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ISO 22000:2005 22000:2005 FOOD SAFETY QUALITY QUALITY MANUAL MANUAL
ISO 22000:2005 Quality Manual Manual
QUALITY MANUAL
ISO 22000:2005 Food Safety Management
HACCPEu!"a Pu#li$ati!n% 20&2
QUALITY MANUAL
ISO 22000:2005 Food Safety Management
HACCPEu!"a Pu#li$ati!n% 20&2
Table of Contents Int!'u$ti!n (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( & &(0 T)* C!+"any P!,il* (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 2 ISO 22000: 2005 Ba$-.!un' an' Hi%t!y((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( / &(& Int!'u$ti!n (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( / &(2 A""li$ati!n (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &(/ Quality Sy%t*+ C!nt!l ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &( Quality Sy%t*+ C)an.*% (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 5 &(5 F!!' Sa,*ty P!li$y ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 5 &(1 F!!' Sa,*ty Mana.*+*nt Sy%t*+ O#*$ti3*% (((((((((((((((((((((((((((((((((((((((((((((((( 5 &(4 Aut)!iati!n Stat*+*nt ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 1 &(6 O.aniati!n ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 1 2(0 Sy%t*+ R*7ui*+*nt% (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 6 2(& F!!' Sa,*ty T*a+ (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 6 /(0 C!nt!l% an' Di%ti#uti!n (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 8 /(& Stu$tu* !, ISO 22000 Manual ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 8 /(2 R*%"!n%i#ility (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &0 /(/ R*,**n$*% ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &0 /( A+*n'+*nt R*$!' S)**t (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &0 (0 Quality Mana.*+*nt Sy%t*+ (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( && (& 9*n*al R*7ui*+*nt% ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( && (2 D!$u+*ntati!n R*7ui*+*nt% ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &2 5(0 Mana.*+*nt R*%"!n%i#ility ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &5 5(& Mana.*+*nt C!++it+*nt ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &5 5(2 Cu%t!+* F!$u% ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &5 5(/ F!!' Sa,*ty P!li$y ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &1 5( Plannin. ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &1 5( R*%"!n%i#ility an' Aut)!ity (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &6 5(5 F!!' %a,*ty t*a+ l*a'* (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &8 5(1 C!++uni$ati!n (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 20 5(4 E+*.*n$y "*"a*'n*%% an' *%"!n%* (((((((((((((((((((((((((((((((((((((((((((((((((((((((( 2& 5(6 Mana.*+*nt R*3i* (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 2&
1(0 R*%!u$* Mana.*+*nt (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 2 1(& P!3i%i!n !, R*%!u$*% ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 2 1(2 Hu+an R*%!u$* (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 2 1(/ In,a%tu$tu* (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 25 1( ;!- En3i!n+*nt(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 21 4(0 Plannin. an' R*aliati!n !, %a,* "!'u$t% ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 24 4(& 9*n*al (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( 24 4(2 P**7ui%it* "!.a+%
*i,i$ati!n "lannin. ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( /2 4(8 Ta$*a#ility %y%t*+ ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( // 4(&0 C!nt!l !, n!n$!n,!+ity (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( / 6(0 >ali'ati!n? 3*i,i$ati!n an' i+"!3*+*nt !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+ (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( /6 6(& 9*n*al (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( /6 6(2 >ali'ati!n !, C!nt!l +*a%u* $!+#inati!n% (((((((((((((((((((((((((((((((((((((((((((((( /6 6(/ C!nt!l !, +!nit!in. an' +*a%uin. (((((((((((((((((((((((((((((((((((((((((((((((((((((((((( /6 6( F!!' %a,*ty +ana.*+*nt %y%t*+ 3*i,i$ati!n (((((((((((((((((((((((((((((((((((((((((((((( /8 6(5 I+"!3*+*nt (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( &
I S O
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F O O D
S A F E T Y
M A N A G E M E N T
! A " I T Y
M A N ! A "
T)* +anual '*%$i#*% )! +anu,a$tu*% ill $!+"ly it) t)* *7ui*+*nt% !, t)* ISO 22000:2005 an' HACCP
Int$od%&t'on T)* $!+"any '*3*l!"*' an' i+"l*+*nt*' a Quality Mana.*+*nt Sy%t*+
#
I S O
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M A N ! A "
#(0 T)e Com*any +$of'le
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ISO 22000: 2005 -a&.g$o%nd and /'sto$y
ISO 22000:2005 i% a ,!!' %a,*ty +ana.*+*nt %y%t*+% '*3*l!"*' it)in ISO #y *"*t% ,!+ t)* ,!!' in'u%ty an' ,! t)* ,!!' in'u%ty( It $l*aly "!3i'*% a ,a+*!- !, int*nati!nally )a+!ni*' *7ui*+*nt% ,! t)* .l!#al a""!a$) t)at i% n**'*'( ISO 22000 int*.at*% t)* "in$i"l*% !, t)* Haa' Analy%i% an' Citi$al C!nt!l P!int
#(# Int$od%&t'on
1.1.1 T)i% Quality Mana.*+*nt Sy%t*+ i% *%ta#li%)*' an' +aintain*' in !'* t! '*,in* an' "!3i'* an !3*3i* !, t)* Quality Mana.*+*nt Sy%t*+
T)**,!*? t)i% Quality Sy%t*+ Manual? "!3i'in. an !3*3i* !, t)* Quality Mana.*+*nt Sy%t*+ i% 'i3i'*' int! *i.)t %*$ti!n%? +!'*l*' a,t* t)* %*$ti!nal !.aniati!n !, t)* ISO 22000:2005( Ea$) %u#%*$ti!n !, t)i% Quality Sy%t*+ Manual '*,in*% .*n*al "!li$i*% an' #a%i$ "in$i"l*% "*tin*nt t! t)* "!$*%%*%? %u++ai*% *%"!n%i#iliti*% an' +*t)!'%? an' *,**n$*% *l*3ant SOP% an' !t)* *7ui*' '!$u+*nt%(
,
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1.1.2 Fut)*? t)i% Quality Sy%t*+ Manual i% *%ta#li%)*' an' +aintain*' t! i'*nti,y t)* "!$*%%*% an' '*,in* t)* int*a$ti!n% !, t)*%* "!$*%%*%? an' t)*i +ana.*+*nt? t! %ati%,y %"*$i,i*' *7ui*+*nt%( 1.1.3 T)i% Quality Sy%t*+ Manual i% *%ta#li%)*' an' +aintain*' t! '*+!n%tat* Mana.*+*nt% $!++it+*nt t! 7uality? *n%uin. t)at #!t) t)* !"*ati!n an' $!nt!l !, "!$*%%*% a* *,,*$ti3*@ *n%uin. t)* a3aila#ility !, *%!u$*% an' in,!+ati!n n*$*%%ay t! %u""!t t)* !"*ati!n an' +!nit!in. !, t)*%* "!$*%%*%@ t! +!nit!? +*a%u*? )** a""li$a#l*? an' analy* t)*%* "!$*%%*%? an' i+"l*+*nt a$ti!n% n*$*%%ay t! a$)i*3*' "lann*' *%ult% an' $!ntinually i+"!3* t)*%* "!$*%%*%(
#(2 A**l'&at'on
1.2.1 T)i% Quality Mana.*+*nt Sy%t*+? in$lu'in. t)i% Quality Sy%t*+% Manual? all int**lat*' "!$*'u*%? !- in%tu$ti!n%? an' a%%!$iat*' ,!+% an' *$!'% i% a""li$a#l* t! +ana.*+*nt an' "*%!nn*l it) a%%i.n*' *%"!n%i#iliti*% )a3in. t)* "!t*ntial t! a,,*$t "!'u$t an'! %*3i$* 7uality( 1.2.2 T)* Quality Mana.*+*nt Sy%t*+ a""li*% t! all "!'u$t%? +anu,a$tu*' ! !ut%!u$*'? 'i%ti#ut*' #y THE COMPANY? an' in$lu'*%? )** a""li$a#l* t)* '*%i.n? +anu,a$tu*? +*a%u*+*nt? an' 'i%ti#uti!n !, all "!'u$t%? an' i% *%ta#li%)*' an' +aintain*' t! '*+!n%tat* t)* a#ility !, THE COMPANY t! $!n%i%t*ntly "!3i'* "!'u$t an' %*3i$*% t)at +**t% $u%t!+* *7ui*+*nt%( 1.2.3 T)* Quality Mana.*+*nt Sy%t*+ i% *%ta#li%)*' an' +aintain*' t! *n)an$* $u%t!+* %ati%,a$ti!n t)!u.) t)* *,,*$ti3* a""li$ati!n !, t)* %y%t*+? %"*$i,i$ally in$lu'in. "!$*%%*% ,! $!ntinual i+"!3*+*nt !, t)* %y%t*+? an' t)* a%%uan$* !, $!n,!+ity t! $u%t!+* *7ui*+*nt% an' in'u%ty %tan'a'%( 1.2.4 E$lu%i!n%: THE COMPANY '!*% n!t )**in $lai+ ! u%ti,y any *$lu%i!n ,!+ t)* %u# $lau%*% !, t)* %tan'a'%(
#(, %al'ty System Cont$ol
1.3.1 T)i% Quality Manual? al!n. it) Quality Sy%t*+ P!$*'u*%? ;!In%tu$ti!n%? F!+%? an' Dain.% ill #* +aintain*' un'* '!$u+*nt <*3i%i!n= $!nt!l( 1.3.2 D!$u+*nt Di%ti#uti!n: T)* $u*nt *3i%i!n l*3*l !, *a$) $!nt!ll*' '!$u+*nt ill #* +a'* a3aila#l* t! a""li$a#l* %ta,, 3ia t)* $!+"ut* %y%t*+( D!$u+*nt% +ay #* "int*' ,! *,**n$* !nly? an' ill #* $!n%i'**' !#%!l*t* at t)* *n' !, t)* 'ay? unl*%% !t)*i%* $!nt!ll*'( I, $!nt!ll*' "a"* $!"i*% !, '!$u+*nt% a* "int*' an' 'i%ti#ut*'? it ill #* t)* *%"!n%i#ility !, t)* Quality Man.* t! +aintain a li%t !, t)* '!$u+*nt%? al!n. it) t)* *$i"i*nt%(
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1.3.2.1 C!nt!ll*' '!$u+*nt% a* n!t 'i%ti#ut*' !ut%i'* !, t)* !.aniati!n it)!ut t)* "*+i%%i!n !, t!" +ana.*+*nt( I, t)i% Quality Sy%t*+ Manual i% 'i%ti#ut*' !ut%i'* !, THE COMPANY
#( %al'ty System C)anges
1.4.1 N!ti,i$ati!n !, C)an.*% <%u#%tanti3* $)an.*%=? in$lu'in. Mana.*+*nt $)an.* O.aniati!n Stu$tu*? C)an.* !, Fa$ility? %u#%tanti3* $)an.*% t! t)* Quality Sy%t*+ Manual? ill #* "!3i'*' in itin. t! t)* ISO R*.i%ta? i, *7ui*'( 1.4.2 T)* %ta,, ill #* n!ti,i*' !, $)an.*% t)!u.) t)* ,!+al $)an.* $!nt!l "!$*%%?
Ref.: Document and Data Control.
