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Lessons Learned in the Meat Industry:Lessons Learned in the Meat Industry:Lessons Learned in the Meat Industry:Lessons Learned in the Meat Industry:Control of Listeria in RTE Meat and Poultry ProductsControl of Listeria in RTE Meat and Poultry Products
Randall Huffman, Ph.D.Randall Huffman, Ph.D.
Control of Listeria in RTE Meat and Poultry ProductsControl of Listeria in RTE Meat and Poultry Products
Randall Huffman, Ph.D.Randall Huffman, Ph.D.Randall Huffman, Ph.D.Randall Huffman, Ph.D.PresidentPresidentAmerican Meat Institute FoundationAmerican Meat Institute Foundation
Randall Huffman, Ph.D.Randall Huffman, Ph.D.PresidentPresidentAmerican Meat Institute FoundationAmerican Meat Institute Foundation
John Butts, Ph.D.John Butts, Ph.D.Vice President Research and DevelopmentVice President Research and DevelopmentJohn Butts, Ph.D.John Butts, Ph.D.Vice President Research and DevelopmentVice President Research and DevelopmentLand O’FrostLand O’Frost
CMC Annual Technical ConferenceCMC Annual Technical Conference
Land O’FrostLand O’Frost
CMC Annual Technical ConferenceCMC Annual Technical ConferenceToronto, CanadaToronto, CanadaSeptember 19, 2008September 19, 2008Toronto, CanadaToronto, CanadaSeptember 19, 2008September 19, 2008
“Selling Safe Food is the“Selling Safe Food is the“Selling Safe Food is the“Selling Safe Food is the“Selling Safe Food is the “Selling Safe Food is the Right Thing to DoRight Thing to Do ---- It isIt is
“Selling Safe Food is the “Selling Safe Food is the Right Thing to DoRight Thing to Do ---- It isIt isRight Thing to Do Right Thing to Do It is It is Good for Business and Good for Business and Right Thing to Do Right Thing to Do It is It is Good for Business and Good for Business and Good for Consumers”Good for Consumers”Good for Consumers”Good for Consumers”
Timeline of Major EventsTimeline of Major EventsListeria monocytogenesListeria monocytogenes
Timeline of Major EventsTimeline of Major EventsListeria monocytogenesListeria monocytogenes
AMI Workshops
AMI Workshops
Outbreak, Outbreak, USDA
Product USDA
Product
Listeria monocytogenesListeria monocytogenesListeria monocytogenesListeria monocytogenes
deaths and major recalls
deaths and major recalls FDA-FSIS Risk
Assessment – Deli FDA-FSIS Risk
Assessment – Deli
Sampling began
Sampling began
CDC surveillance
CDC surveillance Food NetFood Net
P lP l“Not For “Not For
Meats deemed High Risk
Meats deemed High Risk
Mexican Cheese
outbreak
Mexican Cheese
outbreak
PulsenetDNA
Linkage
PulsenetDNA
Linkage
Cause” Risk Verification
Testing
Cause” Risk Verification
Testing
AMI Guidelines
AMI Guidelines
USDA Product Sampling continually ratcheted upUSDA Product Sampling continually ratcheted upTurkey Frank fatality
Turkey Frank fatality
85 88 90 92 94 96 98 00 02 04 06 0885 88 90 92 94 96 98 00 02 04 06 08
fatalityfatality
Cycle of ControlCycle of ControlAwareness:
Detect Problem
Enlightenment:Collect data to
d t d th
Predictive:Measure
understand the problem
impact of interventions
Preventative:Preventative:Implement
Interventions and Best Practices
Preventative:ID appropriate
points of controlp
Share Best Practices across industry
Evolution of ControlEvolution of ControlAwareness phaseAwareness phase
Early 90sEarly 90sEarly 90sEarly 90sProduct and contact surface sampling Product and contact surface sampling dominateddominateddominateddominatedGrowth niches discovered in hollow Growth niches discovered in hollow rollersrollersrollersrollersIndustry recognized benefits and needs Industry recognized benefits and needs of separationof separationof separation of separation
painted lines on floorpainted lines on floor
Evolution of ControlEvolution of ControlE li ht t PhE li ht t Ph
Mid 90sMid 90sEquipment teardown became common Equipment teardown became common
Enlightenment PhaseEnlightenment Phase
q pq pSeek & Destroy concept developedSeek & Destroy concept developed
Internal equipment redesign became Internal equipment redesign became commonplacecommonplacecommonplacecommonplaceSuppliers were informed of design problemsSuppliers were informed of design problems
Conflicting design expectation evolvedConflicting design expectation evolvedg g pg g pEquipment manufacturers given a moving targetEquipment manufacturers given a moving target
Floor problems persistedFloor problems persistedFloors/drains were recognized as harborage andFloors/drains were recognized as harborage andFloors/drains were recognized as harborage and Floors/drains were recognized as harborage and chronic problem areaschronic problem areasMethods to clean floors continuously failed Methods to clean floors continuously failed D i t t d t b L fD i t t d t b L fDrains were not expected to be Ls freeDrains were not expected to be Ls free
Evolution of ControlEvolution of Control
Mid 90sMid 90sP i t t d i t thP i t t d i t th
Enlightenment PhaseEnlightenment Phase (con’t)(con’t)
Persistent deep equipment growth Persistent deep equipment growth niches were discovered and niches were discovered and recognized as root cause problemrecognized as root cause problemrecognized as root cause problem recognized as root cause problem areasareasFacility areas were recognized as Facility areas were recognized as y gy gsources of sources of ListeriaListeria harborage harborage
walls, freezer walls, absorbent materials walls, freezer walls, absorbent materials in doors wet floors and cracks in floorsin doors wet floors and cracks in floorsin doors, wet floors and cracks in floorsin doors, wet floors and cracks in floors
MidMid--shift cleanups were recognized as shift cleanups were recognized as problem causing sources ofproblem causing sources ofproblem causing sources of problem causing sources of recontaminationrecontamination
Evolution of ControlEvolution of Control
LateLate 90s90sPreventative PhasePreventative Phase
Benefits of dry floors were realizedBenefits of dry floors were realizedCooking/pasteurization of equipment became Cooking/pasteurization of equipment became commonplacecommonplacecommonplacecommonplaceLarge area sampling became commonplaceLarge area sampling became commonplaceDNA linkage evolvesDNA linkage evolvesggMethods for “construction process control” Methods for “construction process control” evolvesevolvesSpread of organisms from growth nichesSpread of organisms from growth nichesSpread of organisms from growth niches Spread of organisms from growth niches became more understoodbecame more understoodPhysical separation of RTE areas became Physical separation of RTE areas became y py pcommon placecommon place
Evolution of ControlEvolution of Control20002000
First AMI WorkshopFirst AMI Workshop –– June 2000June 2000
Predictive PhasePredictive Phase
First AMI Workshop First AMI Workshop June, 2000June, 2000Consensus in methods and Best Practices was attainedConsensus in methods and Best Practices was attainedSix “Strategies for Control” developedSix “Strategies for Control” developedOver 15 workshops held reaching over 1000 industry Over 15 workshops held reaching over 1000 industry p g yp g yemployeesemployees
October 2001October 2001AMI Board declared “Food Safety Not Competitive”AMI Board declared “Food Safety Not Competitive”
