Quality Plan For Elastimold Products

Elastimold Quality Manual Quality Plan: 25kV Underground Connectors/Hydro-Quebec E!!ecti"e #ate: $anuary %& 2''%E!!
ecti"e (e)tember 2& 2''5
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Thomas & Betts Corporation
Thomas & Betts Corporation Elastimold + -ac.ettstow% Facility Es%a #ar. -ac.ettstow%, N/ (! 0( #$o%e& '1( ) 52+""22 FA,& '1( ) "*+2"6(
Elastimold Albuquerque Facility 6625 Bluewater Rd. N.W. Albuquerque, NM !"2" #$o%e& '5(5) *6+2(2( FA,& '5(5) **+2622
ELASTIMOLD
QUALITY Quality Plan Elastimold 25kV Under round !onne"tors #ydro$Que%e"&s Outline !ontra"t 'o( )*++++*,-./,2+ Pur"0ase Order 'o(1 AllMA'UAL
Pre)ared and -y:.))ro"ed -y: .))ro"ed -y:
-ruce Clauser Quality Manager-Hackettsto/n Mic0ael Malia Product Managaer1imot0y 1aylor Product Manager-Hackettsto/n
#ate: #ate:
(e)tember +& 2''5 (e)tember +& 2''5
Con!idential )ro)erty o! Elastimold2 not to be disclosed to ot0ers3 ,,4 Elastimold3 #5 651 *EP*5#UCE /it0out /ritten )ermission3 #ocument must be returned u)on demand to Elastimold3
Elastimold Quality Manual Quality Plan: 25kV Underground Connectors/Hydro-Quebec E!!ecti"e #ate: $anuary %& 2''%E!!ecti"e (e)tember 2& 2''5
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.))ro"ed -y:
Marisol -rito Quality Manager-.lbu7uer7ue
#ate
(e)tember +& 2''5
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1.0
Scope
Introduction
"." -istory a%d #roducts
Elastimold ma%u2actures $i3$+4olta3e u%der3rou%d electrical co%%ectors. Ma%u2acturi%3 is 5er2ormed at two se5arate 2acilities& o%e located i% Albuquerque, NM a%d o%e i% -ac.ettstow%, N/. Eac$ 2acility is i%de5e%de%tly ma%a3ed as 2urt$er described i% t$is ma%ual, wit$ su55ort 5ro4ided by 67B8s cor5orate 2u%ctio%s located i% Mem5$is, 6N. 6$e Elastimold #roduct li%es are a% e95a%sio% o2 5roducts de4elo5ed a%d i%troduced by Elastimold i% "16*, wit$ t$e i%itial ma%u2acturi%3 5er2ormed i% -ac.ettstow%. E95a%sio% o2 t$e co%2i3uratio%s a%d 4olume o2 5roductio% led to t$e o5e%i%3 o2 t$e Albuquerque 2acility i% "1!*. Ado5tio% o2 t$e 5roducts beyo%d t$e :%ited ;tates $as resulted i% <oi%t 4e%tures i% /a5a%, Bel3ium, 6aiwa%, E3y5t a%d =%dia. Elastimold was ori3i%ally or3a%i>ed as a com5lete busi%ess u%it wit$ res5o%sibility 2or Mar.eti%3, E%3i%eeri%3, Ma%u2acturi%3, ;ales a%d ?eli4ery. =% "116, 67B acquired t$e Amerace @or5oratio% w$ic$ i%cluded t$e Elastimold busi%ess, a%d reor3a%i>ed t$e busi%ess to co%2orm to t$e 5re4aili%3 67B structure. =% Au3ust, 2((( t$e 67B or3a%i>atio% was re4ised 2rom a t$ree+ dime%sio%al matri9 structure to a 5roduct li%e a%d busi%ess u%it 3rou5. @e%trali>ed 2u%ctio%s 2or sales a%d mar.eti%3 remai% i% Mem5$is, 6N, a%d co%ti%ue to i%teract wit$ Elastimold as i% t$e 5ast. 6$e day to day o5eratio%s at t$e Albuquerque a%d -ac.ettstow% 2acilities are ma%a3ed by t$e #la%t Ma%a3ersA $owe4er, t$e -ac.ettstow% #la%t Ma%a3er is also t$e Elastimold Be%eral Ma%a3er res5o%sible 2or o5eratio%s at bot$ 5la%ts a%d all Elastimold e%3i%eeri%3.
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Organization
6$e quality 5la% i%cludes t$e reali>atio%, mo%itori%3 a%d measuri%3 acti4ities 2or t$e ma%u2acturi%3 o2 06((((6!"*1!2( u%der3rou%d co%%ectors a%d t$e s5eci2ic requireme%ts o2 -ydro+Cuebec outli%e co%tract %umber. 2.0 Remarks 2." @$a%3e F6" Article *." D@o%tract Re4iewE is 5er2ormed at @or5orate -eadquarters locarted i% Mem5$is, 6e%%essee a%d by t$e ;ales ?e5artme%t located i% Mo%treal. 2.2 @lause F6" articles *.2 D?esi3% a%d de4elo5me%t 5la%%i%3E is dealt wit$ accordi%3 to t$e C;#+*((" 5rocedure a%d *.2.! D@o%trol o2 desi3% a%d de4elo5me%t c$a%3esE is dealt wit$ accordi%3 to t$e C;#+0((0 5rocedure. @lause F6" article *.* is dealt wit$ accordi%3 to #urc$asi%3 #rocedures #W= 15(", 15(*, a%d 15(5. @lause F6" article *.0 D@ustomer 5ro5ertyE & t$e customer does %ot su55ly 67B wit$ 5roducts i% t$is co%tract. @lause F6" article 0.2 D#erso%%el s5eci2ic quali2icatio%sE is %ot a55licable. Note& Names a%d co%tacts o2 su55liers a%d subco%tractors are %ot issued to our customersA $owe4er, re4iew o2 suc$ are allowed u5o% 4isitatio% o2 Cuality Re5rese%tati4e.
2.* 2.0 2.5 2.6
3.0 #.0
Ta !e o" Contents Flow @$art =%s5ectio% 7 6est #la%s #roduct E%3i%eeri%3 6est #ro3ram E%3i%eeri%3 tests to A;6M, AN;=, a%d =EEE '=%cluded i% =%s5ectio% 7 6est #la%s) Elastimold o5erates as a #roduct Fi%e wit$i% 67B8s :tility ?i4isio%. Bot$ o2 Elastimold8s ma%u2acturi%3 sites are i%4ol4ed i% 5rocess desi3% a%d 5roductio% o2 5roducts a%d are a 5art o2 t$e 67B 5roduct li%e re5orti%3 to t$e #reside%t o2 t$e :tility Brou5. #roduct E%3i%eeri%3, res5o%sible 2or 5roduct desi3%, is located at t$e -ac.ettstow% ?e4elo5me%t @e%ter a%d re5orts to t$e -ac.ettstow% #la%t Ma%a3er. 6$e Albuquerque a%d -ac.ettstow% ma%u2acturi%3 sites alo%3 wit$ t$e ?e4elo5me%t @e%ter are collecti4ely res5o%sible 2or t$e desi3% a%d ma%u2acture o2 Elastimold+bra%d 5roducts a%d ot$er assi3%ed 67B 5roducts. Mar.eti%3, ;ales a%d #roduct Ma%a3eme%t o2 Elastimold 5roducts are 5er2ormed at 67B @or5orate $eadquarters i% Mem5$is, 6N.
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2."
Fu%ctio%al Brou5s
6$e dia3ram below ide%ti2ies t$e eleme%ts a%d i%teractio%s associated wit$ t$e desi3%, ma%u2acture, sale a%d deli4ery o2 Elastimold 5roducts. =t also i%dicates w$ic$ locatio%s are i%4ol4ed i% t$e i%teractio%s.
@:;6GMER; a%d /G=N6 VE61U*E(& 85*9#8:#E
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2.2
#la%t ;tructure a%d Res5o%sibilities
6$e Albuquerque a%d -ac.ettstow% 2acilities eac$ re5ort to t$eir ow% #la%t Ma%a3erA $owe4er, t$e -ac.ettstow% #la%t Ma%a3er is also t$e Elastimold Be%eral Ma%a3er res5o%sible 2or bot$ locatio%s, w$o i% tur% re5orts to t$e ;r. Hice #reside%t o2 G5eratio%s at 67B i% Mem5$is, 6N. Eac$ #la%t Ma%a3er determi%es t$e o4erall or3a%i>atio%al %eeds a%d structure. Be%eral res5o%sibilities are s$ow% below. Eac$ #la%t Ma%a3er as well as de5artme%tal Ma%a3ers are res5o%sible 2or t$e o4erall Cuality ;ystem wit$i% t$eir area o2 co%trol. Be%eral Ma%a3eme%t Res5o%sible 2or o4erall 5la%t 5er2orma%ce, directio% a%d leaders$i5. #roduct E%3i%eeri%3 Res5o%sible 2or t$e desi3%, material selectio%, 4eri2icatio% a%d 4alidatio% 2or e9isti%3, modi2ied a%d %ew 5roducts. Ma%u2acturi%3 E%3i%eeri%3 Res5o%sible 2or tool desi3% equi5me%t selectio%, a%d demo%stratio% a%d docume%tatio% o2 ca5able 5rocesses 2or all ma%u2actured 5roducts. #urc$asi%3 #urc$ases all %ecessary materials a%d com5o%e%ts to e%sure u%i%terru5ted 5roductio%. #la%%i%3 ;c$edules t$e material a%d 5roductio% requireme%ts 2or 5ro4idi%3 5roducts as required to 5ro4ide i%4e%tory a%d 2ill customer orders o% time. #roductio% a%d G5eratio% G5erates 5roductio% equi5me%t a%d ma%a3es trai%ed wor.2orce to 5roduce 5roducts w$ic$ meet Elastimold a%d @ustomer requireme%ts. Cuality + Cuality ma%a3eme%t, 5la%%i%3, co%trol a%d im5ro4eme%t, measuri%3 a%d test equi5me%t co%trol, 6CM, a%d =;G 1((( com5lia%ce. =%4e%tory @o%trol Recei4es a%d ma%a3es all i%+stores materials a%d com5o%e%ts u%til issued to #roductio% 2or use, a%d all 2i%is$ed 3oods awaiti%3 s$i5me%t to customers. ;$i55i%3 5er2orms 2i%al 5ac.a3i%3, labeli%3 a%d 5$ysical s$i5me%t o2 all out3oi%3 2i%is$ed 3oods to customers. -uma% Resources, is res5o%sible 2or em5loyee relatio%s, trai%i%3 o2 em5loyees, 5ayroll '-ac.ettstow%) a%d o4erseei%3 em5loyee be%e2its. Fi%a%ce, is res5o%sible 2or 2i%a%cial ma%a3eme%t i%cludi%3 5ayroll 'Albuquerque), bud3ets, 5la%t accou%ti%3, a%d ca5ital e95e%ditures. =%2ormatio% 6ec$%olo3y '=6) Mai%tai% %etwor. co%%ectio%s a%d 2u%ctio%i%3 esse%tial to t$e commu%icatio% o2 commercial i%2ormatio% 2rom a%d to 67B, Mem5$is a%d su55ort t$e #@ so2tware a%d $ardware at t$e s5eci2ic 2acility. 6$e Ma%a3eme%t structures 2or eac$ 2acility are 4isible o% t$e com5a%y i%tra%et. 6$e -uma% Resources de5artme%t i% eac$ locatio% mai%tai%s a more detailed or3a%i>atio%al c$art.
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2.*
