iso 9001-14001 ims manual
TRANSCRIPT
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Company Nam:
Address:
Company Logo
INTEGRATED MANAGEMENTSYSTEM
MANUAL ISO 9001:2008, ISO14001:2004
Prepared by
Name:
Designation:
Signature:
Reviewed by
Name:
Designation:
Signature:
Approved by
Name:
Designation:
Signature:
C.E.O
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Company LogoINTEGRATED MANAGEMENT
SYSTEM MANUAL
DOCUMENT ISTORY
RE!
NoDATE
SECTIO
NDCR No NATURE O" AMENDMENT
* All changes made n !he doc"men! are no!#ed n !he Doc"men! $s!ory%&or de!als o' amendmen!s( please re'er !o rele)an! DCR Doc ChangeRe+"es!,%
Doc"men!
-:
RE
.:
E/ec!)e
Da!e:
0age 1o'
#8
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TA$LE O" CONTENTS
S%&'(on S%&'(on T(')% *ag% No
1 11 Company *+o)% -MS EMS .
211
Scope 2%3 // 4E5cl"son 11 11 4S!r"c!"re o' 6"al!y( $eal!h 7 Sa'e!y 7En)ronmen!al Managemen! Sys!emMan"al
11 11 4
# 11 D%n('(on A+%3(a'(on #0 11 8
4
11 In'%g+a'%5 Manag%m%n' Sy'%m 40 40 1#9%2 General Re+"remen!s 9%2 11 2
9%; Managemen! o' Doc"men!s and Records9%;%9%;%9
9%9%%2 11 3
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S%&'(on S%&'(on T(')% *ag% No
>%; Mon!orng and Meas"remen! >%; 11 311 C"s!omer Sa!s'ac!on >%;%2 11 311 In!ernal A"d! >%;%; 9%%9 9%%< Impro)emen! >%< 11 11 Con!n"al Impro)emen! >%%
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SECTION 1
COM*ANY *RO"ILE
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COMPANY PROFILE
Com@ned has s c"rren!ly s!r"c!"red aro"nd maor depar!men!s( hch
are as 'ollos:
1-
2-
3-
4- .
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SECTION 2
SCO*E
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2 SCO*E
The scope o' !hs In!egra!ed Managemen! Sys!em man"al s !odemons!ra!e !he companys comm!men! !o pro)de conss!en!ly prod"c!s!ha! mee! c"s!omer and reg"la!ory re+"remen!s% I! apples !o all !he
ac!)!es and '"nc!ons o' company rela!ed !o S!orages( Inspec!on( and0acng e!c% Ths man"al es!a@lshes complance !h !he re+"remen!s o'6"al!y and En)ronmen!al Managemen! Sys!em as ell as reg"la!ons%
21 E;&)7(on
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SECTION #
DE"INITIONS A$$RE!IATIONS
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# DE"INITIONS AND A$$RE!IATIONS
All applca@le s!andards- here !he !erm all applicable standards s "sed
n !he 6"al!y and En)ronmen!al Managemen!Sys!em Man"al( all doc"men!s ls!ed n !heApplca@le s!andards and reg"la!ons sec!on o'!hs doc"men! apply
C0A 1 Correc!)e and 0re)en!)e Ac!on
6"al!y- Con'ormance !o !he re+"remen!s o' n!eres!ed
par!es or a@sence o' )ara!on
6MS- 6"al!y Managemen! Sys!em
EMS- En)ronmen!al Managemen! Sys!em
?$SAS- ?cc"pa!onal $eal!h and Sa'e!y Managemen!
Sys!em
IMS- In!egra!ed Managemen! Sys!em
E0M- En)ronmen!al Managemen! 0rogram
SMD- Sys!em Managemen! 7 De)elopmen!
NE6S 1 Na!onal En)ronmen! 6"al!y S!andard
Accden!BIncden! 1An "ndesred e)en! g)ng rse !o dea!h( llness(n"ry( damage( or o!her loss%
A"d!or 1A person !h !he compe!ence !o cond"c! ana"d!%
Con!n"al Impro)emen! 1A rec"rrng process o' enhancng !he IMS norder !o ache)e mpro)emen!s n o)erall IMS
per'ormance conss!en! !h IMS 0olcy%
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Correc!)e Ac!ons 1Ac!ons !o elmna!e !he ca"se o' a de!ec!ednoncon'ormance%
Doc"men! 1In'orma!on and !s s"ppor!ng med"m%
En)ronmen! 1S"rro"ndngs n hch C&L opera!es( ncl"dng ar(a!er( land( na!"ral reso"rces( Hora( 'a"na(h"mans( and !he )aro"s n!errela!onshps o' !hea@o)e%
En)ronmen!al Aspec!s 1Elemen!s o' C&L ac!)!es( prod"c!s or ser)ces!ha! can n!erac! !h !he en)ronmen!%
En)ronmen!al Impac!s 1Any change !o !he en)ronmen!( he!her ad)erseor @ene#cal( holly or par!ally( res"l!ng 'rom C&Len)ronmen!al aspec!s%
$aFard Iden!#ca!on 1A process o' recognFng !ha! a haFard e5s!s andde#nng !s charac!ers!cs%
$aFards 1So"rces or s!"a!ons !h a po!en!al 'or harm n!erms o' n"ry or llness( damage !o proper!y( or acom@na!on o' !hese%
$eal!h and Sa'e!y 1Cond!ons and 'ac!ors !ha! a/ec! !he ell1@engo' employees( !emporary orers( con!rac!ors(
)s!ors( and any o!her person n !he orplace%
