Importance of PEM• Preventing recalls • Long term program improvements• Verification of cleaning and sanitizing program• Verification of hygienic/transition areas• Required written records under FSMA
Presenter
Presentation Notes
Recalls are expensive and the risk of recalls due to food safety and quality issues has increased significantly Drive long term improvements in food safety and quality programs including GMPs, cleaning and sanitation and sanitary equipment and plant design Verifies the effectiveness of sanitation programs Verifies that hygienic zoning is working to: Protect product from cross-contamination or recontamination Prevent microbial harborage Understand “normal” environmental conditions vs. something has changed or something unusual is going on Federal regulations require establishing and maintaining written programs as part of their food safety plan. The FDA has instituted a zero-tolerance policy regarding the presence of Listeria in any ready-to-eat food.
Pathogen Control Principles
Separate Raw from
RTE
GMPs and Controlled Conditions
Sanitary Facility and Equipment
Design
Effective Cleaning & Sanitizing
Procedures/Controls
PEMEffective Pathogen Control
Separate Raw from Ready To Eat (RTE)
Presenter
Presentation Notes
Utilize hygienic zoning to control cross-contamination Control employee, equipment, and product flow including packaging, pallets, and forklifts Adopt use of footbaths and foamers in transition areas, replace shoe covers Prevent post-pasteurization contamination from contaminated equipment and inclusions
GMPs and Controlled Conditions
Presenter
Presentation Notes
Enforce appropriate hand washing procedures including the proper care and maintenance of gloves Require clean uniforms and specific cleanable footwear Implement documented procedure for the cleaning and sanitizing of tools and equipment Infrastructure such as floors, walls, and ceilings must be clean, in good repair, and as dry as possible Potential harborage sites should be maintained—floor grout, pipes (condensate), floor/wall junctions Minimize the growth of pathogens by reducing moisture and available nutrients Control temperature and humidity for raw materials, in-process products, and finished products Institute a documented employee training program
Sanitary Facility and Equipment Design
Presenter
Presentation Notes
Proper design and maintenance of facility and the equipment therein minimizes risk of harborage points for pathogens. Facility and equipment upgrades are necessary to meet sanitation standards Problem areas include (but are limited to) drains, damaged floors, chains and cords, junction boxes and motors, conveyors, rollers, hollow framework, threaded components, pallet jacks and forklifts. Refer to Control of Listeria Monocytogenes: Guidance for the U.S. Dairy Industry pages 17-26 for specific guidelines.
Effective Cleaning & Sanitizing Procedures and Controls
Presenter
Presentation Notes
Routine and non-routine cleaning regimens must be implemented to remove bacteria and reduce persistent growth opportunities Routine cleaning is the cleaning and sanitizing that is performed at a scheduled time within the production cycle. It includes processing equipment, hand-help tools, tubs, mats, carts, transfer hoses, etc. Non-routine (periodic) cleaning is managed by the Master Sanitation Schedule. It includes walls, drains, ceilings, floors, etc. Refer to Control of Listeria Monocytogenes: Guidance for the U.S. Dairy Industry pages 30-31 for examples. Cleaning methods include Manual Cleaning and Sanitizing, Clean-In-Place (CIP), Clean-Out-of-Place (COP) Sanitizing must be carried out on cleaned equipment. Monitoring, corrective actions, and documentation are vital for the verification of the effectiveness of a cleaning and sanitizing program
Pathogen Environmental Monitoring
Presenter
Presentation Notes
Effective pathogen monitoring plans should include the following: Facility-specific risk assessment Monitoring plan that includes target organisms, sampling frequency, number of samples, location and frequency, and sampling and testing methods Evaluation of results, corrective actions Conduct a Root Cause Analysis Documentation and follow-up
Root Cause Analysis:Eliminating Repeat Problems
Potential causes
Information gathering
What do I already know?
