozen facility’s Lm controls
by verifying that preventive programs are effective. An environmental monitoring
program helps you know your environment and make improvements as highlighted
by the findings.

#6 Process Validation
The ability to implement process controls is a critical element of many frozen food
manufacturing processes. When hazards including not only Lm, but also other
pathogens are identified, preventive process controls must be put in place to
address them. Validation of these process controls is an important pre-requisite
to utilizing these controls effectively in the manufacturing process.

#7 Freezer Management
Poor hygienic design, improper preventive, maintenance, and ineffective sanitation
are the primary drivers leading to freezer-related contamination of finished food
products. Application of manual cleaning and clean-in-place systems to support
routine sanitation, active Listeria spp. sampling of freezer sites, and addressing
structural issues, can limit the potential for freezers to serve as the source of Lm
contamination.

Focusing on these core recommendations provides early control and long-term

stability for pathogen management programs. Users of this document will find it

AFFIFoodSafety.org
2
 flexible enough to be studied completely or in sections, depending on the reader’s
interests and needs.

Putting It All Together

This LCP© approach is recommended by the American Frozen Food Institute. It is
part of a broad set of food safety initiatives designed to strengthen manufacturing
practices in frozen processing facilities with the goal of reducing food safety risks.
The control of Lm in a frozen manufacturing environment has been proven possible,
using best food safety practices and an organized and integrated approach. This
approach is illustrated by the LCP©. Essentially, the LCP© can lead food safety
professionals in determining what is important, where to focus resources, and
how to create an integrated plan for remediation of Listeria hazards in the
manufacturing facility. With this knowledge, food safety professionals will be
successful in advancing food safety programs and their objectives.

Hygienic Zoning
The Recommendations The Resources
• Cross traffic (raw/uncooked to cooked/post lethality) Hygienic Zoning in Frozen
is controlled with effective procedures. Traffic barriers Food Facilities
such as walls, rails, fences, vestibules, walkways, are See Image Examples
used as active control measures.
• Traffic plans and zoning maps illustrate area by level
of care i.e. high hygiene, post lethality, raw.

• Trash and inedible areas have established programs Hygienic Zoning in Frozen
and defined routes and storage areas to prevent Food Facilities
cross-contamination with hurdles to prevent
cross contamination from a lower (raw) to higher
(production) care area.

• Employees are well trained, and behavior is reinforced Hygienic Zoning in Frozen
i.e. behavior based training or surveillance cameras. Food Facilities
• Active controls are in place which make it difficult to
violate a policy.

AFFIFoodSafety.org
3
 Hygienic Zoning cont.

The Recommendations The Resources

• Foot and wheel hurdles should be established and Hygienic Zoning in Frozen
maintained at entry points and between hygienic zones. Food Facilities
• Dry powder sanitizer should be used in dry areas and
dry/wet transition zones.
• Foot bath/foamer concentrations, when used, and
condition of all foot and wheel hurdles should be
monitored routinely; corrective actions taken as necessary.

• Cleaning and production utensils should be coded and Hygienic Zoning in Frozen
separated between zones. Food Facilities
• Separation is monitored and deviations addressed with Key Aspects of a Color Coding
proper corrective actions. Program

• Transport vehicles and wheeled items are numbered, Hygienic Zoning in Frozen
designated by zone, cleaned and sanitized on a routine Food Facilities
basis.
• Designated vehicles should be restricted to post lethality/
high hygiene areas.
• Wood pallets should not be used in post lethality/high
hygiene areas.
• Compliance should be monitored routinely and corrective
actions taken as necessary.

• HVAC systems are properly designed and adjusted to Hygienic Zoning in Frozen
maintain positive pressure and humidity levels in areas Food Facilities
where cooked/RTE products are exposed. See Image Examples
• External air is filtered to an appropriate level based on the
risk of contamination.

•W
 ater supply is routinely (minimum 6 months) tested for Hygienic Zoning in Frozen
potability at point of use. Food Facilities

• There are separate storage rooms for packaging materials, Hygienic Zoning in Frozen
raw/uncooked food materials, finished products, and waste Food Facilities
materials. See Image Examples

AFFIFoodSafety.org
4
 Good Manufacturing Practices (GMPs)
The Recommendations The Resources
• Employees, contractors, and visitors know facility GMPs GMPs in Frozen Food Facilities
and do not create a risk to product quality and safety.
• Workforce is empowered and exhibits excellent food
safety behaviors.
• Employees are trained annually on GMPs and receive GMPs in Frozen Food Facilities
frequent reinforcement.
• Employees know and follow the training materials.
• Contractors receive relevant training.
• Training records are maintained and training tools are con-
tinuously improved and reinforced to increase awareness.
• Training expectations are communicated and validated
through observations and performance feedback.
• Internal GMP inspections identify minor and potentially GMPs in Frozen Food Facilities
significant issues or opportunities that may lead to timely
and permanent corrective actions.
• Audits focus on thorough review and documentation.
• Root cause analysis is comprehensive and targets
prevention of recurring issues.
• Internal audits are in place and performed at a regular GMPs in Frozen Food Facilities
frequency.
•C  orrective actions are implemented & documented.
•L  earnings are shared and effectively communicated across
the company with all relevant personnel.
•C  ompany-approved clothing and footwear are used and Recommended PPE for Sanitation
they are clean and well maintained.
• A company-approved program for a captive clothing and
footwear program is highly recommended.
• Color coding of protective workwear (clothing and footwear) Recommended PPE for Sanitation
in high hygiene or post-lethality areas is important to
delineate higher risk and greater concerns of cross
contamination.
• It is highly recommended that employees working in
post-lethality/high hygiene areas wear additional protective
clothing as they enter these areas.

