management system manual iso 90014 feb-11.doc

8/18/2019 Management System Manual iso 90014 fEB-11.doc

1/23

Ultra International Limited QUALITY ASSURANCE

Sahibabad Plant

STANDARD OPERATING PROCEDURE

MANAGEMENT SYSTEM MANUAL

Doc. No. Verion E!!ecti"e Date Re#lace Verion Dated Pa$e Total #a$e A##endice

IMSM-01 01 1 23 -

Prepared by : Approved by : Released by :

Checked by :

istrib!tion :

T%i doc&ment i t%e #ro#ert' o! Ultra International Limited. It m&t (e %andled con!identiall' and m&t not (e co#ied or re#rod&ced) in *%ole or in

#art) in an' *a' *it%o&t e+#licit #ermiion o! t%e com#an'.

Works:

M,S COMPANY NAME.

-,/0)Site1-,/0)Site1IV)Sa%i(a(ad

Ind&trial area)G%a2ia(ad)3U.P4


MANAGEMENT SYSTEM ISO9001:2008

ISSUE NO 1.00

DATE OF ISSUE 01-06-2009TOTAL PAGES 70 pages

ONT!OLLED OPY NO: 01 e"#$%&$'g ()*&


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Com#an' Name QUALITY ASSURANCE

Sahibabad Plant


INTEGRATED MANAGEMENT SYSTEM MANUAL


IMSM-01 01 2 23 -


P"epa"e* a'*Iss+e* ,&

App")e* (&

S$g'a#+"e

Nae M*. As$% A/$ M". P. Ma+*a"

Des$g'a#$)' Ma'agee'#!ep"ese'#a#$e D$"e#)"

Da#e 01-06-2009 01-06-2009


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Sahibabad Plant




IMSM-01 01 3 23 -

TITLE5 INDE6

SECTION NO. DESCRIPTION

ISO

7//05 8/ /9

Cla&e

IMSM " 0#1 I$%& -

IMSM " 0#2 I$'R()C'I($ * R%+ISI($ S,%%' -

IMSM " 0#3 SC(P% ( MA$.%M%$' S/S'%M #0

IMSM " 0# IS' ( C($'R(% C(P/ ,(%R -


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IMSM-01 01 2 23 -

IMSM " 1#0 MA$A.%M%$' S/S'%M ".%$%RA R%)IR%M%$'S #1

IMSM " 1#1 IMS (C)M%$'A'I($ R%)IR%M%$'S - .%$%RA #2#1

IMSM " 1#2 )AI'/ MA$)A #2#2

IMSM " 1#3 C($'R( (C)M%$'S #2#3

IMSM " 1# C($'R( R%C(RS #2#

IMSM " 2#1 MA$A.%M%$' C(MMI'M%$' #1

IMSM " 2#2 C)S'(M%R (C)S #2

IMSM " 2#3 I$'%.RA'% P(IC/ #3

IMSM " 2# I$'%.AR'% (45%C'I+%S ##1

IMSM " 2# IMS PA$$I$. ##2

IMSM " 2#6 (R.A$I7A'I($ C,AR' A$ I$'%RAC% #

IMSM " 2#8 R%SP($SI4II'/ A$ A)',(RI'/ # 8 ##1

IMSM " 2#9 MA$A.%M%$' R%PR%S%$'A'I+% ##2

IMSM " 2# I$'%R$A C(MM)$ICA'I($ ##3

IMSM " 2#10 MA$A.%M%$' R%+I%; #6

IMSM " 3#1 ,)MA$ R%S()RC%S 6#1< 6#2

IMSM " 3#2 I$RAS'R)C')R% A$ ;(R= %$+IR($M%$' 6#3< 6#

IMSM " #1 PA$$I$. ( PR()C' R%AI7A'I($ 8#1

IMSM " #2 C)S'(M%R R%A'% PR(C%SS 8#2

IMSM " #3 %SI.$ * %+%(PM%$' 8#3

IMSM " # P)RC,ASI$. 8#

IMSM " # PR()C'I($ A$ S%R+IC% PR(+ISI($ 8##1


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IMSM-01 01 3 23 -

IMSM " # M($I'%RI$. A$ M%AS)RI$. ( PR()C' 9#2#

IMSM " #6 C($'R( ( $($ C($(RMI$. PR()C' 9#3

IMSM " #8 A$A/SIS ( A'A 9#

IMSM " #9 C($'I$)A IMPR(+%M%$' 9##1

IMSM " # C(RR%C'I+% AC'I($ 9##2

IMSM " #10 PR%+%$'I+% AC'I($ 9##3

%+%-II< III< I+ (C)M%$'S

A$$%&-A IS' ( )AI'/ PR(C%)R%S %+%-II

A$$%&-4 IS' ( %&I,I4I'S %+%-II

A$$%&-C IS' ( S(P>;IS %+%-III

A$$%&- IS' ( )AI'/ R%CR(S %+%-I+

DOCUMENT REVISION S:EET

(C)M%$'

$(:

ISS)%>R%+#

$(

A'% 4RI% %SCRIP'I($ (

C,A$.%

APPR(+% 4/

M :01 1#0 1-0-0 Initial iss!e o? M ?or IS(

001:2009 MS

C%(>irector

M:01 1#0 01-06-0 irst iss!e o? MS ali@n ith

IS( 001:2009

C%(>irector

INTRODUCTION O; ORGANISATION5

)ltra International iBited are Ban!?act!rers o? ?lavo!r coBpo!nds< %ssential (ils< AroBatherapy

(ils< Per?!Bery CoBpo!nds strictly adherin@ to International re@!latory a??airs and ?olloin@ IRA

.!idelines# ;e have ?!lly e!ipped Bodern R* laboratories d!ly reco@niDed by the departBent o?

Science * 'echnolo@y< .overnBent o? India since 11 and are certi?ied IS( 001:2009#Also e

have individ!al application laboratories ?or ra@rances and lavo!rs#

0##1 C)S'(M%RS :

1# ab!r India td#

2# 7yd!s Cadila ,ealthcare

3# 5ohnson * 5ohnson td#

# ;yeth td

# Pepisco td#

6# Cabin =are Pvt# td#

SCOPE O; CERTI;ICATION5

Scope o? this I$'%.AR'% MA$A.%M%$' S/S'%M MA$)A covers the Inte@rated !ality

Mana@eBent SysteB< as per IS( 001: 2009< in )ltra International td-Sahibabad ?or EMan!?act!re

o? ?ra@rances * ?lavo!rs< per?!Bery coBpo!nds< essential oil * aroBatic coBpo!ndsF

%Gcl!sion o? cla!se>s


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IMSM-01 01 2 23 -

ISO 7//058//9 Cl


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IMSM-01 01 3 23 -

INTEGRATED MGT. SYSTEM PROCEDURE 3IMSP4 , ;LO@ C:ART 3C:4

'his is a second level doc!Bent< hich contains the IMS basic proced!res in details as per

IS( 001: 2009 standard re!ireBent * other BaKor processes in the lo Chart ?orB# Control

hich 'his IIIrd level doc!Bentation is prepared by departBental ,ead and approved by M>s )ltra

