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Environmental Monitoring Program - RISK ASSESSMENT - SAMPLE

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100% found this document useful (1 vote)
455 views3 pages

Environmental Monitoring Program - RISK ASSESSMENT - SAMPLE

Uploaded by

Serge Kouassi
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
  • Risk Assessment
  • Suitable Monitoring Techniques

XXXXXXXXXX Rev.

December 20, 2022

ENVIRONMENTAL MONITORING PROGRAM

RISK ASSESSMENT
Risk assessment has been conducted to build the environmental monitoring program (EMP)
that meets the specific needs of XXXXXXX:
a) Relevant microbiological hazards has been defined
 Potential microorganisms of concern for water are Total Coliform & E. Coli as
bacterial indicators that are used to verify the quality of the drinking water (Health
Canada, Overview of the Microbiological Aspects of Drinking Water Quality,
March 20, 2021). With regards to other potential hazards (e.g., microbiological,
general chemical & physical, inorganic, etc.), XXXXXXX relies on the
government testing reports (Drinking Water Analysis Summary and Drinking
Water System Annual Report, city of Toronto)
 Potential microorganisms of concern for air are Yeast & Mold as spoilage
organisms commonly used to verify air quality in food product facilities (Diversity
and Control of Spoilage Fungi in Dairy Products, Science et Technologie du Lait,
France, July 2017; Occurrence and Growth of Yeasts in Yogurts, University of
New South Wales, Australia, July 1981; Quality of Yogurt, Journal of Dairy
Science Vol. 59, No. 2; Codex Alimentarius; Microbiological Air Quality in
Processing Areas in a Dairy Plant, Brazilian Journal of Microbiology, 2003)
 Potential microorganisms of concern for surfaces is Listeria m. as pathogen
commonly found in wet environments and drains (Listeria Policy, Health Canada,
2011; FSSC 22000 Guidance Document: Environmental Monitoring, 2022;
Control measures for Listeria monocytogenes in ready-to-eat foods, Preventive
Controls, CFIA, February 2022). Also, in this category is included E. Coli as an
indicator organism associated with areas where fecal contamination may occur,
such as personnel hands (FSSC 22000 Guidance Document: Environmental
Monitoring, 2022; E. coli and Foodborne Illness, US Food & Drug Administration,
2020)
b) Zones of risk related to the different hazards have been defined. A recommended
method to organize the EMP is the zoning concept, where the facility is divided into
several zones (FSSC 22000 Guidance Document: Environmental Monitoring, 2022;
Control measures for Listeria monocytogenes in ready-to-eat foods, Preventive Controls,
CFIA, February 2022). This allows adapting a sampling and testing strategy to each
zone individually. Zones can be defined according to specific criteria, such as the level of
risk contamination, processing steps or the nature of the food. So, for XXXXXXX
the Zoning has been established as Zone 1 (food contact surfaces (FCS), locations
where the risk is higher because the surfaces are in contact with the product) and

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XXXXXXXXXX Rev. December 20, 2022

Zone 2 (non-food contact surfaces (NON-FSC), locations near food and food contact
surfaces and remote non-food contact surfaces, such as forklift, stairs handrails, etc.)
Sampling points are outlined in XXXXXXX Listeria & Other Pathogen Control Program,
2022
c) Suitable monitoring techniques have been defined:
 Sample types, such as swabs, water samples, and air plates. Additionally, ATP
swabs are used for the verification of cleaning. XXXXXXXLtd. carries out regular
environmental sampling to verify the effectiveness of its sanitation program for
detecting Listeria in the plant environment. Also, the regular ATP swabbing is
performed as a verification of Listeria swabbing. The purpose of the
environmental swabbing is to assess the effectiveness of sanitation and other
GMPs in XXXXXXXLtd. facilities and reduce or eliminate a risk of product
microbiological contamination. In addition, by detecting and responsibly
responding to each positive result, consumer risk can be minimized.
Environmental swabbing includes routine sampling of FCSs, defined as Zone 1,
that come into contact with exposed XXXXXXXLtd. products before final
packaging, and non-FCSs, defined as Zone 2. Routine sampling is conducted in
accordance with a Compendium of Analytical Methods, MFLP-41 (Health
Canada)
 Sampling tools such as Sanicult swabs, ATP swabs, PDA air plates, etc.
 Sampling techniques as per the government guidance (Appendix B – Collection
and Transportation of Samples: Applicable to All Methods in the Compendium of
Analytical Methods, Government of Canada, 2006; Environmental Sampling for
the Detection of Microorganisms, MFLP-41, Government of Canada, 2010; Air
Quality Monitoring Method – Settle Plates, SOP 3.3, Gelda Scientific, 2001)
 Sample sites based on the zoning concept as per company and process
specifics, customer and regulatory requirements, etc. (FSSC 22000 Guidance
Document: Environmental Monitoring, 2022; Control measures for Listeria
monocytogenes in ready-to-eat foods, Preventive Controls, CFIA, February
2022)
 Test methods: laboratory based (except for in-house ATP swabbing),
government-approved and compliant to regulatory requirements (The
Compendium of Analytical Methods, Health Canada)
d) Appropriate monitoring frequencies for routine sampling has been defined. Due to the
fact that XXXXXXX typically produces Category 1 RTE food products (Listeria Policy,
Health Canada, 2011), the frequency of sampling is determined based on risk and
inclusive of trends from the previous period. In some situations, products in various

