SI900000S004-Rev-7 Toxicity 測試標準收集

STANDINGINSTRUCTION

S.I.NO.

900000

SECT.

004

PART

PAGE

PAGE

2

of11

REV

6

TITLE:

GEConsumer&IndustrialToxicityProcedure

CAD-2018(8-95)

GEConsumer&Industrial

__________________________________________________________________________________________________

STANDINGINSTRUCTION

S.I.NO.

900000

SECT.

004

PART

PAGE

1of11

REV

67

TITLE:

GEConsumer&IndustrialToxicityProcedure

GE2006-0960

LATESTRECORD:QuickSearchGENumber>>

Thelatestrevision*ofthisdocumentisavailableonthewebintheelectronicProductDataManagement(ePDM)system.UsetheQuickSearchfeatureontheHOMEpagetoenternumbershowninboxabove.

*NotethatanePDM“version”numbermaybedifferentfromadocument’s“rev”number.

APPROVALS:

EdMcInerney

ChiefEngineer

10.20.0426-Jan-05

L.L.Bishop

Sr.Counsel

10.20.0427--Jan-05

NAME/TITLE:

DATE

NAME/TITLE:

DATE

NAME/TITLE:

DATE

NAME/TITLE:

DATE

NAME/TITLE:

DATE

NAME/TITLE:

DATE

REVISIONS

0

70034AB

J.Mialback

3

12908IU

Srikantamurthy

6

CR2006-1614

B.Osborn

7-22-96

V.Jacoby

7-24-03

M.Finch

12-30-04

T.Hooker

1

70034AY

J.Mialback

4

7

CR2006-2772

3-20-00

V.Jacoby

5-11-04

T.Hooker

31-Jan-2005

J.Dakin

2

70049

J.Mialback

5

CR2005-8443

B.Osborn

8

5-30-01

V.Jacoby

10-20-04

T.Hooker

I.POLICY

ItisGEConsumer&Industrialpolicynottousematerialsthatcouldposeatoxichazardtoconsumers.

II.PURPOSE

Thepurposeofthisprocedureistoformalizeaninstructiontopreventtheproductionofproductsthatcouldpresentatoxichazardtoconsumersandthepublic.Thisdocumentalsoestablishesaproceduretoverifycomplianceandmaintainappropriaterecords.

Inadditiontothisprocedure,GEConsumer&IndustrialhasalsodevelopedaseparateproceduretoensurecompliancewiththeEuropeanUnion’sRestrictionofHazardousSubstancesDirective(RoHS),citation2002/95/EC.ThisprocedureisdocumentedasSI900000Sec.13,“RestrictionofHazardousSubstancesProcedure”.BothSI90000Sec.4andSec13arerequirementsforallmaterialsusedinGEproducts.

III.REQUIREMENTS

A.IdentificationofPossibleToxicityConcern

AllGEConsumer&Industrialproducts,includingparts,kits,packagingoraccessoriessoldworldwidemustbereviewedtodeterminewhetheranyPossibleToxicityConcernsexist.Aconcernmayexistifinhalationof,dermalcontactwith,oringestionof,anytoxicsubstanceispossiblethroughnormalorreasonablyanticipatedinstallation,useanddisposalofthefinishedproductbyaconsumerorchildren.

TodetermineifachangepresentsaPossibleToxicityConcern,theinitiatorofthechangemustidentifytheuseofanynewordifferentmaterials.Thisincludesanyadditivesthatarecompoundedtoformthefinalpartmaterialandanysubstanceusedinthemanufacturingprocess.AMaterialSafetyDataSheet(MSDS),whichlistsspecificchemicalcomponentsregulatedbyOSHAanddescribestoxicpropertiesofthematerial,mayprovidesomeinformation.However,additionalinformationwilllikelybeneededsinceMSDS’sonlyidentifythepresenceofmaterialsaboveaspecificconcentrationthresholdandallMOC’sarenotrequiredtobeidentifiedbyOSHA.

Ataminimum,GEConsumer&IndustrialconsidersthataPossibleToxicityConcernmaybepresentifanyofthesubstancesontheMaterialsofConcern(MOC)list(SeeAppendixA)areincludedinaproduct,partormaterial.Inaddition,aPossibleToxicityConcernmaybepresentforanyproduct,partormaterialwhichisdirectlyorindirectlyexposedtofood,ice,orwater.Thisincludessuchapplicationsaswatervalvesandtubing,icetraysanddispensers,ovenliners,dishwashertubsandracks,refrigeratorliners,shelvesandbins,aswellasmoldings,gasketsandwireinsulationexposedtothefreshandfrozenfoodareas.Partsexposedtowaternotintendedforconsumptionorindirectfoodcontactarereviewedthesameaspartsthatdonotcontactwater.Thisincludessuchapplicationsaswasherbasketsandrefrigerationdrainpans.

