Introdu!tion - ISO 22000 Standard

#., 5enera/

!e ado%tion of a food safet$ mana*ement s$stem b$ an or*aniation in,ol,ed in t!e food c!ain is a useful tool for ensurin* com%liance 'it! re3uirements s%ecified b$ la'+ statute+ re*ulation andGor customers&

!e desi*n and im%lementation of an or*aniations food safet$ mana*ement s$stem are influenced b$ ,ar$i!*

factors+ in %articular food safet$ !aards+ t!e %roducts %ro,ided+ t!e %rocesses em%lo$ed and t!e sie and structure of t!e or*aniation& !is ec!nical S%ecification *i,es *uidance on t!e use of ISO 22000+ '!ic! is based on t!e

%rinci%les of " as described b$ t!e ode limentarius ommission7Jand is desi*ned to be a%%lied to*et!er 'it! rele,ant standards %ublis!ed b$ t!at or*aniation&

#." Food !ain and ro!ess aroa!

ISO 22000 %romotes t!e ado%tion of a food c!ain a%%roac! '!en de,elo%in*+ im%lementin* and im%ro,in* t!e effecti,eness and efficienc$ of a food safet$ mana*ement s$stem& In t!is re*ard+ in ISO 22000 t!e or*aniation is re3uired to consider t!e effects of t!e food c!ain %rior to and subse3uent to its o%erations '!en de,elo%in* and im%lementin* t!e food safet$ mana*ement s$stem&

For an or*aniation to function effecti,el$ and efficientl$+ it !as to identif$ and mana*e numerous lin.ed acti,ities& n acti,it$ usin* resources+ and mana*ed in order to enable t!e transformation of in%uts into out%uts+ is considered as a

%rocess& Often t!e out%ut from one %rocess directl$ forms t!e in%ut to t!e net&

!e a%%lication of a s$stem of %rocesses 'it!in an or*aniation+ to*et!er 'it! t!e i dentification of interactions and t!e mana*ement of t!ese %rocesses can be referred to as t!e B%rocess a%%roac!&B

n ad,anta*e of t!e %rocess a%%roac! is t!e on*oin* control t!at it %ro,ides o,er t!e lin.a*e bet'een t!e indi,idual

%rocesses 'it!in t!e s$stem of %rocesses+ as 'ell as t!eir combination and interaction&

;!en used 'it!in a f ood safet$ mana*ement s$stem+ suc! an a%%roac! em%!asies t!e im%ortance of

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understandin* and fulfillin* t!e re3uirements+

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t!e need to consider %rocesses in terms of food safet$ and traceabilit$+

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obtainin* results of %rocess %erformance and effecti,eness+ and

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continual im%ro,ement of %rocesses based on obecti,e measurement&

Interested %arties %la$ a si*nificant role in definin* re3uirements as in%uts& @onitorin* t!e satisfaction of interested

%arties re3uires e,aluation of information relatin* to t!eir %erce%tion of '!et!er t!e or*aniation !as met t!eir re3uirements or not&

ISOIS 22007:2005QE)

!e model of a %rocess-based food safet$ mana*ement s$stem s!o'n in Fi*ure 1 illustrates t!e %rocess lin.a*es

%resented in lauses 7 to A of ISO 22000:2005& !e model s!o'n in Fi*ure 1 does not s!o' t!e %rocesses at a detailed le,el&

---Fi*ure 1 - once%t of continuous im%ro,ement

0&? Relations!i% 'it! ISO 9001

ISO 22000 !as been desi*ned to 'or. in !armon$ 'it! ISO 9001 and its su%%ortin* standards& ISO 9001 %ro,ides re3uirements for a 3ualit$ mana*ement s$stem t!at can be used for internal a%%lication b$ or*aniations+ or for certification+ or for contractual %ur%oses& It focuses on t!e effecti,eness of t!e 3ualit$ mana*ement s$stem in meetin* customer re3uirements& ISO 22000 %ro,ides t!e essential elements of a food safet$ mana*ement s$stem for similar %ur%oses&

0&7 om%atibilit$ 'it! ot!er mana*ement s$stems

!is ec!nical S%ecification does not include *uidance s%ecific to ot!er mana*ement s$stems+ suc! as t!ose

%articular to en,ironmental mana*ement+ occu%ational !ealt! and safet$ mana*ement+ financial mana*ement+ or ris. mana*ement& o'e,er+ ISO 22000 enables an or*aniation to ali*n or inte*rate its o'n food safet$

mana*ement s$stem 'it! related mana*ement s$stems& It is %ossible for an or*aniation to ada%t its eistin*

mana*ement s$stem(s) in order to establis! a food safet$ mana*ement s$stem t!at follo's t!e re3uirements of ISO 22000&

