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    The New ISO 22000-2018

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    Zsuzsa Komló
    The document summarizes the major changes between the 2005 and 2018 versions of ISO 22000. Some key changes include: 1. Alignment with the High Level Structure which standardized the documentation format. 2. Inclusion of animal food and feed within the standard's scope. 3. Updates to definitions of terms like "significant food safety hazard", "control measure", and "critical control point". 4. Introduction of the concept of "operational prerequisite programs" and "action criteria" to complement critical control points. 5. Expanded guidance around hazard identification, assessment, and establishing controls in the hazard control plan.

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    The New ISO 22000-2018

    Uploaded by

    Zsuzsa Komló
    162 views74 pages
    The document summarizes the major changes between the 2005 and 2018 versions of ISO 22000. Some key changes include: 1. Alignment with the High Level Structure which standardized the documentation format. 2. Inclusion of animal food and feed within the standard's scope. 3. Updates to definitions of terms like "significant food safety hazard", "control measure", and "critical control point". 4. Introduction of the concept of "operational prerequisite programs" and "action criteria" to complement critical control points. 5. Expanded guidance around hazard identification, assessment, and establishing controls in the hazard control plan.

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    The document summarizes the major changes between the 2005 and 2018 versions of ISO 22000. Some key changes include: 1. Alignment with the High Level Structure which standardized the documentation format. 2. Inclusion of animal food and feed within the standard's scope. 3. Updates to definitions of terms like "significant food safety hazard", "control measure", and "critical control point". 4. Introduction of the concept of "operational prerequisite programs" and "action criteria" to complement critical control points. 5. Expanded guidance around hazard identification, assessment, and establishing controls in the hazard control plan.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    162 views74 pages

    The New ISO 22000-2018

    Uploaded by

    Zsuzsa Komló
    The document summarizes the major changes between the 2005 and 2018 versions of ISO 22000. Some key changes include: 1. Alignment with the High Level Structure which standardized the documentation format. 2. Inclusion of animal food and feed within the standard's scope. 3. Updates to definitions of terms like "significant food safety hazard", "control measure", and "critical control point". 4. Introduction of the concept of "operational prerequisite programs" and "action criteria" to complement critical control points. 5. Expanded guidance around hazard identification, assessment, and establishing controls in the hazard control plan.

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    At a glance
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    The key takeaways are that ISO 22000 has been aligned with the High Level Structure used in other ISO standards and now includes animal food and feed in its scope. Significant definitions related to food safety hazards, control measures, and critical control points have been updated.

    The definitions of Significant Food Safety Hazard, Control Measure, and Critical Control Point have been expanded in ISO 22000:2018 to provide more clarity. A key change is that a Control Measure must now prevent or eliminate a food safety hazard, whereas in ISO 22000:2005 it could also reduce the hazard to an acceptable level.

    An Operational PRP is a prerequisite program that is essential to control food safety hazards based on the hazard analysis, while a Control Measure is an action or activity used to prevent, eliminate, or reduce a significant food safety hazard. An Operational PRP may involve one or more control measures.

    The new ISO 22000

    Dr. David Rosenblatt


    Sher Consulting and Training
    Major changes compared to
    ISO 22000:2005
    High Level Structure (HLS) alignment
    Animal food and feed included in scope
    Significant Food Safety Hazard 2005
    Significant Food Safety Hazard 2005
    biological, chemical or physical agent in
    food, or condition of food, with the
    potential to cause an adverse health effect
    Significant Food Safety Hazard 2018
    biological, chemical or physical agent in
    food, or condition of food, with the
    potential to cause an adverse health effect
    Significant Food Safety Hazard 2018
    Significant Food Safety Hazard 2018
    food safety hazard, identified through the
    hazard assessment, which needs to be
    controlled by control measures
    Control Measure 2005
    Control Measure 2005
    action or activity that can be used to
    prevent or eliminate a food safety hazard or
    reduce it to an acceptable level
    Control Measure 2018
    is essential
    action or activity that can be used to
    prevent or eliminate a food safety hazard or
    reduce it to an acceptable level
    Critical Control Point (CCP) 2005
    Critical Control Point (CCP) 2005
    step at which control can be applied
    and is essential to prevent or eliminate a
    food safety hazard or reduce it to an
    acceptable level
    Critical Control Point (CCP) 2018
    a control measure is
    step at which control can be applied
    and is essential to prevent or eliminate a
    food safety hazard or reduce it to an
    acceptable level, and defined critical limits
    and measurement enable the application of
    corrections
    Operational PRP (oPRP) 2005
    Operational PRP (oPRP) 2005
    PRP identified by the hazard analysis as
    essential in order to control the likelihood
    of introducing food safety hazards to
    and/or the contamination or proliferation of
    food safety hazards in the product or in the
    processing environment
    Operational PRP (oPRP) 2018
    PRP identified by the hazard analysis as
    essential in order to control the likelihood
    of introducing food safety hazards to
    and/or the contamination or proliferation of
    food safety hazards in the product or in the
    processing environment
    Operational PRP 2018
    CM or combination of CMs applied to
    prevent or reduce a significant food safety
    hazard to an acceptable level, and where
    action criterion and measurement or
    observation enable effective control of the
    process and/or product
    Action Criterion 2018
    Action Criterion 2018
    measurable or observable specification for the
    monitoring of an oPRP
    Action Criterion 2018
    measurable or observable specification for the
    monitoring of an oPRP
    Note: an AC is established to determine whether an oPRP
    remains in control, and distinguishes between what is
    acceptable (criterion met or achieved means the oPRP is
    operating as intended) and unacceptable (criterion not
    met nor achieved means the oPRP is not operating as
    intended).
    CCP oPRP
    2018
    Control measure or
    Step in the process
    combination of CMs

