SIST-TS ISO/TS 22002-1:2011
Prerequisite programmes on food safety -- Part 1: Food manufacturing
Prerequisite programmes on food safety -- Part 1: Food manufacturing
ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.
ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.
ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply chain.
Food manufacturing operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-1:2009 apply to an individual establishment or process.
Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.
ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene.
In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.
Programmes prérequis pour la sécurité des denrées alimentaires -- Partie 1: Fabrication des denrées alimentaires
L'ISO/TS 22002-1:2009 spécifie les exigences pour établir, mettre en œuvre et mettre à jour des programmes prérequis (PRP) afin d'aider à maîtriser les dangers liés à la sécurité des denrées alimentaires.
L'ISO/TS 22002-1:2009 est applicable à tous les organismes, quelle que soit leur taille ou leur complexité, qui interviennent dans l'étape de fabrication de la chaîne alimentaire et qui souhaitent mettre en œuvre des PRP de manière à satisfaire aux exigences spécifiées dans l'ISO 22000:2005, Article 7.
L'ISO/TS 22002-1:2009 n'est ni conçue pour, ni destinée à être utilisée dans d'autres parties de la chaîne d'approvisionnement alimentaire.
Les opérations de fabrication des denrées alimentaires étant diverses par nature, les exigences spécifiées dans l'ISO/TS 22002-1:2009 ne s'appliquent pas nécessairement en totalité à un établissement ou à un procédé individuel.
Les exclusions ou la mise en œuvre de mesures alternatives nécessitent d'être justifiées et documentées par une analyse des dangers, telle que décrite dans l'ISO 22000:2005, 7.4. Il convient que toute exclusion ou mesure alternative adoptée n'affecte pas la capacité de l'organisme à se conformer à ces exigences. Ces exclusions incluent par exemple les aspects complémentaires concernant les opérations de fabrication énumérées ci-dessous aux points 1), 2), 3), 4) et 5).
L'ISO/TS 22002-1:2009 spécifie des exigences détaillées à prendre en compte en liaison avec l'ISO 22000:2005, 7.2.3: a) la construction et la disposition des bâtiments et des installations associées; b) la disposition des locaux, notamment l'espace de travail et les installations destinées aux employés; c) l'alimentation en air, en eau, en énergie et autres; d) les services annexes, notamment pour l'élimination des déchets et des eaux usées; e) le caractère approprié des équipements et leur accessibilité pour leur nettoyage, leur entretien et leur maintenance préventive; f) la gestion des produits achetés; g) les mesures de prévention contre les transferts de contaminations; h) le nettoyage et la désinfection; i) la maîtrise des nuisibles; j) l'hygiène des membres du personnel.
En outre, l'ISO/TS 22002-1:2009 précise d'autres aspects considérés comme pertinents pour les opérations de fabrication: 1) le retraitement/recyclage; 2) les procédures de rappel de produits; 3) l'entreposage; 4) l'information sur les produits et la sensibilisation des consommateurs; 5) la prévention de l'introduction intentionnelle de dangers dans les denrées alimentaires, la biovigilance et le bioterrorisme.
Prerekvizitni programi za varnost živil - 1. del: Proizvodnja živil
Ta tehnična specifikacija določa zahteve za vzpostavitev, uvedbo in vzdrževanje prerekvizitnih programov (PRP) za pomoč pri nadzoru nevarnosti pri varnosti živil. Ta tehnična specifikacija velja za vse organizacije, ne glede na velikost ali kompleksnost, ki so vključene v proizvodnji korak v živilski verigi in želijo vpeljati PRP tako, da naslovijo zahteve, določene v ISO 22000:2005, klavzuli 7. Ta tehnična specifikacija ni niti zasnovana za uporabo niti ji ni namenjena v drugih delih živilske verige. Postopki proizvodnje hrane so različne narave in vse zahteve, določene v tej tehnični specifikaciji, ne veljajo za posamezno vzpostavitev ali proces. Kjer so izvzete oziroma so izvedeni drugi ukrepi, jih je treba upravičiti in dokumentirati z analizo tveganj, kot je opisano v ISO 22000:2005, točki 7.4. Kakršno koli izvzetje oziroma sprejeti drugi ukrepi ne bi smeli vplivati na sposobnost organizacije, da ravna v skladu s temi zahtevami. Primeri takih izvzetij vsebujejo dodatne vidike, pomembne pri proizvodnih postopkih, navedenih v 1), 2), 3), 4) in 5) spodaj.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2011
Prerekvizitni programi za varnost živil - 1. del: Proizvodnja živil
Prerequisite programmes on food safety -- Part 1: Food manufacturing
Programmes prérequis pour la sécurité des denrées alimentaires -- Partie 1: Fabrication
des denrées alimentaires
Ta slovenski standard je istoveten z: ISO/TS 22002-1:2009
ICS:
67.020 Procesi v živilski industriji Processes in the food
industry
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL ISO/TS
SPECIFICATION 22002-1
First edition
2009-12-15
Prerequisite programmes on food
safety —
Part 1:
Food manufacturing
Programmes prérequis pour la sécurité alimentaire —
Partie 1: Fabrication des aliments
Reference number
©
ISO 2009
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
4 Construction and layout of buildings.4
5 Layout of premises and workspace .5
6 Utilities – air, water, energy.6
7 Waste disposal.8
8 Equipment suitability, cleaning and maintenance.9
9 Management of purchased materials .10
10 Measures for prevention of cross contamination.11
11 Cleaning and sanitizing .12
12 Pest control.13
13 Personnel hygiene and employee facilities.14
14 Rework.16
15 Product recall procedures.17
16 Warehousing.17
17 Product information/consumer awareness .18
18 Food defence, biovigilance and bioterrorism.18
Bibliography.19
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 22002-1 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 17,
Management systems for food safety.
ISO/TS 22002 consists of the following parts, under the general title Prerequisite programmes on food safety:
⎯ Part 1: Food manufacturing
[5]
This Technical Specification is based on BS PAS 220:2008 .
iv © ISO 2009 – All rights reserved
Introduction
ISO 22000:2005 sets out specific food safety requirements for organizations in the food chain. One such
requirement is that organizations establish, implement and maintain prerequisite programmes (PRP) to assist
in controlling food safety hazards (ISO 22000:2005, Clause 7). This Technical Specification is intended to be
used to support management systems designed to meet the requirements specified in ISO 22000:2005, and
sets out the detailed requirements for those programmes.
