SEEK & DESTROY PROCESS

Microbiological Process Control

John Butts Ph.D

United Fresh - PMA

Listeria Workshop

July 2017

Learning Objectives

• Seek & Destroy Process

- Tools of our Trade

• Operational Definitions

- We need a common language

• Sampling Programs can have Differing Purposes

- For Cause vs Not For Cause

• Effects of Sampling Programs Can Help Create or Hurt Development of the Desired Food Safety Culture

- The Purpose of Food Safety Management is not to Create Programs, but to Create The Desired Food Safety Culture

• Maturity Models

LET’S LOOK AT THE TYPICAL ENVIRONMENTAL CONTROL PROGRAM

Today with many, yesterday with a few

Typical Environmental Monitoring Program

• List of sites in Zone 2 & 3

• Sites are selected randomly

• Some sites sampled weekly, some monthly- Positive results initiate intensified sanitation followed by For Cause

Investigation

• Verification by 3 Ls- in a row

• Infrequent periodic investigation sampling outside of above program- Positive results initiate intensified sanitation followed by For Cause

Investigation

• Verification by 3 Ls- in a row

• Zone 1 and Product sampling done with extreme caution

SEEK & DESTROY PROCESS

Deploys Investigative Sampling, Indicator sites as well as Verification Sampling

7

Production Dry clean

Setup

When to Sample ?

Sampling Objective

Rinse

Foam

Sanitize

Break

Assemble

Inspect

Sanitize

Rinse

Break

Break

Break

Break

Production

Production

Production

Production

DisassembleVerify Control Looking for LS

Growth Niches

Effectiveness of Sanitation

Verification Monitoring Program

Find the organism in motion as it is being transferred from a harborage site to the product

• Routine program to verify the effectiveness of the sanitation process control program; includes sampling of:

- Product

- Zone 1, 2, and 3 environmental sites during operation in the RTE area. This program is used for regulatory compliance • Part of the USDA establishment’s HACCP or SSOP program

• For FDA plants, measures the effectiveness of the Preventive Controls deployed

Pillars of Microbiological Process Control Technology

1. Eliminate the organism from Exposed Product Area

2. Control Transfer of the Organism

3. Deploy Process Management Techniques

These work whether you have a kill stop or not to

eliminate any persistent resident strain

Eliminate the Organism From the Exposed Product Area

Operational Definition

Corrective and Preventive Action

• Harborage site(s) located

• Organisms in Harborage sites eliminated with an intervention

• Site(s) either redesigned to eliminate growth niche or managed with Preventive or Predictive Intervention

[Seek]

[Destroy]

[Process]

Prevent Movement of the Organism

Plot Pathways of Movement• Common Vectors

- People

- Equipment

- Materials

- Product

Mark on a plant blueprint with equipment in place each of these vectors. The marked pathways define the primary Verification site locations.

• Drains

- Next plot water flow from sources to drains

Plot Pathways of Movement• The marked pathways define the primary

Verification site locations.

• Flow from source to drains defines pathway of movement to drain.

• The top surface and floor juncture of drains are included as Verification Sites

Control of Transfer Vectors

Sanitary Design 101

• Distinct Hygienic Zones are established in the facility

• Physical separation (raw from RTE) or from one hygienic zone to another

o Personnel, equipment & material flows are controlled to reduce hazards:

• Water accumulation is controlled inside the facility

• Sanitation GMP’s

• Operational GMP’s are designed and executed to establish control and to prevent cross contamination from hygienic zone to hygienic zone and to control the movement of the organism within a hygienic zone.

Adequate hurdles (e.g., doorway foamers, boot washers) are provided at locations as required to maintain zones of control

Barrier wall

Receiving - Storage

Gow

ning

room

with

sole

scru

bber

Conv

eyor

to

flume

Dump

er

Barrier wall

Gow

ning

room

with

sole

scru

bber

2nd

flume

First

flume

Barrier wall

Gow

ning

room

with

sole

scru

bber

Product Prep

Dice, Comitrol etc.Mix

Conv

eyor

to

flume

Dump

er

2nd

flume

First

flume

Product Prep

Dice, Comitrol etc.

