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
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.
Programmes prérequis pour la sécurité des denrées alimentaires -- Partie 1: Fabrication des denrées alimentaires
L'ISO/TS 22002-1:2009 sp�cifie les exigences pour �tablir, mettre en œuvre et mettre � jour des programmes pr�requis (PRP) afin d'aider � ma�triser les dangers li�s � la s�curit� des denr�es alimentaires.
L'ISO/TS 22002-1:2009 est applicable � tous les organismes, quelle que soit leur taille ou leur complexit�, qui interviennent dans l'�tape de fabrication de la cha�ne alimentaire et qui souhaitent mettre en œuvre des PRP de mani�re � satisfaire aux exigences sp�cifi�es dans l'ISO 22000:2005, Article 7.
L'ISO/TS 22002-1:2009 n'est ni con�ue pour, ni destin�e � �tre utilis�e dans d'autres parties de la cha�ne d'approvisionnement alimentaire.
Les op�rations de fabrication des denr�es alimentaires �tant diverses par nature, les exigences sp�cifi�es dans l'ISO/TS 22002-1:2009 ne s'appliquent pas n�cessairement en totalit� � un �tablissement ou � un proc�d� individuel.
Les exclusions ou la mise en œuvre de mesures alternatives n�cessitent d'�tre justifi�es et document�es par une analyse des dangers, telle que d�crite dans l'ISO 22000:2005, 7.4. Il convient que toute exclusion ou mesure alternative adopt�e n'affecte pas la capacit� de l'organisme � se conformer � ces exigences. Ces exclusions incluent par exemple les aspects compl�mentaires concernant les op�rations de fabrication �num�r�es ci-dessous aux points 1), 2), 3), 4) et 5).
L'ISO/TS 22002-1:2009 sp�cifie des exigences d�taill�es � prendre en compte en liaison avec l'ISO 22000:2005, 7.2.3: a) la construction et la disposition des b�timents et des installations associ�es; b) la disposition des locaux, notamment l'espace de travail et les installations destin�es aux employ�s; c) l'alimentation en air, en eau, en �nergie et autres; d) les services annexes, notamment pour l'�limination des d�chets et des eaux us�es; e) le caract�re appropri� des �quipements et leur accessibilit� pour leur nettoyage, leur entretien et leur maintenance pr�ventive; f) la gestion des produits achet�s; g) les mesures de pr�vention contre les transferts de contaminations; h) le nettoyage et la d�sinfection; i) la ma�trise des nuisibles; j) l'hygi�ne des membres du personnel.
En outre, l'ISO/TS 22002-1:2009 pr�cise d'autres aspects consid�r�s comme pertinents pour les op�rations de fabrication: 1) le retraitement/recyclage; 2) les proc�dures de rappel de produits; 3) l'entreposage; 4) l'information sur les produits et la sensibilisation des consommateurs; 5) la pr�vention de l'introduction intentionnelle de dangers dans les denr�es 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.
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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
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ISO/TS 22002-1:2009(R)
©
ISO 2009
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ISO/TS 22002-1:2009(R)
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ISO/TS 22002-1:2009(R)
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
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ISO/TS 22002-1:2009(R)
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 .
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ISO/TS 22002-1:2009(R)
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.
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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;
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ISO/TS 22002-1:2009(R)
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.
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ISO/TS 22002-1:2009(R)
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
методами количества микроорганизмов в окружающей среде до уровня, не представляющего риска
для безопасности или пригодности пищевых продуктов
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[1]
ПРИМЕЧАНИЕ Адаптировано из CAC/RCP 1:2003 , 2.3.
3.10
очистка на месте
cleaning in place
CIP
очистка (3.5) внутренних или наружных поверхностей оборудования либо системы без их разборки
ударом струи или циркуляцией проточных химических растворов, очищающих жидкостей и воды,
которые специально предназначены для этой цели
[2]
[ISO 14159:2002 , 3.3]
3.11
очистка вне рабочего места
cleaning out of place
COP
система, когда оборудование разбирают и очищают в баке или автоматической мойке посредством
циркуляции очищающего раствора и поддержания минимальной температуры на протяжении всего
цикла очистки
3.12
санитарная обработка
sanitizing
〈безопасность пищевых продуктов〉 процесс очистки с последующей дезинфекцией
3.13
санитарно-профилактические меры
sanitation
все действия по очистке или поддержанию гигиенических условий на предприятии, начиная от очистки
и/или санитарной обработки конкретного оборудования до периодических очистных мероприятий на
всём предприятии (включая очистку здания, конструкций и фундаментов)
3.14
сертификат анализа
certificate of analysis
COA
〈безопасность пищевых продуктов〉 документ, представляемый поставщиком, в котором указываются
результаты конкретных испытаний или анализа, включая методику испытания, проведенного на
определенной партии поставляемой продукции
3.15
зонирование
zoning
〈безопасность пищевых продуктов〉 выделение участков на предприятии, где могут применяться
специальные рабочие, гигиенические или другие меры для сведения к минимуму возможности
микробиологического перекрестного загрязнения
NOTE К таким мерам можно отнести: смену одежды на входе или выходе, повышение давления воздуха,
изменение технологических маршрутов.
3.16
этикетка
label
〈безопасность пищевых продуктов〉 печатный материал, который является частью упаковки готового
продукта, дающий конкретную информацию о содержимом упаковки, пищевых ингредиентах и
требованиях к хранению и приготовлению
ПРИМЕР Данный термин означает, не ограничиваясь этим:
a) саму упаковку, печатный материал, прикрепленный к упаковке, или наклейку поверх этикетки;
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ISO/TS 22002-1:2009(R)
b) групповые упаковки, которые имеют внутреннюю этикетку на индивидуальном продукте и внешнюю
объединенную этикетку для всего содержимого.
3.17
отзыв продукта
product recall
изъятие несоответствующего продукта с рынка, из торговли и товарных складов, дистрибьюторских
центров и/или потребительских складов по причине его несоответствия установленным стандартам
3.18
«короче срок годности, раньше отправка»
first expired first out
FEFO
оборот товарных запасов на основе отправки продуктов со склада в порядке истечения их срока
годности: раньше отбирается продукт с самым коротким сроком годности
3.19
«раньше получен, раньше отправлен»
first in first out
FIFO
〈безопасность пищевых продуктов〉 оборот товарных запасов на основе отправки продуктов со склада в
порядке их поступления: в первую очередь отбирается продукт, который раньше поступил на склад
4 Конструкция и планировка зданий
4.1 Общие требования
Проектирование, строительство и техническое обслуживание зданий должны соответствовать
характеру технологических операций, которые будут выполняться, рискам для безопасности пищевых
продуктов, связанным с этими операциями и потенциальными источникам загрязнения из окружающей
среды. Здания должны иметь надежную конструкцию, не представляющую опасностей для продукции.
ПРИМЕЧАНИЕ Примером “надежной конструкции” являются самодренирующиеся крыши, которые не
протекают
4.2 Окружающая среда
Должны быть рассмотрены потенциальные источники загрязнения из местного окружения.
Производство пищевых продуктов не должно выполняться в тех местах, где возможно проникновение в
них потенциально вредных веществ.
Эффективность мер, принимаемых для защиты от потенциальных загрязнителей, должна
периодически пересматриваться.
4.3 Расположение предприятий
Границы строительного участка должны быть четко идентифицированы.
Доступ к участку должен контролироваться.
Строительный участок должен поддерживаться в надлежащем порядке. За растительностью нужно
ухаживать или удалять. Дороги, дворы и парковки должны быть осушены для предотвращения стоячей
воды и поддерживаться в нормальном состоянии.
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5 Расположение служебных помещений и рабочих зон
5.1 Общие требования
Проектирование, конструкция и техническое обслуживание внутренних помещений должны
способствовать надлежащей гигиенической и производственной практике. Схемы перемещения
материалов, продуктов и людей и размещения оборудования должны обеспечивать защиту от
потенциальных источников загрязнения.
5.2 Внутреннее проектирование, планировка и технологические маршруты
В здании должно быть обеспечено достаточное пространство для последовательных перемещений
материалов, продуктов и персонала и физическое разделение участков для сырых и обработанных
материалов.
ПРИМЕЧАНИЕ Примерами физического разделения являются стены, барьеры или перегородки либо
достаточное расстояние, чтобы минимизировать риск.
Отверстия, предназначенные для перемещения материалов, должны проектироваться таким образом,
чтобы свести к минимуму проникновение инородных веществ или паразитов.