Define problem
Presenter
Presentation Notes
Define the problem or describe the event factually. Include the qualitative and quantitative attributes of the harmful outcomes. This usually includes specifying the natures, the magnitudes, the locations, and the timing of events. Gather data and evidence, classifying it along a timeline of events to the final failure or crisis. For every behavior, condition, action, and inaction specify in the "timeline" what should have been done if it differs from what was done. Ask "why" and identify the causes associated with each step in the sequence towards the defined problem or event. "Why" is taken to mean "What were the factors that directly resulted in the effect?" Classify causes into causal factors that relate to an event in the sequence and root causes, that if eliminated, can be agreed to have interrupted that step of the sequence chain. Identify all other harmful factors that have equal or better claim to be called "root causes." If there are multiple root causes, which is often the case, reveal those clearly for later optimum selection. Identify corrective action(s) that will with certainty prevent recurrence of each harmful effect, including outcomes and factors. Check that each corrective action would, if pre-implemented before the event, have reduced or prevented specific harmful effects. Identify solutions that, when effective, and with consensus agreement of the group, prevent recurrence with reasonable certainty , are within the institution's control, meet its goals and objectives and do not cause or introduce other new, unforeseen problems. Implement the recommended root cause correction(s). Ensure effectiveness by observing the implemented recommendation solutions. Identify other methodologies for problem solving and problem avoidance that may be useful. Identify and address the other instances of each harmful outcome and harmful factor
RCA MethodsThe 5 Whys• Keep asking ‘why’
until the root cause is identified
RCA MethodsFishbone Diagram• Used identify possible
causes for a problem• Can induce a different
type of thinking
Myth Busting is CriticalUse data and logic to focus resources
Common misconceptions about root cause• “The organism is airborne”• “Raw meat is (20-40% Lm +) highly contaminated
with the organism”• “It cannot be removed from the processing
environment”• “Drains will always be positive”• Listeria species on contact surfaces means product
is positive for Listeria monocytogenes.
RCA-based Corrective Action
• Identify corrective actionto prevent reoccurrence– If implemented earlier,
would it have prevented the event?
• Implement solution
Presenter
Presentation Notes
Identify corrective action(s) that will with certainty prevent recurrence of each harmful effect, including outcomes and factors. Check that each corrective action would, if pre-implemented before the event, have reduced or prevented specific harmful effects. Identify solutions that, when effective, and with consensus agreement of the group, prevent recurrence with reasonable certainty , are within the institution's control, meet its goals and objectives and do not cause or introduce other new, unforeseen problems. Implement the recommended root cause correction(s). Ensure effectiveness by observing the implemented recommendation solutions. Identify other methodologies for problem solving and problem avoidance that may be useful. Identify and address the other instances of each harmful outcome and harmful factor
Developing a Sampling Plan• Site and product specific
– Wet or dry environment based on product
• Incorporate typical, rotating, and random sites
Pathogens of ConcernPathogens typically monitored in PEM programs• Listeria monocytogenes• Salmonella• Cronobacter spp.
– Typically in infant formula plants – Occasionally monitored in other powdered product
facilities
Presenter
Presentation Notes
Cronobacter: Causes an extremely rare disease in infants Has been linked to consumption of contaminated powdered infant formula (contaminated at processing or at home during or after preparation) Control includes environmental sampling in processing plants (Enterobacteriaceae or specifically Enterobacter sakazakii)
Index and Indicator Organisms• Index organisms: markers whose presence relates to the
possible occurrence of ecologically similar pathogens (e.g., Listeria spp.)
• Indicator organisms: markers whose presence relates to the general microbiological condition of the food or environment (i.e., hygienic quality) (e.g., coliforms, Enterobacteriaceae, SPC) – Negative tests for indicators do not indicate absence of
pathogens
• Long-term trending and analysis needed for pathogens, index, and indicator organisms
Listeria monocytogenes
Presenter
Presentation Notes
Infection causes severe illness in susceptible people – mortality 15-30% Primary sources: Occurs widely in agriculture Transmitted by: Refrigerated RTE foods that support growth Contributing factors: Environmental pathogen spread by environmental contamination, equipment, people, incoming raw ingredients Typically about 3 to 5 cases/million population Approx. 1,300 human cases/year and 255 deaths/year in the US Human listeriosis can occur as epidemic and sporadic cases Causes septicemia, abortion and encephalitis in humans and more than 40 animal species Potentially long incubation period (7-60 days) Affects predominantly elderly and immunocompromised people, pregnant women and newborns High infectious dose: at 1 x 1010 cfu/serving, the dose-response model predicts a median death rate of 1 in 667 servings for pregnancy associated/neonatal listeriosis Grows at refrigeration temperatures and is fairly resistant to may stress conditions (salt) Killed by standard pasteurization type heat treatments Common in certain/many environments
Salmonella
Presenter
Presentation Notes
Salmonellosis is one of the most common foodborne diseases Estimated 1 million cases and 375 death annually the US Environmental contamination sources in processing plants increasingly recognized as a problem, particularly dry environments (for example cereal, bakery products) Infection causes nausea, vomiting, diarrhea, fever, headache Primary sources: Intestinal tract of people and animals Transmitted by meat, poultry, eggs, raw milk, unpasteurized juice, many other foods (nuts, spices, produce, chocolate, flour) Contributing factors: cross-contamination, undercooked food, poor agricultural practices
Testing LocationsZone Sampling Site Examples Microbiological
4 Areas outside processing Hallways, loading docks,
warehouses, locker rooms, cooler/freezers,
Pathogens Monthly 5-10
Ideal Indicator Sites• Locations close to the growth niche that can
identify an active growth niche• Locations that can identify suspect organisms
before they become attached to or imbedded within the equipment.
