listeria_intervention_and_control NSWFA

8/7/2019 listeria_intervention_and_control NSWFA

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Listeria Intervention andControl

Listeria Intervention andListeria Intervention andControlControl

The battle with this organism has caused

more change for producers of RTE deli meatproducts than any one single factor or eventin the last 35 years. Our scars are numerous

and deep.

The battle with this organism has causedThe battle with this organism has caused

more change for producers of RTE deli meatmore change for producers of RTE deli meatproducts than any one single factor or eventproducts than any one single factor or event

in the last 35 years. Our scars are numerousin the last 35 years. Our scars are numerous

and deep.and deep.

John ButtsLand O Frost

NSW Food Authority - Lm WorkshopSydney Au July 2010


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85 88 90 92 94 96 98 00 02 04 06 0885 88 90 92 94 96 98 00 02 04 06 08

MexicanCheese

outbreak

MexicanCheese

outbreak

AMIWorkshops

AMIWorkshops

CDCsurveillance

CDCsurveillance Food NetFood Net

PulsenetDNA

Linkage

PulsenetDNA

Linkage

Not ForCause RiskVerification

Testing

Not ForCause RiskVerification

Testing

Outbreak,deaths and

majorrecalls

Outbreak,deaths and

major

recalls FDA-FSIS RiskAssessment Deli

Meats deemedHigh Risk

FDA-FSIS RiskAssessment Deli

Meats deemedHigh Risk

USDA Product Sampling continually ratcheted upUSDA Product Sampling continually ratcheted up

AMIGuidelines

AMIGuidelines

TurkeyFrankfatality

TurkeyFrankfatality

USDAProduct

Samplingbegan

USDAProduct

Samplingbegan

Timeline of Major EventsListeria monocytogenes

Timeline of Major EventsTimeline of Major EventsListeria monocytogenesListeria monocytogenes


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Evolution of ControlAwareness phaseEvolution of ControlEvolution of ControlAwareness phaseAwareness phase

Early 90s Product and contact surface sampling

dominated

Growth niches discovered in hollowrollers

Industry recognized benefits and needsof separationpainted lines on floor

Early 90s Product and contact surface sampling

dominated

Growth niches discovered in hollowrollers

Industry recognized benefits and needsof separationpainted lines on floor


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Mid 90s

Equipment teardown became common

Seek & Destroy concept developed Internal equipment redesign became

commonplace

Suppliers were informed of design problemsConflicting design expectation evolvedEquipment manufacturers given a moving target

Floor problems persistedFloors/drains were recognized as harborage and

chronic problem areasMethods to clean floors continuously failed

Drains were not expected to be Ls free

Mid 90s

Equipment teardown became commonSeek & Destroy concept developed

Internal equipment redesign becamecommonplace

Suppliers were informed of design problemsConflicting design expectation evolvedEquipment manufacturers given a moving target

Floor problems persistedFloors/drains were recognized as harborage and

chronic problem areasMethods to clean floors continuously failed

Drains were not expected to be Ls free

Evolution of Control

Enlightenment Phase

Evolution of ControlEvolution of Control

Enlightenment PhaseEnlightenment Phase


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Mid 90s

Persistent deep equipment growth nicheswere discovered and recognized as rootcause problem areas

Facility areas were recognized as sourcesof Listeriaharborage walls, freezer walls, absorbent materials in

doors, wet floors and cracks in floors

Mid-shift cleanups were recognized asproblem causing sources of

recontamination

Mid 90s Persistent deep equipment growth niches

were discovered and recognized as rootcause problem areas

Facility areas were recognized as sourcesof Listeriaharborage walls, freezer walls, absorbent materials in

doors, wet floors and cracks in floors

Mid-shift cleanups were recognized asproblem causing sources ofrecontamination

Evolution of Control

Enlightenment Phase (cont)


Enlightenment PhaseEnlightenment Phase(con(cont)t)