5.3 Внутренние конструкции и арматура
Стены и потолки производственного участка должны быть моющимися или очищаемыми
соответственно требованиям предотвращения рисков для технологического процесса или продукта.
Материалы конструкции должны быть стойкими к применяемым чистящим системам.
Конструкция стыков пола и потолка и углов должна способствовать их очистке.
Рекомендуется, чтобы стыки пола и потолка на производственных участках были округленными.
Конструкция полов должна предотвращать застой воды.
На участках влажной обработки полы должны быть герметизированными и дренированными.
Водостоки должны быть изолированы и закрыты.
Потолки и подвесная арматура должны проектироваться таким образом, чтобы минимизировать
скопление пыли и конденсата.
Открывающиеся наружу окна, вентиляционные отверстия в крыше или вентилятор, если имеется,
должны быть защищены от насекомых.
Открывающиеся наружу двери должны быть закрыты или защищены, когда не используются.
5.4 Размещение оборудования
Проектирование и планировка оборудования должны обеспечивать надлежащую гигиеническую
практику и мониторинг.
Размещение оборудования должно обеспечивать доступ для работы, очистки и технического
обслуживания.
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5.5 Лабораторная база
Оборудование для комплексных испытаний необходимо контролировать для минимизации риска
загрязнения продуктов.
Проектирование, планировка и работа микробиологических лабораторий должны обеспечивать
предотвращение заражения людей, растений и продуктов. Они не должны непосредственно
открываться на производственный участок.
5.6 Временные или мобильные сооружения и торговые автоматы
Временные сооружения должны проектироваться, размещаться и строиться таким образом, чтобы не
допускать скопления паразитов и потенциального загрязнения продуктов.
Дополнительные опасности, связанные с временными постройками и торговыми автоматами, должны
оцениваться и контролироваться.
5.7 Хранение пищевых продуктов, упаковочных материалов, ингредиентов и
непищевых химикатов
Средства, используемые для хранения ингредиентов, упаковочных материалов и продуктов, должны
обеспечивать защиту от пыли, конденсатов, протечек, отходов и других источников загрязнения.
Складские помещения должны быть сухие и хорошо вентилированы. Если требуется, проводят
мониторинг и контроль температуры и влажности.
Проектирование и устройство складских помещений должны обеспечивать разделение сырьевых
материалов, незавершенных и готовых продуктов.
Все материалы и продукты не должны храниться на полу, и между ними и стенками должно быть
достаточно места для проведения проверок и борьбы с паразитами.
Проектирование складского помещения должно обеспечивать обслуживание, очистку, предотвращение
загрязнения и сведения к минимуму порчи.
Отдельные, безопасные (запираемые или с иным регулируемым доступом) складские участки должны
быть обеспечены для чистящих материалов, химикатов и других опасных веществ.
Исключения для насыпных материалов или сельскохозяйственных зерновых продуктов должны быть
документированы в системе менеджмента безопасности пищевых продуктов.
6 Коммунальные службы — подвод воздуха, водоснабжение, энергоснабжение
6.1 Общие требования
Предоставление и маршруты распределения коммунальных услуг для производственных и складских
участков проектируются с учетом минимизации риска загрязнения продуктов. С этой целью качество
коммунальных услуг должно регулярно контролироваться.
6.2 Водоснабжение
Подача питьевой воды должна быть достаточной для удовлетворения потребностей производственных
процессов. Проектирование средств для хранения, распределения и, где нужно, для температурного
контроля воды должно соответствовать установленным требованиям к качеству воды.
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Вода, используемая как ингредиент продукта, включая лед или пар (в том числе кулинарный пар), или
как среда, контактирующая с продуктом либо с его поверхностями, должна удовлетворять
установленному качеству и микробиологическим требованиям, соответствующим для этого продукта.
Вода для очистки или применений, где есть риск косвенного контакта с продуктом (например, сосуды с
рубашкой, теплообменники), должна удовлетворять установленному качеству и микробиологическим
требованиям, соответствующим для этого применения.
Когда подается хлорированная вода, необходимо проверять, что остаточное содержание хлора в
пункте использования остается в пределах, установленных в соответствующих технических условиях.
Непитьевая вода должна иметь отдельную систему подачи, которая соответственно маркирована и не
связана с системой подачи питьевой воды. Необходимо принимать меры для предотвращения слива
непитьевой воды в систему питьевой воды.
Рекомендуется, чтобы вода, которая может вступить в контакт с продуктом, поступала по трубам,
которые можно дезинфицировать
6.3 Химикаты для котлов
Если используются химикаты в котлах, они должны быть или:
a) одобренными пищевыми добавками, которые удовлетворяют соответствующим техническим
условиям; или
b) добавками, которые были одобрены соответствующим регулирующим органом как безопасные для
использования в воде, предназначенной для потребления человеком.
Химикаты для котла должны храниться в отдельном безопасном помещении (запертом или с иначе
регулируемым доступом) до непосредственного использования.
6.4 Качество воздуха и вентиляция
Организация должна установить требования для фильтрации, влажности (RH%) и микробиологическим
характеристикам воздуха, применяемого в качестве ингредиента или для непосредственного контакта
с продуктом. В тех местах, где температура и/или влажность рассматриваются организацией как
критические, устанавливается система регулирования и проводится мониторинг.
Вентиляция (естественная или механическая) должна быть установлена, чтобы удалять избыточный
или нежелательный пар, пыль и запахи и обеспечивать сушку после влажной чистки.
Контроль качества подачи комнатного воздуха должен обеспечивать минимизацию риска загрязнения
микробами в воздухе. Протоколы для мониторинга и контроля качества воздуха должны быть приняты
на тех участках, где воздействию подвергаются продукты, которые поддерживают рост или выживание
микроорганизмов.
Системы вентиляции должны быть спроектированы и построены таким образом, чтобы воздух не
циркулировал из загрязненных или сырьевых участков в чистые участки. Должны поддерживаться
установленные перепады давления воздуха. Системы должны быть доступны для очистки, замены
фильтров и технического обслуживания.
Впускные каналы для наружного воздуха должны периодически проверяться на физическую
целостность.
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6.5 Сжатый воздух и другие газы
Сжатые воздух, углекислый газ, азот и другие газовые системы, используемые в производстве и/или
заполнении, должны обрабатываться и поддерживаться таким образом, чтобы предотвращать
загрязнение.
Газы, предназначенные для прямого или побочного контактирования с продуктом (включая те, которые
используются для транспортировки, продувки или сушки материалов, продуктов или оборудования),
должны поступать из источника, одобренного для контактирования с пищевыми продуктами, и
фильтроваться для удаления пыли, масла и воды.
Когда для компрессоров используется масло и существует возможность контактирования воздуха с
продуктом, это масло должно быть пищевого класса.
Рекомендуется использование компрессоров, не содержащих масла.
Должны быть установлены требования для фильтрования, влажности (RH%) и микробиологических
характеристик.
Фильтрование воздуха должно быть как можно ближе к месту использования, если это осуществимо.
6.6 Освещение
Предоставляемое освещение (естественное или искусственное) должно обеспечивать гигиенические
условия работы персонала.
Интенсивность освещения должна соответствовать характеру работы.
Осветительная арматура должна быть защищена для гарантии, что материалы, продукты и
оборудование не будут загрязнены в случае аварии.
7 Удаление отходов
7.1 Общие требования
Для предотвращения загрязнения продуктов или производственных участков должны быть обеспечены
системы идентификации, сбора, удаления и ликвидации отходов.
7.2 Контейнеры для отходов и непищевых или опасных веществ
Контейнеры для отходов и непищевых или опасных веществ должны быть:
a) четко идентифицированы согласно своему назначению;
b) помещены в специально назначенное место;
c) изготовлены из непроницаемого материала, которое можно легко чистить и дезинфицировать;
d) закрыты, когда непосредственно не используются;
e) заперты, если отходы представляют опасность для продукта.
7.3 Управление отходами и их удаление
Должны быть обеспечены условия для отделения, хранения и удаления отходов.
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Нельзя допускать накопления отходов на участках транспортировки или хранения пищевых продуктов.
Для избежания их накоплений необходимо управлять частотой удаления отходов, придерживаясь
еже
...
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/TS 22002-1:2009(E)
©
ISO 2009
---------------------- Page: 1 ----------------------
ISO/TS 22002-1:2009(E)
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ISO/TS 22002-1:2009(E)
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
© ISO 2009 – All rights reserved iii
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ISO/TS 22002-1:2009(E)
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
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ISO/TS 22002-1:2009(E)
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.
