09 - Validation of CCP & OPRP

VALIDATION FOR CCP & OPRP
Document No. USL/HACCP/VP/09

Date of Issue 01/10/2013
United Si!its Limited "e#. No. 01
$o!m Pa%e No. 1 of &'
United Spirits Limited has followed the methodolo! mentioned "elow for #alidation of $ontrol meas%res manaed thro%h
$riti$al $ontrol points and operational pre&re'%isite prorammes( The Validation %ideline is in$orporated as %idan$e to
%nits $arr!in o%t #alidation for CCP & OPRP(
)( *%idan$e+
1.1()ese %uide*ines a*+ to #a*idation of cont!o* measu!es at an+ sta%e of t)e food c)ain.
1.2()ese %uide*ines a!e intended as %uidance to indust!+ and %o#e!nments on t)e #a*idation of indi#idua* cont!o* measu!es, a
*imited com-ination of cont!o* measu!es, o! sets of cont!o* measu!e com-inations fo!min% a food safet+ cont!o* s+stem
.e.%. HACCP, /HP0.
1.3()e too*s, tec)ni1ues, and statistica* !inci*es t)at 2ou*d -e used to #a*idate secific food safet+ cont!o* measu!es a!e
-e+ond t)e scoe of t)e cu!!ent document.
1.3Ad#ice on secific a*ications s)ou*d -e ac1ui!ed f!om scientific o!%ani4ations, cometent aut)o!ities, !ocess cont!o*
e5e!ts o! !e*ated sou!ces of scientific e5e!tise t)at can !o#ide t)e secific !inci*es and -est !actices uon 2)ic) t)e
#a*idation of a secific cont!o* measu!e s)ou*d -e -ased.
,( D-FINITIONS
2.1Control .eas%re+ An+ action and acti#it+ t)at can -e used to !e#ent o! e*iminate a food safet+ )a4a!d o! !educe it to an
acceta-*e *e#e*.
2.2Food Safet! Control S!stem+ ()e com-ination of cont!o* measu!es t)at, 2)en ta6en as 2)o*e, ensu!es t)at food is safe
fo! its intended use.
2.3.onitorin+ ()e act of conductin% a *anned se1uence of o-se!#ations o! measu!ements of cont!o* a!amete!s to assess
2)et)e! a cont!o* measu!e is unde! cont!o*.
2.3Validation+ 7-tainin% e#idence t)at a cont!o* measu!e o! com-ination of cont!o* measu!es, if !oe!*+ im*emented, is
caa-*e of cont!o**in% t)e )a4a!d to a secified outcome.
2.&Verifi$ation+ ()e a*ication of met)ods, !ocedu!es, tests and ot)e! e#a*uations, in addition to monito!in%, to dete!mine
2)et)e! a cont!o* measu!e is o! )as -een oe!atin% as intended.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
The do$%ment is $ontrolled ele$troni$all!(
All paper $opies of this do$%ment are %n$ontrolled %nless stamped as 0CONTROLL-D1 & iss%ed "! .R
2From 3O 4%alit!5
6( CONC-PT FOLLO7-D AND NATUR- OF VALIDATION
3.1Cu!!ent #a*idation focuses on t)e co**ection and e#a*uation of scientific, tec)nica* and o-se!#ationa* info!mation to
dete!mine 2)et)e! cont!o* measu!es a!e caa-*e of ac)ie#in% t)ei! secified u!ose in te!ms of )a4a!d cont!o*.
Va*idation in#o*#es measu!in% e!fo!mance a%ainst a desi!ed food safet+ outcome o! ta!%et, in !esect of a !e1ui!ed *e#e*
of )a4a!d cont!o*.
3.2Va*idation is e!fo!med at t)e time a cont!o* measu!e o! a food safet+ cont!o* s+stem is desi%ned, o! 2)en c)an%es
indicate t)e need fo! !e8#a*idation. Va*idation of cont!o* measu!es is, 2)ene#e! ossi-*e, e!fo!med -efo!e t)ei! fu**
im*ementation.
8( TAS9S PRIOR TO VALIDATION OF CONTROL .-ASUR-S
3.1P!io! to t)e #a*idation of cont!o* measu!es -+ t)e Unit, it is imo!tant to com*ete ce!tain tas6s so t)at #a*idation can -e
accom*is)ed effecti#e*+ and efficient*+.
3.2()e fo**o2in% tas6s cou*d -e ca!!ied out eit)e! indeendent*+ o! in con9unction 2it) t)e esta-*is)ment of /HPs, HACCP,
etc.
3.3(as6s !io! to #a*idation inc*ude:
3.3.1 Identifi$ation of the ha:ards t)at a!e intended to -e cont!o**ed in t)e commodit+ and/o! en#i!onment
conce!ned, ta6in% into account a** !e*e#ant info!mation, inc*udin% info!mation f!om a !is6 assessment.
3.3.2 Identifi$ation the food safet! o%t$ome re'%ired8()e food safet+ outcome can -e dete!mined in a num-e! of
2a+s. Unit s)ou*d dete!mine if t)e!e a!e e5istin% food safet+ outcomes o! ta!%ets, esta-*is)ed -+ t)e cometent
aut)o!it+/In )ouse e5e!iment, !e*e#ant to t)e intended use of t)e food. In t)e a-sence of food safet+ outcomes
o! ta!%ets esta-*is)ed -+ t)e cometent aut)o!it+ o! in8)ouse e5e!iment, ta!%ets s)ou*d -e identified -+ Unit,
as a!o!iate. Unit ma+ a*so set st!icte! ta!%ets t)an t)ose set -+ t)e cometent aut)o!it+.
3.3.3 Identifi$ation of the meas%res that are to "e #alidated; ta<in into a$$o%nt+
3.3.3.1 ()e imo!tance of t)e cont!o* measu!e in ac)ie#in% cont!o* of t)e )a4a!d to a secified outcome.
;5am*es mi%)t inc*ude: No fo!ei%n o-9ect )a4a!dous to )uman )ea*t).
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
3.3.3.2 <)et)e! t)e cont!o* measu!e )as a*!ead+ -een #a*idated
3.3.3.3 Identif+ 2)et)e! t)e cont!o* measu!e )as !e#ious*+ -een #a*idated in a 2a+ t)at is a*ica-*e and
a!o!iate to t)e acti#it+ .e.%. a cont!o* measu!e !e1ui!ed -+ a cometent aut)o!it+ o! #a*idated -+ a
cometent aut)o!it+ o! ot)e! nationa* o! inte!nationa* o!%ani4ation0 o! 2)et)e! its e!fo!mance is so
2e** esta-*is)ed fo! t)e a*ication unde! conside!ation t)at fu!t)e! #a*idation is not necessa!+.