Cuality Ma%ual @o%trol, ?istributio%, a%d Re4isio% -istory
6$is Ma%ual describes t$e Cuality Ma%a3eme%t ;ystem 'Cuality ;ystem) used by 6$omas 7 Betts '67B) Elastimold e%3i%eeri%3 a%d ma%u2acturi%3 2acilities. 6$e Cuality ;ystem is 5la%%ed, establis$ed a%d mai%tai%ed to be i% co%2orma%ce wit$ t$e requireme%ts o2 =;G 1(("&2((( 6$is Ma%ual co%tai%s t$e Cuality #olicy, Cuality ob<ecti4es, t$e i%teractio%s o2 2u%ctio%s wit$i% t$e or3a%i>atio%, descri5tio% o2 t$e #rocesses, re2ere%ce to Cuality #rocedures, a%d a descri5tio% o2 $ow t$e #rocedures co4er t$e =;G eleme%ts. =t is mai%tai%ed a%d distributed i% accorda%ce wit$ Elastimold8s ?ocume%t @o%trol 5rocedure. @$a%3es are re4iewed a%d a55ro4ed by t$e Ma%a3eme%t Re5rese%tati4e a%d t$e Be%eral Ma%a3er at a mi%imum. :sers are res5o%sible 2or e%suri%3 t$ey $a4e t$e curre%t 4ersio% o2 t$is Ma%ual. :%co%trolled co5ies are a4ailable u5o% request 2rom ?ocume%t @o%trol. A% electro%ic co5y o2 t$e ma%ual is also accessible i%ter%ally o% t$e com5a%y i%tra%et. R$%ISIO& 'ISTOR(
Re). *ate "(I""I(2 Brie" *escription o" Change ;i3%i2ica%t re+write a%d re+%umberi%3 to i%cor5orate t$e %ew =;G 1(("&2((( sta%dard. Originator +ppro)ed ,
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Table of Contents
0. Cuality Ma%a3eme%t ;ystem 0." 0.2 5." 5.2 5.* 5.0 5.5 5.6 6." 6.2 6.* 6.0 !." !.2 !.* !.0 !.5 !.6 ." .2 .* .0 .5 Be%eral Requireme%ts ?ocume%tatio% Requireme%ts Ma%a3eme%t @ommitme%t @ustomer Focus Cuality #olicy #la%%i%3 Res5o%sibility, Aut$ority a%d @ommu%icatio% Ma%a3eme%t Re4iew #ro4isio% o2 Resources -uma% Resources =%2rastructure Wor. E%4iro%me%t #la%%i%3 o2 #roduct Reali>atio% @ustomer+related #rocesses ?esi3% a%d ?e4elo5me%t #urc$asi%3 #roductio% a%d ;er4ice #ro4isio% @o%trol o2 Mo%itori%3 a%d Measuri%3 ?e4ices Be%eral Mo%itori%3 a%d Measureme%t @o%trol o2 No%co%2ormi%3 #roduct A%alysis o2 ?ata =m5ro4eme%t Fi3ure ", ;eque%ce 7 =%teractio% o2 Jey #rocesses
5. Ma%a3eme%t Res5o%sibility
6. Resource Ma%a3eme%t
!. #roduct Reali>atio%
. Measureme%t, A%alysis a%d =m5ro4eme%t
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#. 0."
-ua!it, .anagement S,stem Be%eral Requireme%ts Elastimold8s Cuality ;ystem is docume%ted a%d mai%tai%ed to e%sure t$at all sta%dard a%d custom 5roducts co%2orm to s5eci2icatio%s. 6$e Cuality ;ystem i%cludes a quality 5olicy a%d ob<ecti4es, as well as 5rocesses 2or ma%a3eme%t acti4ities, 5ro4idi%3 resources, 5roduct reali>atio%, a%d measureme%t acti4ities. 6o e%sure e22ecti4e o5eratio% a%d co%trol o2 t$ese 5rocesses, Elastimold $as im5leme%ted docume%ted met$ods a%d 5rocedures. ElastimoldKs Cuality ;ystem co%sists o2 2i4e tiers o2 docume%ts describi%3 t$e acti4ities, res5o%sibilities, aut$orities, a%d records required to meet ElastimoldKs quality 5olicy a%d all o2 t$e a55ro5riate eleme%ts o2 =;G 1((". 6ier ". Cuality Ma%ual t$is docume%t describes Elastimold8s structure to meeti%3 customers8 %eeds. 6$e docume%tatio% structure a%d t$e 5olicy a%d res5o%sibilities o2 ma%a3eme%t 2or meeti%3 =;G requireme%ts. 6ier 2. Cuality ;ystem #rocedures t$ese docume%ts describe t$e who, what, when and where ste5s eac$ 5erso% or de5artme%t must 2ollow to meet t$e 5olicies described i% Elastimold8s Cuality Ma%ual. 6$ey also describe t$e docume%tatio% t$at is to be used or is 5roduced as a result o2 t$e acti4ity. ?ue to t$e two di22ere%t locatio%s, a%d t$e %eed to ru% eac$ 2acility u%der similar but di22ere%t 5rocesses t$e Albuquerque 2acility C;# will be 5receded by a% DAE desi3%atio% 'A+C;#) a%d -ac.ettstow% will be 5receded by a D-E desi3%atio% '-+C;#). C;#8s t$at a55ly to bot$ locatio%s will be desi3%ated as C;#. 6ier *. Wor. =%structio%s t$ese docume%ts co%tai% t$e detailed i%structio%s 2or how acti4ities are to be 5er2ormed. 6ier 0. Cuality Records t$ese docume%ts 5ro4ide e4ide%ce t$at t$e required 5roduct or ser4ice quality was ac$ie4ed, or t$at Elastimold8s Cuality ;ystem was im5leme%ted correctly. 6ier 5. =%dustry ;ta%dards w$e% a55licable, t$ese docume%ts are i%cor5orated by re2ere%ce i% to Elastimold8s 6ier * docume%ts, s5eci2ically t$e 5roduct drawi%3s. Mo%itori%3, measureme%t a%d a%alysis are a% i%te3ral 5art o2 e%suri%3 t$at 5rocesses ac$ie4e 5la%%ed results, a%d are .ey 2actors used i% ma.i%3 co%ti%ual im5ro4eme%ts to suc$ 5rocesses. W$ere Elastimold $as outsourced acti4ities t$at a22ect 5roduct co%2ormity to requireme%ts, co%trol o2 t$ose acti4ities is ide%ti2ied wit$i% t$e Cuality ;ystem.
0.2
?ocume%tatio% Requireme%ts 0.2." Be%eral Elastimold $as de2i%ed, docume%ted a%d im5leme%ted a quality system to meet Elastimold8s quality requireme%ts a%d t$ose o2 =;G 1((".
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Elastimold is res5o%sible 2or t$e #la%%i%3, ?esi3%, #roductio%, ;$i5me%t a%d Cuality o2 released Elastimold 5roducts. W$ere required by t$e =;G 1(("&2((( =%ter%atio%al sta%dard, a%d w$ere it is a55ro5riate a%d %ecessary 2or t$e e22ecti4e o5eratio% a%d co%trol o2 5rocesses, Elastimold $as docume%ted 5rocesses t$at are establis$ed, im5leme%ted a%d mai%tai%ed. Additio%ally, records are mai%tai%ed, as well as ot$er docume%ts %eeded to e%sure e22ecti4e 5la%%i%3, o5eratio% a%d 5rocess co%trol. =t is t$e res5o%sibility o2 a%y docume%t user to e%sure t$at t$e docume%t bei%3 used is t$e correct or curre%t 4ersio% a%d t$at it is com5lete. 0.2.2 Cuality Ma%ual
Elastimold mai%tai%s t$is Cuality Ma%ual i% accorda%ce wit$ t$e requireme%ts o2 =;G 1(("&2(((. =t addresses all requireme%ts o2 t$e ;ta%dard a%d is t$e 2irst tier docume%t 2or t$e e%tire Cuality ;ystem. A list o2 all Cuality ;ystem #rocedures 'C;#8s) w$ic$ su55ort t$e 5olicies wit$i% t$is ma%ual is a4ailable o% t$e Elastimold i%tra%et. W$ere t$e sta%dard s5eci2ically calls 2or a docume%ted 5rocedure, Elastimold8s 5rocedure %umber is stated wit$i% t$e corres5o%di%3 sectio% o2 t$is ma%ual. 6$e i%teractio% o2 Cuality ;ystem 5rocesses is described i% t$e 2lowc$art i% Fi3ure " at t$e e%d o2 t$is ma%ual, to s$ow $ow all acti4ities $a4e bee% i%te3rated i%to a co$esi4e system. 0.2.* @o%trol o2 ?ocume%ts
Elastimold $as establis$ed a%d commu%icated res5o%sibilities 2or t$e docume%tatio% o2 all 5rocesses w$ic$ a22ect co%2orma%ce to t$e Elastimold Cuality #olicy a%d t$e =;G 1((" requireme%ts. 6$ese i%clude a55ro5riate co%trols i% 5lace 2or all 6ier = t$rou3$ 6ier H docume%tatio%. Cuality ;ystem docume%ts are mai%tai%ed i% a ma%%er to e%sure t$at t$ey remai% le3ible a%d readily ide%ti2iable. All docume%ts are re4iewed 2or adequacy a%d a55ro4ed by aut$ori>ed 5erso%%el. Eac$ 5la%t e%sures t$at users $a4e access to %ecessary docume%ts at 5oi%ts o2 use, eit$er electro%ically or 4ia distributio% o2 a co%trolled $ard+co5y. ?ocume%ts are made a4ailable 2or eac$ o5eratio% a%d all obsolete docume%ts are remo4ed by a55ro5riately aut$ori>ed 5erso%%el i% accorda%ce wit$ Elastimold 5rocedures. Gbsolete docume%ts, t$ou3$ arc$i4ed 2or researc$ or $istory 5ur5oses, are 5assword 5rotected to 5re4e%t accide%tal use. #er docume%ted 5rocedures, docume%ts may be u5dated or c$a%3ed, but suc$ c$a%3es %eed a55ro4al o2 t$e 5ro5er aut$ority be2ore release. W$e% c$a%3es are made to co%trolled docume%ts, w$ere 5racticable t$e c$a%3e will be ide%ti2ied wit$i% t$e docume%t or as a% attac$me%t. All a55ro4ed, curre%t docume%ts are a4ailable eit$er o% t$e Elastimold =%tra%et or as $ard co5ies wit$ t$e docume%t co%trol coordi%ator. A $istory o2 obsolete re4isio%s is a4ailable o% t$e Elastimold =%tra%et. :sers o2 co%trolled docume%ts are res5o%sible 2or 4eri2yi%3 t$at t$ey are usi%3 t$e curre%t docume%t a%d t$ey ca% 4eri2y t$e latest re4isio% a%dIor e22ecti4e date by usi%3 a termi%al to query t$e =%tra%et. -S/ 1001 discusses Elastimold8s docume%t co%trol requireme%ts. 0.2.0 @o%trol o2 Records #rocedures $a4e bee% establis$ed to 5ro4ide directio% 2or all 5erso%%el re3ardi%3 t$e requireme%ts 2or establis$i%3 a%d mai%tai%i%3 quality records. 6$e #rocess Gw%er or Area Ma%a3er is res5o%sible 2or assuri%3 t$at t$e records %ecessary to demo%strate co%2orma%ce to t$e requireme%ts a%d e22ecti4e o5eratio% o2 t$e quality system are