    Critical limits Action criteria

    Measurement or
    Measurement
    observation
    Control of product or
    Control of product
    process
    CCP oPRP
    2018
    Control measure or
    Step in the process
    combination of CMs

    Critical limits Action criteria

    Measurement or
    Measurement
    observation
    Control of product or
    Control of product
    process
    CCP oPRP
    2018
    Control measure or
    Step in the process
    combination of CMs

    Critical limits Action criteria

    Measurement or
    Measurement
    observation
    Control of product or
    Control of product
    process
    CCP oPRP
    2018
    Control measure or
    Step in the process
    combination of CMs

    Critical limits Action criteria

    Measurement or
    Measurement
    observation
    Control of product or
    Control of product
    process
    CCP oPRP
    2018
    Control measure or
    Step in the process
    combination of CMs

    Critical limits Action criteria

    Measurement or
    Measurement
    observation
    Enable control of
    Enable correction
    product or process
    8.2 PRPs
    8.2 PRPs
    8.2.3 When selecting and/or establishing PRP(s),
    the organization shall ensure that applicable
    statutory, regulatory and mutually agreed
    customer requirements are identified.
    8.2 PRPs
    8.2.3 When selecting and/or establishing PRP(s),
    the organization shall ensure that applicable
    statutory, regulatory and mutually agreed
    customer requirements are identified. The
    organization should consider:
    a) the applicable part of the ISO/TS 22002 series;
    8.2 PRPs 1. Food manufacturing

    2. Catering

    3. Farming

    4. Food packaging

    6. Feed
    8.5 Hazard control
    8.5.1 Preliminary steps to enable hazard analysis
    8.5 Hazard control
    8.5.1 Preliminary steps to enable hazard analysis
    8.5.1.2 The organization shall maintain documented
    information concerning all raw materials, ingredients and
    product contact materials to the extent needed to
    conduct the hazard analysis, including the following, as
    appropriate:
    8.5 Hazard control
    8.5.2 Hazard analysis
    8.5.2.2 Hazard identification
    8.5 Hazard control
    8.5.2 Hazard analysis
    8.5.2.2 Hazard identification
    8.5.2.2.1 The organization shall identify and document
    all food safety hazards that are reasonably expected
    to occur in relation to the type of product, type of
    process and process environment.
    8.5 Hazard control
    8.5.2 Hazard analysis
    8.5.2.2 Hazard identification

    Hazards should be considered in sufficient


    detail to enable hazard assessment and the
    selection of appropriate control measures.
    8.5.2.2 Hazard identification
    2005
    Pathogens
    8.5.2.2 Hazard identification
    2005 2018
    Pathogens Introduction of pathogenic organisms resulting from human hand
    contact:
    8.5.2.2 Hazard identification
    2005 2018
    Pathogens Introduction of pathogenic organisms resulting from human hand
    contact:
    Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
    8.5.2.2 Hazard identification
    2005 2018
    Pathogens Introduction of pathogenic organisms resulting from human hand
    contact:
    Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
    Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
    8.5.2.2 Hazard identification
    2005 2018
    Pathogens Introduction of pathogenic organisms resulting from human hand
    contact:
    Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
    Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
    Fecal worms: A. lumbricoides
    8.5.2.2 Hazard identification
    2005 2018
    Pathogens Introduction of pathogenic organisms resulting from human hand
    contact:
    Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
    Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
    Fecal worms: A. lumbricoides
    Protozoic fecal parasites: C. parvum, E. hystolitica, C. cayatenensis
    8.5.2.2 Hazard identification
    2005 2018
    Pathogens Introduction of pathogenic organisms resulting from human hand
    contact:
    Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
    Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
    Fecal worms: A. lumbricoides
    Protozoic fecal parasites: C. parvum, E. hystolitica, C. cayatenensis
    Staphylococcus aureus
    8.5.2.3 Hazard assessment
    8.5.2.3 Hazard assessment
    The organization shall evaluate each food safety
    hazard with regard to:
    8.5.2.3 Hazard assessment
    2005
    the possible
    severity of adverse
    health effects and
    the likelihood of
    their occurrence
    8.5.2.3 Hazard assessment
    2005 2018
    the possible a) the likelihood of its occurrence
    severity of adverse in the end product prior to
    health effects and application of control measures;
    the likelihood of b) the severity of its adverse
    their occurrence health effects in relation to the
    intended use
    8.5 Hazard control
    8.5.4 Hazard control
    plan (HACCP/oPRP plan)
    8.5 Hazard control
    22000:
    8.5.4 Hazard control 7.6 2005