International td# Release o? any doc!Bent controlled by Baster list o? the doc!Bents is Baintained

by MR# MR controls the iss!e and revision also#'he Bethodolo@y o? n!Bberin@ systeB ?or ;I< (CI

is serial in accordance ith the cla!se n!Bbers o? the IS( 001: 2009 Standard# 'he Bethodolo@y o?

n!Bberin@ systeB ?or lo Charts > S(P is as ?ollos "

TITLE5 IMS DOCUMENTATION REQUIREMENTS ? GENERALAN ;I > S(P > %Ghibits > (CI abbreviation ?olloed by<

4N lo Chart > Standard operatin@ proced!re related to departBent code ?olloed by<

CN Serial $!Bber in the ept# 101 is the ?lo chart n!Bber 1 in !ality Control epartBent

;I>P)R>01 is the ;ork instr!ction n!Bber 1 in P!rchase epartBent< S(P>M$'>01 Standard

operatin@ proced!re ?or Baintenance dept n!Bber 1

;ORMATS 3 ;R 4 , LISTS 3 LS 4 , REGISTERS 3 REG 4

'hese are I+th level doc!Bents intended to provide evidence o? the activity per?orBed and also to

ens!re e??ective plannin@< operation * control o? the IMS processes# orBats are prepared byinchar@e< approved by ,( and iss!e is controlled by MR# A speciBen Baster copy is kept ith MR

?or control< approval iss!e and chan@es# 'he Bethodolo@y o? n!Bberin@ systeB ?or these doc!Bents

is siBilar to that o? lo Charts e#@# >C>01 is the ?orBat n!Bber 1 in !ality Control

epartBent# Raisin@ the revision n!Bber n!Berically ?olloin@ the doc!Bent chan@e proced!re

Bakes the revisions to the ork proced!re and ?orBats or access o? c!rrent revision o? the ?orBat no<

iss!e< rev and dt# o? e??ective is ritten beneath o? the ?orBs or top o? the ?orBat#

;ORMATS 3;4 , LISTS 3LS4 , REGISTERS 3;R4

'hese are o!rth level doc!Bents intended to provide evidence o? the activity per?orBed re@ardin@

IMSM and as also to ens!re e??ective plannin@< operation * control o? the IMS #rocee#

orBats are prepared by IC) approved and iss!ed by MR. A speciBen copy is kept ith MR ?or control< approval iss!e and chan@es#

'he Bethodolo@y o? n!Bberin@ systeB ?or these doc!Bents is siBilar to that o? lo Charts

e#@# ;,QCD,/0 is the ?orBat n!Bber 1 in !ality Control epartBent

Raisin@ the revision n!Bber n!Berically ?olloin@ the oc!Bent Chan@e Proced!re Bakes the

revisions to the ork proced!re and ?orBats#

'his ?o!r level doc!Bent systeB is s!pported by doc!Bent like C!stoBer rain@ > Speci?ication<

!ality Plans< Ra Baterial speci?ications< $ational> International Standards %tc#

'heir details are re?erred to in P > %Ghibit Ban!al herever appropriate#

Abbreviations !sed are as ?ollos :

CEOChie? %Gec!tive

MT Marketin@

IMSM Inte@rated M@t SysteB

Man!al

LB:abel

MR

Mana@eBentQCD

!alityIMS5

Inte@ratedLS:ist


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IMSM-01 01 2 23 -

RepresentativeControlepartBent

Mana@eBentSysteB

EMP5

%nvironBentMana@eBent Pro@raBBe

IC

In char@ePUR P!rchase @I

;orks Instr!ctionE

%Ghibit

ASST

AssistantPAC Packin@ QP

!ality Proced!reQP !ality plan

O#t

(perator STR

Stores;

orBatsREG

Re@ister

Sr#

S!pervisor Di

ispatchMnt:

MaintenanceCS

C!stoBers Spcn

TITLE5 INTEGRATED MANGEMENT SYSTEM MANUAL

'he Ist# level apeG doc!Bent is Inte@rated Mana@eBent SysteB Man!al LIMSMJO it is prepared by

MR and approved by irector

MR is responsible to control the !ality Ban!al# 'he apeG doc!Bent contains the !ality Policy<

o!tline o? Inte@rated !ality Mana@eBent SysteB as per IS( 001:2009O and obKectives o? the

Mana@eBent# It also de?ines responsibilities and a!thorities o? vario!s eBployees< Bana@eBent

eGec!tives related to !ality activities# It @ives the details o? vario!s processes and its se!ence and

interaction# It also speci?ies controls over these processes ith re?erence to related ork proced!res#

%very doc!Bent o? !ality Man!al is @iven a !ni!e n!Bber#

Director revies the !ality M@t SysteB Man!al d!rin@ Mana@eBent Revie Meetin@ to assess

contin!ity< ade!acy and con?orBity to c!stoBer re!ireBents# Any sta?? o? Ultra International Ltd

ho ants to Bake any chan@e to IMSM coBB!nicates it on oc!Bent Chan@e Re!est $ote

LCR$J to MR# I? approved by C%(< necessary chan@es are Bade# Revisions are identi?ied

n!Berically# ;henever any pa@e o? doc!Bent is revised< the hole doc!Bent is revised to neGt

revision# 4rie? description o? revision is @iven on ERevision Stat!s Esheet# A?ter nine revisions o? any

doc!Bent< iss!e o? entire Ban!al is raised to neGt iss!e n!Bber and ?or neGt iss!e no#< revision

becoBes H7%R( H?or all the doc!Bents contained ithin it# Identi?ied by Ehi@hli@htin@F the n!Bber

on IMSM-0## MR Bay take additional copies ?or the copyholder#

TITLE5 INTEGRATED MANGEMENT SYSTEM MANUALMR Baintains Master copy o? !ality Man!al< top pa@e o? hich bears a staBp HMaster- Copy .

MR takes photocopy o? this Master Copy and sends it to controlled copy holder a?ter

StaBpin@ its top pa@e ith staBp Controlled co#' HLOnl' Bl&e colorJ# MR sends controlled copy

to certi?yin@ 4ody !nder coverin@ letter#

)ncontrolled copy ith a staBp as ERe?erence Copy E< MR can iss!e ith perBission ?roB Director

only< the !ncontrolled copy no !pdatin@ services are provided#

Master Copies o? invalid > (bsolete doc!Bents are either destroyed or kept ith the staBp E(bsolete

CopyF< henever re!ired# All other photocopies are proBptly destroyed by copyholders#

I$'%.RA'% MA$.%M%$' S/S'%M MA$)A is revieed every telve Bonths ?or

interlinkin@ o? cla!ses#


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IMSM-01 01 3 23 -

TITLE5 CONTROL O; DOCUMENTS

M#R is priBary responsible ?or Baintain and keep control over doc!Bent approval< iss!e and

chan@es# Respective orks head>In-char@es are prepared the doc!Bents o? IInd< III rd and I+th level

and approved by M#R#

;ollo*in$ are t%e doc&ment :