Fillin

g a

nd

Pa

cka

gin

g

Barrier wall

Fillin

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g

Fillin

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ing

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Pro

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Initial Veg Prep

Secondary Packaging

Cartoning, Casing and

Palletizing

Secondary

Veg Prep

Filling and Packaging

Zo

ne

s w

ith n

o w

oo

d o

r ca

rdb

oa

rd

Barrier Wall Concept with Zones of Risk Control

Receiving

Initial Prep

Packoff

Filling – Pkging

Secondary Prep

Process Management

We’ve all heard:

You are not sampling hard

enough, if you are not

finding positives

Operational DefinitionsFor Cause InvestigationThe purpose of a For Cause Investigation is to find the root cause of a Verification Site positive

- A For Cause Investigation is triggered by a Verification Program positive (Product, Z1, Z2 or Z3)

– Verification program by definition measures the effectiveness of the plant’s Sanitation Process Control System or the Environmental Control Program

- Example:

• Food Safety has been compromised by a product positive

• Food Safety may be potentially compromised by a Z1 Ls positive

• Investigation following a Z2 or Z3 Ls Verification Site positive

For Cause Investigation is conducted in response to a positive finding that calls into question the effectiveness of the control system

The Effect of Verification Driven

Control

Contact Surface Positive

Product Positive

Verification Site Positive

Food Safety System

Failure

- Reassess

POSITIVES CAN BE A SUCCESS!

Define Indicator Sites that are Early Warning Predictors of the Loss of Control

We want a reason to buy pizza!

Sampling Methods to Control

Environmental Pathogens

Pathogen Control

Verification Monitoring

Indicator Sites

Operational Definitions

Preventive Control (Not For Cause) Investigation

• Food Safety has not been compromised

- Examples:• Samples taken to find a new growth niche

• Samples taken to find a new transfer vector / pathway

• Samples taken to establish or qualify a hurdle or barrier system

• Samples taken to establish a monitoring procedure or process

• Samples taken to assess or characterize risk of a control procedure, part of facility or process change

Operational Definitions

Preventive Control (Not For Cause) Investigation

• Food Safety has not been compromised

- Examples:• Can be triggered by a Z2, Z3 or Z4 indicator site positive.

– These indicator sites are strategically located in close proximity to a known growth niche, barrier or hurdle. Movement of the organism from the indicator site through a verification site or area would be required before violation of food safety.

– These indicator sites over time measure the strength of the barrier or hurdle or the effectiveness of the management of growth niches

Operational Definitions

Preventive Control (Not For Cause) Investigation

• Food Safety has not been compromised

- Examples:• Seek and Destroy Investigation on a new piece of equipment to

develop sanitation methods and identify potential areas of risk

• Seek and Destroy Investigation on a piece of equipment that has been in operation without any linked Verification positives. The purpose of this investigation is to measure effectiveness of sanitation methods below the normal level of disassembly.

• Investigative sampling to identify optimal locations for placement of indicator sites in either Z3 or Z4

• Measurement of risk in Z4 area

1. The punitive effect of “Verification Only” monitoring

programs

a) Creates excessive firefighting

b) Fails to promote a “Preventive Mindset” and a strong Food Safety

Culture

2. Sampling Programs can be designed to create “success”

when positives are found.

3. Aggressive sampling techniques can aid in discovering

problems before contact surfaces or product are engaged.

4. Data from Sampling Programs is used to measure the

application of Preventive controls

Cause & Effect

“Nothing succeeds like success”Alexandre Dumas

Sources of Ls in High-Risk RTE Area

• Transferred from Zone 4 area outside of the High-Risk RTE area- Homeless, but looking for a harborage location

- Typically found with a transfer point monitoring positive

- On incoming product

• Growth niches within High-Risk RTE area1. This means they are established, and have found 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.