#(5 Food Safety +ol'&y
It i% t)* "!li$y t! "!'u$* an' %u""ly %a,* ,!!' "!'u$t% !, a.**' 7uality t! $!n%i%t*ntly +**t $u%t!+* n**'% an' *"*$tati!n% an' *n)an$* $u%t!+* %ati%,a$ti!n% %! t)at t)** i% $!+"l*t* a%%uan$* t)at !u $u%t!+*% *$*i3* t)* !"ti+u+ n!ui%)+*nt? an' a* unli-*ly t! #*$!+* ill ! inu*' #y ,!*i.n !#*$t% "*%*nt in !u ,!!'( In !'* t! a$)i*3* t)i% !#*$ti3*? * ill i.!!u%ly a')** t! *l*3ant Statut!y G R*.ulat!y R*7ui*+*nt% an' it) +utually a.**' ,!!' %a,*ty *7ui*+*nt% !, $u%t!+*%( ;* ill +a-* *3*y *,,!t t! +ai+i* $u%t!+* %ati%,a$ti!n #y: Su""lyin. %a,* an' )y.i*n* ,!!' "!'u$t% t! t)* $!n%u+* P*3*nti!n at)* t)an '*t*$ti!n *$ti,i$ati!n C!+"lyin. *7ui*+*nt% G $!ntinually i+"!3* t)* *,,*$ti3*n*%% !, F!!' Sa,*ty Mana.*+*nt Sy%t*+( C*atin. an *n3i!n+*nt !, t*a+!- a% *ll a% in3!l3*+*nt an' %y%t*+ aa*n*%% t! all *+"l!y**%(
#(1 Food Safety Management System Obe&t'3es
Ou F!!' Sa,*ty !#*$ti3*% a* a% ,!ll!%: Stat* a%"*$t% !, "*%!nal )y.i*n* t)at *lat* t! ,!!' %a,*ty D*%$i#* "!"* ay% t! ,!!' %a,*ty D*%$i#* +*t)!'% !, %anitiin. ,!!' "*"aati!n a*a% an' *7ui"+*nt
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I'*nti,y "!"* a%)in. "a$ti$*% E"lain )! t! "*3*nt $!nta+inati!n !, ,!!' Cit* *a+"l*% !, ,!!'#!n* illn*%%
#(4 A%t)o$'at'on Statement
THE COMPANY i% $!++itt*' t! t)* *%ta#li%)+*nt an' +aint*nan$* !, F!!' Sa,*ty Mana.*+*nt Sy%t*+ .i3*n in t)i% +anual an' i+"l*+*nt*' #y THE COMPANY t! +**t t)* *7ui*+*nt% !, ISO 22000: 2005 F!!' %a,*ty +ana.*+*nt %y%t*+%( T)* +*+#*% !, t)* O.aniati!n %)all %ti$tly a')** t! t)* 3ai!u% FSMS "!$*'u*% an' !- in%tu$ti!n% a% %u""!t*' #y t)* "!li$i*% !utlin*' in t)i% +anual( T*a+ l*a'* !, ,!!' %a,*ty )a% #**n a""!int*' a% F!!' % a,*ty t*a+ l*a'* !, O.aniati!n( T)* F!!' Sa,*ty T*a+ L*a'* i% *%"!n%i#l* ,! *n%uin. $!+"lian$* it) t)* FSMS *7ui*+*nt% %ti"ulat*' in t)i% +anual( H* i% aut)!i*' t! *n%u* t)at t)* FSMS %y%t*+ i% *%ta#li%)*'? i+"l*+*nt*' an' +aintain*' #y THE COMPANY( T!" Mana.*+*nt %)all .i3* ,ull %u""!t an' $! !"*ati!n F!!' Sa,*ty T*a+ L*a'*(
#(6 O$gan'at'on
T! *n%u* a ,!+al !.aniati!nal $)at i% +aintain*' )i$) $l*aly '*,in*% t)* !.aniati!nal %tu$tu* !, t)* $!+"any( T)i% $)at '*,in*% t)* *"!tin. %tu$tu*? )i*a$)y l*3*l% !, aut)!ity? #a%i$ *%"!n%i#iliti*%( T)* O"*atin. P!$*'u*% %u""!tin. t)i% ISO 22000 Manual '*,in* in'i3i'ual *%"!n%i#iliti*% in *%"*$t t! aut)!ity? a$ti!n% t! #* ta-*n in t)* *3*nt !, *!%? $!*$ti3* a$ti!n an' any **3aluati!n n*$*%%ay t! *n%u* !u !"*ati!n% *+ain in $!+"lian$* it) !u "!li$y an' !#*$ti3*%? %u""!t*' #y '*tail*' !# ,un$ti!n '*%$i"ti!n%(
Ref: Management Responsibility
#(6(# 7eso%$&es
T! *n%u* a'*7uat* *%!u$*% a* "!3i'*' ,! t)* "*,!+an$* !, all !"*ati!n%? $!u"l*' it) tain*' *%!u$*% in !'* t! +aintain !u !3*all "!$*%% $a"a#ility in t)* #*%t int**%t% !, !u $u%t!+*%(
1
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R*%!u$*% in$lu'* $a"ital "lant an' *7ui"+*nt@ !-in. *n3i!n+*nt an' "*%!nn*l t)at a* #a%i$ally $!n%i'**' t)* "**7ui%it*% !, t)* ISO 22000( Ou O"*atin. P!$*'u*% '*,in* t)* *%!u$*% t! #* utili*' in $!nun$ti!n it) !# '*%$i"ti!n%? %-ill% +ati*% an' !- in%tu$ti!n%( A% "at !, ISO 22000 +**tin.% t)* a'*7ua$y !, *%!u$*% i% *3aluat*' an' )** n*$*%%ay a''iti!nal? %uita#l* *%!u$*% '**+*' "!3i'*'( All ISO 22000 +**tin. )*l' ,!+ally ! in,!+ally %)!ul' #* * $!'*'(
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2(0 System 7e8%'$ements THE COMPANY )a% *%ta#li%)*' '!$u+*nt*' an' i+"l*+*nt*' ISO 22000 %y%t*+ t! *n%u* t)at all -n!n "!t*ntial )aa'% a* i'*nti,i*' an' t)at all *l*3ant )aa'% a* $!nt!ll*' in %u$) a +ann* t)at t)* "!'u$t% !, t)* $!+"any '! n!t )a+ t)* u%*$!n%u+*( T)* %$!"* !, t)* 7uality %y%t*+ $!3*% t)* !.aniati!n? *%"!n%i#iliti*% an' aut)!iti*%? "!$*'u*%? +*t)!'% an' t)* *%!u$*% t! a$)i*3* an' +aintain 7uality !, %*3i$* in a$$!'an$* it) t)* FSMS "!li$y !, t)* $!+"any( THE COMPANY )a% *%ta#li%)*' an' +aintain*' '!$u+*ntati!n t! t)* *,,*$t t)at t)* FSMS %y%t*+ i% *%ta#li%)*' in $!+"lian$* it) t)* ISO 22000 *7ui*+*nt% !, %tan'a'(
2(# Food Safety Team
THE COMPANY )a% *%ta#li%)*' a +ulti'i%$i"linay ISO 22000 t*a+ i% %*t u" t! '*3*l!"? *%ta#li%)? +aintain an' *3i* t)* FSMS %y%t*+( T)* FSMS t*a+ %)all )a3* -n!l*'.* an' *"*i*n$* it) *.a' t! t)* $!+"any% "!'u$t%? "!$*%%*% an' )aa'% it)in t)* %$!"* an' ,i*l' !, a""li$ati!n( D!$u+*ntati!n t! t)i% *,,*$t %)all #* +aintain*'( ;)** t)* a%%i%tan$* !, *t*nal *"*t% i% *7ui*' ,! t)* !"*ati!n !, t)* ISO 22000 %y%t*+? an a.**+*nt %)all #* +a'* t! '!$u+*nt t)* *%"!n%i#ility an' aut)!ity !, %u$) *"*t% it) *.a' t! t)* ISO 22000 %y%t*+(
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,(0 Cont$ols and D'st$'b%t'on ,(# St$%&t%$e of ISO 22000 Man%al
T)i% +anual i% "*"a*' a$$!'in. t! t)* ta#l* !, $!nt*nt%( Ea$) $)a"t* #*.in% it) "a.* & an' t)* nu+#*in. $!ntinu*% it)in t)* $)a"t* an' n !t t)!u.)!ut t)* +anual( T)i% )a% #**n '!n* t! ,a$ilitat* ,utu* a''iti!n '*l*ti!n !, "a.*%( T)* +anual i% %u""!t*' #y '!$u+*nt*' %y%t*+ $!3*in. ISO 22000 "!$*'u*% an' !- in%tu$ti!n% ! t*%t "!$*'u*%( ISO 22000 %y%t*+ i% "*"a*' #y ISO 22000 t*a+ !n t)* #a%i% !, 4 "in$i"al% !, ISO 22000( ISO 22000 +anual .i3*% #!a' .ui'*lin* ,! i+"l*+*ntati!n !, t)* F!!' Sa,*ty Mana.*+*nt Sy%t*+ *7ui*+*nt%( T!" Mana.*+*nt )a% i'*nti,i*' a +ulti'i%$i"linay ISO 22000 T*a+ *"*%*nt*' #y )*a'% !, *%"*$ti3* a*a( T)* t*a+ $!n'u$t*' )aa' analy%i% /ACC+ +$'n&'*le ;#< ,!+ t)* "!int !, $!n%u+"ti!n( T)* t*a+ ,ut)* *%ta#li%)*' +!nit!in. %y%t*+ an' $!*$ti3* a$ti!n% )** n**'*'( Ba%*' !n )aa' analy%i% t)* t*a+ i'*nti,i*' t)* Si.ni,i$ant Haa'%? ,! )i$)? Citi$al C!nt!l P!int% *i,i$ati!n "!$*%%? t)* '*tail% in$lu'in. t)* *%"!n%i#ility? ,*7u*n$y G +*t)!' !, 3*i,i$ati!n a* $l*aly '*,in*' ,! *n%uin. t)* *,,*$ti3*n*%% !, F!!' Sa,*ty Mana.*+*nt Sy%t*+( N*$*%%ay $!nt!l ,*atu*% a* al%! a''*%%*' in *l*3ant F!!' Sa,*ty Mana.*+*nt Sy%t*+ P!$*'u* ;!In%tu$ti!n%( T)* i+"l*+*ntati!n !, t)i% +anual an' *lat*' 7uality "!$*'u* i% +an'at!y ,! all '*"at+*nt%( T)* $)an.*% +a'* in t)i% +anual a* *,,*$t*' t)!u.) t)* '!$u+*nt $!nt!l "!$*'u*% an' +u%t #* a""!3*' #y t)* T!" Mana.*+*nt(
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,(2 7es*ons'b'l'ty
Di*$t! a""!3*% F!nt C!3* "a.* !, t)* ISO 22000 Manual( T)* $!nt!l an' +aint*nan$* !, t)i% +anual i% t)* *%"!n%i#ility !, F!!' Sa,*ty T*a+ L*a'* )! i% +aintainin. +a%t* li%t !, +anual( Al%! )*n any $)an.*% a+*n'+*nt a* t)**? t)*n t)* %a+* "a.* i% a""!3*' #y t)* T!" Mana.*+*nt #*,!* i%%u* !, %u$) $)an.*' a+*n'*' "a.* t! t)* $!n$*n*' $!"y)!l'*(
,(, 7efe$en&es
ISO 22000: 2005 F!!' Sa,*ty +ana.*+*nt %y%t*+ R*7ui*+*nt% R*7ui*+*nt% ,! ISO 22000 #a%*' ,!!' %a,*ty %y%t*+
,( Amendment 7e&o$d S)eet Do&%ment /'sto$y
Version
Created By
Issued to
Type
Date
Do&%ment Cont$olle$
Ite#
Des$ription
&o' o(e' Te(ep&one' )#ai('
#0
e!ie"ed Appro!ed By By
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(0 %al'ty Management System (# Gene$al 7e8%'$ements
THE COMPANY )a% *%ta#li%)*'? '!$u+*nt*'? i+"l*+*nt*' an' +aintain*' a F!!' Sa,*ty Mana.*+*nt Sy%t*+ an' $!ntinually i+"!3*% it% *,,*$ti3*n*%% in a$$!'an$* it) t)* *7ui*+*nt% !, ISO 22000: 2005( THE COMPANY )a% '*,in*' t)* %$!"* !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+ in $)a"t* N!( 0& t! t)i% Manual( ;* )a3* i'*nti,i*'? *3aluat*' an' $!nt!ll*' t)* ,!!' %a,*ty )aa'% %! t)at t)* "!'u$t% <+anu,a$tu*' in THE COMPANY= '! n!t? 'i*$tly ! in'i*$tly? )a+ t)* $!n%u+*( ;* )a3* $!++uni$at*' a""!"iat* in,!+ati!n t)!u.)!ut t)* ,!!' $)ain *.a'in. %a,*ty i%%u*% *lat*' t! t)* "!'u$t%( N*$*%%ay in,!+ati!n i% $!++uni$at*' *.a'in. '*3*l!"+*nt? i+"l*+*ntati!n an' u"'atin. !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+ t)!u.)!ut t)* !.aniati!n? t! t)* *t*nt n*$*%%ay t! *n%u* t)* ,!!' %a,*ty *7ui*' #y t)i% Int*nati!nal Stan'a'( N*$*%%ay "*i!'i$al *3aluati!n !, t)* %a,*ty +ana.*+*nt %y%t*+ i% $ai*' !ut t! *n%u* t)at t)* %y%t*+ *,l*$t% THE COMPANY% a$ti3iti*% an' in$!"!at*% t)* +!%t *$*nt in,!+ati!n !n t)* ,!!' %a,*ty )aa'%( 4.1.1 QMS "!$*%%*% an' %u#"!$*%%*% a* '*,in*' in t)i% Quality Manual an' in a%%!$iat*' Quality Sy%t*+ P!$*'u*%
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Ref. !urc"asing
(2 Do&%mentat'on 7e8%'$ements (2(# Gene$al
T)* itt*n '!$u+*nt% a* "*"a*' #y THE COMPANY a% "* li%t .i3*n #*l!: D!$u+*nt*' %tat*+*nt !, ,!!' %a,*ty "!li$y an' !#*$ti3*% ISO 22000 P!$*'u*% ISO 22000 R*$!'% HACCP Plan? Haa' Analy%i%? ;!- In%tu$ti!n% t! *n%u* t)* *,,*$ti3* '*3*l!"+*nt? i+"l*+*n tati!n an' u"'atin. !, t)* ,!!' +ana.*+*nt %y%t*+(
(2(2 %al'ty System Man%al M<
T)i% t!"l*3*l '!$u+*nt '*,in*% 7uality "!li$y? '*,in*% t)* %$!"* !, t)* Quality Mana.*+*nt Sy%t*+@ '*%$i#*% t)* !3*all 7uality %y%t*+? it% "!$*%%*%? an' t)*i %*7u*n$* an' int**lati!n%)i"%@ an' ,ut)* *,**n$*% a""li$a#l* Quality Sy%t*+ P!$*'u*%
"u"!%* !, QSP% i% t! .ui'* "*%!nn*l in t)* "*,!+an$* !, "!$*%%*%? %u$) a% $ayin. !ut an' $!nt!llin. "!$*%%*%? )an'lin. "!'u$t%? +aintainin. an' $ali#atin.? $!n'u$tin. t*%t% an' in%"*$ti!n%? *t$( SOP% a* nu+#**'? a% illu%tat*' in t)* ta#l* #*l!: Example: Q*+ Cate,ory