This Technical Specification does not duplicate requirements given in ISO 22000:2005 and is intended to be
used in conjunction with ISO 22000:2005.
TECHNICAL SPECIFICATION ISO/TS 22002-1:2009(E)
Prerequisite programmes on food safety —
Part 1:
Food manufacturing
WARNING — The text of this Technical Specification assumes that the execution of its provisions is
entrusted to appropriately qualified and experienced people, for whose use it has been produced.
This Technical Specification does not purport to include all the necessary provisions of a contract.
Users are responsible for its correct application. Compliance with this Technical Specification does
not in itself confer immunity from legal obligations.
1 Scope
This Technical Specification specifies requirements for establishing, implementing and maintaining
prerequisite programmes (PRP) to assist in controlling food safety hazards.
This Technical Specification is applicable to all organizations, regardless of size or complexity, which are
involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address
the requirements specified in ISO 22000:2005, Clause 7.
This Technical Specification is neither designed nor intended for use in other parts of the food supply chain.
Food manufacturing operations are diverse in nature and not all of the requirements specified in this Technical
Specification apply to an individual establishment or process.
Where exclusions are made or alternative measures implemented, these need to be justified and documented
by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted
should not affect the ability of the organization to comply with these requirements. Examples of such
exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and
5) below.
This Technical Specification specifies detailed requirements to be specifically considered in relation to
ISO 22000:2005, 7.2.3:
a) construction and layout of buildings and associated utilities;
b) layout of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance;
f) management of purchased materials;
g) measures for the prevention of cross-contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene.
In addition, this Technical Specification adds other aspects which are considered relevant to manufacturing
operations:
1) rework;
2) product recall procedures;
3) warehousing;
4) product information and consumer awareness;
5) food defence, biovigilance and bioterrorism.
NOTE Measures for prevention of malicious contamination are outside the scope of this Technical Specification.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 22000:2005, Food safety management systems — Requirements for any organization in the food chain
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22000:2005 and the following apply.
3.1
contamination
〈food safety〉 introduction or occurrence of a contaminant (3.2) in food or food environment
[1]
NOTE Adapted from CAC/RCP 1:2003 , 2.3.
3.2
contaminant
〈food safety〉 any biological or chemical agent, foreign matter or other substances not intentionally added to
food which may compromise food safety or suitability
[1]
[CAC/RCP 1:2003 , 2.3]
3.3
establishment
〈food safety〉 any building or area in which food is handled and the surroundings under the control of the same
management
[1]
[CAC/RCP 1:2003 , 2.3]
3.4
materials
〈food safety〉 general term used to indicate raw materials, packaging materials, ingredients, process aids,
cleaning materials and lubricants
2 © ISO 2009 – All rights reserved
3.5
cleaning
〈food safety〉 removal of soil, food residue, dirt, grease or other objectionable matter
[1]
NOTE Adapted from CAC/RCP 1:2003 , 2.3.
3.6
product contact
all surfaces that are in contact with the product or the primary package during normal operation
3.7
material specification
product specification
〈food safety〉 detailed documented description or enumeration of parameters, including permissible variations
and tolerances, which are required to achieve a defined level of acceptability or quality
3.8
food grade
lubricants and heat transfer fluids formulated to be suitable for use in food processes where there may be
incidental contact between the lubricant and the food
3.9
disinfection
〈food safety〉 reduction, by means of chemical agents and/or physical methods, of the number of
microorganisms in the environment, to a level that does not compromise food safety or suitability
[1]
NOTE Adapted from CAC/RCP 1:2003 , 2.3.
3.10
cleaning in place
CIP
cleaning (3.5) of equipment
...
TECHNICAL ISO/TS
SPECIFICATION 22002-1
First edition
2009-12-15
Prerequisite programmes on food
safety —
Part 1:
Food manufacturing
Programmes prérequis pour la sécurité alimentaire —
Partie 1: Fabrication des aliments
Reference number
©
ISO 2009
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
4 Construction and layout of buildings.4
5 Layout of premises and workspace .5
6 Utilities – air, water, energy.6
7 Waste disposal.8
8 Equipment suitability, cleaning and maintenance.9
9 Management of purchased materials .10
10 Measures for prevention of cross contamination.11
11 Cleaning and sanitizing .12
12 Pest control.13
13 Personnel hygiene and employee facilities.14
14 Rework.16
15 Product recall procedures.17
16 Warehousing.17
17 Product information/consumer awareness .18
18 Food defence, biovigilance and bioterrorism.18
Bibliography.19
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 22002-1 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 17,
Management systems for food safety.
ISO/TS 22002 consists of the following parts, under the general title Prerequisite programmes on food safety:
⎯ Part 1: Food manufacturing
[5]
This Technical Specification is based on BS PAS 220:2008 .
iv © ISO 2009 – All rights reserved
Introduction
ISO 22000:2005 sets out specific food safety requirements for organizations in the food chain. One such
requirement is that organizations establish, implement and maintain prerequisite programmes (PRP) to assist
in controlling food safety hazards (ISO 22000:2005, Clause 7). This Technical Specification is intended to be
used to support management systems designed to meet the requirements specified in ISO 22000:2005, and
sets out the detailed requirements for those programmes.
This Technical Specification does not duplicate requirements given in ISO 22000:2005 and is intended to be
used in conjunction with ISO 22000:2005.
TECHNICAL SPECIFICATION ISO/TS 22002-1:2009(E)
Prerequisite programmes on food safety —
Part 1:
Food manufacturing
WARNING — The text of this Technical Specification assumes that the execution of its provisions is
entrusted to appropriately qualified and experienced people, for whose use it has been produced.
This Technical Specification does not purport to include all the necessary provisions of a contract.
Users are responsible for its correct application. Compliance with this Technical Specification does
not in itself confer immunity from legal obligations.
1 Scope
This Technical Specification specifies requirements for establishing, implementing and maintaining
prerequisite programmes (PRP) to assist in controlling food safety hazards.
This Technical Specification is applicable to all organizations, regardless of size or complexity, which are
involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address
the requirements specified in ISO 22000:2005, Clause 7.