In!eres!ed 0ar!y 1A person or gro"p concerned !h or a/ec!ed @y!he 6$SE per'ormance o' C&L
In!ernal A"d!s 1A sys!ema!c( ndependen!( and doc"men!edprocess 'or o@!anng a"d! e)dence ande)al"a!ng ! o@ec!)ely !o de!ermne !he e5!en!!o hch !he 6$SE Managemen! Sys!em a"d!cr!era se! @y C&L are '"l#lled%
Noncon'ormance 1The non1'"l#llmen! o' a re+"remen!%
0re)en!)e Ac!ons 1Ac!ons !o elmna!e !he ca"se o' a po!en!alnoncon'ormance( pre)en!on o' employee n"res(poll"!on "se o' processes( prac!ces( !echn+"es(ma!erals( prod"c!s( ser)ces( or energy !o a)od(red"ce or con!rol !he crea!on( emsson( ordscharge o' any !ype o' poll"!an! or as!e( norder !o red"ce ad)erse en)ronmen!al mpac!s(+"al!y de'ec!s( sa'e!y and heal!h haFards%
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IMS 10ar! o' C&L In!egra!ed Managemen! Sys!em "sed!o de)elop and mplemen! !s In!egra!ed Sys!em0olcy and manage !s +"al!y concerns( c"s!omerre+"es!s( heal!h ss"es and en)ronmen!alaspec!s% The managemen! sys!em s a se! o'
n!errela!ed elemen!s "sed !o es!a@lsh polcy ando@ec!)es and !o ache)e !hose o@ec!)es% TheIn!egra!ed Managemen! Sys!em ncl"des C&Ls!r"c!"re( plannng ac!)!es( respons@l!es(prac!ces( proced"res( processes( and reso"rces%
6$SE ?@ec!)e 1An o)erall en)ronmen!al goal( conss!en! !h!he 6$SE 0olcy !ha! C&L has se! !sel' !o ache)e%
6"al!y( $eal!h( Sa'e!y 7 En)ronmen!al 0er'ormance1Meas"ra@le res"l!s o' C&L Managemen! o' !sen)ronmen!al aspec!s( sa'e!y haFards( +"al!yconcerns and !ems% In !he con!e5! o' !heIn!egra!ed Managemen! Sys!em( !ha! !heseres"l!s can @e meas"red agans! C&L 6$SE 0olcy(o@ec!)es( !arge!s( and o!her IMS per'ormancere+"remen!s%
IMS 0olcy1The o)erall n!en!ons and drec!on o' C&L rela!ed!o !s IMS per'ormance( as 'ormally e5pressed @y
!op managemen!% ?"r IMS 0olcy pro)des a'rameor 'or ac!on and 'or !he se!!ng o' IMSo@ec!)es and !arge!s%
6"al!y( $eal!h( Sa'e!y 7 En)ronmen!al Targe!1A de!aled per'ormance re+"remen!( applca@le!o C&L or par!s !hereo'( !ha! arses 'rom !he IMSo@ec!)es and !ha! needs !o @e se! and me! norder !o ache)e !hose o@ec!)es%
Rs 1A com@na!on o' !he lelhood and conse+"ences
o' a spec#ed haFardo"s e)en! occ"rrng%
Rs Assessmen! 1A pro!ocol !o es!ma!e !he magn!"de o' rs anddecde he!her or no! !he rs s !olera@le%
Sa'e!y 1&reedom 'rom "naccep!a@le rs or harm%
Tolera@le Rs 1Rs !ha! has @een red"ced !o a le)el !ha! can @eend"red @y o"r company !h respec! !o o"r legalo@lga!ons and 6$SE polcy%
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SECTION 4
INTEGRATED MANAGEMENT SYSTEM>ISO: 9001, ISO: 14001?
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4 INTEGRATED MANAGEMENT SYSTEM >IMS?
41 G%n%+a) R%@7(+%m%n'
$arrson 0harmace"!cals has doc"men!ed( mplemen!ed andman!aned an In!egra!ed Managemen! Sys!em @ased on 6"al!y andEn)ronmen!al Managemen! Sys!em n accordance !h !here+"remen!s o' all applca@le s!andards and reg"la!ons% con!n"allympro)es !he e/ec!)eness o' !s sys!em !ha!:
a, Iden!#es !he processes needed 'or !s opera!ons and !herapplca!on !hro"gho"! !he organFa!on
@, De!ermnes !he se+"ence and n!erac!on o' !hese prmaryprocesses
c, Iden!#es !he assoca!ed heal!h 7 sa'e!y haFards anden)ronmen! aspec!s and con!rol !hem a'!er and @e'ore !heprocesses
d, De!ermnes cr!era and me!hods needed !o ens"re !ha! @o!h !heopera!on and managemen! o' !hese processes are e/ec!)e
e, Ens"res !he a)ala@l!y o' reso"rces and n'orma!on necessary!o s"ppor! !he opera!on and mon!orng o' !hese processes
', Ens"res mplemen!a!on o' ac!ons necessary !o ache)e plannedres"l!s and con!n"al mpro)emen! o' !hese processes
g, E)al"a!e perodcally !he IMS and "pda!e !he sys!em hene)er!s necessary
42 Manag%m%n' o= Do&7m%n' an5 R%&o+5
421G%n%+a)
The 'ollong con!rolled doc"men!s ens"re !he e/ec!)e opera!onand con!rol o' o"r processes:
L%3%) Do&7m%n'a'(on Typ%
IIn!egra!ed Sys!em 0olcy( In!egra!ed sys!emMan"al( o@ Descrp!ons( ?rganFa!onal Char!
II In!egra!ed Sys!em 0roced"res
III0rocess &los B or Ins!r"c!onsBS?0s B Sa'e!ySgns
I. &orms and &orma!s B Records
422IMS Man7a)
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Ths man"al de#nes polces and g"delnes necessary !o ens"re !ha!
