quality plan for elastimold products

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  • 8/13/2019 Quality Plan for Elastimold Products

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    Elastimold Quality Manual Quality Plan: 25kV UndergroundConnectors /Hydro-Quebec

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    .))ro"ed y: Marisol ritoQuality Manager -.lbu7uer7ue

    #ate (e)tember +& 2''5

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    1.0 Scope Introduction

    "." -istory a%d #roducts

    Elastimold ma%u actures $i3$+4olta3e u%der3rou%d electrical co%%ectors.Ma%u acturi%3 is er ormed at two se arate acilities& o%e located i% Albuquerque, NM a%d o%e i% -ac ettstow%, N/. Eac$ acility is i%de e%de%tlyma%a3ed as urt$er described i% t$is ma%ual, wit$ su ort ro4ided by 7B8scor orate u%ctio%s located i% Mem $is, N.

    $e Elastimold #roduct li%es are a% e9 a%sio% o roducts de4elo ed a%di%troduced by Elastimold i% "16*, wit$ t$e i%itial ma%u acturi%3 er ormed i%-ac ettstow%. E9 a%sio% o t$e co% i3uratio%s a%d 4olume o roductio% led tot$e o e%i%3 o t$e Albuquerque acility i% "1!*. Ado tio% o t$e roducts beyo%dt$e :%ited ;tates $as resulted i% ed as a com lete busi%ess u%it wit$res o%sibility or Mar eti%3, E%3i%eeri%3, Ma%u acturi%3, ;ales a%d ?eli4ery. =%"116, 7B acquired t$e Amerace @or oratio% w$ic$ i%cluded t$e Elastimoldbusi%ess, a%d reor3a%i>ed t$e busi%ess to co% orm to t$e re4aili%3 7Bstructure. =% Au3ust, 2((( t$e 7B or3a%i>atio% was re4ised rom a t$ree+dime%sio%al matri9 structure to a roduct li%e a%d busi%ess u%it 3rou .@e%trali>ed u%ctio%s or sales a%d mar eti%3 remai% i% Mem $is, N, a%dco%ti%ue to i%teract wit$ Elastimold as i% t$e ast.

    $e day to day o eratio%s at t$e Albuquerque a%d -ac ettstow% acilities arema%a3ed by t$e #la%t Ma%a3ers $owe4er, t$e -ac ettstow% #la%t Ma%a3er isalso t$e Elastimold e%eral Ma%a3er res o%sible or o eratio%s at bot$ la%tsa%d all Elastimold e%3i%eeri%3.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    2 Organization$e quality la% i%cludes t$e reali>atio%, mo%itori%3 a%d measuri%3 acti4ities or

    t$e ma%u acturi%3 o 06(((( 6!"* 1!2( u%der3rou%d co%%ectors a%d t$e s eci icrequireme%ts o -ydro+Cuebec outli%e co%tract %umber.

    2.0 Remarks2." @$a%3e F6" Article *." D@o%tract Re4iew is er ormed at @or orate-eadquarters locarted i% Mem $is, e%%essee a%d by t$e ;ales?e artme%t located i% Mo%treal.

    2.2 @lause F6" articles *.2 D?esi3% a%d de4elo me%t la%%i%3 is dealt wit$accordi%3 to t$e C;#+*((" rocedure a%d *.2.! D@o%trol o desi3% a%dde4elo me%t c$a%3es is dealt wit$ accordi%3 to t$e C;#+0((0

    rocedure.

    2.* @lause F6" article *.* is dealt wit$ accordi%3 to #urc$asi%3 # rocedures

    #W= 15(", 15(*, a%d 15(5.2.0 @lause F6" article *.0 D@ustomer ro erty & t$e customer does %ot su ly

    7B wit$ roducts i% t$is co%tract.

    2.5 @lause F6" article 0.2 D#erso%%el s eci ic quali icatio%s is %ot a licable.

    2.6 Note& Names a%d co%tacts o su liers a%d subco%tractors are %ot issuedto our customers $owe4er, re4iew o suc$ are allowed u o% 4isitatio% oCuality Re rese%tati4e.

    3.0 Ta !e o" Contents#.0Flow @$art

    =%s ectio% 7 est #la%s

    #roduct E%3i%eeri%3 est #ro3ram E%3i%eeri%3 tests to A; M, AN;=, a%d =EEE '=%cluded i% =%s ectio% 7 est #la%s)

    Elastimold o erates as a #roduct i%e wit$i% 7B8s :tility ?i4isio%. Bot$ oElastimold8s ma%u acturi%3 sites are i%4ol4ed i% rocess desi3% a%d roductio% o

    roducts a%d are a art o t$e 7B roduct li%e re orti%3 to t$e #reside%t o t$e:tility rou . #roduct E%3i%eeri%3, res o%sible or roduct desi3%, is located at t$e-ac ettstow% ?e4elo me%t @e%ter a%d re orts to t$e -ac ettstow% #la%t Ma%a3er.

    $e Albuquerque a%d -ac ettstow% ma%u acturi%3 sites alo%3 wit$ t$e?e4elo me%t @e%ter are collecti4ely res o%sible or t$e desi3% a%d ma%u acture oElastimold+bra%d roducts a%d ot$er assi3%ed 7B roducts. Mar eti%3, ;ales a%d#roduct Ma%a3eme%t o Elastimold roducts are er ormed at 7B @or orate$eadquarters i% Mem $is, N.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    2." Fu%ctio%al rou s

    $e dia3ram below ide%ti ies t$e eleme%ts a%d i%teractio%s associated wit$ t$edesi3%, ma%u acture, sale a%d deli4ery o Elastimold roducts. =t also i%dicatesw$ic$ locatio%s are i%4ol4ed i% t$e i%teractio%s.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

    @:; GMER; a%d /G=NVE61U*E(& 8 *9#8 #E

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    2.2 #la%t ;tructure a%d Res o%sibilities

    $e Albuquerque a%d -ac ettstow% acilities eac$ re ort to t$eir ow% #la%t Ma%a3er$owe4er, t$e -ac ettstow% #la%t Ma%a3er is also t$e Elastimold e%eral Ma%a3erres o%sible or bot$ locatio%s, w$o i% tur% re orts to t$e ;r. Hice #reside%t o G eratio%s at

    7B i% Mem $is, N. Eac$ #la%t Ma%a3er determi%es t$e o4erall or3a%i>atio%al %eedsa%d structure. e%eral res o%sibilities are s$ow% below. Eac$ #la%t Ma%a3er as well asde artme%tal Ma%a3ers are res o%sible or t$e o4erall Cuality ;ystem wit$i% t$eir area oco%trol.

    e%eral Ma%a3eme%t Res o%sible or o4erall la%t er orma%ce, directio% a%d

    leaders$i .

    #roduct E%3i%eeri%3 Res o%sible or t$e desi3%, material selectio%, 4eri icatio% a%d4alidatio% or e9isti%3, modi ied a%d %ew roducts.