3.3.3.3 In eit)e! case, a $ood Safet+ must ensu!e t)at t)e conditions .e.%. !a2 mate!ia*s, !e*e#ant )a4a!ds,
com-inations of cont!o* measu!es, intended use, and dist!i-ution and consumtion atte!ns0 in t)ei!
a!ticu*a! oe!ation do not diffe! f!om t)e conditions unde! 2)ic) t)e cont!o* measu!e 2as !e#ious*+
#a*idated.
3.3Priorit! of #alidation8Conside!in% t)at food safet+ outcomes a!e often deendent on mu*ti*e cont!o* measu!es,
!io!iti4ation of #a*idation acti#ities ma+ -e necessa!+ and ma+ ta6e into account:
3.3.1 Ad#erse health effe$t+ ()e )i%)e! t)e otentia* fo! an ad#e!se )ea*t) effect f!om a )a4a!d, t)e mo!e attention
s)ou*d -e aid to assu!in% t)at t)e set of cont!o* measu!es se*ected is effecti#e. Conside!ation s)ou*d -e %i#en
to t)e si4e of t)e ou*ation and t)e a%e/se5 of %!ous most at !is6.
3.3.2 3istori$al e=perien$e+ =ased on e5tensi#e )isto!+ t)at secific measu!es used to cont!o* food -o!ne )a4a!ds
a!e effecti#e. If *itt*e o! no e5e!ience e5ists 2it) !esect to t)e e!fo!mance of a cont!o* measu!e in cont!o**in% a
a!ticu*a! )a4a!d 2it)in a secified conte5t, it -ecomes mo!e imo!tant t)at #a*idation -e unde!ta6en. In ce!tain
instances, t)ese )isto!ica* data ma+ o-#iate t)e need to conduct #a*idations. Ho2e#e!, it is imo!tant to a#oid
assumin% t)at a food !oduction o! !ocessin% s+stem is safe -ased so*e*+ on )isto!ica* e5e!ience. A** !e*e#ant
cu!!ent info!mation s)ou*d -e conside!ed 2)en e#a*uatin% t)e ade1uac+ of )isto!ica* info!mation, as it ma+ -e
outdated. $o! e5am*e, sam*in% and testin% !ocedu!es used to o-tain t)e o!i%ina* data ma+ -e insufficient in
t)e conte5t of cu!!ent oe!atin% !ocedu!es. $o! e%. Ne2 st!ains of mic!o-ia* at)o%ens ma+ no2 e5ist t)at do
not -e)a#e in t)e same manne! as t)e st!ains of at)o%ens o! su!!o%ate mic!oo!%anisms used fo! dete!minin%
ea!*+ food cont!o* !ocesses o! ne2 t+e of c)emica* )a4a!ds a!e identified. Ne2 eidemio*o%ica* and/o! c*inica*
info!mation ma+ indicate t)at t)e cont!o* measu!es used in t)e ast 2e!e *ess effecti#e t)an !e#ious*+ t)ou%)t.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
3.3.3 Other fa$tors>$onstraints8A-i*it+ to monito! and #e!if+ t)e cont!o* measu!e. In !io!iti4in% cont!o* measu!es fo!
#a*idation, conside!ation s)ou*d -e %i#en to t)e amena-i*it+ of t)e cont!o* measu!e to monito!in% and/o!
#e!ification afte! im*ementation. Cont!o* measu!es t)at a!e of suc) a natu!e t)at it is not feasi-*e to dete!mine
t)ei! 1uantitati#e effect on secific )a4a!ds ma+ not a*2a+s -e conside!ed !io!it+ fo! #a*idation. ;5am*es of
suc) cont!o* measu!es inc*ude ai! *oc6s to minimi4e c!oss contamination, )and 2as)in% !ocedu!es, and se#e!a*
ot)e! -asic )+%iene !actices desc!i-ed in t)e Inte!nationa* "ecommended Code of P!actice: /ene!a* P!inci*es
of $ood H+%iene .CAC/"CP 1819>90.
3.3.3 S$ientifi$ and te$hni$al feasi"ilit!&In !io!iti4in% cont!o* measu!es fo! #a*idation, conside!ation s)ou*d -e %i#en
to an+ scientific and/o! tec)nica* c)a**en%es to #a*idatin% t)e measu!e. ()is 2ou*d inc*ude conside!ation of t)e
#a!ia-i*it+ associated 2it) t)e cont!o* measu!e -ein% #a*idated, t)e food -ein% conside!ed, and t)e )a4a!ds -ein%
cont!o**ed.
3.3.& Reso%r$es&Va*idation acti#ities ma+ -e !esou!ce intensi#e. Pa!ticu*a! #a*idation acti#ities, suc) as e5e!imenta*
t!ia*s, !ocess caa-i*it+ studies, su!#e+s, mat)ematica* mode**in%, !oduct o! en#i!onmenta* sam*in% and
ana*+tica* testin%, a!ticu*a!*+ 2)en a*ied in an a!o!iate statistica* fas)ion, !e1ui!e si%nificant !esou!ces. ()e
e5tent to 2)ic) sufficient !esou!ces a!e a#ai*a-*e and suc) acti#ities can -e unde!ta6en 2i** *ace *imits on t)e
a-i*it+ to de#e*o and #a*idate food safet+ cont!o* measu!es. Necessa!+ assistance .e.%. de#e*oment of
%uide*ines fo! indust!+, t!ainin% and tec)nica* assistance0, a!ticu*a!*+ to sma** and *ess8de#e*oed -usinesses,
!o#ided -+ nationa* and inte!nationa* o!%ani4ations cou*d )e* to e!fo!m #a*idation of food safet+ cont!o*
measu!es.
?( T3- VALIDATION PROC-SS
&.1A !an%e of a!oac)es to #a*idation can -e used to #a*idate t)e !ocess. ()e !ecise a!oac) 2i** deend, amon% ot)e!
t)in%s, on t)e natu!e of t)e )a4a!d, t)e natu!e of t)e !a2 in%!edients and !oduct, t)e t+e of cont!o* measu!es o! food
safet+ cont!o* s+stem se*ected to cont!o* t)e )a4a!d, and t)e intended st!in%enc+ of cont!o* of t)e )a4a!d.
