PAS 220-2008 Prerequisite programmes on food safety for food manufacturing《食品制造业食品安全的必要程序》.pdf

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1、PUBLICLY AVAILABLE SPECIFICATION PAS 220:2008Prerequisite programmes on foodsafety for food manufacturingICS code: 67.020NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSIPAS 220:20

2、08 BSI October 2008Publishing and copyright informationThe BSI copyright notice displayed in this document indicates when the documentwas last issued.This Publicly Available Specification comes into effect on 25 October 2008. BSI October 2008ISBN 978 0 580 62878 8Amd. No. Date CommentsLicensed Copy:

3、 Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSIPAS 220:2008 BSI October 2008iContentsPageForewordiiIntroduction11 Scope12 Normative references.23 Terms and definitions.34 Construction and layout of buildings55 Layout of premises and workspace56 Utilities air, wa

4、ter, energy.77 Waste disposal88 Equipment suitability, cleaning and maintenance.99 Management of purchased materials1110 Measures for prevention of cross contamination.1211 Cleaning and sanitizing1312 Pest control.1413 Personnel hygiene and employee facilities.1514 Rework1815 Product recall procedur

5、es1816 Warehousing.1917 Product information/consumer awareness.1918 Food defence, biovigilance and bioterrorism19Bibliography.20Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSIPAS 220:2008 BSI October 2008iiThe development of this PAS was sponsored

6、by theConfederation of the Food and Drink Industries of the European Union (CIAA). Acknowledgement is given to the followingorganizations and individuals who assisted with thedevelopment of this specification: Technical author: Steve Mould (Kraft Foods)Organizations Danone Kraft Foods Nestle Unileve

7、rPAS Steering GroupAndrew CurtisFood and Drink Federation (FDF)Bizhan PourkomailianMcDonaldsChris LewisGeneral Mills Europe(Representing FDF Food Hygiene Committee)Cor GroenveldLloyds Register Quality Assurance Ltd. (LRQA)Member of the ISO working group for developing ISO 22000:2005Didier SebeonFren

8、ch National Association of Food Industries(Representing CIAA)Member of the ISO working group for developing ISO 22000:2005Dr Didier BlancProCert, Certification body Member of the ISO working group for developing ISO 22000:2005Paul WhitehouseUnileverForewordThis Publicly Available Specification (PAS)

9、 has been prepared by the British StandardsInstitution (BSI) to specify requirements for prerequisite programmes to assist incontrolling food safety hazards. This PAS is intended to be used in conjunction with BS EN ISO 22000 to support management systems designed to meet therequirements specified i

10、n BS EN ISO 22000. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSIPAS 220:2008 BSI October 2008iiiPublishing informationThis PAS comes into effect on 25 October 2008.This PAS has been prepared and published by BSI whichretains its ownership and cop

11、yright. BSI reserves theright to withdraw or amend this PAS on receipt ofauthoritative advice that it is appropriate to do so. ThisPAS will be reviewed at intervals not exceeding twoyears, and any amendments arising from the reviewwill be published as an amended Publicly AvailableSpecification and p

12、ublicized in Update Standards. This PAS is not to be regarded as a British Standard,European Standard or International Standard. In theevent that this PAS is put forward to form the basis of a full British Standard, European Standard orInternational Standard, it will be withdrawn.Use of this documen

13、tIt has been assumed in the preparation of this PAS that the execution of its provisions will be entrusted to appropriately qualified and experienced people, for whose use it has been produced.Presentational conventionsThe provisions of this PAS are presented in roman (i.e. upright) type. Its requir

14、ements are expressed insentences in which the principal auxiliary verb is “shall”.Its recommendations are expressed in sentences inwhich the principal auxiliary verb is “should”.Commentary, recommendations, explanation andgeneral informative material is presented in smalleritalic type, using the hea

15、ding NOTE, and does notconstitute a normative element.Contractual and legal considerationsThis publication does not purport to include all the necessary provisions of a contract. Users areresponsible for its correct application.Compliance with this PAS does not in itself conferimmunity from legal ob

16、ligations. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSIPAS 220:2008 BSI October 20081This Publicly Available Specification (PAS) specifiesrequirements for establishing, implementing andmaintaining prerequisite programmes (PRP) to assist in contr