    Ma%u acturi%3 E%3i%eeri%3 Res o%sible or tool desi3% equi me%t selectio%, a%ddemo%stratio% a%d docume%tatio% o ca able rocesses or all ma%u actured roducts.

    #urc$asi%3 #urc$ases all %ecessary materials a%d com o%e%ts to e%sureu%i%terru ted roductio%.

    #la%%i%3 ;c$edules t$e material a%d roductio% requireme%ts or ro4idi%3 roductsas required to ro4ide i%4e%tory a%d ill customer orders o% time.

    #roductio% a%d G eratio% G erates roductio% equi me%t a%d ma%a3es trai%edwor orce to roduce roducts w$ic$ meet Elastimold a%d @ustomer requireme%ts.

    Cuality + Cuality ma%a3eme%t, la%%i%3, co%trol a%d im ro4eme%t, measuri%3 a%d testequi me%t co%trol, CM, a%d =;G 1((( com lia%ce.

    =%4e%tory @o%trol Recei4es a%d ma%a3es all i%+stores materials a%d com o%e%tsu%til issued to #roductio% or use, a%d all i%is$ed 3oods awaiti%3 s$i me%t tocustomers.

    ;$i i%3 er orms i%al ac a3i%3, labeli%3 a%d $ysical s$i me%t o all out3oi%3i%is$ed 3oods to customers.

    -uma% Resources, is res o%sible or em loyee relatio%s, trai%i%3 o em loyees,ayroll '-ac ettstow%) a%d o4erseei%3 em loyee be%e its.

    Fi%a%ce, is res o%sible or i%a%cial ma%a3eme%t i%cludi%3 ayroll 'Albuquerque),bud3ets, la%t accou%ti%3, a%d ca ital e9 e%ditures.

    =% ormatio% ec$%olo3y '= ) Mai%tai% %etwor co%%ectio%s a%d u%ctio%i%3esse%tial to t$e commu%icatio% o commercial i% ormatio% rom a%d to 7B, Mem $isa%d su ort t$e #@ so tware a%d $ardware at t$e s eci ic acility.

    $e Ma%a3eme%t structures or eac$ acility are 4isible o% t$e com a%y i%tra%et. $e-uma% Resources de artme%t i% eac$ locatio% mai%tai%s a more detailed or3a%i>atio%alc$art.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    2.* Cuality Ma%ual @o%trol, ?istributio%, a%d Re4isio% -istory

    $is Ma%ual describes t$e Cuality Ma%a3eme%t ;ystem 'Cuality ;ystem) used by$omas 7 Betts ' 7B) Elastimold e%3i%eeri%3 a%d ma%u acturi%3 acilities. $e Cuality

    ;ystem is la%%ed, establis$ed a%d mai%tai%ed to be i% co% orma%ce wit$ t$erequireme%ts o =;G 1(("&2(((

    $is Ma%ual co%tai%s t$e Cuality #olicy, Cuality obatio%, descri tio% o t$e #rocesses, re ere%ce to Cuality #rocedures,a%d a descri tio% o $ow t$e #rocedures co4er t$e =;G eleme%ts. =t is mai%tai%ed a%ddistributed i% accorda%ce wit$ Elastimold8s ?ocume%t @o%trol rocedure. @$a%3es arere4iewed a%d a ro4ed by t$e Ma%a3eme%t Re rese%tati4e a%d t$e e%eral Ma%a3er ata mi%imum. :sers are res o%sible or e%suri%3 t$ey $a4e t$e curre%t 4ersio% o t$isMa%ual. :%co%trolled co ies are a4ailable u o% request rom ?ocume%t @o%trol. A%electro%ic co y o t$e ma%ual is also accessible i%ter%ally o% t$e com a%y i%tra%et.

    R$%ISIO 'ISTOR(

    Re). *ate Brie" *escription o" Change Originator +ppro)ed ,"(I""I(2 ;i3%i ica%t re+write a%d re+%umberi%3 to i%cor orate

    t$e %ew =;G 1(("&2((( sta%dard.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    Page atio%!." #la%%i%3 o #roduct Reali>atio%!.2 @ustomer+related #rocesses!.* ?esi3% a%d ?e4elo me%t!.0 #urc$asi%3

    !.5 #roductio% a%d ;er4ice #ro4isio%!.6 @o%trol o Mo%itori%3 a%d Measuri%3 ?e4ices

    . Measureme%t, A%alysis a%d =m ro4eme%t." e%eral.2 Mo%itori%3 a%d Measureme%t.* @o%trol o No%co% ormi%3 #roduct.0 A%alysis o ?ata.5 =m ro4eme%t

    Fi3ure ", ;eque%ce 7 =%teractio% o Jey#rocesses

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    #. -ua!it, anagement S,stem

    0." e%eral Requireme%ts

    Elastimold8s Cuality ;ystem is docume%ted a%d mai%tai%ed to e%sure t$at all sta%darda%d custom roducts co% orm to s eci icatio%s. $e Cuality ;ystem i%cludes a quality

    olicy a%d obatio%, a%d measureme%t acti4ities. o e%sure e ecti4eo eratio% a%d co%trol o t$ese rocesses, Elastimold $as im leme%ted docume%tedmet$ods a%d rocedures. ElastimoldKs Cuality ;ystem co%sists o i4e tiers o docume%tsdescribi%3 t$e acti4ities, res o%sibilities, aut$orities, a%d records required to meetElastimoldKs quality olicy a%d all o t$e a ro riate eleme%ts o =;G 1((".

    ier ". Cuality Ma%ual t$is docume%t describes Elastimold8s structure to meeti%3customers8 %eeds. $e docume%tatio% structure a%d t$e olicy a%dres o%sibilities o ma%a3eme%t or meeti%3 =;G requireme%ts.

    ier 2. Cuality ;ystem #rocedures t$ese docume%ts describe t$e who, what, whenand where ste s eac$ erso% or de artme%t must ollow to meet t$e oliciesdescribed i% Elastimold8s Cuality Ma%ual. $ey also describe t$e docume%tatio%t$at is to be used or is roduced as a result o t$e acti4ity. ?ue to t$e twodi ere%t locatio%s, a%d t$e %eed to ru% eac$ acility u%der similar but di ere%t

    rocesses t$e Albuquerque acility C;# will be receded by a% DA desi3%atio%'A+C;#) a%d -ac ettstow% will be receded by a D- desi3%atio% '-+C;#).C;#8s t$at a ly to bot$ locatio%s will be desi3%ated as C;#.

    ier *. Wor =%structio%s t$ese docume%ts co%tai% t$e detailed i%structio%s orhow acti4ities are to be er ormed.

    ier 0. Cuality Records t$ese docume%ts ro4ide e4ide%ce t$at t$e requiredroduct or ser4ice quality was ac$ie4ed, or t$at Elastimold8s Cuality ;ystem

    was im leme%ted correctly.

    ier 5. =%dustry ;ta%dards w$e% a licable, t$ese docume%ts are i%cor orated byre ere%ce i% to Elastimold8s ier * docume%ts, s eci ically t$e roductdrawi%3s.

