A WELL-ROUNDED ENVIRONMENTAL MONITORING TEAM

Roles and responsibilities for environmental monitoring and support are defined. Environmental monitoring team leadership and support groups are aligned; cross-functional communication is routine and frequent.

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A WELL-ROUNDED HYGIENIC DESIGN TEAM

Members of the food safety/sanitation staff trained in equipment and infrastructure hygienic design are requested for input on hygienic design prior to the initiation of project start-up.

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A WELL-ROUNDED SANITATION TEAM

Roles and responsibilities for sanitation management and support are defined. Sanitation leadership and support groups are aligned; cross-functional communication is routine and frequent.

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ADJACENT PROCESSING LINE CLEANING

Adequate steps must be taken when cleaning equipment/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.

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APPLICATION OF AFFI’S FOOD SAFETY SYMBOL

Follow AFFI’s brand guidelines to apply the recommended “Cook for Safety” symbol.

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AUTOMATED CLEANING TECHNOLOGIES

Sanitation technologies are sufficient to effectively and efficiently clean equipment and the facility. Adequate systems (spray bars, COP, ACS, CIP) are provided to facilitate proper cleaning and sanitizing practices.

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BASICS OF CLEANING AND SANITATION

Employees receive GMP, sanitation and safety, HACCP, and other required training as well as job specific knowledge. Sanitors understand basics of food safety, sanitation and task requirements. Proficiencies are confirmed through testing or supervisory evaluation and qualification.

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BASICS OF CLEANING CHEMISTRY

Cleaning chemistry should be appropriate for soil, environment, water, surface, and method of application. Cleaning chemicals should be optimized and validated for effectiveness.

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BASICS OF MAINTAINING A DRY PRODUCTION ENVIRONMENT

If areas are dry, keep them dry during operation and sanitation. Sequenced dry cleaning processes (using necessary tools and methodology) are defined and stringently followed. Areas are monitored and maintained to ensure dry conditions in the environment. Zone barriers and operational and dry sanitation processes are maintained on a continuous basis and monitored appropriately

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BASICS OF SANITATION CHEMISTRY

Sanitizing chemistry should be appropriate for level of microbial lethality, method of application, type of microorganism and properties of the sanitizer. Sanitizers are optimized and validated for effectiveness.

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CHARACTERISTICS OF HYGIENIC FOOD CONTACT SURFACES

All food contact surfaces are seamless, with rounded corners and are constructed of materials that can be properly cleaned and sanitized. These materials should be non-toxic, nonabsorbent, corrosion resistant and highly resistant to cleaning and sanitizing chemicals

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CLEAN-IN-PLACE CLEANING AND SANITATION

CIP systems are designed to control TACT parameters. System(s) are adequately monitored and managed. Raw and post lethality/high hygiene systems are separate. CIP circuits are interlocked to ensure compliance with TACT parameters and support cleaning requirements in a timely manner to support production needs. Facility expertise is sufficient to diagnose and troubleshoot performance as necessary. Systems are verified and validated on a routine basis.

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CONTROLLED USE OF WATER

Water pressures are controlled so that atomization is 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.

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CONTROLLED USE OF WATER

High pressure water should not be used during production to avoid aerosoling and potentially cross-contaminating the production environment.

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CONTROLLING LM IN POST-LETHALITY AREAS

Post-processing or post-lethality areas should be clean and in good sanitary condition so as to prevent post-processing contamination.

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COOKING INSTRUCTIONS ON NRTE FROZEN FOOD PACKAGING

Establish appropriate time-temperature recommendations using challenge studies for each specific product in different domestic cooking ovens and microwaves

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CORRECTIVE ACTIONS

Positives are followed up with immediate retesting to prove consecutive negatives (minimum 3). Source identification (vectoring) is applied source is eliminated. Learnings are applied in operations as appropriate.

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DESIGN OF FLOORS AND WALLS

Floors are generally cleanable, non-porous and show no cracks. By design, floors are resistant to chemicals used. Floor/wall junctions are completely sealed. 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.