This Technical Specification is neither designed nor intended for use in other parts of the food supply chain.
Food manufacturing operations are diverse in nature and not all of the requirements specified in this Technical
Specification apply to an individual establishment or process.
Where exclusions are made or alternative measures implemented, these need to be justified and documented
by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted
should not affect the ability of the organization to comply with these requirements. Examples of such
exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and
5) below.
This Technical Specification specifies detailed requirements to be specifically considered in relation to
ISO 22000:2005, 7.2.3:
a) construction and layout of buildings and associated utilities;
b) layout of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance;
f) management of purchased materials;
g) measures for the prevention of cross-contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene.
In addition, this Technical Specification adds other aspects which are considered relevant to manufacturing
operations:
1) rework;
2) product recall procedures;
3) warehousing;
4) product information and consumer awareness;
5) food defence, biovigilance and bioterrorism.
NOTE Measures for prevention of malicious contamination are outside the scope of this Technical Specification.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 22000:2005, Food safety management systems — Requirements for any organization in the food chain
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22000:2005 and the following apply.
3.1
contamination
〈food safety〉 introduction or occurrence of a contaminant (3.2) in food or food environment
[1]
NOTE Adapted from CAC/RCP 1:2003 , 2.3.
3.2
contaminant
〈food safety〉 any biological or chemical agent, foreign matter or other substances not intentionally added to
food which may compromise food safety or suitability
[1]
[CAC/RCP 1:2003 , 2.3]
3.3
establishment
〈food safety〉 any building or area in which food is handled and the surroundings under the control of the same
management
[1]
[CAC/RCP 1:2003 , 2.3]
3.4
materials
〈food safety〉 general term used to indicate raw materials, packaging materials, ingredients, process aids,
cleaning materials and lubricants
2 © ISO 2009 – All rights reserved
3.5
cleaning
〈food safety〉 removal of soil, food residue, dirt, grease or other objectionable matter
[1]
NOTE Adapted from CAC/RCP 1:2003 , 2.3.
3.6
product contact
all surfaces that are in contact with the product or the primary package during normal operation
3.7
material specification
product specification
〈food safety〉 detailed documented description or enumeration of parameters, including permissible variations
and tolerances, which are required to achieve a defined level of acceptability or quality
3.8
food grade
lubricants and heat transfer fluids formulated to be suitable for use in food processes where there may be
incidental contact between the lubricant and the food
3.9
disinfection
〈food safety〉 reduction, by means of chemical agents and/or physical methods, of the number of
microorganisms in the environment, to a level that does not compromise food safety or suitability
[1]
NOTE Adapted from CAC/RCP 1:2003 , 2.3.
3.10
cleaning in place
CIP
cleaning (3.5) of equipment by impingement or circulation of flowing chemical solutions, cleaning liquids and
water rinses into, on to and over surfaces in equipment or systems without dismantling and designed for the
purpose
[2]
[ISO 14159:2002 , 3.3]
3.11
cleaning out of place
COP
system where equipment is disassembled and cleaned in a tank or in an automatic washer by circulating a
cleaning solution and maintaining a minimum temperature throughout the cleaning cycle
3.12
sanitizing
〈food safety〉 process of cleaning, followed by disinfection
3.13
sanitation
all actions dealing with cleaning or maintaining hygienic conditions in an establishment, ranging from cleaning
and/or sanitizing of specific equipment to periodic cleaning activities throughout the establishment (including
building, structural, and grounds cleaning activities)
3.14
certificate of analysis
COA
〈food safety〉 document provided by the supplier which indicates results of specific tests or analysis, including
test methodology, performed on a defined lot of the supplier’s product
© I
...
SPÉCIFICATION ISO/TS
TECHNIQUE 22002-1
Première édition
2009-12-15
Programmes prérequis pour la sécurité
des denrées alimentaires —
Partie 1:
Fabrication des denrées alimentaires
Prerequisite programmes on food safety —
Part 1: Food manufacturing
Numéro de référence
©
ISO 2009
PDF – Exonération de responsabilité
Le présent fichier PDF peut contenir des polices de caractères intégrées. Conformément aux conditions de licence d'Adobe, ce fichier
peut être imprimé ou visualisé, mais ne doit pas être modifié à moins que l'ordinateur employé à cet effet ne bénéficie d'une licence
autorisant l'utilisation de ces polices et que celles-ci y soient installées. Lors du téléchargement de ce fichier, les parties concernées
acceptent de fait la responsabilité de ne pas enfreindre les conditions de licence d'Adobe. Le Secrétariat central de l'ISO décline toute
responsabilité en la matière.
Adobe est une marque déposée d'Adobe Systems Incorporated.
Les détails relatifs aux produits logiciels utilisés pour la création du présent fichier PDF sont disponibles dans la rubrique General Info
du fichier; les paramètres de création PDF ont été optimisés pour l'impression. Toutes les mesures ont été prises pour garantir
l'exploitation de ce fichier par les comités membres de l'ISO. Dans le cas peu probable où surviendrait un problème d'utilisation,
veuillez en informer le Secrétariat central à l'adresse donnée ci-dessous.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2009
Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publication ne peut être reproduite ni utilisée sous
quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit
de l'ISO à l'adresse ci-après ou du comité membre de l'ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Version française parue en 2010
Publié en Suisse
ii © ISO 2009 – Tous droits réservés
Sommaire Page
Avant-propos .iv
Introduction.v
1 Domaine d'application .1
2 Références normatives.2
3 Termes et définitions .2
4 Construction et disposition des bâtiments .5
5 Disposition des locaux et de l'espace de travail.5
6 Services généraux — air, eau, énergie.7
7 Élimination des déchets .8
8 Aptitude, nettoyage et maintenance des équipements.9
9 Gestion des produits achetés .10
10 Mesures de prévention des transferts de contamination (contaminations croisées) .11
11 Nettoyage et désinfection.13
12 Maîtrise des nuisibles .14
13 Hygiène des membres du personnel et installations destinées aux employés.15
14 Produits retraités/recyclés .17
15 Procédures de rappel de produits .18
16 Entreposage.18
17 Information sur les produits et sensibilisation des consommateurs .19
18 Prévention de l'introduction intentionnelle de dangers dans les denrées alimentaires,
biovigilance et bioterrorisme .19
Bibliographie.20
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée
aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
Dans d'autres circonstances, en particulier lorsqu'il existe une demande urgente du marché, un comité
technique peut décider de publier d'autres types de documents:
⎯ une Spécification publiquement disponible ISO (ISO/PAS) représente un accord entre les experts dans
un groupe de travail ISO et est acceptée pour publication si elle est approuvée par plus de 50 % des
membres votants du comité dont relève le groupe de travail;
⎯ une Spécification technique ISO (ISO/TS) représente un accord entre les membres d'un comité technique
et est acceptée pour publication si elle est approuvée par 2/3 des membres votants du comité.
