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Jorge Acosta, VP of Technical Services, Alchemy

The Keys to Building an Effective Environmental Monitoring Program

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Today’s Speaker

Jorge AcostaVP of Technical ServicesAlchemy

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Agenda

✓The Importance of an Environmental Monitoring Program (EMP)

✓Steps to a Successful EMP

✓How to Ensure Your Program Complies with Government and Industry Regulations

✓Testing & Training Protocols Necessary for Maintaining Your Program

✓Best Practices for Integrating an EMP into Your Safety Culture

✓Questions?

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The Importance of an EMP

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The Importance of an Environmental Monitoring Program (EMP)

➢A measurement of the effectiveness of your Sanitation Program, Sanitary Design, Personnel Practices and Plant Zoning

➢A proactive system that can give plant personnel key information to help direct resources to pro-actively mitigate pathogenic contamination

➢Helps to identify Hot-Spots and harborage areas of the plant

➢Validate in a period of time if the sanitation program has adequately reduced microbiological hazards

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The Importance of an Environmental Monitoring Program (EMP)

➢Helps to design effective sanitation controls within the facility

➢A tool to provide feedback and continuous improvement for sanitation

➢Provides regulatory compliance

➢Provides GFSI/Customer compliance

➢Reduces risk and legal exposure

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Steps to a Successful EMP

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Sanitation Control

• It is key to implement a world class sanitation program – first!

• Inhibit the entry of pathogens into the food facility

– Shoe control, sanitizer baths at entry, design of equipment facility without harborage points and cleanable

• Prevent the growth of harmful bacteria

– Clean and remove food frequently

– Remove standing water

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Sanitation Control

• Effective GMP and Personnel controls should be in place and enforced including handwashing

• Evaluate traffic patterns to prevent bacteria from moving from high risk to low risk areas of the plant

• Dust control in dry environments

• Effective and validated sanitation procedures

• CIP - For facilities that use CIP systems

– FDA recommends separate systems for raw and finished product systems

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Risk Assessment

• Risk-based EMPs should be in place for pathogens or spoilage organisms

– Risk Assessment

– Control limits defined

– Describe corrective actions for failure to meet control limits

– Review program annually, based on risk & based on failures

– Includes a review for consistently negative results

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Hygienic Zoning

• Infrastructure

• Personnel, materials and other traffic flow

• Cross-over areas

• Room air

• Compressed air, if used in direct product contact

• Adjacent and support areas

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Risk Assessment

• The EMP program should be specific to your facility

• The EMP program should evaluate the types of products produced, regulatory requirements, and known hazards

• Product flow and the threats to finished products in the plant should be evaluated

– Avoid raw products near or over finished products

– Raw products come in one end of the facility, are converted to finished products, and shipped out the other end

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EMP Compliance with Government & Industry Regulations

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Comply with Regulatory & Customer Requirements

• United States Department of Agriculture (USDA)

– Meet the requirements of 9 CFR part 430, the Listeria Rule

– Originally introduced in 2003

“RTE products are considered adulterated

if they contain Lm or come in direct contact

with a FCS that is contaminated with Lm”

- FSIS ComplianceGuide

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Comply with Regulatory & Customer Requirements

FDA - FSMA compliance is required based on 21 CFR part 117 “Current Good Manufacturing Practice, Hazard Analysis, and Risk

Based Preventive Controls for Human Food” for those who manufacture, process, pack, or hold ready-to-eat (RTE) foods.

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Comply with Regulatory & Customer Requirements

• FDA

– Environmental monitoring for an environmental pathogen or for an appropriate indicator organism, if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples

• Where ready-to-eat food can be contaminated post-lethality or before packaging an EMP program should be implemented

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Comply with Regulatory & Customer Requirements

• International requirements

– The Safe Food for Canadians Regulation (SFCR) “Make sure that the food you import was manufactured, prepared, stored, packaged and labelled under at least the same level of protection as that provided” by Canadian regulation

– SFCR has similar requirements for Sanitation and Preventive controls as FSMA has, including “Control measures for Listeria monocytogenes in ready-to-eat foods” SFCR

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Comply with Regulatory & Customer Requirements

• Global Food Safety Initiative programs (SQF, BRC, FSSC 22000)