    Mo%itori%3, measureme%t a%d a%alysis are a% i%te3ral art o e%suri%3 t$at rocessesac$ie4e la%%ed results, a%d are ey actors used i% ma i%3 co%ti%ual im ro4eme%ts tosuc$ rocesses. W$ere Elastimold $as outsourced acti4ities t$at a ect roductco% ormity to requireme%ts, co%trol o t$ose acti4ities is ide%ti ied wit$i% t$e Cuality;ystem.

    0.2 ?ocume%tatio% Requireme%ts

    0.2." e%eral

    Elastimold $as de i%ed, docume%ted a%d im leme%ted a quality system to meetElastimold8s quality requireme%ts a%d t$ose o =;G 1((".

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    Elastimold is res o%sible or t$e #la%%i%3, ?esi3%, #roductio%, ;$i me%t a%d Cuality oreleased Elastimold roducts. W$ere required by t$e =;G 1(("&2((( =%ter%atio%alsta%dard, a%d w$ere it is a ro riate a%d %ecessary or t$e e ecti4e o eratio% a%dco%trol o rocesses, Elastimold $as docume%ted rocesses t$at are establis$ed,im leme%ted a%d mai%tai%ed. Additio%ally, records are mai%tai%ed, as well as ot$erdocume%ts %eeded to e%sure e ecti4e la%%i%3, o eratio% a%d rocess co%trol. =t is t$eres o%sibility o a%y docume%t user to e%sure t$at t$e docume%t bei%3 used is t$ecorrect or curre%t 4ersio% a%d t$at it is com lete.

    0.2.2 Cuality Ma%ual

    Elastimold mai%tai%s t$is Cuality Ma%ual i% accorda%ce wit$ t$e requireme%ts o =;G1(("&2(((. =t addresses all requireme%ts o t$e ;ta%dard a%d is t$e irst tier docume%t

    or t$e e%tire Cuality ;ystem. A list o all Cuality ;ystem #rocedures 'C;#8s) w$ic$su ort t$e olicies wit$i% t$is ma%ual is a4ailable o% t$e Elastimold i%tra%et. W$ere t$esta%dard s eci ically calls or a docume%ted rocedure, Elastimold8s rocedure %umberis stated wit$i% t$e corres o%di%3 sectio% o t$is ma%ual. $e i%teractio% o Cuality;ystem rocesses is described i% t$e lowc$art i% Fi3ure " at t$e e%d o t$is ma%ual, tos$ow $ow all acti4ities $a4e bee% i%te3rated i%to a co$esi4e system.

    0.2.* @o%trol o ?ocume%ts

    Elastimold $as establis$ed a%d commu%icated res o%sibilities or t$e docume%tatio% oall rocesses w$ic$ a ect co% orma%ce to t$e Elastimold Cuality #olicy a%d t$e =;G1((" requireme%ts. $ese i%clude a ro riate co%trols i% lace or all ier = t$rou3$ ierH docume%tatio%. Cuality ;ystem docume%ts are mai%tai%ed i% a ma%%er to e%sure t$att$ey remai% le3ible a%d readily ide%ti iable.

    All docume%ts are re4iewed or adequacy a%d a ro4ed by aut$ori>ed erso%%el. Eac$la%t e%sures t$at users $a4e access to %ecessary docume%ts at oi%ts o use, eit$er

    electro%ically or 4ia distributio% o a co%trolled $ard+co y. ?ocume%ts are made a4ailableor eac$ o eratio% a%d all obsolete docume%ts are remo4ed by a ro riately aut$ori>ederso%%el i% accorda%ce wit$ Elastimold rocedures. Gbsolete docume%ts, t$ou3$

    arc$i4ed or researc$ or $istory ur oses, are assword rotected to re4e%t accide%taluse.

    #er docume%ted rocedures, docume%ts may be u dated or c$a%3ed, but suc$ c$a%3es%eed a ro4al o t$e ro er aut$ority be ore release. W$e% c$a%3es are made toco%trolled docume%ts, w$ere racticable t$e c$a%3e will be ide%ti ied wit$i% t$edocume%t or as a% attac$me%t. All a ro4ed, curre%t docume%ts are a4ailable eit$er o%t$e Elastimold =%tra%et or as $ard co ies wit$ t$e docume%t co%trol coordi%ator. A$istory o obsolete re4isio%s is a4ailable o% t$e Elastimold =%tra%et. :sers o co%trolleddocume%ts are res o%sible or 4eri yi%3 t$at t$ey are usi%3 t$e curre%t docume%t a%dt$ey ca% 4eri y t$e latest re4isio% a%dIor e ecti4e date by usi%3 a termi%al to query t$e=%tra%et.-S/ 1001 discusses Elastimold8s docume%t co%trol requireme%ts.

    0.2.0 @o%trol o Records

    #rocedures $a4e bee% establis$ed to ro4ide directio% or all erso%%el re3ardi%3 t$erequireme%ts or establis$i%3 a%d mai%tai%i%3 quality records. $e #rocess Gw%er or

    Area Ma%a3er is res o%sible or assuri%3 t$at t$e records %ecessary to demo%strateco% orma%ce to t$e requireme%ts a%d e ecti4e o eratio% o t$e quality system are

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    establis$ed, iled a%d accessible. At a mi%imum, t$e ollowi%3 records are mai%tai%ed,corres o%di%3 to s eci ic sectio%s o t$is ma%ual&

    Elastimold reco3%i>es t$e im orta%ce o com lete a%d le3ible quality records, a%dmai%tai%s all records accordi%3ly. -S/ 100 urt$er discusses Elastimold8s rocess orco%trol o quality records

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    . anagement Responsi i!it,

    5." Ma%a3eme%t @ommitme%t

    Elastimold ma%a3eme%t is committed to t$e de4elo me%t a%d im leme%tatio% o aquality system, a%d or ro4idi%3 t$e im etus or its co%ti%ual im ro4eme%t.?e artme%t ma%a3ers a%d su er4isors are res o%sible or ide%ti yi%3, docume%ti%3 a%dim leme%ti%3 all quality rocedures a%d wor i%structio%s %ecessary to ide%ti y,im leme%t a%d 4eri y e ecti4e solutio%s, re4e%t %o%+co% orma%ces a%d roblems wit$quality records, a%d to co%trol %o%co% ormi%3 materials u%til ro er dis ositio% $as bee%determi%ed.

    =% additio% to t$is, ma%a3eme%t demo%strates its commitme%t by

    a) @ommu%icati%3 wit$ em loyees a%d e9 lai%i%3 t$e %eed to co%ti%uously meetcustomer as well as statutory a%d re3ulatory requireme%ts

    b) Establis$i%3 a quality olicy rele4a%t to customer requireme%tsc) Establis$i%3 quality ob

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    de artme%t er orma%ce measureme%ts, u%dersta%ds t$e role t$at eac$ $as i%satis yi%3 t$is olicy.

    5.0 #la%%i%3

    5.0." Cuality Gb

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    wit$i% Elastimold to 3et t$e issues resol4ed. $e MRC u%ctio% also dissemi%atescustomer satis actio% i% ormatio% to a ro riate erso%%el or t$eir aware%ess.

