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    Synergy Global Standardisation Services SA, Rue de Carouge 106, Case postale 302, CH - 1211 Genve 4 - www.synergy-gss.com1/18

    Supplier 22000

    Design specification

    Summary

    1. Introduction.......................................................................................................................21.1 Background ..............................................................................................................21.2 Preliminary work and documents .............................................................................2

    2. Title and type of normative document ..............................................................................33. User needs and evaluation of impacts and benefits.........................................................34. Objectives.........................................................................................................................55. Scope ...............................................................................................................................56. Compatibility and consistency ..........................................................................................67. Model and feature.............................................................................................................6

    7.1 Synergy 22000 generic PRP specification in addition to ISO 22000 .....................67.2 Supplier 22000 category specific CCPs & oPRPs in addition to Synergy 22000 ..77.3 Supplier 22000 relationships & complementarity with other FSMS standards ......7

    8. Structure of the normative document ...............................................................................88.1 Summary overview ...................................................................................................88.2 Structure of food chain category or subcategory ......................................................98.3 Methodological annex...............................................................................................9

    9. Subjects to be addressed in the text of the normative document.....................................910. Proposed process.........................................................................................................9

    10.1 Scope .......................................................................................................................910.2 Applicable PRP (selected from PRP 22000) ............................................................910.3 Hazards ..................................................................................................................1010.4 Control measures ...................................................................................................1010.5 Monitoring systems.................................................................................................1010.6 Verification..............................................................................................................10

    10.7 Additional certification scheme requirements .........................................................1011. Interested parties to be involved.................................................................................1112. Project organisation....................................................................................................12

    12.1 Procedures & participants ......................................................................................1212.2 Timeframe ..............................................................................................................12

    13. Working documents to be considered ........................................................................1214. Liaison ........................................................................................................................1315. Author of the proposition ............................................................................................1316. Owner of the normative document .............................................................................1317. Final dispositions ........................................................................................................13

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    1. Introduction1.1 BackgroundMajor food safety scandals are generated by food safety hazards that have been introduced within thefood chain at a primary production or raw material supplier level.

    Under pressure and requirements from retailers, certification of the food safety management system(FSMS) is nowadays the rule for the food manufacturing or processing industries.

    Reliable and approved certification schemes have been developed and acknowledged for that purpose(e.g. ISO 22000, BRC, IFS).

    But there is a lack of similar applicable schemes and approaches at the upper levels of the food chain.In particular:

    - food industry needs reliable and reproducible schemes to have their suppliers audited, approved

    and monitored;

    - currently available FSMS schemes do not address primary production and raw material supplierlevels;

    - implemented HACCP and FSMS solutions lack consistency, reliability and validation;

    - (raw material) suppliers have limited resources to develop and implement such solutions;

    - (raw material) suppliers mostly have common processes and food safety hazard control issues,which allow reliance on shared and common FSMS solutions.

    - suppliers are audited by third parties or/and by customers with different approaches and standards,relevant for supplier status or not, resulting in suppliers adapting their FSMS to these needs.

    - the focus on hazard identification and assessment as being key for food safety is not wellunderstood, so relevant hazards are not monitored and verified with appropriate control measures(as oPRPs or HACCP-Plan according to ISO 22000).

    - the principle of hazard analysis is to control hazards at their source and not to focus on endproduct testing (preventive character, see HACCP according Codex Alimentarius). But thisapproach is often not well managed, as only company-related hazards are considered.

    There is an evident need for another approach to assist suppliers by focusing on relevant hazards withappropriate oPRPs and HACCP plans, based on adapted PRPs.

    1.2 Preliminary work and documentsSynergy has already developed, published and applied for GFSI endorsement the following documents:

    PRP 22000, Food safety management systems Prerequisite Programmes (PRPs) requirements forany organisation in the food chain

    Synergy 22000 certification scheme Requirements for bodies providing audit and certification ofSynergy 22000 Food Safety Management Systems

    Synergy 22000 is the unique GFSI compatible FSMS certification scheme applicable with commondocuments and approach to the entire food chain.

    In order to address users needs (in particular the food industry and retailers) as described above, the

    generic system and HACCP requirements (as specified by ISO 22000) and PRP requirements (asspecified by PRP 22000) need to be completed by (sub)category specific mandatory CCP or oPRPspecifications.

