Environmental Monitoring
Environmental Monitoring
Environmental monitoring is a critical component of a successful Listeria control program in any frozen food facility. This section provides valuable ways to recognize and address positive Listeria findings, implement corrective actions, conduct root cause analysis, and interpret data and trends.
Environmental Monitoring Recommendations
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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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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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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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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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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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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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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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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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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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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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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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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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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