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ISO/TS 22002-1:2009(en)
ISO - Cover page
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Construction and layout of buildings
 4.1 General requirements
 4.2 Environment
 4.3 Locations of establishments
5 Layout of premises and workspace
 5.1 General requirements
 5.2 Internal design, layout and traffic patterns
 5.3 Internal structures and fittings
 5.4 Location of equipment
 5.5 Laboratory facilities
 5.6 Temporary or mobile premises and vending machines
 5.7 Storage of food, packaging materials, ingredients and non-food chemicals
6 Utilities — air, water, energy
 6.1 General requirements
 6.2 Water supply
 6.3 Boiler chemicals
 6.4 Air quality and ventilation
 6.5 Compressed air and other gases
 6.6 Lighting
7 Waste disposal
 7.1 General requirements
 7.2 Containers for waste and inedible or hazardous substances
 7.3 Waste management and removal
 7.4 Drains and drainage
8 Equipment suitability, cleaning and maintenance
 8.1 General requirements
 8.2 Hygienic design
 8.3 Product contact surfaces
 8.4 Temperature control and monitoring equipment
 8.5 Cleaning plant, utensils and equipment
 8.6 Preventive and corrective maintenance
9 Management of purchased materials
 9.1 General requirements
 9.2 Selection and management of suppliers
 9.3 Incoming material requirements (raw/ingredients/packaging)
10 Measures for prevention of cross-contamination
 10.1 General requirements
 10.2 Microbiological cross-contamination
 10.3 Allergen management
 10.4 Physical contamination
11 Cleaning and sanitizing
 11.1 General requirements
 11.2 Cleaning and sanitizing agents and tools
 11.3 Cleaning and sanitizing programmes
 11.4 Cleaning in place (CIP) systems
 11.5 Monitoring sanitation effectiveness
12 Pest control
 12.1 General requirements
 12.2 Pest control programmes
 12.3 Preventing access
 12.4 Harbourage and infestations
 12.5 Monitoring and detection
 12.6 Eradication
13 Personnel hygiene and employee facilities
 13.1 General requirements
 13.2 Personnel hygiene facilities and toilets
 13.3 Staff canteens and designated eating areas
 13.4 Workwear and protective clothing
 13.5 Health status
 13.6 Illness and injuries
 13.7 Personal cleanliness
 13.8 Personal behaviour
14 Rework
 14.1 General requirements
 14.2 Storage, identification and traceability
 14.3 Rework usage
15 Product recall procedures
 15.1 General requirements
 15.2 Product recall requirements
16 Warehousing
 16.1 General requirements
 16.2 Warehousing requirements
 16.3 Vehicles, conveyances, and containers
17 Product information and consumer awareness
18 Food defence, biovigilance, and bioterrorism
 18.1 General requirements
 18.2 Access controls
Bibliography

Technical

Specification

ISO 22002-1
Prerequisite programmes on food safety —
Part 1:
Food manufacturing
Programmes prérequis pour la sécurité des denrées alimentaires —
Partie 1: Fabrication des denrées alimentaires
Reference number
ISO/TS 22002-1:2009(en)
First edition
2009-12

Contents Page

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
This Technical Specification is based on BS PAS 220:2008[5].

Introduction

ISO 22000:2005 sets out specific food safety requirements for organizations in the food chain. One such requirement is that organizations establish, implement and maintain prerequisite programmes (PRP) to assist in controlling food safety hazards (ISO 22000:2005, Clause 7). This Technical Specification is intended to be used to support management systems designed to meet the requirements specified in ISO 22000:2005, and sets out the detailed requirements for those programmes.
This Technical Specification does not duplicate requirements given in ISO 22000:2005 and is intended to be used in conjunction with ISO 22000:2005.

Technical Specification ISO/TS 22002-1:2009(en)
Prerequisite programmes on food safety —
Part 1:
Food manufacturing

1 Scope

This Technical Specification specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.
This Technical Specification is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.
This Technical Specification is neither designed nor intended for use in other parts of the food supply chain.
Food manufacturing operations are diverse in nature and not all of the requirements specified in this Technical Specification apply to an individual establishment or process.
Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.
This Technical Specification specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3:
a)
construction and layout of buildings and associated utilities;
b)
layout of premises, including workspace and employee facilities;
c)
supplies of air, water, energy and other utilities;
d)
supporting services, including waste and sewage disposal;
e)
suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance;
f)
management of purchased materials;
g)
measures for the prevention of cross-contamination;
h)
cleaning and sanitizing;
i)
pest control;
j)
personnel hygiene.
In addition, this Technical Specification adds other aspects which are considered relevant to manufacturing operations:
1)
rework;
2)
product recall procedures;
3)
warehousing;
4)
product information and consumer awareness;
5)
food defence, biovigilance and bioterrorism.
NOTE Measures for prevention of malicious contamination are outside the scope of this Technical Specification.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 22000:2005, Food safety management systems — Requirements for any organization in the food chain

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 22000:2005 and the following apply.
3.1
contamination
<〈food safety〉> introduction or occurrence of a contaminant (3.2) in food or food environment
Note 1 to entry: Adapted from CAC/RCP 1:2003[1], 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
[SOURCE: CAC/RCP 1:2003[1], 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
[SOURCE: CAC/RCP 1:2003[1], 2.3]
3.4
materials
<〈food safety〉> general term used to indicate raw materials, packaging materials, ingredients, process aids, cleaning materials and lubricants
3.5
cleaning
<〈food safety〉> removal of soil, food residue, dirt, grease or other objectionable matter
Note 1 to entry: Adapted from CAC/RCP 1:2003[1], 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
Note 1 to entry: Adapted from CAC/RCP 1:2003[1], 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
[SOURCE: ISO 14159:2002[2], 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
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 1 to entry: 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

Bibliography
[1]
CAC/RCP 1:2003, Recommended international code of practice — General principles of food hygiene. Available [2009-11-23] at www.codexalimentarius.net/download/standards/23/cxp_001e.pdf
[2]
ISO 14159:2002, Safety of machinery — Hygiene requirements for the design of machinery
[3]
ISO/TS 22003, Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems
[4]
ISO/TS 22004:2005, Food safety management systems — Guidance on the application of ISO 22000:2005
[5]
BS PAS 220:2008, Prerequisite programmes on food safety for food manufacturing
ICS 67.020; 03.100.70
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