,i © ISO 2005 - ll ri*!ts reser,ed

TE(;NI(AL S'E(IFI(ATION ISOITS ""##4:"##$%E&

Food safety management systems - 5uidan!e on te a/i!ation of ISO ""###:"##$

, S!oe

!is ec!nical S%ecification %ro,ides *eneric *uidance t!at can be a%%lied in t!e use of ISO 22000&

>OE ;!ere a subclause of ISO 22000 is not mentioned+ *uidance is not *i,en&

" Normati3e referen!es

!e follo'in* referenced documents are indis%ensable for t!e a%%lication of t!is document& For dated references+

onl$ t!e edition cited a%%lies& For undated references+ t!e latest edition of t!e referenced document (includin* an$

amendments) a%%lies&

ISO 22000:2005+ Food safety management s$stems - +e,uirements for any organi9ation in the food chain

6 Terms and definitions

For t!e %ur%oses of t!is document+ t!e terms and definitions *i,en in ISO 22000 a%%l$&

4 5uidan!e on te use of ISO ""###:"##$@ (/ause 4: Food safety management system

4., 5enera/ requirements

Eternal com%etences ma$ be used b$ t!e or*aniation to de,elo% and im%lement a food safet$ mana*ement s$stem accordin* to ISO 22000 %ro,ided t!at it is ensured t!at suc! outsourced %rocesses !a,e been de,elo%ed and are im%lemented+ monitored+ maintained and u%dated in com%liance 'it! t!e re3uirements of ISO 22000&

@oreo,er+ ISO 22000 allo's an$ or*aniation+ in %articular a small andGor less de,elo%ed or*aniation+ to im%lement an eternall$ de,elo%ed and establis!ed combination of %rere3uisite %ro*ramme(s) "R"(s)J+ o%erational "R"(s) and aard nal$sis and ritical ontrol "oint (") %lans %ro,ided t!at it can be demonstrated t!at

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t!is combination !as been de,elo%ed in com%liance 'it! t!e re3uirements of ISO 22000 s%ecified for t!e !aard anal$sis+ "R"(s) and " %lan+

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s%ecific measures !a,e been underta.en to ada%t t!e eternall$ de,elo%ed combination to t!e or*aniation+ and

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t!is combination !as been im%lemented and is o%erated in accordance 'it! t!e ot!er re3uirements of ISO 22000&

4." Do!umentation requirements

!e or*aniation s!ould use documents of eternal ori*in rele,ant for food safet$ in its ,arious acti,ities+ for eam%le in meetin* statutor$+ re*ulator$ and customer re3uirements& In some- situations+ electronic documentation ma$ be re3uired to com%l$ 'it! re*ulator$ re3uirements&

ISOITS ""##4:"##$%E&

!e t$%e and etent of documentation 'ill %robabl$ differ from one or*aniation to anot!er due to t!e sie and com%leit$ of t!e acti,it$ and t!e com%etence of %ersonnel+ as 'ell as t!e etent of t!e use of eternall$ de,elo%ed combinations of "R"s+ o%erational "R"s and " %lans&

Ifeternall$ de,elo%ed combinations of "R"s+ o%erational "R"s and " %lans are used+ t!eir suitabilit$ s!ould be documented and t!is documentation s!ould be a %art of t!e food safet$ mana*ement s$stem&

;!ere ISO 22000 refers to a documented %rocedure or statement+ t!is s!ould be inter%reted to mean t!at t!e

%rocedure or statement is establis!ed+ documented+ im%lemented+ re,ie'ed and maintained b$ t!e or*aniation as

%art of t!e food safet$ mana*ement s$stem& #ocuments t!at usuall$ form %art of t!e s$stem include %roduct s%ecifications+ " %lans+ o%erational "R"s and "R"s and ot!er re3uired o%eratin* %rocedures+ includin*

contracts for an$ outsourced %rocesses (e&*& %est control+ %roduct testin*)& !e documents used b$ t!e or*aniation s!ould be a,ailable '!en and '!ere re3uired and ma$ be in an$ ,alid format (e&*& %a%er+ electronic or %icture)&

 critical acti,it$ for an$ or*aniation is t!e retention of a%%ro%riate records for s%ecified %eriods and under controlled conditions& !e or*aniation s!ould base its decision on record retention '!en it !as considered t!e intended use of its %roducts and t!e e%ected s!elf-life alon* t!e food c!ain&

$ 5uidan!e on te use of ISO ""###:"##$@ (/ause $: 7anagement resonsi8i/ity

$., 7anagement !ommitment

!e met!od '!ereb$ t!e or*aniation %ro,ides e,idence of to% mana*ement commitment to t!e food safet$

mana*ement s$stem includes t!e settin* of a'areness and leaders!i% initiati,es lin.ed to t!e de,elo%ment and im%lementation of t!e s$stem&