© ISO 2009 – All rights reserved v
---------------------- Page: 5 ----------------------
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;
© ISO 2009 – All rights reserved 1
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ISO/TS 22002-1:2009(E)
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
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ISO/TS 22002-1:2009(E)
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
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ISO/TS 22002-1:2009(E)
3.15
zoning
〈food safety〉 demarcation of an area within an establishment where specific operating, hygiene or other
practices may be applied to minimize the potential for microbiological cross-contamination
NOTE Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic flow
patterns.
3.16
label
〈food safety〉 printed matter that is part of the finished product package conveying specific information about
the contents of the package, the food ingredients and any storage and preparation requirements
EXAMPLE The term covers, but is not limited to:
a) the package itself, printed matter attached to the package, or a sticker used for over-labelling;
b) multi-packs which have an inner label on the individual product and an outer combined label for the whole contents.
3.17
product recall
removal of a non-conforming product from the market, trade and warehouses, distribution centres and/or
customer warehouses because it does not meet specified standards
3.18
first expired first out
FEFO
stock rotation based on the principle of despatching earliest expiration dates first
3.19
first in first out
FIFO
〈food safety〉 stock rotation based on the principle of despatching earliest received products first
4 Construction and layout of buildings
4.1 General requirements
Buildings shall be designed, constructed and maintained in a manner appropriate to the nature of the
processing operations to be carried out, the food safety hazards associated with those operations and the
potential sources of contamination from the plant environs. Buildings shall be of durable construction which
presents no hazard to the product.
NOTE An example of “durable construction” is self-draining roofs which do not leak.
4.2 Environment
Consideration shall be given to potential sources of contamination from the local environment.
Food production should not be carried out in areas where potentially harmful substances could enter the
product.
The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed.
4 © ISO 2009 – All rights reserved
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ISO/TS 22002-1:2009(E)
4.3 Locations of establishments
The site boundaries shall be clearly identified.
Access to the site shall be controlled.
The site shall be maintained in good order. Vegetation shall be tended or removed. Roads, yards and parking
areas shall be drained to prevent standing water and shall be maintained.
5 Layout of premises and workspace
5.1 General requirements
Internal layouts shall be designed, constructed and maintained to facilitate good hygiene and manufacturing
practices. The movement patterns of materials, products and people, and the layout of equipment, shall be
designed to protect against potential contamination sources.
5.2 Internal design, layout and traffic patterns
The building shall provide adequate space, with a logical flow of materials, products and personnel, and
physical separation of raw from processed areas.
NOTE Examples of physical separation include walls, barriers or partitions, or sufficient distance to minimize risk.
Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests.
5.3 Internal structures and fittings
Process area walls and floors shall be washable or cleanable, as appropriate for the process or product
hazard. Materials of construction shall be resistant to the cleaning system applied.
Wall floor junctions and corners shall be designed to facilitate cleaning.
It is recommended that wall floor junctions be rounded in processing areas.
Floors shall be designed to avoid standing water.
In wet process areas, floors shall be sealed and drained. Drains shall be trapped and covered.
Ceilings and overhead fixtures shall be designed to minimize build-up of dirt and condensation.
External opening windows, roof vents or fan, where present, shall be insect screened.
External opening doors shall be closed or screened when not in use.
5.4 Location of equipment
Equipment shall be designed and located so as to facilitate good hygiene practices and monitoring.
Equipment shall be located to permit access for operation, cleaning and maintenance.
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ISO/TS 22002-1:2009(E)
5.5 Laboratory facilities
In-line and on-line test facilities shall be controlled to minimize risk of product contamination.
Microbiology laboratories shall be designed, located and operated so as to prevent contamination of people,
plant and products. They shall not open directly on to a production area.
5.6 Temporary or mobile premises and vending machines
Temporary structures shall be designed, located and constructed to avoid pest harbourage and potential
contamination of products.
Additional hazards associated with temporary structures and vending machines shall be assessed and
controlled.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals
Facilities used to store ingredients, packaging and products shall provide protection from dust, condensation,
drains, waste and other sources of contamination.
Storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity shall be
applied where specified.
Storage areas shall be designed or arranged to allow segregation of raw materials, work in progress and
finished products.
All materials and products shall be stored off the floor and with sufficient space between the material and the
walls to allow inspection and pest control activities to be carried out.
The storage area shall be designed to allow maintenance and cleaning, prevent contamination and minimize
deterioration.
A separate, secure (locked or otherwise access controlled) storage area shall be provided for cleaning
materials, chemicals and other hazardous substances.
Exceptions for bulk or agricultural crop materials shall be documented in the food safety management system.
6 Utilities — air, water, energy
6.1 General requirements
The provision and distribution routes for utilities to and around processing and storage areas shall be
designed to minimize the risk of product contamination. Utilities’ quality shall be monitored to minimize product
contamination risk.
6.2 Water supply
The supply of potable water shall be sufficient to meet the needs of the production process(es). Facilities for
storage, distribution and, where needed, temperature control of the water shall be designed to meet specified
water quality requirements.
Water used as a product ingredient, including ice or steam (including culinary steam), or in contact with
products or product surfaces, shall meet specified quality and microbiological requirements relevant to the
product.
6 © ISO 2009 – All rights reserved
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ISO/TS 22002-1:2009(E)
Water for cleaning or applications where there is a risk of indirect product contact (e.g. jacketed vessels, heat
exchangers) shall meet specified quality and microbiological requirements relevant to the application.
Where water supplies are chlorinated, checks shall ensure that the residual chlorine level at the point of use
remains within limits given in relevant specifications.
Non-potable water shall have a separate supply system that is labelled and not connected to the potable
water system. Take measures to prevent non-potable water refluxing into the potable system.
It is recommended that water that can come into contact with the product should flow through pipes that can
be disinfected.
6.3 Boiler chemicals
Boiler chemicals, if used, shall be either:
a) approved food additives which meet relevant additive specifications; or
b) additives which have been approved by the relevant regulatory authority as safe for use in water intended
for human consumption.
Boiler chemicals shall be stored in a separate, secure (locked or otherwise access-controlled) area when not
in immediate use.
6.4 Air quality and ventilation
The organization shall establish requirements for filtration, humidity (RH%) and microbiology of air used as an
ingredient or for direct product contact. Where temperature and/or humidity are deemed critical by the
organization, a control system shall be put in place and monitored.
Ventilation (natural or mechanical) shall be provided to remove excess or unwanted steam, dust and odours,
and to facilitate drying after wet cleaning.
Room air supply quality shall be controlled to minimize risk from airborne microbiological contamination.
Protocols for air quality monitoring and control shall be established in areas where products which support the
growth or survival of microorganisms are exposed.
Ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw
areas to clean areas. Specified air pressure differentials shall be maintained. Systems shall be accessible for
cleaning, filter changing and maintenance.
Exterior air intake ports shall be examined periodically for physical integrity.
6.5 Compressed air and other gases
Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall be
constructed and maintained so as to prevent contamination.
Gases intended for direct or incidental product contact (including those used for transporting, blowing or
drying materials, products or equipment) shall be from a source approved for food contact use, filtered to
remove dust, oil and water.
Where oil is used for compressors and there is potential for the air to come into contact with the product, the
oil used shall be food grade.
Use of oil free compressors is recommended.
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ISO/TS 22002-1:2009(E)
Requirements for filtration, humidity (RH%) and microbiology shall be specified.
Filtration of the air should be as close to the point of use as is practicable.
6.6 Lighting
The lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner.
The intensity of the lighting should be appropriate to the nature of the operation.
Light fixtures shall be protected to ensure that materials, product or equipment are not contaminated in the
case of breakages.
7 Waste disposal
7.1 General requirements
Systems shall be in place to ensure that waste materials are identified, collected, removed and disposed of in
a manner which prevents contamination of products or production areas.
7.2 Containers for waste and inedible or hazardous substances
Containers for waste and inedible or hazardous substances shall be:
a) clearly identified for their intended purpose;
b) located in a designated area;
c) constructed of impervious material which can be readily cleaned and sanitized;
d) closed when not in immediate use;
e) locked where the waste may pose a risk to the product.
7.3 Waste management and removal
Provision shall be made for the segregation, storage and removal of waste.
Accumulation of waste shall not be allowed in food-handling or storage areas. Removal frequencies shall be
managed to avoid accumulations, with a minimum daily removal.