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establis$ed, 2iled a%d accessible. At a mi%imum, t$e 2ollowi%3 records are mai%tai%ed, corres5o%di%3 to s5eci2ic sectio%s o2 t$is ma%ual&
Elastimold reco3%i>es t$e im5orta%ce o2 com5lete a%d le3ible quality records, a%d mai%tai%s all records accordi%3ly. -S/ 1000 2urt$er discusses Elastimold8s 5rocess 2or co%trol o2 quality records
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1. 5."
.anagement Responsi i!it, Ma%a3eme%t @ommitme%t Elastimold ma%a3eme%t is committed to t$e de4elo5me%t a%d im5leme%tatio% o2 a quality system, a%d 2or 5ro4idi%3 t$e im5etus 2or its co%ti%ual im5ro4eme%t. ?e5artme%t ma%a3ers a%d su5er4isors are res5o%sible 2or ide%ti2yi%3, docume%ti%3 a%d im5leme%ti%3 all quality 5rocedures a%d wor. i%structio%s %ecessary to ide%ti2y, im5leme%t a%d 4eri2y e22ecti4e solutio%s, 5re4e%t %o%+co%2orma%ces a%d 5roblems wit$ quality records, a%d to co%trol %o%co%2ormi%3 materials u%til 5ro5er dis5ositio% $as bee% determi%ed. =% additio% to t$is, ma%a3eme%t demo%strates its commitme%t by a) @ommu%icati%3 wit$ em5loyees a%d e95lai%i%3 t$e %eed to co%ti%uously meet customer as well as statutory a%d re3ulatory requireme%ts b) Establis$i%3 a quality 5olicy rele4a%t to customer requireme%ts c) Establis$i%3 quality ob<ecti4es to dri4e im5ro4eme%t d) @o%ducti%3 a 5eriodic re4iew o2 t$e Cuality ;ystem, i% order to e%sure its co%ti%ui%3 suitability a%d e22ecti4e%ess relati4e to =;G 1((" a%d i%ter%al Elastimold quality sta%dards. e) Em5oweri%3 de5artme%t ma%a3ers a%d su5er4isors to request a%d de4elo5 t$e resources required to meet t$e quality system requireme%ts.
5.2
@ustomer Focus Elastimold8s 5rimary 2ocus is t$e customer, a%d customer satis2actio% is o%e o2 t$e .ey te%a%ts o2 our quality 5olicy. ?etermi%atio% o2 customer %eeds a%d requireme%ts related to 5roduct is 2urt$er addressed i% sectio% !.2.", a%d mo%itori%3 a%d measureme%t o2 customer satis2actio% is 2urt$er addressed i% sectio% .2." o2 t$is ma%ual .
5.*
Cuality #olicy Elastimold $as establis$ed a quality 5olicy as t$e 2ramewor. 2or 2ocusi%3 a%d establis$i%3 quality ob<ecti4es. 6$is 5olicy is 5eriodically re4iewed 2or its co%ti%ui%3 suitability. 6$e ma%a3eme%t team $as de4elo5ed, e%dorsed a%d su55orts t$e 2ollowi%3 Cuality #olicy& We will always meet our customers requirements and continuously improve. =t is reco3%i>ed t$at DalwaysE a%d Dco%ti%uouslyE are co%sta%t 3oals, requiri%3 a55ro5riate actio%s to mai%tai% a%d im5ro4e t$e system. 6$e 5olicy is co%siste%t wit$ t$e busi%ess ob<ecti4es o2 o5erati%3 a 3rowt$ orie%ted busi%ess 2ocused o% customer %eeds t$rou3$ em5owered em5loyees obtai%i%3 t$e %ecessary retur% 2or our i%4estors. 6$e 5olicy is commu%icated re3ularly to all em5loyees a%d is 5rese%ted to %ew em5loyees as a% eleme%t o2 t$eir orie%tatio%. Eac$ em5loyee, t$rou3$ i%di4idual a%d
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de5artme%t 5er2orma%ce measureme%ts, u%dersta%ds t$e role t$at eac$ $as i% satis2yi%3 t$is 5olicy. 5.0 #la%%i%3 5.0." Cuality Gb<ecti4es Elastimold ide%ti2ies Cuality Gb<ecti4es as 5art o2 t$e Ma%a3eme%t Re4iew 5rocess. Gb<ecti4es c$a%3e 2rom time to time to suit customer a%d busi%ess requireme%ts. Cuality Gb<ecti4es are docume%ted i% t$e Ma%a3eme%t Re4iew mi%utes. Wit$i% Elastimold, eac$ 2u%ctio%al ?e5artme%t may also establis$ de5artme%tal+s5eci2ic 5er2orma%ce ob<ecti4es t$at co%tribute to o%e or more o2 t$e 5rimary Cuality Gb<ecti4es. 6$ese measureme%ts are mai%tai%ed by de5artme%t. 5.0.2 Cuality Ma%a3eme%t ;ystem #la%%i%3
All system acti4ities are 5la%%ed i% order to allow a smoot$ 2low o2 i%2ormatio% a%d com5o%e%ts a%d e%sure t$at customer, statutory, a%d re3ulatory requireme%ts are bei%3 met. Elastimold 5roducts are ma%u2actured wit$ t$e aid o2 wor. i%structio%s. All e9isti%3 sta%dard 5roducts $a4e docume%ts co%trolli%3 t$e 5urc$ase, ma%u2acture, a%d i%s5ectio% o2 all materials, com5o%e%ts a%d 5roducts 5roduced by Elastimold. A%y c$a%3es to t$e quality system a%d quality 5la%s is re4iewed a%d a55ro4ed i% order to e%sure t$at t$e i%te3rity a%d e22ecti4e%ess o2 t$ese systems is %ot %e3ati4ely im5acted. 5.5 Res5o%sibility, Aut$ority a%d @ommu%icatio% 5.5." Res5o%sibility a%d Aut$ority =% order to sustai% t$e system, 4arious res5o%sibilities a%d aut$orities $a4e bee% de2i%ed, 5er t$e table below&
6$ese res5o%sibilities a%d aut$orities are commu%icated 4ia t$is quality ma%ual a%d 4ia <ob descri5tio%s mai%tai%ed by t$e $uma% resources de5artme%t. =% additio%, t$ese roles are e%2orced duri%3 sta22 a%d de5artme%tal meeti%3s. 5.5.2 Ma%a3eme%t Re5rese%tati4e
6o assist wit$ t$e e22ecti4e ma%a3eme%t o2 t$e quality system, Elastimold $as ide%ti2ied a Ma%a3eme%t Re5rese%tati4e 2or Cuality 'MRC) 2u%ctio%. 6$is 2u%ctio% is carried out by t$e Cuality Ma%a3ers at t$e two 5la%ts wit$ su55ort 2rom two #roduct E%3i%eers. =% additio% to t$e res5o%sibilities summari>ed i% t$e table abo4e, t$e res5o%sibilities o2 t$e MRC are to 5romote o4erall aware%ess o2 customer requireme%ts t$rou3$out t$e com5a%y by 5artici5ati%3 i% co%tract re4iews a%d desi3% re4iews, as a55ro5riate. =% additio%, t$e MRC re4iews customer com5lai%ts a%d wor.s wit$ t$e 4arious 2u%ctio%s
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wit$i% Elastimold to 3et t$e issues resol4ed. 6$e MRC 2u%ctio% also dissemi%ates customer satis2actio% i%2ormatio% to a55ro5riate 5erso%%el 2or t$eir aware%ess. 5.5.* =%ter%al @ommu%icatio% 6o5 ma%a3eme%t e%sures t$at commu%icatio% ta.es 5lace re3ardi%3 t$e e22ecti4e%ess o2 t$e Cuality ;ystem t$rou3$ 4arious met$ods. Amo%3 t$ese, are& #osti%3 o2 metrics o% bulleti% boards ?e5artme%tal meeti%3s to discuss o4erall 5er2orma%ce #eriodic emails or 5ayroll stu22ers to em5loyees #eriodic Dcom5a%y wideE meeti%3s to s$are t$e state o2 t$e busi%ess a%d customer tre%ds 5.6 Ma%a3eme%t Re4iew 5.6." Be%eral
6$e Ma%a3eme%t Re5rese%tati4e 2or Cuality 'MRC) s$all i%itiate a t$orou3$ re4iew o2 t$e Cuality ;ystem, as de2i%ed i% our 5rocedures a%d t$is ma%ual, to e%sure its co%ti%ui%3 suitability a%d e22ecti4e%ess relati4e to =;G 1((" a%d t$e i%ter%al Elastimold quality requireme%ts. 6$e re4iews also i%clude assessme%t o2
o55ortu%ities 2or im5ro4eme%t, a%d assessme%t o2 a%y c$a%3es t$at mi3$t be %eeded to t$e Cuality ;ystem i%cludi%3 t$e quality 5olicy a%dIor de2i%ed quality ob<ecti4es. 5.6.2 Re4iew =%5ut Ma%a3eme%t Re4iews i%clude i%2ormatio% o% t$e 2ollowi%3 at a mi%imum. Gt$er i%2ormatio% may be i%cluded as deemed a55ro5riate by t$e MRC or ot$er ma%a3eme%t& a) audit results, 2rom bot$ i%ter%al a%d e9ter%al audits, b) customer 2eedbac. 't$rou3$ #AR7Rs, customer audits, a%d i%5uts 2rom ;ales or Mar.eti%3), c) 5rocess 5er2orma%ce a%d 5roduct co%2orma%ce to requireme%ts, d) status o2 5re4e%ti4e a%d correcti4e actio%s, e) 2ollow+u5 actio%s 2rom 5re4ious Ma%a3eme%t Re4iews, 2) E9ter%al or =%ter%al c$a%3es to t$e com5a%y t$at could a22ect t$e Cuality ;ystem, 3) recomme%datio%s 2or im5ro4eme%t. 5.6.* Re4iew Gut5ut
Meeti%3 mi%utes are de4elo5ed a%d mai%tai%ed as a quality record o2 t$e ma%a3eme%t re4iew meeti%3s. 6$ese mi%utes ca5ture all decisio%s a%d actio%s related to& a) b) im5ro4eme%ts i% e22ecti4e%ess o2 t$e Cuality ;ystem a%d its 5rocesses, 5roduct im5ro4eme%ts related to customer 2eedbac. a%dIor customer requireme%ts, c) resource %eeds to mai%tai% or e%$a%ce t$e Cuality ;ystem. 2. Resource .anagement
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6."