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    2. Title and type of normative documentThe proposed title is:

    Synergy Supplier 22000 Applicable CCPs and oPRPs specifications for the various food chain

    categories Requirements

    NOTE: due to the specific situation of primary production, where certification of famer groups might bean adequate approach, some additional scheme specification might become necessary in the followingdocument:

    Synergy 22000 certification scheme Requirements for bodies providing audit and certification ofSynergy 22000 Food Safety Management Systems

    3. User needs and evaluation of impacts and benefitsFood chain level Needs Benefits

    Suppliers - Externally developed andvalidated CCPs and oPRPs,acknowledged by the foodindustry

    - Consistency with GFSI endorsedISO 22000 schemes (e.g.Synergy 22000)

    - Become involved in thestandardisation process (noexternally forced means and

    solutions)

    - Focus on Food Safety withoutconfusion with other objectives

    - Simple solutions, ready to beadapted by any supplier

    - Time and cost sharing byimplementation

    - Acceptance and commitment ofmajor buyers (food industry)

    - GFSI endorsement through linkwith Synergy 22000 certificationscheme

    - Strong and single focus on foodsafety issues, not other issuessuch as environment protection

    - Opportunity to participate in theexpert group

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    Food chain level Needs Benefits

    Food industry - Control of hazards introduced by

    suppliers- Harmonised and validated CCPs

    and oPRPs implemented by allsimilar suppliers

    - Consistency with GFSI endorsedISO 22000 schemes (e.g.Synergy 22000)

    - Reliable audits by third parties,less dependency on competenceof single auditors and CBs

    - Simple solutions, ready to be

    adapted by any food industry(supplier)

    - Opportunity to participate in theexpert group

    - Co-decision, knowledge andvalidation of CCPs and oPRPsimplemented by suppliers

    - Efficient and transparentcommunication with suppliersregarding food safety hazards and

    related CCPs and oPRPs- GFSI endorsement through link

    with Synergy 22000 certificationscheme

    Retailers - Effective food safety hazardscontrol over complete food chain

    - GFSI endorsement

    - Reliable audits by third parties,less dependency on competenceof single auditors and CBs

    - International commitmentsupporting ISO 22000

    - GFSI endorsement through linkwith Synergy 22000 certificationscheme

    - Opportunity to participate in the

    expert group- Shared responsibility with supplier,

    by strengthening food safetycontrol competence of suppliers.

    - Neutral and with the support &commitment of all interestedparties

    - Unique standard & schemeapplicable to the entire food chain

    Certification

    Bodies

    - Qualified and competent auditors

    in each category and at differentlevels of the food chain.

    - Scheme ensuring focused auditson key food safety issues

    - More support for training andqualification of auditors

    - Managing risks of failing with anincompetent auditor

    - Support documents for training of

    auditors and focused audits- Less differences between auditors

    and better calibration of auditors

    - Simplified communication withclients about hazards and theircontrol

    - Reduction of insurance risks

    - Opportunity to participate in theexpert group

    - Shared audit findings for auditconsistency and continuousimprovement.

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    Food chain level Needs Benefits

    Authorities - Self-responsibility & involvementin all levels of the food chain with

    regard to food safety issues.- Scientific-based hazard

    approach, with focus on realhazards.

    - Opportunity to participate in theexpert group

    - Clear focus on relevant hazards

    4. ObjectivesAddress users needs by:

    - developing adequate additions to the Synergy 22000 certification scheme

    - assisting suppliers in implementing consistent, simple and validated solutions

    - ensuring consistency of supplier control, audit, approval and monitoring

    5. ScopeThe following food chain categories (according to ISO TS 22003 Annex A) may be included within thescope of the project (see also 10.1):

    Categorycodes

    Categories Examples of sectors

    A Farming 1 (Animals)

    animals; fish; egg production; milk production;

    beekeeping; fishing; hunting; trapping; including farmpacking

    B Farming 2 (Plants)fruits; vegetables; grain; spices; horticultural products;including farm packing

    (C)

    Processing 1(Perishable animal products)including all activities after farming, e.g.slaughtering

    meat; poultry; eggs; dairy and fish products

    (D)Processing 2(Vegetal perishable product)

    fresh fruits and fresh juices; preserved fruits; freshvegetables; preserved vegetables

    (E)Processing 3(long shelf life at ambient temperature)

    canned products; biscuit; snacks; oil; drinking water;beverages; pasta; flour; sugar; salt

    F Feed production animal feed; fish feedJ Transport and storage transport and storage