1 !ality Policy

2 !ality (bKectives

3 !ality Mana@eBent SysteB Man!al LMSM4

!ality Mana@eBent SysteB Proced!res 3QMSPJ

;ork -(peration control Instr!ction L@OCIJ

6 Standard operatin@ proced!res LS(PJ *

8 'echnical Standin@ (rder L'S(J>Material Sa?ety ata sheet LMSDS4

9 Prod!ct oc!Bents L%GhibitJ

'estin@ Speci?ication 'echnical Speci?ication< Calibration Certi?icate

10 $ational > International Standards

11 Stat!tory and Re@!latory as

12 Catalo@!es > 4roch!res

Q&alit' Record and ;ormat5

A!thoriDed persons as @iven above ?irst approve the ade!acy o? the doc!Bent to be iss!ed# 'he tier

I * tier II doc!Bents like !ality Ban!al< !ality proced!res< ork instr!ctions< (CI S(P is si@ned

only on the revision sheet LIMSM-1#0J ?or approval ?or the ori@inal iss!e as ell as ?or each chan@e

therea?ter# A Baster list and revision sheet is prepared# Identi?yin@ iss!e and revision o? the

doc!Bent# It is ens!red that the latest iss!es o? doc!Bents are available at the locations here

!ality operations concernin@ theB are per?orBed# 'he responsibility ?or this activity is ith

respective controlled copyholder and MR also veri?ies this d!rin@ internal !ality a!dits#

TITLE5 CONTROL O; DOCUMENTSIt is ens!red that the doc!Bents are le@ible and identi?iable ith !ni!e n!Bbers#

%Gternal doc!Bents like $ational > International Standards and C!stoBer speci?ication > 'echnical

Speci?ication > calibration and 'est Certi?icates are also controlled# CoBp!teriDed and hard copies

orBats are controlled by Baster list to ens!re that pertinent latest ?orBats are !se at the respective

departBent# M#R# is also ens!re that (r@aniDation !se latest version o? $ational>International

standard applicable to prod!ct !ality

'he obsolete standard< Ban!al< book is destroyed or kept ith staBp E(bsolete Copy E(n ?irst and

last pa@e< a?ter iss!e is proc!red# ata Baintained on coBp!ter is protected ith passord and vir!s

controlled systeB# 4ack!p is Baintained ?or retrieval in case o? deletion o? any data#

ata Baintained in electronic ?orB on coBp!ter is protected ith passord and 4ack!p is

Baintained# Chan@es in doc!Bents and data are revieed by the saBe ?!nctions > a!thority hich

Per?orBs ori@inal revie and approval# 'he so!rces ?or initiatin@ doc!Bent chan@e are 5

AN oc!Bent Chan@es Re!est $ote LCR$J

4N $CRs in internal > eGternal a!dits


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IMSM-01 01 2 23 -

CN Mana@eBent Revie Meetin@

(bsolete doc!Bent are reBoved and Master Copy is kept ith E(bsolete Copy EstaBp are clearly

identi?ied and Barked as H(bsolete#ABendBents and chan@es > revisions in internal doc!Bents are

Bade as soon as received ?roB c!stoBer > $ational > international standard 4odies > .overnBent

4odies herever re!ired# All controlled copyholders are destroy earlier revision > iss!e a?ter receipt

o? latest revision > iss!e# 'he (bsolete doc!Bents retained ?or le@al or re?erence p!rpose

MR Baintains departBent ise list o? doc!Bents ith the revision stat!s#

Re!erence Doc&ment 5 IMSP , IMS , /0 Proced&re !or doc&ment and data control

TITLE 5CONTROL O; RECORDS

PriBary responsibility ?or this ?!nction is *it% MR , re#ecti"e in c%ar$e,:ODS#

Records are Baintained to deBonstrate con?orBance to the speci?ied re!ireBents o? !ality

Mana@eBent SysteBs#

@or Proced&re i laid do*n to $i"e detail o! identi!ication) #rotection) inde+in$) acce)

!ilin$) location) tora$e) retention and di#oal o! record.

A label< indicatin@ above details is p!t on records# 'his also helps to ens!re that records are

retrievable hen re!ired# It is ens!red that records are le@ible * ell protected * Baintained d!rin@

its retention period# ;here a@reed contract!ally< records are Bade available to c!stoBer ?or the

eval!ation# Records Baintained on coBp!ter are protected ith passord< vir!s control systeB and

their re@!lar back !p is Baintained#

Re!erence Doc.5 IMSP,IMS,/8 Proced&re !or control o! Q&alit' record.

TITLE5 MANAGEMENT COMMITMENT

'he top Bana@eBent o? )ltra International td is coBBitted ?or developBent * iBpleBentation<

Baintain and contin!ally iBprovin@ o? !ality Mana@eBent SysteBs as per IS( 001:2009#

irector< MR and all sta?? are responsible ?or co-ordination o? these activities# 'hey have shon their

coBBitBent ?or the !ality Mana@eBent SysteB by ?olloin@ ays#

1J !l?ill o? all re!ireBents ?or Interested Party


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IMSM-01 01 3 23 -

TITLE 5 CUSTOMER ;OCUS

Marketin@ departBent LM='J co-ordinates ith the c!stoBer ?or @ettin@ the c!stoBer re!ireBents#

'hese are Bet by s!pplyin@ prod!cts are re!ired as per c!stoBers need stated and !nstated both#

C!stoBer satis?action level is Bonitored by the ?olloin@ Bethods and s!itable corrective actions

are taken to iBprove c!stoBer satis?action 5

1J 'rackin@ n!Bber o? ne c!stoBers added

2J 'rackin@ c!stoBer coBplaints

3J 'rackin@ pendin@ or coBpleted orders

J 'rackin@ tiBely deliveries

J .ettin@ c!stoBer satis?action ?eedback re@!larly and ork o!t c!stoBer satis?action indeG#

'o kno c!stoBer satis?action level BiniB!B once a year satis?action s!rvey to be cond!cted by

sendin@ c!stoBer ?eed back ?orB thro!@h Bailirector

TITLE 5 MANAGEMENT SYSTEM PLANNING

'he Bana@eBent systeB plannin@ incl!des all processes as applicable ?or o!r or@aniDation# etail o?

it< is @iven in IMSM " 1#0# inkin@ o? these processes is clearly de?ined in IMSM 2#6 o? this Ban!al#

'he responsibility ?or each process and the Bethodolo@y ?or Bonitorin@ and Beas!reBent o? these

processes are clearly de?ined# It is ens!red that the inte@rity o? process is Baintained even hen a

part it !nder@oes a chan@e or Bodi?ication# S!itable chan@es in other related processes or its parts are

planned and iBpleBented to Baintain the inte@rity o? the process#

#

Re! 5 04 IMSP,IMS,/91 Identi!ication) com#liance) ae and date t%e le$al and ot%er

