fsma training: environmental monitoring...environmental monitoring the program should be designed...
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Environmental Monitoring
FSMA TRAINING: ENVIRONMENTAL MONITORING
Environmental Monitoring
Theo Morille-Hinds – Kellogg’s
Listeria Monitoring: Frozen Food Industry
Environmental Monitoring
Our Vision To enrich and delight the world through
foods and brands that matter
Environmental Monitoring Frozen Food Industry Best Practices
• Ingredients & Packaging • Processes • Environment
IDENTIFY • Hazard Analysis
• Science Based Justification UNDERSTAND • Cause & Justification
• HACCP CCP • HACCP Control Point • Pre-requisite PCs
PREVENT • Identify PCs
• Observe & Test • Identify Triggers • ID when limits exceeded
MONITOR • Adherence to PCs
• Mitigate Issue • Correct Process & Root Cause • Prevent Re-occurrence
ADJUST • Corrective Actions
VERIFY • Compliance & Effectiveness Pathogen Environmental Monitoring
Management Commitment
Employee Engagement
Regulation
Science-based Standards
Documentation
Sustainability
HACCP Program
Essentials Preventive Control (PC) Cycle
Chemical Control
GMPs
Facility / Equipment
Allergen Control
Sanitation
Pest Control
Utilities / Waste
Product Protection
Supplier Mgmt.
Trace and Recall
Production Control
Storage & Dist.
Training
Food Defense
Documentation
Building food safety into every Kellogg product, every day!
Foundational Pre-requisite Programs
Environmental Monitoring Golden Six
Environmental Monitoring
The program should be designed to: 1. Verify the effectiveness of your preventive control programs. Preventive
control programs include but not limited to: Sanitation Facility hygienic zoning Personnel practices GMP
2. Find, eliminate and prevent growth niches (seek-and-destroy)
A proactive approach to aggressively identify opportunities for continuous improvement
Finding a positive in this case should be rewarded
Listeria Environmental Monitoring Program (LEMP)
Environmental Monitoring
Risk based & flexible Cross functional team Target organism(s) Site map & zone selection
Testing frequency & criteria
for site rotation.
Root cause analysis and corrective actions
Data analysis & trending.
Reporting and escalation process
Training Documentation & Record
Keeping. Verification and Validation
LEMP Program design – Things to consider:
Environmental Monitoring
STAGE 1 STAGE 2 STAGE 3 STAGE 4 STAGE 5 Environmental Pathogen Sampling Plan
Swab Sampling Frequency Daily Weekly 2x per Month Monthly Determined by risk
assessment Zones Impacted Z2-4
Type of test Listeria spp. or Salmonella (OR Both) Total Swab Quantity 1 of 4 data sets from the master plan
Rotation of Swabs For each scheduled sampling event, rotate through each of the 4 sub-sets derived from the master plan until all sub-sets are sampled.
Ability to escalate or de-escalate based on risk (routine, adverse event, construction) Listeria spp. vs L. monocytogenes
Listeria spp. are a broad indicator of conditions favorable for growth of L. monocytogenes.
Table 1 – Sample stage approach
LEMP Program Design: Risk Base & Flexible
Environmental Monitoring
Zone 4 Remote areas from the RTE
manufacturing areas. Example: loading dock,
receiving area.
Zone 3 Other surfaces within the
RTE room. Example: floors, walls,
drains.
Zone 2 Surfaces adjacent to
Zone 1 areas Examples: equipment guards
and frames
Zone 1
Direct and in-direct food contact surfaces with high
potential impact food. Example conveyor belts. inside covers of conveyor
belts over open food.
LEMP Zones
Environmental Monitoring Starburst Sampling Pattern
for Vectoring
Original Positive
site
Environmental Monitoring Conclusion
LEMP should be a component of your food safety plan.
The program must be flexible and risk based. Include a robust training program Finding a positive during “seek & destroy” should be
rewarded. An effectively designed and implemented program
will significantly reduce the risk of contamination to the RTE food.
Follow the data.
Environmental Monitoring
APPENDIX
Environmental Monitoring Root Cause Analysis &
Corrective Action
Root cause analysis and corrective actions should be conducted any time Listeria spp. or L. monocytogenes positive is identified in the processing facility.
Review of cleaning records Review of environmental data of the
area as well as adjacent areas Review of line records, for mechanical
down time or unusual activity Interview employees Inspection of the area and the
equipment for potential harborage points
Vectoring; monitor traffic pattern
Typical RCA includes but not limited to:
Increase swabbing frequency Increase number of sites Evaluate the need for finished food testing
if positive is Z1 Reinforce hygienic practices and retrain
employees, if necessary Make any appropriate repairs. For example,
repair damaged walls, drains and floors Adjust LEMP as needed
Typical CA includes but not limited to:
Environmental Monitoring Documentation
All facilities where food is subjected to post-process contamination
should consider an LEMP. Document all LEMP monitoring activities. These could include the date,
time, zone, line, and sampling location (may include condition of location).
Documentation should be reviewed and maintained as per company policy.
Document corrective action activities and outcomes. Document all test results and corrective actions to close out the
incident. The documentation demonstrates due diligence and can also serve as a
reference should a similar incident surface. Document updates and changes to the LEMP.
.