Do$u#ent Des$ription Internal Audit Control of Records Management Review raining !urc"asing !roduct Identification and raceability !roduct #andling$ %torage$ !ac&aging$ !reservation$ ' Delivery Complaint #andling Monitoring and Measurement of !roduct Control of (onconforming Materials
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E=te$nal Standa$ds and G%'del'nes: T)*%*
'!$u+*nt% a* !,t*n *,**' t! a% '!$u+*nt% !, *t*nal !i.in an' in$lu'* in'u%ty %tan'a'%
(2(, Cont$ol of Do&%ments
All t)* '!$u+*nt% *latin. t! t)* ,!!' %a,*ty %y%t*+ *7ui*+*n t% a* $!nt!ll*' a% "* '!$u+*nt*' "!$*'u*( All "!"!%*' $)an.*% a* *3i**' "i! t! i+"l*+*ntati!n t! '*t*+in* t)*i *,,*$t% !n ,!!' %a,*ty an' t)*i i+"a$t !n t)* ,!!' %a,*ty +ana.*+*nt %y%t*+( 4.2.3.1 THE COMPANY )a% *%ta#li%)*' an' +aintain% Do&%ment and Data Cont$ol t! '*,in* t)* $!nt!l% n**'*' t!: a= D*,in* a %tan'a'i*' "!$*%% ,! t)* '*3*l!"+*nt !, n* '!$u+*nt% *7ui*' #y t)* QMS i(*(? QSP%? ;I%? an' F!+%J #= R*3i* an' a""!3*' '!$u+*nt% ,! a'*7ua$y "i! t! i%%u*@ $= R*3i* an' u"'at*? a% n*$*%%ay? an' *a""!3* '!$u+*nt%@ '= T! *n%u* t)at $)an.*% an' t)* $u*nt *3i%i!n %tatu% !, '!$u+*nt% a* i'*nti,i*'@ *= T! *n%u* t)at t)* *l*3ant *3i%i!n% !, a""li$a#l* '!$u+*nt% a* a3aila#l* at t)* "!int !, u%*@ ,= T! *n%u* t)at '!$u+*nt% *+ain l*.i#l* an' *a'ily i'*nti,ia#l*@ .= T! *n%u* t)at '!$u+*nt% !, *t*nal !i.in )documents suc" as industry standards and guidance documents indispensable for t"e application of t"e I* +uality Management %ystem, a* i'*nti,i*'? t)*i 'i%ti#uti!n i% $!nt!ll*'? an' t)** i% an int*nal "!$*%% t! *n%u* t)at t)* !.aniati!n% 7uality +ana.*+*nt %y%t*+ a''*%%*% all *7ui*' *l*+*nt% !, t)* +!%t $u*nt *3i%i!n !, t)*%* %tan'a'%( )= T! "*3*nt t)* unint*n'*' u%* !, !#%!l*t* '!$u+*nt%? an' t! a""ly %uita#l* i'*nti,i$ati!n t! t)*+ i, t)*y a* *tain*' ,! any "u"!%*( 4.2.3.2 THE COMPANY +aintain% a D!$u+*nt Ma%t* Li%t t! i'*nti,y t)* '!$u+*nt% *7ui*' #y t)* Quality Mana.*+*nt Sy%t*+? an' t)*i $u*nt *3i%i!n %tatu%(
(2( Cont$ol of 7e&o$ds
All 7uality *$!'%? )i$) a* .*n*at*' in 3ai!u% a*a% in$lu%i3* !, t)!%* *$*i3*' a% KT*%t C*ti,i$at*% ! Cali#ati!n C*ti,i$at*%K a* +aintain*' t! '*+!n%tat* t)* *,,*$ti3* !"*ati!n !, t)* Quality Sy%t*+( F!!' %a,*ty *$!'% a* +aintain*' t! '*+!n%tat* t)* *,,*$ti3* i+"l*+*ntati!n !, F!!' Sa,*ty Mana.*+*nt Sy%t*+( T)* *$!'% a* -*"t l*.i#l*? i'*nti,ia#l* an' *ti*3a#l*( T)* '*tail %y%t*+ ,! i'*nti,i$ati!n? $!ll*$ti!n? %t!a.*? "!t*$ti!n? ,ilin.? *ti*3al? *t*nti!n ti+* an'
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'i%"!%iti!n !, 7uality *$!'% i% '*%$i#*' in t)* Quality P!$*'u*( T)* %y%t*+ i% a""li$a#l* ,! )a' $!"y !, *$!'% a% *ll a% *$!'% <%!,t $!"y= +aintain*' in *l*$t!ni$ +*'ia( All t)* ,!+at% u%*' a% Quality R*$!'% a* "!"*ly i'*nti,i*' an' $!nt!ll*'(
Ref. Document and Data Control Ref. Control of +uality Records
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5(0 Management 7es*ons'b'l'ty 5(# Management Comm'tment
T!" Mana.*+*nt% $!++it+*nt t! t)* )i.)*%t 7uality !, "!'u$t% an' %*3i$*% t! !u $u%t!+*% i% *3i'*n$*' in t)* '*3*l!"+*nt an' i+"l*+*ntati!n !, t)* Quality Mana.*+*nt Sy%t*+ in $!n,!+an$* it) t)* *7ui*+*nt% !, ISO 22000:2005 Quality Mana.*+*nt Sy%t*+ R*7ui*+*nt%? a% *ll t)* *%ta#li%)+*nt !, "!$*%%*% t! +!nit!? +*a%u*? an' $!ntinu!u%ly i+"!3* it% *,,*$ti3*n*%% #y: C!++uni$atin. t! t)* !.aniati!n t)* i+"!tan$* !, +**tin. $u%t!+*? a% *ll a% %tatut!y an' *.ulat!y *7ui*+*nt%@ E%ta#li%)in. t)* Quality P!li$y@ En%uin. t)at 7uality !#*$ti3*% a* *%ta#li%)*'@ C!n'u$tin. +ana.*+*nt *3i*% t! !utin*ly *3aluat* t)* %uita#ility? *,,*$ti3*n*%%? an' '*.** !, i+"l*+*ntati!n !, t)* QMS@ En%uin. an annual int*nal au'it !, t)* QMS t! 3*i,y t)at t)* !.aniati!n $!ntinually ,!ll!% t)* *7ui*+*nt% !, t)* QMS an' i+"l*+*nt $!*$ti3* a$ti!n t! $!ntinu!u%ly i+"!3* t)* %y%t*+@ En%uin. t)* a3aila#ility !, *%!u$*% THE COMPANY )a% i'*nti,i*' *%!u$* *7ui*+*nt% an' )a% "!3i'*' a'*7uat* in )!u%* *%!u$*% in t*+% !, 7uali,i*' "*%!nn*l? t*%t *7ui"+*nt an' ,a$ility ,! "!'u$ti!n an' t*%tin. a% "* t)* *7ui*+*nt% !, %a,* ,!!' "a$ti$*( T!" Mana.*+*nt i% *%"!n%i#l* ,! "!3i'in. a""!"iat* *%!u$*% an' tain*' "*%!nn*l ,! *,,*$ti3* i+"l*+*ntati!n !, t)* ISO 22000 Sy%t*+ in t)*i *%"*$ti3* a*a%(
5(2 C%stome$ Fo&%s
-.2.1 T)* "in$i"l* !#*$ti3* !, t)* Quality Mana.*+*nt Sy%t*+ i% t! i'*nti,y $u%t!+*% an' t! ,!$u% !u !.aniati!n !n t)* $u%t!+*? an' in "ati$ula $u%t!+* %ati%,a$ti!n( T! t)at *n' T!" Mana.*+*nt i% $!++itt*' t! a$)i*3in. )i.) $u%t!+* %ati%,a$ti!n t)!u.) an a$$uat* '*t*+inati!n an' un'*%tan'in. !, $u%t!+* *7ui*+*nt% an' *,,*$ti3* 3*i,i$ati!n t)at t)* *7ui*+*nt% a* +*t( -.2.2 P!'u$t Cu%t!+*%: T)* .!al !, t)* QMS i% %tat*' in t)* Quality P!li$y t! +**t an'! *$**' !u $u%t!+*% *7ui*+*nt% ;* ill a$$!+"li%) t)i% !#*$ti3* #y $a*,ully li%t*nin. t! t)* 3!i$* !, t)* $u%t!+* t)!u.) $!+"laint% an' $u%t!+* %ati%,a$ti!n %u3*y *"!t%? an' !t)* +*an% !, ,**'#a$- *.a'in. !u "!'u$t% an' %*3i$*%( ;* ill !utin*ly $!++uni$at* it) !u $u%t!+*%? a% "!%%i#l*? t! un'*%tan' !u $u%t!+*% %tat*' an' i+"li*' *7ui*+*nt%( ;* ill *%ta#li%) an' +aintain "!$*%%*% t)at a* *lia#l* t! *n%u* t)at "!'u$t% a* !ut%!u$*' an'! +anu,a$tu*' in %ti$t a$$!'an$* it) %"*$i,i$ati!n% an' 'ain.%(
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5(, Food Safety +ol'&y
F!!' %a,*ty "!li$y )a% '*,in*'? '!$u+*nt*' an' $!++uni$at*' t! all *+"l!y**% #y t)* t!" +ana.*+*nt( F!!' %a,*ty "!li$y i% lai' '!n an' i% %i.n*' #y T!" Mana.*+*nt It i% a""!"iat* t! t)* !l* !, THE COMPANY in t)* ,!!' $)ain( It $!n,i+% #!t) %tatut!y an' *.ulat!y *7ui*+*nt% a% *ll a% ,!!' %a,*ty *7ui*+*nt% !, t)* $u%t!+*( It i% $!++uni$at*'? i+"l*+*nt*' an' +aintain*' it)in !.aniati!n It i% *3i**' ,! $!ntinuin. %uita#ility( M*a%ua#l* !#*$ti3*% a* i'*nti,i*' an' "ut #*l! t)* ,!!' %a,*ty "!li$y(
-It is t"e policy of #E C*M!A( to meet and/or exceed our customer re0uirements by on1 time delivery of t"e "ig"est 0uality of products$ in strict compliance wit" safety and regulatory re0uirements$ w"ile providing maximum value and superior customer service during and after t"e sale of products.2 -.3.1 T!" Mana.*+*nt %)all annually *3i* t)* Quality P!li$y ,! $!ntinu*' a""!"iat*n*%% an' %uita#ility t! t)* +i%%i!n an' !#*$ti3*%( T)i% annual *3i* !, t)* Quality P!li$y %)all #* '!$u+*nt*' in a$$!'an$* it) Management 7e3'e> of t)e %al'ty Management System(
-.3.2 T)* Quality P!li$y "!3i'*% an !3*all ,a+*!- ,! *%ta#li%)in. %"*$i,i$ 7uality !#*$ti3*%? an' "!3i'*% 'i*$ti!n ,! t)* .!al !, $!ntinual i+"!3*+*nt( -.3.3 T!" Mana.*+*nt %)all *n%u* t)at t)* Quality P!li$y i% -n!n an' un'*%t!!' #y all *+"l!y**%? i% "!+in*ntly 'i%"lay*' t)!u.)!ut t)* ,a$ility? an' i% 'i%ti#ut*' t! $u%t!+*% an' !t)* int**%t*' "ati*%(
Ref. Management Review
5( +lann'ng
T)* *%!u$*% n**'*' t! a$)i*3* t)* !#*$ti3*% a* i'*nti,i*'? 'i%$u%%*' in t)* +ana.*+*nt *3i* +**tin. an' "lann*'( T)* *%!u$* "lannin. i% '!$u+*nt*'( T!" Mana.*+*nt *n%u*% t)at "lannin. !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+ i% $ai*' !ut in lin* it) ISO 22000:2005 *7ui*+*nt% an' !#*$ti3*%( T)* 7uality "lannin. in$lu'*% a= P!$*%%*% !, t)* F!!' %a,*ty +ana.*+*nt %y%t*+ #= R*%!u$*% n**'*' $= R*7ui*+*nt% !, %a,* ,!!' "a$ti$*% '= C!ntinual i+"!3*+*nt
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Plannin. an' i+"l*+*ntati!n *n%u*% t)at $)an.*% a* $!n'u$t*' in a $!nt!ll*' +ann*( Duin. t)* $)an.* int*.ity !, F!!' %a,*ty +ana.*+*nt %y%t*+ i% +aintain*'(
5((# %al'ty Obe&t'3es
Quality O#*$ti3*%? $!n%i%t*nt it) t)* Quality P!li$y? a* *%ta#li%)*' t)!u.)!ut THE COMPANY in !'* t! +**t *7ui*+*nt% ,! "!'u$t% an' "!$*%%*%? an' t! i+"!3* t)* 7uality %y%t*+ an' 7uality "*,!+an$*( T!" Mana.*+*nt i% *%"!n%i#l* ,! *%ta#li%)in. an' $!++uni$atin. Quality O#*$ti3*% t! *l*3ant ,un$ti!n% it)in THE COMPANY( Quality !#*$ti3*% a*: a= Quantitati3* an' +*a%u*a#l*@ #= Attaina#l* an' *ali%ti$@ $= C!n%i%t*nt it) t)* Quality P!li$y '= C!nt!ll*' #y t)* *l*3ant ,un$ti!n% *= M!nit!*' an' +*a%u*'( In"ut% int! t)* "!$*%% !, *%ta#li%)in. Quality O#*$ti3*% +ay in$lu'* *l*3ant ,in'in.% ,!+ +ana.*+*nt *3i*%? $u*nt "!'u$t *%ult%? $u%t!+* %ati%,a$ti!n atin.%? $u%t!+* $!+"laint%? an' "!$*%% +!nit!in. *%ult%(
5((2 %al'ty Management System +lann'ng
-.4.2.1 T)* ISO 22000:2005 an' Quality Mana.*+*nt Sy%t*+ R*7ui*+*nt% a* t)* "i+ay in"ut% in '*t*+inin. t)* *7ui*+*nt% !, t)* Quality Mana.*+*nt Sy%t*+( Quality Mana.*+*nt Sy%t*+ "!$*%%*% a* "lann*' t! *n%u* t)at t)* QMS i% a""!"iat* ,! it% int*n'*' "u"!%*? an' t)at it i% *,,*$ti3*ly i+"l*+*nt*' an' +ana.*'( -.4.2.2 T)* Quality A%%uan$* Mana.* i% *%"!n%i#l* ,! *n%uin. t)at t)* QMS "!$*%% *7ui*' a* i+"l*+*nt*'? an' t)at t)* %*7u*n$* an' int*a$ti!n !, t)*%* "!$*%%*% a* i'*nti,i*'( P!$*%%*% a* '!$u+*nt*' an' $!nt!ll*' an' +!nit!*' t)!u.): Quality Sy%t*+ P!$*'u*% ;!- In%tu$ti!n%? )** %"*$i,i*' Fl! C)at% P!'u$t Quality Plannin. R*$!'% -.4.2.3 T)* !ut"ut !, Quality Sy%t*+ Plannin. i% '!$u+*nt*' in t)i% Quality Manual? in Quality Sy%t*+ P!$*'u*%
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Ref. Document and Data Control
5( 7es*ons'b'l'ty and A%t)o$'ty