all ac!ons a/ec!ng +"al!y( heal!h 7 sa'e!y and en)ronmen!al
ss"es are cond"c!ed accordng !o doc"men!ed proced"resJ !he end
res"l! @eng !he con!rol o' processes hch a/ec! !he +"al!y o'
prod"c!s pro)ded !o o"r c"s!omers%
42#Con'+o) o= Do&7m%n'
A sys!em s man!aned !o con!rol doc"men!s re+"red 'or !he
n!egra!ed managemen! sys!em% Doc"men!ed proced"res e5s! !o
es!a@lsh !he 'ollong le)els o' con!rol:
a, Appro)al o' doc"men!s 'or ade+"acy pror !o ss"e
@, Re)e( "pda!e as necessary and re1appro)al o'
doc"men!sc, Iden!#ca!on o' !he c"rren! re)son s!a!"s o'
doc"men!s
d, Ass"rance !ha! rele)an! )ersons o' applca@le doc"men!s
are a)ala@le a! pon!s o' "se
e, Ass"rance !ha! doc"men!s remans leg@le( den!#a@le
and readly re!re)a@le
', Ass"rance !ha! doc"men!s o' e5!ernal orgn are den!#ed
and !her ds!r@"!on con!rolled
g, 0re)en!ng !he "nn!ended "se o' o@sole!e doc"men!s(
and !o apply s"!a@le den!#ca!on !o !hem ' !hey are
re!aned 'or any p"rpose
424Con'+o) o= R%&o+5
Con!rol all !he records re+"red 'or !he In!egra!ed Managemen!Sys!em% S"ch records are man!aned !o pro)de e)dence o'con'ormance !o re+"remen!s and e/ec!)e opera!on o' !hen!egra!ed managemen! sys!em% A 0roced"re has @een de#ned !odoc"men! !he den!#ca!on( s!orage( re!re)al( pro!ec!on( re!en!on!me and dspos!on o' records%
42.R%)a'%5 Do&7m%n':
% 0roced"re 'or Doc"men!s and Records Con!rol
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SECTION .
MANAGEMENTRES*ONSI$ILITY
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5. MANAGEMENT RES*ONSI$ILITY
5.1 Manag%m%n' Comm('m%n'
Top managemen! o' $arrson 0harmace"!cals has de#ned !he o)eralls!ra!egy and o@ec!)es 'or !he In!egra!ed Managemen! Sys!em n !he'orm o' !he In!egra!ed Sys!em IMS, 0olcy%
Top managemen! s comm!!ed !o con!n"e mpro)emen! o' !hen!egra!ed managemen! sys!em s shon !hro"gh ac!)e par!cpa!on n!he Managemen! Re)e Mee!ngs 7 @y endorsemen! and re)e o' !heIn!egra!ed Sys!em 0olcy%
.11Top managemen! den!#es and pro)des ade+"a!e reso"rces
!o ache)e !he In!egra!ed Sys!em 0olcy o@ec!)es% The need'or re+"red reso"rces s dsc"ssed a! Managemen! Re)e
Mee!ngs and doc"men!ed n !he Mn"!es o' Managemen!
Re)e Mee!ngs%
.12Top managemen! reg"larly comm"nca!es !o !he organFa!on
!he mpor!ance o' mee!ng IMS re+"remen!s( c"s!omer and
reg"la!ory re+"remen!s%
.1#Top managemen! s also comm!!ed !o mnmFe poll"!on and
ens"re heal!h 7 sa'e!y r"les are 'olloed hle ens"rng
en)ronmen!al 'rendly cond!ons n all !he s!es and !he
orng premses%
.2 C7'om%+ "o&7
Each '"nc!on man!ans hgh c"s!omer 'oc"s !hro"gh !ranngs andaareness sessons and mang !he employees realFe !he mpor!ance o'mee!ng and "nders!andng c"s!omer re+"remen!s% Top managemen!ens"res !ha! c"s!omer re+"remen!s are den!#ed and are me! !h !heam o' mpro)ng c"s!omer sa!s'ac!on and gong @eyond !here5pec!a!ons%
.# In'%g+a'%5 Sy'%m *o)(&y
$arrson 0harmace"!cals has de#ned an n!egra!ed sys!em polcyaccordng !o !he re+"remen!s o' In!egra!ed Managemen! Sys!em%
a, Top managemen! comm"nca!es !he IMS 0olcy !o !heorganFa!on and !he n!en! o' !he polces and ens"res !ha!!hey are "nders!ood a! all le)els o' !he organFa!on%
@, The polces and o@ec!)es are perodcally re)eed 'or
s"!a@l!y @y !op managemen! as par! o' !he Managemen!Re)e
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R%)a'%5 Do&7m%n':% In!egra!ed Sys!em 0olcy
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IMS *OLICY
hle carryng o"! !s ac!)!es( !he am o' Com@ned &a@rc s !o ens"re heal!h
andsa'e!y o' !s employees( con!rac!ors( c"s!omers and local comm"n!es( !o
pro!ec! !heen)ronmen! and ens"re p"@lc sa'e!y on !he @ass o' !he 'ollongg"dng prncples:
all ac!)!es m"s! @e managed n s!rc! complance !h reg"la!ons and
@"yers !erms o' engagemen!sJ
!he adop!on o' prncples( s!andards and sol"!ons !ha! cons!!"!e
n!erna!onal @es!prac!ces n @"sness 'or !he pro!ec!on o' heal!h( sa'e!y(
!he en)ronmen! and p"@lc sa'e!yJ
opera!onal managemen! m"s! @e @ased on de#ned cr!era n !erms o'
en)ronmen!al pro!ec!on and !he o@ec!)e m"s! @e p"rs"ed o#mpro)ng
heal!h and sa'e!y cond!ons accordng !o prac!ces and proced"resJ
personnel !ranng and !he e5change o' e5perence and n'orma!on m"s!
