QMS Nonconformity and Corrective Action Procedures

 

 

Ybsplnsdigb Lffdkb/Cdvdsdln  Lffdkb/Cdvdsdln  Sdtgb: HC[OP Sdtgb:  HC[OP _H[ Nlnklnflrhdty onc Klrrbktdvb Oktdln Prlkbcurb

Clkuhbnt Nl.: P0004.006 Vbrsdln Cotb:  Cotb:  90?4-0?-??

Poab: ? Poab:  ? lf ?0 Bffbktdvb Cotb: 90?4-0?-?2

Prljbkt Honoabr:  Honoabr:  HC[OP Sboh

Soigb lf Klntbnts ?. Purplsb/Plgdky Purplsb/Plgdky ............................................... ......................................................................... ................................................... .........................? 9. [klpb........................................ .................................................................. ................................................... .............................................. .....................9 ;. Cbfdndtdlns/Okrln Cbfdndtdlns/Okrlnyhs yhs ................................................... ............................................................................. ..................................... ........... 9 3. Outelrdtdbs/Ybsp Outelrdtdbs/Ybsplnsdidgd lnsdidgdtdbs tdbs .................................................. ............................................................................ ............................. ...9 2. Prlkbcurbs Prlkbcurbs ................................................ .......................................................................... .................................................... ............................. ... ; 2.? Dcbntdfydna Dcbntdfydna onc Ybplrtdna Nlnklnflrhdtdbs Nlnklnflrhdtdbs .................................. .................................................. ................; 2.9 Ydsm Ossbsshbnt Ossbsshbnt ........................................... ..................................................................... .............................................. ....................3 2.; Dnvbstdaotdln Dnvbstdaotdln lf Nlnkln Nlnklnflrhdtdbs flrhdtdbs................................................. .................................................................. .................2 2.3 Dhpgbhbntdna Dhpgbhbntdna Klrrbktdvb Klrrbktdvb Oktdlns ................................................ ................................................................. .................6 2.2 Sdhbfrohbs................................... ............................................................ ................................................... ...................................... ............5 2.6 Kglsblut ................................................... ............................................................................. ................................................... .........................5 2.1 Ybaugotlry Outelrdty Klunkdg (YOK) Ybvdbw lf Klrrbktdvb Oktdlns Curdna Honoabhbntt Ybvdbw Honoabhbn Ybvdbw ............................................... ......................................................................... .......................................... ................5 2.5 HC[OP _H[ Honoabhbnt Ybprbsbntotdvb Ybvdbw lf Klrrbktdvb Oktdlns . 4 6. Flrhs............................................. ...................................................................... .................................................. .......................................... .................4 1. Ybfbrbnkb Ybfbrbnkb Clkuhbnts Clkuhbnts ................................................. ........................................................................... ..................................... ........... 4 5. Clkuhbnt Clkuhbnt Edstlry ............................................... ........................................................................ ............................................ ...................?0   Opprlvogg [dan-Lff [ebbt  Opprlvo [ebbt 

?. Purplsb/Plgdky  Seb purplsb lf teds clkuhbnt ds tl cbskrdib prlkbcurbs flr teb Hbcdkog Cbvdkb [dnagb Oucdt Prlaroh (HC[OP) tl dcbntdfy, clkuhbnt, dhpgbhbnt, hlndtlr onc kglsb klrrbktdvb oktdlns.  O Klrrbktdvb Klrrbktdvb Oktdln Oktdln prlkbcurb prlkbcurb cbfdnbs cbfdnbs rbqudrbhbnts rbqudrbhbnts flr flr rbvdbwdna rbvdbwdna nlnklnflrhdtdbs= cbtbrhdndna teb kousb lf nlnklnflrhdtdbs= bvoguotdna teb nbbc flr oktdln tl bnsurb teot nlnklnflrhdtdbs cl nlt rbkur= cbtbrhdndna onc dhpgbhbntdna oktdln nbbcbc= upcotdna clkuhbntotdln= rbklrcdna teb rbsugts lf Rnklntrlggbc webn prdntbc: Flr teb hlst kurrbnt klpy, klntokt  klntokt HC[[email protected] HC[[email protected]  

 

HC[OP _H[ Nlnklnflrhdty onc Klrrbktdvb Oktdln Prlkbcurb

Clkuhbnt Nl.: HC[OP _H[ P0004.006

Poab 9 lf ??

teb dnvbstdaotdln onc lf teb oktdln tombn= rbvdbwdna teb klrrbktdvb oktdln tombn= onc vbrdfydna teb bffbktdvbnbss lf teb oktdln.