2001 to today2001 to today2001 to today2001 to todayMany lines and processes brought under controlMany lines and processes brought under controlElimination of single growth niches produced new Elimination of single growth niches produced new levels of controllevels of controllevels of controllevels of controlMore aggressive sampling was deployedMore aggressive sampling was deployed
Evolution of ControlEvolution of ControlPredictive PhasePredictive Phase
2001 to today2001 to todayP t i ti f l h b d t bP t i ti f l h b d t bPasteurization of large chubs and roasts became Pasteurization of large chubs and roasts became common placecommon placeThe use of DNA analysis (ribotyping, PFGE, Rep The use of DNA analysis (ribotyping, PFGE, Rep PCR) to ID sources of growth niches and degree of PCR) to ID sources of growth niches and degree of the diversity of RTE contaminationthe diversity of RTE contaminationAMI Equipment Design Task ForceAMI Equipment Design Task Force -- 20032003AMI Equipment Design Task Force AMI Equipment Design Task Force 20032003Some plants had achieved new levels of control Some plants had achieved new levels of control
One year without drain positiveOne year without drain positiveL t tL t t di t t i d t t l thdi t t i d t t l thLactate Lactate ––diacetate recognized to control growthdiacetate recognized to control growthAMI Facility Design Task Force AMI Facility Design Task Force -- 20042004Most (>90%) of the Lm recalls are due to plant not Most (>90%) of the Lm recalls are due to plant not ( 9 %) p( 9 %) pholding product being testedholding product being tested
The Evolution of Environmental The Evolution of Environmental P th C t lP th C t l
The Evolution of Environmental The Evolution of Environmental P th C t lP th C t l
StageStage C t l M th dC t l M th d
Pathogen ControlPathogen ControlPathogen ControlPathogen ControlStage Stage (mindset)(mindset) Control MethodsControl MethodsAwarenessAwareness Sample ProductSample Product
EnlightenmentEnlightenment Recognize existence of Growth niches. Sample contact Recognize existence of Growth niches. Sample contact and some floor and environmental to surfaces controland some floor and environmental to surfaces controland some floor and environmental to surfaces control. and some floor and environmental to surfaces control. Starting the redesign phase.Starting the redesign phase.
PreventativePreventative Potential Growth niches mapped. Some scheduled Potential Growth niches mapped. Some scheduled intervention practices in place. Managing “Critical Factors” intervention practices in place. Managing “Critical Factors” p p g gp p g gof the Sanitation process. Engaged in Equipment and of the Sanitation process. Engaged in Equipment and Facility redesign.Facility redesign.
PredictivePredictive Early warning sampling in place. Scheduled intervention Early warning sampling in place. Scheduled intervention practices in place with all RTE equipment. Focus on zone practices in place with all RTE equipment. Focus on zone 4 and facilities. Advanced phases of both Equipment and 4 and facilities. Advanced phases of both Equipment and Facility redesign.Facility redesign.
The Evolution of Environmental The Evolution of Environmental Pathogen ControlPathogen Control
The Evolution of Environmental The Evolution of Environmental Pathogen ControlPathogen Control
StageStage S li R ltS li R lt
Pathogen ControlPathogen ControlPathogen ControlPathogen ControlStageStage Sampling ResultsSampling ResultsAwarenessAwareness Contact Surface and Product positives Contact Surface and Product positives
EnlightenmentEnlightenment Expanded and regular sampling of contact surfaces and Expanded and regular sampling of contact surfaces and environmental sites. Intermittent positives on contact environmental sites. Intermittent positives on contact ppsurfaces. Routine positives on environmental sites surfaces. Routine positives on environmental sites
PreventativePreventative Early preventative phase positive results dominated by Early preventative phase positive results dominated by environmental positives. In final phase of preventative, environmental positives. In final phase of preventative, only rare Contact Surface positives. No Product Positives. only rare Contact Surface positives. No Product Positives. Investigative facility based positives dominate RTE.Investigative facility based positives dominate RTE.
PredictivePredictive No Contact surface positives. Zone 4 positives No Contact surface positives. Zone 4 positives d i t H dl t f i t li dd i t H dl t f i t li dpredominate. Hurdle transfer point sampling produces rare predominate. Hurdle transfer point sampling produces rare
positives.positives.
Appreciate the efforts of thef ll i iAppreciate the efforts of thef ll i ifollowing companies:following companies:
Lessons LearnedLessons LearnedLessons LearnedLessons Learned
“The battle with this organism“The battle with this organismThe battle with this organism (Listeria) has caused more change
for producers of RTE deli meat
The battle with this organism (Listeria) has caused more change
for producers of RTE deli meatfor producers of RTE deli meat products than any one single
factor or event in the last 30 years
for producers of RTE deli meat products than any one single
factor or event in the last 30 yearsfactor or event in the last 30 years. Our scars are numerous and
deep ”
factor or event in the last 30 years. Our scars are numerous and
deep ”deep.Dr. John ButtsV P R h
deep.Dr. John ButtsV P R hV.P. ResearchLand O’ FrostV.P. ResearchLand O’ Frost
Investigation andInvestigation andInvestigation andInvestigation andInvestigation and Investigation and Corrective ActionCorrective ActionInvestigation and Investigation and Corrective ActionCorrective ActionCorrective ActionCorrective ActionCorrective ActionCorrective Action
“Follow the data trail to the source but always be alert and aware to the
“Follow the data trail to the source but always be alert and aware to the y
organism’s ubiquitous presence and pervasive nature.”
yorganism’s ubiquitous presence and
pervasive nature.”
John ButtsLand O’ FrostCMCToronto Sept 2008
DocumentationDocumentationDocumentationDocumentationDocumentationDocumentationDocumentationDocumentation• First and foremost documentation provides• First and foremost documentation providesFirst and foremost documentation provides
history for the workers responsible for Food Safety.
• Results of prior investigations
First and foremost documentation provides history for the workers responsible for Food Safety.
• Results of prior investigations• Results of prior investigations • Often provide insights into actions to take for
subsequent investigations.• They also provide insight into why certain policies and
• Results of prior investigations • Often provide insights into actions to take for
subsequent investigations.• They also provide insight into why certain policies and• They also provide insight into why certain policies and
procedures are in place. • Management can sometimes forget, particularly in times
of turnover why certain things must be done
• They also provide insight into why certain policies and procedures are in place.