@e consdered '"ndamen!al !ools n order !o ache)e 6$SE o@ec!)es( !h
a )e !o !hecon!n"o"s mpro)emen! o' pre)en!on and pro!ec!on
s!andardsJ
employees( hen carryng o"! !her d"!es( m"s! @e "se o' 0ersonal
0ro!ec!)e E+"pmen! 00E, le Mas( Apron( Glo)es e!c% here
applca@le,J
employees( a"!hor!es and !he general p"@lc m"s! @e n'ormed
perodcally a@o"! !heres"l!s ache)ed n !erms o' en)ronmen!al
pro!ec!on( heal!h and sa'e!y
hen re+"es!ed( coopera!on m"s! @e ens"red !h compe!en! a"!hor!es
regardng!he prepara!on o' !echncal reg"la!ons and g"delnes
concernng $SE ss"esJ
!he 'oregong prncples m"s! @e re)eed cons!an!ly and !her applca!on
mon!oredperodcally%
OUR COMMITMENTS
-7a)('y
Ens"re +"al!y rgh! 'rom !he so"rce
Impro)e +"al!y @y s!rc! +"al!y con!rol and +"al!y ass"rance%
Con!n"al e/or!s !o man!an s"peror +"al!y prod"c!s a! mos! reasona@le
En3(+onm%n'
MnmFe !he en)ronmen!al mpac! o' opera!ons and prod"c! !hro"gh
!he adap!ons o' s"s!ana@le prac!ces and con!n"o"s mpro)emen! n
en)ronmen!al per'ormance
Ens"re reg"lar mon!orng o' EK"en! dscharge( Ar Emssons and o!her
parame!ers assoca!ed !h )aro"s processes and ac!)!es a! or
place
Managng as!es !hro"gh proper segrega!on and dsposal
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.4 *)ann(ng
a, Top managemen! ens"res !ha! o@ec!)es( ncl"dng !hose needed!o mee! re+"remen!s 'or prod"c!( are es!a@lshed a! rele)an!'"nc!ons and le)els% The o@ec!)es are meas"ra@le and
conss!en! !h !he polces%
@, Top managemen! ens"res !ha! !he reso"rces needed !o ache)e!he In!egra!ed Sys!em o@ec!)es are den!#ed and planned%
c, 0lannng s cond"c!ed !o ens"re !ha! changes !o !hemanagemen! sys!ems are cond"c!ed n a con!rolled manner s"ch!ha! !he n!egr!y o' !he managemen! sys!em s man!aned%
.41 E3a)7a'(on o= S(gn(&an' En3(+onm%n'a) Ap%&'
$arrson 0harmace"!cals !aes n!o acco"n! !he 'ollong 'or !heongong plannng heal!h and sa'e!y haFard den!#ca!on( rsassessmen! and rs con!rol( and den!#ca!on o' en)ronmen!alaspec!s !ha! ha)e or can ha)e sgn#can! mpac!s, on !heen)ronmen!%
a, Ac!)!es o' all personnel ha)ng access !o !heorplace ncl"dng s"@con!rac!ors and )s!ors,J
@, Ro"!ne and non1ro"!ne( %e% perodc oremergency ac!)!esJ
c, Ac!)!es( prod"c!s or ser)ces !ha! can @econ!rolled or nH"enced( %e% p"rchaseJ
d, The en)ronmen!al concerns o' n!eres!edpar!esJ
e, E5s!ng and changng en)ronmen!allegsla!on and reg"la!onsJ
', All n'orma!on on occ"pa!onal heal!h sa'e!yhaFards and en)ronmen!al aspec!s and mpac!sassessmen!s s ep! "p !o da!e and reg"larly re)eedJ
R%)a'%5 Do&7m%n':
% 0roced"re 'or En)ronmen!al Aspec!s Analyss
.42 IMS O%&'(3% Ta+g%'
IMS o@ec!)es 7 !arge!s are se! eepng n )e !he 'ollongparame!ers:
a,In!egra!ed Sys!em 0olcy@,Sgn#can! en)ronmen!al aspec!s and den!#ed heal!h and
sa'e!y rssc, Applca@le legal and o!her re+"remen!sd,.e o' n!eres!ed par!ese,&nancal( ?pera!onal and o!her re+"remen!s
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.4#Manag%m%n' *+og+am
$arrson 0harmace"!cals has es!a@lshed a sys!em !o ens"re !se/ec!)eness !hro"gh Managemen! 0rogram hch descr@es !he
'ollong:a, Reso"rce Re+"remen! 'or each s!ep B !arge!@, Respons@le persons, 'or each s!epc, Targe! da!ed, S!ar!ng da!ee, Comple!on da!e', Remars 'or any correspondence re'erence e!c%
R%)a'%5 Do&7m%n':
% 0roced"re 'or ?@ec!)es and Targe!s
.42L%ga) an5 O'B%+ R%@7(+%m%n'
$arrson 0harmace"!cals has es!a@lshed( doc"men!ed andman!aned a proced"re 'or den!'yng !he legal and o!herre+"remen!s !ha! are applca@le !o !he en)ronmen!al aspec!s andmpac!s and ?cc"pa!onal $eal!h haFards o' !s opera!ons%
a, 0olcy re+"remen!s@, Legal re+"remen!sc, Non1reg"la!ory g"delnes
d, Company s!andards
Managemen! Represen!a!)e man!ans a record o' legal and o!herre+"remen!s and mon!ors amendmen!s or add!ons%
R%)a'%5 Do&7m%n':% 0roced"re 'or Legal and ?!her Re+"remen!s
.. R%pon(()('y, A7'Bo+('y an5 Comm7n(&a'(on
..1R%pon(()('y an5 A7'Bo+('y
Respons@l!es and a"!hor!es !hn !he organFa!on are de#nedn 'orm o' organFa!onal char!s and o@ descrp!ons% Each employees ss"ed !h hs o@ descrp!on%
R%)a'%5 Do&7m%n':% o@ Descrp!ons% ?rganFa!onal Char!