Re&irement

TITLE5 O(Hecti"e) Tar$et and Pro$ramme34or settin@ and revie o? obKectives and tar@ets< a proced!re has been established hich are

consistent ith the or@aniDations technolo@ical options< ?inancial< operational re!ireBents and

vies o? interested parties#


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IMSM-01 01 2 23 -

TITLE 5 RESPONSIBILITY AND AUT:ORITY 5

1# irector

2# Mana@eBent Representative

3# Concerned ) In-Char@e

# C>A In-char@e

Q U,Prod INC:ARGES5 Responsible> a!thoriDed ?or :

iJ IBpleBentation and aareness o? !ality policy in )s !nder his control

iiJ Responsible ?or iBpleBentin@ relevant !ality systeB proced!re and operational control

instr!ctions in )s !nder his controliiiJ Identi?yin@ and ?olloin@ applicable le@al and other re@!latory norBs in )s !nder his control

TITLE5 RESPONSIBILITY AND AUT:ORITY

CheBist>C I>ch: responsible >A!thoriDed ?or

iJ IBpleBentation and aareness o? !ality policy in )s !nder his control

iiJ Responsible ?or iBpleBentin@ relevant !ality systeB proced!re and operational control

instr!ctions in )s !nder his control

iiiJ Identi?yin@ and ?olloin@ applicable le@al and other re@!latory norBs in )s !nder his control

ivJ Conservation o? nat!ral reso!rces by e??ective Bonitorin@

TITLE5 MANAGEMENT REPRESENTATIVEMohd# Asi? Ali has been appointed as Mana@eBent Representative ?or IS( 001-2009

In addition to his responsibility as Sr# Mana@er L.eneralJ and their ro!tine d!ty< ,e isO

1# Responsible ?or ens!rin@ that the processes needed ?or the Mana@eBent SysteB LMSJ is

established< iBpleBented and Baintained in accordance ith the International standards#

2# Responsible ?or reportin@ on the per?orBance o? the !ality Mana@eBent SysteBs to the top

Mana@eBent d!rin@ the Bana@eBent systeB revie Beetin@ LMRMJ on the basis o?

planned>tar@eted M L!alityJ obKectives#

3# ,e is responsible ?or proBotion o? aareness o? c!stoBer re!ireBents< interested party and

stack holder o? the process thro!@h o!t the or@aniDation

# ,e is also responsible ?or liaison ith eGternal parties ?or Batters relatin@ to the !ality

Mana@eBent SysteBs#

# or above activities< he is directly reportin@ to the !ndersi@ned#

6# ,avin@ all necessary a!thority to achievin@ (r@aniDation .oal#

Date5 /0 F&l' 8//7 C%ie! E+ec&ti"e o!!icer, Director

'I'%: I$'%R$A C(MM)$ICA'I($

+ario!s Bethods o? coBB!nication o? in?orBation ithin the or@aniDation are as ?ollos :isplay the !ality obKectives< MRM< ;ork Proced!re< operation control instr!ction L(CIJ !ality

(bKectives data Sheet< P!rchase (rders< Marketin@ Plans< and C!stoBer approved speci?ications >

Speci?ication< o??ice BeBo > ?aG > e-Bail > telephone#


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IMSM-01 01 3 23 -

Above Bethods o? coBB!nication are !sed by the persons concerned to ens!re that coBB!nication

is e??ective# 'he res!lts are Bonitored in terBs o? achieveBents o? obKectives set ?or each process and

the e??ectiveness o? !ality Mana@eBent SysteB is Bonitored and coBB!nicated thro!@h res!lts o?

internal !ality A!dits * Mana@eBent Revies#

TITLE5 MANAGEMENT REVIE@

irector revies the contin!in@ s!itability and e??ectiveness o? !ality Mana@eBent SysteB# In

Bana@eBent revie Beetin@ held once in a siG Bonths#

'he inp!t ?or Bana@eBent revie Beetin@ is :

L1J ollo !p actions revie o? previo!s Bin!tes o? Beetin@#

L2J Revie o? !ality policy and e??ectiveness o? !ality obKectives#

L3J Res!lt o? internal !ality a!dits * corrective actions on non-con?orBities in systeB a!dits#

LJ Corrective actions on process per?orBance and prod!ct con?orBity incl!din@ deviations#

LJ Corrective actions on c!stoBer ?eedback#

L6J Records o? preventative and corrective actions#

L8J RecoBBendations ?or iBproveBents#

L9J Revie o? reso!rces#

LJ Any other !ality related iss!es< hich can a??ect the !ality Bana@eBent systeB#MR arran@es Bana@eBent revie Beetin@ by iss!in@ a circ!lar# 'his Beetin@ is presided over by

irector and all epartBent ,eads and Section ,eads attend this Beetin@

'he o!tp!t o? Bana@eBent revie Beetin@ Bainly consists o?

1# IBproveBent o? e??ectiveness o? the !ality Mana@eBent SysteB and its processes#

2# IBproveBents o? processes

3# IBproveBent o? prod!ct related to c!stoBer re!ireBents#

# Reso!rce needs#

MR prepares the Bin!tes o? the Beetin@< hich are approved by C%(

MR circ!lates a copy o? the Bin!tes o? Mana@eBent Revie Meetin@ to concern I>c#

Retention period o? Bin!tes o? Mana@eBent Revie Beetin@ is 3 years

Re! Doc5 1 IMSP,IMS,/ Proced&re !or mana$ement re"ie*

'I'%: PR(+ISI($ ( R%S()RC%S)'RA I$'%R$A'I($A ' has ?!ll capabilities to Beet c!stoBer re!ireBents and to enhance

satis?action in terBs o? !ality#

Ade!acies o? these reso!rces are revieed d!rin@O

• Special C!stoBer re!ireBent ?or prod!ct realiDation

• Mana@eBent revie

• Contract revie

• Internal !ality A!dit

• C!stoBer coBplaints revie

• $e esi@n* evelopBent o? the Prod!ct


14/23


Sahibabad Plant




IMSM-01 01 2 23 -

'I'%: ,)MA$ R%S()RC%S

'he or@aniDation has a Botivated teaB o? eBployees# 'hey are @iven periodical trainin@ dependin@

!pon the coBpetence and aareness needs identi?ied by respective departBent I>C# 'hey are also

Bade aare o? their role in achievin@ !ality obKectives#

+ario!s areas o? trainin@ identi?ied consist o? technical trainin@ as ell as other aspects like !ality

aareness< coBB!nication skills< attit!dinal trainin@ etc# 'he or@aniDation has trained the sta??