-.4.1. T!" Mana.*+*nt )a% '*,in*' *%"!n%i#iliti*% an' aut)!iti*% an' t)*i int**lati!n ,! all t)* "*%!n% an' $!++uni$at*' t)* %a+* it)in t)* !.aniati!n t! *n%u* t)* *,,*$ti3* !"*ati!n an' +aint*nan$* !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+( -.4.2. All %ta,, +*+#*% a* *%"!n%i#l* ,! *"!tin. "!#l*+% it) ,!!' %a,*ty +ana.*+*nt %y%t*+ t! aut)!i*' "*%!n( -.4.3. P*%!nn*l in THE COMPANY at 3ai!u% l*3*l a* *%"!n%i#l* an' )a3* t)* aut)!ity it)in t)*i '*,in*' a*a% !, $!nt!l ,!: T)* 7uality !, !- $ai*' !ut( Initiatin. a$ti!n t! "*3*nt t)* !$$u*n$* !, "!'u$t N!nC!n,!+an$*( I'*nti,yin. an' *$!'in. "!#l*+%( R*7ui*+*nt% !, %a,* ,!!' "a$ti$*%( Initiatin.? *$!++*n'in. an' "!3i'in. %!luti!n% t! "!#l*+%( T! 3*i,y t)* *,,*$ti3*n*%% !, t)* %!luti!n%( C!nt!llin. ,ut)* "!$*%%in. until all $!n'iti!n% a* %ati%,a$t!y( T)* !.aniati!n $)at ,! !u $!+"any? %)!in. t)* int**lati!n !, all t)* "*%!nn*l )! +ana.*? "*,!+ an' 3*i,y t)* !- *n%uin. 7uality? i% .i3*n at t)* *n' !, t)i% $)a"t*( -.4.4. Aut)!ity an' *%"!n%i#ility ,! all t)* $!n$*n*' "*%!n% i% '!$u+*nt*' in !# '*%$i"ti!n an' $!++uni$at*' t! t)*+ in !'* t! ,a$ilitat* *,,*$ti3* F!!' Sa,*ty Mana.*+*nt Sy%t*+( Al%! $!"i*% !, !# '*%$i"ti!n an' %"*$i,i$ati!n% a* .i3*n t! t)* $!n$*n*'( -.4.-. In $a%* !, 3a$an$y a#%*nt**i%+ t)* '*l*.ati!n !, aut)!ity %)all #* u"a' an' *%"!n%i#ility .!*% '!na' unl*%% !t)*i%* %"*$i,i*' in t)* '!$u+*nt%( -.4.. Int**lati!n%)i" !, all "*%!nn*l )! +ana.*? "*,!+ an' 3*i,y !a,,*$tin. "!'u$t 7uality i% i'*nti,i*' in an O.aniati!nal C)at <%** #*l!=( -.4./. All '*"at+*nt% an' ,un$ti!n% in t)* $!+"any a* *%"!n%i#l* ,! i+"l*+*ntin.? +aintainin. an' i+"!3in. t)* Quality Mana.*+*nt Sy%t*+(
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5(5 Food safety team leade$
T!" Mana.*+*nt )a% a""!int*' F!!' %a,*ty t*a+ l*a'* a% %)!n in t)* O.aniati!n %tu$tu*( A"at ,!+ t)*i !t)* 'uti*%? )* %)* )a% #**n .i3*n t)* aut)!ity ,! *n%uin. *%ta#li%)+*nt? i+"l*+*ntati!n an' +aint*nan$* !, t)* F!!' %a,*ty +ana.*+*nt %y%t*+( a= F!!' %a,*ty t*a+ l*a'* )a3* *%"!n%i#ility an' aut)!ity t! +an.* a ,!!' %a,*ty t*a+( #= F!!' %a,*ty t*a+ l*a'* "!3i'*% tainin. an' *'u$ati!n t! t)* ,!!' %a,*ty t*a+ +*+#*%( $= F!!' %a,*ty t*a+ l*a'* $!!'inat*% it) T!" Mana.*+*nt an' Fun$ti!nal H*a'% an' $!ntinu!u%ly +!nit!% t)* a$ti3iti*% #y *3i*in. *$!'% t! 3*i,y *,,*$ti3* i+"l*+*ntati!n an' u"'atin. !, t)* %y%t*+( '= H* ill *"!t t! t)* T!" Mana.*+*nt !n t)* *,,*$ti3*n*%% an' %uita#ility !, t)* %y%t*+( *= Aut&ori0ed person a%%u+*% t)* *%"!n%i#iliti*% an' aut)!iti*% !, t)* Mana.*+*nt R*"*%*ntati3* 'uin. )i% a#%*n$*(
5(5(# Management 7e*$esentat'3e of t)e MS
T!" Mana.*+*nt )a% a""!int*' t)* Quality Mana.* t! #* t)* Mana.*+*nt R*"*%*ntati3* !, t)* QMS? )! i*%"*$ti3* !, !t)* *%"!n%i#iliti*% )a% *%"!n%i#ility an' aut)!ity )i$) in$lu'*%: a= En%uin. t)at t)* QMS i% *%ta#li%)*'? i+"l*+*nt*'? +aintain*'? an' $!ntinually i+"!3*'@ #= En%uin. t)at "!$*%%*% n**'*' ,! t)* QMS a* *%ta#li%)*'? i+"l*+*nt*' an' +aintain*'@ $= P!+!tin. 7uality? *.ulat!y an' $u%t!+* aa*n*%% t)!u.)!ut t)* !.aniati!n@ '= R*"!tin. t! t!" +ana.*+*nt !n t)* "*,!+an$* !, t)* QMS? in$lu'in. *$!++*n'ati!n% ,! i+"!3*+*nt@ *= 9*n*atin.? in $!nun$ti!n it) "*%!nn*l $!n$*n*'? "!$*'u*% an' in%tu$ti!n% '*,inin. t)* !.aniati!n% .*n*al "!$*%%*%? an' )** n*$*%%ay@ ,= C!nt!llin.? u"'atin. an' i%%uin. t)* !.aniati!n% QSP%@ .= En%uin. t)at t)** i% a %y%t*+ !, 3*i,i$ati!n an' au'it% in'*"*n'*nt !, t)* "*%!n ! aut)!ity $ayin. !ut t)* ,un$ti!n%@ )= Analyin. all *"!t*' 7uality "!#l*+% an' *n%uin. $!*$ti3* a$ti!n<%= a* ta-*n@ i= C!!'inatin. $!++uni$ati!n it) *t*nal "ati*% !n +att*% *latin. t! t)* QMS( = En%uin. t)* "!+!ti!n !, aa*n*%% !, $u%t!+* *7ui*+*nt% t)!u.)!ut t)* !.aniati!n(
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5(1 Comm%n'&at'on 5(1(# E=te$nal Comm%n'&at'on
a= THE COMPANY *n%u*% t)at %u,,i$i*nt in,!+ati!n !n i% %u*% $!n$*nin. ,!!' %a,*ty i% a3aila#l* t)!u.)!ut t)* ,!!' $)ain( #= THE COMPANY )a% *%ta#li%)*' i+"l*+*nt*' an' +aintain*' *,,*$ti3* aan.*+*nt% ,! $!++uni$atin. it) Su""li*% an' C!nta$t!%? Cu%t!+*% ! C!n%u+*%? in *lati!n t! "!'u$t in,!+ati!n )i$) in$lu'*% in%tu$ti!n *.a'in. int*n'*' u%*? %"*$i,i$ %t!a.* *7ui*+*nt%? %)*l, li,*? *n7ui*%? $!nta$t% !'*? a+*n'+*nt% an' $u%t!+* ,**'#a$in$lu'in. $u%t!+* $!+"laint%? %tatut!y an' *.ulat!y aut)!iti*%? !t)* !.aniati!n t)at )a3* an i+"a$t !n? ! ill #* a,,*$t*' #y? t)* *,,*$ti3*n*%% ! u"'atin. !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+( $= R*$!'% a* +aintain*' ,! $!++uni$ati!n? )i$) "!3i'* in,!+ati!n !n ,!!' %a,*ty a%"*$t% !, "!'u$t%( '= F!!' %a,*ty *7ui*+*nt% ,!+ %tatut!y an' *.ulat!y aut)!iti*% an' $u%t!+*% a* a3aila#l*( *= T!" Mana.*+*nt )a% '*,in*' *%"!n%i#ility an' aut)!ity t! $!++uni$at* *t*nally any in,!+ati!n $!n$*nin. ,!!' %a,*ty( In,!+ati!n !#tain*' t)!u.) *t*nal $!++uni$ati!n i% in$lu'*' a% in"ut t! %y%t*+ u"'atin. an' +ana.*+*nt *3i*(
5(1(2 Inte$nal Comm%n'&at'on
-..2.1 Int*nal $!++uni$ati!n ,l!% t! ay%: Mana.*+*nt $!++uni$at*% t! t)* !.aniati!n t)* Quality P!li$y an' Quality O#*$ti3*%@ $u%t!+* an' *.ulat!y *7ui*+*nt%@ "!'u$t an' "!$*%% %"*$i,i$ati!n%@ 3*i,i$ati!n an' 3ali'ati!n *7ui*+*nt%@ an' in%tu$ti!n% !n )! t! i+"l*+*nt an' +aintain t)* QMS( T)* !.aniati!n $!++uni$at*% t! Mana.*+*nt in,!+ati!n an' 'ata *.a'in. 7uality "*,!+an$* an' *,,*$ti3*n*%% !, t)* QMS( -..2.2 In,!+ati!n i% $!++uni$at*' a% ,!ll!%: Pa"* ! *l*$t!ni$ '!$u+*nt%? %u$) a% t)* Quality Manual? SOP% in%tu$ti!n%? %"*$i,i$ati!n%? 7uality *$!'%? *"!t%? *t$( E+ail%? +*+!% an' +**tin.% >*#al $!++uni$ati!n Tainin. an' aa*n*%% "!.a+% Sta,, M**tin.% All *+"l!y** +**tin.% S"*$ial n!ti$*% "!3i'*' )*n t)** a* %i.ni,i$ant $)an.*% t! '!$u+*ntati!n P*,!+an$* *3aluati!n% E+"l!y** %u..*%ti!n% an' ,**'#a$-..2.3 Mana.*+*nt R*3i* +**tin.% )a3* a %"*$ial !l* in *n%uin. "!"* $!++uni$ati!n #*t**n t)* Quality C!un$il an' t)* !.aniati!n( T)* +**tin.
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"!3i'*% a ,a+*!- ,! t)* !.aniati!n t! *"!t !n t)* %tatu% !, 7uality *lat*' i%%u*% an' a$ti3iti*%? an' ,! Mana.*+*nt t! ,!+ulat* an' $!++uni$at* "!li$i*% an' 'i*$ti3*% t! i+"!3* t)* QMS? a% '*,in*' in +M %ection 3.4( -..2.4 E+"l!y**% a* *n$!ua.*' t! "!3i'* $!n%tu$ti3* %u..*%ti!n% an' ,**'#a$- t! Mana.*+*nt( -..2.-. T)* !.aniati!n )a% *%ta#li%)*'? i+"l*+*nt*' an' +aintain*' *,,*$ti3* aan.*+*nt ,! $!++uni$atin. it) ,un$ti!nal an' %ta,, !n i%%u*% )a3in. i+"a$t !n ,!!' %a,*ty T)* !.aniati!n *n%u*% t)at t)* ,!!' %a,*ty t*a+ i% in,!+*' in a ti+*ly +ann* !, $)an.*% t! +aintain t)* *,,*$ti3*n*%% !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+? a% ,!ll!%: a= P!'u$t% ! n* "!'u$t%( #= Ra +at*ial? in.*'i*nt% an' %*3i$*%( $= P!'u$ti!n %y%t*+% an' *7ui"+*nt( '= P!'u$ti!n "*+i%*%? l!$ati!n !, *7ui"+*nt? %u!un'in. *n3i!n+*nt( *= Cl*anin. an' %anitati!n "!.a++*%( ,= Pa$-a.in.? %t!a.* an' 'i%ti#uti!n %y%t*+%( .= P*%!nn*l 7uali,i$ati!n l*3*l% an' ! all!$ati!n !, *%"!n%i#iliti*% an' aut)!iati!n%( )= Statut!y an' *.ulat!y *7ui*+*nt%( i= n!l*'.* *.a'in. ,!!' %a,*ty )aa'% an' $!nt!l +*a%u*%( = Cu%t!+*? %*$t! an' !t)* *7ui*+*nt% t)at t)* !.aniati!n !#%*3*%( -= R*l*3ant *n7ui*% ,!+ *t*nal int**%t*' "ati*%( l= C!+"laint in'i$atin. ,!!' %a,*ty )aa'% a%%!$iat*' it) t)* "!'u$t( += Ot)* $!n'iti!n t)at )a3* an i+"a$t !n ,!!' %a,*ty( T)* ,!!' %a,*ty t*a+ *n%u*% t)at a#!3* in,!+ati!n i% in$lu'*' in t)* u"'atin. !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+( T!" +ana.*+*nt *n%u*% t)at *l*3ant in,!+ati!n i% in$lu'*' a% in"ut t! t)* +ana.*+*nt *3i*(
5(4 Eme$gen&y *$e*a$edness and $es*onse
T!" +ana.*+*nt )a3* *%ta#li%)*'? i+"l*+*nt*' an' +aintain*' "!$*'u* t! +ana.* "!t*ntial *+*.*n$y %ituati!n% an' a$$i'*nt% t)at $an i+"a$t ,!!' %a,*ty an' )i$) a* *l*3ant t! t)* !l* !, t)* !.aniati!n in t)* ,!!' $)ain(
5(6 Management 7e3'e> 5(6(# Gene$al
T)* %y%t*+ *%ta#li%)*' in THE COMPANY i% %y%t*+ati$ally *3i**' ,! it% $!ntinu!u% %uita#ility an' *,,*$ti3*n*%% in $!n,i+in. t)* *7ui*+*nt% !, ,!!' %a,*ty %y%t*+ +ana.*+*nt a% "* '!$u+*nt*' "!$*'u*( T)* *3i* in$lu'*% i+"l*+*ntati!n !, !u ,!!' %a,*ty P!li$y an' O#*$ti3*% t! i'*nti,y any a*a%? )i$) *7ui* i+"!3*+*nt an' *3aluat* n** ' ,! $)an.*% ,! *,,*$ti3* ,un$ti!nin. !, t)* %y%t*+ i+"l*+*ntati!n an' %a,* ,!!' +anu,a$tuin. "a$ti$*%(
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It al%! in$lu'*% any $)an.*% in !u ,!!' %a,*ty %y%t*+? Haa' analy%i%? HACCP "lan% an' *%ult% !, +!nit!in. !, $iti$al $!nt!l "!int%( T)i% *3i* i% $ai*' !ut at l*a%t !n$* a y*a #y T!" Mana.*+*nt ! t)*i n!+in** #y )!l'in. Mana.*+*nt R*3i* M**tin.%? )i$) a* att*n'*' #y F!!' Sa,*ty T*a+ L*a'* an' all T!" Mana.*+*nt( It i% t)* *%"!n%i#ility !, t)* Mana.*+*nt R*"*%*ntati3* t! "*"a* t)* a.*n'a an' +inut*% !, +ana.*+*nt *3i* +**tin. $!3*in.: Di%$u%%i!n )*l'? A$ti!n "lann*'? Ta.*t 'at* !, $!+"l*ti!n ,! "lann*' a$ti!n%( P*%!n *%"!n%i#l* t! $!+"l*t* "lann*' a$ti!n% -..2. Mana.*+*nt *3i*% !, t)* QMS a* $!n'u$t*' annually? a% a +ini+u+? in !'* t! *n%u* t)* $!ntinuin. %uita#ility? a'*7ua$y an' *,,*$ti3*n*%% !, t)* QMS in a$$!'an$* it) Management 7e3'e> of t)e %al'ty Management System?