AFFIFoodSafety.org
5
 Good Manufacturing Practices (GMPs) cont.
The Recommendations The Resources
• A culture of proper housekeeping and organization should Elements of a Sanitation Team
be developed and these behaviors must be consistently
applied
• Routine monitoring throughout the facility and plant grounds,
followed by necessary corrective actions are critical.
• Product, ingredients and work-in-process should be
designated to zone-labeled and/or coded containers.
• Containers should be restricted to specific areas in
accordance with plant policies.
• Traceability should be maintained for ingredients, work in
progress and product through delivery to the customer.
• Waste should be handled so as not to contaminate the
production environment or product.
• Waste should be separated, staged and stored in readily
identifiable containers which are routinely emptied, cleaned
and sanitized.
• Waste should be appropriately classified (trash, recycle,
by-product for animal feed) regularly. Any spillage should
be removed and cleaned immediately.
• Waste receptacles including dumpsters, compactors,
balers, etc., should be cleaned routinely.
•H
 igh pressure water should not be used during production Controlled Use of Water
to avoid aerosoling and potentially cross-contaminating See Image Examples
within the production environment.
• A dedicated transition area should be used to don Hygienic Zoning in Frozen
appropriate clothing/gear and to wash hands prior to Food Facilities
entering production areas. See Image Examples
• Signage is present to alert employees of areas with
their respective “care” designations.
• Maintenance
 inspections and work order systems are Elements of a Maintenance and
synchronized between the QA and operations teams. Temporary Repair Policy
• A mechanism for audits and feedback should be Maintenance, Construction and
established to ensure building and equipment are Demolition Containment Procedure
adequately maintained so that they do not become
harborage points for potential contamination.

AFFIFoodSafety.org
6
 Good Manufacturing Practices (GMPs) cont.

The Recommendations The Resources

• Maintenance personnel comply with facility GMP Elements of a Maintenance and
programs, including PPE and doning requirements. Temporary Repair Policy
• Tools are cleaned and sanitized routinely; preferably Maintenance, Construction and
dedicated to post lethality/high hygiene areas. Demolition Containment Procedure
• All materials are stored off the floor on clean pallets at Principles of Hygienic Design
least 18 inches away from the wall to facilitate cleaning for Facilities
and pest control activities and to allow product ventilation. Facility Design Checklist
Overview of Pest Control

• Temperature control in critical storage areas is maintained Principles of Hygienic Design

and temperature recording devices or indicators are for Facilities
appropriately located and accessible. Facility Design Checklist
• Temperature control chart or other temperature collection
See Image Examples
methods are available.
• Manual checking and recording are used as a cross-
reference to automatic controls at agreed frequency with
immediate corrective action in case of non-conformance.
• Minimum annual calibration frequency.

•V
 ehicles used for distribution of frozen foods are loaded Containment Policy Considerations
using sealed docks. See Image Examples
•T
 railers, containers and rail cars maintain specified
temperatures.
•T
 emperatures are recorded during transit and meet
specifications.
•A vehicle inspection program is established. Containment Policy Considerations
• Prior to loading and unloading, all delivery vehicles are See Image Examples
inspected to ensure they are clean and free from moisture.
• Internal inspection reports are easily accessible.
• Non-conformances and corrective action records are
easily accessible.

AFFIFoodSafety.org
7
 Hygienic Design of Equipment and Facilities
The Recommendations The Resources
• Floors are generally cleanable, non-porous and show no Principles of Hygienic Design
cracks. for Facilities
• By design, floors are resistant to chemicals used. Facility Design Checklist
• Floor/wall junctions are completely sealed.
See Image Examples
• Concrete base sealed with epoxy or urethane material
which is chemically resistant or dairy brick with continuous
grouting.
• Coved at floor/wall juncture for good drainage.
• Floors very durable to extreme conditions.
• For dry areas: use smooth finish to allow for dry cleaning
that is resistant to chemicals and cracking.
• Drains are smooth, cleanable – no rust or pitting. Principles of Hygienic Design
for Facilities
Facility Design Checklist

• Floor drains are circular and not directly under equipment Principles of Hygienic Design
or processes (or covered during production). for Facilities
• Easily accessible and cleaned during each sanitation Facility Design Checklist
cycle or sanitized daily.
See Image Examples
• Level with floor surface and of sufficient size and
distribution to take away water and resist backups.
• Trench-style drains only when necessary in post lethality/
high hygiene areas, continuously welded and stainless steel.
• Floors are sloped 1/4 inch/foot, smooth, self-draining, and dry. Principles of Hygienic Design
• If floors are not perfectly self-draining, they are easily for Facilities
drained with squeegees. Facility Design Checklist
•W  et areas are clean and may be wet with sanitizer, with
See Image Examples
no pooling.