Labelled materials, products or printed packaging designated as waste shall be disfigured or destroyed to
ensure that trademarks cannot be reused. Removal and destruction shall be carried out by approved disposal
contractors. The organization shall retain records of destruction.
7.4 Drains and drainage
Drains shall be designed, constructed and located so that the risk of contamination of materials or products is
avoided. Drains shall have capacity sufficient to remove expected flow loads. Drains shall not pass over
processing lines.
Drainage direction shall not flow from a contaminated area to a clean area.
8 © ISO 2009 – All rights reserved
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ISO/TS 22002-1:2009(E)
8 Equipment suitability, cleaning and maintenance
8.1 General requirements
Food contact equipment shall be designed and constructed to facilitate cleaning, disinfection and maintenance.
Contact surfaces shall not affect, or be affected by, the intended product or cleaning system.
Food contact equipment shall be constructed of durable materials able to resist repeated cleaning.
8.2 Hygienic design
Equipment shall be able to meet established principles of hygienic design, including:
a) smooth, accessible, cleanable surfaces, self draining in wet process areas;
b) use of materials compatible with intended products and cleaning or flushing agents;
c) framework not penetrated by holes or nuts and bolts.
Piping and ductwork shall be cleanable, drainable, and with no dead ends.
Equipment shall be designed to minimize contact between the operator’s hands and the products.
8.3 Product contact surfaces
Product contact surfaces shall be constructed from materials designed for food use. They shall be
impermeable and rust or corrosion free.
8.4 Temperature control and monitoring equipment
Equipment used for thermal processes shall be able to meet the temperature gradient and holding conditions
given in relevant product specifications.
Equipment shall provide for the monitoring and control of the temperature.
8.5 Cleaning plant, utensils and equipment
Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils and equipment are
cleaned at defined frequencies.
The programmes shall specify what is to be cleaned (including drains), the responsibility, the method of
cleaning (e.g. CIP, COP), the use of dedicated cleaning tools, removal or disassembly requirements and
methods for verifying the effectiveness of the cleaning.
8.6 Preventive and corrective maintenance
A preventive maintenance programme shall be in place.
The preventive maintenance programme shall include all devices used to monitor and/or control food safety
hazards.
NOTE Examples of such devices include screens and filters (including air filters), magnets, metal detectors and X-ray
detectors.
Corrective maintenance shall be carried out in such a way that production on adjoining lines or equipment is
not at risk of contamination.
© ISO 2009 – All rights reserved 9
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ISO/TS 22002-1:2009(E)
Maintenance requests which impact product safety shall be given priority.
Temporary fixes shall not put product safety at risk. A request for replacement by a permanent repair shall be
included in the maintenance schedule.
Lubricants and heat transfer fluids shall be food grade where there is a risk of direct or indirect contact with
the p
...
SLOVENSKI STANDARD
SIST-TS ISO/TS 22002-1:2011
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
SIST-TS ISO/TS 22002-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST-TS ISO/TS 22002-1:2011
---------------------- Page: 2 ----------------------
SIST-TS ISO/TS 22002-1:2011
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/TS 22002-1:2009(E)
©
ISO 2009
---------------------- Page: 3 ----------------------
SIST-TS ISO/TS 22002-1:2011
ISO/TS 22002-1:2009(E)
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Published in Switzerland
ii © ISO 2009 – All rights reserved
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SIST-TS ISO/TS 22002-1:2011
ISO/TS 22002-1:2009(E)
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
© ISO 2009 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST-TS ISO/TS 22002-1:2011
ISO/TS 22002-1:2009(E)
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
---------------------- Page: 6 ----------------------
SIST-TS ISO/TS 22002-1:2011
ISO/TS 22002-1:2009(E)
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.
© ISO 2009 – All rights reserved v
---------------------- Page: 7 ----------------------
SIST-TS ISO/TS 22002-1:2011
---------------------- Page: 8 ----------------------
SIST-TS ISO/TS 22002-1:2011
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;
© ISO 2009 – All rights reserved 1
---------------------- Page: 9 ----------------------
SIST-TS ISO/TS 22002-1:2011
ISO/TS 22002-1:2009(E)
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
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ISO/TS 22002-1:2009(E)
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
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3.15
zoning
〈food safety〉 demarcation of an area within an establishment where specific operating, hygiene or other
practices may be applied to minimize the potential for microbiological cross-contamination
NOTE Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic flow
patterns.
3.16
label
〈food safety〉 printed matter that is part of the finished product package conveying specific information about
the contents of the package, the food ingredients and any storage and preparation requirements
EXAMPLE The term covers, but is not limited to:
a) the package itself, printed matter attached to the package, or a sticker used for over-labelling;
b) multi-packs which have an inner label on the individual product and an outer combined label for the whole contents.
3.17
product recall
removal of a non-conforming product from the market, trade and warehouses, distribution centres and/or
customer warehouses because it does not meet specified standards
3.18
first expired first out
FEFO
stock rotation based on the principle of despatching earliest expiration dates first
3.19
first in first out
FIFO
〈food safety〉 stock rotation based on the principle of despatching earliest received products first
4 Construction and layout of buildings
4.1 General requirements
Buildings shall be designed, constructed and maintained in a manner appropriate to the nature of the
processing operations to be carried out, the food safety hazards associated with those operations and the
potential sources of contamination from the plant environs. Buildings shall be of durable construction which
presents no hazard to the product.
NOTE An example of “durable construction” is self-draining roofs which do not leak.
4.2 Environment
Consideration shall be given to potential sources of contamination from the local environment.
Food production should not be carried out in areas where potentially harmful substances could enter the
product.
The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed.
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4.3 Locations of establishments
The site boundaries shall be clearly identified.
Access to the site shall be controlled.
The site shall be maintained in good order. Vegetation shall be tended or removed. Roads, yards and parking
areas shall be drained to prevent standing water and shall be maintained.
5 Layout of premises and workspace
5.1 General requirements
Internal layouts shall be designed, constructed and maintained to facilitate good hygiene and manufacturing
practices. The movement patterns of materials, products and people, and the layout of equipment, shall be
designed to protect against potential contamination sources.
5.2 Internal design, layout and traffic patterns
The building shall provide adequate space, with a logical flow of materials, products and personnel, and
physical separation of raw from processed areas.
NOTE Examples of physical separation include walls, barriers or partitions, or sufficient distance to minimize risk.
Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests.
5.3 Internal structures and fittings
Process area walls and floors shall be washable or cleanable, as appropriate for the process or product
hazard. Materials of construction shall be resistant to the cleaning system applied.
Wall floor junctions and corners shall be designed to facilitate cleaning.
It is recommended that wall floor junctions be rounded in processing areas.
Floors shall be designed to avoid standing water.
In wet process areas, floors shall be sealed and drained. Drains shall be trapped and covered.
Ceilings and overhead fixtures shall be designed to minimize build-up of dirt and condensation.
External opening windows, roof vents or fan, where present, shall be insect screened.
External opening doors shall be closed or screened when not in use.
5.4 Location of equipment
Equipment shall be designed and located so as to facilitate good hygiene practices and monitoring.
Equipment shall be located to permit access for operation, cleaning and maintenance.
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ISO/TS 22002-1:2009(E)
5.5 Laboratory facilities
In-line and on-line test facilities shall be controlled to minimize risk of product contamination.
Microbiology laboratories shall be designed, located and operated so as to prevent contamination of people,
plant and products. They shall not open directly on to a production area.
5.6 Temporary or mobile premises and vending machines
Temporary structures shall be designed, located and constructed to avoid pest harbourage and potential
contamination of products.
Additional hazards associated with temporary structures and vending machines shall be assessed and
controlled.
5.7 Storage of food, packaging materials, ingredients and non-food chemicals
Facilities used to store ingredients, packaging and products shall provide protection from dust, condensation,
drains, waste and other sources of contamination.
Storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity shall be
applied where specified.
Storage areas shall be designed or arranged to allow segregation of raw materials, work in progress and
finished products.
All materials and products shall be stored off the floor and with sufficient space between the material and the
walls to allow inspection and pest control activities to be carried out.
The storage area shall be designed to allow maintenance and cleaning, prevent contamination and minimize
deterioration.
A separate, secure (locked or otherwise access controlled) storage area shall be provided for cleaning
materials, chemicals and other hazardous substances.
Exceptions for bulk or agricultural crop materials shall be documented in the food safety management system.