#ro4isio% o2 Resources Elastimold $as ide%ti2ied a%d 5ro4ides resources suc$ as 5eo5le, i%2rastructure, wor. e%4iro%me%ts, i%2ormatio% %eeds, su55liers, 5art%ers, a%d 2u%di%3 %ecessary to im5leme%t a%d mai%tai% t$e Cuality Ma%a3eme%t ;ystem. All em5loyees are res5o%sible 2or requesti%3, t$rou3$ t$eir su5er4isors a%d ma%a3eme%t, t$e %ecessary resources, i%cludi%3 tooli%3, equi5me%t, su55lies, materials a%d trai%i%3, required to 5er2orm t$eir duties. 6$ese resources $el5 Elastimold to& a) im5leme%t a%d mai%tai% t$e Cuality ;ystem as de2i%ed i% t$is ma%ual, i%cludi%3 t$e quality 5olicy a%d quality ob<ecti4es, b) co%ti%ually im5ro4e its e22ecti4e%ess, c) e%$a%ce customer satis2actio% by meeti%3 or e9ceedi%3 customer requireme%ts.
6.2
-uma% Resources 6.2." Be%eral 6$e $uma% resources de5artme%t ma%a3es o4erall sta22i%3 2or Elastimold a%d e%sures t$at all %ew+$ires meet 5rescribed com5ete%cy le4els. #erso%%el w$o 5er2orm wor. t$at a22ects 5roduct quality are co%sidered com5ete%t to 5er2orm assi3%ed tas.s o% t$e basis o2 a55ro5riate educatio%, trai%i%3, s.ills, a%dIor e95erie%ce. Grie%tatio% is 5ro4ided 2or eac$ %ew em5loyee by t$e em5loyee8s su5er4isor. Elastimold8s -uma% Resources $as establis$ed a u%i2orm met$od 2or trac.i%3 all trai%i%3 acti4ities. 6$e 2ollowi%3 ide%ti2ies quality+related to5ics i%cluded i% orie%tatio% a%d t$e Fu%ctio% or 5erso% res5o%sible&
6.2.2 @om5ete%ce, Aware%ess a%d 6rai%i%3 Elastimold u%dersta%ds t$e role o2 em5loyee com5ete%ce, aware%ess, a%d trai%i%3 as .ey 2u%ctio%s towards im5ro4ed 5roduct quality. Accordi%3ly, t$e com5a%y em5$asi>es a%d 5ro4ides a% i%2rastructure to $el5 eac$ em5loyee to u%dersta%d t$eir assi3%me%t a%d to demo%strate t$eir ability to meet t$e requireme%ts related to quality. Elastimold e%sures t$at a) b) c) d) e) 6.* t$e com5ete%ce %eeded 2or 5erso%%el 5er2ormi%3 wor. a22ecti%3 5roduct quality is determi%ed a%d de2i%ed i% <ob descri5tio%s a%d tas.+s5eci2ic i%structio%s, w$e% %ecessary, w$ere trai%i%3 or ot$er actio% is %eeded to e%sure 5erso%%el are com5ete%t, t$at trai%i%3 %eed is satis2ied, t$e e22ecti4e%ess o2 t$e trai%i%3 5ro4ided or ot$er actio% ta.e% is e4aluated to e%sure com5ete%ce, as a55ro5riate, em5loyees are aware o2 t$e rele4a%ce a%d im5orta%ce o2 t$eir acti4ities, a%d $ow t$ey co%tribute to meeti%3 our quality ob<ecti4es, a55ro5riate records a%dIor docume%tatio% o2 5erso%%el educatio%, trai%i%3, s.ills, a%d rele4a%t e95erie%ce are mai%tai%ed.
=%2rastructure
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=%2rastructure %eeds $a4e bee% assessed 3i4i%3 co%sideratio% to buildi%3s, wor. s5aces, wor. statio%s, utilities, 5rocess equi5me%t 'i%cludi%3 $ardware a%d so2tware), a%d su55ort ser4ices suc$ as tra%s5ortatio%, commu%icatio%, a%d custodialI mai%te%a%ce ser4ices. ;uitable i%2rastructure is 5ro4ided a%d mai%tai%ed to e%sure Elastimold ca% 5roduce a%d deli4er 5roduct t$at co%2orms to requireme%ts. 6.0 Wor. E%4iro%me%t Elastimold acti4ely ma%a3es t$e wor. e%4iro%me%t so t$at t$e or3a%i>atio% ca% ac$ie4e co%2ormity to 5roduct requireme%ts. @o%sideratio% is 3i4e% to im5ro4i%3 t$is e%4iro%me%t by loo.i%3 at co%ditio%s suc$ as 5$ysical, social, 5syc$olo3ical a%d e%4iro%me%tal 2actors. Ma%a3eme%t also co%siders t$e 2ollowi%3 i% order to $a4e a 5ositi4e i%2lue%ce o% moti4atio% a%d satis2actio% o2 em5loyees& creati4e wor. met$ods a%d o55ortu%ities 2or i%4ol4i%3 em5loyees i% area set+u5s sa2ety rulesI3uida%ce, i%cludi%3 use o2 5rotecti4e equi5me%t er3o%omics wor.5lace locatio% 'wit$ res5ect to $eat, $umidity, li3$t, air2low, etc.) social i%teractio% a%d reco3%itio% 2or 3ood wor. adequate 2acilities 2or em5loyees
6o su55leme%t t$e abo4e, Elastimold is mo4i%3 towards a D5;E culture w$ic$ will 2urt$er e%$a%ce t$e wor. e%4iro%me%t. 3. !." /roduct Rea!ization #la%%i%3 o2 #roduct Reali>atio% Elastimold $as 5la%%ed a%d de4elo5ed CM; 5rocesses %eeded 2or 5roduct reali>atio%. #roduct reali>atio% 5la%%i%3 i%cludes determi%atio% o2& a) 5roduct requireme%ts a%d quality ob<ecti4es, b) t$e %eed to establis$ su55orti%3 5rocesses, docume%ts, a%d 5ro4ide resources s5eci2ic to t$e 5roduct, c) %ecessary 5roduct 4eri2icatio%, 4alidatio%, mo%itori%3, i%s5ectio% a%d test acti4ities, a%d t$e criteria 2or 5roduct acce5ta%ce, d) records suc$ as desi3% re4iew mi%utes, i%s5ectio% data, 5urc$asi%3 i%2ormatio%, quality 5la%s a%d ma%u2acturi%3 5rocess data as e4ide%ce t$at t$e reali>atio% 5rocesses a%d 2i%al 5roduct meet requireme%ts. Gt$er Cuality ;ystem requireme%ts 2or 5roduct desi3% a%d de4elo5me%t as related to 5roduct reali>atio% are described i% ;ectio% !.* o2 t$is ma%ual. !.2 @ustomer+related #rocesses !.2." ?etermi%atio% o2 Requireme%ts Related to t$e #roduct
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Elastimold determi%es 5roduct c$aracteristics a%d requireme%ts 2or deli4ery a%d 5ost+ deli4ery acti4ities. Additio%ally, t$e com5a%y $as ide%ti2ied ot$er requireme%ts %ecessary 2or t$e 5roductKs i%te%ded use e4e% i2 %ot stated by t$e customer. #roducts are ma%u2actured to co%2orm to i%dustry sta%dards, a%d 5roduct+rele4a%t statutory a%d re3ulatory requireme%ts. A%y additio%al requireme%ts ide%ti2ied by Elastimold are also i%cor5orated i%to t$e 5roduct as a55ro5riate. !.2.2 Re4iew o2 Requireme%ts Related to t$e #roduct Cuotatio% requests a%d %ew orders are re4iewed by 67B Mar.eti%3 i% Mem5$is, 6e%%essee, to co%2irm t$at t$e requested 5roduct is a% a55ro4ed, structured combi%atio%. @ombi%atio%s or co%2i3uratio%s %ot 5re4iously a55ro4ed are re4iewed by 67B Mar.eti%3 a%d Elastimold #roduct E%3i%eeri%3 to co%2irm t$at a 5roduct ca% be structured to meet t$e customer8s s5eci2icatio%. Records o2 t$ese re4iews a%d actio%s arisi%3 2rom re4iews are mai%tai%ed. 6$ese re4iews e%sure t$at& a) 5roduct requireme%ts are de2i%ed, b) co%tractIorder requireme%ts di22eri%3 2rom t$ose 5re4iously de2i%ed are resol4ed, c) Elastimold is able to meet t$e de2i%ed requireme%ts. #roduct built 2or customers wit$ s5ecial %eeds is ide%ti2ied wit$ t$e letters D@;E '@ustomer ;5ecial) built i%to t$e 5art %umber. W$ere t$e customer does %ot 5ro4ide docume%ted requireme%ts stateme%ts, Elastimold co%2irms t$e requireme%ts wit$ t$e customer 5rior to acce5ta%ce. Elastimold 5eriodically ma.es 5roduct c$a%3es. 6$e com5a%y e%sures t$at a22ected docume%ts are ame%ded to re2lect t$e c$a%3e, a%d t$at rele4a%t 5erso%%el are made aware o2 t$e c$a%3es. @ustomers are also ad4ised o2 5roduct c$a%3es t$rou3$ t$e 5roduct catalo3 5ublis$ed by Elastimold. !.2.* @ustomer @ommu%icatio% Elastimold $as determi%ed a%d im5leme%ted t$e %ecessary ste5s to e%sure e22ecti4e customer commu%icatio%. A%y questio%s re3ardi%3 5roduct s5eci2icatio% or co%tract terms are re4iewed a%d resol4ed wit$ t$e customer by 67B Mar.eti%3, Mem5$is, 6e%%essee, 5rior to acce5ti%3 t$e order. 6$e com5a%y8s 5rocesses e%able e22ecti4e commu%icatio% wit$ customers related to& a) 5roduct i%2ormatio% b) i%quiries, order $a%dli%3, co%tracts 7 ame%dme%ts, a%d c) customer 2eedbac., i%cludi%3 customer com5lai%ts 4ia t$e #AR7R system. 6$omas 7 Betts $as a% %etwor. o2 distributors a%d customer ser4ice re5rese%tati4es w$o re3ularly commu%icate wit$ t$e customer base. 6$ey 2orward rele4a%t i%2ormatio% to Elastimold 2or t$e 5la%t to ta.e a55ro5riate actio% i% res5o%se to customer %eeds. !.* ?esi3% a%d ?e4elo5me%t !.*." ?esi3% a%d ?e4elo5me%t #la%%i%3 Elasimold8s #roduct E%3i%eeri%3 3rou5 co%trols 5roduct desi3% a%d de4elo5me%t t$rou3$ t$e a55oi%tme%t o2 a 5ro<ect ma%a3er. 6$e 5ro<ect ma%a3er $as o4erall
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res5o%sibility 2or e%suri%3 t$at 5roduct desi3% a%d de4elo5me%t is e9ecuted i% accorda%ce wit$ docume%ted desi3% 7 de4elo5me%t 5la%s. 6$ese 5la%s i%clude& a) t$e determi%atio% o2 a55ro5riate sta3es o2 desi3% a%d de4elo5me%t, b) t$e re4iew, 4eri2icatio% a%d 4alidatio% a55ro5riate to eac$ sta3e, a%d c) t$e related a%d su55orti%3 res5o%sibilities a%d aut$orities 2or desi3% a%d de4elo5me%t. ?esi3% a%d de4elo5me%t 5la%%i%3 ca% i%4ol4e i%ter2aci%3 wit$ di22ere%t 2u%ctio%al areas to e%sure t$at all 2acets o2 t$e desi3% are adequately re4iewed. 6$e 5ro<ect ma%a3er coordi%ates t$is e22ort by clearly commu%icati%3 t$e 5ro<ect status a%d clear assi3%me%t o2 res5o%sibility to all team members.