• Floor/equipment junctions are mounted, grouted in Principles of Hygienic Design

place and are accessible for cleaning. for Equipment
• Equipment legs are designed to minimize moisture Equipment Design Checklist
entrapment (no hollow tubing). FAQs: Hygienic Design of
• Other equipment has solid pin legs with a rounded tip Equipment
to minimize moisture.
See Image Examples

AFFIFoodSafety.org
8
 Hygienic Design of Equipment and Facilities cont.

The Recommendations The Resources

• Water pressures are controlled so that atomization is Controlled Use of Water
minimized to prevent cross-contamination. Hot Water Supply
• High pressure hoses are not utilized during equipment or
Overview of Floor and Drain Cleaning
drain cleaning.
• Sanitation personnel are trained and monitored to control Overview of Cleaning Procedure
direction and quantity of rinsing and aligned with sequential See Image Examples
cleaning process requirements.
• Floors are clean with minimal items stored, determined by Principles of Hygienic Design
immediate production needs and are staged for use. for Facilities
• Guidelines are followed for storing items on the floor which Facility Design Checklist
belong there.
• Food containers, packaging and other sensitive items are
off the floor.
• Tables and cabinets are made of non-corrosive materials
and stored 12 inches off the floor.
• A floor maintenance programs exists and is followed for Principles of Hygienic Design
floor inspection and maintenance. for Facilities
• A process for creating work orders to repair or replace Facility Design Checklist
floors is in place and used.
See Image Examples
• Team utilizes a hygienic design checklist for equipment Principles of Hygienic Design for
and a hygienic design checklist for infrastructure in Facilities
conjunction with other standards. Principles of Hygienic Design for
• Audit results are reviewed and acted upon by the facility Equipment
team in an organized and documented manner.
FAQs: Hygienic Design of Equipment
• Corporate support is available for assistance with Elements of a Multidisciplinary
hygienic design compliance and if not- available Hygienic Design Team
support is contracted externally. FAQs: Hygienic Design of Equipment
• Facility employs a trained sanitarian with knowledge
of hygienic design of equipment and infrastructure.
•M
 embers of the food Safety/sanitation staff trained in Elements of a Multidisciplinary
equipment and infrastructure hygienic design are Hygienic Design Team
requested for input on hygienic design prior to the FAQs: Hygienic Design of
initiation of project start-up. Equipment

AFFIFoodSafety.org
9
 Hygienic Design of Equipment and Facilities cont.

The Recommendations The Resources

• New equipment design is reviewed by trained personnel Principles of Hygienic Design for
for hygienic design compliance from concept to start to Equipment
identify and mitigate areas of concern related to hygienic Equipment Design Checklist
design.
FAQs: Hygienic Design of Equipment
Equipment Acceptance Process
Assessing Equipment for Food
Manufacturing

• Members of engineering, sanitation, food safety and a Principles of Hygienic Design for
trained sanitarian are involved with all repairs for cooked/ Equipment
RTE zones with approval documented as a team for post Equipment Design Checklist
lethality/high hygiene compliance to hygienic design
Sanitation Procedures During
requirements for cleaning and inspection.
Construction
Containment Policy Considerations
Containment Decision Making
Template
Maintenance, Construction and
Demolition Containment Procedure
Monitoring During Construction and
Approval Checklist
• Company has a periodic maintenance and sanitation Food Safety: A Maintenance
team that conducts routine equipment and infrastructure Perspective
inspections to identify potential niche environments and Facility Design Checklist
harborage sources.
FAQs: Hygienic Design of Equipment
• Work orders are generated and executed to eliminate
potential sources of Lm due to lack of access or difficulty Containment Policy Considerations
of cleaning and inspection. Containment Decision Making
Template
Maintenance, Construction and
Demolition Containment Procedure
Monitoring During Construction and
Approval Checklist

AFFIFoodSafety.org
10
 Hygienic Design of Equipment and Facilities cont.