&.2A!oac)es fo! #a*idatin% cont!o* measu!es8()e fo**o2in% a!oac)es to #a*idation ma+ -e used indi#idua**+ o! in
com-ination, as a!o!iate. ()ese a!e !esented in no a!ticu*a! o!de!.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. & of &'
&.3Referen$e to s$ientifi$ or te$hni$al literat%re; pre#io%s #alidation st%dies or histori$al <nowlede of the
performan$e of the $ontrol meas%re( Scientific o! tec)nica* info!mation needed to #a*idate cont!o* measu!es ma+, in
man+ instances, -e a#ai*a-*e f!om man+ sou!ces. ()ese inc*ude scientific *ite!atu!e, %o#e!nment %uidance, %uide*ines on
/HP and HACCP cont!o* measu!es 2it) a 6no2n )isto!+ of %ood e!fo!mance #a*idated -+ cometent aut)o!ities o!
indeendent scientific aut)o!ities, inte!nationa* standa!ds o! %uide*ines .e.%. Code5 A*imenta!ius0, and #a*idation studies
f!om indust!+ and/o! e1uiment manufactu!e!s. Ho2e#e!, if !e*+in% on suc) 6no2*ed%e, ca!e s)ou*d -e ta6en to ensu!e
t)at t)e conditions of a*ication in a food safet+ cont!o* s+stem a!e consistent 2it) t)ose identified in t)e scientific
info!mation e5amined. $o! ce!tain 2e**8esta-*is)ed !ocesses, it ma+ -e sufficient to ac1ui!e on*+ t)e data on t)e
conditions o! att!i-utes secific fo! t)e oe!ation in 1uestion.
&.3 S$ientifi$all! #alid e=perimental data that demonstrate the ade'%a$! of the $ontrol meas%re( La-o!ato!+ c)a**en%e
testin% desi%ned to mimic !ocess conditions and indust!ia* o! i*ot *ant t!ia*s of a!ticu*a! asects of a food !ocessin%
s+stem a!e #a*idation tec)ni1ues t)at a!e used common*+, a!ticu*a!*+ in food !ocessin% unit oe!ations. ?uantitati#e
demonst!ation and documentation of a!o!iate to !eduction/!e#ention/ e*imination of )a4a!d is an e5am*e of #a*idation
of a cont!o* measu!e -+ e5e!imenta* t!ia*s. Additiona* safet+ ma!%ins ma+ -e !e1ui!ed to account fo! t)e unce!taint+ o!
#a!ia-i*it+ of t)e cont!o* measu!e o! com-ination of cont!o* measu!es in ac)ie#in% t)e desi!ed *e#e* of cont!o* 2)en
im*emented in a fu** sca*e oe!ation.
&.& Colle$tion of data d%rin operatin $onditions in the whole food operation( <)en t)is a!oac) is used, -io*o%ica*,
c)emica* o! )+sica* data !e*atin% to t)e )a4a!ds of conce!n a!e co**ected fo! a secified e!iod .e.%. 38> 2ee6s of fu** sca*e
!oduction0 du!in% oe!atin% conditions !e!esentati#e of t)e 2)o*e food oe!ation, inc*udin% e!iods 2)e!e !oduction is
inc!eased, e.%. )o*ida+ !us). $o! e5am*e, 2)en t)e food safet+ cont!o* s+stem is contin%ent uon t)e use of %ood
#ete!ina!+ o! a%!icu*tu!a* !actices in t)e fie*d o! %ood )+%ienic !actices in t)e !ocessin% esta-*is)ment, it ma+ -e
necessa!+ to #a*idate t)ese measu!es t)!ou%) t)e use of inte!mediate/finis)ed !oduct and/o! en#i!onmenta* sam*in% and
testin%. Sam*in% s)ou*d -e -ased on t)e use of a!o!iate sam*in% tec)ni1ues, sam*in% *ans and testin%
met)odo*o%+. Data co**ected s)ou*d -e sufficient fo! t)e statistica* ana*+ses !e1ui!ed.
&.> .athemati$al modellin( @at)ematica* mode**in% is a means of mat)ematica**+ inte%!atin% scientific data on )o2 facto!s
affectin% t)e e!fo!mance of a cont!o* measu!e o! com-ination of cont!o* measu!es affect t)ei! a-i*it+ to ac)ie#e t)e
intended food safet+ outcome. ()is can a*so inc*ude t)e use of !is68-ased mode*s t)at e5amine t)e imact of a cont!o*
measu!e o! com-ination of cont!o* measu!es fu!t)e! a*on% t)e food c)ain. ;ffecti#e use of mat)ematica* mode**in% t+ica**+
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. > of &'
!e1ui!es t)at a mode* -e a!o!iate*+ #a*idated fo! a secific food a*ication. ()is ma+ !e1ui!e additiona* testin%.
Va*idation -ased on t)e use of mat)ematica* mode**in% s)ou*d ta6e into conside!ation t)e unce!taint+/#a!ia-i*it+ *imits
associated 2it) t)e mode*sA !edictions.
&.' S%r#e!s( Su!#e+s can -e used to #a*idate cont!o* measu!es, as a!o!iate, in con9unction 2it) ot)e! a!oac)es to
demonst!ate t)e e5ected *e#e* of cont!o* of )a4a!ds can -e ac)ie#ed. $o! e5am*e, an e#a*uation of consume!sA
unde!standin% of info!mation on t)e *a-e* !io! to o! du!in% t)e desi%n of a *a-e* can -e conside!ed a #a*idation a!oac)
fo! *a-e**in% as a cont!o* measu!e.9 Ca!e s)ou*d -e ta6en to ensu!e t)at statistica**+ #a*id su!#e+s o! ot)e! acti#it+ !o#ide
data t)at a!e accu!ate and a!o!iate fo! use -+ an indi#idua* Unit o! cometent aut)o!it+.
()e com-inations defined 2i** dete!mine t)e !e1ui!ement -ased on !actica* a*ications.
@( Steps In#ol#ed in the Validation Pro$ess
Afte! com*etin% t)e tas6s needed !io! to #a*idation, t)e !ocess of #a*idatin% cont!o* measu!es inc*udes t)e fo**o2in% stes:
>.1Decide on t)e a!oac) o! com-ination of a!oac)es.
>.2Define t)e a!amete!s and decision c!ite!ia t)at 2i** demonst!ate t)at a cont!o* measu!e o! com-ination of cont!o*
measu!es, if !oe!*+ im*emented, is caa-*e of consistent*+ cont!o**in% t)e )a4a!d to t)e secified outcome.
>.3Assem-*e !e*e#ant #a*idation info!mation and conduct t)e studies 2)e!e needed.
>.3Ana*+se t)e !esu*ts.
>.&Document and !e#ie2 t)e #a*idation.
"esu*ts of a #a*idation 2i** eit)e! demonst!ate t)at a cont!o* measu!e o! com-ination of cont!o* measu!es, is caa-*e of
cont!o**in% t)e )a4a!d to t)e secified outcome if !oe!*+ im*emented, and t)us, cou*d -e im*emented, o! is not caa-*e of
cont!o**in% t)e )a4a!d to t)e secified outcome and s)ou*d not -e im*emented.
()e *atte! ma+ *ead to !e8e#a*uation of !oduct fo!mu*ation, !ocess a!amete!s, o! ot)e! a!o!iate decisions/actions.