    L (Bio)chemical manufactureradditives; vitamins; pesticides; drugs; fertilizer;cleaning agents; biocultures

    M Packaging material manufacturer packaging material

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    6. Compatibili ty and consis tencyCompatibility and consistency (wording, definitions, structure) is to be guaranteed with the followingstandards and schemes:

    - ISO 22000, Food safety management systems Requirements for any organization in the foodchain

    - ISO TS 22003, Food safety management systems Requirements for bodies providing audit andcertification of food safety management systems

    - PRP 22000, Food safety management systems Prerequisite Programmes (PRPs) requirementsfor any organisation in the food chain

    - PAS 220 - Prerequisite programmes on food safety for food manufacturing- Synergy 22000 certification scheme Requirements for bodies providing audit and certification of

    Synergy 22000 Food Safety Management Systems

    ISO TS 22004 justifies and introduces the Supplier 22000 approach as follows:

    Guidance on the use of ISO 22000:2005, Clause 4: Food Safety Management System

    4.1 General requirements

    External competences may be used by the organization to develop and implement a food safetymanagement system according to ISO 22000 provided that it ensures that such outsourced processeshave been developed and are implemented, monitored, maintained and updated in compliance with the

    requirements of ISO 22000.

    Moreover, ISO 22000 allows any organization, in particular a small and/or less developed one, toimplement an externally developed and established combination of prerequisite programme(s) [PRP(s)],operational PRP(s) and Hazard Analysis and Critical Control Point (HACCP) plans, provided that it canbe demonstrated that this combination has been developed in compliance with the requirements of ISO22000 specified for the hazard analysis, PRP(s) and HACCP plan, specific measures have beenundertaken to adapt the externally developed combination to the organization, and this combination hasbeen implemented and is operated in accordance with the other requirements of ISO 22000.

    7. Model and feature7.1 Synergy 22000 generic PRP specif ication in addit ion to ISO 22000The Synergy 22000 certification scheme has added two normative documents to ISO 22000certification:

    - PRP 22000, Food safety management systems Prerequisite Programmes (PRPs) requirementsfor any organisation in the food chain, that specifies the PRP requirements applicable to any foodchain category, based on Codex Alimentarius,

    - Synergy 22000certification scheme Requirements for bodies providing audit and certification ofSynergy 22000 Food Safety Management Systems, that specifies additional requirements to ISO

    17021 and ISO TS 22003 for any certification body providing Synergy 22000 certification services.

    The Synergy 22000 certification scheme has applied for GFSI endorsement.

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    7.2 Supplier 22000 category specif ic CCPs & oPRPs in addi tion to Synergy 22000Beyond the generic GFSI compliant model provided by the Synergy 22000 certification scheme, the aimof the Supplier 22000 project is to develop (sub)category specific:

    - hazard identification (which hazard may be introduced at which step of the food chain and needs to

    be controlled) ;- selection of control measure combinations addressing these hazards;

    - categorisation of these control measures as belonging to the HACCP plan or oPRPs,

    - design of a monitoring system applicable to the determined HACCP plan and oPRPs;

    - verification procedures for HACCP plan and oPRPs.

    This specification will enable suppliers to implement in a simple way validated and consistent FSMSfeatures, compliant with the needs of the further steps or the food chain.

    The Synergy 22000 certification scheme will be checked as to whether it needs additional requirementsfor addressing supplier 22000 certification, e.g. for farmer groups.

    Figure 1 illustrates the relationships and complementarities between ISO 22000, Synergy 22000,Supplier 22000 and the corresponding applicable certification schemes.

    7.3 Supplier 22000 relationships & complementarity with other FSMS standardsTable 1 illustrates how Supplier 22000 scheme fills the gaps within existing FSMS certification schemes.

    Figure 1 Relationships between ISO 22000, Synergy 22000 and Suppl ier 22000 certifi cation schemes

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    Table 1: Respective scope of ISO 22000, BRC, IFS, GlobalGAP and Supplier 22000

    ISO22000 BRC IFS GlobalGAP Supplier22000

    Scope (according to ISO TS 22003, Annex A)

    A - Breeding + - - - +

    B Primary production + - - + +

    C, D, E Food processing + + + - +

    F Feed production + - - - +

    J Transport and storage + - - - +

    L (Bio)chemical manufacturer + - - - +

    M Packaging material + - - - +

    GFSI Key Elements

    - FSMS + + + (+) +

    - PRP - + + + +

    - HACCP + + + (+) +

    (Sub)category specific requirements:

    - Hazard identification - - - - +

    - Control measures - CCP or oPRP - - - - +

    - CCP or oPRP monitoring systems - - - - +- Verification, audit and certification schemes - - - - +

    Consistent certification scheme (report) - + + - +

    Consistent auditor competence assessment - - + - +

    Opportunity to contribute as an expert + (+)* (+)* - +

    * Opportunity for some users (CBs) to raise comments, but no interdisciplinary expert group meetings and no feedback oncomments.

