(Industrial)

Microbiology Risk Assessment

Dr Nicholas Johnson

ILSI Europe 2014 Annual Symposium

20-21 March 2014

Nestlé, CH

Agenda

• Nestlé team

• Overview of MRA

• Examples of Industrial MRA in Nestlé

2

Food Safety Microbiology (FSM)

P 3

Emerging microbial issues

Address relevant microbiological issues by

understanding the impact of emerging pathogens on

the food chain and on human health and how to

prevent contamination of the food supply

Microbiological risk

assessment Provide:

- Risk assessment methodologies & tools

- State of the art risk assessments to allow

science-based management

Microbiological Product Safety and Quality

Policy

Standards

HACCP

Good Manufacturing

Practices

Risk Assessment and Management

4

Risk Assessment

Risk Management

Risk Communication ALOP

PC

PrC & PdC

FSO/PO

• Governmental policy

defines generic ALOP

• Standards are developed

from the ALOP for specific

foods (via MRA?)

• Specifications, heat

treatments, reduction targets,

FSO

• Operational control

measures derived from

these Criteria

5

Examples of Governmental

MRA studies

Canada

Campylobacter jejuni in fresh

poultry

Salmonella spp. in cracked eggs

L. mono… in raw milk cheese

E. coli O157:H7 in ground beef

Toxoplasma gondii in pork

WHO/FAO

Salmonella Enteritidis in eggs

Salmonella spp. in broilers

L. monocytogenes in RTE foods

Vibrio spp. in seafood

Campylobacter spp. in broilers

USA

Salmonella in shell eggs

Vibrio para…. in raw oysters

Listeria in ready-to-eat retail foods

E. coli O157:H7 in ground beef

Netherlands

Bacillus cereus in pasteurised milk

Campylobacter spp. in broiler chicken

E. coli in steak tartare

B. cereus in vegetable puree

6

JEMRA Output: CCFH use:

MRA content and outputs •Hazard Identification

•Exposure assessment

•Hazard characterization

•Risk Characterization

Nestlé primarily performs Exposure Assessments

or “Safety Assessments”

Hazard identification: identification of biological hazard capable of causing adverse health effect

which may be present in particular food or group of food

Exposure assessments: assessing presence, survival and growth of pathogens in food during and

after production, in order to control the microbiological hazard until time of consumption

End point: Safe Product and Process design… for the safety of our Consumers

Proportion of population affected e.g. Illnesses linked to a specific hazard and food product per 100,000 per year

Chance of a single consumer becoming affected e.g. probability of illness for specific sub-pop, hazard and food product per serving, event or year

Ranking Hazards and Product or Process choices by risk

Impact of choices «What if…?»

Types of MRA

• Reactive – Proactive

• Qualitative –

Quantitative

• Deterministic -

Probabilistic

• Level of ‘Robustness’

• Safety – Spoilage

• Microbiological and

Chemical risk

8

Reactive

• Incidents

• Form basis for rapid assessment of

consumer risk

• Decision-making tool

• Toll House cookie dough and STEC

incident

• 2009-2010

• >60 confirmed cases

• Root-Cause Analysis

9

Reactive - incidents

• MRA can supplement expert opinion in crises RCA

• MRA provides insight and likelihoods for consequences

• RA focused and communicated through tools such as Event Tree

Analysis, FMEA, BowTies and Fishbones

• Nestlé complemented on crises management and investigative

approach

10

Solution

Procedures

People *with access to

the factory

Raw materials EquipmentEnvironment

Maintenance

Food and equipments not covered / separated during maintenance

Lack of release procedures of equipment after maintenance

No dedicated maintenance tools in the different areas

Improper cleaning

Inadequate / Improper personal hygiene

Inadequate cleaning & sanitizing procedures (no validation of efficiency)

No dedicated cleaning tools/equipment for the different areas (brushes mops, squeezes, utensils,...)