Info!mation %ained in t)e #a*idation !ocess ma+ -e usefu* in desi%nin% #e!ification and monito!in% !ocedu!es. $o! e5am*e, if
a cont!o* measu!e o! com-ination of cont!o* measu!es !oduces a !eduction of a at)o%en 2e** in e5cess of t)e !eduction
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. ' of &'
needed fo! )a4a!d cont!o*, it ma+ -e ossi-*e to dec!ease t)e f!e1uenc+ of #e!ification e.%. f!e1uenc+ of
c)emica*/@ic!o-io*o%ica* testin% of end !oduct.
A( N--D FOR R-&VALIDATION
'.1()e!e a!e man+ c)an%es t)at cou*d *ead to a need to !e8#a*idate a cont!o* measu!e o! com-ination of cont!o* measu!es. It
ma+ -e in fo**o2in% instances suc) as
'.2S!stem fail%re+ If monito!in% o! #e!ification identifies fai*u!es fo! 2)ic) a !ocess de#iation cause cannot -e identified, !e8
#a*idation ma+ -e needed. Non8com*iance 2it) monito!in% o! #e!ification c!ite!ia ma+ indicate a need fo! a c)an%e in t)e
a!amete!s .i.e., t)e se*ection and secification of t)e cont!o* measu!es0 on 2)ic) t)e desi%n of t)e food safet+ cont!o*
s+stem is -ased. A s+stem fai*u!e ma+ a*so !esu*t f!om an inade1uate )a4a!d ana*+sis and ma+ !e1ui!e !e8#a*idation.
'.3Pro$ess $hanes+ ()e int!oduction in t)e food safet+ cont!o* s+stem of a ne2 cont!o* measu!e, tec)no*o%+ o! a iece of
e1uiment t)at is *i6e*+ to )a#e a decisi#e imact on t)e cont!o* of t)e )a4a!d ma+ necessitate t)at t)e s+stem o! a!ts of it
-e !e8#a*idated. Simi*a!*+, c)an%es made in !oduct fo!mu*ation o! t)e a*ication of cu!!ent cont!o* measu!es .e.%.
time/teme!atu!e c)an%es0 ma+ !esu*t in t)e need fo! !e8#a*idation of cont!o* measu!es.
'.3New s$ientifi$ or re%lator! information+ "e8#a*idation ma+ -e needed if t)e )a4a!d associated 2it) a food o! in%!edient
c)an%es as a !esu*t of
a0 )i%)e! concent!ations of )a4a!ds t)an o!i%ina**+ encounte!ed and accounted fo! in t)e desi%n,
-0 a c)an%e in !esonse of a )a4a!d to cont!o* .e.%. adatation0,
c0 eme!%ence of a !e#ious*+ unidentified )a4a!d,
d0 ne2 info!mation indicatin% t)at t)e )a4a!d is not -ein% cont!o**ed to t)e *e#e* secified .e.%. ne2 eidemio*o%ica*
findin%s o! ne2 #a*idated and inte!nationa**+ acceted ana*+tica* tec)no*o%ies 0 o!
e0 a ne2 food safet+ outcome.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. B of &'
VALIDATION OF CONTROL .-ASUR- FOR
CCP&B) 4C C3-C9>ONLIN- COTTL- INSP-CTION 2USL>3ACCP>CCP>B85
3ADARD TEP-+ P3ESICAL
ST-P CC&)?
A0 Pre&#alidation Tas<s+
a. 3a:ard+ C)ances of assin% fo!ei%n matte! )a4a!dous to )uman )ea*t) due to missed insection o! %ene!ated du!in%
)and*in%.
-. Food Safet! O%t$ome+ ()e!e s)ou*d -e no fo!ei%n matte! )a4a!dous to )uman )ea*t).
c. Control .eas%re+ ;nsu!in% !oe! insection and e!iodic #e!ification and #a*idation of insection oints e!sons.
Pe!iodic !e*acement of tu-e *i%)ts at insection oints. Ve!ification of t)e *i%)t intensit+ .1000 *u5/m
2
0 annua**+ to ensu!e
t)e ade1uac+ of *i%)t. (!ained insecto!s, e!iodic e+e si%)t c)ec6s and Ca*i-!ation of insectin% e!son and ensu!in%
t)e -ac6%!ound and *i%)t intensit+ of minimum 1000 *u5 etc to identif+ t)e fo!ei%n o-9ect unde! stud+.
=0 Approa$h+
a( Colle$tion of data d%rin normal operation&Data fo! Inte! da+ and int!ada+ stud+ 2i** -e co**ected fo! & Da+s and &
sam*es eac) da+ fo! one da!6 co*o!ed !oduct and one t!ansa!ent !oduct 2it)out info!min% to -ott*e insecto!.
"( Literat%re reardin the ha:ard asso$iated and ade'%a$! of $ontrol meas%re with anal!sed data &As e! US $DA
$oods a!e conside!ed adu*te!ated if: ()e !oduct contains a )a!d o! s)a! fo!ei%n o-9ect t)at measu!es ' mm to 2& mm,
in *en%t), and ()e !oduct is !ead+8to8eat, o! acco!din% to inst!uctions o! ot)e! %uidance o! !e1ui!ements, it !e1ui!es on*+
minima* !ea!ation stes, e.%., )eatin%, t)at 2ou*d not e*iminate, in#a*idate, o! neut!a*i4e t)e )a4a!d !io! to
consumtion .$DA, 19990. No meta* f!a%ments in finis)ed !oduct. .Note: $DACs Hea*t) Ha4a!d ;#a*uation =oa!d )as
suo!ted !e%u*ato!+ action a%ainst !oduct 2it) meta* f!a%ments of 0.3D E' mmF to 1.0D E2&mmF in *en%t). See a*so $DA
Com*iance Po*ic+ /uide G&&&.32&.0, o! No -!o6en o! missin% meta* a!ts f!om e1uiment at t)e CCPs fo! Dmeta*
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
inc*usionD .$DA, 2001a0. No %*ass f!a%ments in finis)ed !oduct. .Note: $DACs Hea*t) Ha4a!d ;#a*uation =oa!d )as
suo!ted !e%u*ato!+ action a%ainst !oducts 2it) %*ass f!a%ments of 0.3D E' mmF to 1.0D E2& mmF in *en%t). See a*so $DA
Com*iance Po*ic+ /uide G&&&.32&.0 No -!o6en %*ass at t)e CCPs fo! D%*ass inc*usionD .$DA, 2001-0.