!.*.2 ?esi3% a%d ?e4elo5me%t =%5uts ?esi3% i%5uts ca% be 5ro4ided by customers or Elastimold 5roduct e%3i%eers. ;uc$ i%5uts are tra%slated i%to s5eci2ic 5roduct requireme%ts by desi3% e%3i%eers. Records are mai%tai%ed 2or i%5uts relati%3 to 5roduct requireme%ts. 6$e 5roduct desi3% a%d de4elo5me%t i%5uts i%clude& a) b) c) d) 2u%ctio%al a%d 5er2orma%ce requireme%ts, a55licable statutory a%d re3ulatory requireme%ts, w$ere a55licable, i%2ormatio% deri4ed 2rom 5re4ious similar desi3%s, a%d ot$er requireme%ts esse%tial 2or desi3% a%d de4elo5me%t, i%cludi%3 t$e assi3%me%t o2 quali2ied sta22, a%d ot$er %ecessary resources.
As 5art o2 t$e desi3% re4iew 5rocess, t$e 5ro<ect ma%a3er e%sures t$at desi3% i%5uts a%d ot$er requireme%ts are %ot ambi3uous, a%d t$at t$ey do %ot co%2lict wit$ eac$ ot$er or wit$ 5re+establis$ed 5roduct requireme%ts. !.*.* ?esi3% a%d ?e4elo5me%t Gut5uts ?esi3% out5ut is 5ro5erly docume%ted a%d 4alidated a3ai%st desi3% i%5ut requireme%ts. Gut5ut records <usti2y t$e i%clusio% or e9clusio% o2 i%5ut requireme%ts i% t$e e4e%t t$at t$e out5ut di22ers 2rom i%5ut requireme%ts. ;5ecial atte%tio% is 5aid to critical 2u%ctio%s o2 t$e 5roduct i%cludi%3 sa2ety, o5erati%3 ra%3e, stora3eI $a%dli%3 or ot$er requireme%ts. Gut5uts are re4iewed a%d a55ro4ed 5rior to bei%3 released. 6$e desi3% a%d de4elo5me%t out5uts& a) b) c) d) meet t$e i%5ut requireme%ts, 5ro4ide a55ro5riate i%2ormatio% 2or 5urc$asi%3, 5roductio%, a%d ser4ice 5ro4isio%, co%tai% or re2er to t$e 5roduct acce5ta%ce criteria, s5eci2y 5roduct c$aracteristics t$at are esse%tial 2or its sa2e a%d 5ro5er use.
!.*.0 ?esi3% a%d ?e4elo5me%t Re4iew
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;ystematic desi3% a%d de4elo5me%t re4iews are co%ducted at suitable sta3es o2 t$e 5rocess as described i% t$e desi3% 5la% 'see !.*."). 6$ese re4iews will& a) e4aluate t$e ability o2 t$e results o2 t$at sta3e to meet requireme%ts, b) ide%ti2y a%y 5roblems a%d 5ro5ose %ecessary actio%s. 6$e desi3% sta3e re4iews i%clude 5artici5a%ts w$o re5rese%t t$e 2u%ctio%s co%cer%ed wit$ t$e sta3e's) bei%3 re4iewed. Records o2 t$e results o2 desi3% sta3e re4iews a%d a%y %ecessary actio%s are mai%tai%ed. !.*.5 ?esi3% a%d ?e4elo5me%t Heri2icatio% At a55ro5riate sta3es 'as de2i%ed i% t$e desi3% 5la% 'see !.*.")), desi3% 4eri2icatio% is 5er2ormed to e%sure t$at desi3% out5ut meets desi3% i%5ut requireme%ts. 6$e desi3% 4eri2icatio% is recorded. =% additio% to desi3% re4iew, 4eri2icatio% may be i%clude& #er2ormi%3 alter%ate calculatio%s @om5ari%3 desi3% to wit$ similar e9isti%3 models A55ro5riate tests a%dIor trials Re4iew o2 desi3% docume%ts, as %ecessary
!.*.6 ?esi3% a%d ?e4elo5me%t Halidatio% Be2ore 5roduct is released 2or 5roductio%, t$e desi3% is 4alidated. Halidatio% may i%4ol4e 2u%ctio%al testi%3 i% a lab setti%3, or at a customer site. #roduct 4alidatio% is 5er2ormed accordi%3 to 5roduct requireme%ts, a%d as s5eci2ied i% t$e desi3% 5la% 'see !.*.") to e%sure t$at t$e resulti%3 5roduct is ca5able o2 meeti%3 t$e requireme%ts 2or t$e s5eci2ied a55licatio% or i%te%ded use, w$ere .%ow%. W$ere 5ractical, 4alidatio% will be com5leted be2ore deli4ery or im5leme%tatio% o2 t$e 5roduct. Elastimold mai%tai%s records o2 t$e results o2 4alidatio%s a%d a%y resulti%3 actio%s. !.*.! @o%trol o2 ?esi3% a%d ?e4elo5me%t @$a%3es #roduct desi3% a%d de4elo5me%t c$a%3es are ide%ti2ied a%d records o2 t$e c$a%3es are mai%tai%ed. 6$e c$a%3es are re4iewed, 4eri2ied a%d 4alidated as a55ro5riate, a%d are a55ro4ed be2ore im5leme%tatio%. 6$e re4iew o2 t$e c$a%3es i%cludes e4aluatio% o2 t$e e22ect o2 t$e c$a%3es o% co%stitue%t 5arts a%d a%y 5roduct already deli4ered. All c$a%3es are trac.ed, a%d a $istory o2 c$a%3es is mai%tai%ed o% t$e 5roduct drawi%3. Records o2 t$e results o2 c$a%3e re4iews a%d a%y %ecessary actio%s are mai%tai%ed i% t$e 2orm o2 a% E%3i%eeri%3 @$a%3e Notice 'E@N). !.0 #urc$asi%3 !.0." #urc$asi%3 #rocess Elastimold uses o%ly t$ose su55liers w$o meet Elastimold8s requireme%ts i% t$e areas o2 ca5acity, quality, ser4ice, a%d 5rice. All %ew or 5ote%tial su55liers are e4aluated based o% t$eir ability to 5ro4ide t$e item's) bei%3 sourced by Elastimold, 2or bot$ sta%dard 'establis$ed, 5roduct+related com5o%e%ts a%d raw materials) a%d %o%+sta%dard 'MRG a%d ot$er related su55lies).
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Elastimold mai%tai%s records o2 all suc$ su55liers quali2ied to 5ro4ide 5roduct's), a%d acti4ely ma%a3es t$ese relatio%s$i5s to e%sure a timely su55ly o2 quality materials. 6$e ty5e a%d e9te%t o2 co%trols a55lied to our su55liers a%d to 5urc$ased 5roduct is de5e%de%t u5o% t$e e22ect a%d use o2 5urc$ased 5roduct i% t$e 2i%al 5roduct or i% subseque%t 5roduct reali>atio% 5rocesses. 6$e su55liersK 5er2orma%ce is mo%itored a%d 5eriodically assessed by t$e <oi%t e22orts o2 t$e #urc$asi%3 a%d Cuality de5artme%ts. 6$e Cuality ?e5artme%t retai%s i%comi%3 i%s5ectio% records co%cer%i%3 5art quality $istory, a%d t$e #urc$asi%3 ?e5artme%t mai%tai%s i%2ormatio% related to 5rici%3. ;u55lier 5er2orma%ce records a%d t$e results o2 e4aluatio%s are mai%tai%ed.
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!.0.2
#urc$asi%3 =%2ormatio%
6$e site #urc$asi%3 de5artme%ts issue 5urc$ase orders to su55liers. All 5urc$asi%3 docume%ts 'i.e., 5urc$ase orders, material requisitio%s, etc.) will i%clude t$e 2ollowi%3, w$ere a55licable& =%2ormatio% suc$ as 5urc$ase order %umber, 5art %umber, qua%tity ordered, aut$ori>i%3 si3%ature a%d deli4ery sc$edule. Re2ere%ce to drawi%3s or s5ecial i%s5ectio% i%structio%sIs5eci2icatio%s t$at de2i%e 5articulars o2 t$e order.
Were a55ro5riate Elastimold will co%sider a%d i%clude o% t$e 5urc$ase orders& a) requireme%ts 2or 5roduct a55ro4al, 5rocess a55ro4al, a%d equi5me%t a55ro4alA b) 5erso%%el quali2icatio%A c) a%y ot$er Cuality ;ystem requireme%ts suc$ as 5roduct 4eri2icatio%, @erti2icates o2 @om5lia%ce, etc. Elastimold re4iews t$e adequacy o2 s5eci2ied 5urc$ase requireme%ts 5rior to t$eir commu%icatio% to t$e su55lier. !.0.* Heri2icatio% o2 #urc$ased #roduct Elastimold 5er2orms a t$orou3$ D2irst articleE i%s5ectio% o2 all 5roducts w$e% 2irst 5urc$ased 2rom a %ew su55lier, to e%sure co%2orma%ce wit$ quality a%d 5er2orma%ce requireme%ts. ;ubseque%t s$i5me%ts o2 5roduct 3o t$rou3$ a recei4i%3 i%s5ectio%. 6$e e9te%t a%d 2reque%cy o2 t$is i%s5ectio% de5e%ds o% t$e e9te%t o2 5rocess co%trols at t$e su55liers8 site a%d su55liers8 5ast quality record. Recei4i%3 a%d recei4i%3 i%s5ectio% 4eri2y t$at t$e 5ro5er material $as bee% recei4ed a%d t$at it meets t$e requireme%ts re2ere%ced o% t$e 5urc$ase order. Material is released to 5roductio% or stores o%ly a2ter a success2ul i%s5ectio% is com5leted a%d recorded. No%co%2ormi%3 material is co%trolled i% accorda%ce wit$ establis$ed Elastimold 5rocedures. Elastimold customers do %ot request to i%s5ect material or com5o%e%ts at Elastimold su55lier8s sites. !.5 #roductio% a%d ;er4ice #ro4isio% !.5." @o%trol o2 #roductio% a%d ;er4ice #ro4isio% Elastimold 5la%s a%d 5er2orms its 5roductio% acti4ities i% a co%trolled ma%%er to e%sure t$e desired out5ut is ac$ie4ed. 6$is co%trol is i%stituted t$rou3$ t$e a) a4ailability o2 i%2ormatio% t$at describes 5roduct c$aracteristics. Wor.ma%s$i5 criteria is commu%icated by drawi%3s, wor. i%structio%s a%d quality s5eci2icatio%s. ;am5le boards a%d 5$oto3ra5$s are used w$e% a55ro5riate. @om5lia%ce wit$ t$e docume%ted 5roductio% requireme%ts 2or 5rocess a%d 5roduct is t$e res5o%sibility o2 t$e area ma%a3er a%d t$e 5la%t quality 5erso%%el. a4ailability o2 wor. i%structio%s as %ecessary, w$ic$ may i%clude some or all o2 t$e 2ollowi%3& Wor. ;eque%ces, G5eratio% Route ;$eets 'GR;), ;ta%dard G5erati%3 #rocedures ';G#), Wor. =%structio%s 'W=8s), drawi%3s, 5rocess 5ri%ts, /ob Aids, a%d quality s5eci2icatio%s.
b)
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c=
d) e)