6 Utilities — air, water, energy
6.1 General requirements
The provision and distribution routes for utilities to and around processing and storage areas shall be
designed to minimize the risk of product contamination. Utilities’ quality shall be monitored to minimize product
contamination risk.
6.2 Water supply
The supply of potable water shall be sufficient to meet the needs of the production process(es). Facilities for
storage, distribution and, where needed, temperature control of the water shall be designed to meet specified
water quality requirements.
Water used as a product ingredient, including ice or steam (including culinary steam), or in contact with
products or product surfaces, shall meet specified quality and microbiological requirements relevant to the
product.
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ISO/TS 22002-1:2009(E)
Water for cleaning or applications where there is a risk of indirect product contact (e.g. jacketed vessels, heat
exchangers) shall meet specified quality and microbiological requirements relevant to the application.
Where water supplies are chlorinated, checks shall ensure that the residual chlorine level at the point of use
remains within limits given in relevant specifications.
Non-potable water shall have a separate supply system that is labelled and not connected to the potable
water system. Take measures to prevent non-potable water refluxing into the potable system.
It is recommended that water that can come into contact with the product should flow through pipes that can
be disinfected.
6.3 Boiler chemicals
Boiler chemicals, if used, shall be either:
a) approved food additives which meet relevant additive specifications; or
b) additives which have been approved by the relevant regulatory authority as safe for use in water intended
for human consumption.
Boiler chemicals shall be stored in a separate, secure (locked or otherwise access-controlled) area when not
in immediate use.
6.4 Air quality and ventilation
The organization shall establish requirements for filtration, humidity (RH%) and microbiology of air used as an
ingredient or for direct product contact. Where temperature and/or humidity are deemed critical by the
organization, a control system shall be put in place and monitored.
Ventilation (natural or mechanical) shall be provided to remove excess or unwanted steam, dust and odours,
and to facilitate drying after wet cleaning.
Room air supply quality shall be controlled to minimize risk from airborne microbiological contamination.
Protocols for air quality monitoring and control shall be established in areas where products which support the
growth or survival of microorganisms are exposed.
Ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw
areas to clean areas. Specified air pressure differentials shall be maintained. Systems shall be accessible for
cleaning, filter changing and maintenance.
Exterior air intake ports shall be examined periodically for physical integrity.
6.5 Compressed air and other gases
Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall be
constructed and maintained so as to prevent contamination.
Gases intended for direct or incidental product contact (including those used for transporting, blowing or
drying materials, products or equipment) shall be from a source approved for food contact use, filtered to
remove dust, oil and water.
Where oil is used for compressors and there is potential for the air to come into contact with the product, the
oil used shall be food grade.
Use of oil free compressors is recommended.
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Requirements for filtration, humidity (RH%) and microbiology shall be specified.
Filtration of the air should be as close to the point of use as is practicable.
6.6 Lighting
The lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner.
The intensity of the lighting should be appropriate to the nature of the operation.
Light fixtures shall be protected to ensure that materials, product or equipment are not contaminated in the
case of breakages.
7 Waste disposal
7.1 General requirements
Systems shall be in place to ensure that waste materials are identified, collected, removed and disposed of in
a manner which prevents contamination of products or production areas.
7.2 Containers for waste and inedible or hazardous substances
Containers for waste and inedible or hazardous substances shall be:
a) clearly identified for their intended purpose;
b) located in a designated area;
c) constructed of impervious material which can be readily cleaned and sanitized;
d) closed when not in immediate use;
e) locked where the waste may pose a risk to the product.
7.3 Waste management and removal
Provision shall be made for the segregation, storage and removal of waste.
Accumulation of waste shall not be allowed in food-handling or storage areas. Removal frequencies shall be
managed to avoid accumulations, with a minimum daily removal.
Labelled materials, products or printed packaging designated as waste shall be disfigured or destroyed to
ensure that trademarks cannot be reused. Removal and destruction shall be carried out by approved disposal
contractors. The organization shall retain records of destruction.
7.4 Drains and drainage
Drains shall be designed, constructed and located so that the risk of contamination of materials or products is
avoided. Drains shall have capacity sufficient to remove expected flow loads. Drains shall not pass over
processing lines.
Drainage direction shall not flow from a contaminated area to a clean area.
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8 Equipment suitability, cleaning and maintenance
8.1 General requirements
Food contact equipment shall be designed and constructed to facilitate cleaning, disinfection and maintenance.
Contact surfaces shall not affect, or be affected by, the intended product or cleaning system.
Food contact equipment shall be constructed of durable materials able to resist repeated cleaning.
8.2 Hygienic design
Equipment shall be able to meet established principles of hygienic design, including:
a) smooth, accessible, cleanable surfaces, self draining in wet process areas;
b) use of materials compatible with intended products and cleaning or flushing agents;
c) framework not penetrated by holes or nuts and bolts.
Piping and ductwork shall be cleanable, drainable, and with no dead ends.
Equipment shall be designed to minimize contact between the operator’s hands and the products.
8.3 Product contact surfaces
Product contact surfaces shall be constructed from materials designed for food use. They shall be
impermeable and rust or corrosion free.
8.4 Temperature control and monitoring equipment
Equipment used for thermal processes shall be able to meet the temperature gradient and holding conditions
given in relevant product specifications.
Equipment shall provide for the monitoring and control of the temperature.
8.5 Cleaning plant, utensils and equipment
Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils and equipment are
cleaned a
...
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/TS 22002-1:2009(F)
©
ISO 2009
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ISO/TS 22002-1:2009(F)
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ii © ISO 2009 – Tous droits réservés
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ISO/TS 22002-1:2009(F)
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
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ISO/TS 22002-1:2009(F)
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 .
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ISO/TS 22002-1:2009(F)
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.
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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;
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ISO/TS 22002-1:2009(F)
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.
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ISO/TS 22002-1:2009(F)
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
spécification du produit
〈sécurité des denrées alimentaires〉 description documentée détaillée ou énumération des paramètres,
variations et tolérances admissibles incluses, requise pour atteindre un niveau d'acceptabilité ou de qualité
défini
3.8
«de qualité alimentaire»
expression qualifiant les lubrifiants et fluides caloporteurs formulés pour pouvoir être utilisés dans les
procédés de fabrication des denrées alimentaires, au cours desquels ils peuvent entrer accidentellement en
contact avec la denrée alimentaire
3.9
désinfection
〈sécurité des denrées alimentaires〉 réduction, par des produits chimiques et/ou des méthodes physiques, du
nombre de micro-organismes présents dans l'environnement, jusqu'à l'obtention d'un niveau ne risquant pas
de compromettre la sécurité ou la salubrité des denrées alimentaires
[1]
NOTE Adapté du CAC/RCP 1:2003 , 2.3.
3.10
nettoyage en place
NEP
nettoyage (3.5) des équipements par projection ou circulation de solutions chimiques, de produits de
nettoyage et d'eau de rinçage dans, sur et au-dessus des surfaces des équipements ou des systèmes, sans
nécessiter de démontage et conçues à cet effet
[2]
[ISO 14519:2002 , 3.3]
3.11
nettoyage hors place
NHP
système dans lequel l'équipement est démonté et nettoyé dans une cuve ou un laveur automatique en faisant
circuler une solution de nettoyage et en maintenant une température minimale tout au long du cycle de
nettoyage
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ISO/TS 22002-1:2009(F)
3.12
nettoyage et désinfection
〈sécurité des denrées alimentaires〉 processus de nettoyage, suivi d'une désinfection
3.13
opérations de maintien de l'hygiène
ensemble des actions en relation avec le nettoyage ou le maintien des conditions d'hygiène dans un
établissement, allant du nettoyage et/ou de la désinfection d'équipements spécifiques, jusqu'aux activités de
nettoyage périodique dans tout l'établissement (y compris les activités de nettoyage du bâtiment, de la
structure et des abords)
3.14
certificat d'analyse
〈sécurité des denrées alimentaires〉 document délivré par le fournisseur et indiquant les résultats d'essais ou
d'analyses spécifiques, incluant la méthodologie d'essai, réalisés sur un lot défini du produit du fournisseur
3.15
zonage
〈sécurité des denrées alimentaires〉 démarcation, à l'intérieur d'un établissement, d'une zone où des
conditions spécifiques d'exploitation, d'hygiène ou autres peuvent être appliquées pour minimiser le potentiel
de transfert de contamination microbiologique
NOTE Les exemples de pratiques incluent le changement de vêtements à l'entrée ou à la sortie, l'application d'une
pression d'air positive, la modification des sens de circulation.