9. [klpb 

Seds prlkbcurb oppgdbs tl HC[OP wlrm prlcukts, prlkbssbs, sbrvdkbs, onc quogdty honoabhbnt systbh.

;. Cbfdndtdlns/Okrlnyhs  Kousb: On dcbntdfdbc rbosln flr teb prbsbnkb lf o cbfbkt lr prligbh. (O[__uogdty Aglssory) Klhpgodnt: Bxprbssdln lf cdssotdsfoktdln hocb tl on lraondzotdln rbgotbc tl dts prlcukt lr sbrvdkb lr teb klhpgodnts-eoncgdna prlkbss dtsbgf, webrb o rbsplnsb lr rbslgutdln ds bxpgdkdtgy bxpbktbc. (D[L 4000:90?2) - Klhpgodnts orb ogsl lijbktdlns, brrlrs, lr nlnklnflrhdtdbs nlnklnflrhdtd bs dnvlgvdna wlrm quogdty, lr fodgurbs tl prlvdcb sbrvdkb lr ltebr rbqubsts lf teb kustlhbr dnkgucdna tdhbgdnbss. Klrrbktdln: Oktdln tl bgdhdnotb o cbtbktbc nlnklnflrhdty. (D[L 4000:90?2) Klrrbktdvb Oktdln: Oktdln tl bgdhdnotb teb kousb lf o nlnklnflrhdty onc tl prbvbnt rbkurrbnkb. (D[L 4000:90?2) Nlnklnflrhdty (NK): Nln-fugfdgghbnt lf o rbqudrbhbnt. (D[L 4000:9002) N Klnkbrn Ybslgutdln Ybplrt Flrh: Flrh usbc tl clkuhbnt o nlnklnflrhdty, onc/lr klhpgodnt, fbbciokm, onc, webn oppgdkoigb, tl dndtdotb klrrbktdvb oktdln(s), onc tl clkuhbnt teb dnvbstdaotdln, dhpgbhbntotdln onc bffbktdvbnbss lf o KO. Seb flrh hoy rbfbr tl teb glkotdln lf rbklrcs osslkdotbc wdte teb NKY (b.a. Dnvbstdaotdln Ybplrt).

3. Outelrdtdbs/Ybsplnsdidgdtdbs  Ybaugotlry Outelrdty Klunkdg (YOK): Os nbkbssory, teb YOK rbvdbws klrrbktdvb oktdlns teot eovb ibbn irluaet tl tebdr ottbntdln iy teb HC[OP _H[ honoabhbnt rbprbsbntotdvb. Dt ds rbklhhbncbc teot teb YOK rbvdbws rbvdbws teb klrrbktdvb oktdlns cotoiosb curdna honoabhbnt rbvdbw hbbtdnas ot gbost lnkb o ybor. Ybaugotlry Outelrdty Klrrbktdvb Oktdln (YO/KO) Klntokt: Seb YO/KO Klntokt wdgg Rnklntrlggbc webn prdntbc: Flr teb hlst kurrbnt klpy, klntokt  klntokt HC[[email protected]  HC[[email protected] 

 

HC[OP _H[ Nlnklnflrhdty onc Klrrbktdvb Oktdln Prlkbcurb

Clkuhbnt Nl.: HC[OP _H[ P0004.006

Poab ; lf ??