Une ISO/PAS ou ISO/TS fait l'objet d'un examen après trois ans afin de décider si elle est confirmée pour trois
nouvelles années, révisée pour devenir une Norme internationale, ou annulée. Lorsqu'une ISO/PAS ou
ISO/TS a été confirmée, elle fait l'objet d'un nouvel examen après trois ans qui décidera soit de sa
transformation en Norme internationale soit de son annulation.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO/TS 22002-1 a été élaborée par le comité technique ISO/TC 34, Produits alimentaires, sous-comité
SC 17, Systèmes de management pour la sécurité des denrées alimentaires.
L'ISO/TS 22002 comprend les parties suivantes, présentées sous le titre général Programmes prérequis pour
la sécurité des denrées alimentaires:
⎯ Partie 1: Fabrication des denrées alimentaires
[5]
La présente Spécification technique est fondée sur la BS PAS 220:2008 .
iv © ISO 2009 – Tous droits réservés
Introduction
L'ISO 22000:2005 définit les exigences relatives à la sécurité des denrées alimentaires, à l'attention des
organismes intervenant dans la chaîne alimentaire. L'une de ces exigences est que les organismes
établissent, mettent en œuvre et mettent à jour des programmes prérequis (PRP) afin de les aider à maîtriser
les dangers liés à la sécurité des denrées alimentaires (ISO 22000:2005, Article 7). La présente Spécification
technique vise à étayer les systèmes de management conçus pour répondre aux exigences spécifiées dans
l'ISO 22000:2005, et détaille les exigences relatives à ces programmes.
La présente Spécification technique ne reproduit pas les exigences de l'ISO 22000:2005. Elle est destinée à
être utilisée conjointement avec l'ISO 22000:2005.
SPÉCIFICATION TECHNIQUE ISO/TS 22002-1:2009(F)
Programmes prérequis pour la sécurité des denrées
alimentaires —
Partie 1:
Fabrication des denrées alimentaires
AVERTISSEMENT — Le texte de la présente Spécification technique implique que l'exécution de ses
dispositions est confiée à du personnel dûment qualifié et expérimenté, à l'usage duquel il est destiné.
La présente Spécification technique ne vise pas à inclure toutes les dispositions nécessaires d'un
contrat. Les utilisateurs sont responsables de son utilisation correcte. Le respect de la présente
Spécification technique ne dispense pas en lui-même des obligations légales.
1 Domaine d'application
La présente Spécification technique spécifie les exigences pour établir, mettre en œuvre et mettre à jour des
programmes prérequis (PRP) afin d'aider à maîtriser les dangers liés à la sécurité des denrées alimentaires.
La présente Spécification technique est applicable à tous les organismes, quelle que soit leur taille ou leur
complexité, qui interviennent dans l'étape de fabrication de la chaîne alimentaire et qui souhaitent mettre en
œuvre des PRP de manière à satisfaire aux exigences spécifiées dans l'ISO 22000:2005, Article 7.
La présente Spécification technique n'est ni conçue pour, ni destinée à être utilisée dans d'autres parties de la
chaîne d'approvisionnement alimentaire.
Les opérations de fabrication des denrées alimentaires étant diverses par nature, les exigences spécifiées
dans la présente Spécification technique ne s'appliquent pas nécessairement en totalité à un établissement
ou à un procédé individuel.
Les exclusions ou la mise en œuvre de mesures alternatives nécessitent d'être justifiées et documentées par
une analyse des dangers, telle que décrite dans l'ISO 22000:2005, 7.4. Il convient que toute exclusion ou
mesure alternative adoptée n'affecte pas la capacité de l'organisme à se conformer à ces exigences. Ces
exclusions incluent par exemple les aspects complémentaires concernant les opérations de fabrication
énumérées ci-dessous aux points 1), 2), 3), 4) et 5).
La présente Spécification technique spécifie des exigences détaillées à prendre en compte en liaison avec
l'ISO 22000:2005, 7.2.3:
a) la construction et la disposition des bâtiments et des installations associées;
b) la disposition des locaux, notamment l'espace de travail et les installations destinées aux employés;
c) l'alimentation en air, en eau, en énergie et autres;
d) les services annexes, notamment pour l'élimination des déchets et des eaux usées;
e) le caractère approprié des équipements et leur accessibilité pour leur nettoyage, leur entretien et leur
maintenance préventive;
f) la gestion des produits achetés;
g) les mesures de prévention contre les transferts de contaminations;
h) le nettoyage et la désinfection;
i) la maîtrise des nuisibles;
j) l'hygiène des membres du personnel.
En outre, la présente Spécification technique précise d'autres aspects considérés comme pertinents pour les
opérations de fabrication:
1) le retraitement/recyclage;
2) les procédures de rappel de produits;
3) l'entreposage;
4) l'information sur les produits et la sensibilisation des consommateurs;
5) la prévention de l'introduction intentionnelle de dangers dans les denrées alimentaires, la
biovigilance et le bioterrorisme.
NOTE Le domaine d'application de la présente Spécification technique ne couvre pas les mesures de prévention des
contaminations issues de la malveillance.
2 Références normatives
Les documents de référence suivants sont indispensables pour l'application du présent document. Pour les
références datées, seule l'édition citée s'applique. Pour les références non datées, la dernière édition du
document de référence (y compris les éventuels amendements) s'applique.
ISO 22000:2005, Systèmes de management de la sécurité des denrées alimentaires — Exigences pour tout
organisme appartenant à la chaîne alimentaire
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans l'ISO 22000:2005 ainsi que les
suivants s'appliquent.