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XXXXXXXXXX Rev. December 20, 2022

stages of processing are used as additional samples to further assess the presence of
Listeria and other pathogens
e) Appropriate methods for sample collection, storage and transportation are defined to
ensure the integrity of the sample is maintained prior to analysis (Appendix B –
Collection and Transportation of Samples: Applicable to All Methods in the Compendium
of Analytical Methods, Government of Canada, 2006)
f) Action limits, corrective actions and responsibilities have been defined should any out-of-
specification results be detected (outlined in Section 6, Responsibilities, Section 8,
Tolerances, and Section 10, Corrective Actions in Case of Deviations, of Elite Diary
Listeria & Other Pathogen Control Program, 2022)
g) Verification system for EMP has been defined to comply with ISO 22000, paragraph 8.8
to review the program in case of:
 Changes related to products, processes, or legislation, where relevant
 Any testing failures related to XXXXXXX products within the scope of the EMP
 Any pathogen detection during routine environmental monitoring
 There are alerts, recalls, or withdrawals relating to products produced by Elite
Dairy
h) Trending of the results, obtained from EMP, has been implemented followed by
necessary actions to address the results of the trends identified. Trend Analysis results
are included into Annual Key Performance Indicator Analysis as per FSSC 22000
requirements
i) EMP review has been defined to be at least annually, or more frequently in case of any
deviations occurred

Page 3 of 3

Common questions

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In a dairy processing environment, sampling and testing strategies include using various sample types like swabs, water samples, and air plates, supplemented with ATP swabs to verify cleaning effectiveness. Routine environmental sampling focuses on Zones 1 and 2, targeting food contact and non-food contact surfaces, respectively. Testing methods are lab-based and compliant with government regulations, ensuring reliable detection of pathogens like Listeria. Regular ATP swabbing serves as an in-house verification tool to verify Listeria swabbing results .

The effectiveness of an environmental monitoring program is verified through compliance with ISO 22000 standards, which involve program reviews in response to product, process, or legislation changes, testing failures, or pathogen detections. Programs are also evaluated against alerts, recalls, or withdrawals related to the products. Regular verification and trending analyses ensure continuous improvement and compliance with international safety standards .

Potential microbiological hazards in an environmental monitoring program are categorized based on the medium of concern: for water, Total Coliform and E. coli are bacterial indicators used to verify drinking water quality; for air, Yeast and Mold are used as spoilage organisms to verify air quality, especially in food product facilities; and for surfaces, Listeria monocytogenes and E. coli are of concern. Listeria is a common pathogen in wet environments, while E. coli indicates possible fecal contamination, particularly on personnel hands .

Environmental monitoring programs are adapted to comply with regulatory and customer requirements by implementing sampling techniques and strategies that align with government guidance, such as those in the Compendium of Analytical Methods. Programs are adjusted according to specific company processes, regulatory standards, and customer expectations, ensuring consistent quality and safety of food products .

Defining monitoring frequencies is crucial for RTE food products because it determines the regularity and intensity of sampling based on risk assessments and past data trends. These frequencies help in effectively detecting pathogens like Listeria, ensuring product safety. They are tailored based on the risk level and categories of food products, allowing for timely adjustments to any detected deviations .

Trend analysis in environmental monitoring programs is used to identify patterns and recurring issues from collected data. By incorporating these insights into annual Key Performance Indicator Analysis, facilities can proactively address potential hazards, adapt their controls and practices to emerging trends, and consistently enhance food safety. This process aligns with FSSC 22000 requirements, ensuring the ongoing effectiveness and reliability of the monitoring program .

Key components of a verification system for an environmental monitoring program include regular review cycles, adaptation to changes in products or legislation, analysis of test failures, and responsiveness to pathogen detections. These components ensure that the program remains effective and compliant with ISO 22000 standards, thereby enhancing its reliability and ability to detect and mitigate contamination risks consistently .

Corrective actions in environmental monitoring programs are structured with defined action limits and assigned responsibilities for rectifying any out-of-specification results. These structures include detailed procedures for addressing deviations, outlined in specific sections of the EMP documentation such as responsibilities, tolerances, and corrective actions. This approach ensures prompt and effective responses to prevent potential hazards from impacting product safety .

Governmental guidance provides standardized methods for sample collection, storage, and transportation, ensuring sample integrity prior to analysis. It dictates the testing frequencies and methods, requiring compliance with approved protocols like those in the Compendium of Analytical Methods. This guidance helps facilities maintain consistent and effective monitoring practices, reducing the risk of contamination and ensuring public health safety .

The zoning concept enhances the effectiveness of an environmental monitoring program by organizing the facility into distinct zones based on risk and processing steps. Zone 1 includes food contact surfaces where the contamination risk is higher, while Zone 2 includes non-food contact surfaces. This approach allows for tailored sampling and testing strategies for each zone, enhancing the program's precision in detecting potential hazards .

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