17、olling food safety hazards. This PAS is applicable to all organizations, regardless of size or complexity, which are involved in themanufacturing step of the food chain and wish to implement PRP in such a way as to address therequirements specified in BS EN ISO 22000:2005, Clause 7. This PAS is neit

18、her designed nor intended for use inother parts of the food supply chain.Food manufacturing operations are diverse in natureand not all of the requirements specified in this PASapply to an individual establishment or process. NOTE Where exclusions are made or alternative measuresimplemented, these n

19、eed to be justified by a hazardassessment. Any exclusions or alternative measures adoptedshould not affect the ability of the organization to complywith these requirements. Examples of such exclusionsinclude the additional aspects relevant to manufacturingoperations listed under i), ii), iii), iv) a

20、nd v) below.This PAS specifies detailed requirements to beconsidered in relation to 7.2.3 of BS EN ISO 22000:2005,specifically:a) construction and layout of buildings and associatedutilities;b) layout of premises, including workspace andemployee facilities;c) supplies of air, water, energy and other

21、 utilities;d) supporting services, including waste and sewagedisposal; e) suitability of equipment and its accessibility forcleaning, maintenance and preventive maintenance;1 ScopeIntroductionBS EN ISO 22000 sets out specific food safetyrequirements for organizations in the food chain. One such requ

22、irement is that organizations establish,implement and maintain prerequisite programmes(PRP) to assist in controlling food safety hazards (BS EN ISO 22000:2005, Clause 7). This PAS is intendedto be used to support management systems designedto meet the requirements specified in BS EN ISO 22000,and se

23、ts out the detailed requirements for thoseprogrammes. This PAS does not duplicate requirements given in BS EN ISO 22000 and is intended to be used inconjunction with BS EN ISO 22000, not in isolation. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSI

24、PAS 220:2008 BSI October 20082f) 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 PAS adds other aspects which areconsidered relevant to manufacturing operations:i) rework;ii) pro

25、duct recall procedures;iii) warehousing;iv) product information and consumer awareness;v) food defence, biovigilance and bioterrorism.2 Normative referencesThe following referenced documents are indispensablefor the application of this PAS. For dated references,only the edition cited applies. For un

26、dated references,the latest edition of the referenced document(including any amendments) applies.BS EN ISO 22000:2005, Food safety managementsystems Requirements for any organization in thefood chain, Clause 7Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy,

27、 (c) BSIPAS 220:2008 BSI October 20083For the purposes of this PAS, the following terms anddefinitions apply.The terms and definitions given in BS EN ISO22000:2005 also apply.3.1 contaminationintroduction or occurrence of a contaminant (see 3.2)in food or food environment Adapted from Codex Alimenta

28、rius, 2.33.2 contaminantany biological or chemical agent, foreign matter orother substances not intentionally added to food which may compromise food safety or suitability Adapted from Codex Alimentarius, 2.3NOTE Measures for prevention of malicious contaminationare outside the scope of this PAS. Fo

29、r further informationand guidance on approaches to the protection of foodbusinesses from all forms of malicious attack see PAS 96.3.3 establishmentany building or area in which food is handled, and the surroundings, under the control of the samemanagementAdapted from Codex Alimentarius, 2.33.4 mater

30、ialsgeneral term used to indicate raw materials, packagingmaterials, ingredients, process aids, cleaning materialsand lubricants3.5 cleaningremoval of soil, food residue, dirt, grease or otherobjectionable matterAdapted from Codex Alimentarius, 2.33.6 product contactall surfaces that are in contact

31、with the product or theprimary package during normal operation3 Terms and definitionsLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSIPAS 220:2008 BSI October 200843.7 material/product specification detailed documented description or enumeration ofpa

32、rameters, including permissible variations andtolerances, which are required to achieve a definedlevel of acceptability or quality3.8 food gradelubricants and heat transfer fluids formulated to besuitable for use in food processes where there may beincidental contact between the lubricant and the fo

33、od3.9 disinfectionreduction, by means of chemical agents and/or physicalmethods, of the number of micro-organisms in theenvironment, to a level that does not compromise food safetyAdapted from Codex Alimentarius, 2.33.10 cleaning in place (CIP)system that cleans solely by circulating and/or flowingc