$." Food safety o/i!y

!e food safet$ %olic$ is t!e basis of an$ or*aniations food safet$ mana*ement s$stem& @easurable obecti,es and tar*ets are defined in t!is %olic$& @easurable acti,ities ma$ include identification and im%lementation of acti,ities to im%ro,e an$ as%ect of t!e s$stem (e&*& reduce t!e number of recallsG'it!dra'als+ decrease t!e occurrence of forei*n bodies)&

Obecti,es s!ould be s%ecific+ measurable+ ac!ie,able+ rele,ant and time-framed&

$.6 Food safety management system /anning

>o *uidance is *i,en&

$.4 Resonsi8i/ity and autority

>o *uidance is *i,en&

$.$ Food safety team /eader

!e food safet$ team leader is central to t!e food safet$ mana*ement s$stem of an$ or*aniation and s!ould be a member of t!e or*aniation and+s!ould understand its food safet$ issues& ;!ere t!e food safet$ team leader !as ot!er res%onsibilities 'it!in t!e or*aniation+ t!ese s!ould not conflict 'it! food safet$ res%onsibilities&

!e res%onsibilit$ of t!e food safet$ team leader ma$ include liaison 'it! eternal %arties on matters relatin* to t!e food safet$ mana*ement s$stem&

Itis recommended t!at t!e food safet$ team leader !a,e a basic .no'led*e of !$*iene mana*ement and a%%lication of t!e " %rinci%les&

2 < ISO 2005 - ll ri*!ts reser,ed

$.9 (ommuni!ation

!e %ur%ose of an$ communication is to ensure t!at t!e necessar$ interactions occur&

ISO 22000 re3uires t!at bot! eternal and internal communication ta.es %lace as %art of t!e food safet$

mana*ement s$stem&

Eternal communication aims to ec!an*e information in order to ensure t!at an$ rele,ant !aard is controlled at one ste% t!rou*! t!e food c!ain b$ interaction+ for eam%le+

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u% and do'n t!e food c!ain+ for food safet$ !aard(s) t!at ma$ not or cannot be controlled b$ t!e or*aniation and '!ic! conse3uentl$ need(s) to be controlled at ot!er ste%s in t!e food c!ain+

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'it! customers as t!e basis for mutual acce%tance of t!e le,el of food safet$ re3uired (b$ t!e customer)+ and

c) 'it! statutor$ and re*ulator$ aut!orities and ot!er or*aniations&

Eternal communication is t!e met!od '!ereb$ t!e or*aniation and t!e eternal or*aniation a*ree b$ contract or ot!er means u%on t!e le,el of food safet$ re3uired and on t!e ca%abilit$ of deli,erin* to t!e a*reed re3uirements&

!annels of communication 'it! statutor$ and re*ulator$ aut!orities and ot!er or*aniations s!ould be establis!ed as a basis for %ro,idin* %ublic acce%tance of t!e le,el of food safet$ and for ensurin* t!e reliabilit$ of t!e or*aniation&

rainin* of desi*nated %ersonnel in communication s.ills ma$ be an im%ortant as%ect as 'ell&

!e internal communication s$stem of t!e or*aniation s!ould ensure t!at sufficient and rele,ant information and data are a,ailable to all %ersonnel in,ol,ed in t!e ,arious o%erations and %rocedures& !e food safet$ team leader

!as a maor role in t!e area of t!e internal communication of food safet$ issues 'it!in t!e or*aniation&

ommunication to %ersonnel 'it!in in t!e or*aniation s!ould be carried out in a clear and timel$ manner on t!e de,elo%ment and launc! of ne' %roducts+ as 'ell as intended c!an*es in ra' materials and in*redients+ %roduction s$stems and %rocesses andGor customers and customer re3uirements& In %articular+ attention s!ould be *i,en to t!e communication of c!an*es in statutor$ and re*ulator$ re3uirements+ ne' or emer*in* food safet$ !aards+ and t!e met!od of control of t!ese ne ' !aards&

n$ member of t!e or*aniation seein* somet!in* '!ic! ma$ !a,e an im%act on food safet$ s!ould .no' !o' to re%ort t!is e,ent&

$. Emergen!y rearedness and resonse

!e or*aniation s!ould be a 'are of %otential emer*enc$ situations '!ic! ma$ include+ for eam%le+ fire+ floodin*+

bioterrorism and sabota*e+ ener*$ failure+ ,e!icle accidents and contamination of t!e en,ironment&

$.< 7anagement re3ie)

!e mana*ement re,ie's %ro,ide mana*ement 'it! an o%%ortunit$ to assess t!e %erformance of t!e or*aniation in meetin* t!e obecti,es 'it! res%ect to its food safet$ %olic$ and t!e o,erall effecti,eness of t!e food safet$

mana*ement s$stem&

9 5uidan!e on te use of ISO ""###:"##$@ (/ause 9: Resour!e management

9., 'ro3ision of resou r!es

>o *uidance is *i,en&

In document ISO 22000 Standard (Page 46-50)