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DESIGN OF STORAGE AREAS

Floors are clean with minimal items stored as determined by immediate production needs and are staged for use. Guidelines are followed for storing items on the floor which belong there. Food containers, packaging and other sensitive items are off of the floor. Tables and cabinets are made of non-corrosive materials and stored 12 inches off of the floor.

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DESIGNATED FACILITY VEHICLES AND MOVEMENT

Transport vehicles and wheeled items are numbered, designated by zone, cleaned and sanitized on a routine 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.

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DEVELOPING AN ENVIRONMENTAL MONITORING SAMPLING PLAN

The outcome of the risk assessment is a program that identifies quantities, locations, schedule and responsibilities. EMP is dynamic incorporating static, rotating and random sites that account for risk factors such as raw/post lethality/high hygiene area, facility/equipment age/condition, history, product type, etc. per risk assessment.

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DEVELOPING VALIDATED COOKING INSTRUCTIONS

Develop validated cooking instructions. Apply clear and easy to follow labeling language that is consistent across the industry.

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DOCUMENTING EQUIPMENT AND FACILITY MODIFICATIONS

Equipment and infrastructure modifications that are conducted to improve hygienic design are documented and undergo a structured verification process to document confirmation of efficacy.

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DRAIN CLEANING

Water pressures are controlled so that atomization is minimized to prevent cross-contamination. High pressure hoses are not utilized during equipment or drain cleaning. Sanitation personnel are trained and monitored to control direction and quantity of rinsing and aligned with sequential cleaning process requirements.

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DRAINS ESSENTIALS

Drains are smooth, cleanable – no rust or pitting.

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ENSURING ROOF AND DRAIN SANITATION

Roof and drains are in good condition and good processes are established, readily available and deployed as necessary to address potential food safety risks arising from special circumstances.

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ENVIRONMENTAL MONITORING DATA COLLECTION AND MANAGEMENT

Data accessible, analyzed and trended so that systemic or repeated issues are quickly identified and acted upon. Data is available to personnel in the EMP group and facility management/leadership. Data trends, both positive and negative, resulting from factors such as seasonality, special events, employee 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.

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ENVIRONMENTAL MONITORING OF FOOD CONTACT SURFACES

EMP samples are collected at least weekly and include samples at eye level, below and above. Greater than 55 swabs are taken per 50,000 sq. ft. per week. (should be focused on risk assessments). As a facility ages, swabbing frequency and levels are increased to reflect increased risks. Swabbing should focus on post lethality/high hygiene areas. Refer to FDA Lm Draft Guidance

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ENVIRONMENTAL MONITORING OF FREEZERS

Visual inspections to identify potential moisture saturation of insulation and targeted EMP activities. Commonly overlooked components include, lights, conduits, hollow framework and floors and roof of freezers.

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EVALUATING HYGIENIC DESIGN OF EQUIPMENT

Team utilizes a hygienic design checklist for equipment and a hygienic design checklist for infrastructure in conjunction with other standards. Audit results are reviewed and acted upon by the facility team in an organized and documented manner.

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EVALUATING HYGIENIC DESIGN OF THE FACILITY

A review of facility infrastructure and equipment is conducted in conjunction with respective corporate staff or outside entity with expertise to identify existing poor hygienic design points and identify corresponding mitigation actions.

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EVALUATING NEW EQUIPMENT

New equipment design is reviewed by trained personnel for hygienic design compliance from concept to start to identify and mitigate areas of concern related to hygienic design.

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FACILITY ENVIRONMENT AND TEMPERATURE

Temperature control in critical storage areas is maintained and temperature recording devices or indicators are appropriately located and and accesible. Temperature control chart or other temperature collection 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.

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FACILITY ENVIRONMENT AND UTILITIES

HVAC systems are properly designed and adjusted to maintain positive pressure and humidity levels in areas where Cooked/RTE products are exposed. External air is filtered to an appropriate level based on the risk of contamination.

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FACILITY WATER SUPPLY

Water supply is routinely (minimum 6 months) tested for potability at point of use.

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FINISHED PRODUCT TESTING

Periodic finished product testing (indicator microorganisms) as part of the verification program

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FLOOR AND DRAIN CLEANING

Documented drain cleaning programs are available. Properly labeled, stored, and restricted supplies and PPE are used. Cleaning 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.