$( USL 3istori$al 9nowlede a"o%t the performan$e of $ontrol meas%re of inspe$tion(
3( Parameters and De$ision Criteria
Cont!o* measu!e 2i** -e conside!ed #a*idated if on*ine insection indicates t)at insection 2i** ensu!e detection of t)e fo!ei%n
matte! )a!dous to )uman )ea*t) fo! fo!ei%n o-9ect si4es unde! stud+
3. Assem"le rele#ant #alidation information(
;nsu!in% !oe! insection and e!iodic #e!ification and #a*idation of insection oints e!sons. Pe!iodic !e*acement of tu-e
*i%)ts at insection oints. Ve!ification of t)e *i%)t intensit+ 1000 *u5/m
2
annua**+ to ensu!e t)e ade1uac+ of *i%)t. (!ained
insecto!s, e!iodic e+e si%)t c)ec6s and Ca*i-!ation of insectin% e!son and ensu!in% t)e 2)ite -ac6%!ound and *i%)t intensit+
of minimum 1000 *u5 etc
a0 Conductin% stud+ fo! & sam*es fo! & da+s to ensu!e fo!ei%n matte! )a4a!dous to )uman )ea*t) is %ettin% detected. A
%*ass iece measu!in% #a!ious si4es !an%in% f!om 1 mm to 10 mm and meta* iece of si4e 1 mm to 10 mm is se*ected fo!
stud+. One dar< $olored prod%$t and one transparent $olored prod%$t to -e se*ected fo! stud+
-0 ;+esi%)t c)ec6s to -e ca!!ied out fo! t)e insecto! -efo!e stud+ and if a*!ead+ c)ec6s a!e conducted !eo!t to -e
attac)ed fo! t)is #a*idation.
c0 Li%)t intensit+ to -e measu!ed -efo!e t)e stud+ and !e*e#ant )isto!ica* communication data to -e co**ected. $o! *i%)t
intensit+. Li%)t intensit+ is -ased t)e !oduct co*o! and -ac6 %!ound co*o! of t)e insection a!ea and t)e a-i*it+ to identif+
t)e fo!ei%n matte!.
d0 Ca*i-!ation of e!son o! #a*idation of t)e e!son -+ coma!in% insection caa-i*ities 2it) 6no2n addition and un6no2n
addition.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
&( Anal!sis of the res%lts
$o**o2in% stud+ is ca!!ied out fo! fo!ei%n o-9ect of si4e 1810 mm one 2it)out info!min% t)e -ott*e insecto!
$o! da!6 Co*o! !oduct.
P!oduct Name:
Da+81
@eta* Sam*e Sam*e 1 Sam*e 2 Sam*e 3 Sam*e 3 Sam*e &
Li%)t Intensit+ in Lu5 at insection
oint
1000
;+esi%)t of t)e Insecto! c)ec6ed
once In Hea! <!ite Hes o! No
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
<)et)e! it is %ettin% detected <!ite H;S if %ets detected <!ite N7 if not detected -+
=ott*e insecto! du!in%
1 1 mm
2 2 mm
3 3 mm
3 3 mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
& & mm
> > mm
' ' mm
B B mm
9 9 mm
10 10 mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
Da+82
oint
1000
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
1 1 mm
2 2 mm
3 3 mm
3 3 mm
& & mm
> > mm
' ' mm
B B mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
9 9 mm
10 10 mm
Da+83
oint
1000
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
1 1 mm
2 2 mm
3 3 mm
3 3 mm
& & mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
> > mm
' ' mm
B B mm
9 9 mm
10 10 mm
Da+83
oint
1000
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
1 1 mm
2 2 mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. 1& of &'
3 3 mm
3 3 mm
& & mm
> > mm
' ' mm
B B mm
9 9 mm
10 10 mm
Da+8&
oint
1000
Hes
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. 1> of &'
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
1 1 mm
2 2 mm
3 3 mm
3 3 mm
& & mm
> > mm
' ' mm
B B mm
9 9 mm
10 10 mm
Stud+ ca!!ied out -+:
>. Do$%ment and re#iew the #alidation details
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. 1' of &'
a0 Va*idation stud+ !otoco* and !esu*ts fo! diffe!ent si4e of meta* and %*ass iece .1810 mm0 of t)e fo!ei%n o-9ects
)a4a!dous to )uman )ea*t)
-0 ;+esi%)t c)ec6s !eco!d fo! -ott*e insecto!.
c0 Li%)t intensit+ at insection oint
'. Con$l%sion
a0 Cont!o* measu!e of on*ine insection fo! fo!ei%n matte! )a4a!dous to )uman )ea*t) is #a*idated as
t)e inte! da+ and int!a da+ stud+ conducted !esu*ted in 100 I detection of t)e fo!ei%n matte! of si4es
!an%in% f!om 1 mm to 10 mm.
-0 ()e 7n*ine Insection can -e used afte! t)e #a*idation as an on8%oin% #e!ification acti#it+ to ensu!e
t)at t)e fo!ei%n matte! )a4a!dous to )uman )ea*t) is cont!o**ed as intended.
Va*idation Conducted -+:
S.N7. Name of t)e Va*idation (eam @em-e! Si%n
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. 1B of &'
OPRP&B) R-C-IVIN* OF RA7 7AT-R
2CANAL 7AT-R>DA. 7AT-R>COR- 7-LL 7AT-R>TAN9-R>.UNICIPAL 7AT-R5
3ADARD TEP-&C3-.ICAL
ST-P 7&)
a. 3a:ard+ C)ances of C)emica* contamination *i6e Pesticide "esidue, /an+ ot)e! un82anted c)emica* Hea#+ @eta*s in t)e 2ate! !ecei#ed f!om
diffe!ent sou!ces. Contamination Limits not matc)in% to t)e IS 10&00:2012
-. Food Safet! O%t$ome+ Sam*e f!om Sou!ce of 2ate! ensu!e com*iance to IS 10&00:2012 Secification fo! D!in6in% 2ate!
c. Control .eas%re+ <ate! is !ecei#ed f!om A!o#ed !esou!ces on*+. <ate! is tested f!om ;5te!na* sou!ces as e! IS 10&00 f!om NA=L
A!o#ed ;5te!na* La-o!ato!+ at once in +ea! o! 2)en t)e!e is Ne2 sou!ce int!oduced. A!ea secu!it+ measu!es to !e#ent intentiona*
contamination communication and im*ementation
C5 Approa$h+
d( Colle$tion of res%lt of e=ternal la"orator! anal!sis of water sample
e( Literat%re reardin the ha:ard asso$iated ph!si$al; $hemi$al and mi$ro"ioloi$al parameters F
f( USL 3istori$al 9nowlede a"o%t the performan$e of $ontrol meas%re of inspe$tion(
( S$ientifi$ literat%re on ha:ards asso$iated with water(
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
8 As e! $SSAI !u*es, 2011 2ate! s)ou*d ota-*e and o!%ani4ation )as conside!ed t)e ";$;";NC;: =IS 10&00: 2012:
D"INJIN/ <A(;" K SP;CI$ICA(I7NS .S;C7ND ";VISI7N0
8 P!e#ious Histo!ica* e5e!ience
8 http://www.who.int/water_sanitation_health/dwq/9241546301_chap2.pdf
8 D!in6in% <ate! Standa!ds K (est Pa!amete!s L $!e1uenc+ Ci!cu*a! Comi*ed: H7 ?ua*it+, Sandee =ansa* $e-A2013
and communicated to Units
Cont!o* measu!e 2i** -e conside!ed #a*idated if t)e 2ate! sam*e ana*+sed meets t)e c!ite!ia as e! IS10&00:2012
(est !eo!t of t)e e5te!na* *a-o!ato!+ as e! IS 10&00:2012
Sou!ce Name:
S.N7. (est Pa!amete! IS 10&00:2012
"efe!ence *imit
Com*iance
Hes o! No
"ema!6 if
noncom*+in% and
fu!t)e! actions
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
Ve!ification ca!!ied out -+:
a. "e#ie2 and #e!ification of t)e !eo!t of e5te!na* *a- 2it) IS10&00:2012
'. Con$l%sion
Cont!o* @easu!e of c)ec6in% t)e sou!ces of 2ate! su*+ is #a*idated as it meets t)e standa!d !e1ui!ement of IS 10&00 2012
and %i#es assu!ance to ensu!e !e#ention and cont!o* of c)emica* )a4a!ds t)!ou%) 2ate!.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
OPRP&B, COTTL- 7AS3IN* 2USL>3ACCP>OPRP>B?5
ST-P C7&)
C0 Pre&#alidation Tas<s+
d. 3a:ard+ C)ances of assin% fo!ei%n matte! )a4a!dous to )uman )ea*t) due to im!oe! -ott*e 2as)in%.