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Late 90s

Benefits of dry floors were realized

Cooking/pasteurization of equipment becamecommonplace

Large area sampling became commonplace DNA linkage evolves

Methods for construction process controlevolves

Spread of organisms from growth nichesbecame more understood

Physical separation of RTE areas becamecommon place

Late 90s

Benefits of dry floors were realized Cooking/pasteurization of equipment became

commonplace

Large area sampling became commonplace

DNA linkage evolves Methods for construction process control

evolves

Spread of organisms from growth nichesbecame more understood

Physical separation of RTE areas became

common place

Evolution of ControlPreventative PhaseEvolution of ControlEvolution of ControlPreventative PhasePreventative Phase


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2000

First AMI Workshop Nov, 2000

Consensus in methods and Best Practices was attainedSix Strategies for Control developedOver 18 workshops held reaching over 1200 industry

employees from around the world

October 2001 AMI Board declared Food Safety Not Competitive

2001 to today Many lines and processes brought under control Elimination of single growth niches produced new levels

of control More aggressive sampling was deployed

2000

First AMI Workshop Nov, 2000Consensus in methods and Best Practices was attainedSix Strategies for Control developedOver 18 workshops held reaching over 1200 industry

employees from around the world

October 2001 AMI Board declared Food Safety Not Competitive

2001 to today Many lines and processes brought under control Elimination of single growth niches produced new levels

of control More aggressive sampling was deployed

Evolution of ControlPredictive PhaseEvolution of ControlEvolution of ControlPredictive PhasePredictive Phase


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Evolution of ControlPredictive Phase


Predictive PhasePredictive Phase2001 to today Pasteurization of large chubs and roasts became

common place The use of DNA analysis (ribotyping, PFGE, Rep PCR)

to ID sources of growth niches and degree of the

diversity of RTE contamination AMI Equipment Design Task Force - 2003

Some plants had achieved new levels of controlOne year without drain positive

Lactate diacetate recognized to control growth

AMI Facility Design Task Force - 2004

Most (>90%) of the Lm recalls are due to plant notholding product being tested

2001 to today Pasteurization of large chubs and roasts became

common place The use of DNA analysis (ribotyping, PFGE, Rep PCR)

to ID sources of growth niches and degree of thediversity of RTE contamination

AMI Equipment Design Task Force - 2003

Some plants had achieved new levels of controlOne year without drain positive

Lactate diacetate recognized to control growth

AMI Facility Design Task Force - 2004

Most (>90%) of the Lm recalls are due to plant not

holding product being tested


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FSISRegulatoryTestingforLMinRTEProducts

byCalendarYear1990 2008

(AllYearsAllProjects)

4.61%

4.03%

3.61%3.44%

2.90%3.02%

2.91%

2.25%

2.54%

1.91%

1.45%1.32%

1.03%

0.76%

0.91%

0.68%

0.48% 0.43% 0.43%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

4.0%

4.5%

5.0%

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

CalendarYear


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20032003 20042004 20052005 20062006 20072007 20082008 TotalTotal

No. of RecallsNo. of Recalls 1414 1313 2626 55 99 1313 8080

No. of RecallsNo. of Recalls

due to Illnessdue to Illness

InvestigationInvestigation(%)(%)

00 00 00 00 00 00 00

No. of RecallsNo. of Recalls

due to FSIS/due to FSIS/CompanyCompany

Sample (%)Sample (%)

13*13*

(93%)(93%)

12*12*

(92%)(92%)

25*25*

(96%)(96%)

55

(100%)(100%)

99

(100%)(100%)

1313

(100%)(100%)

7777

(96%)(96%)

Listeria monocytogenesListeria monocytogenesRecallsRecalls

* In this year there was one recall due to state health agency testing.


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Recommendations forManufacturers

Recommendations forRecommendations for

ManufacturersManufacturers

Focus on designing and manufacturingproducts that limit the growth of Listeriamonocytogenes

Implement a science based samplingprogram with data from that programavailable to the Agency

Maintain appropriate data validating theeffectiveness of the chosen intervention; post-lethality treatment, antimicrobial agent,

antimicrobial process, or any combination ofthe above

Focus on designing and manufacturingproducts that limit the growth of Listeriamonocytogenes

Implement a science based samplingprogram with data from that programavailable to the Agency

Maintain appropriate data validating theeffectiveness of the chosen intervention; post-lethality treatment, antimicrobial agent,antimicrobial process, or any combination ofthe above


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Sampling MethodsSampling MethodsSampling Methods

In God we trust. Everyone else please bring data!