BeBbers to carry o!t the Internal A!dit o? the !ality Mana@eBent SysteB#

Appropriate ?lo chart is laid don alon@ ith necessary ?orBats to identi?y coBpetency needs< skillneeded< ed!cational back@ro!nd< eGperience etc# s!itable plannin@ o? trainin@ activities and

iBpleBentation o? trainin@ pro@raBs and veri?ication o? the trainin@ iBparted are also doc!Bented

thro!@h these ?orBats# %??ectiveness o? trainin@ and aareness is revieed at appropriate intervals#

Persons per?orBin@ speci?ic assi@ned tasks are trained on the basis o? appropriate ed!cation< skill or

eGperience< as re!ired to Bake theB aare o? the relevance and iBportance o? their activities and

their contrib!tion in achievin@ the !ality obKectives#

Records o? ed!cation< skill< -coBpetence eval!ation< orkin@ eGperience and trainin@ are Baintained#

Cro1re!erence 5 IMSP,TRG,/0 Proced&re !or Trainin$

TITLE5 IN;RASTUCTURE

'he or@aniDation has ade!ate in?rastr!ct!re viD# space and Baterial handlin@ e!ipBents and related

Prod!ct con?irBation< ,ardare and so?t are in coBp!ter as ell as inspection * testin@ ?acilities

Lre?er IMSM- 0#3J to Beet c!stoBer re!ireBents# Ade!ate Baintenance processes incl!din@

preventive Baintenance as ell as eno!@h stand-by o? Bachines and spares ?or Ban!?act!rin@ are

available in case o? the breakdon takes place#

TITLE5 @OR ENVIROMENT

All departBental head and y M#R Hs are responsible to Baintain appropriate ork environBent and?ollo necessary sa?ety r!les#

'he ork environBent considerin@ ho!sekeepin@< sa?ety< personal< %,S L%ssential ,ealth *Sa?etyJ

cleanliness etc# is ade!ately provided * Baintained# Sa?ety< ?irst aid and ho!sekeepin@ are s!itably

addressed# It is handled by MR#* y M#R< the ?ire eGtin@!ishersO ?irst aid boGes are provided and

Baintained by respective prod!ction inchar@e#herever necessary# 'hese are Baintained and records

are doc!Bented ade!ate ventilation< protective cloths > aprons > caps > @loves > ?oot ares >

Basks>@o@@les etc are provided * the ork ?orce is ell trained ?or the !se to it#

;ork instr!ctions as ell operational control instr!ctions at every critical processO operations o?

Bachines plants are displayed#

TITLE5 PLANNING O; PRODUCT REALIJATIONPlannin@ ?or prod!ct realiDation is the priBary responsibility o? prod!ction inchar@e and A inchar@e

on present prod!cts viD# conc# cheBicals< ind!strial and decorative pints< resins etc# It ens!res all

details o? plannin@ ?or prod!ct realiDation as ell as !ality (bKectives Preparation o? !ality Plans


15/23


Sahibabad Plant




IMSM-01 01 3 23 -

re!ireBents o? Material speci?ication< Material Sa?ety data sheet LMSSJ< CoBpetence o? S!pplier

is ens!red and eGec!ted by ;ork head and Prod!ct Inspectors LC< I>ChJ

;henever a ne prod!ct is la!nched< the c!stoBer re!ireBent > prod!ct speci?ication is analyDed *

re!ireBent re@ardin@ e!ipBent< processes< doc!Bents etc are identi?ied# 'he plannin@ also incl!des

veri?ication< inspection< test activities< and con?orBin@ o? MSS speci?ic to the prod!ct and the

criteria ?or prod!ct acceptance#

Records needed to provide evidence that the realiDation processes and res!ltin@ prod!ct Beets

re!ireBents and are established< Baintained and periodically veri?ied#

Re!5 Mater Lit o! @OCI

TITLE5 CUSTOMER RELATED PROCESSES

C!stoBer related processes are priBarily the responsibility o? Marketin@ ept# hich deals ith

receipt o? c!stoBers en!iries and revies * deterBines the re!ireBents o? the prod!ct incl!din@

those re!ireBents< hich are not stated and also the stat!tory or re@!latory re!ireBents< as

applicable as ell as the re!ireBents ?or delivery and post delivery activities# 'his is done in

association ith other departBents like P!rchase< Store and Prod!ction< i? any and then tender or

order is accepted#

Pre * post (rder or tender>contract revies are Bade# 'he orders > tenders are revieed ith respect

to !otation ?or the technical ?easibility and ability o? Ban!?act!rin@ as ell as other aspects like

price< delivery< and coBBercial terBs by coBB!nicated to c!stoBer by IC LM='J#

All aBbi@!ities and do!bts are resolved ith the c!stoBer at the tiBe o? acceptance o? order and

coBB!nicate order con?irBation

It is ens!red that all verbal instr!ction received ?roB the c!stoBer is disc!ssed ith the c!stoBer and

bilateral a@reeBent prior to the eGec!tion o? the order and are recorded

Provision is Bade in contract revie to identi?y the re@!latory re!ireBents o? o!r prod!ct in the

co!ntry o? !se#

Contact is Baintained ith the c!stoBer ?or any other details< hich are ?o!nd incoBplete< or to

obtain ?eedback< to ?!l?ill c!stoBers re!ireBents# C%(> IC LM='J acts as channel o?

coBB!nication# ABendBents to the orders are recorded and pass on the persons responsible ?or the

eGec!tion o? these aBendBents# 'he catalo@!es or advertisin@ Baterial< hich are Baintained by the

or@aniDation< are revieed and controlled to ens!re that they @ive the latest details#!ality Records o? revie and related activities are Baintained

Cro1re!erence5 IMSP,MT,/0 Proced&re !or Contract re"ie*

TITLE5 DESIGN AND DEVLOPMENT5

esi@n and evelopBent o? ne prod!ct or revie the %Gistin@ Prod!cts ?or Alternation< cost

red!ction are to be done by esi@n and evelopBent epartBent and C%( esi@n is over all-

responsible ?or this eleBent< and Methodolo@y o? esi@n Process is to be carried o!t as ?ollos:

Dei$n In#&t

esi@n inp!t re!ireBents relatin@ to the prod!ct are identi?ied< doc!Bented and their selection is

revieed ?or ade!acy#


16/23


Sahibabad Plant




IMSM-01 01 2 23 -

iJ Contract revie doc!Bents are considered ?or desi@n inp!t#

iiJ Applicable stat!tory re!ireBents are also identi?ied< doc!Bented and revieed#

iiiJ C!stoBers S!@@estion d!rin@ ?eed back

ivJ Internal revie and M%A analysis

Dei$n O&t#&t

esi@n o!tp!t is doc!Bented and eGpressed in terBs that can be veri?ied and validated a@ainst desi@n

inp!t re!ireBents#It is ens!red that desi@n o!tp!t Beets the desi@n inp!t re!ireBents and contains

acceptance criteria ?or characteristics cr!cial to the sa?e and proper per?orBance o? the prod!ct#

or developBent prod!ct< prod!ct brie? becoBes desi@n o!tp!t#

esi@n o!tp!t is revieed be?ore release# esi@n In-char@e Baintains necessary records and relevantdoc!Bents#