3.1
contamination
〈sécurité des denrées alimentaires〉 introduction ou présence d'un contaminant (3.2) dans une denrée
alimentaire ou un environnement alimentaire
[1]
NOTE Adapté du CAC/RCP 1:2003 , 2.3.
3.2
contaminant
〈sécurité des denrées alimentaires〉 produit biologique ou chimique, corps étranger ou autre substance ajouté
non intentionnellement à une denrée alimentaire et susceptible d'en compromettre la sécurité ou la salubrité
[1]
NOTE Adapté du CAC/RCP 1:2003 , 2.3.
2 © ISO 2009 – Tous droits réservés
3.3
établissement
〈sécurité des denrées alimentaires〉 bâtiment ou zone de manipulation d'une denrée alimentaire, et milieu
environnant placé sous le contrôle de la même direction
[1]
NOTE Adapté du CAC/RCP 1:2003 , 2.3.
3.4
matériaux
〈sécurité des denrées alimentaires〉 terme générique désignant les matières premières, matériaux d'emballage,
ingrédients, auxiliaires alimentaires, produits de nettoyage et lubrifiants
3.5
nettoyage
〈sécurité des denrées alimentaires〉 élimination des souillures, résidus de denrées alimentaires, poussières,
graisses ou autres substances inacceptables
[1]
NOTE Adapté du CAC/RCP 1:2003 , 2.3.
3.6
surface en contact
toute surface en contact avec le produit ou l'emballage primaire pendant l'exploitation normale
3.7
spécification du matériau
spécific
...
ТЕХНИЧЕСКИЕ ISO/TS
УСЛОВИЯ 22002-1
Первое издание
2009-12-15
Программы предварительных условий
для безопасности пищевых продуктов.
Часть 1.
Производство пищевых продуктов
Prerequisite programmes on food safety —
Part 1: Food manufacturing
Ответственность за подготовку русской версии несёт GOST R
(Российская Федерация) в соответствии со статьёй 18.1 Устава ISO
Ссылочный номер
©
ISO 2009
Отказ от ответственности при работе в PDF
Настоящий файл PDF может содержать интегрированные шрифты. В соответствии с условиями лицензирования, принятыми
фирмой Adobe, этот файл можно распечатать или вывести на экран, но его нельзя изменить, пока не будет получена
лицензия на загрузку интегрированных шрифтов в компьютер, на котором ведется редактирование. В случае загрузки
настоящего файла заинтересованные стороны принимают на себя ответственность за соблюдение лицензионных условий
фирмы Adobe. Центральный секретариат ISO не несут никакой ответственности в этом отношении.
Adobe торговый знак фирмы Adobe Systems Incorporated.
Подробности, относящиеся к программным продуктам, использованным для создания настоящего файла PDF, можно найти в
рубрике General info файла; параметры создания PDF были оптимизированы для печати. Были приняты во внимание все
меры предосторожности с тем, чтобы обеспечить пригодность настоящего файла для использования комитетами-членами
ISO. В редких случаях возникновения проблемы, связанной со сказанным выше, просьба проинформировать Центральный
секретариат по адресу, приведенному ниже.
ДОКУМЕНТ ЗАЩИЩЕН АВТОРСКИМ ПРАВОМ
© ISO 2009
Все права сохраняются. Если не указано иное, никакую часть настоящей публикации нельзя копировать или использовать в
какой-либо форме или каким-либо электронным или механическим способом, включая фотокопии и микрофильмы, без
предварительного письменного согласия ISO по соответствующему адресу, указанному ниже, или комитета-члена ISO в стране
заявителя.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Опубликовано в Швейцарии
ii © ISO 2009 – Все права сохраняются
Содержание Страница
Предисловие .iv
Введение .v
1 Область применения .1
2 Нормативные ссылки .2
3 Термины и определения .2
4 Конструкция и планировка зданий .5
5 Расположение служебных помещений и рабочих зон.6
6 Коммунальные службы — подвод воздуха, водоснабжение, энергоснабжение.7
7 Удаление отходов.9
8 Пригодность, очистка и техническое обслуживание .10
9 Менеджмент закупаемых материалов.11
10 Меры для предотвращения перекрестного заражения .12
11 Очистка и санитарная обработка .14
12 Борьба с паразитами .15
13 Личная гигиена и санитарно-гигиеническое оборудование для персонала.16
14 Исправимый брак.18
15 Процедуры отзыва продукта .19
16 Хранение на складах.19
17 Информация о продукте и осведомленность потребителей .20
18 Защита пищевых продуктов, биологическая бдительность и биотерроризм.20
Библиография.21
Предисловие
Международная организация по стандартизации (ISO) является всемирной федерацией национальных
организаций по стандартизации (комитетов-членов ISO). Разработка международных стандартов
обычно осуществляется техническими комитетами ISO. Каждый комитет-член, заинтересованный в
деятельности, для которой был создан технический комитет, имеет право быть представленным в этом
комитете. Международные правительственные и неправительственные организации, имеющие связи с
ISO, также принимают участие в работах. Что касается стандартизации в области электротехники, ISO
работает в тесном сотрудничестве с Международной электротехнической комиссией (IEC).
Проекты международных стандартов разрабатываются по правилам, указанным в Директивах ISO/IEC,
Часть 2.
Главная задача технических комитетов состоит в разработке международных стандартов. Проекты
международных стандартов, принятые техническими комитетами, рассылаются комитетам-членам на
голосование. Их опубликование в качестве международных стандартов требует одобрения, по
меньшей мере, 75 % комитетов-членов, принимающих участие в голосовании
При других обстоятельствах, особенно когда существует срочная потребность рынка в таких
документах, технический комитет может принять решение о публикации других типов нормативного
документа:
— общедоступные технические условия ISO (ISO/PAS) представляют собой соглашение между
техническими экспертами в рабочей группе ISO и принимаются к публикации после одобрения
более чем 50 % членов основного комитета, участвующих в голосовании;
— технические условия ISO (ISO/TS) представляют собой соглашение между членами технического
комитета и принимаются к публикации после одобрения 2/3 членов комитета, участвующих в
голосовании.
ISO/PAS или ISO/TS пересматриваются каждые три года для принятия решения либо о продлении их
действия на следующие три года, либо о переработке для придания им статуса международного
стандарта, либо о прекращении срока действия. Если принимается решение о продлении действия
ISO/PAS или ISO/TS, они снова пересматриваются через следующие три года и тогда должны быть
или преобразованы в международный стандарт или отменены.