3.16
étiquette
〈sécurité des denrées alimentaires〉 ensemble des éléments imprimés faisant partie de l'emballage du produit
fini et donnant des informations spécifiques sur le contenu de l'emballage, les ingrédients alimentaires et les
exigences en matière d'entreposage et de préparation
EXEMPLE Ce terme inclut de manière non exhaustive:
a) l'emballage lui-même, les éléments imprimés apposés sur ce dernier ou sur un autocollant rajouté;
b) les emballages groupés qui ont une étiquette interne sur chaque produit individuel et une étiquette externe globale.
3.17
rappel de produit
enlèvement d'un produit du marché, des commerces et des entrepôts, des centres de distribution et/ou des
dépôts des clients en raison de sa non-conformité aux normes spécifiées
3.18
premier périmé, premier sorti
FEFO
méthode de rotation du stock basée sur le principe que le produit dont la date de péremption est la plus
proche est expédié en premier
3.19
premier entré, premier sorti
FIFO
〈sécurité des denrées alimentaires〉 méthode de rotation du stock basée sur le principe que le produit reçu le
plus tôt est expédié en premier
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ISO/TS 22002-1:2009(F)
4 Construction et disposition des bâtiments
4.1 Exigences générales
Les bâtiments doivent être conçus, construits et entretenus de manière adaptée à la nature des opérations de
traitement à exécuter, aux dangers liés à ces opérations vis-à-vis de la sécurité des denrées alimentaires et
aux sources potentielles de contamination des abords de l'usine. Les bâtiments doivent avoir une construction
durable qui ne présente pas de danger pour le produit.
NOTE Un exemple de «construction durable» est illustré par des toitures auto-drainantes et étanches.
4.2 Environnement
Les sources potentielles de contamination par l'environnement local doivent être prises en compte.
Il convient qu'aucune denrée alimentaire ne soit produite dans des zones où des substances potentiellement
nocives sont susceptibles de pénétrer dans le produit.
L'efficacité des mesures de protection prises contre les contaminants potentiels doit être périodiquement
passée en revue.
4.3 Emplacement des établissements
Les limites du site doivent être clairement identifiées.
L'accès au site doit être contrôlé.
Le site doit être entretenu et en bon état. La végétation doit être entretenue ou retirée. Les routes, les cours et
les zones de stationnement doivent être entretenues et drainées afin d'éviter la stagnation d'eau.
5 Disposition des locaux et de l'espace de travail
5.1 Exigences générales
Les locaux intérieurs doivent être conçus, construits et entretenus de manière à faciliter les bonnes pratiques
d'hygiène et de fabrication. La disposition des équipements et les plans de circulation des matériaux, produits
et personnes doivent être conçus pour assurer une protection vis-à-vis des sources de contamination
potentielles.
5.2 Conception interne, disposition et plans de circulation
Le bâtiment doit offrir un espace adapté avec une circulation logique des matériaux, produits et personnes, et
une séparation physique entre les zones où se trouvent les matières premières et les matières
traitées/fabriquées.
NOTE La séparation physique peut par exemple se présenter sous forme de murs, de barrières ou de cloisons, ou
être constituée par une distance suffisante afin de minimiser le risque.
Les ouvertures destinées au transfert de matériaux doivent être conçues pour minimiser l'entrée de corps
étrangers et de nuisibles.
5.3 Structures internes et raccords
Selon le type de danger encouru par le procédé ou le produit, les murs et sols des zones de fabrication
doivent être lavables ou nettoyables. Les matériaux de construction doivent être résistants au système de
nettoyage appliqué.
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ISO/TS 22002-1:2009(F)
Les jonctions sols-murs et les coins doivent être conçus pour faciliter le nettoyage.
Il est recommandé d'arrondir les jonctions sols-murs dans les zones de fabrication.
Les sols doivent être conçus pour éviter la stagnation d'eau.
Dans les zones de fabrication humides, les sols doivent être étanches et drainés. Les systèmes d'écoulement
doivent être munis d'un siphon et être recouverts.
Les plafonds et les dispositifs suspendus doivent être conçus de manière à minimiser l'accumulation de
poussière et la condensation.
Lorsqu'ils sont présents, les fenêtres, cheminées d'évacuation par le toit ou ventilateurs donnant sur
l'extérieur doivent comporter des moustiquaires/grillages contre les insectes.
Les portes donnant sur l'extérieur doivent être fermées ou équipées de protections lorsqu'elles ne sont pas
utilisées.
5.4 Emplacement des équipements
Les équipements doivent être conçus et positionnés de manière à faciliter les bonnes pratiques d'hygiène et
la surveillance.
L'emplacement des équipements doit permettre un accès facile pour l'exploitation, le nettoyage et la
maintenance.
5.5 Installations de laboratoire
Les installations de mesure/d'analyse en ligne ou hors ligne doivent être contrôlées de façon à minimiser le
risque de contamination du produit.
Les laboratoires de microbiologie doivent être conçus, implantés et exploités de manière à empêcher la
contamination des personnes, de l'usine et des produits. Ils ne doivent pas déboucher directement sur une
zone de production.
5.6 Locaux temporaires ou mobiles et distributeurs
Les structures temporaires doivent être conçues, implantées et construites de façon à éviter qu'elles n'abritent
des nuisibles et à éviter la contamination potentielle des produits.
Les dangers supplémentaires liés aux structures temporaires et aux distributeurs automatiques de vente
doivent être évalués et maîtrisés.
5.7 Entreposage des denrées alimentaires, matériaux d'emballage, ingrédients et produits
chimiques non alimentaires
Les installations utilisées pour entreposer les ingrédients, les emballages et les produits doivent assurer une
protection contre la poussière, la condensation, les écoulements, les déchets et autres sources de
contamination.
Les zones d'entreposage doivent être sèches et correctement ventilées. Lorsque cela est spécifié, la
température et l'humidité doivent être surveillées et maîtrisées.
Les zones d'entreposage doivent être conçues ou organisées de manière à pouvoir séparer les matières
premières, les denrées en cours de traitement et les produits finis.
Tous les matériaux et produits doivent être entreposés à distance du sol et avec un espace suffisant entre les
matériaux et les murs pour permettre les activités d'inspection et de maîtrise des nuisibles.
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ISO/TS 22002-1:2009(F)
La zone d'entreposage doit être conçue pour permettre la maintenance et le nettoyage, empêcher la
contamination et minimiser la détérioration.
Une zone d'entreposage dédiée et sécurisée (fermée à clé ou sous contrôle d'accès) doit être prévue pour les
produits de nettoyage, les produits chimiques et autres substances dangereuses.
Les exceptions relatives aux matériaux en vrac ou aux produits provenant de récoltes agricoles doivent être
documentées dans le système de management de la sécurité des denrées alimentaires.
6 Services généraux — air, eau, énergie
6.1 Exigences générales
Les circuits d'approvisionnement et de distribution des services généraux vers et autour des zones de
fabrication et d'entreposage doivent être conçus pour minimiser le risque de contamination du produit. Le bon
état de ces services doit être surveillé afin de minimiser le risque de contamination des produits.
6.2 Alimentation en eau
L'alimentation en eau potable doit être suffisante pour répondre aux besoins du ou des procédés de
production. Les installations d'entreposage, de distribution et, lorsque cela est nécessaire, de maîtrise de la
température de l'eau, doivent être conçues pour satisfaire aux exigences spécifiées pour la qualité de l'eau.
L'eau utilisée en tant qu'ingrédient dans un produit, y compris sous forme de glace ou de vapeur (y compris la
vapeur culinaire), ou en contact direct avec des produits ou avec des surfaces en contact avec des produits,
doit remplir les exigences spécifiques de qualité et de microbiologie correspondant au produit concerné.
L'eau utilisée pour le nettoyage ou les applications où il existe un risque de contact indirect avec le produit
(cuves à double paroi ou échangeurs thermiques, par exemple) doit répondre aux exigences spécifiques de
qualité et de microbiologie correspondant à l'application concernée.
Lorsque les alimentations en eau sont chlorées, des vérifications doivent garantir que le niveau de chlore
résiduel au point de consommation reste dans les limites indiquées dans les spécifications concernées.
Le réseau d'alimentation en eau non potable doit être séparé, repéré, sans raccordement au réseau d'eau
potable. Prendre des mesures afin d'empêcher tout reflux d'eau non potable dans le réseau d'eau potable.
Il est recommandé que l'eau susceptible d'entrer en contact avec le produit circule dans des tuyaux pouvant
être désinfectés.
