09_Validation of CCP & OPRP

8/11/2019 09_Validation of CCP & OPRP

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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 $ontrol points and operational prere'%isite prorammes( The Validation %ideline is in$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+steme.%. HACCP, HP.

1.3()e too*s, tec)niues, and statistica* !inci*es t)at ou*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.Ad#ice on secific a*ications s)ou*d -e acui!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 )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 anacceta-*e *e#e*.

2.2Food Safet! Control S!stem+ ()e com-ination of cont!o* measu!es t)at, )en ta6en as )o*e, ensu!es t)at food is safe

fo! its intended use.

2.3.onitorin+ ()e act of conductin% a *anned seuence of o-se!#ations o! measu!ements of cont!o* a!amete!s to assess)et)e! a cont!o* measu!e is unde! cont!o*.

2.Validation+ 7-tainin% e#idence t)at a cont!o* measu!e o! com-ination of cont!o* measu!es, if !oe!*+ im*emented, iscaa-*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)et)e! a cont!o* measu!e is o! )as -een oe!atin% as intended.

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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 todete!mine )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 !eui!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! )en c)an%esindicate t)e need fo! !e8#a*idation. Va*idation of cont!o* measu!es is, )ene#e! ossi-*e, e!fo!med -efo!e t)ei! fu**im*ementation.

8( TAS9S PRIOR TO VALIDATION OF CONTROL .-ASUR-S

.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 -eaccom*is)ed effecti#e*+ and efficient*+.

.2()e fo**oin% tas6s cou*d -e ca!!ied out eit)e! indeendent*+ o! in conunction it) t)e esta-*is)ment of HPs, HACCP,etc.

.3(as6s !io! to #a*idation inc*ude:

.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!onmentconce!ned, ta6in% into account a** !e*e#ant info!mation, inc*udin% info!mation f!om a !is6 assessment.

.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

a+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 cometentaut)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+ outcomeso! 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 Identifi$ation of the meas%res that are to "e #alidated; ta


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.3.3.2


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$o!m Pa%e No. of &'

..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!minet)ei! uantitati#e effect on secific )a4a!ds ma+ not a*a+s -e conside!ed !io!it+ fo! #a*idation. ;5am*es ofsuc) cont!o* measu!es inc*ude ai! *oc6s to minimi4e c!oss contamination, )and as)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*esof $ood H+%iene CAC/"CP 1819>9.

.. 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#ento an+ scientific and/o! tec)nica* c)a**en%es to #a*idatin% t)e measu!e. ()is ou*d inc*ude conside!ation of t)e#a!ia-i*it+ associated it) t)e cont!o* measu!e -ein% #a*idated, t)e food -ein% conside!ed, and t)e )a4a!ds -ein%

cont!o**ed...& Reso%r$esVa*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% andana*+tica* testin%, a!ticu*a!*+ )en a*ied in an a!o!iate statistica* fas)ion, !eui!e si%nificant !esou!ces. ()ee5tent to )ic) sufficient !esou!ces a!e a#ai*a-*e and suc) acti#ities can -e unde!ta6en i** *ace *imits on t)ea-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* assistance, 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) i** deend, amon% ot)e!t)in%s, on t)e natu!e of t)e )a4a!d, t)e natu!e of t)e !a in%!edients and !oduct, t)e t+e of cont!o* measu!es o! foodsafet+ 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**oin% a!oac)es to #a*idation ma+ -e used indi#idua**+ o! incom-ination, as a!o!iate. ()ese a!e !esented in no a!ticu*a! o!de!.

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$o!m Pa%e No. > of &'

!eui!es t)at a mode* -e a!o!iate*+ #a*idated fo! a secific food a*ication. ()is ma+ !eui!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+ *imitsassociated it) t)e mode*s !edictions.