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FLOOR MAINTENANCE

A floor maintenance programs exists and is followed for floor inspection and maintenance. A process for creating work orders to repair or replace floors is in place and used.

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FOOD SAFETY CULTURE AND PERSONNEL BEHAVIOR

Employees are well trained, and behavior is re-enforced, i.e. behavior based training or surveillance cameras. Active controls are in place which make it difficult to violate a policy.

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FOOD SAFETY CULTURE FOR LM CONTROL

A culture of proper housekeeping and organization should be developed and these behaviors must be consistently applied. Routine monitoring throughout the facility and plant grounds, followed by necessary corrective actions are crit

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FOOTBATHS AND ENTRY AREAS

Foot and wheel hurdles should be established and maintained at entry points and between hygienic zones. 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.

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FREEZER CLEANING PROCEDURES

Freezer management team should establish dedicated cleaning methods and cleaning products for freezers

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FREEZER CLEANING SYSTEMS

Freezers should include and implement well-designed and managed automated CIP sytems

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FREEZER MANAGEMENT TEAM AND PROGRAM

Internal and external expertise comprising cross-functional experts should be availed to build sound freezer management programs

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FREEZER SANITATION FREQUENCY

Cleaning frequency should be based on a risk assessment (product exposure to the freezer).

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FREEZER SANITATION PROCEDURE

Cleaning procedures should be validated, especially if product is exposed to the freezer.

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FREQUENCY OF ENVIRONMENTAL MONITORING ACTIVITIES

EMP samples are collected at least weekly and include samples at eye level, below and above. Greater than 55 swabs are taken per 50,000 sq. ft. per week. (should be focused on risk assessments). As a facility ages, swabbing frequency and levels are increased to reflect increased risks. Swabbing should focus on post lethality/high hygiene areas. Refer to FDA Lm Draft Guidance

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GMP AUDITING

Internal audits are in place and performed at a regular frequency. Corrective actions are implemented & documented. Learnings are shared and effectively communicated across the company with all relevant personnel.

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GMP INSPECTIONS

Internal GMP inspections identify minor and potentially 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.

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HOW TO VALIDATE A PROCESS CONTROL

All blanchers and thermal processing equipment that are used as the preventive process control step must be validated

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HOW TO VALIDATE YOUR BLANCHER

The use of thermal processing equipment as a preventive 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.

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HYGIENIC CEILING DESIGN

Facility ceilings are solid, smooth, cleanable, accessible, and moisture resistant. Lighting is recessed. An ongoing inspection and repair program is present. A facility food safety hazard evaluation is ongoing with remedial actions identified and implemented.

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HYGIENIC CONVEYOR BELT DESIGN AND USE

Product conveyors are located a minimum of 18 inches off the floor and from the ceiling (for overhead conveyors). Conveyors are placed in easy to access areas to facilitate cleaning. Conveyor usage is minimized and if placement is strategic with considerations of proper cleaning and inspection.

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HYGIENIC DRAIN DESIGNS

Floor drains are circular and not directly under equipment or processes (or covered during production). Easily accessible and cleaned during each sanitation cycle or sanitized daily. 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.

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HYGIENIC EQUIPMENT DESIGN

All food contact equipment is designed prior to purchase and installed to be self-draining and not entrap water and soils, provide access for cleaning and inspection and are able to withstand the plant environment.

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HYGIENIC FACILITY DESIGN

Facility design defines hygienic zones and dedicated entry points with hurdles to sensitive processing areas. Proper mitigation steps are identified and implemented for all points of entry into processing areas.

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HYGIENIC FLOOR DESIGNS

Floors are sloped 1/4 inch / foot, smooth and self-draining, are dry. If floors are not perfectly self-draining, they are easily drained with squeegees. Wet areas are clean and may be wet with sanitizer, with no pooling.

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HYGIENIC USE OF WATER IN THE FACILITY

Water temperature and pressure meet requirements at peak usage times. Hoses, nozzles, and mix stations are functional and routinely monitored/maintained. Locations and hose length ensure accessibility to all process areas.

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IDENTIFYING HIGH RISK AREAS IN A FREEZER

Identify hotspots based on exposure of product in the freezer.

