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  • UNILEVERSEAC - Risk Analysis Group

    Colworth House, Sharnbrook,

    United KingdomLEON.GORRIS@UNILEVER.COM

    Operational food safety Operational food safety

    management based on riskmanagement based on riskLeon Gorris

    Wageningen-UREuropean Chair in Food Safety Microbiology

    Wageningen University & Research

    P.O. Box 8129 6700 EV Wageningen

    The Netherlands

  • 2

    Basis of safe food production

    Risk based metrics linked to HACCP

    Some examples of how to use / meet risk metrics

    Risk-based food safety management: industry impact

    Outline

  • 3

    A food industrys view on food safety

    Food safety is a given; it is non-negotiable and non-competitive.

    Safe performance of foods on the market needs to be assured.

    We take on board guidance / learning's from public bodies to

    optimise product safety.

    Industries share knowledge & technologies regarding safety.

    For industry to be competitive, requires major innovations and

    ideas that attract customers.

  • 4

    Good Practices (GAP,GMP,GHP)Good Practices (GAP,GMP,GHP)

    H A C C PH A C C P

    Food Safety Control (Risk Management):

    high level, generic

    policy bases guidance

    specific standards, criteria

    Operation level

    Country level

    Food Safety Management:

    Local, specific management

    at supply chain level

    INCLUDES ALL HAZARDS

    StandardsStandards

    PolicyPolicy

    Public & Private roles Management of Food Safety

  • Food Safety Assurance

    Chain of events:

    Establish Safe Product + Process design

    Validate design from lab-, over pilot- to operational-scale

    Implement design in operational management systems

    Verify control during manufacture

    Monitor & Review as appropriate

    But what is / are the benchmark(s) to design safe food against?5

  • Benchmarks?

    Governments are responsible for articulating food safety

    requirements

    They may do this

    - in general terms: industry is responsible for providing safe and

    wholesome food,

    - by strongly recommending certain process criteria (2, 70C) or

    product criteria (pH < 4.5),

    - or by mandating microbiological criteria for final products at some point

    in the food supply chain.

    However, it is difficult to directly relate in-chain values or

    general guidance to the actual safety of final food products

    6

  • Evolution of Food Safety Management

    Governmental / societal drivers evolved food safety management

    to provide:

    More effective and efficient protection of public health

    Necessary tools to prioritize resources, considering health impact

    More responsibility & accountability to industry

    Flexibility in measures to control food safety concerns

    From HAZARD based to RISK based decision making

    From IN CHAIN to END OF CHAIN quantitative guidance

    7

  • 8

    Good Practices (GAP,GMP,GHP)Good Practices (GAP,GMP,GHP)

    H A C C PH A C C P

    Food Safety Control (Risk Management):

    high level, generic

    policy bases guidance

    specific standards, criteria

    Operation level

    Country level

    Food Safety Management:

    Local, specific management

    at supply chain level

    INCLUDES ALL HAZARDS

    StandardsStandards

    PolicyPolicy

    ALOP - FSO - PO - PC

    Improved connection of public and private roles

  • 9

    Basis of safe food production

    Risk based metrics linked to HACCP

    Some examples of how to use / meet risk metrics

    Risk-based food safety management: industry impact

    Outline

  • primary

    productionmanufacturing retail Preparation / cooking for consumptiontransport

    Explicit, risk-based guidance of levels of a hazard not to be surpassed

    Operational actions, building onto HACCP and Good practices

    Country level

    Operational food chain level

    Micro

    criterion

    Food Safety

    ObjectivePerformance

    Objective

    Exposure

    Performance

    standard

    Performance

    Objective

    Performance

    criterion

    Performance

    criterion

    Performance

    criterion

  • How to work with the risk-based metrics?

    11

    Primary

    production

    (step 1)

    Process 2 Packaging Transport

    (step 3)

    Process 1

    Manufacturing (step 2)

    Step 1

    Performance

    objective (PO)

    Step 2

    Performance

    objective (PO)

    Retail

    (step 4)

  • How to work with the risk-based metrics?