e. Food Safet! O%t$ome+ ()e!e s)ou*d -e no fo!ei%n matte! )a4a!dous to )uman )ea*t) afte! -ott*e 2as)in%
f. Control .eas%re+ C)ec6in% fo! fo!ei%n o-9ect #isua**+. C)ec6in% of !insin% 2ate! !essu!e !e%u*a!*+. P!e#enti#e
maintenance c)ec6s fo! t)e -ott*e 2as)e!, insection of 2as)ed -ott*es !io! to use and fu!t)e! sta%es fina* insection
2i** ensu!e !e#ention of food safet+ )a4a!d in !oduct. Pe!iodic ca*i-!ation of t)e insection e!son and ensu!e *i%)t
intensit+ of minimum 2&0 *u5.
D0 Approa$h+
h( Colle$tion of data d%rin normal operation&Data fo! Inte! da+ and int!ada+ stud+ 2i** -e co**ected fo! & Da+s and &
sam*es eac) da+ fo! 2as)ed -ott*es 2it)out info!min% to -ott*e insecto!.
i( Literat%re reardin the ha:ard asso$iated and ade'%a$! of $ontrol meas%re with anal!sed data &As e! US $DA
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
G( USL 3istori$al 9nowlede a"o%t the performan$e of $ontrol meas%re of inspe$tion(
Cont!o* measu!e 2i** -e conside!ed #a*idated if 2as)in% and #isua* insection indicates cont!o* measu!e 2i** ensu!e detection of
t)e fo!ei%n matte! )a!dous to )uman )ea*t) fo! fo!ei%n o-9ect
;nsu!in% !oe! insection and e!iodic #e!ification and #a*idation of insection oints e!sons. Pe!iodic !e*acement of tu-e
*i%)ts at insection oints. Ve!ification of t)e *i%)t intensit+ @inimum 2&0 *u5/m
2
annua**+ to ensu!e t)e ade1uac+ of *i%)t. (!ained
insecto!s, e!iodic e+e si%)t c)ec6s and Ca*i-!ation of insectin% e!son and ensu!in% t)e 2)ite -ac6%!ound and *i%)t intensit+
of minimum 2&0 *u5 etc
e0 Conductin% stud+ fo! & sam*es fo! & da+s to ensu!e fo!ei%n matte! )a4a!dous to )uman )ea*t) is %ettin% detected. A
%*ass iece measu!in% #a!ious si4es !an%in% f!om 1 mm to 10 mm and meta* iece of si4e 1 mm to 10 mm is se*ected fo!
stud+. ()e fo!ei%n o-9ect is added -efo!e 2as)in% and #isua* insection is ca!!ied out to #e!if+ it is %ettin% !emo#ed
du!in% 2as)in%.
f0 ;+esi%)t c)ec6s to -e ca!!ied out fo! t)e insecto! -efo!e stud+ and if a*!ead+ c)ec6s a!e conducted !eo!t to -e
attac)ed fo! t)is #a*idation.
%0 Li%)t intensit+ to -e measu!ed -efo!e t)e stud+ and !e*e#ant )isto!ica* communication data to -e co**ected. $o! *i%)t
intensit+. Li%)t intensit+ is 6et minimum 2&0 as -ott*es 2i** -e emt+.
)0 Ca*i-!ation of e!son o! #a*idation of t)e e!son -+ coma!in% insection caa-i*ities 2it) 6no2n addition and un6no2n
addition.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o**o2in% stud+ is ca!!ied out fo! fo!ei%n o-9ect of si4e 1810 mm one 2it)out info!min% t)e -ott*e insecto!
=ott*e t+e si4e etc:
Da+81
oint
1000
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
<)et)e! it is %ettin% !emo#ed <!ite H;S, <!ite N7 if not %ettin% !emo#ed -+ =ott*e
2as)in% and not detected afte! -ott*e 2as)in%
1 1 mm
2 2 mm
3 3 mm
3 3 mm
& & mm
> > mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
' ' mm
B B mm
9 9 mm
10 10 mm
Da+82
oint
1000
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
1 1 mm
2 2 mm
3 3 mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
3 3 mm
& & mm
> > mm
' ' mm
B B mm
9 9 mm
10 10 mm
Da+83
oint
1000
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
1 1 mm
2 2 mm
3 3 mm
3 3 mm
& & mm
> > mm
' ' mm
B B mm
9 9 mm
10 10 mm
Da+83
oint
1000
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
1 1 mm
2 2 mm
3 3 mm
3 3 mm
& & mm
> > mm
' ' mm
B B mm
9 9 mm
10 10 mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
Da+8&
oint
1000
Hes
Sam*e
No.