In God we trust. Everyone else please bring data!

John ButtsLand O Frost

NSW Food Authority - Lm WorkshopSydney Au July 2010


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Indicator SitesIndicator SitesIndicator Sites

Process Management SamplingProcess Management Sampling


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Indicator Site SamplingIndicator Site SamplingIndicator Site Sampling

A focused effort not directed towardsprocess validation sites such as

Product and

Product Contact SurfacesHigh traffic floor flow patterns

But directed to indicator sites such as

development of interventions and

measurement of the effectiveness of hurdles.

A focused effort not directed towardsnot directed towardsprocess validation sites such as

Product and

Product Contact SurfacesHigh traffic floor flow patterns

But directed toBut directed to indicator sites such as

development of interventions and

measurement of the effectiveness of hurdles.


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Routine Environmental Monitoring is Intended to

Verify Control of Listeriaby the HACCP plan, SSOPsand GMPs

Routine Environmental Monitoring is Intended toRoutine Environmental Monitoring is Intended to

Verify Control ofVerify Control of ListeriaListeriaby the HACCP plan, SSOPsby the HACCP plan, SSOPsand GMPsand GMPs

Sanitation Good Manufacturing

Practices

Employee Training

Sanitation Good Manufacturing

Practices

Employee Training

Plant Layout Equipment Design

Traffic Patterns

Lot/line Separation

Plant Layout Equipment Design

Traffic Patterns

Lot/line Separation

HACCP Plan


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Monitoring to VerifyControl of LM

Monitoring to VerifyMonitoring to Verify

Control of LMControl of LM

Two basic types of monitoring:Environmental sampling

Routine

Investigational/Special Cause

Finished product sampling

Two basic types of monitoring:Environmental sampling

Routine

Investigational/Special Cause

Finished product sampling


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Environmental Monitoring:

Routine

Environmental Monitoring:Environmental Monitoring:

RoutineRoutine

Two major types of sites to target

Transfer point sites: have high potential of

transferring the organism from one location to another

Floor in high traffic area, electric pallet jacks, handtrucks, pull cords for doors, employee gloves

Proper data analysis of transfer point positives can lead

to finding the growth niche Potential growth niches: moisture + food + time

Difficult to reach and clean (also difficult to sample)

Sandwich areas

Two major types of sites to target

Transfer point sites: have high potential of

transferring the organism from one location to another

Floor in high traffic area, electric pallet jacks, handtrucks, pull cords for doors, employee gloves

Proper data analysis of transfer point positives can lead

to finding the growth niche

Potential growth niches: moisture + food + time

Difficult to reach and clean (also difficult to sample)

Sandwich areas


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Air as a Source of ListeriaAir as a Source ofAir as a Source of ListeriaListeria

Previous studies have not substantiated air as a

significant source of L. monocytogenes1

Poultry Processing - Lawrence and Gilmour, 1994

Delicatessens - Salvat et al., 1995

Rainbow Trout Processing - Autio et al., 1999

Dairy Operation - Jacquet et al., 1993

1L. monocytogeneswas not recovered from any air samples

taken in the above studies

Previous studies have not substantiated air as a

significant source of L. monocytogenes1

Poultry Processing - Lawrence and Gilmour, 1994

Delicatessens - Salvat et al., 1995

Rainbow Trout Processing - Autio et al., 1999

Dairy Operation - Jacquet et al., 1993

1L. monocytogeneswas not recovered from any air samples

taken in the above studies

S li g Wh dSampling: When andSampling: When and


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Sampling: When and

Frequency

Sampling: When andSampling: When and

FrequencyFrequency Time of day:

Pre-opPost-op

Operational

First shift / second shift Weekly, monthly, quarterly

Number of samples per line

History and trends should influence when

and frequency

Time of day:

Pre-op

Post-op

Operational

First shift / second shift Weekly, monthly, quarterly

Number of samples per line

History and trends should influence whenand frequency


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Routine SamplingRoutine SamplingRoutine Sampling Sample LARGE areas using sponge or

gauze pad Compositing is an option for routine

samples with good history

Cotton tipped swabs - not normally usedfor routine sampling but can be useful

when investigating a source involvingsmall nooks and crannies

Sample LARGE areas using sponge or

gauze pad

Compositing is an option for routinesamples with good history

Cotton tipped swabs - not normally usedfor routine sampling but can be useful

when investigating a source involvingsmall nooks and crannies


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Environmental Monitoring:

Investigational

Environmental Monitoring:Environmental Monitoring:

InvestigationalInvestigational Samples taken after a routine verification

monitoring positive Samples taken to find a new growth niche

Samples taken to find a new transfer vector

Samples taken to establish or qualify a hurdle orbarrier system

Samples taken to assess or characterize risk of acontrol procedure, part of facility or processchange (special cause)

Samples taken after a routine verification

monitoring positive Samples taken to find a new growth niche

Samples taken to find a new transfer vector

Samples taken to establish or qualify a hurdle orbarrier system

Samples taken to assess or characterize risk of acontrol procedure, part of facility or processchange (special cause)


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Investigative/Special CauseSampling

Investigative/Special CauseInvestigative/Special Cause

SamplingSampling

Usually more targeted and more intense Example Seek and Destroy sampling of a

slicer

Done after production, before sanitationSlicer torn down piece by piece

Careful to document exactly where the sample

was taken

Careful to avoid cross-contamination

May take 50 or more samples from one slicer

Usually more targeted and more intense

Example Seek and Destroy sampling of a

slicer

Done after production, before sanitationSlicer torn down piece by piece

Careful to document exactly where the sample

was takenCareful to avoid cross-contamination

May take 50 or more samples from one slicer


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Special Cause SamplingSpecial Cause SamplingSpecial Cause Sampling

Example special sampling duringconstructionUse hazard analysis ideas

Disruptions to normal flow of people, product,packaging, equipment, air, water, waste, etc.

Air sampling may make sense do not

use MOX settling platesVerify that special precautions are working

to segregate the construction area

Example special sampling duringconstructionUse hazard analysis ideas

Disruptions to normal flow of people, product,packaging, equipment, air, water, waste, etc.

Air sampling may make sense do not

use MOX settling platesVerify that special precautions are working

to segregate the construction area


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Sampling PlansSampling PlansBiased - not random

Focused on finding the problemDo not care about the overall average percent positives on the

floor

Use indicator sites that are more likely to be positivethan an average site

Sample High Risk areas at a higher rate than Low Risk

areas Often include non specific siteswhich are open for the

investigator to try to find problems (take 5 samples

every other week of potential problem areas)

BiasedBiased -- not randomnot random

Focused on finding the problemFocused on finding the problemDo not care about the overall average percent positives on theDo not care about the overall average percent positives on the

floorfloor

Use indicator sites that are more likely to be positiveUse indicator sites that are more likely to be positivethan an average sitethan an average site

Sample High Risk areas at a higher rate than Low RiskSample High Risk areas at a higher rate than Low Risk

areasareas Often includeOften include non specific sitesnon specific siteswhich are open for thewhich are open for the

investigator to try to find problems (take 5 samplesinvestigator to try to find problems (take 5 samples

every other week of potential problem areas)every other week of potential problem areas)


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Sampling PlansSampling Plans

Dynamic not static

As process control procedures and practices evolvesites may change. If this happens the plan may bechanged. If a site that typically is positive at a greater

frequency than other similar sites in the area continuesto be negative, the investigator may remove it from theplan and insert one that is more frequently positive

Corrective action particularly when redesign is involvedcauses a change to the sampling plan.

Seasonality can cause changes in sampling plans

Plant load or volume may cause plan changes

Dynamic not staticDynamic not static

As process control procedures and practices evolveAs process control procedures and practices evolvesites may change. If this happens the plan may besites may change. If this happens the plan may be

changed. If a site that typically is positive at a greaterchanged. If a site that typically is positive at a greater

frequency than other similar sites in the area continuesfrequency than other similar sites in the area continues

to be negative, the investigator may remove it from theto be negative, the investigator may remove it from the

plan and insert one that is more frequently positiveplan and insert one that is more frequently positive

Corrective action particularly when redesign is involvedCorrective action particularly when redesign is involvedcauses a change to the sampling plan.causes a change to the sampling plan.