    plan (HACCP/oPRP plan) CCPs


    7.5
    oPRPs

    HCP
    8.5 Hazard control
    8.5.4.2 Critical limits and action criteria
    8.5 Hazard control
    8.5.4.2 Critical limits and action criteria
    CCP oPRP
    Conformance with critical
    limits shall ensure that the
    acceptable level is not
    exceeded.
    8.5 Hazard control
    8.5.4.2 Critical limits and action criteria
    CCP oPRP
    Conformance with critical Conformance with action
    limits shall ensure that the criteria shall contribute to
    acceptable level is not the assurance that the
    exceeded. acceptable level is not
    exceeded.
    8.5 Hazard control
    8.5.4.3 Monitoring systems:
    8.5 Hazard control
    8.5.4.3 Monitoring systems:
    the monitoring method and frequency shall be
    CCP oPRP
    capable of timely detection of
    any failure to remain within
    critical limits, to allow timely
    isolation and evaluation of the
    product
    8.5 Hazard control
    8.5.4.3 Monitoring systems:
    the monitoring method and frequency shall be
    CCP oPRP
    capable of timely detection of proportionate to the likelihood
    any failure to remain within of failure and the severity of
    critical limits, to allow timely consequences.
    isolation and evaluation of the
    product
    8.7 Control of monitoring and measuring
    8.7 Control of monitoring and measuring
    When the equipment or process environment is
    found not to conform to requirements, the
    organization shall assess the validity of the
    previous measurement results…
    8.7 Control of monitoring and measuring
    The organization shall take appropriate action in
    relation to the equipment or process
    environment and any product affected by the
    non-conformance.
    8.7 Control of monitoring and measuring
    Interpretation: devices used to monitor CCPs and
    oPRPs should be verified for accuracy at least
    daily!
    8.9 Control of nonconformities
    8.9 Control of nonconformities
    CCP oPRP
    When critical
    limits at CCPs are
    not met, affected
    products shall be
    identified and
    handled as
    potentially
    unsafe products
    8.9 Control of nonconformities
    CCP oPRP
    When critical Where action criteria for an OPRP are not
    limits at CCPs are met, the following shall be carried out:
    not met, affected a) determination of the consequences of that
    products shall be failure;
    identified and b) determination of the cause(s) of failure;
    handled as c) identification of the affected products and
    potentially handling in accordance with 8.9.4 (Handling
    unsafe products of potentially unsafe products).
    8.9 Control of nonconformities
    8.9.4 Handling of potentially unsafe products
    8.9 Control of nonconformities
    8.9.4 Handling of potentially unsafe products
    CCP oPRP
    Products affected by failure
    to remain within critical
    limits at CCPs shall not be
    released, but shall be
    handled in accordance with
    8.9.4.3 (Disposition of
    nonconforming products).
    8.9 Control of nonconformities
    8.9.4 Handling of potentially unsafe products
    CCP oPRP
    Products affected by failure Products affected by failure to
    to remain within critical meet action criterion for OPRPs
    limits at CCPs shall not be shall only be released as safe
    released, but shall be when any of the following
    handled in accordance with conditions apply:
    8.9.4.3 (Disposition of
    nonconforming products).
    8.9 Control of nonconformities
    8.9.4 Handling of potentially unsafe products
    a) evidence other than the monitoring system
    demonstrates that the control measures have been
    effective;
    8.9 Control of nonconformities
    8.9.4 Handling of potentially unsafe products
    b) evidence shows that the combined effect of the
    control measures for that particular product conforms
    to the performance intended (i.e. identified
    acceptable levels);
    8.9 Control of nonconformities
    8.9.4 Handling of potentially unsafe products
    c) the results of sampling, analysis and/or other
    verification activities demonstrate that the affected
    products conform to the identified acceptable levels
    for the food safety hazard(s) concerned.

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