5(6(, Management 7e3'e> In*%t
T)* "u"!%* !, Mana.*+*nt R*3i*% i% t! *3aluat*' $!ll*$t*' 'ata ,!+ t)* ,!ll!in. %!u$*%:
R*%ult% !, au'it%
5(6( Management 7e3'e> O%t*%t
T)* !ut"ut ,!+ Mana.*+*nt R*3i* in$lu'*% '*$i%i!n% an' a$ti!n% *latin. t!: I+"!3*+*nt !, t)* *,,*$ti3*n*%% !, t)* QMS an' it% "!$*%%*% I+"!3*+*nt !, "!'u$t *lat*' t! $u%t!+* *7ui*+*nt%@ R*%!u$* n**'% E%ta#li%)+*nt !, Quality O#*$ti3*%
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-..- Mana.*+*nt R*3i* +**tin.% a* '!$u+*nt*' in +inut*% an' *tain*' a% Quality R*$!'%(
Ref. Management Review of t"e +uality Management %ystem$
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1(0 7eso%$&e Management 1(# +$o3's'on of 7eso%$&es
T!" +ana.*+*nt '*t*+in*% an' "!3i'*% t)* *%!u$*% n*$*%%ay t! i+"l*+*nt an' +aintain t)* 7uality +ana.*+*nt %y%t*+ an' ,! it% $!ntinu!u% i+"!3*+*nt? a% *ll a% ,! t)* *%!u$*% n*$*%%ay ,! *n)an$in. $u%t!+* %ati%,a$ti!n t)!u.) +**tin. ! *$**'in. $u%t!+* *7ui*+*nt% in$lu'in. )u+an *%!u$*%? in,a%tu$tu*? !- *n3i!n+*nt? "!$*%% *7ui"+*nt? IMGT *7ui"+*nt? an' %u""li*%J( THE COMPANY "!3i'*% a'*7uat* *%!u$*% ,! t)* *%ta#li%)+*nt? i+"l*+*ntati!n? +aint*nan$* an' u"'atin. !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+( A'*7ua$i*% !, t)*%* *%!u$*% a* *3i**'? ,! *a+"l* 'uin. Mana.*+*nt *3i* C!nta$t *3i* Int*nal 7uality au'it *%ult% Cu%t!+* $!+"laint *3i*
1(2 /%man 7eso%$&e 1(2(# Gene$al
T)* ,!!' %a,*ty t*a+ an' !t)* "*%!nn*l? )! $ai*' !ut a$ti3iti*% )a3in. i+"a$t !n ,!!' %a,*ty a* %uita#ly tain*'? $!+"*t*nt? )i.)ly %-ill*' an' *"*i*n$*' an' )a3in. a""!"iat* *'u$ati!n( Any -in' !, *t*nal *"*t% a* n!t *7ui*' #y THE COMPANY a% !, n!? #ut )*n*3* n**'*' ,! a%%i%tan$* !, *t*nal *"*t% *$!'% !, a.** +*nt ! $!nta$t% '*,inin. t)* *%"!n%i#ility an' aut)!ity a* +aintain*'( .2.1.1. THE COMPANY )a% *%ta#li%)*' an' +aintain% Com*eten&e A>a$eness and T$a'n'ng t! .ui'* t)* "!$*%% !, '*t*+inin. an' "!3i'in. %u,,i$i*nt "*%!nn*l !, t)* a""!"iat* *'u$ati!n? %-ill%? *"*i*n$* an' tainin. t! "*,!+ !- a,,*$tin. $!n,!+ity t! "!'u$t *7ui*+*nt%( .2.1.2. THE COMPANY )a% *%ta#li%)*' an' +aintain% !# '*%$i"ti!n% ,! *a$) "!%iti!n a,,*$tin. "!'u$t 7uality? )i$) i'*nti,y a""!"iat* *'u$ati!n? %-ill%? *"*i*n$* an' tainin. ,! t)* "!%iti!n(
1(2(2 Com*eten&e? A>a$eness and T$a'n'ng
a= T)* $!+"any i'*nti,i*% n*$*%%ay $!+"*t*n$y !, *+"l!y**% "*,!+in. a$ti3iti*% i+"a$tin. !n ,!!' %a,*ty( #= P!3i'*% n*$*%%ay tainin. an' !n t)* !# tainin. ,! t)*i %ta,, ,! u".a'in. t)*i -n!l*'.* an' %-ill %! t)at n*$*%%ay $!+"*t*n$i*% i%
2
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! A " I T Y
M A N ! A "
!#tain*'( Al%! 'uin. !utin* !- 'u* t! $)an.* in a*a !, !- ! any !t)* *a%!n t)* tainin. n**'% a* i'*nti,i*' an' "!3i'*' En%u*% t)at *+"l!y**% a* tain*'? )! a* *%"!n%i#l* ,! +!nit!in.? $!*$ti!n% an' $!*$ti3* a$ti!n% !, t)* ,!!' %a,*ty +ana.*+*nt %y%t*+ E3aluat*% t)* *,,*$ti3*n*%% an' i+"l*+*ntati!n !, t)* tainin. "!3i'*' a% "* t)* *%ta#li%)*' "!$*%% a""!a$) En%u*% t)at *+"l!y**% a* aa* !, t)* *l*3an$* an' i+"!tan$* !, t)*i a$ti3iti*% an' )! t)*y $!nti#ut* t! t)* a$)i*3*+*nt !, t)* ,!!' %a,*ty( En%u*% t)* *7ui*+*nt ,! *,,*$ti3*% $!++uni$ati!n i% un'*%t!!' #y all "*%!nn*l )!%* a$ti3iti*% i+"a$tin. !n ,!!' %a,*ty Maintain% a""!"iat* *$!'% ,! t)* *'u$ati!n? *"*i*n$*? tainin. an' 7uali,i$ati!n
.2.2.1 THE COMPANY )a% *%ta#li%)*' an' +aintain% Com*eten&e A>a$eness and T$a'n'ng t! '*,in* t)* "!$*%% ,!: D*t*+inin. t)* n*$*%%ay $!+"*t*n$* ,! "*%!nn*l "*,!+in. !a,,*$tin. $!n,!+ity t! "!'u$t *7ui*+*nt%? ! any !t)* I'*nti,yin. t)* tainin. n**'%? an' "!3i'* tainin.? in$lu'in. !nt)*!# tainin.? )** n*$*%%ay ,! "*%!nn*l in any n* ! +!'i,i*' !# a,,*$tin. "!'u$t 7uality? in$lu'in. $!nta$t ! a.*n$y "*%!nn*l@ E3aluatin. t)* *,,*$ti3*n*%% !, tainin.? ! !t)* a$ti!n% ta-*n@ En%uin. t)at "*%!nn*l a* aa* !, t)* *l*3an$* an' i+"!tan$* !, t)*i a%%i.n*' *%"!n%i#iliti*% an' ta%-%? an' )! t)*y $!nti#ut* t! t)* a$)i*3*+*nt !, t)* 7uality !#*$ti3*% !, t)* !.aniati!n@ En%uin. t)at "*%!nn*l )!%* !- $an a,,*$t 7uality a* in,!+*' a#!ut t)* $!n%*7u*n$*% t! t)* $u%t!+* !, n!n$!n,!+ity t! 7uality *7ui*+*nt%@ D!$u+*ntin. tainin. an' +aintainin. *$!'% !, *'u$ati!n? tainin.? %-ill% an' *"*i*n$*(
Ref. raining
1(, Inf$ast$%&t%$e
THE COMPANY "!3i'*% n*$*%%ay *%!u$*% ,! t)* *%ta#li%)+*nt? +ana.*+*nt an' +aint*nan$* !, t)* in,a%tu$tu* n**'*' t! i+"l*+*nt t)* *7ui*+*nt% in a$$!'an$* it) int*nati!nal %tan'a'( .3.1( THE COMPANY )a% *%ta#li%)*' an' +aintain% 2a$i(ities and )3uip#ent Maintenan$e ? in !'* t! a%%i.n *%"!n%i#ility an' '*,in* t)* "!$*%% at ,! t)* i'*nti,i$ati!n? +aint*nan$* an' $!nt!l !, all ,a$iliti*%? +a$)in*% an' *7ui"+*nt? in$lu'in. +at*ial )an'lin. *7ui"+*nt? u%*' in %u""!t !, "!'u$t *aliati!n "!$*%%*%( In,a%tu$tu* in$lu'*%? a% a""li$a#l*: Buil'in.%? !-%"a$* an' a%%!$iat*' ,a$iliti*%@
25
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P!$*%% *7ui"+*nt <#!t) )a'a* an' %!,ta*=@ an' Su""!tin. %*3i$*% <%u$) a% in,!+ati!n %y%t*+%=(
.3.2. T!" +ana.*+*nt i% *%"!n%i#l* t! *n%u* t)at ,a$iliti*% a* !, %uita#l* %i*? $!n%tu$ti!n? an' l!$ati!n it) a'*7uat* $!nt!l %y%t*+% t! ,a$ilitat* !"*ati!n%( .3.3. T!" +ana.*+*nt i% *%"!n%i#l* t! *n%u* t)at ,a$iliti*% a* +aintain*' in a .!!' %tat* !, *"ai( .3.4. P*3*nti3* Maint*nan$* !, *%%*ntial ,a$iliti*% an' *7ui"+*nt i% "lann*'? i+"l*+*nt*' an' '!$u+*nt*'( .3.-. D*"at+*nt +ana.*%%u"*3i%!% a* *%"!n%i#l* ,! i'*nti,yin. t)* n**' an' *7ui*+*nt% ,! n* an'! +!'i,i$ati!n ! *"ai t! *i%tin. in,a%tu$tu* an' ,a$iliti*%( R*7u*%t% ,! $)an.*% a* %u#+itt*' t! t)* 9*n*al Mana.* ,! *3i* an' a""!3al( .3.. Maint*nan$* !, ,a$iliti*% an' *7ui"+*nt i% "*,!+*' #y int*nal "*%!nn*l? )** %"*$i,i*'? an' #y !ut%i'* $!nta$t*' %*3i$*%( .3./. In,a%tu$tu* *7ui*+*nt% a* *3aluat*' a% a $!+"!n*nt !, Mana.*+*nt R*3i*(
1( @o$. En3'$onment
A""!"iat* !- *n3i!n+*nt i% i'*nti,i*' t! a$)i*3* $!n,!+ity !, "!'u$t an' "!3i'*' $!n%i'*in. )u+an an' ")y%i$al ,a$t!%( C!n%i'*in. natu* !, !u "!'u$t% all n*$*%%ay $a* ,! ,!!' %a,*ty a% *ll a% "*%t $!nt!l an' "*%!nn*l )y.i*n* "a$ti$*% a* ,!ll!*'( T)* *nti* n*$*%%ay *n3i!n+*nt a% "* PRP "!.a+% an' int*nati!nal %tan'a'% a* i+"l*+*nt*'( .4.1. It i% t)* *%"!n%i#ility !, t!" +ana.*+*nt t! '*t*+in* an' +an.* t)* !*n3i!n+*nt n**'*' t! a$)i*3* $!n,!+ity t! "!'u$t *7ui*+*nt%? )i$) in$lu'*% *n%uin. t)at t)* ,a$ility i% +aintain*' in a .!!' %tat* !, *"ai? !.aniati!n? an' $l*anlin*%% $!n%i%t*nt it) t)* "!'u$t an' +anu,a$tuin. *7ui*+*nt%(
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4(0 +lann'ng and 7eal'at'on of safe *$od%&ts 4(# Gene$al
Plannin. ,! %*7u*n$* !, "!$*%%*% an' %u# "!$*%%*% i% $!n%i%t*nt it) %a,* ,!!' "a$ti$* *7ui*+*nt% !, THE COMPANY an' '!$u+*nt*' in t)* HACCP Plan P!$*%% A""!a$) D!$u+*nt%( T)* "!$*%% ,l! $)at !, THE COMPANY i% .i3*n in ann*u* III !, t)i% +anual( T)!u.) *,,*$ti3* PRP% an' HACCP "lan THE COMPANY )a% i+"l*+*nt*'? !"*at*' an' *n%u*' t)* *,,*$ti3*n*%% !, t)* "lann*' a$ti3iti*% an' any $)an.*% t! t)!%* a$ti3iti*%(
4(#(# +lann'ng of +$od%&t 7eal'at'on
In !'* t! *%ta#li%) "!$*%%*% an' *%"!n%i#iliti*% ,! "*,!+in. 7uality "lannin. in !'* t! *n%u* all a""li$a#l* $u%t!+* an' !t)* *t*nal an' int*nal "!'u$t *7ui*+*nt% a* i'*nti,i*' an' %ati%,i*'? THE COMPANY )a% *%ta#li%)*' an' +aintain% P!'u$t Quality Plannin.? )i$) '*,in*% )! '*t*+in*% t)* ,!ll!in.: Quality !#*$ti3*% an' *7ui*+*nt% ,! t)* "!'u$t@ T)* n**' t! *%ta#li%) "!$*%%*% an' '!$u+*nt%? an' t! *n%u* a""!"iat* *%!u$*% a* "!3i'*' %"*$i,i$ t! t)* "!'u$t@ R*7ui*' 3*i,i$ati!n? 3ali'ati!n? +!nit!in.? +*a%u*+*nt? in%"*$ti!n an' t*%t a$ti3iti*% %"*$i,i$ t! t)* "!'u$t? an' t)* $it*ia ,! "!'u$t a$$*"tan$*@ R*$!'% n**'*' t! "!3i'* !#*$ti3* *3i'*n$* t)at t)* *aliati!n "!$*%% an' *%ultin. "!'u$t +**t *7ui*+*nt%(
4(2 +$e$e8%'s'te *$og$ams +7+s<
/.2.1 THE COMPANY )a% *%ta#li%)*'? i+"l*+*nt*' an' +aintain*'
F!!' %a,*ty t*a+ +*+#*% )a3* i'*nti,i*'? "*"a*' an' i+"l*+*nt*' PRP% t)!u.)!ut t)* "!'u$ti!n %y%t*+ $!n%i'*in. t)* %i* !, !"*ati!n? ty"* !, !"*ati!n? natu* !, t)* "!'u$t( THE COMPANY )a% i'*nti,i*' %tatut!y an' *.ulat!y *7ui*+*nt% *lat*' t! t)* "!'u$t% an' '*%$i#*' in "!'u$t '*%$i"ti!n( /.2.3 THE COMPANY )a% $!n%i'**' ,!ll!in. )il* *%ta#li%)in. t)* PRP% C!n%tu$ti!n an' lay!ut !, #uil'in.% an' a%%!$iat*' utiliti*%@ Lay!ut "*+i%*%? in$lu'in. !-%"a$* an' *+"l!y** ,a$iliti*%@ Su""li*% !, ai? at*? *n*.y an' !t)* utiliti*%@ Su""!tin. %*3i$*%? in$lu'in. a%t* an' %*a.* 'i%"!%al@
24