Lack of release procedures of equipment after cleaning

Manufacturing practices

Bad handling of reworks

Insufficient chlorination of water

Breakdowns during production process and delay in further steps (favourable for microbiological growth)

Contamination from raw materials packaging during tipping / batching

Improper handling procedures of non conforming goods

Insufficient quality monitoring controls

Improper sampling procedures (environmental & microbiological)

Inadequate / improper pathogen monitoring

Lack of trend analysis

No or inadequate microbiological methods

Building

Leaking roof, pipes, condensation, uncleaned roof (build up of dirt on roofs)

Healthy carriers

Sick people at work

People associated with cattle, farms, fields & handling manure,etc

GMP violations (cause:

lack of training and reinforcement)

Insufficient personal hygiene (failure of handwashing, etc.)

Sanitation practices not followed in production area

Improper traffic flow of employees in between

factories, production areas, zones (high risk to low risk)

Quality of raw materials Microbiological hazards not identified

Lack of quality monitoring at suppliers

Cleaning procedures not implemented / followedTransport

Unsuitable transport for food

Contamination from previously transported goods

Lack of/Improper cleaning of bulk transport

Damaged packaging

Tampering

Reception

Lack of visual inspection during unloading & of COA

Acceptance of non-conforming raw materials

Cleaning Residue build up

Validation of cleaning procedures not performed

Installation and equipment design

Hollow bodies / dead ends

Difficult to clean areas

Configuration of the line (discharge valves too close to floor)

Product exposed to water (leaks, drips, condensation)

Product exposed to dust (air flows, filters, process air)

Maintenance

Holes, cracks etc not fixed

Dirty spare parts

Water leakages not fixed (e.g. double jacket vessels, pipes, heat exchangers, etc)

Release of equipment / line after maintenance without sanitation

Packaging material for finished product

Use of non approved suppliers

Storage

Condensation inside silos or bulk storage

Water leakages (roof, building) in storage rooms/silos

Air filters in poor condition

Dissemination of contamination by pest

Lack of separation of non conforming raw materials

Dirty air ducts / filters

Improper pest management

Improper zoning and flows (product/people/tools/wastes/...)

Improper air flow

Gaps (holes) in roof, walls

Stagnant water on floor

Improper design, location & maintenance of drains

(too close to production line & equipment)

Operations

Improper cleaning of production areas

Construction work during this period

Wastes not collected, separated & disposed properly

Extreme weather conditions (heavy rains, ice storms, etc.)

External

Fertilizing farm fields with manure in surrounding areas

Location of effluent treatment close to factory

Bad handling/storage practices leading to contamination between raw materials

Water (ingredient and cleaning)

Water backflows between facilities, dead ends,...

Insufficient chlorination

Biofilms in pipes and at point of use

Excessive organic matter

Contamination of equipment during maintenance

Manufacturing process Inadequate process parameters

Change over in between shifts or products

Too long run times / down times

Improper rework handling

Improper production schedules and sequences

Intermediate product storage time / temperature abuse

People disseminating contamination

(between plants)

Maintenance team

Cleaning crew

Pest controllers

Waste removal crew

Nearby irrigation with contaminated surface water

Slaughter house, rendering nearby the factory

Waste collectors visiting different facilities

Lack of specifications to the suppliers

Use of approved suppliers but not audited

Raw material reception procedures not in place/followed

Lack of sampling, monitoring, verification and release procedures

Improper choice of chemicals used for sanitation

Equipment transfer between facilities without sanitation and release

Quality/laboratory team

New raw materials introduced for R&D/AG trials

R&D/AG team

Proactive - Hazard Identification

p.

11 FrD/FSM/QS/NRC 2011-11-25

•~ 500 Nestlé factories and NQAC laboratories

•Over 200 000 analyses per day (FP, Environment, Lines, RM)

•Global system to collect the data (SAP)

•TIC: database on prevalence of hazard in RM = Tools for Identification of Contaminants

14 microbial hazards and almost 4,800 raw material-process classes = >66,000 qualitative exposure levels

Proactive – selection of hazard

targets for novel process validation

• Where to spend

resources?