The Recommendations The Resources

• A review of facility infrastructure and equipment is conducted Principles of Hygienic Design
in conjunction with respective corporate staff or outside for Equipment
entity with expertise to identify existing poor hygienic Equipment Design Checklist
design points and identify corresponding mitigation actions.
•E
 quipment and infrastructure modifications that are FAQs: Hygienic Design
conducted to improve hygienic design are documented of Equipment
and undergo a structured verification process to
document confirmation of efficacy.
• All food contact surfaces are seamless, with rounded Principles of Hygienic Design
corners and are constructed of materials that can be for Equipment
properly cleaned and sanitized. These materials should Equipment Design Checklist
be non-toxic, nonabsorbent, corrosion resistant and
See Image Examples
highly resistant to cleaning and sanitizing chemicals
• All food contact equipment is designed prior to Principles of Hygienic Design for
purchase and installed to be self-draining and not Equipment
entrap water and soils, provide access for cleaning Equipment Design Checklist
and inspection and are able to withstand the plant
Assessing Equipment for Food
environment.
Manufacturing
FAQs Hygienic Design of Equipment
See Image Examples
• Facility design defines hygienic zones and dedicated Principles of Hygienic Design
entry points with hurdles to sensitive processing areas. for Facilities
Proper mitigation steps are identified and implemented Facility Design Checklist
for all points of entry into processing areas.
See Image Examples

• All hand wash sinks are hands free. Principles of Hygienic Design
• Hand wash and sanitizer stations are located for ready for Facilities
and frequent use in Zone 2 and 3 areas. Facility Design Checklist
• Hand drying methods are consistent with hygiene zones.
See Image Examples

• All food processing equipment is positioned away from Principles of Hygienic Design
adjacent walls or other obstructions at a minimum of 3 for Facilities
feet to allow for cleaning and inspection. Facility Design Checklist
See Image Examples

AFFIFoodSafety.org
11
 Hygienic Design of Equipment and Facilities cont.
The Recommendations The Resources
• Product conveyors are located a minimum of 18 inches off Principles of Hygienic Design for
the floor and from the ceiling (for overhead conveyors). Equipment
• Conveyors are placed in easy to access areas to facilitate Equipment Design Checklist
cleaning.
FAQs: Hygienic Design of Equipment
• Conveyor usage is minimized and if placement is strategic
with considerations of proper cleaning and inspection. See Image Examples

• Facility ceilings are solid, smooth, cleanable, accessible, Principles of Hygienic Design
and moisture resistant. for Facilities
• Lighting is recessed. Facility Design Checklist
• An ongoing inspection and repair program is present.
See Image Examples
• A facility food safety hazard evaluation is ongoing with
remedial actions identified and implemented.
• Positive and negative air pressure is created through Principles of Hygienic Design
the use of automated control systems to compensate for Facilities
for changes in the room air pressure. Facility Design Checklist
• Direction of airflow from the post lethality/high hygiene
See Image Examples
areas to less sensitive areas.
•W  ater backflow protection is verified and documented via a Principles of Hygienic Design
quarterly audit conducted by trained internal personnel. for Facilities
• An annual audit for verification is conducted by an outside Facility Design Checklist
certified service.
Hot Water Supply
• Water temperature and pressure meet requirements Hot Water Supply
at peak usage times. Principles of Hygienic Design for
• Hoses, nozzles, and mix stations are functional and
Facilities
routinely monitored/maintained.
• Locations and hose length ensure accessibility to all Facility Design Checklist
process areas. Wet Cleaning: A Seven Step Program
See Image Examples

AFFIFoodSafety.org
12
 Sanitation Controls
The Recommendations The Resources
• Roles and responsibilities for sanitation management and Elements of a
support are defined. Multidisciplinary Sanitation
• Sanitation leadership and support groups are aligned; Team
cross-functional communication is routine and frequent.
• Sanitation programs are developed with cross-functional Introduction to Routine Cleaning
input based on experience with facility’s product and
finished product.
• Sanitation processes consider product sensitivity/risk,
hygienic design of equipment and facility, resources,
industry/customer expectations and success criteria.
• Sanitation related metrics (KPIs) detail effectiveness and Sanitation Program KPIs
efficiency of sanitation controls and are used to track gaps Sanitation KPIs (Template)
as well as continuous improvement efforts.
• Employees receive GMP, sanitation and safety, HACCP, and Good Manufacturing Practices
other required training as well as job specific knowledge. in Frozen Food Facilities
•S  anitors understand basics of food safety, sanitation and Seven-Step Wet Cleaning
task requirements.
4x4 Sanitation
•P  roficiencies are confirmed through testing or supervisory
evaluation and qualification. Wet Cleaning: A Seven Step
Program
• A comprehensive master sanitation program exists that Introduction to Non-Routine Cleaning
references an SSOP for each task. Master Sanitation Schedule
• Periodic equipment and infrastructure cleaning tasks are (Template)
specified within the program.
• Master sanitation program is used to monitor schedule
and resourcing, regularly measured for scheduled
completion and evaluated for effectiveness.
•H
 igh risk equipment is disassembled, cleaned and PEC Assessment and Procedure
assessed on a routine basis.
•R
 eviews are planned, documented and cross-functionally
executed.

AFFIFoodSafety.org
13
 Sanitation Controls cont.