    5.5.* =%ter%al @ommu%icatio%

    o ma%a3eme%t e%sures t$at commu%icatio% ta es lace re3ardi%3 t$e e ecti4e%esso t$e Cuality ;ystem t$rou3$ 4arious met$ods. Amo%3 t$ese, are&

    #osti%3 o metrics o% bulleti% boards ?e artme%tal meeti%3s to discuss o4erall er orma%ce #eriodic emails or ayroll stu ers to em loyees #eriodic Dcom a%y wide meeti%3s to s$are t$e state o t$e busi%ess a%d

    customer tre%ds

    5.6 Ma%a3eme%t Re4iew

    5.6." e%eral

    $e Ma%a3eme%t Re rese%tati4e or Cuality 'MRC) s$all i%itiate a t$orou3$re4iew o t$e Cuality ;ystem, as de i%ed i% our rocedures a%d t$is ma%ual, toe%sure its co%ti%ui%3 suitability a%d e ecti4e%ess relati4e to =;G 1((" a%d t$ei%ter%al Elastimold quality requireme%ts. $e re4iews also i%clude assessme%t oo ortu%ities or im ro4eme%t, a%d assessme%t o a%y c$a%3es t$at mi3$t be %eeded tot$e Cuality ;ystem i%cludi%3 t$e quality olicy a%dIor de i%ed quality ob

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    6." #ro4isio% o Resources

    Elastimold $as ide%ti ied a%d ro4ides resources suc$ as eo le, i% rastructure, wore%4iro%me%ts, i% ormatio% %eeds, su liers, art%ers, a%d u%di%3 %ecessary toim leme%t a%d mai%tai% t$e Cuality Ma%a3eme%t ;ystem. All em loyees areres o%sible or requesti%3, t$rou3$ t$eir su er4isors a%d ma%a3eme%t, t$e %ecessaryresources, i%cludi%3 tooli%3, equi me%t, su lies, materials a%d trai%i%3, required to

    er orm t$eir duties. $ese resources $el Elastimold to&

    a) im leme%t a%d mai%tai% t$e Cuality ;ystem as de i%ed i% t$is ma%ual,i%cludi%3 t$e quality olicy a%d quality ob

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    =% rastructure %eeds $a4e bee% assessed 3i4i%3 co%sideratio% to buildi%3s, wors aces, wor statio%s, utilities, rocess equi me%t 'i%cludi%3 $ardware a%d so tware),a%d su ort ser4ices suc$ as tra%s ortatio%, commu%icatio%, a%d custodialImai%te%a%ce ser4ices. ;uitable i% rastructure is ro4ided a%d mai%tai%ed to e%sureElastimold ca% roduce a%d deli4er roduct t$at co% orms to requireme%ts.

    6.0 Wor E%4iro%me%t

    Elastimold acti4ely ma%a3es t$e wor e%4iro%me%t so t$at t$e or3a%i>atio% ca% ac$ie4eco% ormity to roduct requireme%ts. @o%sideratio% is 3i4e% to im ro4i%3 t$is e%4iro%me%tby loo i%3 at co%ditio%s suc$ as $ysical, social, syc$olo3ical a%d e%4iro%me%tal

    actors. Ma%a3eme%t also co%siders t$e ollowi%3 i% order to $a4e a ositi4e i% lue%ceo% moti4atio% a%d satis actio% o em loyees&

    creati4e wor met$ods a%d o ortu%ities or i%4ol4i%3 em loyees i% area set+u s sa ety rulesI3uida%ce, i%cludi%3 use o rotecti4e equi me%t er3o%omics wor lace locatio% 'wit$ res ect to $eat, $umidity, li3$t, air low, etc.) social i%teractio% a%d reco3%itio% or 3ood wor adequate acilities or em loyees

    o su leme%t t$e abo4e, Elastimold is mo4i%3 towards a D5; culture w$ic$ will urt$ere%$a%ce t$e wor e%4iro%me%t.

    . /roduct Rea!ization

    !." #la%%i%3 o #roduct Reali>atio%

    Elastimold $as la%%ed a%d de4elo ed CM; rocesses %eeded or roduct reali>atio%.#roduct reali>atio% la%%i%3 i%cludes determi%atio% o &

    a) roduct requireme%ts a%d quality obatio%

    rocesses a%d i%al roduct meet requireme%ts.

    Gt$er Cuality ;ystem requireme%ts or roduct desi3% a%d de4elo me%t as related toroduct reali>atio% are described i% ;ectio% !.* o t$is ma%ual.

    !.2 @ustomer+related #rocesses

    !.2." ?etermi%atio% o Requireme%ts Related to t$e #roduct

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    Elastimold determi%es roduct c$aracteristics a%d requireme%ts or deli4ery a%d ost+deli4ery acti4ities. Additio%ally, t$e com a%y $as ide%ti ied ot$er requireme%ts%ecessary or t$e roductKs i%te%ded use e4e% i %ot stated by t$e customer. #roductsare ma%u actured to co% orm to i%dustry sta%dards, a%d roduct+rele4a%t statutory a%dre3ulatory requireme%ts. A%y additio%al requireme%ts ide%ti ied by Elastimold are alsoi%cor orated i%to t$e roduct as a ro riate.

    !.2.2 Re4iew o Requireme%ts Related to t$e #roduct

    Cuotatio% requests a%d %ew orders are re4iewed by 7B Mar eti%3 i% Mem $is,e%%essee, to co% irm t$at t$e requested roduct is a% a ro4ed, structured

    combi%atio%. @ombi%atio%s or co% i3uratio%s %ot re4iously a ro4ed are re4iewed by7B Mar eti%3 a%d Elastimold #roduct E%3i%eeri%3 to co% irm t$at a roduct ca% be

    structured to meet t$e customer8s s eci icatio%. Records o t$ese re4iews a%d actio%sarisi%3 rom re4iews are mai%tai%ed. $ese re4iews e%sure t$at&

    a) roduct requireme%ts are de i%ed,b) co%tractIorder requireme%ts di eri%3 rom t$ose re4iously de i%ed are resol4ed,c) Elastimold is able to meet t$e de i%ed requireme%ts. #roduct built or customers wit$

    s ecial %eeds is ide%ti ied wit$ t$e letters D@; '@ustomer ; ecial) built i%to t$e art%umber.

    W$ere t$e customer does %ot ro4ide docume%ted requireme%ts stateme%ts, Elastimoldco% irms t$e requireme%ts wit$ t$e customer rior to acce ta%ce.

    Elastimold eriodically ma es roduct c$a%3es. $e com a%y e%sures t$at a ecteddocume%ts are ame%ded to re lect t$e c$a%3e, a%d t$at rele4a%t erso%%el are madeaware o t$e c$a%3es. @ustomers are also ad4ised o roduct c$a%3es t$rou3$ t$e

    roduct catalo3 ublis$ed by Elastimold.