Seek and Destroy

• Systematic approach to finding sites of persistent growth ("niches") in food processing plants

• Environmental sampling with follow up on every positive sample

• Goal is to either eradicate or mitigate effects of niches• Seek and Destroy can be applied to specific equipment (e.g.,

new equipment qualification) or the facility as a whole

INVESTIGATION METHODS

Tools in your toolbox

Complete Disassembly

THE EVOLUTION OF THE S&D PROCESS

Doubtful to Internalized

The Food Safety Culture Journey

Enlightenment

Awareness

Preventive

Internalized

Firefighting Intensity

Credit to Dr. Lone Jespersen

Formerly Maple Leaf Foods

now Cultivate Food Safety

Predictive

Seek & Destroy Maturity Model

Listeria Control in Processed Meats

Stage 1

Doubt

Stage 2

Awareness

Stage 3

Enlightenment

Stage 4

Preventive

Stage 5

Predictive

No testing or

only testing

as required to

meet

regulatory

requirements

Think “Blue

Bell”, Bars and

Stripes…..

Initially sampled

finished product,

then some contact

surfaces and

environmental sites

Environmental

sampling and

corrective action

resulted in giving the

drains to Listeria.

Growth niches

recognized in

both equipment

and facilities

Interventions

developed and

applied to

manage growth

niches. Sanitary

design applied to

eliminate.

Comprehensive

indicator site process

controlling facility

and equipment

growth niches

combined with

hurdles and barriers

to control transfer

pathways.

Indicator sites used

to measure risk and

signal when to apply

intervention or

strengthen hurdle

Listeria Control in Processed MeatsThere has been no linked illness or death from a US federally

inspected plant since 2003

Stage 1

Doubt

Stage 2

React to

Stage 3

Know of

Stage 4

Predict

Stage 5

Internalize

No testing or

only testing

as required

to meet

regulatory

requirements

Sampled finished

product

And contact surfaces

Environmental

sampling and

corrective action

resulted in giving the

drains to Listeria.

Growth niches

recognized and

harborage sites

either redesigned or

managed with

interventions

Interventions

applied when

needed based

on indicator

sites

Comprehensive

indicator site process

controlling facility

and equipment

growth niches

combined with

hurdles and barriers

to control transfer

pathways

TimeframeMid 80’s to

early 90’s

90’s Late 90’s to early 2000

AMI Lm workshop

started in 2000

AMI Board declared

Food Safety non-

competitive in 2001

Mid 2000’s 2010

Maturity Model

Listeria Control in FDA Regulated Production

Stage 1

Doubt

Stage 2

Awareness

Stage 3

Enlightenment

Stage 4

Preventive

Stage 5

Predictive

No testing or

only testing

as required to

meet

regulatory

requirements

Think “Blue

Bell”, Bars and

Stripes…..

Zone 2 & 3 sites

randomly sampled.

Positive results

trigger intensified

cleaning of affected

area followed by

investigative vector

sampling.

Most of sampling

done at preop or

early in production

run

Growth niches

recognized in

both equipment

an.

Some minor amt

sampling

towards end of

production

d facilities

Interventions

developed and

applied to

manage growth

niches. Sanitary

design applied to

eliminate.

Comprehensive

indicator site process

controlling facility

and equipment

growth niches

combined with

hurdles and barriers

to control transfer

pathways.

Indicator sites used

to measure risk and

signal when to apply

intervention or

strengthen hurdle

Maturity Model

Listeria Control in FDA Regulated Production

Stage 2

Awareness

Stage 3

Enlightenment

Stage 4

Preventive

Stage 5

PredictiveHygienic

Zoning

Product stream

only. Perimeter

hurdles applied

equally

Recognition of more

positives in less

processed areas.

Product streams of

varying risks

comingled

Products of varying

risk separated.

Physical barriers

with hurdles

separate processes

as microbial

reduction occurs

Comprehensive indicator sites

measure effectiveness of

hurdles and barriers to

control transfer pathways.