Seasonality can cause changes in sampling plansSeasonality can cause changes in sampling plans

Plant load or volume may cause plan changesPlant load or volume may cause plan changes


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Sampling PlansSampling Plans

Variable not fixed Investigations often add focused efforts

over short periods of time to sample

problematic areas

Often include testing of potential

process changes with may or may notbe effective

Variable not fixedVariable not fixed Investigations often add focused effortsInvestigations often add focused efforts

over short periods of time to sampleover short periods of time to sample

problematic areasproblematic areas

Often include testing of potentialOften include testing of potential

process changes with may or may notprocess changes with may or may notbe effectivebe effective


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Limitations of ProductTesting

Limitations of ProductLimitations of Product

TestingTesting

For 100% confidence, would need totest 100% of product

Distribution of LM typically sporadic and

low-level If 2% of packages contain LM, if you

tested 100 samples from the lot, wouldstill be a 13% chance of missing all thepositive packages

For 100% confidence, would need totest 100% of product

Distribution of LM typically sporadic and

low-level If 2% of packages contain LM, if you

tested 100 samples from the lot, wouldstill be a 13% chance of missing all thepositive packages


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Data AnalysisData Analysis

Food Safety is ..the unseen foundationon which the LOFbusiness and our products are built.


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Data AnalysisData Analysis Must recognize the biased, non-random, variable and

dynamic nature of the sampling plan generating thedata.

Traditional statistical analysis tools (mean, standard

deviation, correlation coefficient, etc.) can oftenmislead as opposed to direct the investigation team.

The best statistical tool is often a Pareto analysis

which ranks grouped data

Must recognize the biased, nonMust recognize the biased, non--random, variable andrandom, variable and

dynamic nature of the sampling plan generating thedynamic nature of the sampling plan generating thedata.data.

Traditional statistical analysis tools (mean, standardTraditional statistical analysis tools (mean, standard

deviation, correlation coefficient, etc.) can oftendeviation, correlation coefficient, etc.) can oftenmislead as opposed to direct the investigation team.mislead as opposed to direct the investigation team.

The best statistical tool is often a Pareto analysisThe best statistical tool is often a Pareto analysiswhich ranks grouped datawhich ranks grouped data


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Location TrackingLocation Tracking

Divide plant area into grids Enable location tracking and analysis Divide plant area into grids Enable location tracking and analysis

A B .. ZZ

1

2.

n


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Data AnalysisData Analysis

Convert results to numeric logic valuesNegative = 0

Positive = 1

Suspect = 1

Convert results to numeric logic valuesNegative = 0

Positive = 1

Suspect = 1

Spreadsheet DesignSpreadsheet Design Manual Data EntryManual Data Entry


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Date Composite monitoring, Indiv resample

Number Location n %+ 06/30 07/07 07/13 07/20 07/27 08/04 08/101 Location 1 2 0.0%

2 Location 2 14 7.1% 1 0 0 0 0

3 Location 3 14 7.1% 1 0 0 0 0

4 Location 4 16 6.3% 1 0 0 0 0

5 Location 5 12 8.3% 1 0 0 0 0

6 Location 6 10 10.0% 1 0 0 07 Location 7 9 11.1% 1 0 0 0

8 Location 8 8 12.5% 1 0 0 0

" " " "

41 Location 41 16 12.5% 1 0 0 0

42 Location 42 18 16.7% 1 0 0 1 0 0

43 Location 43 17 11.8% 1 0 0 0

44 Location 44 14 14.3% 1 0 0 0

Total

56 15 6 6 6 1 0 0

569 15 24 30 25 24 16 99.8% 100.0% 25.0% 20.0% 24.0% 4.2% 0.0% 0.0%

Number of sites sampledPercent positive

Number positivees

Spreadsheet DesignSpreadsheet Design Manual Data EntryManual Data Entry

Identify the areas with the greatest problems


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(Pareto analysis)

Floors & drains

LocationCommon Name N - S E - W n %+

19 C 9 22.2%

3 A 6 16.7%

4 A 7 14.3%

9 B 7 14.3%

5 B 15 13.3%

12 A 8 12.5%20 C 9 11.1%

10 C 10 10.0%

3 C 16 6.3%

15 C 16 6.3%

18 B 16 6.3%

1 A 3 0.0%

1 B 3 0.0%1 C 5 0.0%

2 A 1 0.0%

2 B 9 0.0%

Total number of sites sampled 315

Percent of sites Listeria positive (%Ls+) 4.1%

Grey shaded areas are selected high frequency monitoring

sites (high traffic areas).