    !.2.* @ustomer @ommu%icatio%Elastimold $as determi%ed a%d im leme%ted t$e %ecessary ste s to e%sure e ecti4ecustomer commu%icatio%. A%y questio%s re3ardi%3 roduct s eci icatio% or co%tractterms are re4iewed a%d resol4ed wit$ t$e customer by 7B Mar eti%3, Mem $is,

    e%%essee, rior to acce ti%3 t$e order. $e com a%y8s rocesses e%able e ecti4ecommu%icatio% wit$ customers related to&

    a) roduct i% ormatio%b) i%quiries, order $a%dli%3, co%tracts 7 ame%dme%ts, a%dc) customer eedbac , i%cludi%3 customer com lai%ts 4ia t$e #AR7R system.

    $omas 7 Betts $as a% %etwor o distributors a%d customer ser4ice re rese%tati4esw$o re3ularly commu%icate wit$ t$e customer base. $ey orward rele4a%t i% ormatio%to Elastimold or t$e la%t to ta e a ro riate actio% i% res o%se to customer %eeds.

    !.* ?esi3% a%d ?e4elo me%t

    !.*." ?esi3% a%d ?e4elo me%t #la%%i%3

    Elasimold8s #roduct E%3i%eeri%3 3rou co%trols roduct desi3% a%d de4elo me%tt$rou3$ t$e a oi%tme%t o a ro

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    Page atio% rocesses. $e su liersK er orma%ce is mo%itored a%d

    eriodically assessed by t$e

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    !.0.2 #urc$asi%3 =% ormatio%

    $e site #urc$asi%3 de artme%ts issue urc$ase orders to su liers. All urc$asi%3docume%ts 'i.e., urc$ase orders, material requisitio%s, etc.) will i%clude t$e ollowi%3,w$ere a licable&

    =% ormatio% suc$ as urc$ase order %umber, art %umber, qua%tity ordered,aut$ori>i%3 si3%ature a%d deli4ery sc$edule.

    Re ere%ce to drawi%3s or s ecial i%s ectio% i%structio%sIs eci icatio%s t$at de i%earticulars o t$e order.

    Were a ro riate Elastimold will co%sider a%d i%clude o% t$e urc$ase orders&a) requireme%ts or roduct a ro4al, rocess a ro4al, a%d equi me%t a ro4alb) erso%%el quali icatio%c) a%y ot$er Cuality ;ystem requireme%ts suc$ as roduct 4eri icatio%,

    @erti icates o @om lia%ce, etc.

    Elastimold re4iews t$e adequacy o s eci ied urc$ase requireme%ts rior to t$eircommu%icatio% to t$e su lier.

    !.0.* Heri icatio% o #urc$ased #roduct

    Elastimold er orms a t$orou3$ D irst article i%s ectio% o all roducts w$e% irsturc$ased rom a %ew su lier, to e%sure co% orma%ce wit$ quality a%d er orma%ce

    requireme%ts. ;ubseque%t s$i me%ts o roduct 3o t$rou3$ a recei4i%3 i%s ectio%. $ee9te%t a%d reque%cy o t$is i%s ectio% de e%ds o% t$e e9te%t o rocess co%trols at t$esu liers8 site a%d su liers8 ast quality record. Recei4i%3 a%d recei4i%3 i%s ectio%4eri y t$at t$e ro er material $as bee% recei4ed a%d t$at it meets t$e requireme%ts

    re ere%ced o% t$e urc$ase order. Material is released to roductio% or stores o%ly a tera success ul i%s ectio% is com leted a%d recorded. No%co% ormi%3 material isco%trolled i% accorda%ce wit$ establis$ed Elastimold rocedures.

    Elastimold customers do %ot request to i%s ect material or com o%e%ts at Elastimoldsu lier8s sites.

    !.5 #roductio% a%d ;er4ice #ro4isio%

    !.5." @o%trol o #roductio% a%d ;er4ice #ro4isio%

    Elastimold la%s a%d er orms its roductio% acti4ities i% a co%trolled ma%%er to e%suret$e desired out ut is ac$ie4ed. $is co%trol is i%stituted t$rou3$ t$e

    a) a4ailability o i% ormatio% t$at describes roduct c$aracteristics. Wor ma%s$icriteria is commu%icated by drawi%3s, wor i%structio%s a%d quality s eci icatio%s.;am le boards a%d $oto3ra $s are used w$e% a ro riate. @om lia%ce wit$ t$edocume%ted roductio% requireme%ts or rocess a%d roduct is t$e res o%sibility ot$e area ma%a3er a%d t$e la%t quality erso%%el.

    b) a4ailability o wor i%structio%s as %ecessary, w$ic$ may i%clude some or all o t$eollowi%3& Wor ;eque%ces, G eratio% Route ;$eets 'GR;), ;ta%dard G erati%3

    #rocedures ';G#), Wor =%structio%s 'W=8s), drawi%3s, rocess ri%ts, /ob Aids,a%d quality s eci icatio%s.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    c= use o suitable equi me%t as desi3%ated by Ma%u acturi%3 E%3i%eeri%3, w$o isres o%sible or t$e desi3% a%dIor selectio% o roductio% equi me%t 33#roductio%equi me%t is mai%tai%ed by t$e roductio% mai%te%a%ce erso%%el w$o areres o%sible or re4e%ti4e a%d correcti4e mai%te%a%ce.

    d) a4ailability a%d use o mo%itori%3 a%d measuri%3 de4ices w$ic$ are calibrated or4eri ied as %ecessary at eriodic i%ter4als, a%d

    e) im leme%tatio% o mo%itori%3 a%d measureme%t by o erators a%d i%s ectors.G erators re ort t$e s$o order %umber bei%3 rocessed a%d t$e results or eac$cycle or s$i t o t$e rocess i%4ol4ed. ;tatistical #rocess @o%trol is bei%3i%troduced. =%+ rocess i%s ectors a%d rocess tec$%icia%s also er ormi%de e%de%t mo%itori%3 o ma%u acturi%3 rocesses.

    Elastimold does %ot ro4ide a%y ost+deli4ery ser4ices or co%tracted ser4ici%3.

    !.5.2 Halidatio% o #rocesses or #roductio% a%d ;er4ice #ro4isio%

    W$ere resulti%3 rocess out ut ca%%ot be 4eri ied by subseque%t measureme%t or test,t$e rocess is 4alidated. Elastimold8s roductio% i%cludes se4eral s ecial, co%trolled

    rocesses, i% w$ic$ sam les are destructi4ely tested to eriodically co% irm t$e rocesser orma%ce. $is 4alidatio% demo%strates t$e ability o t$e rocess to ac$ie4e t$ela%%ed results. Arra%3eme%ts establis$ed or t$ese rocesses i%clude&

    a) de i%ed criteria or re4iew a%d a ro4al o t$e rocessb) a ro4al o equi me%t a%d quali icatio% o erso%%elc) use o s eci ic met$ods a%d rocedures,d) records o t$e rocess 4alidatio%, a%de) re4alidatio%.