&.' S%r#e!s( Su!#e+s can -e used to #a*idate cont!o* measu!es, as a!o!iate, in conunction it) ot)e! a!oac)es todemonst!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!sunde!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#idedata 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 i** dete!mine t)e !eui!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**oin% 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 i** 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 )e!e needed.

>.Ana*+se t)e !esu*ts.

>.&Document and !e#ie t)e #a*idation.

"esu*ts of a #a*idation i** eit)e! demonst!ate t)at a cont!o* measu!e o! com-ination of cont!o* measu!es, is caa-*e ofcont!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 ofcont!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, ifa cont!o* measu!e o! com-ination of cont!o* measu!es !oduces a !eduction of a at)o%en e** in e5cess of t)e !eduction

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$o!m Pa%e No. ' of &'

needed fo! )a4a!d cont!o*, it ma+ -e ossi-*e to dec!ease t)e f!euenc+ of #e!ification e.%. f!euenc+ of

c)emica*/@ic!o-io*o%ica* testin% of end !oduct.

( 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. Itma+ -e in fo**oin% instances suc) as

'.2S!stem fail%re+If monito!in% o! #e!ification identifies fai*u!es fo! )ic) a !ocess de#iation cause cannot -e identified, !e8#a*idation ma+ -e needed. Non8com*iance it) monito!in% o! #e!ification c!ite!ia ma+ indicate a need fo! a c)an%e in t)ea!amete!s i.e., t)e se*ection and secification of t)e cont!o* measu!es on )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 inadeuate )a4a!d ana*+sis and ma+ !eui!e !e8#a*idation.

'.3Pro$ess $hanes+()e int!oduction in t)e food safet+ cont!o* s+stem of a ne cont!o* measu!e, tec)no*o%+ o! a iece ofeuiment 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%es ma+ !esu*t in t)e need fo! !e8#a*idation of cont!o* measu!es.

'.New s$ientifi$ or re%lator! information+"e8#a*idation ma+ -e needed if t)e )a4a!d associated it) a food o! in%!edientc)an%es as a !esu*t of

a )i%)e! concent!ations of )a4a!ds t)an o!i%ina**+ encounte!ed and accounted fo! in t)e desi%n,

- a c)an%e in !esonse of a )a4a!d to cont!o* e.%. adatation,

c eme!%ence of a !e#ious*+ unidentified )a4a!d,

d ne info!mation indicatin% t)at t)e )a4a!d is not -ein% cont!o**ed to t)e *e#e* secified e.%. ne eidemio*o%ica*findin%s o! ne #a*idated and inte!nationa**+ acceted ana*+tica* tec)no*o%ies o!

e a ne food safet+ outcome.

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$o!m Pa%e No. B of &'

VALIDATION OF CONTROL .-ASUR- FORCCPB) 4C C3-C9>ONLIN- OTTL- INSP-CTION 2USL>3ACCP>CCP>B85

3AARD TEP-+ P3ESICALST-P )?

A Pre#alidation Tas


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inc*usion $DA, 2001a. No %*ass f!a%ments in finis)ed !oduct. Note: $DAs Hea*t) Ha4a!d ;#a*uation =oa!d )as

suo!ted !e%u*ato!+ action a%ainst !oducts it) %*ass f!a%ments of 0.3 E' mmF to 1.0 E2& mmF in *en%t). See a*so $DACom*iance Po*ic+ uide G&&&.2&. No -!o6en %*ass at t)e CCPs fo! %*ass inc*usion $DA, 2001-.

$( USL 3istori$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 i** -e conside!ed #a*idated if on*ine insection indicates t)at insection i** ensu!e detection of t)e fo!ei%nmatte! )a!dous to )uman )ea*t) fo! fo!ei%n o-ect si4es unde! stud+

. 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 2annua**+ to ensu!e t)e adeuac+ of *i%)t. (!ainedinsecto!s, e!iodic e+e si%)t c)ec6s and Ca*i-!ation of insectin% e!son and ensu!in% t)e )ite -ac6%!ound and *i%)t intensit+of minimum 1000 *u5 etc

a 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+. Onedar< $olored prod%$tand one transparent $olored prod%$tto -e se*ected fo! stud+

- ;+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 -eattac)ed fo! t)is #a*idation.

c 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%)tintensit+. 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!.

d Ca*i-!ation of e!son o! #a*idation of t)e e!son -+ coma!in% insection caa-i*ities it) 6non addition and un6nonaddition.