The Recommendations The Resources

• A sequential approach to sanitation is employed to facilitate Overview of Cleaning Procedure
effective and efficient cleaning of the plant (equipment and Overview of Sanitizing Procedure
infrastructure).
Seven-Step Wet Cleaning
• SSOPs are defined for each routine cleaning task. SSOPs
are current, sequenced through defined (i.e. 7-step or 4x4) 4x4 Sanitation
methodology and readily available. SSOP (Template)
• Procedures provide step-by-step instructions for efficient
and repeatable sanitation.
• Procedures describe tools, chemicals and concentrations,
safety requirements and training needed are defined for
each process.
• Photographs with appropriate detail are used to aid in
training.
• Roof and drains are in good condition and good Special Cause Cleaning Procedure
processes are established, readily available and Drain Backup Procedure
deployed as necessary to address potential food Overview of Floor and Drain Cleaning
safety risks arising from special circumstances.
• Food safety preventive maintenance tasks are executed Considerations and Procedures
and red-tag processes are deployed as needed. for Maintenance and Temporary
• Temporary repairs are followed by permanent solutions. Repair Policy
Temporary and Emergency Repair
Procedure
Red Tag Procedure
• Sanitation is monitored to provide timely feedback. Monitoring, Verification,
• Sanitation is verified to ensure consistent processes. and Validation of Cleaning
• Sanitation is validated to ensure the process is capable
of delivering the desired level of cleanliness.
• Cleaning chemistry should be appropriate for soil, Cleaning Chemistry and
environment, water, surface, and method of application. Selecting the Right Chemicals
• Cleaning chemicals should be optimized and validated
for effectiveness.

AFFIFoodSafety.org
14
 Sanitation Controls cont.

The Recommendations The Resources

• Sanitizing chemistry should be appropriate for level of Sanitizing Chemistry and
microbial lethality, method of application, type of Selecting the Right Sanitizers
microorganisms and properties of the sanitizer.
• Sanitizers are optimized and validated for effectiveness.
• If areas are dry, keep them dry during operation and Dry Cleaning and Maintaining a
sanitation. Dry Production Environment
• Sequenced dry cleaning processes (using necessary tools Dry Cleaning Basics - Removing
and methodology) are defined and stringently followed. Soils Without Water (VIDEO)
• Areas are monitored and maintained to ensure dry
Vacuuming: The Preferred Dry
conditions in the environment.
Cleaning Method (VIDEO)
• Zone barriers and operational and dry sanitation
processes are maintained on a continuous basis and
monitored appropriately.
• Water pressures are controlled so that atomization is Controlled Use of Water
minimized.
• High pressure hoses are not utilized during equipment
or drain cleaning.
• Sanitors are trained and monitored to control direction
and quantity of rinsing in unison with sequential cleaning
process requirements.
•D  ocumented drain cleaning programs are available. Overview of Floor and Drain Cleaning
•P  roperly labeled, stored, and restricted supplies and PPE Drain Cleaning Procedure
are used.
Drain Cleaning Procedures (VIDEO)
•C  leaning drains in production areas during production
should be avoided and always completed before cleaning
equipment to avoid potential cross-contamination.
• All drains are mapped, adequately designed and
maintained.
• Adequate steps must be taken when cleaning equipment/ Overview of Adjacent Line Cleaning
areas that are in close proximity to other operational
processing lines.
• A validated adjacent line cleaning process is documented
and executed as designed and monitored.

AFFIFoodSafety.org
15
 Sanitation Controls cont.

The Recommendations The Resources

• All food contact equipment is inspected for cleanliness Pre-operational Inspection
prior to starting production. Pre-operational
• Inspections are documented with corrective actions taken Inspection (Template)
for non-conformance to standards.
• Results of ATP and APC swabs are trended and
adjustments to sanitation procedures, training programs,
or the facility/equipment are made based on data.
• Procedures addressing special cause cleaning events Special Cause Cleaning Procedure
such as roof leaks, drain overflow, zone breaches, and Investigative Cleaning Procedure
environmental positives are developed to mitigate and
Roof Leak Procedure
control potential food safety risks.
Drain Backup Procedure
• All employees are trained, well-versed to execute these
protocols as needed. Overview of Floor and Drain
• Investigative cleaning processes are used to enhance Cleaning
sanitation and containment processes arising from
uncertain food safety risk situations.
• Maintenance responsibilities governing sanitation support, Elements of a Maintenance and
communications and compliance to food safety practices Temporary Repair Policy
are identified and followed. Food Safety: A Maintenance
• Maintenance employees are trained in tool accountability Perspective
and sanitation.
Containment Policy Considerations
• Food safety preventive maintenance tasks are executed,
lubrication is controlled, red-tag processes are deployed. Containment Decision Making
• Temporary repairs are followed by permanent solutions. Template
• Frequent communication and planning between Maintenance, Construction and
maintenance, sanitation, QA and operations is a Demolition Containment Procedure
cultural expectation. Monitoring During Construction
and Approval Checklist
Red Tag Procedure

AFFIFoodSafety.org
16
 Sanitation Controls cont.