    !.5.* =de%ti icatio% a%d raceability

    #roduct is ide%ti ied by suitable mea%s t$rou3$out t$e roduct reali>atio% rocesses.:se o tra4el ta3s a%d s$i t ide%ti iers $el trac roduct t$rou3$out ma%u acturi%3.W$ere mo%itori%3 a%d measureme%t $as bee% e9ecuted, t$e corres o%di%3 roductstatus is ide%ti ied. Elastimold ide%ti ies out 3oi%3 roduct wit$ t$e date o ma%u actureto ro4ide traceability.

    !.5.0 @ustomer #ro erty

    Elastimold does %ot recei4e or use a%y materials or roducts su lied by customers.Neit$er does Elastimold retai% a%y customer8s Li%tellectual ro ertyL i%cludi%3 customer+ow%ed s eci icatio%s, drawi%3s a%d ro rietary or co% ide%tial i% ormatio%. W$ererequired, Elastimold will mai%tai% co%trol o suc$ ro erty to e%sure co% ide%tiality, a%d%oti y t$e customer i% case o loss.

    !.5.5 #reser4atio% o #roduct

    W$ere4er roduct or material is $a%dled, eac$ i%di4idual e%sures t$at all required$a%dli%3 met$ods a%d recautio%s are obser4ed to re4e%t dama3e or deterioratio%.

    $e stora3e o raw materials, i%+ rocess a%d i%is$ed 3oods i%4e%tory co%trol a%ddisburseme%t are er ormed i% accorda%ce to sta%dard ractices wit$i% t$e acility i%order to re4e%t dama3e. ; ecial co%sideratio% is 3i4e% to t$e stora3e o $a>ardousmaterials.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    $e cycli%3 o items wit$ s$el li e restrictio%s is accom lis$ed by orderi%3 small lots a%dmo%itori%3 e9 iratio% dates o% t$e roduct. =% order to detect deterioratio%, stored

    roduct will eriodically be c$ec ed.

    W$e% s eci ied, roduct is ac a3ed i% accorda%ce wit$ customer requireme%ts. =%ot$er cases, i%is$ed 3oods ac a3i%3 a%d labeli%3 will be er ormed i% accorda%ce wit$i%ter%al s eci icatio%s3

    #rocesses are i% lace to e%sure t$e reser4atio% o roduct co% ormity duri%3 i%ter%alrocessi%3 a%d deli4ery to t$e i%te%ded desti%atio%. $e reser4atio% i%cludes

    ide%ti icatio%, $a%dli%3, ac a3i%3, stora3e a%d rotectio%. $e co%stitue%t arts oroduct w$ere a licable are also a orded t$ese reser4atio% measures.

    !.6 @o%trol o Mo%itori%3 a%d Measuri%3 ?e4ices

    Elastimold $as determi%ed t$e mo%itori%3 a%d measureme%t to be do%e, a%d t$emo%itori%3 a%d measuri%3 de4ices %eeded to ro4ide e4ide%ce t$at roduct meetsrequireme%ts. E%3i%eeri%3 a%d Cuality are res o%sible or t$e ide%ti icatio% a%dcalibratio% o all =%s ectio%, measuri%3, mo%itori%3, a%d test equi me%t w$ic$ is used todemo%strate co% orma%ce to t$e Cuality ;ystem requireme%ts wit$i% t$e ?e4elo me%t@e%ter a%d #la%ts res ecti4ely. Elastimold e%sures t$at t$e mo%itori%3 a%d measuri%3

    rocesses are carried out i% a ma%%er co%siste%t wit$ docume%ted requireme%ts. =%additio%, w$ere %ecessary to e%sure 4alid results, measuri%3 equi me%t is&

    a) calibrated or 4eri ied at s eci ied i%ter4als, or rior to use, a3ai%st measureme%tsta%dards traceable to %atio%al measureme%t sta%dards. W$ere %o suc$ sta%darde9ists, t$e basis used or calibratio% or 4eri icatio% is recorded

    b) ad

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    . easurement4 +na!,sis and Impro)ement

    ." e%eral

    Elastimold $as la%%ed a%d im leme%ted met$ods or mo%itori%3, measureme%t ,a%alysis, a%d t$e im ro4eme%t o rocesses %eeded to&

    a) demo%strate roduct co% orma%ce,b) e%sure co% ormity o t$e Cuality ;ystem, a%dc) co%ti%ually im ro4e t$e e ecti4e%ess o t$e Cuality ;ystem.

    $ese met$ods i%clude statistical tec$%iques suc$ as areto a%alysis a%d tre%d a%alysislus ot$er met$ods to trac o%+3oi%3 er orma%ce.

    .2 Mo%itori%3 a%d Measureme%t

    .2." @ustomer ;atis actio%

    Elastimold mo%itors customer satis actio% as o%e o t$e measureme%ts to i%dicatee ecti4e er orma%ce o t$e Cuality ;ystem. @ustomer ;atis actio% is determi%edt$rou3$ i% ormatio% obtai%ed rom&

    @ustomer @om lai%ts '4ia #AR7Rs) @ustomer @o%cer%sI=deas 'as commu%icated t$rou3$ #roduct Mar eti%3 E%3i%eers) @ustomer o%+site audits Hisits to customer locatio%s ?iscussio%s o com etiti4e acti4ity @or orate eedbac a%d sur4eys.

    $ese i% uts are s$ared wit$ ma%a3eme%t o t$e u%ctio%al areas a ected by t$ecustomer commu%icatio%, a%d are addressed i% Ma%a3eme%t Re4iew meeti%3s toe%sure t$at Elastimold stays ocused o% t$e customers8 %eeds a%d e9 ectatio%s.

    .2.2 =%ter%al Audit

    =%ter%al audits are reco3%i>ed as esse%tial to t$e co% irmatio% o t$e e ecti4e%ess o t$eElastimold Cuality ;ystem, a%d ser4e as a source o ob

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    t$e roduct reali>atio% requireme%ts '!."), t$e requireme%ts o t$e =;G ;ta%dard, a%d establis$ed Elastimold Cuality ;ystem requireme%ts.

    Audit sc$edules a%d re orts are roduced a%d mai%tai%ed by t$e MRC. ?etails o t$e

    i%ter%al audit ro3ram are urt$er described i% docume%ted rocedure -S/ 100 , asrequired by t$e =;G 1(("&2((( sta%dard.

    .2.* Mo%itori%3 a%d Measureme%t o #rocesses

    Elastimold em loys met$ods or mo%itori%3 a%d, w$ere a licable, measureme%t oCuality ;ystem rocesses. $e 3oal i% em loyi%3 t$ese met$ods is to e%sure t$at t$e

    rocesses ac$ie4e t$e la%%ed results or out uts. $e met$ods used or mo%itori%3a%d measuri%3 t$e e ecti4e%ess o t$e Cuality ;ystem8s rocesses i%clude, but are %otlimited to&

    i%ter%al audits

    ormal ma%a3eme%t re4iew i%+ rocess sam li%3 a%d i%s ectio% c$arti%3 a%d re orti%3 o% customer com lai%ts re4iew o trai%i%3 e ecti4e%ess

    .2.0 Mo%itori%3 a%d Measureme%t o #roduct

    Elastimold $as systems t$at mo%itor a%d measure roduct or co% ormity at se4eralsta3es t$rou3$out t$e ma%u acturi%3 rocess. #roduct c$aracteristics are 4eri ied as

    ollows&

    Recei4i%3 =%s ectio% a%d esti%3& Recei4i%3 a%d recei4i%3 i%s ectio% 4eri y t$att$e ro er material $as bee% recei4ed a%d t$at it meets t$e requireme%ts re ere%cedo% t$e urc$ase order. Material is released to roductio% or stores o%ly a ter asuccess ul i%s ectio% is com leted a%d recorded. No%co% ormi%3 material isco%trolled i% accorda%ce wit$ establis$ed Elastimold rocedures.