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&( Anal!sis of the res%lts

$o**oin% stud+ is ca!!ied out fo! fo!ei%n o-ect of si4e 1810 mm one it)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 Sam*e &

Li%)t Intensit+ in Lu5 at insectionoint

1000

;+esi%)t of t)e Insecto! c)ec6edonce In ea!

es

Sam*eNo.

Si4e of t)e fo!ei%no-ect /mate!ia*

1 1 mm

2 2 mm

3 3 mm

mm

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CLASSCThe do$%ment is $ontrolled ele$troni$all!(

All paper $opies of this do$%ment are %n$ontrolled %nless stamped as 0CONTROLL-D1 & iss%ed "! .R2From 3O 4%alit!5


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& & mm

> > mm

' ' mm

B B mm

9 9 mm

10 10 mm

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Da+82



1000


es

Sam*eNo.


1 1 mm

2 2 mm

3 3 mm

mm

& & mm

> > mm

' ' mm

B B mm

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9 9 mm

10 10 mm

Da+83



1000


es

Sam*eNo.


1 1 mm

2 2 mm

3 3 mm

mm

& & mm

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> > mm

' ' mm

B B mm

9 9 mm

10 10 mm

Da+8



1000


es

Sam*eNo.


1 1 mm

2 2 mm

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$o!m Pa%e No. 1& of &'

3 3 mm

mm

& & mm

> > mm

' ' mm

B B mm

9 9 mm

10 10 mm

Da+8&



1000


es

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$o!m Pa%e No. 1> of &'

Sam*eNo.


1 1 mm

2 2 mm

3 3 mm

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

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$o!m Pa%e No. 1' of &'

a Va*idation stud+ !otoco* and !esu*ts fo! diffe!ent si4e of meta* and %*ass iece 1810 mm of t)e fo!ei%n o-ects

)a4a!dous to )uman )ea*t)

- ;+esi%)t c)ec6s !eco!d fo! -ott*e insecto!.

c Li%)t intensit+ at insection oint

'. Con$l%sion

a Cont!o* measu!e of on*ine insection fo! fo!ei%n matte! )a4a!dous to )uman )ea*t) is #a*idated ast)e inte! da+ and int!a da+ stud+ conducted !esu*ted in 100 detection of t)e fo!ei%n matte! of si4es!an%in% f!om 1 mm to 10 mm.

- ()e 7n*ine Insection can -e used afte! t)e #a*idation as an on8%oin% #e!ification acti#it+ to ensu!et)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

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$o!m Pa%e No. 1B of &'

VALIDATION OF CONTROL .-ASUR- FOROPRPB) R-C-IVIN* OF RA7 7AT-R

2CANAL 7AT-R>DA. 7AT-R>OR- 7-LL 7AT-R>TAN9-R>.UNICIPAL 7AT-R53AARD TEP-C3-.ICAL

ST-P 7)

A5 Pre#alidation Tas


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8 As e! $SSAI !u*es, 2011 ate! s)ou*d ota-*e and o!%ani4ation )as conside!ed t)e ";$;";NC;: =IS 10&00: 2012:D"INJIN


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Ve!ification ca!!ied out -+:


a. "e#ie and #e!ification of t)e !eo!t of e5te!na* *a- it) IS10&00:2012

'. Con$l%sion

Cont!o* @easu!e of c)ec6in% t)e sou!ces of ate! su*+ is #a*idated as it meets t)e standa!d !eui!ement of IS 10&00 2012and %i#es assu!ance to ensu!e !e#ention and cont!o* of c)emica* )a4a!ds t)!ou%) ate!.