    8. Structure of the normative document8.1 Summary overviewSummary is to be structured as follows:

    - Introduction

    - Normative reference

    - Definitions

    - General requirements and use of this document

    - Food chain category A or subcategory

    - Food chain category B or subcategory

    - Food chain category n or subcategory

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    8.2 Structure of food chain category or subcategoryFor each category or subcategory included in the scope (see 5), the document will specify the followingtopics:

    1. Applicable PRP (selected out of PRP 22000);

    2. Hazard that need to be controlled or significant hazard (in further use) (=assessed as necessary tobe eliminated, reduced to acceptable levels and the control needed to enable the definedacceptable levels to be met (clause 7.4.3, ISO 22000);

    3. Control measure combinations addressing these hazards;

    4. Resulting CCPs or oPRPs;

    5. Monitoring system applicable to the determined CCPs and oPRPs;

    6. Verification procedures.

    7. Additonal scheme requirements if adequate8. Annex B illustrates the rough output of steps 2 to 4 above.

    8.3 Methodological annexAnnex A illustrates the ways in which hazards are to be controlled and the corresponding food chainsteps are to be identified (see 10.1). This matrix will be published as an Informative annex in the finaldocument.

    9. Subjects to be addressed in the text of the normative documentSee 8 above.

    10. Proposed process10.1 ScopePrincipal objective of the supplier 22000 project is to provide the food processing industry with acertification scheme that will allow and ensure control of their suppliers, active at other steps in the foodchain. So, basically, the food industry would not need to be included within the scope.

    But it might appear that, for instance, that some control measures addressing supplier steps in the foodchain have to be applied at a food industry level in order to be effective.

    Therefore, categories C, D & E appear in brackets under 5 and in figure 1.

    To clarify this scope issue, the expert group will have to comment on:

    a) The opportunity or need to address categories C, D & E.

    b) The way to address these categories: requirements or guidance/recommendations (shall or shouldwording).

    c) The applicability of the supplier 22000 certification scheme to these categories.

    10.2 Applicable PRP (selected from PRP 22000)The PRP 22000 standard already specifies which PRP requirements are applicable for which food chaincategory. But it includes some conditional wording (e.g. if applicable, as necessary) that might also bestated in consideration of specific subcategories.

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    10.3 HazardsAnnex A has been developed in order to design the approach and to validate its feasibility.

    It illustrates the basic methodology for structuring the identification of relevant hazards (see ISO 22000,

    7.4.2) and their attribution to the food chain categories or subcategories where they may beintroduced into the food chain.

    This works as follows:

    - Column A - hazards are first identified from various sources: rapid alert systems, legislation, retailerrequirements, etc. The fact that these hazards are specifically addressed in the applicablelegislation and/or product recall or alert is sufficient to consider them as needing to be controlled so no specific hazard assessment will be made (which would anyway be difficult considering thenumber and diversity of the final products potentially concerned);

    - Column B to T the type of end products where the identified hazards may occur are determined,

    with an indication of the corresponding information source;- Column U key examples are listed in order to provide inputs and reminders for further steps. This

    is neither exhaustive nor restrictive;

    - Column V applicable acceptable levels as specified in the different sources are displayed in orderto orientate further work;

    - Column W to AF food chain categories or subcategories where the identified hazards may beintroduced into the food chain are determined according to experience & knowledge of experts,literature, information gathered in columns B to T and other relevant sources;

    Once finished, columns W to AF allow the determination of the specific scope of hazards to be

    controlled at each step (category or subcategory) in the food chain. This introduces the nextmethodological step, as described by the example in Annex B.

    10.4 Control measuresThe table in Annex B is intended to be used as a working tool for selecting and categorising (as CCP oroPRP) the suitable control measure combinations.

    As a result of the application of this tool, the following items are going to be incorporated in a suitableform into the main body of the document text:

    - Hazards.