• Z4 to Z3 Transfer areas• Sanitary Facility Design issues
Presenter
Presentation Notes
Our challenge in sampling is to define those areas that will predict or identify a situation before it becomes a problem. Indicator sites can serve two roles.
Testing Considerations• Prioritize sampling sites
– After kill step (pasteurization)– Before final packaging
• Focus attention on zones 2 & 3.• Sites with historic positive results• Reference plant layout, traffic patterns and
hygienic zone areas to help determine additional sites
Hygienic Zoning Areas
How do these relate to sampling zones?
Adapted from Food Safety Preventive Controls Alliance
Zone 4 Zone 4
Zones 3 & 4
Zones 1 & 2
Zones 1 & 2
Presenter
Presentation Notes
Does the product formulation have an intrinsic property that would kill the environmental pathogen of concern (e.g., a high acid level)? Is the product or ingredient associated with pathogen contamination? Does the product receive a validated process control designed to kill environmental pathogens? Is the product exposed to the environment after the kill step and before packaging? Are ready-to-eat ingredients used to produce a ready-to-eat product? Does a refrigerated ready-to-eat product support the growth of Listeria monocytogenes?
Example Hygienic Zoning Areas
Hall
Shi
ppin
g &
Rec
eivi
ngM
ain-
tena
nce
Mec
ha-
nica
l
Offices
Lab
Non-manufacturing, Transition, Basic GMP, Primary pathogen control area –CONTROLLED ACCESS
Ent
ry a
rea
Men
’s R
oom
Wom
en’s
Roo
m
Hall
Refr. Ingr. Storage
Ambient Ingr. Storage
Packaging Storage
Frozen Storage
Cook Area
Assemble, Wrap AreaC
arto
n A
ssem
bly
Fill,
labe
l
Met
al
Det
ect
Spiral Freeze
Mix Room
Utensil and Small Equipment Cleaning
Room
Hal
lH
all
Hal
l
Adapted from Food Safety Preventive Controls Alliance
Traffic Flow: Product, Equipment, and Personnel
Timing• Pre-operational
• During Production (recommended)
• Post-rinse
Presenter
Presentation Notes
Pre-operational Less likely to yield positive samples More easy to interpret, will identify sanitation weaknesses During Production (recommended) At least 4 hours into production cycle. Harborage sites may become more easily detectable due to vibration and moisture conditions during production
Frequency
• Daily– As a corrective action for a specified amount of
time
• Weekly– Zones 2 and 3
• Monthly– Zone 4
Presenter
Presentation Notes
Can range from daily to weekly or monthly Sites are typically pre-determined, but may be randomly rotated so that not all sites are sampled every times For example, only 15 of 30 predetermined sites may be sampled every time Sampling frequency and sample numbers should be determined through a risk-based approach
Number of Samples: Considerations
• Based on facility size• Aging facilities=increased risk=increased sampling• Geography of facility
– Proximity to hazards
• Budget• Manpower
Presenter
Presentation Notes
Traditionally based on facility size. Accepted guidelines include 1 sample/1000 sq. ft./week. Condition of facility - Age and upkeep (floors, walls, ceilings) Geography of building – are there hazards? (near water source, air quality) Budget considerations for lab testing and employee allocation Goal is to have the correct balance between the number of samples and the effectiveness of your plan. Minimum: PEM samples are collected at least weekly and include samples at eye level, below and above. A minimum of 30 sponges are taken per 50,000 sq. ft. (5,000 m2) per week: Raw:7, RTE/HH: 20, Zone 4: 3 Best of class: PEM samples are collected at least weekly and include samples at eye level, below and above. Greater than 55 sponges are taken per 50,000 sq. ft. (5,000 m2) per week: Raw:14, RTE/HH 35, Zone 4: 6. As facility ages, swabbing increases to reflect increased risks.