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VALIDATION OF CONTROL .-ASUR- FOROPRPB, OTTL- 7AS3IN* 2USL>3ACCP>OPRP>B?5

3AARD TEP-+ P3ESICALST-P 7)

C Pre#alidation Tas


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suo!ted !e%u*ato!+ action a%ainst !oducts it) %*ass f!a%ments of 0.3 E' mmF to 1.0 E2& mmF in *en%t). See a*so $DA

Com*iance Po*ic+ uide G&&&.2&. No -!o6en %*ass at t)e CCPs fo! %*ass inc*usion $DA, 2001-.G( USL 3istori$al 9nowlede a"o%t the performan$e of $ontrol meas%re of inspe$tion(


Cont!o* measu!e i** -e conside!ed #a*idated if as)in% and #isua* insection indicates cont!o* measu!e i** ensu!e detection oft)e fo!ei%n matte! )a!dous to )uman )ea*t) fo! fo!ei%n o-ect


;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/m2annua**+ to ensu!e t)e adeuac+ of *i%)t. (!ainedinsecto!s, e!iodic e+e si%)t c)ec6s and Ca*i-!ation of insectin% e!son and ensu!in% t)e )ite -ac6%!ound and *i%)t intensit+of minimum 2&0 *u5 etc

e 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-ect is added -efo!e as)in% and #isua* insection is ca!!ied out to #e!if+ it is %ettin% !emo#eddu!in% as)in%.

f ;+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 -eattac)ed fo! t)is #a*idation.

% 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%)tintensit+. Li%)t intensit+ is 6et minimum 2&0 as -ott*es i** -e emt+.

) Ca*i-!ation of e!son o! #a*idation of t)e e!son -+ coma!in% insection caa-i*ities it) 6non addition and un6nonaddition.

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$o**oin% stud+ is ca!!ied out fo! fo!ei%n o-ect of si4e 1810 mm one it)out info!min% t)e -ott*e insecto!

=ott*e t+e si4e etc:

Da+81



1000


es

Sam*eNo.


1 1 mm

2 2 mm

3 3 mm

mm

& & mm

> > mm

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' ' mm

B B mm

9 9 mm

10 10 mm

Da+82



1000


es

Sam*e

No.

Si4e of t)e fo!ei%n

o-ect /mate!ia*

as)in% and not detected afte! -ott*e as)in%

1 1 mm

2 2 mm

3 3 mm

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mm

& & mm

> > mm

' ' mm

B B mm

9 9 mm

10 10 mm

Da+83


Li%)t Intensit+ in Lu5 at insection

oint

1000


es

Sam*eNo.


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1 1 mm

2 2 mm

3 3 mm

mm

& & mm

> > mm

' ' mm

B B mm

9 9 mm

10 10 mm

Da+8



1000

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es

Sam*eNo.


1 1 mm

2 2 mm

3 3 mm

mm

& & mm

> > mm

' ' mm

B B mm

9 9 mm

10 10 mm

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Da+8&



1000


es

Sam*e

No.

Si4e of t)e fo!ei%n

o-ect /mate!ia*

as)in% and not detected afte! -ott*e as)in%

1 1 mm

2 2 mm

3 3 mm

mm

& & mm

> > mm

' ' mm

B B mm

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9 9 mm

10 10 mm



d Va*idation stud+ !otoco* and !esu*ts fo! diffe!ent si4e of meta* and %*ass iece 1810 mm of t)e fo!ei%n o-ects

)a4a!dous to )uman )ea*t)

e ;+esi%)t c)ec6s !eco!d fo! -ott*e insecto!.

f Li%)t intensit+ at insection oint

'. Con$l%sion

c Cont!o* measu!e of -ott*e as)in% and identification fo! fo!ei%n matte! )a4a!dous to )uman )ea*t)afte! -ott*e as)in% is #a*idated as t)e inte! da+ and int!a8da+ stud+ conducted !esu*ted in 100 !emo#a* of t)e fo!ei%n matte! of si4es !an%in% f!om 1 mm to 10 mm.

d ()e 7n*ine Insection can -e used afte! t)e #a*idation as an on8%oin% #e!ification acti#it+ to ensu!et)at t)e fo!ei%n matte! )a4a!dous to )uman )ea*t) is cont!o**ed as intended.