The Recommendations The Resources

• Construction processes are evaluated prior to project Sanitation Procedures During
inception. Construction
• Personnel (internal and external) involved in construction Containment Policy Considerations
activities are trained and monitored to comply with GMP
Containment Decision Making
requirements.
Template
• Areas under construction are isolated.
• Dedicated foot traffic patterns are established. Maintenance, Construction &
• Increased swabbing for pathogens is carried out during Demolition Containment Procedure
and after construction and equipment installation Monitoring During Construction
processes. and Approval Checklist

• COP tanks and automated cleaning systems are Automated Cleaning Technologies
sufficiently sized and monitored to support timely and
effective cleaning.
• CIP circuits are interlocked to ensure compliance with
TACT parameters and support cleaning requirements
in a timely manner to support production needs.
• Systems are verified and validated on a routine basis.
• Sanitation technologies are sufficient to effectively and Automated Cleaning Technologies
efficiently clean equipment and the facility. CIP Systems for Cleaning and
• Adequate systems (spray bars, COP, ACS, CIP) are Sanitation
provided to facilitate proper cleaning and sanitizing practices.
•C
 IP systems are designed to control TACT parameters. CIP Systems for Cleaning and
System(s) are adequately monitored and managed. Sanitation
•R
 aw and post lethality/high hygiene systems are separate. Automated Cleaning Technologies
•C
 IP circuits are interlocked to ensure compliance with
TACT parameters and support cleaning requirements in a
timely manner to support production needs.
•F
 acility expertise is sufficient to diagnose and troubleshoot
performance as necessary.
•S
 ystems are verified and validated on a routine basis.
• Proper PPE is utilized and controlled to ensure employee Recommended PPE for Sanitation
safety and minimize potential cross-contamination.

AFFIFoodSafety.org
17
 Sanitation Controls cont.

The Recommendations The Resources

• Sanitation tools and supplies are appropriately designed, Sanitation Tools and Utensils
stored, cleaned, monitored for condition and replaced
when necessary.
• Evaluation conducted on a defined basis.

Environmental Monitoring
The Recommendations The Resources
• Roles and responsibilities for environmental monitoring Elements of a Multidisciplinary
and support are defined. Environmental Monitoring Team
• Environmental monitoring team leadership and support
groups are aligned; cross-functional communication is
routine and frequent.
• Environmental monitoring program (EMP) actively detects Importance of Environmental
Listeria spp. in the plant environment and aggressively Monitoring in Frozen Food Facilities
focuses on Zones 1, 2, 3 & 4, enables early detection & Hygienic Zoning in Frozen Food
elimination, and sites are reviewed frequently. Facilities
• The monitoring plan should be based on historical data,
experience and science.
• Site zoning (1-4) and hygienic zoning are defined based Designing an Environmental
on risk assessment Monitoring Program
Hygienic Zoning in Frozen
Food Facilities
•C
 orrective actions are taken to eliminate the cause of an Vector Sampling Practices
environmental positive are not only effective, appropriate Root Cause Analysis and
and documented, but also shared with EM cross-functional Corrective Action
team and applied as appropriate.
Corrective Action Report
•P
 ositives are followed up with immediate retesting to prove
(Template 1)
consecutive negatives (minimum 3).
•S
 ource identification (vectoring) is thoroughly applied and Corrective Action Report
source is eliminated. (Template 2)

AFFIFoodSafety.org
18
 Environmental Monitoring cont.

The Recommendations The Resources

• EMP is designed to seek and destroy Lm. Designing an Environmental
• The EMP team conducts a robust risk assessment that will Monitoring Program
lead to the determination of the sampling locations, timing
and frequency of samplings.
• The assessment should include (at a minimum): plant
layout, equipment, processes, GMP implementation etc.
• Baseline swabbing is utilized as a tool in the risk evaluation
process.
• Data is accessible, analyzed and trended so that systemic Environmental Monitoring Data
or repeated issues are quickly identified and acted upon. Collection and Management
• Data is available to personnel in the EMP group and facility Overview of Environmental
management/leadership. Monitoring Data Trends
• Data trends, both positive and negative, resulting from
Environmental Monitoring Data
factors such as seasonality, special events, employee
Trends (Template)
vacation, etc. are identified and addressed by facility
leadership.
• Potential industry trends are shared with industry partners
through an appropriate platform.
• Records are readily accessible to corporate program
leadership.
• Employees performing EMP functions are properly trained Elements of a Multidisciplinary
in sampling techniques and site selection. Environmental Monitoring Team
• Training also includes troubleshooting and investigational
sampling (vectoring).
• Additionally, they are encouraged to research EMP
improvements and upgrades for implementation.
• All training is documented and knowledge verified.

• The outcome of the risk assessment is a program that Designing an Environmental

identifies quantities, locations, schedule and responsibilities. Monitoring Program
•E  MP is dynamic incorporating static, rotating and random Environmental Monitoring and
sites that account for risk factors such as raw/post lethality/ Sampling Plan
high hygiene area, facility/equipment age/condition, history,
product type, etc. per risk assessment.

AFFIFoodSafety.org
19
 Environmental Monitoring cont.