• Management can sometimes forget, particularly in times of turnover why certain things must be doneof turnover, why certain things must be done.
• Listeria is living proof that history does repeat itself.
of turnover, why certain things must be done.• Listeria is living proof that history does repeat
itself.
Sources of Ls in HighSources of Ls in High--Risk RTE Risk RTE AA
Sources of Ls in HighSources of Ls in High--Risk RTE Risk RTE AAAreaAreaAreaArea
• Transferred from Zone 4 area outside of the High-Risk RTE area
H l b t l ki f h b l ti
• Transferred from Zone 4 area outside of the High-Risk RTE area
H l b t l ki f h b l tiHomeless, but looking for a harborage location Typically found with a transfer point monitoring positive
Homeless, but looking for a harborage location Typically found with a transfer point monitoring positivep
• Growth niches within High-Risk RTE area1. This means they are established, and have found
t ti h i i t f ilit
p• Growth niches within High-Risk RTE area
1. This means they are established, and have found t ti h i i t f ilita protective home in equipment or facility.
2. They may exist in a transient home such as rework pans, trash containers or other difficult to
a protective home in equipment or facility. 2. They may exist in a transient home such as
rework pans, trash containers or other difficult to clean mobile container / environment.clean mobile container / environment.
T f P i t Ni hT f P i t Ni hT f P i t Ni hT f P i t Ni hTransfer Points vs NichesTransfer Points vs NichesTransfer Points vs NichesTransfer Points vs NichesMany positive sites found during monitoring
are not growth niches. They are transfer Many positive sites found during monitoring
are not growth niches. They are transfer points (i.e., a product handler’s gloved hands, floor sample in high traffic pathway)
points (i.e., a product handler’s gloved hands, floor sample in high traffic pathway)pathway). pathway).
Transfer points are not growth nichesbecause the organism is eliminated during the cleaning and sanitizing
processprocess.
GROWTHGROWTH NICHESNICHESGROWTHGROWTH NICHESNICHESGROWTHGROWTH NICHESNICHESGROWTHGROWTH NICHESNICHES
Locations harboring the organism after the routine sanitation process for that area has been completed
Locations harboring the organism after the routine sanitation process for that area has been completedcompleted.completed.
Examples– Hollow roller on conveyorHollow roller on conveyor
transporting food product• Hollow rollers not
disassembled cleaned anddisassembled cleaned and sanitized or heat treated in a manner to eliminate any contaminatingany contaminating organisms can become growth niches.
GROWTHGROWTH NICHE CONTROLNICHE CONTROLGROWTHGROWTH NICHE CONTROLNICHE CONTROLGROWTHGROWTH NICHE CONTROLNICHE CONTROLGROWTHGROWTH NICHE CONTROLNICHE CONTROL
Factors affecting growth niche development• Design problemFactors affecting growth niche development• Design problem• Design problem• Operational conditions
P d t d b i k it i t
• Design problem• Operational conditions
P d t d b i k it i tProduct debris works its way into a uncleanable location• Mid shift cleanup
Product debris works its way into a uncleanable location• Mid shift cleanup• Mid shift cleanup
• Use of high pressure during cleaning• Mid shift cleanup
• Use of high pressure during cleaning
Growth NichesGrowth NichesGrowth NichesGrowth Niches
Hollow roller with solid stainless steel shaft in center (almost press fit).shaft in center (almost press fit).When center shaft removed organic matter is evident.
Challenge Guideline or Challenge Guideline or “Conventional Wisdom” of Boosted“Conventional Wisdom” of Boosted
Challenge Guideline or Challenge Guideline or “Conventional Wisdom” of Boosted“Conventional Wisdom” of BoostedConventional Wisdom of Boosted Conventional Wisdom of Boosted
& High Pressure Rinsing& High Pressure RinsingConventional Wisdom of Boosted Conventional Wisdom of Boosted
& High Pressure Rinsing& High Pressure RinsingDegree of Growth Niche Development and Penetration
High Low
Boosted pressure
Boosted pressure
Regular dairy hose tap water delivery pressure
Regular dairy hose tap water
delivery y p ypressure
Difficult to rinse
Dry non-sticky
Difficult to rinse product
Dry non-sticky products
producty
productsp p
GROWTHGROWTH NICHESNICHESGROWTHGROWTH NICHESNICHESGROWTHGROWTH NICHESNICHESGROWTHGROWTH NICHESNICHESMust either be designed out of the system or managed as a part of the processMust either be designed out of the system or managed as a part of the processmanaged as a part of the process.
• Design Examples
managed as a part of the process.
• Design Examples
Equipment is redesigned to eliminate or seal hollow areas
• Hollow areas of equipment (e g frames rollers) must
Equipment is redesigned to eliminate or seal hollow areas
• Hollow areas of equipment (e g frames rollers) must• Hollow areas of equipment (e.g., frames, rollers) must be eliminated where possible or permanently sealed (caulking not acceptable). Bolts, studs, mounting plates, brackets, junction boxes, name plates, end
• Hollow areas of equipment (e.g., frames, rollers) must be eliminated where possible or permanently sealed (caulking not acceptable). Bolts, studs, mounting plates, brackets, junction boxes, name plates, end p , , j , p ,caps, sleeves and other such items must be continuously welded to the surface of the equipment and not attached via drilled and tapped holes.
p , , j , p ,caps, sleeves and other such items must be continuously welded to the surface of the equipment and not attached via drilled and tapped holes.
AMI Equipment Design Task Force
G h Ni hG h Ni hG h Ni hG h Ni hGrowth NichesGrowth NichesGrowth NichesGrowth Niches
Minimize with process controlMinimize with process controlMinimize with process control techniques
Minimize with process control techniques
• The potential to support growth still exists within the machine, part or area
• The potential to support growth still exists within the machine, part or areaarea
» Whenever this becomes the chosen path remember to implement methods that
area» Whenever this becomes the chosen path
remember to implement methods thatremember to implement methods that will hold the gains with turnover in both hourly and management ranks.
remember to implement methods that will hold the gains with turnover in both hourly and management ranks.