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..2Manag%m%n' R%p+%%n'a'(3%
Top managemen! o' $arrson 0harmace"!cals has appon!ed aManag%m%n' R%p+%%n'a'(3% 'or n!egra!ed managemen!sys!em% The Managemen! Represen!a!)e:
a, Ens"res !ha! prod"c!s are prod"ced !ha! sa!s'y !he c"s!omerand 6$SE re+"remen!s
@, Ens"res !he pre)en!on o' poll"!on and heal!h 7 sa'e!yhaFards !hro"gh complance !o reg"la!ons( consolda!on andre)e o' en)ronmen!al mpac!s%
c, $as !he a"!hor!y and respons@l!y !o ens"re !ha! !here+"remen!s o' !he n!egra!ed managemen! sys!em arees!a@lshed( mplemen!ed and man!aned
d, Repor!s on !he s!a!"s o' !he managemen! sys!em andcon!n"al mpro)emen! as np"!s !o !he Managemen! Re)e
Mee!ngse, 0romo!es aareness o' c"s!omer and reg"la!ory re+"remen!s
!hro"gho"! !he organFa!on
..# In'%+na) Comm7n(&a'(on
Top managemen! ens"res !ha! appropra!e comm"nca!onprocesses are es!a@lshed and comm"nca!on !aes place regardng!he e/ec!)eness o' !he n!egra!ed managemen! sys!em !hro"ghmee!ngs( nesle!!ers( and n!ernal pos!ngs e!c%
The company has selec!ed employees represen!a!)es 'or !hecons"l!a!on on !he @ehal' o' employees 'or !he de)elopmen! re)eo' polces 'or managng !he rss% The employees are also cons"l!edhere !here are any changes !ha! co"ld a/ec! !he orplace heal!hand sa'e!y% All !he cons"l!a!on s doc"men!ed%
The ss"es !ha! are comm"nca!ed !o !he employees are @"! no!lm!ed !oJ
a, Incl"son o' ne prod"c! n !he prod"c! lne
@, Any change or ncl"son n e+"pmen!c, Change n +"al#ca!on le)el o' !he employees
d, Change n o@ descrp!on
e, Reg"la!ory re+"remen!s
', Ne n'orma!on 'or con!rollng !he den!#ed haFards
g, Complan!s
..4E;'%+na) Comm7n(&a'(on
C"s!omer 'eed@ac and complan!s !ha! a/ec! c"s!omer sa!s'ac!on
are doc"men!ed and dsc"ssed a! Managemen! Re)e mee!ngsand necessary ac!on !aen 'or mpro)emen!%
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R%)a'%5 Do&7m%n':
( 0roced"re 'or In!ernal and E5!ernal Comm"nca!on
(( 0roced"re 'or C"s!omer &eed@ac and Complan!s
.6 Manag%m%n' R%3(%
Top managemen! has es!a@lshed a process !o re)e !he In!egra!edManagemen! Sys!em a! planned n!er)als !o e)al"a!e !s e/ec!)enessand s"!a@l!y and )er'y !ha! IMS polces and o@ec!)es are @engsa!s#ed%
A! a mnm"m( !he a!!endees o' !he Managemen! Re)e Mee!ng needs!o @e !he depar!men! managers B heads or desgna!es andrepresen!a!on 'rom !op managemen!%
R%)a'%5 Do&7m%n':
% 0roced"re 'or Managemen! Re)es
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SECTION 6
RESOURCSE MANAGEMENT
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6. RESOURCE MANAGEMENT
61 *+o3((on o= R%o7+&%
Top managemen! o' $arrson 0harmace"!cals den!#es and pro)des !hereso"rces( ncl"dng e+"pmen!( ra ma!erals( or areas( and !ranedpersonnel 'or mplemen!ng and con!n"ally mpro)ng !he e/ec!)enesso' !he n!egra!ed managemen! sys!em%
The "s!#ca!on and ac+"s!on o' !he re+"red reso"rces s dsc"ssed a!!he Managemen! Re)e Mee!ng and doc"men!ed n Managemen!Re)e mn"!es% Roles and respons@l!es !o man!an and mpro)e !hen!egra!ed managemen! sys!ems are de#ned n concerned o@descrp!ons%
62 7man R%o7+&%
621G%n%+a)
$arrson 0harmace"!cals has den!#ed )aro"s n1ho"se )er#ca!onac!)!es ncl"dng n1process and #nal )er#ca!on o' prod"c! and!he personnel respons@le 'or carryng o"! !hese ac!)!es n order !omee! spec#ed re+"remen!s% 0ersonnel per'ormng !he a@o)emen!oned ac!)!es are compe!en! on !he @ass o' appropra!eed"ca!on( !ranng( slls and e5perence%
The con!rac! o' e5!ernal e5per!s n)ol)ed n !he de)elopmen!(mplemen!a!on( opera!on or assessmen! o' IMS s ep! n records%
622Comp%'%n&%, T+a(n(ng an5 Aa+%n%
a, Compe!ency needs 'or personnel per'ormng ac!)!es !ha!
mpac! +"al!y( heal!h( sa'e!y and en)ronmen!al complance are
den!#ed n o@ descrp!ons%
@, Tranng needs 'or all employees are de!ermned @ased on o@
descrp!ons and reg"la!ory re+"remen!s% The Managemen!
represen!a!)e es!a@lshes a !ranng plan !o address !heseneeds%
c, Tranng e/ec!)eness s e)al"a!ed agans! prede!ermned
re+"remen!s !o de!ermne !he employees compe!ency%
d, Managemen! ens"res !ha! employees are aare o' !he rele)ance
and mpor!ance o' !her or ac!)!es and ho !hey con!r@"!e
!o !he ache)emen! o' !he o@ec!)es%
e, General aareness !ranng s cond"c!ed 'or all employees%
Tranng records are s!ored and man!aned%
R%)a'%5 Do&7m%n':
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% 0roced"re 'or Compe!ence( Tranng and Aareness
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6# In=+a'+7&'7+%
Managemen! o' $arrson 0harmace"!cals s comm!!ed !o pro)de !heen!re necessary n'ras!r"c!"re !o ens"re complance !h !here+"remen!s o' n!eres!ed par!es n!ernal c"s!omer 7 e5!ernal
c"s!omer,
a, In'ras!r"c!"re needs are ell den!#edBde#ned a! plannng s!age%These ncl"de:
% E+"pmen!( hardare and so'!are
% Good Man!enance
% S"ppor!ng Ser)ces
)% orspace and assoca!ed 'acl!es
@, 0roper sa'e!y arrangemen!s le personal pro!ec!)e e+"pmen!J &ree5!ng"shers( e!c% are pro)ded%
c, Ade+"a!e s!orage areas 'or spare par!s( hardare !ems andma!eral are ell man!aned%
d, S!orage areas 'or ra ma!eral are ell man!aned% All s!ores ha)eproper racsB palle!s( den!#ca!on pla!es( @nsBcar!ons !o eep !hesmall !ems%
e, Appropra!e comm"nca!on channels are pro)ded !o !he Managersand s!a/ mem@ers ho ha)e sgn#can! role n prod"c! con'orm!y%&a5( e1mal( n!ercom and In!erne! 'acl!es are a)ala@le as lnes o'comm"nca!on%
', Comp"!ers and area ne!orng s pro)ded n all depar!men!s%here re+"red,%
g, Appropra!e so'!are programs are ns!alled n !he comp"!ers 'orro"!ne or and essen!al prod"c! 7 process analyss%
64 o+ En3(+onm%n'Managemen! has den!#ed and pro)ded !he or en)ronmen!necessary !o prod"ce con'ormng prod"c! as per !he re+"remen!s o'In!egra!ed Managemen! Sys!em%
a, 0roper Lgh!ng 'acl!es( sa'e!y re+"remen!s Sgnages,( asles
marng( proper )en!la!on( and eno"gh space s pro)ded 'or or
!ha! maes !he orers com'or!a@le%
@, Managemen! has es!a@lshed com'or!a@le( clean and ell1
man!aned oces a! s"!a@le loca!ons !hn !he 'acl!y and on !he
d/eren! s!es% Decson1maers are pro)ded !h ell1!raned and
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s"ppor!ng s!a/ helpng !hem !o accomplsh !her or smoo!hly%
c, 0roper Hoor marng( passage areas and emergency e5!s are
mared !o al n case o' emergency and !o mo)e !he
prod"c!sB!ems !ho"! any o@s!acle%
SECTION
*RODUCT REALIFATION
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7. *RODUCT REALIFATION
1 *)ann(ng o= *+o57&' R%a)(a'(on
The organFa!on plans and de)elops !he processes needed 'or prod"c!realFa!on% 0lannng o' prod"c! realFa!on s ens"red !o @e conss!en!!h !he re+"remen!s o' !he o!her processes o' !he n!egra!edmanagemen! sys!em and sho"ld mee! !he c"s!omer re+"remen!s%Records o' plannng are man!aned%
Ths s ache)ed !hro"gh e/ec!)e de)elopmen!( mplemen!a!on andmon!orng !he planned ac!)!es% has de)eloped a comprehens)esys!em 'or !he mon!orng o' con!rol meas"res !hro"gho"! !heprocessng and n !he e)en!s o' noncon'orm!es%
2 C7'om%+/R%)a'%5 *+o&%%
21D%'%+m(na'(on R%3(% o= R%@7(+%m%n' R%)a'%5 'o'B% *+o57&' an5 In'%n5%5 U%
Re+"remen!s 'or ser)ce are den!#ed and doc"men!ed% Thesere+"remen!s ncl"de:
a, Re+"remen!s spec#ed @y !he c"s!omer B "sers@, Re+"remen!s no! s!a!ed @y !he c"s!omer B "sers @"!
necessary 'or spec#ed or n!ended "se( hen non
c, Any add!onal re+"remen!s de!ermned @y !he Com@ne&a@rc Lm!ed%
22R%)a'%5 Do&7m%n':
I% 0roced"re 'or C"s!omer &eed@ac and Complan! $andlng
# D%(gn D%3%)opm%n'
No'%: IS? 8332:;33> Cla"se 4% Desgn 7 De)elopmen! s no!applca@le !o !he C&L
4 *7+&Ba(ng*+o&%
41*7+&Ba(ng *+o&%
I! s !he respons@l!y o' p"rchasngdepar!men! !o ens"re !ha!ma!erals "sed n a prod"c! are proc"red 'rom appro)ed s"pplersho can comply !h !he p"rchase order and reg"la!oryre+"remen!s as spec#ed% An Appro)ed S"ppler Ls! s man!aned%S"pplers are selec!ed on !he @ass o' !her a@l!y !o mee! p"rchaseorder re+"remen!s( and B or !he res"l!s o' a +"al!y sys!em re)e(
here applca@le% Assessmen! o' s"pplers s cond"c!ed @e'ore anyp"rchase% S"ppler assessmen! records are man!aned%
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42*7+&Ba(ng R%@7(+%m%n'
0"rchasng depar!men! ens"res !ha! p"rchase doc"men!s clearlydescr@e !he prod"c! ordered% The applca@le ss"e o' s!andards and
spec#ca!ons are spec#ed or re'erenced on !he p"rchasedoc"men!s%
here appropra!e( p"rchase doc"men!s also descr@e !here+"remen!s 'or +"al#ca!on o' personnel and +"al!y B heal!h andsa'e!yBen)ronmen!al managemen! sys!em re+"remen!s 'applca@le,% Changes !o proc"remen! doc"men!s re+"re !he samedegree o' con!rol as !he orgnal ss"e%
4# !%+(&a'(on o= *7+&Ba%5 *+o57&'
The amo"n! o' nspec!on re+"red 'or !he p"rchased prod"c!s sde!ermned @ased on !he !ype o' ma!eral( !he mpac! o' !hema!eral on #nal prod"c! +"al!y( and !he hs!orcal capa@l!y o's"pplers pro)dng !he ma!eral% here !he company or !sc"s!omer n!ends !o per'orm )er#ca!on a! !he s"pplers premses(!he organFa!on s!a!es !he n!ended )er#ca!on arrangemen!s andme!hod o' prod"c! release n !he p"rchasng doc"men!s%
R%)a'%5 Do&7m%n':
% 0roced"re 'or 0"rchase
. *+o57&'(on an5 S%+3(&% *+o3((on
.1 Con'+o) o= *+o57&'(on an5 S%+3(&% *+o3((on
$arrson 0harmace"!cals plans and carres o"! all !s prod"c!onac!)!es "nder con!rolled cond!ons% All !hose opera!ons !ha! canha)e sgn#can! en)ronmen!al aspec!s or can @e haFardo"s 'orheal!h and sa'e!y are den!#ed !hro"gh e)al"a!on o' sgn#can!aspec!s and rs assessmen!%