Environmental Monitoring ofFrank Area

Grid

Sample locations for ongoing Environmental Monitoring of IQF area725 8.6% Date Composite monitoring, Indiv resample Indiv monit

Number Location n %+ 06/29 07/07 07/13 07/20 07/27 08/04 08/10 8/17 08/24 08/31 09/08 09/14 09/21 0928 10/05 10/12

1 Location 1 2 0.0%

2 Location 2 14 7 1% 1 0 0 0 0


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2 Location 2 14 7.1% 1 0 0 0 0

3 Location 3 14 7.1% 1 0 0 0 0 0

4 Location 4 16 6.3% 1 0 0 0 0 0

5 Location 5 12 8.3% 1 0 0 0 0 0

6 Location 6 10 10.0% 1 0 0 0 0

7 Location 7 9 11.1% 1 0 0 0

8 Location 8 8 12.5% 1 0 0 0

9 Location 9 3 0.0%

10 Location 10 2 0.0% 0

11 Location 11 2 0.0% 0

12 Location 12 1 0.0% 0

13 Location 13 9 0.0% 0 0 0 0

14 Location 14 9 0.0% 0 0 0 0

15 Location 15 9 0.0% 0 0 0 0

16 Location 16 10 0.0% 0 0 0

17 Location 17 13 0.0% 0 0 0 0

18 Location 18 13 0.0% 0 0 0 0

19 Location 19 17 11.8% 1 0 0 0 0 0

20 Location 20 19 15.8% 1 0 0 0 0 0

21 Location 21 19 21.1% 1 0 0 0 0 0

22 Location 22 19 10.5% 1 0 0 0 0 0

23 Location 23 17 17.6% 1 0 0 0 0 0

24 Location 24 17 11.8% 1 0 0 0 0 0

25 Location 25 16 6.3% 1 0 0 0 0 0 0

26 Location 26 16 6.3% 1 0 0 0 0 0 027 Location 27 21 14.3% 1 0 0 0 1 0 0 0 1 0

28 Location 28 14 7.1% 1 0 0 0 0 0 0

29 Location 29 14 7.1% 1 0 0 0 0 0 0

30 Location 30 17 11.8% 1 0 0 0 0 1 0 0 0 0

31 Location 31 12 8.3% 1 0 0 0 0 0

32 Location 32 11 9.1% 1 0 0 0 0 0

33 Location 33 15 13.3% 1 0 0 0 1 0 0 0 0

34 Location 34 9 11.1% 1 0 0 0 0 0

35 Location 35 10 10.0% 1 0 0 0 0 036 Location 36 9 11.1% 1 0 0 0 0 0

37 Location 37 18 16.7% 1 0 0 0 0 0

38 Location 38 20 20.0% 1 0 0 0 0 1 0 0

39 Location 39 18 16.7% 1 0 0 0 0 0

40 Location 40 20 20.0% 1 0 0 0 0 0

41 Location 41 16 12.5% 1 0 0 0 0 0

42 Location 42 18 16.7% 1 0 0 1 0 0 0 0

43 Location 43 17 11.8% 1 0 0 0 0 0

44 Location 44 14 14.3% 1 0 0 0 0 0

56 15 6 6 6 1 0 0 1 0 1 1 0 1 0 1 0

569 15 24 30 25 24 16 9 12 12 10 10 8 14 11 9 8

9.8% 100% 25% 20% 24% 4% 0% 0% 8% 0% 10% 10% 0% 7% 0% 11% 0%

Area En ironmentalsArea Environmentals


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0%

20%

40%

60%

80%

100%

0

6/29

0

7/13

0

7/27

0

8/10

0

8/24

0

9/08

0

9/21

1

0/05

1

0/19

1

1/02

1

1/16

1

1/30

1

2/14

1

2/28

0

1/11

0

1/25

0

2/08

0

2/22

2/28

0

3/14

0

3/28

0

4/11

0

4/25

0

5/09

0

5/23

0

6/06

Date

%Lss

+

Identify trends in a given area or common location

Determine overall effectiveness (%Listeriaspecies or Listerialike free)