G h Ni hG h Ni hG h Ni hG h Ni hGrowth NichesGrowth NichesGrowth NichesGrowth Niches
• Examples of how to minimize with process control techniques
• Examples of how to minimize with process control techniqueswith process control techniques
Disassemble clean and sanitizewith process control techniques
Disassemble clean and sanitizeHeat sanitize• Cook in oven or smokehouseHeat sanitize• Cook in oven or smokehouse• Cook in oven or smokehouse• Cover with tarp and inject steam• Cook in oven or smokehouse• Cover with tarp and inject steam• Place in COP tank• Place in COP tank
Equipment at End of Production
emble
Normal level
Disassem
Predefined Interval based
Clean & Sanitize
Routine / Daily
Hand Clean & Sanitize. Parts to COP
Intensive level
Disassemble
To a greater level
Interval based on need
Predefined Interval based
on need
Hand Clean & Sanitize, Small Parts to COP and
Large Parts to Smokehouse
Disass
emble
To con
trol c
old sp
ot
on need
Clean & Sanitize
Cooking level
Clean & Sanitize
Pasteurize
Transfer PointsTransfer PointsTransfer PointsTransfer Points
I t i T L tiI t i T L tiI t i T L tiI t i T L tiInterim or Temporary Locations Interim or Temporary Locations Harboring the OrganismHarboring the Organism
Interim or Temporary Locations Interim or Temporary Locations Harboring the OrganismHarboring the Organismg gg gg gg g
Transfer PointsTransfer PointsTransfer PointsTransfer PointsTransfer PointsTransfer PointsTransfer PointsTransfer Points• Any surface between the growth niche and the • Any surface between the growth niche and the y g
product.• Almost all contact surfaces are transfer points,
t th i h
y gproduct.
• Almost all contact surfaces are transfer points, t th i hnot growth niches.
• Contact surfaces are “indicator sites” of potential product contamination.
not growth niches.• Contact surfaces are “indicator sites” of potential
product contamination.product contamination.• Contact surfaces are probably not the best early
warning predictors of potential product t i ti
product contamination.• Contact surfaces are probably not the best early
warning predictors of potential product t i ticontamination.
• Contact surface sampling measures the effect of upstream process control efforts.
contamination.• Contact surface sampling measures the effect of
upstream process control efforts.upstream process control efforts.upstream process control efforts.
Sampling Transfer PointsSampling Transfer PointsSampling Transfer PointsSampling Transfer PointsSampling Transfer PointsSampling Transfer PointsSampling Transfer PointsSampling Transfer Points• Monitoring• MonitoringMonitoring
Biased not random method to monitor areas such as floors
MonitoringBiased not random method to monitor areas such as floorsEach plant is different, but common traffic ways exist in each plant
Th t h il t l d
Each plant is different, but common traffic ways exist in each plant
Th t h il t l d• The most heavily traveled areas can serve as potential problem indicators
• Targeted
• The most heavily traveled areas can serve as potential problem indicators
• TargetedTargetedInvestigative sampling of questionable areas
TargetedInvestigative sampling of questionable areasTrying to find transfer vector or growth nicheTrying to find transfer vector or growth niche
Transfer Point ManagementTransfer Point ManagementTransfer Point ManagementTransfer Point Management
C t li i t t f i tC t li i t t f i tCannot eliminate transfer points -- Must minimize their effect
Cannot eliminate transfer points -- Must minimize their effect
Operational Definitions Operational Definitions for Corrective Actionfor Corrective Action
Operational Definitions Operational Definitions for Corrective Actionfor Corrective Actionfor Corrective Actionfor Corrective Actionfor Corrective Actionfor Corrective Action
High Risk SituationsHigh Risk SituationsHigh Risk SituationsHigh Risk Situations
High Risk SituationsHigh Risk SituationsHigh Risk SituationsHigh Risk Situationsgggg• Drain backup • A packaging line is moved or modified • Drain backup • A packaging line is moved or modified
significantly.• There is an equipment breakdown.
Personnel are used interchangeably between raw
significantly.• There is an equipment breakdown.
Personnel are used interchangeably between raw• Personnel are used interchangeably between raw and cooked products.
• Construction in or adjacent to CPA.
• Personnel are used interchangeably between raw and cooked products.
• Construction in or adjacent to CPA.j• Warm room• Wet area or process
j• Warm room• Wet area or process
If one of the above High Risk situations exists then a documented and auditable process control program should be deployedand auditable process control program should be deployed.
High Risk Situations High Risk Situations High Risk Situations High Risk Situations • Transfer equipment from storage or another plant• Loss of refrigeration in a room• Transfer equipment from storage or another plant• Loss of refrigeration in a room• Loss of refrigeration in a room• Use of high pressure water or air on floor or in a
drain
• Loss of refrigeration in a room• Use of high pressure water or air on floor or in a
drain• Wet in-process clean up• Rinsing or cleaning equipment on the floor• Equipment used interchangeably between raw
• Wet in-process clean up• Rinsing or cleaning equipment on the floor• Equipment used interchangeably between raw• Equipment used interchangeably between raw
and cooked products.• Crack in floor that retains water
• Equipment used interchangeably between raw and cooked products.
• Crack in floor that retains water• Cooked product is transported through a raw
product area• Cooked product is transported through a raw
product areaIf one of the above High Risk situations exists then a documentedIf one of the above High Risk situations exists then a documented and auditable process control program should be deployed.
Methods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures for Methods or Procedures for InvestigationInvestigation
Methods or Procedures for Methods or Procedures for InvestigationInvestigation
• Plan, Do, Check, Act (Shewhart PDCA Cycle)• Plan, Do, Check, Act (Shewhart PDCA Cycle)(Shewhart PDCA Cycle)(Shewhart PDCA Cycle)
Methods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures for Methods or Procedures for InvestigationInvestigation
Methods or Procedures for Methods or Procedures for InvestigationInvestigation
Plan• Define the scope of the investigation
Plan• Define the scope of the investigation• Define the scope of the investigation
Affected area from cleanup through clean up during all shifts.