The Recommendations The Resources

• Sampling materials and test methods are selected based Selecting Microbial Test Methods
on scientific approaches. Swabbing Procedure
• Methods are documented, approved and scientifically
validated for intended use.
• A process with a detailed written plan is established for Environmental Monitoring and
special events that may require sampling, regardless of Sampling Plan
time or day. Equipment Acceptance Process
•S  pecial event examples may include new/recommissioned
equipment, construction events, processing changes, roof
leaks, etc. depending on the risk assessment and management.
• Where areas are positive (presumptive or confirmed), root Root Cause Analysis and
cause investigations, mitigation and/or corrective action Corrective Action
strategies are deployed. Corrective Action Report
• Possible mitigation strategies include rerouting traffic, (Template 1)
employment of GMPs, and/or sanitation.
Corrective Action Report
• In addition, employees are trained to spot the signs of
(Template 2)
potentially positive areas and take action while alerting
facility management. Implications of Positive Listeria
• Learnings from events are transferred across the company. Finding
Persistent and Transient Listeria
•P
 ositives are followed up with immediate retesting to prove Vector Sampling Practices
consecutive negatives (minimum 3).
Root Cause Analysis and
•S
 ource identification (vectoring) is applied and source is
Corrective Action
eliminated.
•L
 earnings are applied in operations as appropriate. Corrective Action Report
(Template 1)
Corrective Action Report
(Template 2)
• Risk assessment is a key driver for improvements to Hygienic Zoning in Frozen Food
infrastructure and equipment based on prioritization of Facilities
equipment and infrastructure condition and contamination Designing an Environmental
related to environmental findings. Monitoring Program
• There is strategic designation of resources to align with
Environmental Monitoring and
the findings.
Sampling Plan
Persistent and Transient Listeria

AFFIFoodSafety.org
20
 Environmental Monitoring cont.

The Recommendations The Resources

• Compositing is limited to 5 or less “like” samples and does Environmental Monitoring and
not occur in areas with a recent history of positives. Sampling Plan
• A separate sponge is used for each site. Swabbing Procedure
• Compositing methods are validated to ensure detectability. What is a Swabathon
• Compositing of greater than 5 samples may be done
Preparing for a FDA Swabathon
through a validated method.
FDA Draft Lm Guidance

• Zone 1 testing may be conducted based on the specific Environmental Monitoring and
circumstances of the product and process and where the Sampling Plan
data can support implementation of effective Lm control Implications of Positive Listeria
and monitoring programs. Findings
• Affected product, between validated clean-ups, is put on
Persistent and Transient Listeria
hold until results are available.
WGS and Implications to Frozen
Food Industry
• The EMP takes into account facility conditions. Selecting Microbial Test Methods
• Cold or wet areas are sampled for Listeria spp. Environmental Monitoring and
• In addition program leadership actively seeks the newest Sampling Plan
information about Lm risk conditions and detection so the What is a Swabathon
EMP is consistent with industry practices.

• EMP sites and quantities are selected based on zones, Selecting Microbial Test Methods
drain locations/quantities, equipment/plant layouts as it Environmental Monitoring and
relates to Lm risks. Sampling Plan
• Quantities are based on facility size, equipment amount, What is a Swabathon
layout and workflow.
• A site map is used to define post lethality/high hygiene and
zone 4 areas.

AFFIFoodSafety.org
21
 Environmental Monitoring cont.

The Recommendations The Resources

• EMP samples are collected at least weekly and include Selecting Microbial Test Methods
samples at eye level, below and above. Environmental Monitoring and
• Greater than 55 swabs are taken per 50,000 sq. ft. Sampling Plan
per week. (should be focused on risk assessments).
Swabbing Procedure
• As a facility ages, swabbing frequency and levels are
increased to reflect increased risks. What is a Swabathon
• Swabbing should focus on post lethality/high hygiene areas. Preparing for a FDA Swabathon
• Refer to FDA Lm Draft Guidance FDA Draft Lm Guidance

• If the food safety plan identifies Lm as a hazard that Considerations for Lab-Scale
requires a preventive control, then the facility should Blanching Validation Study
address this hazard by the application of a preventive Considerations for In-Plant
process control. Blanching Validation Study
• One potential method may include a thermal processing
step with a 5-log pathogen reduction capability. How to Validate a Blancher

• All blanchers and thermal processing equipment that are How to Validate a Blancher
used to facilitate the preventive process control step must
be validated
• The use of thermal processing equipment as a preventive How to Validate a Blancher
process control step should utilize verification systems.
• Temperatures are monitored and recorded at the beginning
of production, at least hourly, or at any time an adjustment
is made during thermal processing (batch and continuous).
• A recording chart should be used to continuously record
the (blancher) temperature with an alarm system for
immediate notification of deviations.
• The controls should automatically stop the continuous
system belt if the blancher/thermal processor is unable
to reach the minimum temperature.