Обращается внимание на то, что некоторые элементы данного документа могут быть объектом
патентных прав. ISO не несет ответственности за идентификацию какого-либо одного или всех таких
патентных прав.
ISO/TS 22002 были разработаны Техническим комитетом ISO/TC 34, Пищевые продукты,,
Подкомитетом SC 17, Системы менеджмента для безопасности пищевых продуктов.
ISO/TS 22002 состоит из следующих частей под общим заглавием Программы необходимых
предварительных условий для безопасности пищевых продуктов:
⎯ Часть 1. Производство пищевых продуктов
[5]
Настоящие технические условия основаны на BS PAS 220:2008 .
iv © ISO 2009 – Все права сохраняются
Введение
ISO 22000:2005 устанавливает специальные требования к безопасности пищевых продуктов для
организаций в цепи производства и потребления пищевых продуктов (пищевая цепь). Одно из таких
требований состоит в том, что организации должны устанавливать, внедрять и поддерживать
программы предварительных условий (PRP), обеспечивающие контроль рисков для безопасности
пищевых продуктов (ISO 22000:2005, Раздел 7). Настоящие технические условия предназначены для
поддержки систем менеджмента, которые должны удовлетворять требованиям, определенным в
ISO 22000:2005, и устанавливают детальные требования для этих программ.
Настоящие технические условия не дублируют требования, приведенные в ISO 22000:2005, и
предназначены для совместного использования с ISO 22000:2005.
ТЕХНИЧЕСКИЕ УСЛОВИЯ ISO/TS 22002-1:2009(R)
Программы предварительных условий для безопасности
пищевых продуктов.
Часть 1.
Производство пищевых продуктов
ПРЕДУПРЕЖДЕНИЕ — Текст настоящих технических условий подразумевает, что их
использование и выполнение доверено людям соответствующей квалификации и опыта.
Настоящие технические условия не претендуют на включение всех необходимых условий
контракта. Ответственность за их правильное применение возлагается на пользователей.
Соответствие этим техническим условиям само по себе не дает освобождения от правовых
обязательств.
1 Область применения
Настоящие технические условия устанавливают требования для создания, выполнения и поддержки
программ необходимых предварительных условий (PRP), обеспечивающих контроль рисков для
безопасности пищевых продуктов.
Эти технические условия применимы для всех организаций независимо от размера или сложности,
которые включены в производственный этап цепи пищевых продуктов и хотят выполнять PRP в
соответствии с требованиями, установленными в ISO 22000:2005, Раздел 7.
Эти технические условия не разработаны и не предназначены для использования в других частях цепи
поставок пищевых продуктов.
Технологии производства пищевых продуктов различаются по характеру, и не все требования,
установленные в этих технических условиях, применимы к отдельным предприятиям или процессам.
Когда делаются исключения или применяются альтернативные меры, они должны быть
аргументированы и документированы посредством анализа рисков, как описано в ISO 22000:2005, 7.4.
Любые принятые исключения или альтернативные меры не должны влиять на способность
организации соответствовать этим требованиям. Примеры таких исключений представляют
дополнительные аспекты, соответствующие производственным процессам, перечисленным ниже в
пунктах 1), 2), 3), 4) и 5).
Настоящие технические условия устанавливают детальные требования, которые будут специально
рассматриваться в связи с ISO 22000:2005, 7.2.3:
a) конструкция и планировка зданий и связанных коммунальных служб;
b) расположение служебных помещений, включая рабочие зоны и удобства для персонала;
c) подвод воздуха, водопровод, энергоснабжение и другие коммунальные службы;
d) вспомогательные службы, включая удаление отходов и сточных вод;
e) пригодность оборудования и его доступность для очистки, технического обслуживания и
профилактики;
f) менеджмент закупаемых материалов;
g) меры для предотвращения перекрестного загрязнения;
h) чистка и санитарная обработка;
i) борьба с вредителями;
j) личная гигиена персонала.
Кроме того настоящие технические условия добавляют другие аспекты, относящиеся к
производственным операциям:
1) исправление брака;
2) процедуры отзыва продуктов;
3) хранение на складах;
4) информация о продукции и осведомленность потребителя;
5) защита пищевых продуктов, бдительность относительно биологических опасностей, биотерроризм.
ПРИМЕЧАНИЕ Настоящие технические условия не распространяются на меры для предотвращения
злоумышленных загрязнений.
2 Нормативные ссылки
Следующие ссылочные нормативные документы являются обязательными при применении данного
документа. Для жестких ссылок применяется только цитированное издание документа. Для плавающих
ссылок необходимо использовать самое последнее издание нормативного ссылочного документа
(включая любые изменения).
ISO 22000:2005, Системы менеджмента безопасности пищевых продуктов. Требования ко всем
организациям в цепи производства и потребления пищевых продуктов
3 Термины и определения
Для этого документа используются термины и определения, данные в ISO 22000:2005, и следующие.
3.1
загрязнение
contamination
〈безопасность пищевых продуктов〉 появление или возникновение загрязнителя (3.2) в пищевом
продукте или пищевой среде
[1]
ПРИМЕЧАНИЕ Адаптировано из CAC/RCP 1:2003 , 2.3.
2 © ISO 2009 – Все права сохраняются
3.2
загрязнитель
contaminant
〈безопасность пищевых продуктов〉 любой биологический или химический агент, инородное вещество
или другие вещества, неумышленно добавленные к пищевому продукту, которые могут подвергнуть
риску безопасность или пригодность пищевого продукта
[1]
[CAC/RCP 1:2003 , 2.3]
3.3
предприятие
establishment
〈безопасность пищевых продуктов〉 любое здание или участок, где обрабатываются пищевые продукты,
и окружающие места, находящееся под управлением того же руководящего органа
[1]
[CAC/RCP 1:2003 , 2.3]
3.4
материалы
materials
〈безопасность пищевых продуктов〉 общий термин для сырья, упаковочных материалов, ингредиентов,
вспомогательных технологических средств, очищающих материалов и смазок
3.5
очистка
cleaning
〈безопасность пищевых продуктов〉 удаление почвы, пищевых остатков, грязи, жира и других
нежелательных веществ
[1]
ПРИМЕЧАНИЕ Адаптировано из CAC/RCP 1:2003 , 2.3.