• Define the scope of the investigation Affected area from cleanup through clean up during all shifts. gAnalyze data with blueprints and flow charts. Trace movement of product, people, &
i t
gAnalyze data with blueprints and flow charts. Trace movement of product, people, &
i tequipment.Small areas are easier and more manageable.Small areas have a higher risk of not including
equipment.Small areas are easier and more manageable.Small areas have a higher risk of not includingSmall areas have a higher risk of not including the growth niche Small areas have a higher risk of not including the growth niche
Clearly and Concisely Define the Scope of the Investigation as a Physical Area
Clearly and Concisely Define the Scope of the Investigation as a Physical Area
Machine 1
Machine 2Machine 2
Machine 3
Machine 4
Machine 5
Machine 6
Machine 7
Clearly and Concisely Define the Scope of the Investigation as a Physical Area
MachineMachine Component 1
Machine Machine Component 2
Machine Component 3Component 3
Machine Component 4p
Machine Component 5
Machine Component 6
Machine Component 7
Methods or Procedures for Methods or Procedures for Methods or Procedures for Methods or Procedures for InvestigationInvestigationInvestigationInvestigation
DoDoDoConduct investigations• Investigative Sampling Methods
DoConduct investigations• Investigative Sampling Methods• Investigative Sampling Methods
Seek and Destroy Timed Studies
• Investigative Sampling MethodsSeek and Destroy Timed StudiesTimed StudiesSwat Team Sampling--- Discuss AMI Workshop
• Process Reviews
Timed StudiesSwat Team Sampling--- Discuss AMI Workshop
• Process ReviewsOperating proceduresGMP’s. Review SSOP’s and Line Separation
Operating proceduresGMP’s. Review SSOP’s and Line SeparationReview SSOP s and Line Separation documentationReview SSOP s and Line Separation documentation
Product transportTime Study Locating a Transfer
Operator tools Line workers
Sample everything coming to line
a Transfer Vector
Process 1
MaintenanceMaterialsSample everything coming to line
Process 2A Time Study consists of
The Time Study typically starts
during setup and
Process 3
consists of sampling the line components and
during setup and assembly . Samples
will be taken as k d d t
Process 4
every thing that comes to the line over a period of time
workers and product come to the line,
repeated after line is over a period of timerunning then every 2
hrs thereafter
S T S liS T S liS T S liS T S liSwat Team SamplingSwat Team SamplingSwat Team SamplingSwat Team Sampling• Sample during an idle period after sanitation,
before production i.e. Saturday when no • Sample during an idle period after sanitation,
before production i.e. Saturday when no production is running
• Sample large areas using sponges or gauze.production is running
• Sample large areas using sponges or gauze.• Sample areas not typically sampled during
routine sampling• Sample areas not typically sampled during
routine samplingWe found a transient growth niche using this method – COP basket handleWe found a transient growth niche using this method – COP basket handle
Methods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures for Methods or Procedures for InvestigationInvestigation
Methods or Procedures for Methods or Procedures for InvestigationInvestigation
Check
Define indicator areas to test for
Check
Define indicator areas to test for• Define indicator areas to test foreffectiveness of corrective action.
• Define indicator areas to test foreffectiveness of corrective action.
• Sample then test indicator areas.
• Analyze results
• Sample then test indicator areas.
• Analyze results• Analyze results.• Analyze results.
Methods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures forMethods or Procedures for Methods or Procedures for InvestigationInvestigation
Methods or Procedures for Methods or Procedures for InvestigationInvestigation
Act• Put into practice corrective actions that
Act• Put into practice corrective actions that• Put into practice corrective actions that
minimized or prevented the contamination to occur.
• Put into practice corrective actions that minimized or prevented the contamination to occur.to occur.
SSOP changesTraining program changes
to occur.SSOP changesTraining program changesEquipment redesignEquipment redesign
Methods or Procedures for InvestigationMethods or Procedures for InvestigationMethods or Procedures for InvestigationMethods or Procedures for Investigationgggg
< PDCA Cycle >P t I
< PDCA Cycle >P t I
< PDCA Cycle >Part II
< PDCA Cycle >Part IIPart I
• Location of Growth NicheFirst phase is directed
Part I• Location of Growth Niche
First phase is directed
Part II• GMP’s & Transfer point
Management
Part II• GMP’s & Transfer point
Managementtowards finding and eliminating the growth niche
R l if th i h
towards finding and eliminating the growth niche
R l if th i h
Second phase focuses on procedures and process control systems to minimize or control growth niches or
Second phase focuses on procedures and process control systems to minimize or control growth niches or• Recycle if growth niche
not foundExpand scope of investigation
• Recycle if growth niche not found
Expand scope of investigation
or control growth niches or transfer pointsUse time studies to identify when and where transfer take
l
or control growth niches or transfer pointsUse time studies to identify when and where transfer take
lplace
• Process is recycled until qualification is achieved
place
• Process is recycled until qualification is achieved
Th Pl t M t R !Th Pl t M t R !Th Pl t M t R !Th Pl t M t R !The Plant Must Run!The Plant Must Run!The Plant Must Run!The Plant Must Run!
Procedures for Investigation & Procedures for Investigation & Corrective ActionCorrective Action
Procedures for Investigation & Procedures for Investigation & Corrective ActionCorrective ActionCorrective ActionCorrective ActionCorrective ActionCorrective Action
< PDCA Cycle >Part I Find source
< PDCA Cycle >Part I Find source
< Enhanced Sanitation and Operating Activities to
< Enhanced Sanitation and Operating Activities toPart I Find source
• Investigate – Seek and Destroy Mission
Part I Find source • Investigate – Seek and Destroy
Mission
Operating Activities to Assure Control >
• Heat treat the equipment in question.
Operating Activities to Assure Control >
• Heat treat the equipment in question.
Part II GMP’s – Transfer Point Management
• Time Study – sample every 2 hrs
Part II GMP’s – Transfer Point Management
• Time Study – sample every 2 hrs
question.• Deep Clean• Multiple Sanitizer applications to
assure coverage
question.• Deep Clean• Multiple Sanitizer applications to
assure coverage• Time Study – sample every 2 hrs• Brainstorm with group of
employeesRecycle if growth niche not
• Time Study – sample every 2 hrs• Brainstorm with group of
employeesRecycle if growth niche not
g• High Concentration Sanitizer• Quat foam entire area• Heat process all ancillary
g• High Concentration Sanitizer• Quat foam entire area• Heat process all ancillaryy g
foundExpand scope of investigation
y gfound
Expand scope of investigation
Heat process all ancillary equipment
• Intensify monitoring activities in the area of the indicator site
Heat process all ancillary equipment
• Intensify monitoring activities in the area of the indicator site
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
PlanPlan PlPl
< PDCA Cycle >Find Growth Niche Transfer Points – GMP’s
Plan• Use blue print analysis to identify
equipment/area in questionThe scope of the investigation
Plan• Use blue print analysis to identify
equipment/area in questionThe scope of the investigation
Plan• Use flow chart and
brainstormingTh f th i ti ti
Plan• Use flow chart and
brainstormingTh f th i ti tiThe scope of the investigation
should include surfaces that are within the process or line area.
• Collect and analyze each sample
The scope of the investigation should include surfaces that are within the process or line area.
• Collect and analyze each sample
The scope of the investigation should include transfer points and potentially all surfaces directly touched by any person
The scope of the investigation should include transfer points and potentially all surfaces directly touched by any person
individually.
• Define an appropriate sampling rate for the affected line during the
individually.