    =%+ rocess =%s ectio% a%d esti%3& G erators are res o%sible or i%s ecti%3 eac$art rocessed. Cuality erso%%el i%s ect arts at start o a s$o order to co% irm

    t$at ro er materials are used a%d t$at t$e o erator is correctly ide%ti yi%3acce table u%its. Audits are er ormed by Cuality erso%%el.

    Fi%al =%s ectio% a%d esti%3& =% additio% to t$e o erator i%s ectio%s, moldedcom o%e%ts are tested or dielectric i%te3rity as a ro riate. All a aratus bus$i%3sare tested or seal i%te3rity. Fi%al #roduct a%d ;$i i%3 audits are er ormedra%domly o% all roducts to co% irm t$at t$e co%te%ts are correct a%d acce table tot$e most dema%di%3 customer.

    =%s ectio% a%d test results are recorded o% t$e s$o loor data system, as a ro riate.W$e% a ro riate, material or roducts aili%3 i%s ectio% are re4iewed by t$e MaterialRe4iew Board or i%al dis ositio%. E4ide%ce o co% orma%ce to acce ta%ce criteria is

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    mai%tai%ed, a%d records i%dicate t$e erso%'s) w$o aut$ori>e release o roduct to t$e%e9t rocess.

    .* @o%trol o No%co% ormi%3 #roduct

    Elastimold $as im leme%ted a docume%ted rocess to e%sure t$at roduct w$ic$ does%ot co% orm to roduct requireme%ts is ide%ti ied wit$ -old a3s, a%d co%trolled to

    re4e%t its u%i%te%ded use or deli4ery. #roducts w$ic$ ca%%ot meet t$e requireme%t arescra ed. #roducts w$ic$ do %ot meet t$e s eci icatio%s may be submitted to t$eMaterial Re4iew Board or dis ositio%. G erators are required to re+i%s ect a%y lotw$ic$ does %ot ass t$e audit. $e re+i%s ected lot is audited by Cuality rior to release.-old ta3s may o%ly be remo4ed by t$e quality de artme%t. = %ecessary, %o%co% ormi%3material is recalled rom customers i it is detected a ter deli4ery.

    Elastimold $as docume%ted t$e rocess or co%trolli%3 %o%co% ormi%3 roduct i%-S/ 1010 as required by t$e =;G 1(("&2((( sta%dard. $e rocedure de i%es met$ods

    or deali%3 wit$ %o%co% ormi%3 roduct, a%d also de i%es t$e records mai%tai%ed o t$e%ature o %o%co% ormities a%d a%y subseque%t actio%s ta e%, i%cludi%3 co%cessio%sobtai%ed.

    .0 A%alysis o ?ata

    Elastimold collects a%d a%aly>es data to demo%strate t$e suitability a%d e ecti4e%ess ot$e Cuality ;ystem, a%d to e4aluate w$ere im ro4eme%t ca% be made. $is i%cludesdata rom mo%itori%3 a%d measureme%t acti4ities, as well as data rom ot$er rele4a%tsources.

    $e data a%alysis er ormed ro4ides i% ormatio% or decisio% ma i%3 related to&

    a) customer satis actio% 'see .2."),b) co% ormity to roduct requireme%ts 'see !."),c) c$aracteristics a%d tre%ds o rocesses a%d roducts i%cludi%3 o ortu%ities or

    re4e%ti4e actio%, a%dd) su lier er orma%ce.

    .5 =m ro4eme%t

    .5." @o%ti%ual =m ro4eme%t

    $e com a%y stri4es to co%ti%ually im ro4e o4erall e ecti4e%ess o t$e quality systemt$rou3$ t$e use o t$e quality olicy, quality ob

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    Page 2;

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    5!o6 Chart. .2 Correcti)e +ction

    S,stem non7con"ormances and product de"iciencies not identi"ied at the norma!point o" inspection4 re8uire that appropriate correcti)e actions e identi"ied and

    imp!emented. $!astimo!d has de)e!oped a documented procedure "or thisoccurrence4 inc!uding a standardized "orm "or the recording o" the statement o"the pro !em4 the ana!,sis and actions taken and con"irmation o" e""ecti)eness.

    Correcti)e action is re8uired in response to customer comp!aints4 *iscrepantateria! Reports 9* R: and;or interna! audit "indings. +na!,sis is conducted to

    determine the root cause and to identi",4 imp!ement and con"irm e""ecti)eness o"se!ected correcti)e actions. +!! product or process changes resu!ting "rom

    correcti)e actions are documented.

    $!astimo!d: determining the causes o" noncon"ormities>

    c: e)a!uating the need "or action to ensure that noncon"ormities do not recur>d: determining and imp!ementing action needed>

    e: records o" resu!ts o" action taken> and": re)ie6ing correcti)e action taken.

    The correcti)e action process is de"ined in documented procedure -S/ 101 .

    . .3 /re)enti)e +ction

    $!astimo!d recognizes the importance o" proper pre)enti)e action as a too! "orcontinuous impro)ement and to e!iminate the causes o" potentia!

    noncon"ormities. +ccording!,4 $!astimo!d has esta !ished a pre)enti)e actionprocedure 6hich addresses re8uirements "or=

    a: determining potentia! noncon"ormities and their causes>

    : e)a!uating the need "or action to pre)ent occurrence o" noncon"ormities>c: determining and imp!ementing action needed>

    d: records o" resu!ts o" action taken> ande: re)ie6ing pre)enti)e action taken.

    The pre)enti)e action process is de"ined in documented procedure -S/ 101 .