rbvdbw teb nlnklnflrhdty tl cbtbrhdnb df teb dssub selugc ib ossdanbc flr klrrbktdvb oktdln tl teb KO Ossdanbb lr kglsbc wdte o klrrbktdln. Df o klrrbktdvb oktdln ds rbqudrbc, teb YO/KO Klntokt wdgg ossdan teb nlnklnflrhdty tl o KO  Ossdanbb  Ossdanb b wdtedn tebdr tebdr lraondzotdln lraondzotdln.. Boke Ybaugotlry Ybaugotlry Outelrdty Outelrdty hust hust cbsdanotb cbsdanotb on YO/KO Klntokt. Klrrbktdvb Oktdlns Ochdndstrotlr: Seb Klrrbktdvb Oktdlns Ochdndstrotlr wdgg bntbr nlnklnflrhdtdbs dntl teb cotoiosb onc pbrdlcdkoggy pbrflrh o quogdty rbvdbw lf teb klntbnts lf teb cotoiosb. Seb Klrrbktdvb Oktdlns Ochdndstrotlr ds ogsl rbsplnsdigb flr teb rlutdnb rlutdna onc honoabhbnt lf klrrbktdvb oktdlns. Seds rlgb kon ib fdggbc iy teb HC[OP _H[ Honoabhbnt Ybprbsbntotdvb, HC[OP _H[ [dtb Ybprbsbntotdvb, Ybprbsbntotdvb, lr ltebr cbsdanbb. Seb Klrrbktdvb Oktdlns  Ochdndstrotlr  Ochdndstro tlr wdgg ossdan on dcbntdfdbc nlnklnflrhdty nlnklnflrhdty tl teb teb Klrrbktdvb Klrrbktdvb Oktdln Oktdln Klntokt cbsdanotbc iy teb Ybaugotlry Outelrdty flr teb offbktbc kluntry/rbadln. Klrrbktdvb Oktdln Ossdanbb: Seb Ossdanbb ds rbsplnsdigb flr cbvbglpdna onc trokmdna klrrbktdlns onc klrrbktdvb oktdlns, onc tl rbplrt prlarbss tl teb Klrrbktdvb Oktdlns Ochdndstrotlr onc teb YO/KO Klntokt. Ony hbhibr lf teb HC[OP hoy sbrvb os o KO Ossdanbb. HC[OP _H[ Honoabhbnt Ybprbsbntotdvb: Elgcs pbrdlcdkoggy rbvdbws lf teb Cotoiosb onc klhhundkotb wdte YOK df ony cdskrbponkdbs orb bnkluntbrbc. Flgglws up wdte boke HC[OP _uogdty Honoabhbnt [ystbh [dtb Ybprbsbntotdvb os nbkbssory. Klrrbktdvb Oktdlns [ystbh [ystbh Honoabr: Seb YOK YOK Keodr ds ossdanbc teds rlgb. Seb Klrrbktdvb Oktdlns [ystbh Honoabr eos lvbrogg rbsplnsdidgdty flr teb KO systbh honoabhbnt.

2. Prlkbcurbs 

2.? Dcbntdfydna onc Ybplrtdna Nlnklnflrhdtdbs  

 Ony HC[OP HC[OP pbrslnnbg pbrslnnbg lr prlaroh prlaroh portdkdpont portdkdpont hoy dcbntdfy dcbntdfy nlnklnflrhdtdbs nlnklnflrhdtdbs os o rbsugt lf: (?) teb dnvbstdaotdln lf klhpgodnts (ilte dntbrnog onc bxtbrnog tl HC[OP): (9) prlkbss fodgurbs= (;) dntbrnog oucdts= (3) honoabhbnt rbvdbws= lr (2) ony ltebr slurkb. Seb dncdvdcuog rbplrtdna o nlnklnflrhdty selugc bgbktrlndkoggy clkuhbnt teb bvbnt usdna teb flrh HC[OP _H[ F00?;.? Klnkbrn Ybslgutdln Ybplrt Flrh onc flrworc teb flrh iy bhodg tl teb Klrrbktdvb Oktdlns  Ochdndstrotlr  Ochdndstro tlr flr ossdanhbnt ossdanhbnt.. Seb Klrrbktdvb Oktdlns Ochdndstrotlr wdgg usb teb glkotdln lf o klhpgodnt / nlnklnflrhdty tl cbtbrhdnb onc ossdan on opprlprdotb YO/KO Klntokt. Seb YO/KO Klntokt hoy kglsb o NK wdte o klrrbktdln onc rbfbr teb bvbnt iokm tl teb Rnklntrlggbc webn prdntbc: Flr teb hlst kurrbnt klpy, klntokt  klntokt HC[[email protected]  HC[[email protected] 

 

HC[OP _H[ Nlnklnflrhdty onc Klrrbktdvb Oktdln Prlkbcurb

Clkuhbnt Nl.: HC[OP _H[ P0004.006

Poab 3 lf ??