34、hemical detergent solutions and water rinses bymechanical means onto and over surfaces to becleaned 3.11 cleaning out of place (COP) system where equipment is disassembled and cleanedin a tank or in an automatic washer by circulating a cleaning solution and maintaining a minimumtemperature throughou

35、t the cleaning cycle3.12 sanitizingthe process of cleaning, followed by disinfection3.13 sanitationall actions dealing with cleaning or maintaininghygienic conditions in an establishment, ranging from cleaning and/or sanitizing of specific equipmentto periodic cleaning activities throughout theestab

36、lishment (including building, structural, andgrounds cleaning activities)3.14 certificate of analysis (COA) document provided by the supplier which indicatesresults of specific tests/analysis, including testmethodology, performed on a defined lot of thesuppliers product3.15 zoningdemarcation of an a

37、rea within an establishment wherespecific operating, hygiene or other practices may beapplied to minimize the potential for microbiologicalcross contamination NOTE Examples include: clothing change on entry/exit,positive air pressure, modified traffic flow patterns. 3.16 labelprinted matter that is

38、part of the finished productpackage conveying specific information about thecontents of the package, the food ingredients and any storage and preparation requirementsNOTE This includes, but is not limited to:a) the package itself, printed matter attached to thepackage, or a sticker used for over-lab

39、elling;b) multi packs which have an inner label on the individualproduct and an outer combined label for the wholecontents.3.17 product recallremoval of a non-conforming product from themarket, trade and warehouses, distribution centresand/or customer warehouses because it does not meetspecified sta

40、ndards3.18 First Expired First Out (FEFO) stock rotation based on the principle of despatchingearliest expiration dates first 3.19 First In First Out (FIFO)stock rotation based on the principle of despatchingearliest received products firstLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02

41、/2009 07:33, Uncontrolled Copy, (c) BSI4 Construction and layout of buildings4.1 General requirementsBuildings shall be designed, constructed andmaintained in a manner appropriate to the nature ofthe processing operations to be carried out, the foodsafety hazards associated with those operations and

42、the potential sources of contamination from the plantenvirons. Buildings shall be of durable constructionwhich presents no hazard to the product.NOTE For example, roofs should be self-draining and not leak.4.2 EnvironmentConsideration shall be given to potential sources ofcontamination from the loca

43、l environment.NOTE Food production should not be carried out in areaswhere potentially harmful substances could enter theproduct.The effectiveness of measures taken to protect againstpotential contaminants shall be periodically reviewed. 4.3 Locations of establishmentsThe site boundaries shall be cl

44、early identified.Access to the site shall be controlled.The site shall be maintained in good order. Vegetationshall be tended or removed. Roads, yards and parkingareas shall be drained to prevent standing water andshall be maintained.PAS 220:2008 BSI October 200855.1 General requirementsInternal lay

45、outs shall be designed, constructed and maintained to facilitate good hygiene andmanufacturing practices. The movement patterns of materials, products and people, and the layout of equipment, shall be designed to protect againstpotential contamination sources. 5.2 Internal design, layout and traffic

46、patternsThe building shall provide adequate space, with alogical flow of materials, products and personnel, andphysical separation of raw from processed areas.NOTE Examples of physical separation may include walls,barriers or partitions, or sufficient distance to minimize risk.Openings intended for

47、transfer of materials shall bedesigned to minimize entry of foreign matter and pests.5.3 Internal structures and fittingsProcess area walls and floors shall be washable orcleanable, as appropriate for the process or producthazard. Materials shall be resistant to the cleaningsystem applied.Wall floor

48、 junctions and corners shall be designed tofacilitate cleaning. NOTE It is recommended that wall floor junctions arerounded 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 ov

49、erhead fixtures shall be designed tominimize build up of dirt and condensation.External opening windows, roof vents or fan, wherepresent, shall be insect screened.External opening doors shall be closed or screenedwhen not in use.5.4 Location of equipmentEquipment shall be designed and located so as tofacilitate good hygiene practices and monitoring. Equipment shall be located to permit access foroperation, cleaning and maintenance. 5 Layout of premises and workspaceLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 03/02/2009 07:33, Uncontrolled Copy, (c) BSI