    - Control measures (worded as requirements).

    - Categorisation as CCP or oPRP.

    10.5 Monitoring systemsSpecification of the monitoring systems applicable for the determined CCPs or oPRPs will beestablished following the systematic and structure of the table in Annex C.

    10.6 VerificationNo specific methodology is required.

    10.7 Additional certification scheme requirementsAn amendment of Synergy 22000 certification scheme, targeted in particular on the farmer group

    approach.

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    11. Interested parties to be involvedAccording to the scope of the project, representative experts of following interested parties shall at leastbe involved in the expert group:

    Category / Interested party Name Country Organisation Function

    A - Breeding

    B Primary production

    C, D, E Food processing

    F Feed production

    H Distribution / Retail

    J Transport and storage

    L (Bio)chemical manufacturer

    M Packaging material

    Universities

    Authorities

    Certification bodies

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    12. Project organisation12.1 Procedures & participantsThe project will be organised and managed in compliance with Synergy standardisation guidelines.

    The editorial committee will draft the outputs in the form of tables in Annexes A, B and C.

    The expert group will be invited to comment on these outputs.

    Additional experts and/or specific subgroups or enlarged editorial committees may be involved for thecategory specific work.

    12.2 TimeframeFollowing timeframe is proposed for the development of the supplier 22000 project:

    N (month) - Design specification approval

    N + 1 - Project leader & editorial committee appointment

    - Expert group assembling

    - Gathering and sharing working documents

    - Working draft preparation

    N + 2 - Issue working draft (WD)

    N + 3 - Working draft circulated for comments (expert group)

    N + 4 - Expert group meeting

    N + 5 - Issue draft standard (DS)- Draft standard circulated for comments (expert group + interested parties panel)

    N + 7 - Expert group meeting

    N + 8 - Issue final draft standard (FDS)

    - Final draft standard circulated for comments (expert group)

    N + 10 - Issue public standard

    13. Working documents to be consideredFollowing working documents shall be considered and circulated within the expert group:

    - Synergy Standardisation Guidelines (current version)

    - ISO 22000, Food safety management systems Requirements for any organization in the foodchain

    - ISO TS 22003, Food safety management systems Requirements for bodies providing audit andcertification of food safety management systems

    - PRP 22000, Food safety management systems Prerequisite Programmes (PRPs) requirementsfor any organisation in the food chain

    - PAS 220 - Prerequisite programmes on food safety for food manufacturing- ISO/IEC 17021:2006, Conformity assessment Requirements for bodies providing audit and

    certification of management systems

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    - ISO/IEC Guide 65:1996 - General requirements for bodies operating product certification systems

    - ISO TS 22003, Food safety management systems Requirements for bodies providing audit andcertification of food safety management systems

    - Synergy 22000 certification scheme Requirements for bodies providing audit and certification ofSynergy 22000 Food Safety Management Systems

    - Annex A: hazard identification matrix

    - Annex B: example of category specific hazard analysis

    - Annex C: CCP or oPRP monitoring system

    - European Commission - The Rapid Alert System for Food and Feed (RASFF) Annual Report 2007

    - COMMISSION REGULATION (EC) No2073/2005 on microbiological criteria for foodstuffs

    - FCD - Critres microbiologiques applicables partir de 2008 aux marques de distributeurs,

    marques premiers prix et matires premires dans leur conditionnement initial industriel

    14. LiaisonLiaison will be provided by the expert group in charge of the following documents:

    - PRP 22000, Food safety management systems Prerequisite Programmes (PRPs) requirementsfor any organisation in the food chain

    - Synergy 22000 certification scheme Requirements for bodies providing audit and certification ofSynergy 22000 Food Safety Management Systems

    15.Author of the proposition

    Synergy mandated Dr Didier Blanc, expert within both the ISO 22000 and PRP/Synergy 22000 expertgroups, to prepare the technical aspects of the present design specification.

    16. Owner of the normative documentSynergy Global Standardisation Services SA, CH - 1211 Genve 4

    17. Final disposi tionsAccording to the Synergy Standardisation Guidelines ( 4.2.1), the present design specification hasbeen validated and released by the Synergy central secretariat and may be circulated within potential

    experts.