Si4e of t)e fo!ei%n
o-9ect /mate!ia*
1 1 mm
2 2 mm
3 3 mm
3 3 mm
& & mm
> > mm
' ' mm
B B mm
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
9 9 mm
10 10 mm
d0 Va*idation stud+ !otoco* and !esu*ts fo! diffe!ent si4e of meta* and %*ass iece .1810 mm0 of t)e fo!ei%n o-9ects
)a4a!dous to )uman )ea*t)
e0 ;+esi%)t c)ec6s !eco!d fo! -ott*e insecto!.
f0 Li%)t intensit+ at insection oint
'. Con$l%sion
c0 Cont!o* measu!e of -ott*e 2as)in% and identification fo! fo!ei%n matte! )a4a!dous to )uman )ea*t)
afte! -ott*e 2as)in% is #a*idated as t)e inte! da+ and int!a8da+ stud+ conducted !esu*ted in 100 I
!emo#a* of t)e fo!ei%n matte! of si4es !an%in% f!om 1 mm to 10 mm.
d0 ()e 7n*ine Insection can -e used afte! t)e #a*idation as an on8%oin% #e!ification acti#it+ to ensu!e
t)at t)e fo!ei%n matte! )a4a!dous to )uman )ea*t) is cont!o**ed as intended.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
OPRP&B6 R-C-IVIN* OF N-7>OLD *LASS COTTL-S>P-T COTTL-S
3ADARD TEP-&C3-.ICAL
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
ST-P *C&)>ST-P U*C&)
a. 3a:ard+ C)ances of C)emica* contamination *i6e oi*/%!ease o! an+ un2anted c)emica*/odou! o! im!oe! 1ua*it+ of =ott*e/)a4a!dous to )uman
)ea*t) No C)emica* !esidues )a4a!dous to )uman )ea*t) @i%!ation ce!tificate fo! com*iance to mi%!ation test fo! P;( -ott*e as e! IS: 122&2 8
Secification fo! Po*+ a*6+*ene te!e)at)a*ates
-. Food Safet! O%t$ome+ Sam*e f!om Sou!ce of 2ate! ensu!e com*iance to IS 10&00:2012 Secification fo! D!in6in% 2ate!
c. Control .eas%re+ <ate! is !ecei#ed f!om A!o#ed !esou!ces on*+. <ate! is tested f!om ;5te!na* sou!ces as e! IS 10&00 f!om NA=L
A!o#ed ;5te!na* La-o!ato!+ at once in +ea! o! 2)en t)e!e is Ne2 sou!ce int!oduced. A!ea secu!it+ measu!es to !e#ent intentiona*
contamination communication and im*ementation
C5 Approa$h+
<( Colle$tion of res%lt of e=ternal la"orator! anal!sis of report from S%pplier for .iration test as per IS+ ),,?,
l( Literat%re reardin the ha:ard asso$iated P-T "ottles
m( USL 3istori$al 9nowlede a"o%t the performan$e of $ontrol meas%re of inspe$tion(
n( S$ientifi$ literat%re on ha:ards asso$iated with water(
Cont!o* measu!e 2i** -e conside!ed #a*idated if t)e 2ate! sam*e ana*+sed meets t)e c!ite!ia as e! IS+ ),,?,
In )ouse stud+ and Com*iance t)!ou%) #e!ification of C7A and mi%!ation test !eo!t.
IS: 122&2 Secification fo! Po*+ a*6+*ene te!e)at)a*ates and P!e#ious Histo!ica* e5e!ience
(est !eo!t of t)e e5te!na* *a-o!ato!+ as e! IS+ ),,?,
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
Sou!ce Name:
S.N7. (est Pa!amete! IS+ ),,?, "efe!ence
*imit
Com*iance
Hes o! No
"ema!6 if
noncom*+in% and
fu!t)e! actions
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
"eo!t Ve!ification ca!!ied out -+:
a. "e#ie2 and #e!ification of t)e !eo!t of e5te!na* *a- 2it) IS+ ),,?,
'. Con$l%sion
Cont!o* @easu!e of ensu!in% mate!ia* com*ies 2it) IS: 122&2 and )isto!ica* e5e!ience is #a*idated as it meets t)e standa!d
!e1ui!ement of IS+ ),,?, and %i#es assu!ance to ensu!e !e#ention and cont!o* of c)emica* )a4a!ds t)!ou%) P;( -ott*es.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
OPRP&B8 FILTRATION )B .ICRON 2Cartride .i$ron Filter5 2USL>3ACCP>OPRP>B?5
ST-P CC&))
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
;0 Pre&#alidation Tas<s+
%. 3a:ard+ C)ances of assin% fo!ei%n matte! )a4a!dous to )uman )ea*t) due to dama%ed fi*te!s.
). Food Safet! O%t$ome+ ()e!e s)ou*d -e no fo!ei%n matte! )a4a!dous to )uman )ea*t) afte! fi*t!ation
i. Control .eas%re+ P!essu!e d!o c)ec6in% t)!ou%) ca*i-!ated !essu!e %au%e and f*o2 !ate c)ec6in%, c)an%in% of fi*te!
as and 2)en !e1ui!ed. P!e#ious ste of sa!6*e fi*te! 2it) !o#ision of non8 !etu!n #a*#e in outf*o2 *ine to a#oid fi*t!ation
-ed distu!-ance f!om t)e !etu!ned *i1uo! du!in% o2e! t!iin%.
$0 Approa$h+
o( Colle$tion of data d%rin normal operation&Data fo! Inte! da+ and int!ada+ stud+ 2i** -e co**ected fo! & Da+s and &
sam*es eac) da+ fo! fi*t!ation, !essu!e d!o c)ec6s
p( Literat%re reardin the ha:ard asso$iated and ade'%a$! of $ontrol meas%re with anal!sed data &As e! US $DA
'( USL 3istori$al 9nowlede a"o%t the performan$e of $ontrol meas%re of inspe$tion whene#er there is damae to
filter press%re drops
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
Cont!o* measu!e 2i** -e conside!ed #a*idated if fi*t!ation 2it) 10 mic!on as cont!o* measu!e 2i** ensu!e !e#ention of t)e fo!ei%n
matte! )a!dous to )uman )ea*t) fo! fo!ei%n o-9ect and fu!t)e! stes of insection
a. C)ec6in% t)e fi*te! inte%!it+ and !essu!e d!o a*on% 2it) fu!t)e! stes of insection fo! fo!ei%n o-9ects at -ott*e insection
oint.
$o**o2in% stud+ is ca!!ied out fo! fi*te! inte%!it+, f*o2 !ate and !essu!e d!o du!in% !outine !ocess oe!ations fo! & fi*te!s at
diffe!ent *ocation
$i*te! t+e
Location:
Pa!amete! Da+ 1 Da+ 2 Da+ 3 Da+ 3 Da+ &
P!essu!e <!ite t)e !essu!e at t)e
time of insection 0 )ou!s
time of insection B )ou!s
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
time of insection 1> )ou!s
$i*te! inte%!it+ <!ite 7J if not
dama%ed. <!ite Dama%ed if found
to -e dama%ed.
$i*te! t+e
Location:
P!essu!e <!ite t)e !essu!e at t)e time
of insection 0 )ou!s
of insection B )ou!s
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
of insection 1> )ou!s
$i*te! inte%!it+ <!ite 7J if not dama%ed.
<!ite Dama%ed if found to -e dama%ed.
$i*te! t+e
Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
to -e dama%ed.
$i*te! t+e
Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
to -e dama%ed.