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T)* %uita#ility !, *7ui"+*nt an' a$$*%%i#ility ,! $l*anin.? +aint*nan$* an' "*3*ntati3* +aint*nan$*@ Mana.*+*nt !, "u$)a%*' +at*ial%? %u""li*%? 'i%"!%al% an' )an'lin. !, "!'u$t% <*(.( %t!a.* an' tan%"!tati!n=@ M*a%u*% ,! t)* "*3*nti!n !, $!%% $!nta+inati!n@ Cl*anin. an' %anitiin.@ P*%t $!nt!l@ P*%!nn*l )y.i*n* Ot)* a%"*$t% a% a""!"iat*( R*$!'% a* +aintain*' ,! 3*i,i$ati!n% an' +*'i$ati!n(
4(, +$el'm'na$y ste*s to enable )aa$d analys's 4(,(# Gene$al
All *l*3ant in,!+ati!n i% a3aila#l* t! $!ll*$t? +aintain? u"'at* an' '!$u+*nt )aa' analy%i%( 4(,(2 Food safety team
T!" +ana.*+*nt )a% a""!int*' ,!!' %a,*ty t*a+ $!n%i'*in. -n! l*'.* an' *"*i*n$* !, "*%!nn*l(
4(,(, +$od%&t &)a$a&te$'st'&s 4(,(,(# 7a> mate$'als? 'ng$ed'ents and *$od%&t &onta&t mate$'als
Ra +at*ial%? in.*'i*nt% an' "!'u$t $!nta$t +at*ial% '!$u+*nt% $!n%i%t ,!ll!in. a% a""!"iat*@ Bi!l!.i$al? $)*+i$al an' ")y%i$al $)aa$t*i%ti$%( C!+"!%iti!n !, ,!+ulat*' in.*'i*nt%( Oi.in M*t)!' "!'u$ti!n Pa$-a.in. an' '*li3*y +*t)!' St!a.* $!n'iti!n an' %)*l, li,* P*"aati!n an' ! )an'lin. #*,!* u%* ! "!$*%%in. F!!' %a,*ty *lat*' a$$*"tan$* $it*ia ! %"*$i,i$ati!n !, "u$)a%*' +at*ial% an' in.*'i*nt% a""!"iat* t! t)*i int*n'*' u%*
4(,(,(2 C)a$a&te$'st'&s of end *$od%&ts
T)* "!'u$t '*%$i"ti!n !, ,ini%) "!'u$t% in$lu'*% ,!ll!in. a% a""!"iat*@ P!'u$t na+* ! %i+ila i'*nti,i$ati!n@ C!+"!%iti!n@ Bi!l!.i$al? $)*+i$al an' ")y%i$al $)aa$t*i%ti$% *l*3ant ,! ,!!' %a,*ty@ Int*n'*' %)*l, li,* an' %t!a.* $!n'iti!n%@ Pa$-a.in.@
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La#*llin. *latin. t! ,!!' %a,*ty an'! in%tu$ti!n% ,! )an'lin.? "*"aati!n an' u%a.*@ M*t)!'<%= !, 'i%ti#uti!n(
4(,( Intended %se
In "!'u$t '*%$i"ti!n )an'lin.? +i%)an'lin. an' +i%u%*% !, t)* *n' "!'u$t i% '!$u+*nt*' )i$) in$lu'*% .!u"% !, u%*%(
4(,(5 Flo> d'ag$ams? *$o&ess ste*s and &ont$ol meas%$es 4(,(5(# Flo> d'ag$am
THE COMPANY )a% "*"a*' $l*a? a$$uat* an' '*tail*' ,l! 'ia.a+% )i$) "!3i'*% a #a%i% ,! *3aluatin. t)* "!%%i#l* !$$u*n$*? in$*a%* ! int!'u$ti!n !, ,!!' %a,*ty )aa'% $!n%i'*in. ,!ll!in. a% a""!"iat*@ T)* %*7u*n$* an' int*a$ti!n !, all %t*"% in t)* !"*ati!n@ Any !ut%!u$*' "!$*%% an' %u#$!nta$t*' !-@ ;)** a +at*ial%? in.*'i*nt% an' int*+*'iat* "!'u$t% *nt* t)* ,l!@ ;)** *!-in. an' *$y$lin. ta-* "la$*@ ;)** *n' "!'u$t%? int*+*'iat* "!'u$t%? #y "!'u$t% an' a%t* a* *l*a%*' ! *+!3*'
4(,(5(2 Des&$'*t'on of *$o&ess ste*s and &ont$ol meas%$es
THE COMPANY )a% '*,in*' *itin. $!nt!l +*a%u*%? "!$*%% "aa+*t*% an' )! t)*y a""li*' in %uita#l* *$!'%: Any !ut%!u$*' "!$*%% an' %u#$!nta$t*' !-@ ;)** a +at*ial%? in.*'i*nt% an' int*+*'iat* "!'u$t% *nt* t)* ,l!@ ;)** *n' "!'u$t%? int*+*'iat* "!'u$t%? #y "!'u$t% an' a%t* a* *l*a%*' ! *+!3*' • • •
4( /aa$d analys's 4((# Gene$al
T)* ,!!' %a,*ty t*a+ $!n'u$t% a )aa' analy%i% t! '*t*+in* )i$) )aa'% n**' t! #* $!nt!ll*'? t)* '*.** !, $!nt!l *7ui*' t! *n%u* ,!!' %a,*ty? an' )i$) $!+#inati!n !, $!nt!l +*a%u*% i% *7ui*' 4((2 /aa$d 'dent'f'&at'on and dete$m'nat'on of a&&e*table le3els
/.4.2.1 All ,!!' %a,*ty )aa'% a* i'*nti,i*' an' *$!'*' $!n%i'*in. ty"* !, "!'u$t? ty"* !, "!$*%% an' a$tual "!$*%%in. ,a$iliti*%( T)* i'*nti,i$ati!n !, )aa'% i% #a%*' !n ,!ll!in.@ T)* "*li+inay in,!+ati!n an' 'ata $!ll*$t*' a$$!'in. t! 4(/? E"*i*n$*?
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Et*nal in,!+ati!n in$lu'in.? t! t)* *t*nt "!%%i#l*? *"i'*+i!l!.i$al an' !t)* )i%t!i$al 'ata? an' In,!+ati!n ,!+ t)* ,!!' $)ain !n ,!!' %a,*ty )aa'% t)at +ay #* !, *l*3an$* ,! t)* %a,*ty !, t)* *n' "!'u$t%? int*+*'iat* "!'u$t% an' t)* ,!!' at $!n%u+"ti!n T)* %t*"% at )i$) *a$) ,!!' )aa' +ay #* int!'u$*' 4(( 2(2 F!ll!in. a* $!n%i'**' )il* i'*nti,yin. t)* )aa'%? T)* %t*"% "!$**'in. an' ,!ll!in. t)* %"*$i,i*' !"*ati!n? T)* "!$*%% *7ui"+*nt? utiliti*% %*3i$*% an' %u!un'in.%? an' T)* "*$*'in. an' ,!ll!in. lin-% in t)* ,!!' $)ain
/.4.2.2 F! all i'*nti,i*' ,!!' %a,*ty )aa'% * )a3* '*t*+in*' t)* a$$*"ta#l* l*3*l !, t)* ,!!' %a,*ty )aa' in t)* *n' "!'u$t? )i$) )a% $!n%i'**' t)* *%ta#li%)*' %tatut!y an' *.ulat!y *7ui*+*nt% an' $u%t!+* ,!!' %a,*ty *7ui*+*nt%? t)* int*n'*' u%* #y t)* $u%t!+*( Su$) *$!'% ,! '*t*+inati!n a* +aintain*'(
4((, /aa$d assessment
F!!' Sa,*ty T*a+ )a% $!n'u$t*' )aa' a%%*%%+*nt t! '*t*+in*? ,! *a$) ,!!' %a,*ty )aa' i'*nti,i*' )*t)* it% *li+inati!n ! *'u$ti!n t! a$$*"ta#l* l*3*l% i% *%%*ntial t! t)* "!'u$ti!n !, %a,* ,!!' an' )*t)* it% $!nt!l i% n**'*' t! *na#l* t)* '*,in*' a$$*"ta#l* l*3*l t! #* +*t( Ea$) ,!!' %a,*ty )aa' )a% #**n *3aluat*' a$$!'in. t! t)* "!%%i#l* %*3*ity !, a'3*%* )*alt) *,,*$t% an' t)* li-*li)!!' !, t)*i !$$u*n$*( F!!' Sa,*ty T*a+ )a% *$!'*' t)* +*t)!'!l!.y u%*' an' t)* *%ult% !, t)* ,!!' %a,*ty )aa' a%%*%%+*nt %)all #* *$!'*'(
4(( Sele&t'on and assessment of &ont$ol meas%$es
F!!' Sa,*ty T*a+ )a% %*l*$t*' $!nt!l +*a%u*%? )i$) a* $a"a#l* !, "*3*ntin.? *li+inatin. ! *'u$in. all ,!!' %a,*ty )aa'% t! '*,in*' a$$*"ta#l* l*3*l%( All t)* $!nt!l +*a%u*% *3i**' it) *%"*$t t! it% *,,*$ti3*n*%% a.ain%t t)* i'*nti,i*' ,!!' %a,*ty )aa'%( Ea$) $!nt!l +*a%u*% a* $at*.!i*' #*t**n !"*ati!nal PRP% ! HACCP Plan $!n%i'*in. ,!ll!in.@ It% *,,*$t !n i'*nti,i*' ,!!' %a,*ty )aa'% *lati3* t! t)* %ti$tn*%% a""li*'( It% ,*a%i#ility ,! +!nit!in.( It% "la$* it)in t)* %y%t*+ *lati3* t! !t)* $!nt!l +*a%u*%( T)* li-*li)!!' !, ,ailu* in t)* ,un$ti!nin. !, a $!nt!l +*a% u* ! %i.ni,i$ant "!$*%%in. 3aia#ility@ T)* %*3*ity !, t)* $!n%*7u*n$* in t)* $a%* !, ,ailu* in it% ,un$ti!nin .@ ;)*t)* t)* $!nt!l +*a%u* i% %"*$i,i$ally *%ta#li%)*' an' a""li*' t! *li+inat* ! %i.ni,i$antly *'u$* t)* l*3*l !, )aa'% Syn*.i%ti$ *,,*$t%( C!nt!l +*a%u*% $at*.!i*' a% #*l!n.in. t! t)* HACCP "lan a* i+"l*+*nt*' in a$$!'an$* it) it an' !t)* $!nt!l +*a%u*% a* i+"l*+*nt*' a% !"*ati!nal PRP%(
,0
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! A " I T Y
M A N ! A "
4(5 Establ's)'ng t)e o*e$at'onal *$e$e8%'s'te *$og$ams +7+s<
F!!' Sa,*ty T*a+ )a% '!$u+*nt*' O"*ati!nal PRP%? )i$) in$lu'* t)* ,!ll!in. in,!+ati!n ,! t)* *a$) "!.a+@ F!!' %a,*ty )aa'? )i$) a* $!nt!ll*' #y t)* "!.a+( E%ta#li%)*' +!nit!in. "!$*'u*%( T)* !"*ati!nal PRP% a* *+ain% in "la$*( C!*$ti3* a$ti!n% a* ta-*n i, +!nit!in. %)!% t)at t)* !"*ati!nal PRP% a* n!t in $!nt!l( F!!' Sa,*ty T*a+ )a% '*,in*' t)* R*%"!n%i#iliti*% an' aut)!iti*%( R*$!'% !, +!nit!in. a* +aintain*'(
4(1 Establ's)'ng t)e /ACC+ +lan 4(1(# /ACC+ +lan
F!!' Sa,*ty T*a+ )a% '!$u+*nt*' HACCP Plan ,! *a$) i'*nti,i*' $iti$al $!nt!l "!int
4(1(2 Ident'f'&at'on of C$'t'&al &ont$ol *o'nts CC+s<
F!!' Sa,*ty T*a+ )a% i'*nti,i*' all CCP% ,! all t)* $!nt!l +*a%u*% an' t)at a* all in$lu'*' in t)* HACCP "lan? )i$) $!nt!ll*' *a$) ,!!' )aa'%(
4(1(, Dete$m'nat'on of &$'t'&al l'm'ts fo$ &$'t'&al &ont$ol *o'nts
F!!' Sa,*ty T*a+ )a% '*t*+in*' $iti$al li+it% ,! t)* +!nit!in. *%ta#li%)*' ,! *a$) CCP( Citi$al li+it% a* *%ta#li%)*' t! *n%u* t)at t)* i'*nti,i*' a$$*"ta#l* l*3*l !, t)* ,!!' %a,*ty )aa' in t)* *n' "!'u$t i% n!t *$**'*'( All $iti$al li+it% a* +*a%ua#l*( F!!' Sa,*ty T*a+ )a% '!$u+*nt*' t)* ati!nal* ,! t)* $)!%*n $iti$al li+it%( I, *7ui*' n*$*%%ay in%tu$ti!n? %"*$i,i$ati!n? *'u$ati!n an' tainin. a* "*"a*' ,! $iti$al li+it% #a%*' !n %u#*$ti3* 'ata(
4(1( System fo$ t)e mon'to$'ng of &$'t'&al &ont$ol *o'nts
F!!' Sa,*ty T*a+ )a% *%ta#li%)*' a +!nit!in. %y%t*+ ,! *a$) CCP? )i$) in$lu'*% all %$)*'ul*' +*a%u*+*nt% ! !#%*3ati!n% *lati3* t! t)* $iti$al li+it%(
,#
I S O
2 2 0 0 0 : 2 0 0 5
! A " I T Y
M A N ! A "
T)* +!nit!in. %y%t*+ $!n%i%t% !, *l*3ant "!$*'u*%? in%tu$ti!n% an' *$!'% t)at $!3* t)* ,!ll!in. M*a%u*+*nt% ! !#%*3ati!n% t)at "!3i'* *%ult% it)in an a'*7uat* ti+* ,a+*( M!nit!in. '*3i$*% u%*'( A""li$a#l* $ali#ati!n +*t)!'%( M!nit!in. ,*7u*n$y( R*%"!n%i#ility an' aut)!ity *lat*' t! +!nit!in. an' *3aluati!n !, +!nit!in. *%ult%( R*$!' *7ui*+*nt% an' +*t)!'%( T)* +!nit!in. +*t)!'% an' ,*7u*n$y a* $a"a#l* !, '*t*+inin. )*n t)* $iti$al li+it% )a3* #**n *$**'in. in ti+* ,! t)* "!'u$t(
4(1(5 A&t'ons >)en mon'to$'ng $es%lts e=&eed &$'t'&al l'm'ts
HACCP "lan %"*$i,i*% t)* "lann*' $!*$ti!n% an' $!*$ti3* a$ti!n% )*n $iti$al li+it% a* *$**'*'( T)* a$ti!n *n%u* t)at t)* $au%* !, n!n$!n,!+ity i% i'*nti,i*'? t)at t)* "aa+*t*% a* $!nt!ll*' at t)* CCP% a* #!u.)t #a$- un'* $!nt!l an' t)at *$u*n$* i% "*3*nt*'( D!$u+*nt*' "!$*'u*% a* *%ta#li%)*' an' +aintain*' ,! t)* a""!"iat* )an'lin. !, un%a,* "!'u$t% t! *n%u* t)at "!'u$t% a* n!t *l*a%*' un til "!'u$t% )a3* #**n *3aluat*'(
4(4 !*dat'ng of *$el'm'na$y 'nfo$mat'on and do&%ments s*e&'fy'ng t)e +7+s and t)e /ACC+ *lan