Klrrbktdvb Oktdlns Ochdndstrotlr. Flr bxohpgb, o euhon brrlr dn tronskrdidna dnflrhotdln flr nlnklnflrhdty dntl o cotoiosb, lr dntl o rbplrt, ds lftbn o lnb-tdhb lvbrsdaet nlt rbqudrdna Klrrbktdvb Oktdln. Seb YO/KO Klntokt hust clkuhbnt ln teb Klnkbrn Ybslgutdln Ybplrt Flrh on bvoguotdln lf teb NK onc webtebr lr nlt o Klrrbktdvb Oktdln ds rbqudrbc. Df o Klrrbktdvb Oktdln ds rbqudrbc, teb YO/KO Klntokt wdgg ossdan teb nlnklnflrhdty tl o Klrrbktdvb Oktdln Ossdanbb wdtedn eds/ebr lraondzotdln. Qebn nbkbssory, teb YO/KO Klntokt hoy klnsugt wdte teb Klrrbktdvb Oktdlns  Ochdndstrotlr  Ochdndstro tlr tl homb homb teds cbtbrhdnotd cbtbrhdnotdln. ln. Lnkb o cbkdsdln ds hocb, hocb, teb YO/KO Klntokt wdgg bhodg teb Klrrbktdvb Oktdlns Ochdndstrotlr clkuhbntdna teb rboslns flr rbqudrdna, lr nlt rbqudrdna, KO flr teb bvbnt. Df teb Klrrbktdvb Oktdlns  Ochdndstrotlr  Ochdndstro tlr okkbpts okkbpts teb prlplsog prlplsog flr Klrrbktdvb Klrrbktdvb Oktdln, Oktdln, teb YO/KO YO/KO Klntokt Klntokt hust bntry teb KO dn teb HC[OP _H[ F00?;.? Klnkbrn Ybslgutdln Ybplrt Flrh wdte o torabt klhpgbtdln cotb oglna wdte teb Klrrbktdvb Oktdln Ossdanbb wel wdgg ib rbsplnsdigb flr teb Klrrbktdvb Oktdln. Lnkb o Klrrbktdvb Oktdln Ossdanbb eos rbkbdvbc nltdfdkotdln lf on lpbn Klrrbktdvb Oktdln, teb ossdanbb ibklhbs teb lwnbr lf teb dssub. Seb ossdanbb hoy rbqubst ossdstonkb frlh ltebr HC[OP hbhibrs tl dcbntdfy, dhpgbhbnt, onc vbrdfy teb bffbktdvbnbss lf opprlprdotb klrrbktdvb oktdlns. Seb Klrrbktdvb Oktdlns ossdanbb selugc klhhundkotb tl teb Klrrbktdvb Oktdlns Klntokt onc  Ochdndstrotlr  Ochdndstro tlr ony cdffdkugtdbs cdffdkugtdbs bnkluntbrbc, bnkluntbrbc, lr occdtdlnog occdtdlnog rbslurkbs rbslurkbs rbqudrbc rbqudrbc tl prlarbss klrrbktdvb oktdlns tl klhpgbtdln. Lnkb ossdanbc o Klrrbktdvb Oktdln, teb Klrrbktdvb Oktdln Ossdanbb hust cbtbrhdnb onc clkuhbnt teb flgglwdna dnflrhotdln usdna HC[OP _H[ F00?;.? Klnkbrn Ybslgutdln Ybplrt (KYY) Flrh.

Nlnklnflrhdt Nlnklnfl rhdtyy cbs cbs krd pt ptdln: dln:   Seb Klrrbktdvb Oktdln Ossdanbb selugc rbklrc o cbskrdptdln lfbnoigbs teb NK wdte foktuogtlonc prbkdsb gonauoab teot kgborgylf stotbs teb rbqudrbhbnt, teb rbocbr klhprbebnc teb nln-fugfdgghbnt o rbqudrbhbnt, onc rbfbrbnkbs dnflrhotdln tl supplrt teb kgodh. Seb dnflrhotdln prbsbntbc selugc ib on okkurotb rbprbsbntotdln lf teb rbklrcs, sohpgbs onc prlkbcurbs rbvdbwbc, os wbgg os dntbrvdbws klncuktbc. Seb Klrrbktdvb Oktdln  Ossdanbb  Ossdanb b hoy klhidnb klhidnb hugtdpgb hugtdpgb dnstonkbs dnstonkbs lf teb nln-fugfdgghbnt nln-fugfdgghbnt lf o rbqudrbhbnt rbqudrbhbnt dntl o sdnagb nlnklnflrhdty ungbss teb dnstonkbs lrdadnotb lr rbgotb tl cdffbrbnt ospbkts lf o rbqudrbhbnt.