use o2 suitable equi5me%t as desi3%ated by Ma%u2acturi%3 E%3i%eeri%3, w$o is res5o%sible 2or t$e desi3% a%dIor selectio% o2 5roductio% equi5me%t33 #roductio% equi5me%t is mai%tai%ed by t$e 5roductio% mai%te%a%ce 5erso%%el w$o are res5o%sible 2or 5re4e%ti4e a%d correcti4e mai%te%a%ce. a4ailability a%d use o2 mo%itori%3 a%d measuri%3 de4ices w$ic$ are calibrated or 4eri2ied as %ecessary at 5eriodic i%ter4als, a%d im5leme%tatio% o2 mo%itori%3 a%d measureme%t by o5erators a%d i%s5ectors. G5erators re5ort t$e s$o5 order %umber bei%3 5rocessed a%d t$e results 2or eac$ cycle or s$i2t o2 t$e 5rocess i%4ol4ed. ;tatistical #rocess @o%trol is bei%3 i%troduced. =%+5rocess i%s5ectors a%d 5rocess tec$%icia%s also 5er2orm i%de5e%de%t mo%itori%3 o2 ma%u2acturi%3 5rocesses.
Elastimold does %ot 5ro4ide a%y 5ost+deli4ery ser4ices or co%tracted ser4ici%3. !.5.2 Halidatio% o2 #rocesses 2or #roductio% a%d ;er4ice #ro4isio% W$ere resulti%3 5rocess out5ut ca%%ot be 4eri2ied by subseque%t measureme%t or test, t$e 5rocess is 4alidated. Elastimold8s 5roductio% i%cludes se4eral s5ecial, co%trolled 5rocesses, i% w$ic$ sam5les are destructi4ely tested to 5eriodically co%2irm t$e 5rocess 5er2orma%ce. 6$is 4alidatio% demo%strates t$e ability o2 t$e 5rocess to ac$ie4e t$e 5la%%ed results. Arra%3eme%ts establis$ed 2or t$ese 5rocesses i%clude& a) b) c) d) e) de2i%ed criteria 2or re4iew a%d a55ro4al o2 t$e 5rocess a55ro4al o2 equi5me%t a%d quali2icatio% o2 5erso%%el use o2 s5eci2ic met$ods a%d 5rocedures, records o2 t$e 5rocess 4alidatio%, a%d re4alidatio%.
!.5.* =de%ti2icatio% a%d 6raceability #roduct is ide%ti2ied by suitable mea%s t$rou3$out t$e 5roduct reali>atio% 5rocesses. :se o2 tra4el ta3s a%d s$i2t ide%ti2iers $el5 trac. 5roduct t$rou3$out ma%u2acturi%3. W$ere mo%itori%3 a%d measureme%t $as bee% e9ecuted, t$e corres5o%di%3 5roduct status is ide%ti2ied. Elastimold ide%ti2ies out 3oi%3 5roduct wit$ t$e date o2 ma%u2acture to 5ro4ide traceability. !.5.0 @ustomer #ro5erty
Elastimold does %ot recei4e or use a%y materials or 5roducts su55lied by customers. Neit$er does Elastimold retai% a%y customer8s Li%tellectual 5ro5ertyL i%cludi%3 customer+ ow%ed s5eci2icatio%s, drawi%3s a%d 5ro5rietary or co%2ide%tial i%2ormatio%. W$ere required, Elastimold will mai%tai% co%trol o2 suc$ 5ro5erty to e%sure co%2ide%tiality, a%d %oti2y t$e customer i% case o2 loss. !.5.5 #reser4atio% o2 #roduct W$ere4er 5roduct or material is $a%dled, eac$ i%di4idual e%sures t$at all required $a%dli%3 met$ods a%d 5recautio%s are obser4ed to 5re4e%t dama3e or deterioratio%. 6$e stora3e o2 raw materials, i%+5rocess a%d 2i%is$ed 3oodsA i%4e%tory co%trolA a%d disburseme%t are 5er2ormed i% accorda%ce to sta%dard 5ractices wit$i% t$e 2acility i% order to 5re4e%t dama3e. ;5ecial co%sideratio% is 3i4e% to t$e stora3e o2 $a>ardous materials.
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6$e cycli%3 o2 items wit$ s$el2 li2e restrictio%s is accom5lis$ed by orderi%3 small lots a%d mo%itori%3 e95iratio% dates o% t$e 5roduct. =% order to detect deterioratio%, stored 5roduct will 5eriodically be c$ec.ed. W$e% s5eci2ied, 5roduct is 5ac.a3ed i% accorda%ce wit$ customer requireme%ts. =% ot$er cases, 2i%is$ed 3oods 5ac.a3i%3 a%d labeli%3 will be 5er2ormed i% accorda%ce wit$ i%ter%al s5eci2icatio%s3 #rocesses are i% 5lace to e%sure t$e 5reser4atio% o2 5roduct co%2ormity duri%3 i%ter%al 5rocessi%3 a%d deli4ery to t$e i%te%ded desti%atio%. 6$e 5reser4atio% i%cludes ide%ti2icatio%, $a%dli%3, 5ac.a3i%3, stora3e a%d 5rotectio%. 6$e co%stitue%t 5arts o2 5roduct w$ere a55licable are also a22orded t$ese 5reser4atio% measures. !.6 @o%trol o2 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$e mo%itori%3 a%d measuri%3 de4ices %eeded to 5ro4ide e4ide%ce t$at 5roduct meets requireme%ts. E%3i%eeri%3 a%d Cuality are res5o%sible 2or t$e ide%ti2icatio% a%d calibratio% o2 all =%s5ectio%, measuri%3, mo%itori%3, a%d test equi5me%t w$ic$ is used to demo%strate co%2orma%ce to t$e Cuality ;ystem requireme%ts wit$i% t$e ?e4elo5me%t @e%ter a%d #la%ts res5ecti4ely. Elastimold e%sures t$at t$e mo%itori%3 a%d measuri%3 5rocesses are carried out i% a ma%%er co%siste%t wit$ docume%ted requireme%ts. =% additio%, w$ere %ecessary to e%sure 4alid results, measuri%3 equi5me%t is& a) calibrated or 4eri2ied at s5eci2ied i%ter4als, or 5rior to use, a3ai%st measureme%t sta%dards traceable to %atio%al measureme%t sta%dards. W$ere %o suc$ sta%dard e9ists, t$e basis used 2or calibratio% or 4eri2icatio% is recordedA b) ad<usted or read<usted as %eededA c) ide%ti2ied so t$at t$e calibratio% status ca% be determi%edA d) sa2e3uarded 2rom ad<ustme%ts t$at would i%4alidate t$e measureme%t resultA e) 5rotected 2rom dama3e a%d deterioratio% duri%3 $a%dli%3, mai%te%a%ce a%d stora3e. =2 mo%itori%3 a%d measuri%3 equi5me%t is 2ou%d to %ot co%2orm to requireme%ts, t$e res5o%sible aut$ority assesses a%d records t$e 4alidity o2 t$e 5re4iously obtai%ed measureme%t results. W$e% com5uter so2tware is used 2or mo%itori%3 a%d measuri%3 s5eci2ied requireme%ts, t$e ability o2 t$e so2tware to satis2y t$e i%te%ded a55licatio% is co%2irmed 5rior to i%itial use, a%d is reco%2irmed as %ecessary.
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0. ."
.easurement4 +na!,sis and Impro)ement Be%eral Elastimold $as 5la%%ed a%d im5leme%ted met$ods 2or mo%itori%3, measureme%t , a%alysis, a%d t$e im5ro4eme%t o2 5rocesses %eeded to& a) demo%strate 5roduct co%2orma%ce, b) e%sure co%2ormity o2 t$e Cuality ;ystem, a%d c) co%ti%ually im5ro4e t$e e22ecti4e%ess o2 t$e Cuality ;ystem. 6$ese met$ods i%clude statistical tec$%iques suc$ as 5areto a%alysis a%d tre%d a%alysis 5lus ot$er met$ods to trac. o%+3oi%3 5er2orma%ce.
.2
Mo%itori%3 a%d Measureme%t .2." @ustomer ;atis2actio% Elastimold mo%itors customer satis2actio% as o%e o2 t$e measureme%ts to i%dicate e22ecti4e 5er2orma%ce o2 t$e Cuality ;ystem. @ustomer ;atis2actio% is determi%ed t$rou3$ i%2ormatio% obtai%ed 2rom& @ustomer @om5lai%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 o2 com5etiti4e acti4ity @or5orate 2eedbac. a%d sur4eys.
6$ese i%5uts are s$ared wit$ ma%a3eme%t o2 t$e 2u%ctio%al areas a22ected by t$e customer commu%icatio%, a%d are addressed i% Ma%a3eme%t Re4iew meeti%3s to e%sure t$at Elastimold stays 2ocused o% t$e customers8 %eeds a%d e95ectatio%s. .2.2 =%ter%al Audit =%ter%al audits are reco3%i>ed as esse%tial to t$e co%2irmatio% o2 t$e e22ecti4e%ess o2 t$e Elastimold Cuality ;ystem, a%d ser4e as a source o2 ob<ecti4e e4ide%ce o2 co%2orma%ce. =%ter%al audits also $el5 wit$ t$e ide%ti2icatio% o2 %ecessary correcti4e actio%s a%d o55ortu%ities 2or 5roduct a%d system im5ro4eme%ts. =%ter%al quality audits are co%ducted o% t$e basis o2 t$e =;G 1((" requireme%ts a%d coordi%ated by t$e MRC's). Auditors are %ot allowed to audit t$eir ow% wor., a%d are assi3%ed to audit a 3i4e% area to e%sure ob<ecti4ity a%d im5artiality o2 t$e audit 5rocess. Audits are sc$eduled wit$ co%sideratio% to t$e status a%d im5orta%ce o2 t$e 5rocesses as well as results o2 5re4ious audits. 6$e ma%a3eme%t 5erso%%el res5o%sible 2or t$e area bei%3 audited are required to ta.e timely correcti4e actio% o% t$e de2icie%cies 2ou%d duri%3 t$e audit. Follow+u5 4eri2icatio% acti4ities are 5er2ormed to co%2irm t$e e22ecti4e%ess o2 correcti4e actio%s. Elastimold8s i%ter%al audit 5ro3ram is desi3%ed to e4aluate w$et$er t$e Cuality ;ystem co%2orms to
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t$e 5roduct reali>atio% requireme%ts '!."), t$e requireme%ts o2 t$e =;G ;ta%dard, a%d establis$ed Elastimold Cuality ;ystem requireme%ts.