6.3 Produits chimiques pour les chaudières
Les produits chimiques pour les chaudières, s'ils sont utilisés, doivent être:
a) soit des additifs approuvés pour les denrées alimentaires, qui satisfont aux spécifications pertinentes sur
les additifs;
b) soit des additifs que l'autorité compétente réglementaire a approuvés comme étant sûrs pour l'utilisation
dans l'eau destinée à la consommation humaine.
Lorsqu'ils ne sont pas immédiatement utilisés, les produits chimiques pour les chaudières doivent être
entreposés dans une zone dédiée et sécurisée (fermée à clé ou sous contrôle d'accès).
6.4 Qualité de l'air et ventilation
L'organisme doit établir des exigences en matière de filtration, d'humidité (% HR) et de microbiologie de l'air
utilisé comme ingrédient ou destiné à venir au contact direct du produit. Lorsque l'organisme estime que la
température et/ou l'humidité sont critiques, un système de maîtrise doit être mis en place et surveillé.
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ISO/TS 22002-1:2009(F)
Une ventilation (naturelle ou mécanique) doit être prévue pour éliminer la présence indésirable ou les excès
de vapeur, la poussière et les odeurs et faciliter le séchage après un nettoyage humide.
La qualité de l'alimentation en air des locaux doit être maîtrisée afin de minimiser le risque de contamination
microbiologique aéroportée. Des protocoles de surveillance et de maîtrise de la qualité de l'air doivent être
établis dans les zones où des produits, qui présentent des conditions favorables au développement ou à la
survie de micro-organismes, sont exposés à l'air.
Les installations de ventilation doivent être conçues et construites de manière à empêcher la circulation d'air
depuis les zones contaminées ou celles contenant des matières premières vers les zones propres. Les
différentiels de pression d'air spécifiés doivent être maintenus. Les installations doivent être accessibles pour
le nettoyage, le remplacement des filtres et la maintenance.
Les prises d'air extérieur doivent être examinées périodiquement afin de vérifier leur intégrité physique.
6.5 Air comprimé et autres gaz
Les installations d'air comprimé, de dioxyde de carbone, d'azote et d'autres gaz utilisés pour la fabrication
et/ou le remplissage doivent être construites et entretenues de manière à empêcher la contamination.
Les gaz destinés à entrer directement ou accidentellement en contact avec le produit (y compris ceux utilisés
pour le transport, le soufflage ou le séchage de matériaux, produits ou équipements) doivent provenir d'une
source dont l'utilisation est approuvée pour le contact avec des denrées alimentaires, et dont la poussière,
l'huile et l'eau ont été éliminées par filtrage.
En cas d'utilisation de compresseurs à huile et s'il existe une possibilité de contact entre l'air et le
...
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:
SIST-TS ISO/TS 22002-1 : 2011 7 a) gradnjo ter tloris stavb in pripadajočihprostorov,
a) construction and layout of buildings and associated utilities;
b) tloris prostorov, vključno s proizvodnimiprostori in prostori za zaposlene,
b) layout of premises, including workspace and employee facilities;
c) vire zraka, vode, energije in druge vire,
c) supplies of air, water, energy and other utilities;
d) podporne storitve, vključno z odlaganjemodpadkov in odplak,
d) supporting services, including waste and sewage disposal;
e) ustreznost opreme in dostopnost za čiščenje,vzdrževanje in preventivno vzdrževanje,
e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance;
f) upravljanje z nabavljenimi materiali,
f) management of purchased materials;
g) ukrepe za preprečevanje navzkrižnegaonesnaženja,
g) measures for the prevention of cross-contamination;
h) čiščenje in sanitacijo,
h) cleaning and sanitizing;
i) nadzor nad škodljivci,
i) pest control;
j) osebno higieno.
j) personnel hygiene.
Dodatno ta tehnična specifikacija navaja tudi druge vidike, ki veljajo za pomembneza proizvodne procese:
In addition, this Technical Specification adds other aspects which are considered relevant to manufacturing operations:
1) predelavo,
1) rework;
2) postopke odpoklica proizvoda,
2) product recall procedures;
3) skladiščenje,
3) warehousing;
4) informacije o proizvodu in ozaveščanjepotrošnikov,
4) product information and consumer awareness;
5) zaščito živil, biološko previdnostin bioterorizem.
5) food defence, biovigilance and bioterrorism. OPOMBA: Ukrepi za preprečevanje zlonamernihonesnaženj so zunaj področja uporabe te tehnične specifikacije.
NOTE Measures for prevention of malicious contamination are outside the scope of this Technical Specification.
2 Zveze s standardi
2 Normative references
Za uporabo tega dokumenta so nujno potrebnispodaj navedeni dokumenti. Pri datiranihdokumentih velja samo navedena izdaja. Prinedatiranih dokumentih velja najnovejša izdajadokumenta (vključno z morebitnimispremembami).
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, Sistemi vodenja varnosti živil– Zahteve za vsako organizacijo v prehranskiverigi
ISO 22000:2005, Food safety management systems – Requirements for any organization in the food chain
SIST-TS ISO/TS 22002-1 : 2011 8 3 Izrazi in definicije
3 Terms and definitions
V tem dokumentu se uporabljajo izrazi indefinicije, navedeni v standardu ISO 22000:2005, in spodaj navedeni.
For the purposes of this document, the terms and definitions given in ISO 22000:2005 and the following apply.
3.1
3.1 onesnaženje
contamination
+varnost živil, vnos ali pojav onesnaževala(3.2) v živilu ali okolici živila
+food safety,introduction or occurrence of a contaminant (3.2) in food or food environment OPOMBA: Povzeto iz CAC/RCP 1:2003[1], 2.3.
NOTE Adapted from CAC/RCP 1:2003[1], 2.3.
3.2
3.2 onesnaževalo
contaminant
+varnost živil, kateri koli biološki ali kemičnidejavnik, tujek ali druge snovi, ki niso bilenamenoma dodane živilu in ki lahko ogrozijovarnost ali primernost živila
+food safety, any biological or chemical agent, foreign matter or other substances not intentionally added to food which may compromise food safety or suitability
[CAC/RCP 1:2003[1], 2.3]
[CAC/RCP 1:2003[1], 2.3]
3.3
3.3 obrat
establishment
+varnost živil, katera koli stavba ali območje, v katerem se ravna z živili, ter okolica, ki je podnadzorom istega upravitelja
+food safety,any building or area in which food is handled and the surroundings under the control of the same management
[CAC/RCP 1:2003[1], 2.3]
[CAC/RCP 1:2003[1], 2.3]
3.4
3.4 materiali
materials
+varnost živil, splošen izraz, ki označujesurovine, embalažo, sestavine, pomožnatehnološka sredstva, čistila in maziva
+food safety,general term used to indicate raw materials, packaging materials, ingredients, process aids, cleaning materials and lubricants 3.5
3.5 čiščenje
cleaning
+varnost živil, odstranjevanje zemlje, ostankovživil, umazanije, maziv ali drugih neželenihsnovi
+food safety,removal of soil, food residue, dirt, grease or other objectionable matter
OPOMBA: Povzeto po CAC/RCP 1:2003 [1], 2.3.
NOTE Adapted from CAC/RCP 1:2003[1], 2.3.
3.6
3.6 stik s proizvodom
product contact
vse površine, ki se med običajnimi postopkistikajo s proizvodom ali primarno embalažo
all surfaces that are in contact with the productor the primary package during normal operation 3.7
3.7 specifikacija materiala
material specification specifikacija proizvoda
product specification
+varnost živil, podroben dokumentiran opis aliseznam lastnosti, vključno z dovoljenimi razlikamiin odstopanji, ki so zahtevane za doseganjedoločene ravni sprejemljivosti ali kakovosti
+food safety,detailed documented description or enumeration of parameters, including permissible variations and tolerances, whichare required to achieve a defined level of acceptability or quality
SIST-TS ISO/TS 22002-1 : 2011 9 3.8
3.8 primernost za živila
food grade maziva in hladilne tekočine, prilagojene zauporabo v obdelavi živil, kjer lahko pomotomanastane stik med mazivom in živilom
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
3.9 razkuževanje
disinfection
+varnost živil, zmanjšanje števila mikro-organizmov v okolju s pomočjo delovanjakemičnih sredstev ali fizikalnih postopkov dostopnje, ko varnost ali primernost živila nistaveč ogroženi
+food safety,reduction, by means of chemical agents and/or physical methods, of the number of microorganisms in the environment, to alevel that does not compromise food safety or suitability
OPOMBA: Povzeto po CAC/RCP 1:2003[1], 2.3.