    Geneva, October 23rd 2009

    Annex A: hazard identification matrix

    Annex B: example of category specific hazard analysis

    Annex C: CCP or oPRP monitoring system

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    Supplier 22000 - Design Sepcification

    Annex A: hazard identification matrix

    Sources for hazard relevance:

    H History

    R Rapid Alert System for Food and Feed (RASFF)

    C Canadian Food Inspection Agency

    L Legislation (R 2005/2073)

    F FCD

    D Divers

    Products

    Fisheryproducts

    Honey

    E

    ggs&eggproducts

    Meatandmeat

    products

    otherthan

    oultr

    M

    ilk&milkproducts

    P

    oultrymeat&prod

    C

    erals&bakeryprod

    Cocoa,coffe,tea

    Confectionnary

    Fruit&vegetables

    Herbs&spices

    Foodsupplements

    N

    on-alcoholicbever

    N

    uts&nutproducts

    Fats&oils

    S

    oups,broths&sau

    Feed

    Petfood

    F

    oodcontactmateri

    Manufacturing

    Slaughtering

    Milking

    Breeding

    Feedindustry

    Feedgrowing

    R

    awmaterialstorage

    Crops(Harvest)

    Growing

    Packaging

    Key examples Acceptable level C/D/E C A A F B J B B M

    Microbiological hazards

    Salmonella LRF LF LR L RH LR R LF LRF RF L R R R

    egg, poultry

    past. milk

    soft cheese

    peanuts, pistachio

    abs. in 25 g x x x x x

    E. Coli F F F LF F LF F L Fruit juice < 100 / g x x x x

    E. Coli O 157 RHC x x x

    E. Coli O 026 H x x x

    E. Coli Verotox. HF x x x

    Listeria

    MonocytogenesRF R HF R F RF F

    soft cheese

    pre-cut salad

    absence in 25 g

    < 100 / gx x x x x x

    Staphylococcus

    Coagulase +F F F LF F F F raw milk cheese < 10000 / g x x x x

    Campylobacter H R x x x

    Vibrio RF x

    Cl. Perfringens F F x x x

    Histamine LRF 200 mg/kg x x

    Chemical hazards

    Veterinary drugs

    Nitrofurane R R R R x x x x

    Chloramphenicol R R R RH R x x x x

    Sulphonamides R H x x x x

    Streptomycin R H x x x x

    Penicillin H x x x

    Malachite grren R x x

    Food additives

    Sulphites R R

    E 210 - benzoic acid R

    E 452 - polyphosph R

    Colour additives R R R R

    Heavy metals

    Cadmium R D R x x x x x

    Mercury R x

    Mycotoxines

    Aflatoxins R R R R x x x x

    Fumonisins R x x x x

    Ochratoxin A R R R R x

    Pesticide residues

    Pesticide residues in general R R R x x

    Carbendazim R x x

    Methomyl R x x

    Oxamyl R x x

    Isophenphos-methyl R x x

    Food contact material (migration of)

    Chromium R x x

    Lead R x x

    Nickel R x x

    Isopropyl thioxanthone R x x

    Primary aromatic amines R x xFormaldehyde R x x

    Phtalates R x x

    Total migration R x x

    Other

    Melamine R R R R 2.5 mg / kg x x x

    PAH R R x x x

    Iodine R x x

    Allergens R R R x x x x

    Irradiation R

    Dioxin R RH R Pig x x x x

    PCB H x x x x

    - allow to group some hazards by addressing them with the same control measures at specific steps

    - determine which partial HACCP studies shall be developed at the different steps

    - provide an annex to the supplier 22000 standard (in order to trace / justify the addressed topics and structure)

    Objectives of the matrix

    - determine which hazards are relevant at which steps in consideration of key representative end products

    - identify the contribution of each step to the overall control measures combination addressing each relevant hazard

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    Supplier 22000 - Design Sepcification

    Annex B: example of category specific hazard analysis

    Hazards

    P no GAP compliance (hygiene rules) select suppliers participating a monitored GAP programme a

    insuring GAP training to their personalO absence of any prevention programme

    poor farm hygiene

    chose suppliers (and/or country of origin) applying sanitary p

    programmes

    M facilities difficult to disinfect

    I contaminated feed, bought animals or visitors

    E infected farms in the neighbourhood

    P personnel not trained select suppliers participating a monitored GAP programme a

    insuring GAP training to their personal

    O use of medicamentous feedself-medication (without veterinary)

    no respect of waiting times

    absence/lack of records

    absence of any prevention programme

    poor farm hygiene

    chose suppliers (and/or country of origin) applying sanitary pprogrammes

    M contaminated ustensils

    I

    E

    P

    O

    M

    I

    E

    Nitrofurane

    Chloramphenicol

    Sulphonamides

    Streptomycin

    Penicillin

    Malachite grren

    PAH

    Dioxin

    PCB

    Salmonella

    L. monocytogenes

    E. Coli

    E. Coli O 157

    E. Coli O 026

    E. Coli Verotox.

    Staphylococcus

    Coagulase +

    Campylobacter

    Vibrio

    Cl. Perfringens

    Cause1*

    Cause 2

    Control measures combination

    select suppliers participating a monitored GAP programme a

    regularly inspected

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    Supplier 22000 - Design Sepcification