Doc"men!ed ns!r"c!ons e5s! 'or any ac!)!y here !he a@sence o's"ch ns!r"c!ons o"ld ad)ersely a/ec! +"al!y( heal!h 7 sa'e!y oren)ronmen!% Man"'ac!"rng spec#ca!ons may @e s"pplemen!ed @yo!her doc"men!s s"ch as 0roced"res( or Ins!r"c!ons( TechncalMan"als TMs,( e!c% hen deemed necessary% $eal!h and Sa'e!y andEn)ronmen!al ns!r"c!ons are a)ala@le 'or processes ha)ngsgn#can! En)ronmen!al or $eal!h and Sa'e!y rs%
R%)a'%5 Do&7m%n':
%0roced"re 'or En)ronmen!al Aspec! Analyss
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.2 !a)(5a'(on o= *+o&%% =o+ *+o57&'(on an5 S%+3(&%
*+o3((on
E5cl"ded 'rom !he managemen! sys!em @eca"se prod"c!re+"remen!s can @e )alda!ed !hro"gh prod"c!on mon!orng andprod"c! !es!ng
.# I5%n'(&a'(on an5 T+a&%a()('y
Ma!erals "sed n del)era@le prod"c! are readly den!#ed nrela!on !o !he man"'ac!"rng process( ra ma!erals( s!orage anddspa!ched prod"c!s records% Ma!eral hch has los! !s orgnal
den!!y canno! @e appled !o an order "n!l !s den!!y s re1es!a@lshed%
.4 C7'om%+ *+op%+'y
The c"s!omer pro)des drangsBpc!"res and spec#ca!onaccordng !o hch !he prod"c!s are !o @e made% All !hesespec#ca!ons and drangsBpc!"res are properly den!#ed ands!ored%
6 Manag%m%n' o= Mon('o+(ng an5 M%a7+(ng D%3(&%
To ens"re 6$SE complance( !he organFa!on has de!ermned !hemeas"remen!s !o @e made( re+"red acc"racy( ns!r"men!capa@l!y( e+"pmen! !o @e cal@ra!ed( 're+"ency o' cal@ra!on( and!he )ald!y o' pre)o"s meas"remen! res"l!s hen ns!r"men!s are'o"nd !o @e o"! o' cal@ra!on%
4%=%2 Iden!#ed e+"pmen! s cal@ra!ed or )er#ed pror !o "se"nder normal en)ronmen!al cond!ons and agans! s!andards!racea@le !o n!erna!onal or na!onal s!andards% here no
s"ch s!andards e5s!( !he @ass "sed 'or cal@ra!on or)er#ca!on s doc"men!ed%
4%=%; The cal@ra!on s!a!"s o' e+"pmen! s den!#a@le !hro"gh !he"se o' la@els( !ags( color1codng( engra)ng and records( e!c%and s sa'eg"arded agans! ad"s!men!s !ha! o"ld n)alda!emeas"remen! res"l!s%
4%=% E+"pmen! s pro!ec!ed 'rom damage d"rng handlngman!enance and s!orage%
4%=%9 I' re+"red Cons"l!an!1admns!ered a"d!s ll @e "sed 'or !he
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e)al"a!on o' legal complance% These a"d!s are cond"c!ed amnm"m o' e)ery !hree years%
R%)a'%5 Do&7m%n'
% 0roced"re 'or E+"pmen! Managemen!
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SECTION 8
MEASUREMENT, ANALYSISAND
IM*RO!EMENT
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8 MEASUREMENT, ANALYSIS ANDIM*RO!EMENT
81 G%n%+a)
Meas"remen! and mon!orng ac!)!es needed !o ass"re con'orm!yand con!n"ally mpro)e !he e/ec!)eness o' !he In!egra!edManagemen! Sys!em as de#ned( planned( and mplemen!ed%
Ths ncl"des !he de!ermna!on o' !he need 'or( and "se o'(applca@le me!hodologes ncl"dng s!a!s!cal !echn+"es%
82Mon('o+(ng an5 M%a7+%m%n'
821C7'om%+ Sa'(=a&'(on
In'orma!on rela!ng !o c"s!omer percep!on as !o he!her !hecompany has me! c"s!omer re+"remen!s s mon!ored%Me!hods o' analyss are de!ermned and doc"men!ed% Res"l!so' c"s!omer sa!s'ac!on meas"remen!s are par! o' !heManagemen! Re)e and are "sed !o den!'y and pror!Fecon!n"al mpro)emen! proec!s%
R%)a'%5 Do&7m%n'
% 0roced"re 'or C"s!omer &eed@ac and Complan!s
822In'%+na) A75('
In!ernal a"d!s are sched"led on !he @ass o' !he res"l!s o'pre)o"s a"d!s and mpor!ance o' !he ac!)!y @eng a"d!edand are per'ormed @y personnel ndependen! 'rom !he ac!)!y@eng a"d!ed% A"d!s are per'ormed n accordance !h adoc"men!ed proced"re%
A"d! #ndngs are doc"men!ed @y !he a"d!or and repor!ed !o
!he area S"per)sor B Manager o' !he ac!)!y a"d!ed(correc!)e ac!on s !aen @y !he respons@le personnel( and'ollo1"p ac!)!y s per'ormed and recorded !o )er'y !ha! !hecorrec!)e ac!on !aen has @een mplemen!ed !ho"! "nd"edelay and s e/ec!)e%
A"d! res"l!s are man!aned as records and are a par! o' !hemanagemen! re)e o' !he managemen! sys!em
R%)a'%5 Do&7m%n'
% 0roced"re 'or In!ernal A"d!ng
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82#Mon('o+(ng an5 M%a7+%m%n' o= *+o&%%
Mon!orng and meas"remen! o' n!egra!ed managemen!
sys!em processes are per'ormed and dsc"ssed as par! o'Managemen! Re)e%
824Mon('o+(ng an5 M%a7+%m%n' o= *+o57&'
Iden!#ca!on o' nspec!on and !es! s!a!"s s man!aned!hro"gho"! prod"c!on and del)ery o' !he prod"c! !o ens"re!ha! only prod"c! !ha! has passed all re+"red nspec!ons sdel)ered !o !he c"s!omer%
Incomng nspec!ons are cond"c!ed on ma!erals "sed n
del)era@le prod"c! and doc"men!ed as de!aled n +"al!yproced"res%
In1process nspec!ons and !es!s are per'ormed as ndca!ed on!he man"'ac!"rng spec#ca!on andBor nspec!on proced"res%
&nal prod"c!s are nspec!ed !o ens"re !ha! ! s comple!e andre+"red opera!ons ha)e @een per'ormed%
Each "n! lo! or @a!ch o' prod"c! s )er#ed !o a #nal !es!