NOTE Adapted from CAC/RCP 1:2003[1], 2.3.
3.10
3.10 čiščenje v postopku
cleaning in place CIP (cleaning in place)
CIP čiščenje (3.5) opreme s kemičnimi raztopinami, čistilnimi tekočinami in vodnim izpiranjem, kizadevajo v površino opreme in nerazstavljenihsistemov, zasnovanih glede na namen, krožijo okoli njih in tečejo preko njih
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
[ISO 14159:2002[2], 3.3]
[ISO 14159:2002[2], 3.3]
3.11
3.11 čiščenje zunaj postopka
cleaning out of place COP (cleaning out of place)
COP
sistem čiščenja, pri katerem se opremarazstavi in čisti v bazenu ali pralnem stroju s kroženjemčistilne tekočine pri najmanj najnižji temperaturičistilnega cikla
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
3.12 sanitacija
sanitizing
+varnost živil, postopek čiščenja, ki vključujerazkuževanje
+food safety,process of cleaning, followed by disinfection
3.13
3.13 sanitarni red
sanitation
vsi ukrepi, povezani s čiščenjem alivzdrževanjem higienskih razmer v obratu, odčiščenja in/ali sanitacije določene opreme doperiodičnih postopkov čiščenja kjer koli v obratu(vključno s postopki za čiščenje stavb, tal in struktur)
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
3.14 poročilo o analizi
certificate of analysis COA (certificate of analysis)
COA
+varnost živil, dokument dobavitelja, ki podajarezultate določenih preskusov ali analiz, vključno z navedbo preskusnih metod, uporabljenih nadoločeni seriji dobaviteljevega proizvoda
+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
SIST-TS ISO/TS 22002-1 : 2011 10 3.15
3.15 zaščitena območja
zoning
+varnost živil, oddvojitev območja v obratu, kjer delo lahko poteka po posebnih delovnih, higienskih ali drugih zahtevah, da se zmanjšamožnost mikrobiološkega navzkrižnegaonesnaženja
+food safety,demarcation of an area within an establishment where specific operating, hygiene or other practices may be applied to minimize the potential for microbiological cross-contamination
OPOMBA: Praktični primeri uporabe so: menjavaobleke na vhodu ali izhodu, zračni nadtlak,prilagojeni vzorci smeri prometa.
NOTE Examples of practices include: clothing change on entry or exit, positive air pressure, modified traffic flow patterns.
3.16
3.16 oznaka
label
+varnost živil, natisnjeni podatki na embalažikončnega proizvoda, ki podajajo informacije ovsebini v embalaži in sestavi živila ter navodilaza shranjevanje in pripravo živila
+food safety,printed matter that is part of the finished product package conveying specific information about the contents of the package, the food ingredients and any storage and preparation requirements
PRIMER: Izraz vključuje, vendar ni omejen na:
EXAMPLE: The term covers, but is not limited to:
a) predpotiskano embalažo, natisnjene podatke,dodane embalaži, nalepko preko embalaže,
a) the package itself, printed matter attached to the package, or a sticker used for over-labelling;
b) skupinska pakiranja, ki imajo notranjo oznakona posameznem proizvodu in zunanjokombinirano oznako za celotno vsebino
b) multi-packs which have an inner label on the individual product and an outer combined label for the whole contents.
3.17
3.17 odpoklic proizvoda
product recall
odstranitev neskladnega proizvoda s trga,trgovine in skladišč, distribucijskih centrov in/aliskladišč kupcev, ker proizvod ne izpolnjujedoločenih standardov
removal of a non-conforming product from the market, trade and warehouses, distribution centres and/or customer warehouses because it does not meet specified standards
3.18
3.18 pravilo starejšega
first expired first out FEFO (first expired first out)
FEFO
obračanje zalog po načelu upoštevanja prednostinajkrajšega datuma uporabnosti pri izdaji proizvoda stock rotation based on the principleof despatching earliest expiration dates first
3.19
3.19 pravilo prvega
first in first out FIFO (first in first out)
FIFO
+varnost živil, obračanje zalog po načeluprednosti zgodnejšega prevzema pri izdajiproizvodov
+food safety, stock rotation based on the principle of despatching earliest received products first
4 Gradnja in tloris stavb
4 Construction and layout of buildings
4.1 Splošne zahteve
4.1 General requirements
Stavbe morajo biti načrtovane, zgrajene invzdrževane na način, ki ustreza naravipostopkov obdelave, ki se v njih izvajajo, z njimi povezanim dejavnikom tveganja živil in morebitnim virom onesnaženja iz okoljatovarne. Stavbe morajo biti v konstrukcijitrpežne in ne smejo predstavljati tveganja zaproizvod.
Buildings shallbe designed, constructed and maintained in a manner appropriate to the nature of the processing operations to be carried out, the food safety hazards associated with those operations and the potential sources of contamination from the plant environs. Buildings shall be of durable construction which presents no hazard to the product.
SIST-TS ISO/TS 22002-1 : 2011 11 OPOMBA: Primer “trpežne konstrukcije“je samoodtočna kritina, ki ne pušča.
NOTE An example of “durable construction” is self-draining roofs which do not leak.
4.2 Okolica
4.2 Environment
Upoštevati je treba možne vire onesnaženja izlokalnega okolja.
Consideration shall be given to potential sources of contamination from the local environment.
Proizvodnja živil naj ne poteka na območjih,kjer bi potencialno škodljive snovi lahko vstopile v proizvod.
Food production should not be carried out in areas where potentially harmful substances could enter the product.
Učinkovitost ukrepov, sprejetih za zaščito predmorebitnimi onesnaževali, je treba redno pregledovati.
The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed.
4.3 Lokacija obratov
4.3 Locations of establishments
Meje območja morajo biti jasno razpoznavne.
The site boundaries shall be clearly identified.
Dostop na območje mora biti nadzorovan.
Access to the site shall be controlled.
Območje mora biti vzdrževano v dobrem stanju.Rastline je treba negovati ali odstraniti. Poti,dvorišča in parkirišča morajo odvajati vodo, dase ta ne zadržuje, in morajo biti vzdrževani.
The site shall be maintained in good order. Vegetation shall be tended or removed. Roads, yards and parking areas shall be drained to prevent standing water and shall be maintained. 5 Tloris prostorov in delovnih mest
5 Layout of premises and workspace
5.1 Splošne zahteve
5.1 General requirements
Notranji tlorisi morajo biti načrtovani, postavljeniin vzdrževani tako, da omogočajo dobrohigiensko in proizvodno prakso. Poti premikanjamaterialov, proizvodov in osebja ter namestitevopreme morajo biti načrtovane tako, da varujejopred možnimi viri onesnaženj.
Internal layouts shall be designed, constructed and maintained to facilitate good hygiene and manufacturing practices. The movement patterns of materials, products and people, and the layout of equipment, shall be designed to protect against potential contamination sources. 5.2 Notranji načrt, tloris in prometne poti
5.2 Internal design, layout and traffic patterns Stavba mora zagotavljati ustrezen prostor zalogičen pretok materiala, proizvodov in osebjain za fizično ločevanje območij nepredelanihživil od predelanih.
The building shall provide adequate space, with a logical flow of materials, products and personnel, and physical separation of raw from processed areas.
OPOMBA: Primeri fizičnega ločevanja so stene, ovireali predelne stene ali dovolj velika razdaljaza omejitev tveganja.
NOTE Examples of physical separation include walls, barriers or partitions, or sufficient distance to minimize risk.
Odprtine za premikanje materiala morajo bitinačrtovane tako, da kar najbolj zmanjšajovstop tujih snovi in glodavcev.
Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests.
5.3 Notranje površine in stavbna oprema
5.3 Internal structures and fittings
Tla in stene proizvodnih območij morajo bitipralni ali omogočati čiščenje, primerno procesu ali dejavnikom tveganja proizvoda. Materialipovršin morajo biti odporni proti uporabljenemusistemu čiščenja.
Process area walls and floors shall be washable or cleanable, as appropriate for the process or product hazard. Materialsof construction shall be resistant to the cleaning system applied.
SIST-TS ISO/TS 22002-1 : 2011 12 Stiki med steno in tlemi ter vogali morajo bititakšni, da jih je mogoče čistiti.
Wall floor junctions and corners shall be designed to facilita
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