Audit sc$edules a%d re5orts are 5roduced a%d mai%tai%ed by t$e MRC. ?etails o2 t$e i%ter%al audit 5ro3ram are 2urt$er described i% docume%ted 5rocedure -S/ 1003, as required by t$e =;G 1(("&2((( sta%dard. .2.* Mo%itori%3 a%d Measureme%t o2 #rocesses Elastimold em5loys met$ods 2or mo%itori%3 a%d, w$ere a55licable, measureme%t o2 Cuality ;ystem 5rocesses. 6$e 3oal i% em5loyi%3 t$ese met$ods is to e%sure t$at t$e 5rocesses ac$ie4e t$e 5la%%ed results or out5uts. 6$e met$ods used 2or mo%itori%3 a%d measuri%3 t$e e22ecti4e%ess o2 t$e Cuality ;ystem8s 5rocesses i%clude, but are %ot limited to& i%ter%al audits 2ormal ma%a3eme%t re4iew i%+5rocess sam5li%3 a%d i%s5ectio% c$arti%3 a%d re5orti%3 o% customer com5lai%ts re4iew o2 trai%i%3 e22ecti4e%ess .2.0 Mo%itori%3 a%d Measureme%t o2 #roduct Elastimold $as systems t$at mo%itor a%d measure 5roduct 2or co%2ormity at se4eral sta3es t$rou3$out t$e ma%u2acturi%3 5rocess. #roduct c$aracteristics are 4eri2ied as 2ollows& Recei4i%3 =%s5ectio% a%d 6esti%3& Recei4i%3 a%d recei4i%3 i%s5ectio% 4eri2y t$at t$e 5ro5er material $as bee% recei4ed a%d t$at it meets t$e requireme%ts re2ere%ced o% t$e 5urc$ase order. Material is released to 5roductio% or stores o%ly a2ter a success2ul i%s5ectio% is com5leted a%d recorded. No%co%2ormi%3 material is co%trolled i% accorda%ce wit$ establis$ed Elastimold 5rocedures. =%+5rocess =%s5ectio% a%d 6esti%3& G5erators are res5o%sible 2or i%s5ecti%3 eac$ 5art 5rocessed. Cuality 5erso%%el i%s5ect 5arts at start o2 a s$o5 order to co%2irm t$at 5ro5er materials are used a%d t$at t$e o5erator is correctly ide%ti2yi%3 acce5table u%its. Audits are 5er2ormed by Cuality 5erso%%el. Fi%al =%s5ectio% a%d 6esti%3& =% additio% to t$e o5erator i%s5ectio%s, molded com5o%e%ts are tested 2or dielectric i%te3rity as a55ro5riate. All a55aratus bus$i%3s are tested 2or seal i%te3rity. Fi%al #roduct a%d ;$i55i%3 audits are 5er2ormed ra%domly o% all 5roducts to co%2irm t$at t$e co%te%ts are correct a%d acce5table to t$e most dema%di%3 customer.
=%s5ectio% a%d test results are recorded o% t$e s$o5 2loor data system, as a55ro5riate. W$e% a55ro5riate, material or 5roducts 2aili%3 i%s5ectio% are re4iewed by t$e Material Re4iew Board 2or 2i%al dis5ositio%. E4ide%ce o2 co%2orma%ce to acce5ta%ce criteria is
Page 24 *e"ision +,
mai%tai%ed, a%d records i%dicate t$e 5erso%'s) w$o aut$ori>e release o2 5roduct to t$e %e9t 5rocess. .* @o%trol o2 No%co%2ormi%3 #roduct Elastimold $as im5leme%ted a docume%ted 5rocess to e%sure t$at 5roduct w$ic$ does %ot co%2orm to 5roduct requireme%ts is ide%ti2ied wit$ -old 6a3s, a%d co%trolled to 5re4e%t its u%i%te%ded use or deli4ery. #roducts w$ic$ ca%%ot meet t$e requireme%t are scra55ed. #roducts w$ic$ do %ot meet t$e s5eci2icatio%s may be submitted to t$e Material Re4iew Board 2or dis5ositio%. G5erators are required to re+i%s5ect a%y lot w$ic$ does %ot 5ass t$e audit. 6$e re+i%s5ected lot is audited by Cuality 5rior to release. -old ta3s may o%ly be remo4ed by t$e quality de5artme%t. =2 %ecessary, %o%co%2ormi%3 material is recalled 2rom customers i2 it is detected a2ter deli4ery. Elastimold $as docume%ted t$e 5rocess 2or co%trolli%3 %o%co%2ormi%3 5roduct i% -S/ 1010 as required by t$e =;G 1(("&2((( sta%dard. 6$e 5rocedure de2i%es met$ods 2or deali%3 wit$ %o%co%2ormi%3 5roduct, a%d also de2i%es t$e records mai%tai%ed o2 t$e %ature o2 %o%co%2ormities a%d a%y subseque%t actio%s ta.e%, i%cludi%3 co%cessio%s obtai%ed. .0 A%alysis o2 ?ata Elastimold collects a%d a%aly>es data to demo%strate t$e suitability a%d e22ecti4e%ess o2 t$e Cuality ;ystem, a%d to e4aluate w$ere im5ro4eme%t ca% be made. 6$is i%cludes data 2rom mo%itori%3 a%d measureme%t acti4ities, as well as data 2rom ot$er rele4a%t sources. 6$e data a%alysis 5er2ormed 5ro4ides i%2ormatio% 2or decisio% ma.i%3 related to& a) customer satis2actio% 'see .2."), b) co%2ormity to 5roduct requireme%ts 'see !."), c) c$aracteristics a%d tre%ds o2 5rocesses a%d 5roducts i%cludi%3 o55ortu%ities 2or 5re4e%ti4e actio%, a%d d) su55lier 5er2orma%ce. .5 =m5ro4eme%t .5." @o%ti%ual =m5ro4eme%t 6$e com5a%y stri4es to co%ti%ually im5ro4e o4erall e22ecti4e%ess o2 t$e quality system t$rou3$ t$e use o2 t$e quality 5olicy, quality ob<ecti4es, customer 2eedbac., audit results, data a%alysis, correcti4e a%d 5re4e%ti4e actio%s, a%d ma%a3eme%t re4iews. Bra5$s a%d c$arts s$owi%3 5ro3ress made towards im5ro4eme%t are ce%trally 5osted wit$i% t$e 2acilities.
Page 2; *e"ision +,
5!o6 Chart 0.1.2 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 this occurrence4 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 *iscrepant .ateria! 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<s correcti)e action s,stem co)ers re8uirements "or= a: re)ie6ing noncon"ormities4 inc!uding customer comp!aints> : 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/ 1012. 0.1.3 /re)enti)e +ction $!astimo!d recognizes the importance o" proper pre)enti)e action as a too! "or continuous impro)ement and to e!iminate the causes o" potentia! noncon"ormities. +ccording!,4 $!astimo!d has esta !ished a pre)enti)e action procedure 6hich addresses re8uirements "or= a: determining potentia! noncon"ormities and their causes> : e)a!uating the need "or action to pre)ent occurrence o" noncon"ormities> c: determining and imp!ementing action needed> d: records o" resu!ts o" action taken> and e: re)ie6ing pre)enti)e action taken. The pre)enti)e action process is de"ined in documented procedure -S/ 1013.
Page 2< *e"ision +,
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6ote: 10e numbers accom)anying t0e )rocess relate to t0e :(5-,'' -2''' Elements3
Page 2, *e"ision +,
Thomas & Betts Elastimold Products: Separable Connectors Inspection & Test Plan
Customer 6ame: Hydro-Quebec.ll Customers Part #escri)tion: (e)arable Connectors .))ro"ed -y: -ruce Clauser> Elastimold Hackettsto/n Marisol -rito > Elastimold .lbu7uer7ue ATTRIBUTES TO BE ACTIVITIES VERIFIED Q. 9ab :ns)ect subcontractor (u))lied )0ysical data/ Material certi!ication3 *ecei"ing Plastics& :ns)ect )er Elastimold Engineering Metals/Com)onents #ra/ing/()ec3 Plastic Molding Contact Pre)aration Conducti"e Molding #e!las0ing :nsulation Molding Veri!y critical dimensions and Visual Criteria Veri!y o)erations )er *oute (0eets and Engineering #ra/ings3 Veri!y critical dimensions .!ter insulation molding3 :ns)ect !or "isual de!ects3 Veri!y !las0 remo"al and :ns)ect !or "isual de!ects3 Critical inter!ace dimensions or cable entrance diameter as a))licable :ns)ect !or "isual de!ects3 Veri!y internal 7uality3 Corona& .C Hi-Pot& :m)ulse& or 1est Point Veri!y )er route s0eet and Eng3 #ra/ings3 :ns)ect !or "isual de!ects3 Veri!y correct Packaging @ Contents )er *oute (0eet3 Veri!y correct )art @ 9abeling )er 1icket3 Pre-aut0oriFations as a))licable3 Control of Nonconfor !n" #ro$%ct See Note below: 4etrolo"+7Cal!brat!on Ins#ect!on &'!s%al( )*ra+( or $! ens!onal, to #ro$%ct re-%!re ents t.ro%". all sta"es of #ro$%ct!on. Tools an$ E-%!# ent Elastimold *e7uirement: 1itle: Quality .ssurance Manager Quality .ssurance Manager FREQUENCY Eac0 s0i)ment (am)le )er *e7uirement
st Piece o!! tool and eac0 s0i)ment st Piece @ :n-)rocess :ns)ection by o)erator st Piece o!! tool setu) 5)erator :ns)ection
Customer *e7uirement: :(5 ,'' -2'''1o -e #etermined :(5 ,'' -2'''2 Q(P +'' #ate: .ugust + & 2''5
PROCEDURE 8ork :nstructions ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork :nstructions ?re!3 Master 9ist= Eng3 #ra/ing/()ec32 Control Plans 8ork :nstructions& Eng3 #ra/ings/()ec3 and Control Plans ?Part ()eci!ic= 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist=Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 Visual/B-ray ins)ection 8ork instruction ?re!3 Master 9ist= Eng3 ()ec3 .6(: +<4& 9eak test /0ere a))licable 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3
Cinal Electrical 1esting .ssembly -agging/ -oEing (0i))ing !rom Eit0er Cacility
5)erator :ns)ection eac0 load st Piece o!! tool setu) 5)erator :ns)ection Eac0 container ''D )er .6(: +<4 ''D leak test e)oEy st Piece at start o! o)eration3 5)erator :ns)ection st Piece at start o! 5)eration3 5)erator :ns)ection st Piece at start o! 5)eration3 5)erator :ns)ection eac0 s0i)ment3 Ins#ect!on t.ro%". all sta"es of #ro$%ct!on &QSP*/0/0, Per #roce$%re