• Thermometers are validated using a certified reference How to Validate a Blancher

thermometer at least quarterly.
• The certified thermometer is sent for calibration at least
annually.

AFFIFoodSafety.org
22
 Environmental Monitoring cont.

The Recommendations The Resources

• Areas where blanchers or thermal processers are located Hygienic Zoning in Frozen
or where other ‘log reduction’ processes are performed Food Facilities
are considered as raw/uncooked areas and should be fully
separated from post lethality/high hygiene areas.

• Post-processing or post-lethality areas should be Control of Listeria in Post

clean and in good sanitary condition so as to prevent Lethality Environments
post-processing contamination. Hygienic Zoning in Frozen Food
Facilities
• Daily testing of in-line product and processing water
samples is highly recommended
• Incorporate periodic finished product testing (indicator
microorganisms) as a component part of the food safety
verification program

• Establish appropriate time-temperature recommendations Considerations for Validated

using challenge studies for each specific product in Cooking Instructions for Frozen
different domestic cooking ovens and microwaves. NRTE Foods
Validating Cooking Instructions -
Procedure
Validating Cooking Instructions -
Template
Microwave Wattage Verification
- Template
• Develop validated cooking instructions. Apply clear and Considerations for Validated
easy to follow labeling language that is consistent across Cooking Instructions for
the industry. Frozen NRTE Food

AFFIFoodSafety.org
23
 Freezer Management
The Recommendations The Resources
• Internal and external expertise comprising cross-functional Control Listeria in Freezers
experts should be availed to build sound freezer management Freezer Management:
programs. Guidelines for Listeria Control
• Freezers should include and implement well-designed and Freezer Sanitation Procedure
managed automated CIP systems. Freezer Management:
Guidelines for Listeria Control
• Freezer management team should establish dedicated Freezer Sanitation Procedure
cleaning methods and cleaning products for freezers. Freezer Management:
Guidelines for Listeria Control
•V
 isual inspections to identify potential moisture saturation Environmental Monitoring
of insulation and targeted EMP activities. of Freezers
•C
 ommonly overlooked components include, lights,
conduits, hollow framework and floors and roof of freezers.
• Identify hotspots based on exposure of product in the Environmental Monitoring
freezer. of Freezers
•C
 leaning procedures should be validated, especially Freezer Sanitation Procedure
if product is exposed to the freezer. Freezer Management:
Guidelines for Listeria Control
• Cleaning frequency should be based on a risk Freezer Sanitation Procedure
assessment (product exposure to the freezer) Freezer Management:
Guidelines for Listeria Control

AFFIFoodSafety.org
24
 Process Validation

The Recommendations The Resources

Establish appropriate time-temperature recommendations Considerations for Validated Cooking
using challenge studies for each specific product in different Instructions for Frozen NRTE Foods
domestic cooking ovens and microwaves Validating Cooking Instructions –
Procedure
Validating Cooking Instructions –
Template
Microwave Wattage Verification –
Template
Post-processing or post-lethality areas should be clean and Control of Listeria in Post Lethality
in good sanitary condition so as to prevent post-processing Environments
contamination. Hygienic Zoning in Frozen Food
Facilities

Develop validated cooking instructions. Apply clear and Considerations for Validated Cooking
easy to follow labeling language that is consistent across Instructions for Frozen NRTE Foods
the industry.

Periodic finished product testing (indicator microorganisms) as FSIS

part of the verification program FDA
ICMSF Microbiological Sampling
Plans – Statistical Aspects
ICMSF
All blanchers and thermal processing equipment that are used How to Validate a Blancher
as the preventive process control step must be validated

The use of thermal processing equipment as a preventive How to Validate a Blancher

process control step should utilize verification systems.

Temperatures are monitored and recorded at the beginning

of production, at least hourly, or at any time an adjustment is
made during thermal processing (batch and continuous).

AFFIFoodSafety.org
25
 Process Validation cont.

The Recommendations The Resources

A recording chart should be used to continuously record the How to Validate a Blancher
(blancher) temperature with an alarm system for immediate
notification of deviations.

The controls should automatically stop the continuous system

belt if the blancher/thermal processor is unable to reach the
minimum temperature.

If the food safety plan identifies Lm as a hazard that requires a How to Validate a Blancher
preventive control, then the facility should address this hazard Considerations for Lab-Scale
by the application of a preventive process control. Blanching Validation Study
Considerations for In-Plant
One potential method may include a thermal processing step
Blanching Validation Study
with a 5-log pathogen reduction capability.

Areas where blanchers or thermal processers are located Hygienic Zoning in Frozen Food
or where other ‘log reduction’ processes are performed are Facilities
considered as raw/uncooked areas and should be fully
separated from post lethality/high hygiene areas.

Thermometers are validated using a certified reference How to Validate a Blancher

thermometer at least quarterly.

The certified thermometer is sent for calibration at least

annually.

Daily testing of in-line product and processing water FDA Food Safety Modernization
samples is highly recommended Act, Preventive Controls for Human
Food Regulation

AFFIFoodSafety.org
26