Number of Samples: Recommendations
Minimum• 30 sponges per 50,000 square feet
– Raw area: 7– RTE/High Hygiene: 20– Zone 4: 3
Best in Class• 55 sponges per 50, 000 square feet
– Raw area: 14– RTE/High Hygiene: 35– Zone 4: 6 Innovation Center for US Dairy
Presenter
Presentation Notes
Traditionally based on facility size. Accepted guidelines include 1 sample/1000 sq. ft./week. Condition of facility - Age and upkeep (floors, walls, ceilings) Geography of building – are there hazards? (near water source, air quality) Budget considerations for lab testing and employee allocation Goal is to have the correct balance between the number of samples and the effectiveness of your plan. Minimum: PEM samples are collected at least weekly and include samples at eye level, below and above. A minimum of 30 sponges are taken per 50,000 sq. ft. (5,000 m2) per week: Raw:7, RTE/HH: 20, Zone 4: 3 Best of class: PEM samples are collected at least weekly and include samples at eye level, below and above. Greater than 55 sponges are taken per 50,000 sq. ft. (5,000 m2) per week: Raw:14, RTE/HH 35, Zone 4: 6. As facility ages, swabbing increases to reflect increased risks.
Growth NichesLocations harboring the organism after the routine sanitation process for that area has been completed.
Methodology• Sponge
– used with gloves– most commonly used
• Handled sponge • Crevice Swabs
Sponges
Crevice Swab
Small Crevice Swab
Zone Mapping
Zone3 Zone 2
Zone 2
Zone 2
Zone 3
Zone 3
Zone3
Zone 3
Cornell DairyBlend Room
Zone MappingZone 2
Zone 2
Zone 3Zone 3
Zone 2Zone 3
Zone 3
Zone 2
Zone 3
Zone 3
Zone 2
Zone MappingCornell Dairy 8 oz. Bottled Milk Filler
Zone 3
Zone 3
Zone 3 Zone 3
Zone 3 Zone 3
Zone 3
Zone 2
Zone 1Zone 1
Zone 1
Zone2
Zone 2
Zone 2
Zone Mapping
Zone 1
Zone 2
Zone 1
Zone 3
Zone 3
Zone 2
Zone 2
Zone 1
Zone 3
Zone 1
Zone 3
Zone Mapping
Cornell DairyCultured Products Room
Exterior Tank not near lid
Interior
Zone 3Zone 3
Zone 3
Zone 1near lid
Zone 3
Zone 2
Zone 3
Zone 1
Zone 3
Zone 2
Zone 3
Zone 3
Exterior: Zone 3Interior: Zone 2
Zone 3
Zone Mapping
Zone 3
Zone 2
Zone 3
Zone 1Zone 2
Zone 1Zone 1Zone 3
Compositing• Approach 1:
– Samples from multiple sites– Single sponge– Single Enrichment
• Approach 2:– Samples from multiple sites– Multiple sponges– Single Enrichment
Presenter
Presentation Notes
Compositing of environmental samples may only be appropriate under some very specific conditions Defined as “Compositing is the amalgamation of a number of samples from the same lot/batch to produce a single ‘final sample’ or ‘test portion’ for microbiological or chemical testing” Widely used in the preparation of analytical samples for chemical and physical analyses because by efficient blending of a number of sample units, an analytical sample can be taken that is more truly ‘representative’ of a ‘lot’ May cover two different approaches: Collect samples from multiple sites (e.g., 4 floor drains in the same room) with a single sponge Collect multiple samples with separate sponges and composite sponges (put them all into a single enrichment) for testing Some agencies (USDA) advise against compositing Compositing of environmental samples complicates follow-up and root cause analysis as exact location of positive can not be determined Food contact surface samples should never be composited Samples for follow-up and for cause investigations should not use composting Generally, no more than 5 samples may be composited Compositing may be appropriate if non-FCS samples are composited and if the intervention is the same for all sites
Results• Send samples to a certified lab• Review results upon arrival• Apply corrective actions• Monitor trends
Presenter
Presentation Notes
Review testing results every time results are reported Keep them organized and accessible in a central location. Follow your correction plan for the zone associated with a positive result(s). Take efficient notes, a correction plan may take up to two weeks to conclude. Stay organized. Identify trends of positive results and assess long term corrections.