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VALIDATION OF CONTROL .-ASUR- FOROPRPB6 R-C-IVIN* OF N-7>OLD *LASS OTTL-S>P-T OTTL-S

3AARD TEP-C3-.ICAL

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ST-P *)>ST-P U*)

A5 Pre#alidation Tas


34/57






Sou!ce Name:

S.N7. (est Pa!amete! IS+ ),,?, "efe!ence*imit

Com*iance

es o! No

"ema!6 if noncom*+in% andfu!t)e! actions

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36/57






"eo!t Ve!ification ca!!ied out -+:


a. "e#ie and #e!ification of t)e !eo!t of e5te!na* *a- it) IS+ ),,?,

'. Con$l%sion

Cont!o* @easu!e of ensu!in% mate!ia* com*ies it) IS: 122&2 and )isto!ica* e5e!ience is #a*idated as it meets t)e standa!d!eui!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.



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VALIDATION OF CONTROL .-ASUR- FOROPRPB8 FILTRATION )B .ICRON 2Cartride .i$ron Filter5 2USL>3ACCP>OPRP>B?5

3AARD TEP-+ P3ESICALST-P ))

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38/57






; Pre#alidation Tas


39/57







Cont!o* measu!e i** -e conside!ed #a*idated if fi*t!ation it) 10 mic!on as cont!o* measu!e i** ensu!e !e#ention of t)e fo!ei%nmatte! )a!dous to )uman )ea*t) fo! fo!ei%n o-ect and fu!t)e! stes of insection


a. C)ec6in% t)e fi*te! inte%!it+ and !essu!e d!o a*on% it) fu!t)e! stes of insection fo! fo!ei%n o-ects at -ott*e insectionoint.


$o**oin% stud+ is ca!!ied out fo! fi*te! inte%!it+, f*o !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+ Da+ &

P!essu!e

P!essu!e

P!essu!e

P!essu!e

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P!essu!e

time of insection 1> )ou!s

P!essu!e

P!essu!e

$i*te! inte%!it+

to -e dama%ed.


$i*te! t+e

Location:


P!essu!e

P!essu!e

P!essu!e

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P!essu!e

of insection 12 )ou!s

P!essu!e )ou!s

P!essu!e

P!essu!e

$i*te! inte%!it+


$i*te! t+e

Location:


P!essu!e

P!essu!e

P!essu!e

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////




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time of insection B )ou!s

P!essu!e

P!essu!e )ou!s

P!essu!e

P!essu!e

$i*te! inte%!it+


$i*te! t+e

Location:


P!essu!e

P!essu!e

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////




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time of insection )ou!s

P!essu!e

P!essu!e

P!essu!e )ou!s

P!essu!e

P!essu!e

$i*te! inte%!it+


$i*te! t+e

Location:


P!essu!e

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////




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$o!m Pa%e No. of &'

time of insection 0 )ou!s

P!essu!e

P!essu!e

P!essu!e

P!essu!e )ou!s

P!essu!e

P!essu!e

$i*te! inte%!it+



/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////




45/57





$o!m Pa%e No. & of &'

% Va*idation stud+ !otoco* and !esu*ts indicates t)at t)e fi*te! !essu!e monito!in% e!iodica**+ at )ou!s

'. Con$l%sion

e Cont!o* measu!e of -ott*e as)in% and identification fo! fo!ei%n matte! )a4a!dous to )uman )ea*t)afte! -ott*e as)in% is #a*idated as t)e inte! da+ and int!a8da+ stud+ conducted !esu*ted in 100 !emo#a* of t)e fo!ei%n matte! of si4es !an%in% f!om 1 mm to 10 mm.

f ()e 7n*ine Insection can -e used afte! t)e #a*idation as an on8%oin% #e!ification acti#it+ to ensu!e t)att)e fo!ei%n matte! )a4a!dous to )uman )ea*t) is cont!o**ed as intended.