• Define an appropriate sampling rate for the affected line during the
directly touched by any person or transport equipment in the line area
• Define processing factors that
directly touched by any person or transport equipment in the line area
• Define processing factors thatate o t e a ected e du g t einvestigation and qualification stages
• Use rapid test methods such as
ate o t e a ected e du g t einvestigation and qualification stages
• Use rapid test methods such as
• Define processing factors that may contribute to transferring the organism
• Define Transfer Point Sampling
• Define processing factors that may contribute to transferring the organism
• Define Transfer Point Sampling Use rapid test methods such as ELISA to reduce turn around timeUse rapid test methods such as ELISA to reduce turn around time
p gPlan
p gPlan
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
DD DD
< PDCA Cycle >Find Growth Niche Transfer Points – GMP’s
Do• Review High Risk Process
Controls
Do• Review High Risk Process
Controls
Do• Review and evaluate changes
in processing conditions,
Do• Review and evaluate changes
in processing conditions, • Seek and Destroy on line• Increase frequency of
indicator site sampling
• Seek and Destroy on line• Increase frequency of
indicator site sampling
GMP’s, sanitation and manufacturing operating procedures
GMP’s, sanitation and manufacturing operating procedures
• Review SSOP’s and Line Separation documentation
• Time study sampling at
• Review SSOP’s and Line Separation documentation
• Time study sampling at y p gdefined frequency (I.e. 2 hr)
y p gdefined frequency (I.e. 2 hr)
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
Ch kCh k Ch kCh k
< PDCA Cycle >Find Growth Niche Transfer Points – GMP’s
Check• Analyze data• Plot results on blueprints
Check• Analyze data• Plot results on blueprints
Check• Analyze data• Plot results on flow charts
Check• Analyze data• Plot results on flow charts
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
Corrective Action for a Packaging Line Contact Corrective Action for a Packaging Line Contact Surface PositiveSurface Positive
A tA t ActAct
< PDCA Cycle >Find Growth Niche Transfer Points – GMP’s
Act• Implement corrective action
(permanent process changes)
Act• Implement corrective action
(permanent process changes)
Act• Implement corrective action
(permanent process changes)• Modify training program
Act• Implement corrective action
(permanent process changes)• Modify training programchanges)
Redesign to eliminateModify level of critical factor to control
changes)Redesign to eliminateModify level of critical factor to control
Modify training program• Change frequency of
administration of training programR i t ti t f t i i
Modify training program• Change frequency of
administration of training programR i t ti t f t i i• Expand scope and recycle
PDCA if results continue to be unacceptable or process
ill t lif
• Expand scope and recycle PDCA if results continue to be unacceptable or process
ill t lif
• Require testing as part of training program
• Qualify process if probable cause has been found and eliminated or
• Require testing as part of training program
• Qualify process if probable cause has been found and eliminated or
will not re-qualifywill not re-qualify controlled• Expand scope and recycle PDCA
if results continue to be unacceptable or process will not
controlled• Expand scope and recycle PDCA
if results continue to be unacceptable or process will notunacceptable or process will not re-qualifyunacceptable or process will not re-qualify
Corrective ActionCorrective ActionCorrective ActionCorrective Action
Validation• The growth niche itself and surfacesValidation• The growth niche itself and surfacesThe growth niche itself and surfaces
affected by the growth niche need to be measured negative for 3 consecutive
The growth niche itself and surfaces affected by the growth niche need to be measured negative for 3 consecutive samples.samples.
Prevention and Control TrendsPrevention and Control TrendsPrevention and Control TrendsPrevention and Control TrendsOld way……Old way…… New way……New way……• Reactionary mode• React to Contact • Reactionary mode• React to Contact
• Preventative mode• React to Indicator Site • Preventative mode• React to Indicator Site
Surface positive• Minimal indicator site
li
Surface positive• Minimal indicator site
li
positive• Indicator sites react
b f CS it
positive• Indicator sites react
b f CS itsampling• Corrective Action on
C t t S f
sampling• Corrective Action on
C t t S f
before CS sites• Corrective Action on
iti
before CS sites• Corrective Action on
itiContact SurfaceContact Surface any positiveany positive
Prevention and Control TrendsPrevention and Control TrendsPrevention and Control TrendsPrevention and Control TrendsOld way……
Mi i l h dl tOld way……
Mi i l h dl tNew way……
M lti l h dl tNew way……
M lti l h dl t• Minimal hurdles to prevent entry into RTE
• Deep Clean when Ls+
• Minimal hurdles to prevent entry into RTE
• Deep Clean when Ls+
• Multiple hurdles to prevent entry into RTE
• Scheduled Deep
• Multiple hurdles to prevent entry into RTE
• Scheduled DeepDeep Clean when Ls • Minimal equipment Heat
Treating
Deep Clean when Ls • Minimal equipment Heat
Treating
Scheduled Deep Cleaning
• Scheduled equipment H t T ti
Scheduled Deep Cleaning
• Scheduled equipment H t T ti• Have not disassembled
equipment to find problem growth niches
• Have not disassembled equipment to find problem growth niches
Heat Treating• Know location of deep
growth niches and treat
Heat Treating• Know location of deep
growth niches and treatproblem growth nichesproblem growth niches growth niches and treat accordinglygrowth niches and treat accordingly
The Evolution of Environmental The Evolution of Environmental Pathogen ControlPathogen Control
StageStage Sampling Res ltsSampling Res lts
Pathogen ControlPathogen ControlStageStage Sampling ResultsSampling ResultsAwareness Contact Surface and Product positives
Enlightenment Expanded and regular sampling of contact surfaces and environmental sites. Intermittent positives on contact surfaces. Routine positives on environmental sites
Preventative Early preventative phase positive results dominated by environmental. In final phase of preventative, only rare C t t S f iti N P d t P itiContact Surface positives. No Product Positives. Investigative facility based positives dominate RTE.
Predictive No Contact surface positives. Zone 4 positives predominate Hurdle transfer point sampling produces rarepredominate. Hurdle transfer point sampling produces rare positives.
Pillars of Microbiological Pillars of Microbiological Process Control
TechnologyProcess Control
TechnologyTechnologyTechnology
1 Eli i t th i f E d1 Eli i t th i f E d1. Eliminate the organism from Exposed Product Area
1. Eliminate the organism from Exposed Product Area
2. Control transfer of the organism3. Deploy Process Management 2. Control transfer of the organism3. Deploy Process Management p y g
Techniquesp y g
Techniques
Eliminate the Eliminate the Eliminate the Eliminate the Organism From the Organism From the
E d P d t AE d P d t AOrganism From the Organism From the
E d P d t AE d P d t AExposed Product AreaExposed Product AreaExposed Product AreaExposed Product Area
Eli i h O iEli i h O iEli i h O iEli i h O iEliminate the OrganismEliminate the OrganismEliminate the OrganismEliminate the OrganismRequirements for effective control
Listeria spp. in a plant:Requirements for effective control
Listeria spp. in a plant:1. Investigation coupled with corrective and
preventive action must lead to locating the growth niches.
1. Investigation coupled with corrective and preventive action must lead to locating the growth niches.the growth niches.