Area EnvironmentalsArea Environmentals

Composite samplingSanitizer coverage Found and New


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0%

20%

40%

60%

80%

100%

06/29

07/13

07/27

08/10

08/24

09/08

09/21

10/05

10/19

11/02

11/16

11/30

12/14

12/28

01/11

01/25

02/08

02/22

2/28

03/14

03/28

04/11

04/25

05/09

05/23

06/06

Date

%Ls

s+

Applied flood sanitizer,trained sanitation crew,

switched to individualsampling

inadequateImproperly trained

workforce

Found andeliminatedgrowth

niche

Newsanitationsupervisor

Audited sanitationprocess updated

procedures


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Operation Line n n L + % L+

Slicing 1 520 9 1.7%

2 520 5 1.0%

Franks Brine 104 0 0.0%

1 520 0 0.0%

2 520 0 0.0%

IQF 624 6 1.0%

Total 2808 20 0.7%

Summary Contact SurfaceProvide management reportsProvide management reports

D t tiD t tiD m t ti


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DocumentationDocumentationDocumentation

First and foremost documentation provides history for

the workers responsible for Food Safety. Results of prior investigations

Often provide insights into actions to take for subsequentinvestigations.

They also provide insight into why certain policies andprocedures are in place.

Management can sometimes forget, particularly in times of

turnover, why certain things must be done.

Listeria is living proof that history does repeat itself.

First and foremost documentation provides history forthe workers responsible for Food Safety.

Results of prior investigations

Often provide insights into actions to take for subsequentinvestigations.

They also provide insight into why certain policies andprocedures are in place.

Management can sometimes forget, particularly in times of

turnover, why certain things must be done.

Listeria is living proof that history does repeat itself.


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INVESTIGATION, CORRECTIVEAND PREVENTATIVE ACTIONINVESTIGATION, CORRECTIVEINVESTIGATION, CORRECTIVEAND PREVENTATIVE ACTIONAND PREVENTATIVE ACTION


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Growth NichesGrowth NichesGrowth Niches

Examples of how to minimize withprocess control techniques

Disassemble clean and sanitize

Heat sanitize

Cook in oven or smokehouse

Cover with tarp and inject steam Place in COP tank

Examples of how to minimize withprocess control techniques

Disassemble clean and sanitize

Heat sanitize Cook in oven or smokehouse

Cover with tarp and inject steam

Place in COP tank


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Transfer Points

Interim or Temporary LocationsHarboring the Organism

Transfer PointsTransfer Points

Interim or Temporary LocationsInterim or Temporary LocationsHarboring the OrganismHarboring the Organism


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S i ifi M h dS i tifi M th dS i tifi M th d


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Scientific MethodScientific MethodScientific Method

1. Determine Growth Niches

2. Define Levels of Disassembly

3. Implement Effective of Sanitation

Process Control

1. Determine Growth Niches

2. Define Levels of Disassembly

3. Implement Effective of Sanitation

Process Control


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Normal cleaning andsanitation

Seek and Destroy Process

Observe flood


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Observe assembly

Observe Post assembly sanitizerapplication

Observe flood

sanitization

Disassemble to normal dailysanitation level

Inspect and swab

any suspect areas

Disassemble any remainingmachine components

Observe normal setup andstart up activities

Stop operation before product

is placed on the line

If APC growth is supported then

the suspect area is a potentialgrowth niche

If area is Ls positive then itis a growth niche

Are cleaningmethods

acceptable?

Is degree of

disassembly

acceptable?

Are all parts and

components being

adequatelysanitized (chemical

or heat)?

Clean and flood or heat sanitize alldisassembled line components

Are GMP's

followed?

Evidence of

unacceptable

organicbuildup?