3.6
контакт с продуктом
product contact
все поверхности, которые контактируют с продуктом или первичной упаковкой во время нормального
функционирования
3.7
технические условия на материал
material specification
технические условия на продукт
product specification
〈безопасность пищевых продуктов〉 детальное документированное описание или перечисление
параметров, включая допустимые отклонения и допуски, которые требуются для достижения
определенного уровня приемлемости или качества
3.8
пищевой класс
food grade
смазки и теплопередающие жидкости пищевого класса, изготовленные специально для использования
в технологических процессах для пищевых продуктов, где возможен случайный контакт между смазкой
и пищевым продуктом
3.9
дезинфекция
disinfection
〈безопасность пищевых продуктов〉 уменьшение с помощью химических агентов и/или физическими
методам
...
SLOVENSKA
SIST-TS ISO/TS 22002-1 TEHNIČNA
marec 2011
SPECIFIKACIJA
Prerekvizitni programi za varnost živil – 1. del: Proizvodnja živil
Prerequisite programmes on food safety – Part 1: Food manufacturing
Programmes prérequis pour la sécurité des denrées alimentaires –
Partie 1: Fabrication des denrées alimentaires
Referenčna oznaka ICS 67.020 SIST-TS ISO/TS 22002-1:2011 (sl)
Nadaljevanje na straneh od 2 do 31
© 2011-11. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
SIST-TS ISO/TS 22002-1 : 2011 2 NACIONALNI UVOD
Tehnična specifikacija SIST-TS ISO/TS 22002-1 (sl, en), Prerekvizitni programi za varnost živil –
1. del: Proizvodnja živil, 2011, ima status slovenske tehnične specifikacije in je enakovredna mednarodni tehnični specifikaciji ISO/TS 22002-1 (en), Prerequisite programmes on food safety –
Part 1: Food manufacturing, 2009. NACIONALNI PREDGOVOR
Mednarodno tehnično specifikacijo ISO/TS 22002-1:2009 je pripravil tehnični odbor Mednarodne organizacije za standardizacijo ISO/TC 34/SC 17 Sistemi vodenja varnosti živil. Slovenska tehnična specifikacija SIST-TS ISO/TS 22002-1:2011 je prevod mednarodne tehnične specifikacije ISO/TS 22002-1:2009. V primeru spora glede besedila slovenskega prevoda v tej tehnični specifikaciji je odločilna izvirna mednarodna tehnična specifikacija v angleškem jeziku. Slovensko izdajo tehnične specifikacije je pripravil tehnični odbor SIST/TC KŽP Kmetijski pridelki in živilski proizvodi. Odločitev za izdajo te tehnične specifikacije je dne 11. oktobra 2010 sprejel SIST/TC KŽP Kmetijski pridelki in živilski proizvodi. ZVEZA S STANDARDI
S privzemom te mednarodne tehnične specifikacije veljajo za omenjeni namen referenčnih standardov vsi standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo: SIST EN ISO 22000:2005 Sistemi vodenja varnosti živil – Zahteve za vsako organizacijo v prehranski verigi (ISO 22000:2005) OSNOVA ZA IZDAJO STANDARDA – privzem mednarodne tehnične specifikacije ISO/TS 22002-1:2009 OPOMBI – Povsod, kjer se v besedilu tehnične specifikacije uporablja izraz “mednarodna tehnična specifikacija”, v SIST-TS ISO/TS 22002-1:2011 to pomeni “slovenska tehnična specifikacija”. – Uvod in nacionalni predgovor nista sestavni del standarda.
SIST-TS ISO/TS 22002-1 : 2011 3
VSEBINA Stran CONTENTS PagePredgovor.4Foreword.4Uvod.5Introduction.51 Področje uporabe.61
Scope.62 Zveze s standardi.72
Normative references.73 Izrazi in definicije.83
Terms and definitions.84 Gradnja in tloris stavb.104
Construction and layout of buildings.105 Tloris prostorov in delovnih mest.115
Layout of premises and workspace.116 Preskrba – zrak, voda, energija.136
Utilities – air, water, energy.137 Odstranjevanje odpadkov.157
Waste disposal.158 Ustreznost opreme, čiščenje in
vzdrževanje.168
Equipment suitability, cleaning and maintenance.169 Upravljanje z nabavljenimi materiali .189
Management of purchased materials.1810 Ukrepi za preprečevanje navzkrižnega
onesnaženja.1910
Measures for prevention of cross contamination.1911
Čiščenje in sanitacija.2111
Cleaning and sanitizing.2112
Nadzor nad škodljivci.2212
Pest control.2213
Osebna higiena in prostori za osebje.2413
Personnel hygiene and employee
facilities.2414
Predelava.2714
Rework.2715
Postopki odpoklica proizvoda.2815
Product recall procedures.2816
Skladiščenje.2816
Warehousing.2817
Informacija o proizvodu in osveščanje potrošnika.2917
Product information/consumer
awareness.2918
Zaščita živil, biološka previdnost in bioterorizem.3018
Food defence, biovigilance and
bioterrorism.30Literatura.31Bibliography.31
SIST-TS ISO/TS 22002-1 : 2011 4
Predgovor
Foreword Mednarodna organizacija za standardizacijo (ISO) je svetovna zveza nacionalnih organov za standarde (članov ISO). Mednarodne standarde ponavadi pripravljajo tehnični odbori ISO. Vsak član, ki želi delovati na določenem področju, za katero je bil ustanovljen tehnični odbor, ima pravico biti zastopan v tem odboru. Pri delu sodelujejo tudi vladne in mednarodne organizacije, povezane z ISO. V vseh zadevah, ki so povezane s standardizacijo na področju elektrotehnike, ISO tesno sodeluje z Mednarodno elektrotehniško komisijo (IEC).