    Annex C: CCP or oPRP monitoring system

    Criticallimit

    Method

    /Device

    Oper

    ating

    procedure

    Frequ

    ency

    Pla

    ce

    Pl

    an

    Resp.execution

    Resp.d

    ecision

    Param

    etertocontrol

    Supplier 22000

    Monitoring CCPs or oPRPs

    HazardControl

    measures

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    Synergy Global Standardisation Services SA, Rue de Carouge 106, Case postale 302, CH - 1211 Genve 4 - www.synergy-gss.com17/18

    Annex E Budget

    Days Projectleader

    Editorialcommittee

    Centralsecretariat

    Total

    Design specification 1 1Project organisation 1 1 2

    Preliminary works 2 1 3

    Drafting per sub-category:

    - working draft 2 2- draft standard (incl. comments) 1 1- final draft (incl. comments) 1 1- final standard (incl. comments) 0.5 0.5 1Total per sub-category: 5

    Number of sub-categories: 10Total drafting: 50

    Meetings (2 / subcategory; 5 subcategory / day) 4 4

    Administration Website 2 2

    Survey & Maintenance (2 years) 2 4 2 8

    Total days 70

    Daily rate (CHF) 2'000

    Total cost (CHF) 140'000

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    Annex F Advantages & Services for small & mul tisite organisations

    Which kinds of organisations are addressed?

    Suppliers of the major food industry concerns are mainly:- primary producers (e.g. milk, cereals, fresh produces, coffee, cocoa)

    - cooperatives or traders, collecting, storing and delivering primary products without any processing

    - raw material processors (e.g. oils, fats, flour, meat, coffee, cocoa)

    Why is FSMS certification a hurdle for such organisations?

    Raw material processors may apply for an individual certification but for primary producers andcooperatives:

    - resources and know-how are missing to elaborate and maintain the FSMS

    - certification costs are excessiveWhat solut ion is provided by Synergy Supplier 22000?

    ISO TS 22004 justifies and introduces the SynergySupplier 22000 approach as follows:

    Guidance on the use of ISO 22000:2005, Clause 4: Food Safety Management System

    4.1 General requirements

    External competences may be used by the organization to develop and implement a food safety management systemaccording to ISO 22000 provided that it ensures that such outsourced processes have been developed and areimplemented, monitored, maintained and updated in compliance with the requirements of ISO 22000.

    Moreover, ISO 22000 allows any organization, in particular a small and/or less developed one, to implement an externallydeveloped and established combination of prerequisite programme(s) [PRP(s)], operational PRP(s) and Hazard Analysis andCritical Control Point (HACCP) plans, provided that it can be demonstrated that this combination has been developed incompliance with the requirements of ISO 22000 specified for the hazard analysis, PRP(s) and HACCP plan, specificmeasures have been undertaken to adapt the externally developed combination to the organization, and this combinationhas been implemented and is operated in accordance with the other requirements of ISO 22000.

    Synergy Supplier 22000 will provide for the main suppliers sub-categories:

    - PRP(s)

    - Hazard analysis (identification, assessment, control measures)

    - Operational PRP(s)

    - HACCP Plan(s)

    - Monitoring systems, procedures and tools for oPRP(s) and HACCP Plan(s)What are the advantages for suppliers?

    - No development costs

    - Ready to implement solutions, accepted and validated by major buyers

    - Certification in multisite organisations through cooperatives or any similar structure

    - Low certification costs through multisite sampling approach (applicable for primary production,transport & storage)

    What are the services for suppliers?

    - PRP(s), Hazard analysis, oPRP(s), HACCP Plan(s) & Monitoring systems externally developed by

    international experts- Implementation & audit tools: records, check-lists

    - Web based reporting platform, with follow-up, data analysis, statistics, knowledge bases, etc.