2. Process control must be data-driven; data will be derived from monitoring, qualification and investigative work
the growth niches. 2. Process control must be data-driven;
data will be derived from monitoring, qualification and investigative workqualification and investigative work.
3. Product and contact surface sampling results will validate the effectiveness of
qualification and investigative work. 3. Product and contact surface sampling
results will validate the effectiveness of the program the program
Development of Interventions Development of Interventions Development of Interventions Development of Interventions ppand Indicator Sites and Indicator Sites
ppand Indicator Sites and Indicator Sites
• Each piece of equipment needs an intervention (a process that is capable of eliminating the organism from the most
• Each piece of equipment needs an intervention (a process that is capable of eliminating the organism from the mosteliminating the organism from the most likely point of contamination to the deepest most difficult to remove location).
eliminating the organism from the most likely point of contamination to the deepest most difficult to remove location).p )
• Indicator sites should be deployed to define the effectiveness of the i t ti
p )• Indicator sites should be deployed to
define the effectiveness of the i t tiintervention.
• Indicator site sampling over time determines if residency has been
intervention.• Indicator site sampling over time
determines if residency has beendetermines if residency has been eliminated or contained and controlled.determines if residency has been eliminated or contained and controlled.
Development of InterventionsDevelopment of InterventionsDevelopment of InterventionsDevelopment of InterventionsDevelopment of InterventionsDevelopment of InterventionsDevelopment of InterventionsDevelopment of Interventions
• Each piece of equipment needs an intervention (a process that is
• Each piece of equipment needs an intervention (a process that isan intervention (a process that is capable of eliminating the organism from the most likely
an intervention (a process that is capable of eliminating the organism from the most likelyorganism from the most likely point of contamination to the d t t diffi lt t
organism from the most likely point of contamination to the d t t diffi lt tdeepest most difficult to remove location).deepest most difficult to remove location).
Development of Interventions
Intensive Level of Disassembly and Sanitation or Equipment P
Intensive Level of Disassembly and Sanitation or Equipment P Pasteurization may be the ideal Intervention option.Pasteurization may be the ideal Intervention option.
Prevent MovementPrevent MovementPrevent MovementPrevent MovementPrevent Movement Prevent Movement of the Organismof the Organism
Prevent Movement Prevent Movement of the Organismof the Organismof the Organismof the Organismof the Organismof the Organism
Control of Transfer VectorsControl of Transfer VectorsControl of Transfer VectorsControl of Transfer Vectors• Distinct Hygienic Zones are established in • Distinct Hygienic Zones are established in
the facility• Physical separation of raw from RTE
the facility• Physical separation of raw from RTE
Personnel & material flows are controlled to reduce hazards:Personnel & material flows are controlled to reduce hazards:
• Water accumulation is controlled inside the facilitySanitation GMP’s
• Water accumulation is controlled inside the facilitySanitation GMP’s• Sanitation GMP’s
• Operational GMP’s are designed and executed to establish control and to prevent
• Sanitation GMP’s• Operational GMP’s are designed and
executed to establish control and to preventexecuted to establish control and to prevent cross contamination executed to establish control and to prevent cross contamination
ProcessProcessProcessProcessProcess Process ManagementManagement
Process Process ManagementManagementManagementManagementManagementManagement
Process Control SamplingProcess Control SamplingProcess Control SamplingProcess Control Sampling
• A focused effort not directed towards process validation sites such as
• A focused effort not directed towards process validation sites such as
Product and Product Contact SurfacesHi h t ffi fl fl tt
Product and Product Contact SurfacesHi h t ffi fl fl ttHigh traffic floor flow patterns
• But directed to process control sites such as
High traffic floor flow patterns • But directed to process control sites such
asas development of interventions and measurement of the effectiveness of hurdles
as development of interventions and measurement of the effectiveness of hurdlesmeasurement of the effectiveness of hurdles. measurement of the effectiveness of hurdles.
Components of a Process Control Components of a Process Control PP
Components of a Process Control Components of a Process Control PPProgramProgramProgramProgram
• Listeria positive results from all Operational• Listeria positive results from all Operational• Listeria positive results from all Operational Sampling Programs are investigated
• Contact Surface Sampling validates process
• Listeria positive results from all Operational Sampling Programs are investigated
• Contact Surface Sampling validates process p g pcontrol program
Each line is sampled weekly• Large area sponge sampling
p g pcontrol program
Each line is sampled weekly• Large area sponge sampling• Large area sponge sampling• Finding Ls+ is a “success”• “One size does not fit all” sampling plans
• Large area sponge sampling• Finding Ls+ is a “success”• “One size does not fit all” sampling plansp g p• Sampling plans must be dynamic• Data must drive the process of controlling
the organism
p g p• Sampling plans must be dynamic• Data must drive the process of controlling
the organismthe organismthe organism
SummarySummarySummarySummaryRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control ProgramRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control Program
• The Sanitation process has been proven effective
• The Sanitation process has been proven effective
• The Sanitation process and Sanitary Manufacturing Operating Procedures are
• The Sanitation process and Sanitary Manufacturing Operating Procedures areManufacturing Operating Procedures are defined and repeatable.
G l l d S it ti O t
Manufacturing Operating Procedures are defined and repeatable.
G l l d S it ti O t• General employee and Sanitation Operator Training programs clearly define and effectively communicate the process requirements
• General employee and Sanitation Operator Training programs clearly define and effectively communicate the process requirementscommunicate the process requirements necessary to maintain microbiological control. communicate the process requirements necessary to maintain microbiological control.
Summary Summary Summary Summary yyRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control Program
yyRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control Program
• Trained operators are used at each essential step
• Trained operators are used at each essential stepessential step.
• If a new problem emerges the
essential step.
• If a new problem emerges theIf a new problem emerges, the monitoring and corrective action process will identify and direct the
If a new problem emerges, the monitoring and corrective action process will identify and direct theprocess will identify and direct the Corrective Action Team towards the l ti f th th i h
process will identify and direct the Corrective Action Team towards the l ti f th th i hlocation of the growth niche. location of the growth niche.
Summary Summary Requirements for an EffectiveRequirements for an Effective
Summary Summary Requirements for an EffectiveRequirements for an EffectiveRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control ProgramRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control Program
• Random isolated strikes are proven to not be repeatable.
• Random isolated strikes are proven to not be repeatable.
• Consumer safety is assured by product sampling if process control appears to
• Consumer safety is assured by product sampling if process control appears to p g p ppbe violated.
• Growth niches in any location within the
p g p ppbe violated.
• Growth niches in any location within theGrowth niches in any location within the Exposed Product Area are identified and are either eliminated or managed
Growth niches in any location within the Exposed Product Area are identified and are either eliminated or managedare either eliminated or managed. are either eliminated or managed.