$i*te! t+e
Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
to -e dama%ed.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
%0 Va*idation stud+ !otoco* and !esu*ts indicates t)at t)e fi*te! !essu!e monito!in% e!iodica**+ at 3 )ou!s
'. Con$l%sion
e0 Cont!o* measu!e of -ott*e 2as)in% and identification fo! fo!ei%n matte! )a4a!dous to )uman )ea*t)
afte! -ott*e 2as)in% is #a*idated as t)e inte! da+ and int!a8da+ stud+ conducted !esu*ted in 100 I
!emo#a* of t)e fo!ei%n matte! of si4es !an%in% f!om 1 mm to 10 mm.
f0 ()e 7n*ine Insection can -e used afte! t)e #a*idation as an on8%oin% #e!ification acti#it+ to ensu!e t)at
t)e fo!ei%n matte! )a4a!dous to )uman )ea*t) is cont!o**ed as intended.
OPRP&B? FILLIN*>COTTLIN*
ST-P CC&)6
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
/0 Pre&#alidation Tas<s+
9. 3a:ard+ C)ances of /*ass a!tic*es in -ott*e du!in% fi**in% due to %*ass -!ea6a%e o! nec6 c)iin% and fo!ei%n matte!
)a4a!dous to )uman )ea*t) du!in% fi**in%
6. Food Safet! O%t$ome+ ()e!e s)ou*d -e no fo!ei%n matte! )a4a!dous to )uman )ea*t) afte! fi**in%/-ott*in%
*. Control .eas%re+ A#oidin% t)e %*ass contact 2it) meta*. "emo#a* of t)e -!o6en %*ass/C)ied -ott*es and )and*in%
%*ass -!ea6a%e as e! %*ass -!ea6a%e )and*in% !ocedu!e. P!e#enti#e maintenance of fi**e! as e! !e#enti#e
maintenance sc)edu*e and. Ve!ification of fi**in% no44*es/(ef*on !in%s condition -efo!e sta!t of t)e oe!ation. @aintainin%
!oe! !essu!e du!in% fi**in%.
H0 Approa$h+
r( Colle$tion of data d%rin normal operation&Data fo! Inte! da+ and int!ada+ stud+ 2i** -e co**ected fo! & Da+s and &
sam*es eac) da+ fo! #e!ification of t)e %*ass contact 2it) meta*, !emo#a* o! -!o6en %*ass/c)ied -ott*es and )and*in%
%*ass -!e6a%e as e! %*ass -!ea6a%e )and*in% !ocedu!e. P!e#enti#e maintenance of fi**e! as e! !e#enti#e
maintenance sc)edu*e and. Ve!ification of fi**in% no44*es/(ef*on !in%s condition -efo!e sta!t of t)e oe!ation. @aintainin%
!oe! !essu!e du!in% fi**in%
s( Literat%re reardin the ha:ard asso$iated and ade'%a$! of $ontrol meas%re with anal!sed data &As e! US $DA
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
t( USL 3istori$al 9nowlede a"o%t the performan$e of $ontrol meas%re of inspe$tion whene#er there is no
!e#enti#e maintenance of fi**e! as e! !e#enti#e maintenance sc)edu*e im!oe! #e!ification of fi**in% no44*es/(ef*on
!in%s condition -efo!e sta!t of t)e oe!ation and not @aintainin% !oe! !essu!e du!in% fi**in% inc!ease c)ance of dama%e
and fa**in% c)iin% into t)e !oduct. Com*iance to a!amete! mentioned ensu!es !e#ention and cont!o* of t)e )+sica*
)a4a!ds.
Cont!o* measu!e 2i** -e conside!ed #a*idated if !e#enti#e maintenance of fi**e! as e! !e#enti#e maintenance sc)edu*e and.
Ve!ification of fi**in% no44*es/(ef*on !in%s condition -efo!e sta!t of t)e oe!ation, maintainin% !oe! !essu!e du!in% fi**in% ensu!e
!e#ention and cont!o* of )+sica* )a4a!ds
a. P!e#enti#e maintenance of fi**e! as e! !e#enti#e maintenance sc)edu*e. Ve!ification !eo!t of fi**in% no44*es/(ef*on !in%s
condition -efo!e sta!t of t)e oe!ation, maintainin% !oe! !essu!e du!in% fi**in% ensu!e !e#ention and cont!o* of )+sica*
)a4a!ds
$o**o2in% stud+ is ca!!ied out fo! #a*idation of t)e oe!ationa* !e!e1uisite !o%!amme
$i**e! Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
P!e#enti#e maintenance sc)edu*e
of fi**e! ca!!ied out Hes/No
Ve!ification !eo!t on no44*e/(ef*on
!in%s condition -efo!e sta!t of t)e
oe!ation
P!essu!e of fi**in%
Ve!ification of t)e -ott*es -efo!e
fi**in% fo! insection of fo!ei%n
o-9ect )a4a!dous to )uman )ea*t).
at insection oints
<!ite detai* if an+ fo!ei%n o-9ect
suc) as %*ass c)iin% is found
Ve!ification of t)e fi**ed -ott*es fo!
fo!ei%n o-9ect )a4a!dous to )uman
)ea*t) at 7n*ine -ott*e insection
"ema!6
$i**e! Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
oe!ation
P!essu!e of fi**in%
at insection oints
"ema!6
$i**e! Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. &0 of &'
oe!ation
P!essu!e of fi**in%
at insection oints
"ema!6
$i**e! Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
oe!ation
P!essu!e of fi**in%
at insection oints
"ema!6
$i**e! Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
oe!ation
P!essu!e of fi**in%
at insection oints
"ema!6
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
)0 Va*idation stud+ !otoco* and !esu*ts indicates t)at t)e Cont!o* measu!e of !e#enti#e maintenance, #e!ification of t)e
no44*es -efo!e use, maintainin% fi**e! !essu!e a*on% 2it) on*ine insection ste ensu!e !e#ention and cont!o* of )+sica*
)a4a!d.
'. Con$l%sion
a0 Cont!o* measu!e of !e#enti#e maintenance, #e!ification of t)e no44*es -efo!e use, maintainin% fi**e! !essu!e a*on% 2it)
on*ine insection ste ensu!e !e#ention and cont!o* of )+sica* )a4a!d is #a*idated as du!in% stud+ no fo!ei%n o-9ect
suc) as %*ass c)iin% 2as e#ident.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$i*te! t+e
Location:
to -e dama%ed.
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. && of &'
$i*te! t+e
Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. &> of &'
to -e dama%ed.
$i*te! t+e
Location:
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5
$o!m Pa%e No. &' of &'
to -e dama%ed.
Referen$e for Validation
)( *UID-LIN-S FOR T3- VALIDATION OF FOOD SAF-TE CONTROL .-ASUR-S CAC>*L @H &
,BBI
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
CLASS&C
2From 3O 4%alit!5

09 - Validation of CCP & OPRP

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

09 - Validation of CCP & OPRP

Uploaded by

Copyright:

Available Formats

VALIDATION FOR CCP & OPRP

Document No. USL/HACCP/VP/09

You might also like