See Note below: Pro$%ct !$ent!f!cat!on an$ Date co$e #ro$%ct an$ #ac2a"!n" traceab!l!t+ See Note below: Control of Q%al!t+ recor$s Patrol( f!rst #c !ns#ect!on( s.!# See Note below: t!c2ets( #re*a%t.or!=at!ons as a##l!cable Corm Q(P ''+- -
8ork instruction ?re!3 Master 9ist= 1or2 t!c2et *SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, En". Dra6!n"s7S#ec. 4ater!al Re'!e6 Boar$ &4RB, 1or2 t!c2et 9SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, &QSP*/008, En". Dra6!n"s7S#ec. /00: #er ANSI 3;< 1or2 !nstr%ct!on &ref. 4aster 5!st,( En". S#ec. an$ Dra6!n"s ANSI 3;<. Per eac. sta"e of #ro$%ct!on 1or2 t!c2et *SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, En". Dra6!n"s7S#ec.
Page +' *e"ision +,
Note: The following; Control of nonconforming product, Metrology/Calibration, Product identification and traceability, and control of Quality records may or do occur during all of the abo e phases of manufacturing!
Thomas & Betts Elastimold Products: Splices Inspection & Test Plan
Customer 6ame: Hydro-Quebec.ll Customers Part #escri)tion: ()lices .))ro"ed -y: -ruce Clauser > Elastimold Hackettsto/n Marisol -rito > Elastimold .lbu7uer7ue ATTRIBUTES TO BE ACTIVITIES VERIFIED Q. 9ab :ns)ect subcontractor (u))lied )0ysical data/ Material certi!ication3 *ecei"ing Plastics& :ns)ect )er Elastimold Eng3 Metals/Com)onents #ra/ing/()ec3 Contact Veri!y o)erations )er *oute (0eets Pre)aration and Engineering #ra/ings3 Conducti"e Molding #e!las0ing :nsulation Molding Veri!y critical dimensions .!ter insulation molding3 :ns)ect !or "isual de!ects3 Veri!y !las0 remo"al and :ns)ect !or "isual de!ects3 Critical inter!ace dimensions or cable entrance diameter as a))licable :ns)ect !or "isual de!ects3 Veri!y internal 7uality3 Corona& .C Hi-Pot& :m)ulse& or 1est Point Veri!y )er route s0eet and Eng3 #ra/ings3 :ns)ect !or "isual de!ects3 Veri!y correct Packaging @ Contents )er *oute (0eet3 Veri!y correct )art @ 9abeling )er 1icket3 Pre-aut0oriFations as a))licable
Customer *e7uirement: :(5 ,'' -2'''1o -e #etermimed Elastimold *e7uirement: :(5 ,'' -2'''2 Q(P +'' 1itle: #ate: Quality .ssurance Manager .ugust + & 2''5 Quality .ssurance Manager FREQUENCY Eac0 s0i)ment (am)le )er *e7uirement st Piece @ :n)rocess :ns)ection by o)erator st Piece @ :n)rocess :ns)ection by o)erator 5)erator :ns)ection eac0 load st Piece o!! tool setu) 5)erator :ns)ection eac0 container ''D )er :EEE %'% Piece at start o! 5)eration3 5)erator :ns)ection st Piece at start o! 5)eration3 5)erator :ns)ection st Piece at start o! 5)eration3 5)erator :ns)ection eac0 s0i)ment3 Ins#ect!on t.ro%". all sta"es of #ro$%ct!on &QSP*/0/0, Per #roce$%re &QSP*/008,
st
PROCEDURE 8ork :nstructions ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork :nstructions ?re!3 Master 9ist= Eng3 #ra/ing/()ec32 Control Plans 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist=Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Engineering #ra/ings/()ec3 Visual/B-ray ins)ection 8ork instruction ?re!3 Master 9ist= Eng3 ()ec3 :EEE %'% 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork instruction ?re!3 Master 9ist= 1or2 t!c2et *SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, En". Dra6!n"s7S#ec. 4ater!al Re'!e6 Boar$ &4RB, 1or2 t!c2et 9SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, En". Dra6!n"s7S#ec.
Cinal Electrical 1esting .ssembly
-agging/ -oEing (0i))ing !rom Eit0er Cacility
Control of Nonconfor !n" #ro$%ct See Note Below: 4etrolo"+7Cal!brat!on See Note Below:
Ins#ect!on &'!s%al( )*ra+( or $! ens!onal, to #ro$%ct re-%!re ents t.ro%". all sta"es of #ro$%ct!on. Tools an$ E-%!# ent
Pro$%ct !$ent!f!cat!on an$ Date co$e #ro$%ct an$ #ac2a"!n" traceab!l!t+ See Note Below: CControl of Q%al!t+ Patrol( f!rst #c !ns#ect!on( s.!# recor$s t!c2ets( #re*a%t.or!=at!ons as a##l!cable See Note Below: /00: #er IEEE 808 Per eac. sta"e of #ro$%ct!on
Page + *e"ision +,
1or2 !nstr%ct!on &ref. 4aster 5!st,( En". S#ec. an$ Dra6!n"s IEEE 808. 1or2 t!c2et *SOP3s 1or2 !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 Part #escri)tion: 1erminators .))ro"ed -y: -ruce Clauser > Elastimold Hackettsto/n Marisol -rito > Elastimold .lbu7uer7ue ATTRIBUTES TO BE ACTIVITIES VERIFIED Q. 9ab :ns)ect subcontractor (u))lied )0ysical data/Material certi!ication3 *ecei"ing Plastics& :ns)ect )er Elastimold Metals/Com)onents Eng3 #ra/ing/()ec3 Contact Veri!y o)erations )er *oute (0eets Pre)aration and Engineering #ra/ings3 Conducti"e Molding #e!las0ing :nsulation Molding Cinal Electrical 1esting .ssembly -agging/ -oEing (0i))ing !rom Eit0er Cacility Veri!y critical dimensions .!ter insulation molding3 :ns)ect !or "isual de!ects3 Veri!y !las0 remo"al and :ns)ect !or "isual de!ects3 Critical inter!ace dimensions or cable entrance diameter as a))licable :ns)ect !or "isual de!ects3 Veri!y internal 7uality3 Corona& .C Hi-Pot& :m)ulse& or 1est Point Veri!y )er route s0eet and Eng3 #ra/ings3 :ns)ect !or "isual de!ects3 Veri!y correct Packaging @ Contents )er *oute (0eet3 Veri!y correct )art @ 9abeling )er 1icket3 Pre-aut0oriFations as a))licable Control of Nonconfor !n" #ro$%ct See Note Below: 4etrolo"+ 7Cal!brat!on See Note Below:
Customer *e7uirement: :(5 ,'' -2'''1o -e #etermined Elastimold *e7uirement: :(5 ,'' -2'''2 Q(P +'' 1itle: #ate: Quality .ssurance Manager .ugust + & 2''5 Quality .ssurance Manager FREQUENCY Eac0 s0i)ment (am)le )er *e7uirement st Piece @ :n)rocess :ns)ection by o)erator st Piece o!! tool setu) 5)erator :ns)ection 5)erator :ns)ection eac0 load st Piece o!! tool setu) 5)erator :ns)ection eac0 container Per :EEE %< Piece at start o! o)eration3 5)erator :ns)ection st Piece at start o! 5)eration3 5)erator :ns)ection st Piece at start o! 5)eration3 5)erator :ns)ection eac0 s0i)ment3 Ins#ect!on t.ro%". all sta"es of #ro$%ct!on &QSP*/0/0, Per #roce$%re &QSP*/008,
st
PROCEDURE 8ork :nstructions ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork :nstructions ?re!3 Master 9ist= Eng3 #ra/ing/()ec32 Control Plans 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 Visual/B-ray ins)ection 8ork instruction ?re!3 Master 9ist= Engineering ()ec3 :EEE %< 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork ticket -(5PAs 8ork instruction ?re!3 Master 9ist= Eng3 #ra/ings/()ec3 8ork instruction ?re!3 Master 9ist= 1or2 t!c2et *SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, En". Dra6!n"s7S#ec. 4ater!al Re'!e6 Boar$ &4RB, 1or2 t!c2et 9SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, En". Dra6!n"s7S#ec.
Ins#ect!on &'!s%al( )*ra+( or $! ens!onal, to #ro$%ct re-%!re ents t.ro%". all sta"es of #ro$%ct!on. Tools an$ E-%!# ent
Pro$%ct !$ent!f!cat!on an$ Date co$e #ro$%ct an$ #ac2a"!n" traceab!l!t+ See Note Below: Control of Q%al!t+ recor$s Patrol( f!rst #c !ns#ect!on( s.!# t!c2ets( #re*a%t.or!=at!ons as See Note Below: a##l!cable Corm Q(P ''+- -
Page +2 *e"ision +,
/00: #er IEEE 8; 1or2 !nstr%ct!on &ref. 4aster 5!st,( En". S#ec. an$ Dra6!n"s IEEE 8;. Per eac. sta"e of #ro$%ct!on 1or2 t!c2et *SOP3s 1or2 !nstr%ct!on &ref. 4aster 5!st, En". Dra6!n"s7S#ec.
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Quality Plan For Elastimold Products

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Elastimold Quality Manual Quality Plan: 25kV Underground Connectors/Hydro-Quebec E!!ecti"e #ate: $anuary %& 2''%E!!

ecti"e (e)tember 2& 2''5

Thomas & Betts Corporation

Pre)ared and -y:.))ro"ed -y: .))ro"ed -y:

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

Marisol -rito Quality Manager-.lbu7uer7ue

(e)tember +& 2''5

"." -istory a%d #roducts

2.* 2.0 2.5 2.6

@:;6GMER; a%d /G=N6 VE61U*E(& 85*9#8:#E

#la%t ;tructure a%d Res5o%sibilities

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

Page < *e"ision +,

. Measureme%t, A%alysis a%d =m5ro4eme%t

Page ' *e"ision +,

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!.*.0 ?esi3% a%d ?e4elo5me%t Re4iew

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