Summary Summary Requirements for an EffectiveRequirements for an Effective
Summary Summary Requirements for an EffectiveRequirements for an EffectiveRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control ProgramRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control Program
• Physical transfer of microorganisms within the Exposed Product Area is
• Physical transfer of microorganisms within the Exposed Product Area is addressed by the presence of multiple hurdles. addressed by the presence of multiple hurdles.
• Additions or changes to the process or equipment within the Exposed Product
• Additions or changes to the process or equipment within the Exposed Product Area are monitored and qualified to not introduce or harbor microorganismsArea are monitored and qualified to not introduce or harbor microorganisms
Summary Summary Requirements for an EffectiveRequirements for an Effective
Summary Summary Requirements for an EffectiveRequirements for an EffectiveRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control ProgramRequirements for an Effective Requirements for an Effective
Listeria Control ProgramListeria Control Program
Th i t ithi th E d P d tTh i t ithi th E d P d t• The environment within the Exposed Product Area is controlled to minimize microbial outgrowth
• The environment within the Exposed Product Area is controlled to minimize microbial outgrowthoutgrowth.
• Multiple barriers or hurdles create a “torturous
outgrowth.
• Multiple barriers or hurdles create a “torturous ppathway” to minimize the possibility of entry by a pathogenic organism from outside the
ppathway” to minimize the possibility of entry by a pathogenic organism from outside the Exposed Product Area.
• Ingredient hurdles that minimize growth are not Exposed Product Area.
• Ingredient hurdles that minimize growth are not g gsilver bullets!
g gsilver bullets!
Q i ?Q i ?Questions?Questions?
Myth Busting in CriticalMyth Busting in CriticalUse data and logic to focus resourcesUse data and logic to focus resources
Common misconceptions about root causeCommon misconceptions about root cause“The organism is airborne”“The organism is airborne”gg“Raw meat is (20“Raw meat is (20--40% Lm +) highly 40% Lm +) highly contaminated with the organism”contaminated with the organism”contaminated with the organismcontaminated with the organism“It cannot be removed from the “It cannot be removed from the processing environment”processing environment”processing environmentprocessing environment“Drains will always be positive”“Drains will always be positive”
Summary of “Lessons Learned”Summary of “Lessons Learned”Summary of “Lessons Learned”Summary of “Lessons Learned”
Data, Data, DataData, Data, DataL t d t id th “C l f C t l”L t d t id th “C l f C t l”Data, Data, DataData, Data, DataL t d t id th “C l f C t l”L t d t id th “C l f C t l”Let data guide the “Cycle of Control”Let data guide the “Cycle of Control”Sampling and testing used strategicallySampling and testing used strategicallyLet data guide the “Cycle of Control”Let data guide the “Cycle of Control”Sampling and testing used strategicallySampling and testing used strategicallyVigilant reVigilant re--evaluation of systems is criticalevaluation of systems is criticalIndustry sharing of Best PracticesIndustry sharing of Best PracticesVigilant reVigilant re--evaluation of systems is criticalevaluation of systems is criticalIndustry sharing of Best PracticesIndustry sharing of Best PracticesIndustry sharing of Best PracticesIndustry sharing of Best PracticesAvoid misconceptions Avoid misconceptions –– use the datause the dataIndustry sharing of Best PracticesIndustry sharing of Best PracticesAvoid misconceptions Avoid misconceptions –– use the datause the dataFlexible regulatory approachFlexible regulatory approachFlexible regulatory approachFlexible regulatory approach
P t ti P bli H lthP t ti P bli H lthProtecting Public HealthProtecting Public Health
“Selling Safe Food is the Right “Selling Safe Food is the Right Thing to DoThing to Do It is Good forIt is Good for
“Selling Safe Food is the Right “Selling Safe Food is the Right Thing to DoThing to Do It is Good forIt is Good forThing to Do Thing to Do ---- It is Good for It is Good for
Business and Good for Business and Good for Thing to Do Thing to Do ---- It is Good for It is Good for
Business and Good for Business and Good for Consumers”Consumers”Consumers”Consumers”
The Industry is Making ProgressThe Industry is Making ProgressThe Industry is Making ProgressThe Industry is Making Progress
Listeria monocytogenesListeria monocytogenes RecallsRecalls20032003 20042004 20052005 20062006 20072007 2008**2008** TotalTotal
Listeria monocytogenesListeria monocytogenes RecallsRecalls
No. of RecallsNo. of Recalls 1414 1313 2626 55 99 66 7373
No. of Recalls due No. of Recalls due to Illness to Illness Investigation (%)Investigation (%)
00 00 00 00 00 00 00
No. of Recalls due No. of Recalls due to FSIS/Companyto FSIS/Company
13*13*(93%)(93%)
12* 12* (92%)(92%)
25*25*(96%)(96%)
55(100%)(100%)
99(100%)(100%)
5*5*(83%)(83%)
69 69 (94%)(94%)to FSIS/Company to FSIS/Company
Sample (%)Sample (%)(93%)(93%) (92%)(92%) (96%)(96%) (100%)(100%) (100%)(100%) (83%)(83%) (94%)(94%)
* In these years there were recalls due to state health agency testing
** 2008 data as of 9/08/2008
* In these years there were recalls due to state health agency testing
** 2008 data as of 9/08/2008
Holding of Tested Product Best PracticeHolding of Tested Product Best Practice
Prevalence ofPrevalence of Listeria monocytogenesListeria monocytogenesPrevalence ofPrevalence of Listeria monocytogenesListeria monocytogenesin RTE Meat and Poultry Products in RTE Meat and Poultry Products **
5
3
4
s
2
3
Posi
tives
0
1
Perc
ent
090 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07
Year*FSIS results of routine regulatory testing of ready-to-eat meat and poultry products analyzed for Listeria monocytogenes
Incidence of Foodborne Incidence of Foodborne Illness 1996Illness 1996--2007: 2007: Listeria*Listeria*
0 6
0.5
0.6
National Healthat
ion
0.3
0.4Health Objective: .25
00,0
00 P
opul
a
0 1
0.2
ncid
ence
per
1
0
0.1
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
I
*Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food --- 10 states, 2007
Save the Date!!!Save the Date!!!AMI and CMC to SponsorAMI and CMC to Sponsor
Save the Date!!!Save the Date!!!AMI and CMC to SponsorAMI and CMC to SponsorAMI and CMC to SponsorAMI and CMC to SponsorAMI and CMC to SponsorAMI and CMC to Sponsor
Listeria Intervention and Control Listeria Intervention and Control WorkshopWorkshopWorkshopWorkshop
February 3 February 3 –– 4, 20094, 2009Chicago IllinoisChicago IllinoisChicago, IllinoisChicago, Illinois