Follow-Up and Corrections• Plant specific and may differ by zone
• Consider frequency of sampling vs. root cause analysis
• Intensified cleaning and sanitizing required
• Long-term trending and analysis– Pathogens– Index and indicator organisms
Presenter
Presentation Notes
Corrections based on positive samples need to be plant specific and may differ by zone Trend towards increased frequency of pathogen detection needs to be investigated to determine reason and action needs to be taken to reduce frequency Additional samples should be taken from environmental area that showed positive results (“vector swabbing”) Positive samples should be followed up with additional investigations and root cause analyses as well as intensified cleaning and sanitation Corrective actions may furthermore include: Cleaning and sanitation procedures and SSOPs may need to be changed Maintenance may be needed and preventive maintenance program may need to be improved Equipment may have to be modified and replaced Problem areas may have to be shut down temporarily Consider if a test and hold program is needed
Corrective Actions• Positive samples need follow-up: re-testing
and vector swabbing
• Shutting down problem areas
• Written records
Presenter
Presentation Notes
Corrective actions may furthermore include: Cleaning and sanitation procedures and SSOPs may need to be changed Maintenance may be needed and preventive maintenance program may need to be improved Equipment may have to be modified and replaced
5/15/201323
5/23/2013
Thorough cleaning with an acid cleaner (vs. our old chlorine bleach) was performed
x
ADA 6/13/2013
Vector SwabbingAdditional samples should be taken from
environmental area that showed positive results
Investigation of a Positive Finding• Review infrastructure and equipment in the
area
• Targeted cleaning
• Review records
• Corrective action – Location (zone) – Trends
Presenter
Presentation Notes
Review infrastructure and equipment in the area Targeted cleaning Review records Cleaning Environmental data Maintenance and mechanical down time Test samples from composites individually Corrective action depends on: Location (zone) of positive finding Trends – single isolate or repeated finding
Tracking Results• Track and trend environmental data
• Collect and record data to provide actionable information
• Establish a baseline to monitor trends
• Detection of a pathogen in Zone 1 requires immediate action as product may be contaminated
Presenter
Presentation Notes
Establish a baseline to monitor trends Requires more sampling than needed for ongoing monitoring Attempt to capture a snapshot of the stable/routine operation Several sets of data may be collected to cover seasonal variability Detection of a pathogen in Zone 1 requires immediate action as product may be contaminate
Tracking Results Example
Map with Areas and Positive Swabs
Map with Areas and Positive Swabs
Verification Swabbing: ATP Swabbing
• Rapid test for presence of organic material• Determines relative cleanliness of the surface• Sanitation monitoring and verification activity
Verification Swabbing:What is ATP?• ATP is the “energy currency” molecule of all
living organisms• In cells, ATP loses one or more phosphates to
release energy
Verification Swabbing: Allergen Swabbing
• Control test designed to prevent cross-contact from allergenic food soil on process equipment
• Sanitation monitoring and verification activity • Planning for allergen testing requires clear
communication and coordination with senior management to hold or destroy product, pending results of the testing
Environmental Monitoring Program Revisions
• Review the program at least annually and modify as necessary when:– Indicated by corrective actions – When ingredients and processing changes are made– Following adverse events– When equipment modification, repairs, replacements are
made– When there are consistently no positive findings
FSMA and Environmental Monitoring• Environmental Monitoring as a Verification Activity:
– Verify the effectiveness of sanitation programs– Verify that hygienic zoning is working
• Understand “normal” environmental conditions vs. something has changed or something unusual is going on– Not a specific preventive control, though records are
required for a food safety plan
• A useful program diligently tries to find the organism
Adapted from Food Safety Preventive Controls Alliance
Presenter
Presentation Notes
Purpose of PEM Verify the effectiveness of sanitation programs Verify that hygienic zoning is working to: Protect product from cross-contamination or recontamination Prevent microbial harborage Understand “normal” environmental conditions vs. something has changed or something unusual is going on Not a specific preventive control, though records are required for a food safety plan A useful program diligently tries to find the organism