    12

    Primary

    production

    (step 1)

    Process 2 Packaging Transport

    (step 3)

    Process 1

    Manufacturing (step 2)

    Step 2

    Incoming

    Hazard level

    (H0)

    Step 2

    Performance

    objective (PO)

    Retail

    (step 4)

    Step 2

    Performance

    Criterion (PC)

    Process criteria: e.g. pasteurisation or sterilisation time/temp

    Product criteria: pH, aw, salt, acid, etc

    Control measures: e.g. refrigeration, control of cross-contamination, education

    HACCP

  • How to work with the risk-based metrics?

    13

    Primary

    production

    (step 1)

    Process 2 Packaging Transport

    (step 3)

    Process 1

    Manufacturing (step 2)

    Step 2

    Incoming

    Hazard level

    (H0)

    Step 2

    Performance

    objective (PO)

    Retail

    (step 4)

    Step 2

    Performance

    Criterion (PC)

    H0 - R + I PO or FSO

    1Microbiological testing in Food Safety Management, ICMSF (2002); Book 7

  • 14

    Integrating steps along the food supply chain

    FarmProduction &

    distributionKitchen

    H0- R + I PO

    H0-R +I PO

    H0-R +I FSO

  • Designing safe foods

    n Expertise, scientific and technical knowledge

    n Historical evidence (products with history of safe performance)

    n Product design performance simulation

    - Predictive mathematical modelling

    - MRA approaches & techniques for exposure assessment

    n Validation of design

    - Predictive mathematical modelling

    - Challenge and shelf-life tests

    n Benchmarks

    - regulatory requirements (Micro-criteria, Performance standards)

    - Industry standards (Performance standards)

    - FSO/PO/PC as product safety targets for design.

    15

  • 16

    Role of FSO-PO-PC hierarchy in designing safe foods

    Allows for a quantitative benchmark that integrates the

    performance of the whole food supply chain,

    disregarding its make-up..

    The FSO gives the hazard level that should not be

    surpassed in the food at consumption..

    The various players in the food chain can then

    establish what the maximum hazard level can be at

    the output of the step that they control (H0; PO).

  • Designing a safe food at a step in the food chain

    17

    What do we need to know?

    what level of hazard is tolerable in the output of the particular step

    (= PO) or the end of the chain (= FSO) ?

    how much contamination (level of the hazard) is associated with

    the incoming material (H0) from the previous step: e.g. through

    ingredients, intermediate products) ?

    What is then the overall inactivation required or the tolerance to

    increase (by survival/growth/recontamination) at that step (PC)

    Knowing the PC, choose the control measures (CM) that deliver

    this, which need to be build into GHP/GMP & HACCP

  • HACCP basics.

    Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.

    Monitoring: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.

    Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.

    18

    Design stage

    Production stage

  • 19

    H0 - R + I PO or FSO

    Fermented meat product:Developing control measures and aspects of the HACCP plan

    Initial load (raw material)

    Sum of reductions by processing / conditions

    Sum of increase/growth opportunities

    Target value for design

    PC

    Values to be given are in 10log

  • Hierarchy of Risk Management Options

    20

    Food SafetyObjective

    PerformanceObjective

    PerformanceCriteria

    Process/ProductCriteria

    Target max. level at consumption

    Target max. levelat specific step

    Required control

    on H0 at specific step

    Specific process orProduct conditions

  • 21

    Food SafetyObjective

    PerformanceObjective

    PerformanceCriteria

    Process/ProductCriteria

    Target max. level at consumption

    ?????

    5D reduction in H0

    ?????

    Target organism is E.coli O157:H7

    Fermented meat product:Developing control measures and aspects of the HACCP plan

  • 22

    Reducing the level of the hazard, worst case initial level

    PO/FSO

    0

    10

    20

    30

    40

    50

    60

    70

    80

    90

    1/10Kg 1/Kg 1/100g 1/10g 1/g 10/g 100/g 103/g 104/g 105/g

    Frequency and/or Concentration of Hazard

    Case s per 100,000

    Applying a R of 5 logs, brings the hazard level from +3 (H0

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