spec#ca!on genera!ed or re'erenced !hn !heman"'ac!"rng spec#ca!on%
82.Mon('o+(ng an5 M%a7+%m%n' o= %a)'B, Sa=%'yan5 En3(+onm%n'a) *%+=o+man&%
$arrson 0harmace"!cals has es!a@lshed proced"res 'ormon!orng and meas"rng !he In!egra!ed Managemen!Sys!em per'ormance on a reg"lar @ass% These proced"respro)de 'or @o!h +"al!a!)e and +"an!!a!)e meas"res(proac!)e meas"res !ha! mon!or complance( reac!)e
meas"res o' per'ormance !o mon!or accden!s( near msses(and o!her e)dence o' s"@s!andard IMS per'ormance% Therecordng o' s"ch da!a and !he ens"ng res"l!s are "sed !o'acl!a!e s"@se+"en! correc!)e and pre)en!)e ac!onanalyss% has es!a@lshed appropra!e IMS0Is In!egra!edManagemen! Sys!em 0er'ormance Indca!ors, !o meas"re!hese ndca!ors%
a, Elec!rc!y cons"mp!on@, a!er cons"mp!onc, as!e genera!on Bdsposal
d, 0aper as!e B Usagee, &"el Cons"mp!on
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', Employee In"resg, C"s!omer complan!sh, S"ppler e)al"a!on
R%)a'%5 Do&7m%n'
% 0roced"re 'or Mon!orng and Meas"remen!
826Em%+g%n&y *+%pa+%5n% an5 R%pon%
$arrson 0harmace"!cals has es!a@lshed and man!aned !heEmergency 0reparedness and Response 0lanHhch s "sed!o den!'y po!en!al 'or( and response !o( ncden!s andemergency s!"a!ons( and 'or pre)en!ng and m!ga!ng !helely llness( n"ry or en)ronmen!al mpac!s !ha! may @eassoca!ed !h !hem% Re)es and re)ses( here necessary(
!s emergency preparedness and response proced"res( npar!c"lar( a'!er !he occ"rrence o' accden!s or emergencys!"a!ons% $arrson 0harmace"!cals perodcally !es!s !heseproced"res here prac!ca@le
R%)a'%5 Do&7m%n'
% 0roced"re 'or Emergency 0reparedness 7 Response
8# Con'+o) o= Non/&on=o+man&%,A&&(5%n' an5In&(5%n'
The ncharge o' each sec!on s prmarly respons@le 'or con!rollngand segrega!ng noncon'ormng prod"c! n accordance !h adoc"men!ed proced"re% Noncon'ormng prod"c! s properlyden!#ed !o pre)en! !s nad)er!en! "se%
Records o' noncon'orm!es and any ac!ons !aen( ncl"dng releasea"!hor!y o' accep!ance @y concesson( are man!aned%
I' a noncon'ormance s 'o"nd a'!er del)ery o' prod"c!( !he
organFa!on !aes ac!ons appropra!e !o !he magn!"de andconse+"ences o' !he de'ec!%
Any ncden! or accden! rela!ed !o ?cc"pa!onal Sa'e!y andEn)ronmen! ll n)es!ga!ed accordng !o 0roced"re 'or Incden!In)es!ga!on%
R%)a'%5 Do&7m%n'
% 0roced"re 'or Non1Con'orm!es( Correc!)e and0re)en!)e Ac!on
% 0roced"re 'or Incden! In)es!ga!on
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8#1E3a)7a'(on o= Comp)(an&%
Managemen! Represen!a!)e ll carry o"! ann"al e)al"a!ono' complance !h legal and o!her re+"remen!s( as par! o'!he n!ernal a"d!% The a"d! repor! ll den!'y and descr@e
!he complance s!a!"s and non1con'ormances% I! ll also maerecommenda!ons on ac!ons re+"red !hn g)en !mescales!o address !hese ss"es%
R%)a'%5 Do&7m%n'
% 0roced"re 'or Complance E)al"a!on o' Complance
84Ana)y( o= Da'a
The organFa!on de!ermnes( collec!s and analyses appropra!e da!a
!o demons!ra!e !he s"!a@l!y and e/ec!)eness o' !he n!egra!edmanagemen! sys!em and !o e)al"a!e here con!n"al mpro)emen!o' !he e/ec!)eness o' !he +"al!y managemen! sys!em can @emade% Ths ncl"des da!a genera!ed as a res"l! o' mon!orng andmeas"remen! and 'rom o!her rele)an! so"rces%
The analyss o' da!a pro)des n'orma!on rela!ng !o
a, C"s!omer sa!s'ac!on Manager 0rod"c!on reg"larly !aes!he 'eed@ac 'rom !he c"s!omers and analyses !hem%
@, Con'orm!y !o 0rod"c! Re+"remen!s
c, Charac!ers!cs and !rends o' processes and prod"c!s(ncl"dng oppor!"n!es 'or pre)en!)e ac!on
d, S"pplers Manager 0rod"c!on per'orms !he s"pplere)al"a!on and eeps !he s"ppler per'ormance records%
8. Imp+o3%m%n'
8.1Con'(n7a) Imp+o3%m%n'
The e/ec!)eness o' !he In!egra!ed Managemen! Sys!em scon!n"ally mpro)ed !hro"gh !he "se o'
a, IMS 0olcy and ?@ec!)es
@, Comm"nca!on
c, Managemen! re)e
d, In!ernal a"d!
e, Correc!)e and pre)en!)e ac!on
8.2Co++%&'(3% A&'(on
The n!en! o' correc!)e ac!on s !o den!'y and elmna!e !he
roo! ca"se o' noncon'ormance !o pre)en! rec"rrence% Theneed 'or correc!)e ac!on s @ased on assgna@le non
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