T)* !.aniati!n u"'at*% t)* ,!ll!in. in,!+ati!n )il* ,!ll!in. *%ta#li%)*' !"*ati!nal PRP an' t)* HACCP "lan i, n*$*%%ay@ P!'u$t $)aa$t*i%ti$%( Int*n'*' u%* Fl! 'ia.a+% P!$*%% %t*"%( C!nt!l +*a%u*%( T)* HACCP "lan an' t)* "!$*'u*% an' in%tu$ti!n% %"*$i,yin. t)* PRP% a* a+*n'*' i, *7ui*'(
4(6 Be$'f'&at'on *lann'ng
F!!' Sa,*ty T*a+ )a% '*,in*' t)* "u"!%*? +*t)!'? ,*7u*n$i*% an' *%"!n%i#iliti*% ,! t)* 3*i,i$ati!n a$ti3iti*%( T)* 3*i,i$ati!n T)* PRP% a* i+"l*+*nt*'( In"ut t! t)* )aa' analy%i% i% $!ntinually u"'at*' T)* !"*ati!nal PRP an' t)* *l*+*nt% it)in t)* HACCP "lan a* i+"l*+*nt*' an' *,,*$ti3*(
,2
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M A N ! A "
Haa' l*3*l% a* it)in i'*nti,i*' a$$*"ta#l* l*3*l%( Ot)* "!$*'u*% *7ui*' #y t)* !.aniati!n a* i+"l*+*nt*' an' *,,*$ti3*( T)* !ut"ut !, t)i% "lannin. i% %uita#l* ,! t)* !.aniati!n% +*t)!' !, !"*ati!n%( >*i,i$ati!n *%ult% a* *$!'*' an' $!++uni$at*' t! t) * ,!!' %a,*ty t*a+( >*i,i$ati!n% *%ult% a* "!3i'*' t! *na#l* t)* analy%i% !, t)* *%ult% !, t)* 3*i,i$ati!n a$ti3iti*%( Duin. t)* 3*i,i$ati!n a$ti3iti*% i, t*%t %a+"l* %)!% la$- !, $!n,!+ity it) a$$*"ta#l* l*3*l !, t)* ,!!' %a,*ly )aa' t)* a,,*$t*' l!%t !, "!'u$t a* )an'l*' a% "!t*ntially un%a,*(
4(9 T$a&eab'l'ty system
T)* !.aniati!n )a% *%ta#li%)*' an' a""li*' a ta$*a#ility %y%t*+ t)at *na#l*% t)* i'*nti,i$ati!n !, "!'u$t l!t% an' t)*i *lati!n t! #at$)*% !, a +at*ial%? "!$*%%in. an' '*li3*y *$!'%( T)* ta$*a#ility %y%t*+ i% a#l* t! i'*nti,y in$!+in. +at*ial ,!+ t)* i++*'iat* %u""li*% an' t)* initial 'i%ti#uti!n !ut% !, t)* *n' "!'u$t( Ta$*a#ility *$!'% a* +aintain*' ,! a '*,in*' "*i!' ,! %y%t*+ a%%*%%+*nt t! *na#l* t)* )an'in. !, "!t*ntially un%a,* "!'u$t% an' in t)* *3*nt !, "!'u$t% it)'aal( R*$!'% !n t)* *n' "!'u$t l!t i'*nti,i$ati!n a* +aintain*' a$$!'an$* it) %tatut!y an' *.ulat!y *7ui*+*nt% an' $u%t!+* *7ui*+*nt%( /..1 THE COMPANY )a% *%ta#li%)*' an' +aintain% +$od%&t Ident'f'&at'on and T$a&eab'l'ty t! '*,in* t)* "!$*%% ,! i'*nti,yin. "!'u$t #y %uita#l* +*an% t)!u.)!ut all ")a%*% !, "!'u$t *aliati!n? ,!+ '*%i.nt)!u.) a$7ui%iti!nt)!u.) +anu,a$tuin.t)!u.) %t!a.* an' '*li3*y( /..2 +$od%&t Ident'f'&at'on and T$a&eab'l'ty '*,in*% t)* +*an% i+"l*+*nt*' ,! i'*nti,yin. in%"*$ti!n %tatu% !, $!+"!n*nt% an' "!'u$t t)!u.)!ut all %ta.*% !, "!'u$t *aliati!n? in'i$atin. a$$*"tan$* ! **$ti!n ,! ,ut)* "!$*%%in. ! %)i"+*nt? u%in. *it)* a %ta+" ! in%"*$ti!n aut)!ity initial%( T)* *7ui*' in%"*$ti!n %tatu% ta.% ! +a-in.% a* %"*$i,i*' in 7e&e'3'ng Ins*e&t'on In +$o&ess Ins*e&t'on and F'nal Ins*e&t'on(
,,
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/..3 C!nt!l ,*atu*% in$lu'* *7ui*+*nt% ,! +aint*nan$* ! *"la$*+*nt !, i'*nti,i$ati!n %tatu% an' ta$*a#ility +a-%? an' *$!'(
Ref. !roduct Identification and raceability Ref. Receiving Inspection Ref. In1!rocess Inspection Ref. 5inal Inspection
4(#0 Cont$ol of non&onfo$m'ty 4(#0(# Co$$e&t'on
a= T)* !.aniati!n *n%u*% t)at )*n $iti$al li+it% ,! CCP<%= a* *$**'*' ! t)** i% a l!%% !, $!nt!l !, !"*ati!nal PRP<%=? t)* *n' "!'u$t% a,,*$t*' a* i'*nti,i*' an' $!nt!ll*' it) *.a' t! t)*i u%* an' *l*a%*( #= A '!$u+*nt*' "!$*'u* i% *%ta#li%)*' an' +aintain*' '*,inin.( $= T)* i'*nti,i$ati!n an' a%%*%%+*nt !, a,,*$t*' *n' "!'u$t% t! '* t*+in* "!"* )an'lin.( '= A *3i* !, t)* $!*$ti!n% $ai*' !ut( T)* un%a,* "!'u$t% t)at +anu,a$tu*' un'* $!n'iti!n )** $iti$al li+it% )a3* #**n *$**'*' an' un'* $!n'iti!n )** !"*ati!nal PRP<%= )a3* n!t #**n $!n,!+*' a* )an'l*' a% "* t)* *%ta#li%)*' %y%t*+ an' t)* *$!'% ,! %u$) un%a,* "!'u$t% a* +aintain*'( *= All $!*$ti!n% a* a""!3*' #y t)* *%"!n%i#l* "*%!n% an' a* *$!'*' t!.*t)* it) in,!+ati!n !n t)* natu* !, t)* n!n$!n,!+ity( It% $au%*<%= an' $!n%*7u*n$*<%= in$lu'*' ,! ta$*a#ility "u"!%*% *lat*' t! t)* n!n$!n,!+in. l!t%(
Ref. Control of (on1Conforming !roducts
4(#0(2 Cont$ol of Non&onfo$m'ng +$od%&t
THE COMPANY )a% *%ta#li%)*' an' +aintain% Cont$ol of Non&onfo$m'ng Mate$'als t! '*,in* t)* "!$*%%*% ,! *$!'in.? *3aluati!n? *l*a%* an' 'i%"!%iti!n !, n!n$!n,!+in. "!'u$t? in$lu'in.: ;)*n "!%%i#l*? %*.*.atin. n!n$!n,!+in. "!'u$t t! "*3* nt it% ina'3*t*nt u%*@ Ta-in. a$ti!n t! $!*$t? *"ai? ! *!- t)* '*t*$t*' n!n$!n ,!+ity <*+*'ial a$ti!n t! a''*%% t)* i++*'iat* "!#l*+=@
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Aut)!iin. it% u%*? *l*a%* ! a$$*"tan$* un'* $!n$*%%i!n #y a *l*3ant aut)!ity an'! t)* $u%t!+*? a% a""li$a#l*@ Ta-in. a$ti!n t! "*$lu'* it% !i.inal int*n'*' u%* ! a""li$ati!n@ ;)*n ,*a%i#l*? ta-in. a""!"iat* a$ti!n t! i'*nti,y t)* !!t $au% * !, t)* n!n$!n,!+ity? an' i+"l*+*ntin. $!*$ti3* a$ti!n t! "*3*nt it% *$u*n$*? *,,*$t%? ! "!t*ntial *,,*$t%@ R*in%"*$t all *"ai*' ! *!-*' n!n$!n,!+in. "!'u$t t! '*+!n%tat* $!n,!+ity t! *7ui*+*nt%(
'*,in*% )! N!n$!n,!+in. Mat*ial% a* '!$u+*nt*' an' )! *$!'% !, n!n$!n,!+in. +at*ial% a* $!n%i'**' 7uality *$!'% t)at a* +aintain*' an' *tain*' in a$$!'an$* it) Cont$ol of 7e&o$ds( Cont$ol of Non&onfo$m'ng Mate$'als
4(#0(2(# 7elease o$ A&&e*tan&e of Non&onfo$m'ng +$od%&t
'*,in*% t)* *7ui*+*nt% ,! *l*a%* ! a$$*"tan$* !, n!n$!n,!+in. "!'u$t? in$lu'in.: a= A$$*"tin. "!'u$t% t)at '! n!t %ati%,y all +anu,a$tuin. $it*ia ? "!3i'*' t)at? P!'u$t% %ati%,y t)* '*%i.n a$$*"tan$* $it*ia@ T)* n!n$!n,!+in. +anu,a$tuin. a$$*"tan$* $it*ia a* $at*.!i *' a% unn*$*%%ay t! %ati%,y t)* '*%i.n a$$*"tan$* $it*ia@ ! P!'u$t% a* *"ai*' ! *!-*' t! %ati%,y t)* '*%i.n a$$*"tan$* $it*ia? ! +anu,a$tuin. a$$*"tan$* $it*ia( #= A$$*"tin. "!'u$t% t)at '! n!t %ati%,y t)* !i.inal '*%i.n a$$*"tan$* Mon'to$'ng and Meas%$ement of +$od%&t
$it*ia? "!3i'*' t)at?
T)* +at*ial% ! "!'u$t% %ati%,y n* '*%i.n a$$*"tan$* $it*ia
4(#0(2 Co$$e&t'3e a&t'ons
T)* aut)!i*' "*%!n i% *3aluatin. t)* 'at* '*i3*' ,!+ t)* +!nit!in. !, !"*ati!n% PRP% an' CCP% t! initiat* $!*$ti3* a$ti!n( C!*$ti3* a$ti!n% a* initiat*' )*n $iti$al li+it% a* *$**'*' ! )*n t)** i% a la$- !, $!n,!+ity it) !"*ati!nal PRP<%=( T)* !.aniati!n )a% *%ta#li%)*' an' +aintain*' '!$u+*nt*' "!$*'u*% t)at %"*$i,y a""!"iat* a$ti!n% t! i'*nti,y an' *li+inat* t)* $au%* !, '*t*$t*' n!n$!n,!+iti*%? t! "*3*nt *$u*n$*? an' t! #in. t)* "!$*%% ! %y%t*+ #a$- int! $!nt!l a,t* n!n$!n,!+ity i% *n$!unt**'( T)*%* a$ti!n% in$lu'*: I'*nti,i$ati!n !, a$ti!n ,! $u%t!+* $!+"laint% an' "!'u$t n!n $!n,!+iti*%( I'*nti,i$ati!n !, t*n'% in t*n'% in +!nit!in. *%ult% t)at +ay in'i$at* '*3*l!"+*nt t!a'% l!%% !, $!nt!l
,5
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In3*%ti.ati!n !, t)* $au%* !, n!n$!n,!+iti*% *latin. t! "!'u$t? "!$*%% an' 7uality %y%t*+ an' *$!'in. t)* *%ult% !, t)* in3*%ti.ati!n( T)* $!*$ti3* a$ti!n n**'*' t! *li+inat* t)* $au%* !, n!n $!n,!+iti*% i% '*t*+in*' an' i+"l*+*nt*' R*$!'in. t)* *%ult% !, a$ti!n ta-*n( T)* *,,*$ti3*n*%% !, %u$) $!*$ti3* a$ti!n i% *3i**' C!*$ti3* a$ti!n% a* *$!'*' an' +aintain*'(
4(#0(, /andl'ng of *otent'ally %nsafe *$od%&ts 4(#0(,(# Gene$al
N*$*%%ay a$ti!n% a* ta-*n t! "*3*nt t)* n!n$!n,!+in. "!'u$t% ,!+ *nt*in. t)* ,!!' $)ain an' unl*%% ,!ll!in.: T)* ,!!' %a,*ty )aa'<%= !, $!n$*n )a%<3*= #**n *'u$*' t! t)* '*,in*' a$$*"ta#l* l*3*l%? T)* ,!!' %a,*ty )aa'<%= !, $!n$*n ill #* *'u$*' t! i'* nti,i*' a$$*"ta#l* l*3*l% "i! t! *nt*in. int! t)* ,!!' $)ain? ! T)* "!'u$t% %till +**t% t)* '*,in*' a$$*"ta#l* l*3*l<%= !, t)* %a,*ty )aa'% !, $!n$*n '*%"it* t)* n!n$!n,!+ity( All l!t% !, n!n$!n,!+in. "!'u$t% a* -*"t un'* $!nt!l !, !.aniati!n( I, n!n$!n,!+in. "!'u$t i% i'*nti,i*' a,t* '*li3*y ! u%* )a% %tat*'? t)*n THE COMPANY ta-*% a""!"iat* a$ti!n *.a'in. t)* $!n%*7u*n$*% !, t)* n!n$!n,!+ity an' int**%t*' "ati*% a* in,!+*' t! it)'a t)* +at*ial( T)* $!nt!l% an' *lat*' *%"!n%* an' aut)!iati!n !, n!n $!n,!+in. "!'u$t% a* '!$u+*nt*'(
4(#0(,(2 E3al%at'on fo$ $elease
All n!n$!n,!+in. "!'u$t% a* *l*a%*' a% %a,* )*n any !, t)* ,!ll!in. $!n'iti!n% a""ly@ E3i'*n$* !t)* t)an t)* +!nit!in. %y%t*+ '*+!n%tat*% t)at t)* $!nt!l +*a%u*% )a3* #**n *,,*$ti3*@ E3i'*n$* %)!% t)at t)* $!+#in*' *,,*$t !, t)* $!nt!l +*a%u*% ,! t)at "ati$ula "!'u$t $!+"li*% it) t)* "*,!+an$* int*n'*'( T)* *%ult% !, %a+"lin.? analy%i% an'! !t)* 3*i,i$ati!n a$ti3iti*% '*+!n%tat* t)at t)* a,,*$t l!t !, "!'u$t $!+"li*% it) t)* i'*nti,i*' a$$*"ta#l* l*3*l% ,! t)* ,!!' %a,*ty )aa'% <%= $!n$*n*'(
4(#0(,(, D's*os't'on of non&onfo$m'ng *$od%&ts
T)* n!n$!n,!+in. "!'u$t% a* *3i**' a,t* in%"*$ti!n in a$$!'an$* it) t)* '!$u+*nt*' "!$*'u* an' %u#*$t t! '*$i%i!n ta-*n a% "* ,!ll!in.( a= R*P!$*%%*' R*;!-*' T! M**t T)* S"*$i,i*' R*7ui*+*nt%? #= R* 9a'ati!n R**$t*' An' ! S$a""*'