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INSPECTION OF DELIVERY VEHICLES

A vehicle inspection program is established. Prior to loading and unloading, all delivery vehicles are inspected to ensure they are clean and free from moisture. Internal inspection reports are easily accesible. Non-conformances and corrective action records are easily accesible.

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INSTALLATION OF EQUIPMENT

Floor/equipment junctions are mounted, grouted in place and are accessible for cleaning. Equipment legs are designed to minimize moisture entrapment (no hollow tubing). Other equipment has solid pin legs with a rounded tip to minimize moisture.

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INTRODUCTION TO ROUTINE CLEANING PROGRAMS

Sanitation programs are developed with cross-functional 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.

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LISTERIA RISK ASSESSMENT

EMP is designed to seek and destroy Lm. The EMP team conducts a robust risk assessment that will 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.

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LISTERIA TESTING METHODS

Sampling materials and test methods are selected based on scientific approaches. Methods are documented, approved and scientifically validated for intended use.

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LOADING AND UNLOADING OF DELIVERY VEHICLES

Vehicles used for distribution of chilled or frozen foods are loaded using sealed docks. Trailers, containers and rail cars maintain specified temperatures. Temperatures are recorded during transit and meet specifications.

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MAINTENANCE ACTIVITIES IN THE FACILITY

Maintenance inspections and work order systems are synchronized between the QA and operations teams. A mechanism for audits and feedback should be established to ensure building and equipment are adequately maintained so that they do not become harborage points for potential contamination.

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MAINTENANCE PERSONNEL AND TOOLS

Maintenance personnel comply with facility GMP programs, including PPE and doning requirements. Tools are cleaned and sanitized routinely; preferably dedicated to post lethality/high hygiene areas.

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MANAGING ENVIRONMENTAL MONITORING SAMPLING ACTIVITIES

A process with a detailed written plan is established for special events that may require sampling, regardless of time or day. Special event examples may include new/recommissioned equipment, construction events, processing changes, roof leaks, etc. depending on the risk assessment and management.

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MASTER SANITATION SCHEDULE

A comprehensive master sanitation program exists that references an SSOP for each task. Periodic equipment and infrastructure cleaning tasks are specified within the program. Master sanitation program is used to monitor schedule and resourcing, regularly measured for scheduled completion and evaluated for effectiveness.

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MATERIAL TRACEABLITY WITHIN THE FACILITY

Product, ingredients and work-in-process should be designated to zone-labeled and/or coded containers. Containers should be restricted to specified areas in accordance with plant policies Traceability should be maintained for ingredients, work in progress and product through delivery to the customer.

MOVEMENT OF PERSONNEL IN THE FACILITY

A dedicated transition area should be used to don appropriate clothing/gear and to wash hands prior to entering production areas. Signage is present to alert employees of areas with thier respective “care” designations.

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PERIODIC EQUIPMENT CLEANING

High risk equipment is disassembled, cleaned and assessed on a routine basis. Reviews are planned, documented and cross-functionally executed.

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PERSONAL PROTECTIVE EQUIPMENT

Color coding of protective workwear (clothing and footwear) 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.

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PERSONAL PROTECTIVE EQUIPMENT (PPE) REQUIREMENTS DURING SANITATION

Proper PPE is utilized and controlled to ensure employee safety and minimize potential cross-contamination.

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PERSONNEL BEHAVIORS

Employees, contractors, and visitors know facility GMPs and do not create a risk to product quality and safety. Workforce is empowered and exhibits excellent food safety behaviors.

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PERSONNEL CLOTHING AND FOOTWEAR

Company-approved clothing and footwear are used and they are clean and well maintained. A company-approved program for a captive clothing and footwear program is highly recommended.

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PERSONNEL TRAINING

Employees are trained annually on GMPs and receive frequent reinforcement. Employees know and follow the training materials. Contractors receive relevant training. Training records are maintained and training tools are continuously improved and reinforced to increase awareness. Training expectations are communicated and validated through observations and performance feedback.

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PLACEMENT OF EQUIPMENT IN FACILITIES

All food processing equipment is positioned away from adjacent walls or other obstructions at a minimum 3 feet to allow for cleaning and inspection.