VALIDATION OF CONTROL .-ASUR- FOROPRPB? FILLIN*>OTTLIN*3AARD TEP-+ P3ESICAL

ST-P )6

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46/57





$o!m Pa%e No. > of &'

Pre#alidation Tas


47/57





$o!m Pa%e No. ' of &'

suo!ted !e%u*ato!+ action a%ainst !oducts it) %*ass f!a%ments of 0.3 E' mmF to 1.0 E2& mmF in *en%t). See a*so $DA

Com*iance Po*ic+ uide G&&&.2&. No -!o6en %*ass at t)e CCPs fo! %*ass inc*usion $DA, 2001-.t( USL 3istori$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%eand 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 i** -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%scondition -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**oin% stud+ is ca!!ied out fo! #a*idation of t)e oe!ationa* !e!euisite !o%!amme

$i**e! Location:

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48/57





$o!m Pa%e No. B of &'


P!e#enti#e maintenance sc)edu*eof fi**e! ca!!ied out es/No

Ve!ification !eo!t on no44*e/(ef*on!in%s condition -efo!e sta!t of t)eoe!ation

P!essu!e of fi**in%

Ve!ification of t)e -ott*es -efo!efi**in% fo! insection of fo!ei%no-ect )a4a!dous to )uman )ea*t).at insection oints

Ve!ification of t)e fi**ed -ott*es fo!fo!ei%n o-ect )a4a!dous to )uman)ea*t) at 7n*ine -ott*e insection

"ema!6

$i**e! Location:

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49/57









P!essu!e of fi**in%



"ema!6

$i**e! Location:

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////




50/57





$o!m Pa%e No. &0 of &'




P!essu!e of fi**in%



"ema!6

$i**e! Location:

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51/57









P!essu!e of fi**in%



"ema!6

$i**e! Location:

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52/57









P!essu!e of fi**in%



"ema!6

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////




53/57







) 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)eno44*es -efo!e use, maintainin% fi**e! !essu!e a*on% it) on*ine insection ste ensu!e !e#ention and cont!o* of )+sica*)a4a!d.

'. Con$l%sion

a 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% it)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-ectsuc) as %*ass c)iin% as e#ident.



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$o!m Pa%e No. & of &'

$i*te! t+e

Location:


P!essu!e

P!essu!e

P!essu!e

P!essu!e

P!essu!e )ou!s

P!essu!e

P!essu!e

$i*te! inte%!it+

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$o!m Pa%e No. && of &'


$i*te! t+e

Location:


P!essu!e

P!essu!e

P!essu!e

P!essu!e

P!essu!e )ou!s

P!essu!e

P!essu!e

$i*te! inte%!it+

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56/57





$o!m Pa%e No. &> of &'

to -e dama%ed.


$i*te! t+e

Location:


P!essu!e

P!essu!e

P!essu!e

P!essu!e

P!essu!e

time of insection 1> )ou!s

P!essu!e

P!essu!e

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////




57/57





$o!m Pa%e No. &' of &'

$i*te! inte%!it+

dama%ed.


Referen$e for Validation

)( *UID-LIN-S FOR T3- VALIDATION OF FOOD SAF-TE CONTROL .-ASUR-S CAC>*L @H ,BB

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All paper $opies of this do$%ment are %n$ontrolled %nless stamped as 0CONTROLL-D1 & iss%ed "! .R

09_Validation of CCP & OPRP

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Transcript of 09_Validation of CCP & OPRP