– Each require a risk based EMP program

• Prevent Recalls

• Prevent Liability issues

– Brand Protection

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Testing & Training Protocols for Maintaining Your Program

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Testing

• Use Aseptic Sampling Methods

– Used to prevent contamination by your sampling method

• Test a few hours into production, not right after sanitation

• RA would determine number of samples and locations

– Zones 1-4

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Testing

• Proper testing with trained personnel will help to avoid False Positives and False Negatives

– False Positive – positive result that was obtained based on cross contamination from the testing personnel, and does not represent actual bacteria sampled from the target area

– False Negatives – negative result that was obtained based on poor sampling techniques, and may miss bacteria present (Example: testing immediately after a sanitizer was applied)

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Corrective Action Procedures

• Corrective actions must be taken immediately when positive pathogen indicator results are obtained

• Pre-defined corrective action written into your EMP plan will help you have a defined strategy when the positive occurs

• Root cause and root source

– Vector sampling

• If you receive a positive Listeria Spp. Test on a Food Contact Surface during production both FDA & USDA have issued guidance

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Training

• Employees conducting EMP testing need to have training

• GFSI programs such as SQF require proficiency testing

– Proficiency is a measure of the reliability of the testing methodology

• Training needs to be conducted initially before starting EMP testing and annually after that

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Training

• Training topics

– Collection of samples

– Techniques to avoid contamination of samples

– Guidelines for investigation

– Understanding of sampling sites and choosing from a site list

– Maintain integrity of samples

– Collection and interpretation of results

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Alchemy Drives Safety, Quality, & Productivity

Training• Train up to 150 employees at once

• Multilingual course libraries

• Easily customizable content

Reinforcement• App for on-the-floor observations

• Training-coordinated signage

• Supervisor guides for consistency

Compliance• Automated recordkeeping

• Paperless documentation

• Audit-ready reporting

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Training Solutions for Frontline Workers

• Small company focus (up to 100 employees)

• 77 courses courses on Food Safety, EHS, and HR (no customization available)

• Delivered via eLearning

• Basic LMS and reporting

• 200+ courses on Food Safety, EHS, HR, and more. All courses are customizable or can create your own.

• Multiple delivery options: group-based training (w/ clickers), eLearning, Kiosk mode.

• Robust LMS for documenting and reporting on training records, and building learning plans

• Reinforcement tools such as posters, digital signage, and supervisor huddle guides

• On-the-job coaching app for delivering and documenting employee observations

• Complete client services team – Training, Implementation, & Live Support

10% Discount

Code for CLFP Members

Alchemy’s Consulting Solutions

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✓ FSMA Compliance – Receive assistance ensuring FSMA compliance at your facility that include EMP requirements

✓ Food Defense Plan Development / Validation – Receive assistance to develop, document and validate your Food Defense Plan

✓ SQF, BRC and FSSC 22000 Consulting – Gap Analysis, Program Development, Internal Audits, Audit Support

✓ HACCP Plan / Food Safety Plan Reassessment – Receive a detailed review of your HACCP system to verify accuracy and effectiveness

✓ Food Safety Training – On-site Basic HACCP, Advanced HACCP, Preventive Control for Human Food, Preventive Control for Animal Food, Internal Auditor Training

100% Client Satisfaction

Rate

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Mitigate inherent food safety risks and ensure regulatory compliance with online training

Environmental Monitoring Program eLearning Course

Learn more at: https://academy.alchemysystems.com/environmental-monitoring-program/

Understand environmental

monitoring requirements for FSMA

Access anytime, anywhere –Learn at your own pace and

fit around your busy schedule

Interactive Content –Put knowledge into action

with reality-based exercises

World-Class Curriculum –Developed by Alchemy's expert instructors with

real-world EMP knowledge

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Best practices for Integrating an EMP into Your Safety Culture

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Sustainment & Improvement

• Annual evaluation and validation of the program should occur

• Internal and external audits can be performed to ensure the program is being implemented as intended

• Trending can indicate whether the overall program is considering sanitation, personnel and the EMP program are reducing the amounts of pathogenic organisms found in the plant – if not, change needs to happen

• Training needs to be completed annually

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Sustainment & Improvement

• Stay up to date on regulations, best sanitation practices, and industry standards

• Perform effectiveness checks on closed corrective action plans

• Request for help/assistance

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THANK YOU