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Mednarodni standardi so pripravljeni v skladu s pravili, podanimi v drugem delu Direktiv ISO/IEC.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
Poglavitna naloga tehničnih odborov je priprava mednarodnih standardov. Osnutki mednarodnih standardov, ki jih sprejmejo tehnični odbori, se pošljejo vsem članom v glasovanje. Za objavo mednarodnega standarda je treba pridobiti soglasje najmanj 75 odstotkov članov, ki se udeležijo glasovanja.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standardrequires approval by at least 75 % of the member bodies casting a vote. Tehnični odbor se v posebnih okoliščinah lahko odloči tudi za objavo drugih vrst dokumentov, še posebej ko se pojavi nujna zahteva trga po takih dokumentih:
In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of document: – javno dostopna specifikacija (ISO/PAS) predstavlja dogovor med tehničnimi strokovnjaki v delovni skupini ISO in je sprejeta v objavo, če pridobi soglasje več kot 50 % članov krovnega odbora, ki se udeležijo glasovanja;
– an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; – tehnična specifikacija (ISO/TS) predstavlja dogovor med člani tehničnega odbora in je sprejeta v objavo, če pridobi soglasje 2/3 članov odbora, ki se udeležijo glasovanja.
– an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. Dokument ISO/PAS ali ISO/TS se ponovno pregleda po treh letih z namenom odločitve, ali bo potrjen za nadaljnja tri leta, ali bo popravljen v mednarodni standard ali razveljavljen. Če je dokument ISO/PAS ali ISO/TS potrjen, se ponovno pregleda čez naslednja tri leta in takrat je treba sprejeti odločitev, ali bo preoblikovan v mednarodni standard ali razveljavljen.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn.
SIST-TS ISO/TS 22002-1 : 2011 5 Opozoriti je treba na možnost, da so nekateri elementi tega dokumenta lahko predmet patentnih pravic. ISO ne prevzema odgovornosti za identifikacijo katerih koli ali vseh takih patentnih pravic.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 22002-1 je pripravil tehnični odbor ISO/TC 34 Živilski proizvodi, in sicer pododbor SC 17 Sistemi vodenja varnosti živil.
ISO/TS 22002-1 was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 17,Management systems for food safety. ISO/TS 22002 sestoji iz naslednjih delov pod skupnim naslovom Prerekvizitni programi za varnost živil:
– 1. del: Proizvodnja živil.
ISO/TS 22002 consists of the following parts, under the general title Prerequisite programmes on food safety:
– Part 1: Food manufacturing Ta tehnična specifikacija temelji na BS PAS 220:2008[5].
This Technical Specification is based on BS PAS 220:2008[5]. Uvod
Introduction ISO 22000:2005 podaja specifične zahteve za varnost živil za organizacije v prehranski verigi. Ena od teh zahtev je, da organizacija vzpostavi, izvaja in vzdržuje prerekvizitne programe, ki se uporabljajo pri nadzoru dejavnikov tveganja živil(ISO 22000:2005, 7. točka). Ta tehnična specifikacija je namenjena v pomoč pri snovanju sistemov vodenja za doseganje zahtev, navedenih v ISO 22000:2005, in podaja podrobne zahteve za omenjene programe.
ISO 22000:2005 sets out specific food safety requirements for organizations in the food chain. One such requirement is that organizations establish, implement and maintain prerequisite programmes (PRP) to assist in controlling food safety hazards (ISO 22000:2005, Clause 7). This Technical Specification is intended to be used to support management systems designed to meet the requirements specified in ISO 22000:2005, and sets out the detailed requirements for those programmes. Ta tehnična specifikacija ne podvaja zahtev,podanih v ISO 22000:2005, in je namenjena uporabi skupaj s standardom ISO 22000:2005.
This Technical Specification does not duplicate requirements given in ISO 22000:2005 and is intended to be used in conjunction with ISO 22000:2005.
SIST-TS ISO/TS 22002-1 : 2011 6
Prerekvizitni programi za varnost živil
Prerequisite programmes on food safety
Prvi del:
Part 1: Proizvodnja živil
Food manufacturing OPOZORILO – Glede vsebine tega tehničnegastandarda se predpostavlja, da bodo določila izvajale ustrezno usposobljene in izkušene osebe,za katere je bil standard pripravljen v uporabo.
WARNING – The text of this Technical Specifi-cation assumes that the execution of its provisions is entrusted to appropriately qualified and experienced people, for whose use it has been produced. Ta tehnična specifikacija nima namena vključevativseh potrebnih določil, ki so značilna za pogodbo.Uporabniki so odgovorni za njeno pravilno uporabo. Skladnost s to tehnično specifikacijosama po sebi ne osvobaja od obvez, ki jih nalagazakonodaja.
This Technical Specification does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with this Technical Specification does not in itself confer immunity from legal obligations. 1 Področje uporabe
1 Scope
Ta tehnična specifikacija navaja zahteve zavzpostavitev, izvajanje in vzdrževanjeprerekvizitnih programov (PRP), ki seuporabljajo pri nadzoru dejavnikov tveganjavarnosti živil.
This Technical Specification specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.
Ta tehnična specifikacija je primerna za vseorganizacije ne glede na velikost alikompleksnost, ki so vključene v proizvodniproces v prehranski verigi in želijo vzpostavitiPRP na tak način, kot so zahteve določene v ISO 22000:2005, 7. točka.
This Technical Specification is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.
Ta tehnična specifikacija ni zasnovana niti namenjena za uporabo v drugih delihprehranske verige.
This Technical Specification is neither designed nor intended for use in other parts of the food supply chain.
Postopki proizvodnje živil so po naravi različni,zato se za posamezen obrat ali proces neuporabijo vedno vse zahteve te tehničnespecifikacije v celoti.
Food manufacturing operations are diverse in nature and not all of the requirements specified in this Technical Specification apply to an individual establishment or process.
Kadar so določene zahteve izvzete ali seizvajajo drugačni ukrepi, je treba to zagovarjatiin dokumentirati z analizo tveganja, kot je toopisano v ISO 22000:2005, točka 7.4. V nobenem primeru pa izključitev zahteve ali izvajanje drugačnih ukrepov ne sme vplivati nazmožnost organizacije doseči skladnost s temizahtevami. Primeri takih izjem vključujejododatne vidike, pomembne za proizvodnepostopke, naštete pod 1), 2), 3), 4) in 5) vnadaljevanju besedila.
Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to complywith these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.
Ta tehnična specifikacija določa podrobnezahteve, ki jih je treba upoštevati v povezavi zISO 22000:2005, točka 7.2.3, za:
This Technical Specification specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3:
S
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.