Product transportTime Study Locatinga Transfer


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Process 1

Process 2

Process 3

Process 4

Operator toolsLine workers

MaintenanceMaterials

Sample everything coming to line

A Time Studyconsists ofsampling the linecomponents and

every thing thatcomes to the lineover a period of time

The Time Studytypically starts

during setup andassembly . Samples

will be taken as

workers and productcome to the line,

repeated after line is

running then every 2hrs thereafter

a Transfer

Vector


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Swat Team SamplingSwat Team SamplingSwat Team Sampling Sample during an idle period after sanitation,

before production i.e. Saturday when no

production is running

Sample large areas using sponges or gauze. Sample areas not typically sampled during

routine sampling

We found a transient growth niche using thismethod COP basket handle

Sample during an idle period after sanitation,

before production i.e. Saturday when noproduction is running

Sample large areas using sponges or gauze. Sample areas not typically sampled during

routine sampling

We found a transient growth niche using thismethod COP basket handle


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Listeria EquationListeriaListeria EquationEquation

ControlledTrafficPatterns

ControlledTrafficPatterns

Clean, DryUncracked

Floors

Clean, DryUncracked

Floors

EffectiveSanitationProceduresControls

EffectiveSanitationProceduresControls

SanitaryDesignEquipBuilding

SanitaryDesignEquipBuilding

GMPsGMPs++

++++ ++

== ListeriaControlListeriaControl

SummarySummarySummary


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Summary

Requirements for an EffectiveListeria Control Program

SummarySummary

Requirements for an EffectiveRequirements for an EffectiveListeriaListeriaControl ProgramControl Program

The Sanitation process has been proven effective

The Sanitation process and Sanitary ManufacturingOperating Procedures are defined and repeatable.

General employee and Sanitation Operator Trainingprograms clearly define and effectively communicate

the process requirements necessary to maintainmicrobiological control.

The Sanitation process has been proven effective

The Sanitation process and Sanitary ManufacturingOperating Procedures are defined and repeatable.

General employee and Sanitation Operator Trainingprograms clearly define and effectively communicatethe process requirements necessary to maintainmicrobiological control.



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Summary


SummarySummary


Trained operators are used at each essentialstep.

If a new problem emerges, the monitoring and

corrective action process will identify and

direct the Corrective Action Team towards the

location of the growth niche.

Trained operators are used at each essentialstep.

If a new problem emerges, the monitoring and

corrective action process will identify and

direct the Corrective Action Team towards thelocation of the growth niche.



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Summary


SummarySummary


Random isolated strikes are proven to not be

repeatable.

Consumer safety is assured by product sampling if

process control appears to be violated. Growth niches in any location within the Exposed

Product Area are identified and are either eliminated

or managed.

Random isolated strikes are proven to not be

repeatable.

Consumer safety is assured by product sampling if

process control appears to be violated. Growth niches in any location within the Exposed

Product Area are identified and are either eliminated

or managed.

SummaryRequirements for an Effective

SummarySummaryRequirements for an EffectiveRequirements for an Effective


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Requirements for an Effective

Listeria Control Program

Requirements for an EffectiveRequirements for an Effective

ListeriaListeriaControl ProgramControl Program

The environment within the Exposed Product Area is

controlled to minimize microbial outgrowth.

Multiple barriers or hurdles create a torturous pathway

to minimize the possibility of entry by a pathogenicorganism from outside the Exposed Product Area.

Monitoring Programs consisting of contact surfaces aswell as environmental sites are designed to validate the

effectiveness of the control efforts as well as proficiency

of the indicator sites to predict loss of control

The environment within the Exposed Product Area is

controlled to minimize microbial outgrowth.

Multiple barriers or hurdles create a torturous pathway

to minimize the possibility of entry by a pathogenicorganism from outside the Exposed Product Area.

Monitoring Programs consisting of contact surfaces aswell as environmental sites are designed to validate the

effectiveness of the control efforts as well as proficiency

of the indicator sites to predict loss of control



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Summary


SummarySummary


Physical transfer of microorganisms within theExposed Product Area is addressed by the presenceof multiple hurdles.

Additions or changes to the process or equipmentwithin the Exposed Product Area are monitored andqualified to not introduce or harbor microorganisms

Physical transfer of microorganisms within the

Exposed Product Area is addressed by the presenceof multiple hurdles.

Additions or changes to the process or equipmentwithin the Exposed Product Area are monitored andqualified to not introduce or harbor microorganisms

listeria_intervention_and_control NSWFA

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