Re!erence5 IMSP,DSN,/05 Q&alit' Proced&re !or dei$n

Dei$n Re"ie*

Sta@es o? ?orBal desi@n revies are carried o!t at as described in * plan# ;here re!ired

eGperts are invited and res!lts o? revies are doc!Bented#

Dei$n Veri!ication

'estin@ the prod!ct at ?inal sta@e a@ainst desi@n o!t p!t does desi@n veri?ication and it is ens!red that

test are Beetin@ desi@n inp!t re!ireBents#

Dei$n Validation

esi@n validation is per?orBed to ens!re that prod!ct con?orBs to de?ined !ser needs and>or

re!ireBents# 4ase ?or desi@n validation is c!stoBer ?eed backs only#

Dei$n C%an$e

Proced!re described Bethods to identi?y< revie and approve by desi@n In-char@e be?ore their

iBpleBentation

Appropriate records are Baintained and controlled< by M#R#

TITLE5 PURC:ASING

P!rchasin@ is the responsibility o? the p!rchase s!pervisor and incl!des the ?olloin@ activities ?or

prod!ct hich stated by c!stoBer and i? it is re!ire to ne Ban!?act!rin@ iteB then only approved

selected vender @iven the p!rchase order and all d!e care are taken ?or prod!ct con?orBity#

P&rc%ain$ #roce

It is ens!red that p!rchased prod!ct con?orBs to speci?ied p!rchase re!ireBents by ?olloin@:

E"al&ation o! #lier

S!ppliers are eval!ated to assess their capability to Beet re!ireBents and selected on their Berits *

availability#

'he selected s!ppliers are incl!ded in the list o? approved s!ppliers< hich incl!des s!ppliers

s!pplyin@ services like cons!ltancy > trainin@< Baintenance< calibration< eGternal laboratory

inspection a@ency< s!pportin@ parts ?or a Ban!?act!rin@ prod!ct< transport< c!rrier hich @ives

details like iteBs s!pplied type and eGtent o? control eGercised# !ality per?orBance o? approved

s!ppliers is Bonitored periodically and record is Baintained#


17/23


Sahibabad Plant




IMSM-01 01 3 23 -

'he re-eval!ation ?re!ency depends !pon the score o? eval!ation * the @!idelines are as per the

?orBat L>P)R> 0J

$ote: 'his activity is applied to the s!ppliers o? critical iteBs only#

P&rc%ain$ in!ormation

P!rchase orders > contracts contain acc!rate data abo!t prod!ct description< type< class< @rade<

herever applicable# ;e also @ive re?erence o? applicable iss!es o? speci?ications > Process

re!ireBent > Speci?ication > inspection instr!ction > instr!ction ?or approval o? prod!ct incl!din@

e!ipBent< re!ireBents ?or !ali?ication o? the personnel and !ality Bana@eBent systeB

re!ireBents#

P!rchase orders are revieed and approved be?ore release#

Veri!ication o! #&rc%aed Prod&ct

;e carry o!t veri?ication o? the p!rchased prod!ct at o!r end a?ter receipt o? prod!ct as per !ality

plans > Speci?ications#

+eri?ication at the S!ppliers place is seldoB done b!t receivin@ inspection is ens!rin@ that the

prod!ct is as per !ality Plans > I'P

.enerally o!r c!stoBer do not veri?y the > prod!cts at s!ppliers place# ,oever i? any C!stoBer

speci?ies this re!ireBent< it is disc!ssed at contract revie sta@e and B!t!ally acceptable sol!tion is

?o!nd and recorded in p!rchase order#

'his veri?ication arran@eBent is clearly Bentioned on the p!rchase orders incl!din@ Bethod o?

prod!ct release

Cross-re?erence:

IMSP,PUR,/0 Q&alit' Proced&re !or P&rc%ae

E,PUR,/0 Proce1a##roac% !lo* c%art !or P&rc%ae

TITLE 5 PRODUCTION AND SERVICE PROVISION

C($'R( ( PR()C'I($ A$ S%R+IC% PR(+ISI($

irector is priBarily responsibility and I>C prod!ction is secondary responsible they have @athered

prod!ct in?orBation and also ens!re ?or iBpleBent the standard criteria thro!@h necessary orkinstr!ction ?or prod!ct Ban!?act!rin@<

Servicin@< operation o? e!ipBents#

'hey are also Bonitor and Beas!reBent done at planned interval

And check prod!ct>service con?orBities

'hey have iBpleBented all the criteria o? prod!cts be?ore and post delivery release#

TITLE 5 VALIDATION O; PROCESS ;OR PRODUCT AND SERVICE PROVSION

In o!r prod!ct Ban!?act!rin@ e have no special process hich !ality criteria apparently not

deterBined d!rin@ prod!ct realiDation and need to validation o? the process# 'here?ore this cla!se isnot applicable to o!r IMS re!ireBent and it is address as H%Gcl!sion

TITLE 5 IDENTI;CATION AND TRACEABILITY


18/23


Sahibabad Plant




IMSM-01 01 2 23 -

'he PriBary responsibility ?or the !ality systeB eleBent is ith P!rchase departBent and

s!bse!ently responsibility o? this eleBent is ith prod!ction * store inchar@e# 'he Bethodolo@y

?or identi?yin@ the prod!ct by s!itable naBe and Beans at receivin@< in-process and ?inal sta@e is

established#

'he stat!s o? the prod!ct like accepted< reKected< !nder inspection< in-process or !nder Reork etc# is

clearly Barked on the prod!cts ith the help o? ta@s > stickers > boards>Barkin@ pen#

'otal traceability is Baintained ?or analysis o? non- con?orBity thro!@h label>Barkin@< s!itable ta$

identi?y prod!cts stored > boards< hich co- relates to the s!pplier ho had s!pplied it# ,ence the

lot>batch no# date o? B?@# ra Baterial identi?ication< siDe drain@ etc can be traced to receivin@

inspection report# ot>4atch>,eat n!Bber is recorded as appropriately at receivin@ sta@e< hich isrecorded on incoBin@ inspection re@ister< In-process prod!ction * inspection< asseBbly sta@e< ?inal -

inspection report be?ore dispatch re?er to this parts>ot n!Bber< batch $o Serial $o are shon in

?inished prod!ct# Inspection and test report as ell as B?@ naBe plate parts Ban!?act!rin@ Baster

records are traceable to c!stoBer order>ork order >shipBent detail#

Re!5 IMSP,Str,/85 Prod&ct Identi!ication Trace(ilit' Prod&ct Recall.

CUSTOMER PROPERTY Lcla!se no: 8##J

M#R is priBarily responsible ?or this eleBent# ,e shall Baintain the record o? c!stoBer property

receipt and ret!rn a?ter !se< in case d!rin@ process any non con?orBity is ?o!nd than it is in?orBed to

c!stoBer be?ore it is takin@ in !se# 'he relevant record is established and Baintain as per the !ality

proced!re#

TITLE5 PRESERVATION O; PRODUCT

Store departBent LS'RJ is priBarily responsible ?or this ?!nction#

S!itable Bethods o? handlin@ the prod!ct d!rin@ internal processin@ and delivery to destination

itho!t ca!sin@ daBa@e or deterioration is !sed# Material in the or@aniDation is handled Ban!ally#

esi@nated stora@e areas ith identi?ication o? prod!cts are !sed to store earBarked area>c!pboard<

rakes are provided to store die>patterns< ra Baterial > CoBponents > ?inished @oods and packin@