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

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    Page 2 Elastimold Hackettsto n

    Marisol rito > Elastimold .lbu7uer7ue

    1itle:Quality .ssurance Manager Quality .ssurance Manager

    #ate:.ugust + & 2''5

    ACTIVITIES ATTRIBUTES TO BE

    VERIFIED FREQUENCY PROCEDURE

    Q. 9ab ns)ect subcontractor(u))lied )0ysical data/ Materialcerti!ication3

    Eac0 s0i)ment 8ork nstructions ?re!3 Master 9ist=Eng3 #ra ings/()ec3

    *ecei"ing Plastics&Metals/Com)onents ns)ect )er Elastimold Eng3#ra ing/()ec3 (am)le )er *e7uirement 8ork nstructions ?re!3 Master 9ist=Eng3 #ra ing/()ec3 Control PlansContactPre)aration

    Veri!y o)erations )er *oute (0eetsand Engineering #ra ings3

    st Piece @ n- )rocess ns)ection by o)erator

    8ork ticket -( PAs 8ork instruction ?re!3 Master9ist=Eng3 #ra ings/()ec3

    Conducti"eMolding

    Veri!y critical dimensions.!ter insulation molding3

    ns)ect !or "isual de!ects3

    st Piece @ n- )rocess ns)ection by o)erator

    8ork ticket -( PAs 8ork instruction ?re!3 Master9ist=Eng3 #ra ings/()ec3

    #e!las0ing Veri!y !las0 remo"al andns)ect !or "isual de!ects3

    )eratorns)ection

    eac0 load

    8ork ticket -( PAs 8ork instruction ?re!3 Master9ist= Eng3 #ra ings/()ec3

    nsulationMolding

    Critical inter!ace dimensions or cableentrance diameter as a))licable

    ns)ect !or "isual de!ects3Veri!y internal 7uality3

    st Piece o!!tool setu)

    )eratorns)ection

    eac0 container

    8ork ticket -( PAs 8ork instruction ?re!3 Master9ist= Engineering #ra ings/()ec3

    Visual/B-ray ins)ection

    inal Electrical 1esting Corona& .C Hi-Pot&m)ulse& or 1est Point

    ''D )er EEE%'%

    8ork instruction ?re!3 Master 9ist= Eng3 ()ec3EEE %'%

    .ssembly Veri!y )er route s0eet and Eng3#ra ings3

    ns)ect !or "isual de!ects3

    st Piece at start o!)eration3)erator

    ns)ection

    8ork ticket -( PAs8ork instruction ?re!3 Master 9ist=Eng3 #ra ings/()ec3

    agging/o ing

    Veri!y correct Packaging @Contents )er *oute (0eet3

    st Piece at start o!)eration3)eratorns)ection

    8ork ticket -( PAs8ork instruction ?re!3 Master 9ist=Eng3 #ra ings/()ec3

    (0i))ing !romEit0er acility

    Veri!y correct )art @9abeling )er 1icket3

    Pre-aut0oriFations as a))licable

    st Piece at start o!)eration3

    )eratorns)ection eac0

    s0i)ment3

    8ork ticket -( PAs8ork instruction ?re!3 Master 9ist=Eng3 #ra ings/()ec3

    8ork instruction ?re!3 Master 9ist=

    Control ofNonconfor !n" #ro$%ct

    See Note Below:

    Ins#ect!on &'!s%al( )*ra+( or$! ens!onal, to #ro$%ctre-%!re ents t ro%" all sta"esof #ro$%ct!on.

    Ins#ect!ont ro%" all sta"esof #ro$%ct!on&QSP*/0/0,

    1or2 t!c2et *SOP s1or2 !nstr%ct!on &ref. 4aster 5!st,En". Dra6!n"s7S#ec.4ater!al Re'!e6 Boar$ &4RB,

    4etrolo"+7Cal!brat!on

    See Note Below:

    Tools an$ E-%!# ent Per #roce$%re

    &QSP*/008,

    1or2 t!c2et 9SOP s1or2 !nstr%ct!on &ref. 4aster 5!st,En". Dra6!n"s7S#ec.

    Con!idential )ro)erty o! Elastimold not to be disclosed to ot0ers3,,4 Elastimold3 # 6 1 *EP* #UCE it0out ritten )ermission3

    #ocument must be returned u)on demand to Elastimold3

  • 8/13/2019 Quality Plan for Elastimold Products

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    Elastimold Quality Manual Quality Plan: 25kV UndergroundConnectors /Hydro-Quebec

    Page +

    E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5 *e"ision +,

    Pro$%ct !$ent!f!cat!on an$traceab!l!t+

    See Note Below:

    Date co$e #ro$%ct an$ #ac2a"!n" /00: #er IEEE808

    1or2 !nstr%ct!on &ref. 4aster 5!st,( En". S#ec.an$ Dra6!n"s IEEE 808.

    CC ontrol of Q%al!t+recor$s

    See Note Below:

    Patrol( f!rst #c !ns#ect!on( s !#t!c2ets( #re*a%t or!=at!ons asa##l!cable

    Per eac sta"e of#ro$%ct!on

    1or2 t!c2et *SOP s1or2 !nstr%ct!on &ref. 4aster 5!st,En". Dra6!n"s7S#ec.

    Thomas & Betts Elastimold Products: Terminators Inspection & Test Plan

    Customer 6ame:Hydro-Quebec.ll Customers

    Customer *e7uirement: ( ,'' -2'''1o e #etermined

    Part #escri)tion:1erminators

    Elastimold *e7uirement: ( ,'' -2''' Q(P +''

    .))ro"ed y:ruce Clauser > Elastimold Hackettsto n

    Marisol rito > Elastimold .lbu7uer7ue

    1itle:Quality .ssurance Manager Quality .ssurance Manager

    #ate:.ugust + & 2''5

    ACTIVITIES ATTRIBUTES TO BE

    VERIFIED FREQUENCY PROCEDURE

    Q. 9ab ns)ect subcontractor(u))lied )0ysical data/Materialcerti!ication3

    Eac0 s0i)ment 8ork nstructions ?re!3 Master 9ist=Eng3 #ra ings/()ec3

    *ecei"ing Plastics&Metals/Com)onents

    ns)ect )er ElastimoldEng3 #ra ing/()ec3

    (am)le )er *e7uirement

    8ork nstructions ?re!3 Master 9ist=Eng3 #ra ing/()ec3 Control Plans

    ContactPre)aration

    Veri!y o)erations )er *oute (0eetsand Engineering #ra ings3

    st Piece @ n- )rocess ns)ection by o)erator

    8ork ticket -( PAs 8ork instruction ?re!3 Master9ist= Eng3 #ra ings/()ec3

    Conducti"eMolding

    Veri!y critical dimensions.!ter insulation molding3

    ns)ect !or "isual de!ects3

    st Pieceo!! tool setu)

    )erator ns)ection

    8ork ticket -( PAs8ork instruction ?re!3 Master 9ist=Eng3 #ra ings/()ec3

    #e!las0ing Veri!y !las0 remo"al andns)ect !or "isual de!ects3 )erator ns)ectioneac0 load 8ork ticket -( PAs 8ork instruction ?re!3 Master9ist= Eng3 #ra ings/()ec3nsulation

    MoldingCritical inter!ace dimensions or cableentrance diameter as a))licable

    ns)ect !or "isual de!ects3Veri!y internal 7uality3

    st Piece o!!tool setu)

    )erator ns)ectioneac0 container

    8ork ticket -( PAs 8ork instruction ?re!3 Master9ist= Eng3 #ra ings/()ec3

    Visual/B-ray ins)ectioninal Electrical 1esting Corona& .C Hi-Pot&

    m)ulse& or 1est PointPer EEE %< 8ork instruction ?re!3 Master 9ist= Engineering

    ()ec3 EEE %