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4(#0( @'t)d$a>als
a= T!" +ana.*+*nt )a% a""!int*' an' aut)!i*' t)* ,!!' %a,*ty t*a+ l*a'* t! initiatin. an' **$utin. it)'aal%( #= T)* !.aniati!n )a% *%ta#li%)*' an' +aintain*' a '!$u+*nt*' "!$*'u* t! in,!+ t! $u%t!+*%? $!n%u+*% an' %tatut!y an' *.ulat!y aut)!iti*%( T)* %*7u*n$*% !, a$ti!n t! #* ta-*n t! )an'l* it)'an an' a,,*$t*' "!'u$t% a* al%! '!$u+*nt*' in t)* "!$*'u*( $= R*$!' ,! t)* it)'aal a* +aintain*' an' *"!t*' t! t)* t!" +ana.*+*nt a% a #a%i% !, in"ut t! t)* +ana.*+*nt *3i*( '= T)* *,,*$ti3*n*%% !, t)* it)'aal "!.a++* i% 3*i,i*' an' *$!'% a* +aintain*'(
Ref. !re1re0uisite !rogram Ref. #ACC! !lan and Monitoring for results exceeding Critical 6imits Ref. !roduct wit"drawal Ref. Control of (on1Conforming !roducts Ref. Corrective Action
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6(0 Bal'dat'on? 3e$'f'&at'on and 'm*$o3ement of t)e food safety management system 6(# Gene$al
T)* ,!!' %a,*ty t*a+ )a% "lann*' an' i+"l*+*nt*' t)* "!$*% %*% t! 3ali'at* t)* $!nt!l +*a%u*% t! 3*ity an' i+"!3* t)* ,!!' %a,*ty +ana.*+*nt %y%t*+(
6(2 Bal'dat'on of Cont$ol meas%$e &omb'nat'ons
T)* $!nt!l +*a%u*% "i! t! i+"l*+*nt t)* !.aniati!n 3ali'at*% t)at t)* T)* $!nt!l +*a%u* t)* $!nt!l t)* ,!!' %a,*ty )aa'% T)* $!nt!l +*a%u*% a* *,,*$ti3* an' $a"a#l* !, *n%uin. $!nt!l ! , t)* i'*nti,i*' ,!!' %a,*ty )aa'% t! !#tain *n' "!'u$t% t)at +**t t)* '*,in*' a$$*"ta#l* l*3*l%( I, a#!3* $!nt!l +*a%u*% a* n!t %uita#l* t)*n t)* %a+* a* +!'i,i*' an' * a%%*%%*' a% a""!"iat* i(*( $)an.*% in $!nt!l +*a%u*%? a +at*ial? +anu,a$tuin. t*$)n!l!.i*%? *n' "!'u$t $)aa$t*i%ti$% an' +*t)!' !, 'i%ti#uti!n an' ! in'*nt*' u%* !, *n' "!'u$t%(
6(, Cont$ol of mon'to$'ng and meas%$'ng
.3.1( A""!"iat* +*a%uin. an' t*%t *7ui"+*nt in%tu+*nt%? *t$( $a"a#l* !, n*$*%%ay a$$ua$y an' "*$i%i!n a* u%*' at t)* !- "la$*% t! a%%u* $!n,!+ity !, "!'u$t t! %"*$i,i*' *7ui*+*nt% in$lu'in. t)* *7ui*+*nt% !, %a,* ,!!' "a$ti$*( .3.2. E7ui"+*nt% a* $ali#at*' at *.ula int*3al% an' t)* t!l*an$*% *%ta#li%)*' !n t)* #a%i% !, %ta#ility? "u"!%* an' u%a.*? t)**#y *n%uin. t)at it i% $a"a#l* !, .*ttin. t)* n*$*%%ay a$$ua$y an' +*a%u*+*nt *7ui*+*nt%( .3.3. T)* %ali*nt ,*atu*% !, t)* $ali#ati!n %y%t*+ *%ta#li%)*' an' +aintain*' a* a% un'*: a= E7ui"+*nt u%*' in !u .!u" !, $!+"ani*% a* %*l*$t*' #a%*' !n $a"a#ility? a$$ua$y an' "*$i%i!n !, t)* +*a%u*+*nt *7ui*' t! #* +a'*( #= T)* in%tu+*nt% a* $ali#at*' an' a'u%t*' at *.ula int*3al% a% "* %$)*'ul*% ! "i! t! u%* an' *$!'*'( All t)* $iti$al *7ui"+*nt% .*t $ali#at*' a.ain%t $*ti,i*' *7ui"+*nt )a3in. a -n!n 3ali' *lati!n%)i" t! nati!nally int*nati!nally *$!.ni*' %tan'a' #y tain*' .!u" !, $!+"ani*% "*%!nn*l ! #y *+"l!yin. %*3i$*% !, !ut%i'* "ati*% )a3in. ta$*a#ility it) nati!nal int*nati!nal %tan'a'%( In t)* a#%*n$* !, *%ta#li%)in. %u$) ta$*a#ility? it i% $ali#at*' t)!u.) %!+* *$!.ni*' "ati*% ! a% "* *%ta#li%)*' "!$*'u*(
,6
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! A " I T Y
M A N ! A "
$= P!$*'u*% a* *%ta#li%)*' an' '*tail% a* .i3*n ,! $ali#ati!n +*t)!'%? ,*7u*n$y? *7ui"+*nt i'*nti,i$ati!n %y%t*+ *t$( T)* *$!'% !, $ali#ati!n a* +aintain*'( Cali#ati!n %tatu% !, t)* *7ui"+*nt i% i'*nti,i*' #y %ti$-*% ta.% *$!'% t! *$all #a$- )*n $ali#ati!n i% 'u*( .3.4. In $a%* any *7ui"+*nt i% ,!un' !ut !, $ali#ati!n? t)* 3ali'ity !, "*3i!u% in%"*$ti!n %)all #* a%%*%%*' an' n*$*%%ay $!*$ti3* a$ti!n i% ta-*n( a= T*%t *7ui"+*nt a* $ali#at*' un'* %uita#l* *n3i!n+*ntal $!n'iti!n%( #= E7ui"+*nt a* )an'l*' in a +ann* t! a3!i' 'a+a.* an' '*t*i!ati!n 'uin. )an'lin.? +aint*nan$* an' %t!a.*( Tain*' "*%!n% %)!ul' )an'l* t)* *7ui"+*nt t! *n%u* t)* 3ali'ity !, $ali#ati!n( T)* +*a%uin. an' +!nit!in. '*3i$*% a* %a,*.ua'*' t! *li+inat* t)* "!%%i#ility !, in3ali'ati!n !, t)* $ali#ati!n ! i% %u#*$t*' t! $ali#ati!n #*,!* u%*( $= N* ! *"ai*' *7ui"+*nt an' '*3i$*% u%*' ,! in%"*$ti!n a* %u#*$t*' t! an initial in%"*$ti!n ,! a$$ua$y ! a* "!3*n "i! t! *l*a%* ,! u%* in t*%tin.(
6( Food safety management system 3e$'f'&at'on 6((# Inte$nal A%d't
T)* int*nal au'it i% '!n* at l*a%t !n$* a y*a t! '*t*+in* )*t)* t)* Sy%t*+ $!n,!+% t! ISO 22000 *7ui*+*nt% an' )a% #**n *,,*$ti3*ly i+"l*+*nt*' an' +aintain*'( T)* int*nal au'it i% %$)*'ul*' in THE COMPANY !n t)* #a%i% !, t)* %tatu% an' i+"!tan$* !, a$ti3ity t! #* au'it*' an' "*3i!u% au'it *%ult%( Au'it i% $!n'u$t*' !n t)* lai' '!n ISO 22000 %y%t*+ an' t)* 9ui'in. "in$i"l*% !, ISO 22000 Int*nal F!!' Sa,*ty
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.4.1.3. T'mely 7es*onse Inte$nal A%d't '*,in*% t)* *7ui*+*nt ,! TIOT t! i'*nti,y ti+*ly *%"!n%* ti+*% ,! a''*%%in. '*t*$t*' n!n$!n,!+an$*%( .4.1.4 Inte$nal A%d't '*,in*% )! au'it% a* t! #* '!$u+*nt*'( D!$u+*nt*' au'it *%ult% a* i'*nti,i*' a% 7uality *$!'% an' a* +aintain*' an' *tain*' in a$$!'an$* it) Cont$ol of 7e&o$ds(
A%d't 7e*o$t and Follo>!*
T)* Au'it! "*"a*% n!n$!n,!+ity *"!t !n $!+"l*ti!n !, t)* au'it an' t)* n!n $!n,!+ity i% #!u.)t t! t)* n!ti$* !, au'it**( T)*y 'i%$u%% a#!ut t)* a""!"iat* a$ti!n% t! #* ta-*n an' %$)*'ul* ,! i+"l*+*ntati!n in *%"*$t !, any N!nC!n,!+an$* !#%*3*'( Au'it ,in'in.% a* *$!'*' an' u%*' a% t)* +ain ,!+al +*an% !, *%!l3in. "!#l*+% an' '*,i$i*n$i*% '*t*$t*' in t)* %y%t*+( T)* $!"i*% !, %u$) NCR *"!t% a* .i3*n t! au'it**( A,t* ta-in. ti+*ly $!*$ti3* a$ti!n !n NC *"!t%? t)* au'it** $all% au'it! t! 3*i,y it an' t! $l!%* t)* NCR( Duin. n*t au'it? i+"l*+*ntati!n an' *,,*$ti3*n*%% !, t)* $!*$ti3* a$ti!n ta-*n !n NCR% %)all #* *3i**' an' *$!'*'( All t)* au'it ,in'in.% an' 3*i,i$ati!n !, au'it *%ult% a* *"!t*' t! t)* t!" +ana.*+*nt ,! *3i* an' *3aluati!n !, t)* %y%t*+ an' ta-in. $!*$ti3* a$ti!n%(
6((2 E3al%at'on of 'nd'3'd%al 3e$'f'&at'on $es%lts
T)* ,!!' %a,*ty t*a+ *3aluat*% t)at t)* "lann*' 3*i,i$ati!n a* a$)i*3*'( Al%! n*$*%%ay a$ti!n% a* ta-*n t)!u.) ,!ll!in.@ R*3i* !, *i%tin. "!$*'u*% an' $!++uni$ati!n $)ann*l% T)* $!n$lu%i!n !, t)* )aa' analy%i%? t)* *%ta#li%)*' !"*ati!nal PRP% an' t)* HACCP "lan T)* PRP% R*3i*in. t)* *,,*$ti3*n*%% !, )u+an *%!u$*% an' tainin. a$ti3iti*%(
6((, Analys's of $es%lts of 3e$'f'&at'on a&t'3't'es
T)* ,!!' %a,*ty t*a+ analy*% t)* *%ult% !, 3*i,i$ati!n a$ti3iti*%? t)* *% ult% !, int*nal an' *t*nal au'it%( T)* analy%i% i% $ai*' !ut in !'*: T! $!n,i+ t)at t)* !3*all "*,!+an$* !, t)* %y%t*+ +**t% t)* "l ann* ' aan.*+*nt% an' t)* ,!!' %a,*ty +ana.*+*nt %y%t*+ *7ui*+*nt% *%ta#li%)*' #y t)* !.aniati!n( T! i'*nti,y t)* n**' ,! u"'atin. ! i+"!3in. t)* ,!!' % a,*ty +ana.*+*nt %y%t*+( T! i'*nti,y t)* t*n'% )i$) in'i$at* a )i.)* in$i'*n$* !, "!t*ntially un%a,* "!'u$t%( T! *%ta#li%)*' in,!+ati!n ,! "lannin. !, t)* int*nal au'it "!.a++* $!n$*nin. t)* %tatu% an' i+"!tan$* !, a*a% t! #* au'it*' T! "!3i'* *3i'*n$* t)at any $!*$ti!n% an' $!*$ti3* a$ti !n% t)at )a3* #**n ta-*n a* *,,*$ti3*(
0
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T)* *%ult% !, t)* analy%i% an' *%ultin. a$ti3iti*% a* *$!'*' an' *"!t*' t! t!" +ana.*+*nt an' u%*' a% an in"ut ,! u"'atin. ,!!' %a,*ty +ana.*+*nt %y%t*+(
6(( Mon'to$'ng and Meas%$ement 6(((#( Mon'to$'ng and Meas%$ement of +$o&esses
E3*y '!$u+*nt*' "!$*'u* *%ta#li%)*' an' +aintain*' in t)* Quality Mana.*+*nt Sy%t*+ $!ntain% a %*$ti!n )i$) i'*nti,i*% )! THE COMPANY %)all a""ly %uita#l* +*t)!'% ,! +!nit!in. an'? )** a""li$a#l*? +*a%u*+*nt !, t)* QMS "!$*%%*%(
6(5 Im*$o3ement 6(5(# Cont'n%al Im*$o3ement
T)* "!$*%% i% lai' '!n ,! ,!ll! u" !, "!$*%% ,! $!ntinual i+"!3*+*nt !, t)* F!!' %a,*ty +ana.*+*nt %y%t*+( T)* $!ntinual i+"!3*+*nt !, ,!!' %a,*ty +ana.*+*nt %y%t*+ i% ,a$ilit at*' t)!u.) t)* u%* !, $!++uni$ati!n? +ana.*+*nt *3i*? int*nal au'it? *3aluati!n !, in'i3i'ual 3*i,i$ati!n *%ult%? an' analy%i% !, *%ult% !, 3*i,i$ati!n a$ti3iti*%? 3ali'ati!n !, $!nt!l +*a%u* $!+#inati!n%? $!*$ti3* a$ti!n an' ,!!' %a,*ty +ana.*+*nt %y%t*+ u"'atin.( .-.1.1. THE COMPANY )a% *%ta#li%)*' an' +aintain% Cont'n%al Im*$o3ement t! .ui'* t)* "!$*%% !, $!ntinually i+"!3in. t)* QMS t)!u.) t)* u%* !, t)* Quality P!li$y? 7uality !#*$ti3*%? au'it *%ult%
'*,in*% t)* "!$*%% ,! ta-in. a$ti!n t! *li+inat* t)* $au%*% !, *i%tin. n!n$!n,!+iti*% t! "*3*nt *$u*n$*( T)i% "!$*'u* )a% #**n *%ta#li%)*' t! '*,in* t)* *7ui*+*nt% ,!: R*3i*in. n!n$!n,!+iti*%
.-.1.3. All '!$u+*ntati!n *latin. t! $!*$ti3* a$ti!n i% $!n%i'**' 7uality *$!'% )i$) +u%t #* +aintain*' an' *tain*' in a$$!'an$* it) Cont$ol of 7e&o$ds(
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