Baterials to prevent daBa@e or deterioration#

Appropriate Method o? receipt and iss!es ?roB s!ch areas are iBpleBented#

Packin@ Baterials incl!din@ corr!@ated boGes are standard in nat!re and kept in stock# 'hey are

assessed periodically ?or the !antity available in stores * !ality thereo?# In case o? shorta@e< it is proc!red as aer re!ireBent#

'he condition o? ?inished coBponents incl!din@ packin@ Baterial< in stock at all Sta@es are

periodically checked# 'o detect daBa@e > deterioration d!e to stora@e< store ?ollos ?irst in ?irst o!t

L;I;O4 systeB# Care has taken to ens!re that packin@ is appropriate and ill not ca!se daBa@e to the

prod!ct d!rin@ transit# Preservation o? the prod!ct prior to ?inal delivery is ens!red#

Cro1Re!erence:

TITLE 5 CONTROL O; MONITERING AND MEASURING DEVICES

I>C prod is priBarily responsible ?or this ?!nction# 'he criteria ?or selection o? Beas!rin@ andBonitorin@ devices considers re!ireBent o? capability o? these devices to @ive acc!rate and precise

Beas!reBent so that !ncertainty re@ardin@ Beas!reBent is eliBinated and it provides evidence o?

con?orBity o? prod!ct and process to deterBined re!ireBents#


19/23


Sahibabad Plant




IMSM-01 01 3 23 -

A list o? Beas!rin@ and Bonitorin@ devices hich a??ect the prod!ct > process !ality is Bade and

taken !p ?or calibration# Meas!rin@ and Bonitorin@ devices are identi?ied by label containin@ devices

n!Bber > calibration dates and d!e dates#

'he device is bro!@ht !nder calibration proced!re * is calibration as per ?re!ency decided# 'hey are

adK!sted or re adK!sted as necessary# 'hey are identi?ied to indicate valid state o? calibration *

veri?ication o? these devices is Baintained# Calibration certi?icates are veri?ied ?or the validity o? the

Baster and traceability to $ational > International Standards#

;here no s!ch standards eGist< basis !sed ?or calibration or veri?ication is recorded#

Proper actions Le#@# identi?ication > recallin@ > re-inspection etcJ are taken on prod!ct and the device<

hen any device is ?o!nd o!t o? calibration#

Ade!ate care is taken d!rin@ handlin@< stora@e< preservation * sa?e @!ardin@ o? Beas!rin@ and

Bonitorin@ device * all concern are s!itably ed!cated ?or this p!rpose#

TITLE 5 MEASURMENT) ANALYSIS AND IMPROVEMENT

All In-Char@e are responsible ?or these activities#

Meas!reBent and Bonitorin@ o? data related to prod!ct con?orBity< process capability< !ality

Bana@eBent SysteB and e??ectiveness are done as ?ollos :

1# Collection o? data pertainin@ to prod!ct per?orBance#

2# Meas!reBent reports o? prod!cts#

3# SysteB $CR in a!dits# # C!stoBer Satis?action S!rvey

# C!stoBer coBplaints Bonitorin@#

6# Processes coBplaints Bonitorin@#

8# etails o? non " con?orBin@ prod!cts#

4ased on these details< analysis is Bade !sin@ vario!s Bethods# herever applicable#

S!itable iBproveBents< corrective actions and preventive actions are taken a?ter the analysis as

de?ined in the systeB#

TITLE 5 CUSTOMER SATIS;ACTION

PriBary responsibility ?or this activity is ith C%( "M=' departBent#C!stoBer satis?action details like repeat orders< red!ction in coBplaints<

IBproveBent in per?orBance prod!ct< Barket penetration< c!stoBer ?eedback

or Beetin@ their re!ireBents are so!@ht ?roB the c!stoBer#

Once in a Year Also cond!ct satis?action s!rvey and kno the level o? satis?action< s!@@estion

received ?roB c!stoBer ?or iBproveBent shall also revie and doc!Bented# S!itable actions are

decided based on this Bonitorin@ o? c!stoBer satis?action to achieve iBproveBent in it#

S!itable disposition and corrective actions are taken on c!stoBer coBplaint by e??ective analysis to

prevent their rec!rrences and the saBe is recorded#

TITLE 5 INTERNAL AUDITS

MR is priBarily responsible ?or this activity# Internal A!dits are cond!cted to veri?y hether the

!ality obKectives and related res!lts coBply ith the planned arran@eBents and to deterBine

e??ectiveness o? the !ality Bana@eBent systeB ali@n ith re!ireBents o? the standard#


20/23


Sahibabad Plant




IMSM-01 01 2 23 -

Internal A!dits are sched!led once in i+ mont% to cover all areas o? operations# Trained Internal

A&ditor *%o are trained !or cond&ctin$ A&dit i carr' o&t t%e internal a&dit.

An a!dit plan is prepared to @ive details abo!t a!dit sched!le# A!dit sched!le takes in to acco!nt

stat!s and iBportance o? the processes and areas bein@ a!dited#

'rained a!ditors independent o? activities in the a!ditin@ area are chosen# 'he a!dit sched!le @ives

relevant cla!ses o? the standard< hich are applicable to the departBent

'he a!ditor !ses c%eclit to record the a!dit activity alon@ ith obKective evidences# 4y reviein@

the check list MR ens!re coBprehensiveness o? a!dit coverin@ all re!ireBents o? IS( 001 "2009

standards# $on- con?orBities ?o!nd d!rin@ the a!dit are reported on non- con?orBity report ?orBs

and bro!@ht to the notice o? the a!dited departBent# A!ditee @ives the details o? proposed disposaland corrective action ith tar@et date o? coBpletion# MR revies tar@et date o? coBpletion ?or tiBely

actions# Proposed corrective actions are veri?ied ?or their e??ectiveness in the neGt a!dit# ollo !p

a!dit are cond!cted< as necessary< to ens!re e??ective clos!re o? $CR A s!BBary o? A!dit Reports

?orBs part o? the Min!tes o? Mana@eBent Revie#

Re!. Doc5 1 IMSP,IMS,/ Proced&re !or Internal Q&alit' A&dit

TITLE 5 MONITERING O; PROCESS5

,(s o? respective departBent are responsible ?or this ?!nction< they have Bonitor and Beas!re the

process by applyin@ s!itable Bethod this is incl!de daily operation and eval!ation ?or sBall-steptoard contin!al iBproveBent Beas!reBents o? process per?orBance cover ?or process capability<

reaction>Cycle tiBe< process thro!@h p!t< o!tcoBe yield< e??ectiveness and e??iciency o? people<

;aste red!ction>!ality loss appropriate records are established and Baintain ?or evidence and ?or

revie p!rpose#

TITLE 5 MONITERING AND MEASUREMENT O; PRODUCT

Respective departBents s!ch as Store< Prod!ction and C are responsible ?or Bonitorin@ and

Beas!reBent o? the prod!cts is done at vario!s sta@es as ?ollos#

KA Recei"in$ ta$e5 1

Meas!reBent and testin@ o? all incoBin@ Baterials is done as per !ality Plan>I'P# Records o?