Indicator sites used to

measure risk and signal when

to apply intervention or

strengthen hurdle

Maturity Model

Listeria Control in FDA Regulated Production

Stage 2

Awareness

Stage 3

Enlightenment

Stage 4

Preventive

Stage 5

PredictiveHygienic

Zoning

Product stream

only. Perimeter

hurdles applied

equally

Recognition of more

positives in less

processed areas.

Product streams of

varying risks

comingled

Products of varying

risk separated.

Physical barriers

with hurdles

separate processes

as microbial

reduction occurs

Comprehensive indicator sites

measure effectiveness of

hurdles and barriers to

control transfer pathways.

Indicator sites used to

measure risk and signal when

to apply intervention or

strengthen hurdle

Hygienic

Zoning of

Transient

EquipmentUtensils, tools,

product

containers &

material handling

equipment

No separation Receiving equipment

separated from

packaging equipment.

Product containers

mostly comingled

among all zones

Interventions

developed for high

risk items. High risk

items separated

from other

processing areas

Hygienic zones established

with strict separation.

Interventions applied based

indicator sampling results for

large items. Scheduled

interventions for product

containers. Tools and utensils

have daily or more frequent

interventions applied.

Listeria ControlCurrent Products without a Kill Step

StageDoubtful React to Know of Preventive Internalize

Behavior:

QA Samples

not to find

organism.

Behavior:

Retesting of

positive sites

after

enhanced

sanitation at

positive site

Behavior:

Lots of firefighting.

Problems do not go

away.

Behavior:

Investigative facility based

positives dominate RTE.

S&D team actively seeks

out growth niches and

applies interventions. Z4

positives

Behavior:

S&D Team conducts Not For

Cause Investigations and

constantly monitors Indicator

Sites for trends.

Interventions applied when

and where data indicates

need.

Effects

drivenLooking for root

cause

Cascading hurdles Intervention

Hurdles and

Interventions:

Some minor

reduction

Hurdles and Interventions:

Whole genome sequencing

moves research to farm

and packing houses.

Preventive controls evolve.

Hurdles and Interventions:

Most significant issues are

addressed by preventive

measures

My P

erc

ep

tio

n o

f A

cti

vit

ies

Visual Evidence of the Maturity Level of Organizational Process Thinking &

Environmental Monitoring

Doubt

Firefighting. Ls+ repeatedly found but not eliminated

Interventions & Preventive measures and designs exist.

Root causes are identified.

Preventive practices are understood by the workforce as such

Process design is simplified.

Error rate is low

Variation is measured and managed

Enlightenment

Awareness

Preventive

Predictive

Firefighting

FOOD SAFETY CULTURE MATURITY DRIVES

“MICROBIOLOGICAL PROCESS CONTROL”

If employee line of sight is not created to the Company Mission and

Corporate Strategy then buy-in and a commitment to Food Safety is not

generated

“Culture eats Strategy for Breakfast”

MICROBIOLOGICAL PROCESS CONTROLDRIVES

“FOOD SAFETY CULTURE MATURITY”

-- or --

Summary of “Lessons Learned”

1. Growth niches can be identified and eliminated or managed.

2. Transfer points & pathways can be identified and their effect minimized with GMP practices

3. Sampling techniques such as post rinse sampling can aid in discovering problems before contact surfaces or product are engaged.

4. Sanitation Process Control “Critical Factors” can provide the basis for attaining and maintaining control of microbial contaminates in High-Risk RTE areas.

Summary of “Lessons Learned”

5. The regulatory environment is going to be very

challenging due to DNA linkage and new requirements

6. We must continually build our consumers confidence in

our Food Safety system

a) Food Safety incidents, Recalls, Bad Press in our Food Supply

System is bad for all in the System

i. None of us benefit by another’s loss of control

7. We must share “Best Practices and Preventive Designs”

Questions?

• Thank you Food Safety Consulting Focused to

Prevent

"John Butts"

foodsafetybydesign@gmail.com

219-718-5640

United Fresh

PMA Listeria

Workshop

July 2017