 2.9 Ydsm Ossbsshbnt Prdlr tl teb dnvbstdaotdln lf ony nlnklnflrhdty, teb Klrrbktdvb Oktdln Ossdanbb hust dcbntdfy teb eozorcs (pltbntdog slurkbs lf eorh) osslkdotbc wdte teb nlnklnflrhdty onc bstdhotb teb rdsm(s) osslkdotbc wdte telsb eozorcs. Sebsb rdsm ossbsshbnts hoy dncdkotb teb nlnklnflrhdty ds gdmbgy tl, lr eos kousbc, o Rnklntrlggbc webn prdntbc: Flr teb hlst kurrbnt klpy, klntokt  klntokt HC[[email protected]  HC[[email protected] 

 

HC[OP _H[ Nlnklnflrhdty onc Klrrbktdvb Oktdln Prlkbcurb

Clkuhbnt Nl.: HC[OP _H[ P0004.006

Poab 2 lf ??

systbhdk fodgurb wdtedn teb HC[OP quogdty honoabhbnt systbh lr ds gdmbgy tl kousb, lr eos kousbc, sdandfdkontgy dnokkurotb wlrm prlcukts wedke klugc, lr hoy eovb, gbc tl pllr cbkdsdlns lr ltebr ocvbrsb oktdlns. Seb Klrrbktdvb Oktdln  Ossdanbb  Ossdanb b selugc ogsl pbrflrh pbrflrh o rdsm ossbsshbnt ossbsshbnt ln teb teb prlplsbc prlplsbc klrrbktdvb klrrbktdvb oktdln tl bnsurb teot ony dntrlcukbc eozorcs orb lf on okkbptoigb rdsm.  Ony dnvbstdaotdl dnvbstdaotdln n onc suisbqubnt suisbqubnt klrrbktdvb klrrbktdvb oktdln selugc selugc ib ib klhhbnsurotb klhhbnsurotb wdte teb rdsm(s) plsbc iy teb nlnklnflrhdty. Ydsm Onogysds Sbkendqubs: Sbkendqubs flr teb ossbsshbnt lf rdsm dnkgucb= Fougt Srbb Onogysds (flr eozorc dcbntdfdkotdln) onc Fodgurb Hlcb onc Bffbkts Onogysds (flr teb bstdhotdln onc bvoguotdln lf rdsm), onc hony ltebrs. Ydsm honoabhbnt stoncorcs bxprbss rdsm usdna twl quontdtdbs: ?) teb hoandtucb lr sbvbrdty lf teb eorh teot hoy ordsb ibkousb lf teb nlnklnflrhdty onc 9) teb prlioidgdty lf lkkurrbnkb/rblkkurrbnkb lkkurrbnkb/rblkkurrb nkb lf teb eorh cub tl teb nlnklnflrhdty. Seb Klrrbktdvb  Oktdln Ossdanbb Ossdanbb ds ds tl clkuhbnt clkuhbnt teb ossbssbc rdsm frlh teb teb nlnklnflrhdty nlnklnflrhdty ln teb Klnkbrn Ybslgutdln Ybplrt Ybplrt Flrh. Seb ossbsshbnt hust dnklrplrotb teb twl quontdtdbs nltbc oilvb. Pgbosb rbfbr tl _H[ HC[OP P0003 Ydsm Honoabhbnt Prlkbcurb flr audconkb ln Ydsm Honoabhbnt. 2.; Dnvbstdaotdln lf Nlnklnflrhdtdbs  

Seb Klrrbktdvb Oktdln Ossdanbb hust dnvbstdaotb teb nlnklnflrhdty tl cbtbrhdnb teb kousb ibflrb on opprlprdotb Klrrbktdvb Oktdln ds cbvbglpbc. Seb dnvbstdaotdln selugc iudgc upln ony bxdstdna onogysds, bvoguotdln onc dnvbstdaotdln. [lhb lf teb hlrb klhhln tllgs onc tbkendqubs usbc dn kousb dnvbstdaotdln dnkgucb: 

  Seb 2 Qey—s Onogysds: Onogysds:    Seb alog lfteb tedsbffbkt onogysds ds tl ony trokb teb keodn kousogdty dn cdrbkt dnkrbhbnts frlhlf terluae goybrs lf lf oistroktdln tl o kousb teot stdgg eos slhb klnnbktdln tl teb lrdadnog prligbh. Flr bxohpgb, df teb prligbh ds teot Oucdtdna Lraondzotdlns orb suihdttdna dnklhpgbtb rbplrts tl teb HC[OP Sboh, teb Klrrbktdvb Oktdln  Ossdanbb wlugc osm: osm: ?) Qey