• New processes/recipes

• Ranking of hazards

based on Isolations

and

Incidents/Outbreaks

• Objective and

Subjective criteria

• Similar exercise

undertaken for spoilage

micro-organisms 12

Proactive – Deterministic/Probabilistic

13

Product Category PC number PC code

Base 1 B dried whey and SW-40 whey

RTU 2 R sweetened condensed milk

Aerated / emulsion 3 A Na-caseinate and whey protein

Gravy 4 G dried whey and whey protein

Particulate 5 P dried whey

Unusual 6 U

FI concentrate 7 F

Ingredient RM group B U R A G P F

Salt 9 0 0 1 3 1 5

Meat / veg (cooked) 8 0 0 0 6 0 12 14

HVP 4 0 0 0 0 0

Dairy 5 0 0 1 0 0

Flavours 7 0 0 1 0 0 0

Sweetners / sugars 6 9 7 24 2 0 1 11

Starch / flour 3 0 0 0 0 2 0 0

Oil / fats / shortening 9 1 0 1 30 3 0 1

Stocks / juices / broths 9 0 0 1 0 0

Dried herbs / spices / veg / fruit 2 0 0 0 0 1 0 5

Cocoa powder 1 0

Morsels 9 0

Stabilisers (gums/emulsifiers) 3 0 0 1 0 0

Yeast extract 7 0 0 0

56

None

None

Dairy component Maximum likely consumed portion (g)

12

60

30

30

118

236

% in recipe

• Which raw materials

pose most risk?

• Which products pose

most risk?

• Product / Process

design changes

needed to manage risk

+ volume for SKUs

+ contamination levels for each

raw material Risk ranking of RMs

Unusual Base Gravy Aer / emul Flav In Part RTU

1 4 2 6 3 7 5 PC order

1 1 7 7 6 6 7 5 5.6 7

2 4 6 2 3 1 2 4 3.1 2

3 2 4 1 1 3 1 2 2.0 1

4 3 1 3 6 4 3 5 3.6 3

5 6 2 6 2 6 6 5 4.7 6

6 5 5 5 4 2 5 1 3.9 4

7 6 3 4 5 5 4 3 4.3 5

8 -

FP Ranking 1 4 2 6 3 7 5

RM groups

Overall

risk

ranking

Spoilage – Proactive / Probabilistic • Modelling an Aseptic-UHT

process

• Estimating spoilage risk

from Product and Process

design

Improved operational

setting

Improved design

Training tool

Early product release

Cost-effective monitoring

schemes

RCA analysis tool

14

• 4 micro-organisms

• 130 inputs • 50 probabilistic covering variability/uncertainty

• Modular process model • Heat inactivation/survival, planktonic/biofilm growth and

colonisation, aerial sedimentation, chemical disinfection etc

Raw Materials product

(H0)

MODULE 1

UHT Treatment (∑R)

MODULE 2

Aseptic tank

(∑I = ∑G + ∑C)

MODULE 3

Raw Materials packaging

(H0)

MODULE 4

Sterilization

(∑R)

MODULE 5

Packaging after sterilization before

filling

(∑I = ∑C)

MODULE 6

Product during filling

(∑I = ∑C)

MODULE 7

Product after filling before sealing

(∑I = ∑C)

MODULE 8

Sealing and Storage

(∑I = ∑G + ∑C)

MODULE 9

N4k N1

k

N5k N2

k

N6k N3

k

N7k

N8k

N9k

Spoilage – Ranking using Scenarios

• 30 scenarios

• Risk management

prioritization, e.g. • Ingredients, UHT settings,

filter cycling, cleaning-in-

place, hygienic design etc

• Data gaps

15

Country

Europe

S. America

Raw material

Nb Batch before cleaning

Risk 1

Risk 2

Risk 3

Risk 4

Risk 5

Risk 6

Risk 7

Risk 8

Lowest

Highest

Pujol et al. 2014 IJFM submitted

Conclusions

• Within Nestlé, Industrial MRA is mainly

applied in a ‘safety assessment’ format

• Qualitative, deterministic, concise

• Ad hoc application of in-house tools; TIC,

growth and inactivation models, Monte Carlo

tools

• Highly complex, probabilistic QMRA

approaches are used, but only if….

• Specifically warranted – cost/benefit

16

www.ilsi.eu

Thank you!