Beas!reBent and Baintained# In-coBin@ prod!cts are not !sed !ntil they have been inspected *con?orBance to speci?ied re!ireBents has been veri?ied#

An !r@ently re!ired Baterial Bay seldoB be released prior to veri?ication< b!t it is positively

identi?ied * recorded to perBit recall in the event o? non-con?orBance to Speci?ied re!ireBents

KB In ? #roce ta$e ?

Monitorin@ o? in-process paraBeters as ell as prod!ct Beas!reBents are carried o!t by In-char@e

LCJ and Inchar@e Lprod!ctionJ 'hose respective speci?ications are Bet as per I'P> !ality Plan#

'he records o? in- process Beas!reBent and Bonitorin@ are Baintained# In case o? $on-con?orBin@

prod!ct is res!lted d!rin@ the process< It is recorded and corrected by repair > reork and re-

inspected or re-@raded other ise repairs>reork not possible than it scarped or alternative

application# Repaired * reorked prod!ct is re-inspected in accordance ith !ality plan >

Speci?ication

KC ;inal ta$e ?


21/23


Sahibabad Plant




IMSM-01 01 3 23 -

'he records o? incoBin@ sta@e and in " process sta@e are taken into consideration ;hile oin@ ?inal

testin@ or Beas!reBents o? the prod!ct# In-Char@e LCJ does the ?inal testin@ or Beas!reBent as per

!ality plan# Prod!ct delivery does not proceed !ntil the planned Arran@eBent has been satis?actorily

coBpleted# Acceptance are Bade only hen approved by QC inc%ar$e or by c&tomer#

inal Beas!reBents and test records are properly Baintained and their retention period and Bode o?

disposal is Bentioned on the respective ?ile All the Beas!reBents< testin@< Bonitorin@ records

Baintained speci?y the Prod!cts LPartsJ Ban!?act!rin@ date>batch>lot>Sr#no ise

TITLE 5 CONTROL O; NON1CON;ORMING PRODUCT.

In-Char@e o? prod!ction * C is responsible ?or this ?!nction#

Prod!ct non " con?orBity is identi?ied at every sta@e startin@ ?roB in-coBin@ Baterial thro!@h ?inal?inished prod!ct# Any non-con?orBity in prod!ct hether d!e to internal ?ail!re or coBplaint by the

c!stoBer is identi?ied and controlled to prevent its !nintended !se or delivery# Responsibility and

a!thorities ?or dealin@ ith non "con?orBin@ prod!cts are clearly de?ined in IMSM section 2#6 * 2#8

'he ca!se o? non-con?orBity is investi@ated by systeBatic analysis and one o? the ?olloin@ disposal

Bethod is !sed :

1# Reork to Beet speci?ied re!ireBent

2# Sale in disco!nt

3# ReKected and isposed as scrape

Reork Baterial is identi?ied and re-veri?ied be?ore ?!rther processin@#

;hen non "con?orBin@ prod!ct is detected a?ter delivery or !se has started< appropriate action is

taken to avoid potential e??ects on the prod!ct !ality#

Re! Doc5 1SOP,S11//< Proced&re !or control o! Non1 Con!ormin$ Prod&ct

TITLE5 EMERGENCY PREPAREDNESS ANS RESPONSE

)'RA I$'%R$A'I($A ' has established and Baintained proced!res to respond to accidents

and eBer@ency sit!ation ?or preventin@ and Biti@atin@ the iBpacts that Bay be associated ith

theB# %%P I$)S'RI%S shall revie and revise hen necessary# Its eBer@ency preparation and

response proced!re in partic!lar a?ter the occ!rrence o? accident or eBer@ency sit!ations# 'he

or@aniDation shall also periodically test s!ch proced!res here practicable#

TITLE5 ANALYSIS O; DATAC%( * all In-char@es are priBarily responsible ?or this activity#

MR revie Bonthly the data collected like c!stoBer satis?action details< Beas!reBent or Bonitorin@

reports o? prod!ct and process characteristics< or@aniDational per?orBance report< s!pplier

per?orBance reports< etc# and analyDe this data ?or establishin@< controllin@ and veri?yin@ process

capability< prod!ct characteristics< and iBproveBent areas# 'he revie also ens!res s!itability o? the

!ality Bana@eBent SysteB and the need ?or contin!al iBproveBent in it# At present ?or analyDin@

the c!stoBer coBplaints and internal reKections or prod!ct characteristics< ca!se and e??ect dia@raB >

trend @raphs are !sed as applicable the corrective actions and preventive actions taken are Bonitored

to ens!re their e??ectiveness

TITLE 5 CONTINUAL IMPROVEMENT

S!itable iBproveBents< corrective actions and preventive actions are decided and iBpleBented based

on the analysis o? data# 'he !ality policy< !ality obKectives< internal a!dit ?indin@s< prod!ct >


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process non-con?orBities ?roB the basis ?or contin!al iBproveBent# 'he actions taken are Bonitored

?or e??ectiveness as Bentioned in respective ?orBat or proced!re these can lead to chan@es in !ality

Bana@eBent systeB and other related doc!Bents to iBprove the systeB contin!ally#

TITLE 5 CORRECTIVE ACTION

'he priBary responsibility o? the corrective action on prod!cts * processes lies ith inspection *

C#

$on-MR handles Con?orBities in the systeBs as per doc!Bented ork proced!re that ens!res: -

AN Reviein@ non " con?orBities< characteristics and trends o? processes and prod!cts incl!din@

c!stoBer coBplains

4N eterBinin@ ca!sesCN %val!atin@ the need ?or action to prevent rec!rrence o? non-con?orBities

N eterBinin@ and iBpleBentin@ action needed

%N Records o? corrective actions

N Corrective action revie ?or e??ectiveness

Cro Re!erence5 Re!. Doc5 IMSP,IMS,/= Proced&re !or Correcti"e and Pre"enti"e Action

TITLE5 PREVENTIVE ACTION

'he priBary responsibility o? the Preventive Action lies ith the MR> all IC#

oc!Bented proced!re de?ines details ?or takin@ e??ective preventive action#Preventive Actions are taken on potential non " con?orBities a?ter considerin@ any one or Bore o? the

?olloin@ so!rces:

1# Records o? Mana@eBent Revie

2# Records o? Preventive Maintenance

3# Records o? contract revie

# Records o? s!pplier per?orBances

# Records o? SysteB $on-con?orBities

6# Records o? process or prod!ct $on-Con?orBities

8# 'rainin@ records

9# Records o? C!stoBer CoBplaints

# Characteristics and trends o? processes and prod!cts incl!din@ opport!nity ?or preventiveaction# Pertinent ca!se are identi?ied and actions on potential non-con?orBities are decided

A?ter eval!atin@ the need ?or it# S!itable Preventive Actions are taken thro!@h pertinent

doc!Bents and are recorded# 'he Res!lts are revieed and Bonitored to prevent occ!rrence

o? potential non-con?orBity#

Re!. Doc5 1 IMSP,IMS,/= Proced&re !or Correcti"e and Pre"enti"e Action


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management system manual iso 90014 feb-11.doc

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