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PLACEMENT OF HAND WASHING STATIONS

All hand wash sinks are hands free. Hand wash and sanitizer stations are located for ready and frequent use in Zone 2 and 3 areas. Hand drying methods are consistent with hygiene zones.

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PRE-OPERATIONAL INSPECTIONS

All food contact equipment is inspected for cleanliness prior to starting production. Inspections are documented with corrective actions taken 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.

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PREVENTING WATER RELATED RISKS IN THE FACILITY

Water backflow protection is verified and documented via a quarterly audit conducted by trained internal personnel. An annual audit for verification is conducted by an outside certified service.

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PREVENTIVE PROCESS CONTROL VALIDATION

If the food safety plan identifies Lm as a hazard that requires a preventive control, then the facility should address this hazard by the application of a preventive process control. One potential method may include a thermal processing step with a 5-log pathogen reduction capability.

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REPAIR AND MAINTENANCE OF EQUIPMENT AND FACILITY

Members of engineering, sanitation, food safety and a trained sanitarian are involved with all repairs for cooked/RTE zones with approval documented as a team for post lethality/high hygiene compliance to hygienic design requirements for cleaning and inspection.

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RISK ASSESSMENT AND ENVIRONMENTAL MONITORING PLAN

Risk assessment is a key driver for improvements to infrastructure and equipment based on prioritization of equipment and infrastructure condition and contamination related to environmental findings. There is strategic designation of resources to align with the findings.

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ROOT CAUSE ANALYSIS

Where areas are positive (presumptive or confirmed), root cause investigations, mitigation and/or corrective action strategies are deployed. Possible mitigation strategies include re-routing traffic, employment of GMPs, and/or sanitation. In addition, employees are trained to spot the signs of potentially positive areas and take action while alerting facility management. Learnings from events are transferred across the company.

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SANITATION AND CONSTRUCTION

Construction processes are evaluated prior to project inception. Personnel (internal and external) involved in construction activities are trained and monitored to comply with GMP requirements. Areas under construction are isolated. Dedicated foot traffic patterns are established. Increased swabbing for pathogens is carried out during and after construction and equipment installation processes.

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SANITATION DURING TEMPORARY OR EMERGENCY REPAIRS

Maintenance responsibilities governing sanitation support, communications and compliance to food safety practices are identified and followed. Maintenance employees are trained in tool accountability and sanitation. Food safety preventive maintenance tasks are executed, lubrication is controlled, red-tag processes are deployed as needed Temporary repairs are followed by permanent solutions. Frequent communication and planning between maintenance, sanitation, QA and operations is a cultural expectation.

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SANITATION METHODS AND SUPPLIES

COP tanks and automated cleaning systems are 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.

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SANITATION TOOLS AND SUPPLIES

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

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SANITATION TOOLS AND UTENSILS

Cleaning and production utensils should be coded and separated between zones. Separation is monitored and deviations addressed with proper corrective actions.

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SELECTING ENVIRONMENTAL MONITORING SITES IN THE FACILITY

EMP sites and quantities are selected based on zones, drain locations/quantities, equipment/plant layouts as it relates to Lm risks. Quantities are based on facility size, equipment amount, layout and workflow. A site map is used to define post lethality/high hygiene and zone 4 areas.

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SEPARATION OF RAW AND COOKED AREAS

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

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SEQUENTIAL CLEANING AND SANITATION STEPS

A sequential approach to sanitation is employed to facilitate effective and efficient cleaning of the facility (equipment and infrastructure). SSOPs are defined for each routine cleaning task. SSOPs are current, sequenced through defined (i.e. 7-step or 4×4) methodology and readily available. 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.

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SPECIAL CAUSE CLEANING

Procedures addressing special cause cleaning events such as roof leaks, drain overflow, zone breaches, and environmental positives are developed to mitigate and control potential food safety risks. All employees are trained and well-versed to execute these protocols as needed. Investigative cleaning processes arising from uncertain food safety risk situations.

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STORAGE AREAS IN THE FACILITY

There are separate storage rooms for packaging materials, raw/uncooked food materials, finished products, and waste materials.

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STORAGE OF MATERIALS IN THE FACILITY

All materials are stored off the floor on clean pallets at least 18 inches away from the wall to facilitate cleaning and pest control activities and to allow product ventilation.

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SWABATHONS AND TARGETED ENVIRONMENTAL MONITORING

The EMP takes into account facility conditions. Cold or wet areas are sampled for Listeria spp. In addition program leadership actively seeks the newest information about Lm risk conditions and detection so the EMP is consistent with industry practices.

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SWABBING AND SAMPLING ENVIRONMENTAL SURFACES

Compositing is limited to 5 or less “like” samples and does not occur in areas with a recent history of positives. A separate sponge is used for each site. Compositing methods are validated to ensure detectability. Compositing of greater than 5 samples may be done through a validated method.

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TEAM APPROACH TO IDENTIFYING DESIGN CONSTRAINTS

Company has a periodic maintenance and sanitation team that conducts routine equipment and infrastructure inspections to identify potential niche environments and harborage sources. Work orders are generated and executed to eliminate potential sources of Lm due to lack of access or difficulty of cleaning and inspection.

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TRAINING IN HYGIENIC DESIGN PRINCIPLES

Corporate support is available for assistance with hygienic design compliance and if not- available support is contracted externally. Facility employs a trained sanitarian with knowledge of hygienic design of equipment and infrastructure.

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TRAINING PERSONNEL ON ENVIRONMENTAL MONITORING FUNCTIONS

Employees performing EMP functions are properly trained in sampling techniques and site selection. 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.

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TRASH MANAGEMENT AND CROSS CONTAMINATION

Trash & inedible areas have established programs & defined routes and storage areas to prevent cross-contamination with hurdles to prevent cross contamination from a lower (raw) to higher (production) care area.

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USING KEY PERFORMANCE INDICATORS FOR MEASURING SANITATION EFFECTIVENESS

Sanitation related metrics (KPIs) detail effectiveness and efficiency of sanitation controls and are used to track gaps as well as continuous improvement efforts.

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UTILITIES TO PROMOTE HYGIENIC DESIGN

Positive and negative air pressure is created through the use of automated control systems to compensate for changes in the room air pressure. Direction of airflow from the post lethality/high hygiene areas to less sensitive areas.

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UTILIZING RED TAG PROCESS FOR REPAIRS

Food safety preventive maintenance tasks are executed and red-tag processes are deployed as needed. Temporary repairs are followed by implementation of permanent solutions.

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UTILIZING VERIFICATION TOOLS FOR PROCESS CONTROLS

Thermometers are validated using a certified reference thermometer at least quarterly. The certified thermometer is sent for calibration at least annually.

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VALIDATION OF CLEANING AND SANITATION PROCESSES

Sanitation is monitored to provide timely feedback. Sanitation is verified to ensure consistent processes. Sanitation is validated to ensure the process is capable of delivering the desired level of cleanliness.

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VALIDATION OF WATER SYSTEMS IN THE FACILITY

Daily testing of in-line product and processing water samples is highly recommended

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VECTOR SAMPLING METHODS

Corrective actions are taken to eliminate the cause of an environmental positive are not only effective, appropriate and documented, but also shared with EM cross-funcational team and applied as appropriate. Positives are followed up with immediate retesting to prove consecutive negatives (minimum 3). Source identification (vectoring) is thoroughly applied and source is eliminated.

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WASTE MANAGEMENT

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.

ZONING AND ENVIRONMENTAL MONITORING PLANS

Environmental monitoring program (EMP) actively detects Listeria spp. in the plant environment and aggressively focuses on Zones 1. 2, 3 & 4, enables early detection & elimination, and sites are reviewed frequently. The monitoring plan should be based on historical data, experience and science.

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ZONING AND RISK ASSESSMENT

Site zoning (1-4) and hygienic zoning are defined based on risk assessment

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ZONING AND TRAFFIC PATTERNS

Cross traffic (raw/uncooked to cooked/post lethality) is controlled with effective procedures. Traffic barriers such as walls, rails, fences, vestibules, walkways, are used as active control measures. Traffic plans and zoning maps illustrate area by level of care i.e. high hygiene, post lethality, raw.

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