ToxicConcernsmaybeduetodirectimpactontheconsumer,aswellasindirectandoutsideofnormalproductuse.Theseconcernsmaybeassociatedwithproductshipping,consumerhandlingduringinstallationordisposal,unintendedeventssuchasbreakageandfires,orlandfillingatendoflife.UnintentionaluseofMOC’sshouldbeeliminatedentirely.MOC’smayappearinunexpectedplaces–leadinbrassorsteel,asbestosfillersinsealantsorplastics,andflame-retardants,colorantsoradditivesinplastics.Insomecases,afterthoroughreview,someintentionalusesofMOC’smaybeappropriate.WheneverMOC’sareintentionallypresentproductlinespecificproceduresshouldbefollowed.Forexample,mercuryandradioactiveisotopesaredeliberatelyincludedinsomelampdesigns,wheretheirpresencetriggersmandatorylabelingrequirements.Someflame-retardantsinthermoplasticsmaycontainantimonyorbarium,andthatusemaybeallowedifnoalternativesexistandtherisktotheconsumerhasbeendeterminedtobeconsistentwithlawandcompanypolicy.Cadmiumoxideiscontainedinsomeelectricalcontactstoensurethesafetyoftheconnectors.IfaMOCispresent,itisimportanttounderstanditsroleorfunctioninthematerialtodetermineifitsuseisacceptable.

B.HazardEvaluation

TheEngineerdevelopingormakingachangetoanypartisresponsibleforunderstandingthepart’sapplicationandobtainingfromthesupplier’sauthorizedrepresentativeawrittendisclosureofthematerialcontentsothatheorshemaydeterminewhetheruseoftheparticularmaterialpresentsahazard.

1.TheengineerresponsibleforthepartorchangeshallobtainfromthesupplieralloftheinformationspecifiedontheMaterialInformationRequest(MIR).(SeesamplesinAppendixB,C&D).NotethatadifferentMIRissenttosuppliersofrawmaterialsandparts,thanissenttosuppliersoffinishedgoods.

2.Theengineerresponsibleforthechangemustmakeoneofthefollowingfourfindings:

(Code1) ThechangeisnotsubjecttothisSIbecausethereisnochangeinmaterial,process,ormanufacturingsite;or

(Code2) ThechangeiscompliantwiththisSIbecausethechangedoesnotincludeanymaterialontheMOClistandthematerialisnotexposedtofood,iceorwater;or

(Code3) ThechangecomplieswiththisSIbecauseeventhoughamaterialontheMOClistisincludedorthematerialisexposedtofood,iceorwater;itdoesnotpresentapotentialtoxichazard,(SeepartIII.A.foradditionaldiscussiononwatercontact)or

(Code4) ThechangedoesnotcomplywiththisSIbecauseatoxichazardmaybepresent.

Theengineer’sdecisionmustbedocumentedandexplainedintheTreviewprocess.CompliancewiththisprocedureshallbeanecessarypreconditiontoFirstPieceapproval.Code(3)or(4)mustbereviewedandapprovedperSI900000Sect4,partIV.D.AnyquestionsregardinginterpretationandapplicationoflegalstandardsshallbeaddressedtotheSeniorCounsel,ProductSafety.

C.NotationofPossibleToxicityConcern

TheEngineermakingthechangeshalladdthefollowingnoteonthepartdrawing:“PartmustconformtoSI900000section4ToxicityProcedure.”(“Lighting”or“Appliances”or“ElectricalDevice”maybesubstitutedinthenoteasappropriate)Theengineerisresponsibleforcommunicatinginformationontoxicityrequirementsandpartapplicationtothesupplierasearlyinthedesignprocessaspossible.

IV.ROLESANDRESPONSIBILITIES

A.SystemsManagerorTechnicalLeader

ThesystemsmanagerortechnicalleaderisresponsibleforinclusionofproductlinespecificrequirementsassociatedwiththisSIintheproducttechnicalspecification.Requirementsmayincludelabelingormaterialselectionintoxicitysensitiveapplications.

AB.Engineer

TheengineerinitiatingthechangeisresponsibleforensuringthatanychangeisaccomplishedincompliancewiththisPolicy.

TheengineershouldpreparetheappropriateMaterialInformationRequest(MIR)andforwardittothebuyerfordeliverytothesupplier.

Theengineerdeterminesifapartwillbeclassifiedascode1orcode2andobtainstheconcurrenceoftheSafetyProgramManager(SPM),GlobalSafetyLeader(GSL),ProductLineSafetyLeader(PLSL),orSeniorConsultingEngineer(SCE).

For“C-Changes”,evaluatedasCode2,copiesofthesupplier’sletterandsupportingdocumentation(ifapplicable),shouldbestoredineBCR/eBPCR/ePDM.

ForCode3parts,theengineermustcompletethe“RequestingEngineerApplicationInformation”,AppendixE.Theapplication,supplier’sletter,andallsupportingmaterialsshouldbeforwardedtoTechnicalServicesforreview.Usethee-EngineeringWorkRequest(eEWR)systemonTechnettorequestthisservice.Whencompletingtherequestform,“GlobalAppTech”shouldbeusedforthedisciplinefieldand“Toxicity”fortheplannerfield.

For“C-Changes”evaluatedasCode3,theTechnicalServicescertificationlettershouldbestoredineBCR/eBPCR/ePDM.DonotattachthelettertotheeFPIR.DisseminationoutsideGErequirestheoriginator’spermission.

Ifamaterialorprocessresultsinacode4ruling,theengineermustspecifyanewmaterialorchangetheprocessorboth.

BC.PurchasingBuyer

ThepurchasingorganizationBuyerisresponsibleforforwardingthemostrecentversionoftheGEConsumer&IndustrialToxicityProceduretosupplierssotheywillbeabletoidentifyanymaterialspresentingaPossibleToxicityConcern.Whenasupplierwillnotsubmitorconform,thebuyershouldintervenetoobtainconformanceoridentifyanalternatesupplier.

CD.Supplier

TheSuppliermustrespondfullytotheMIR,andprovidesuchotherinformationasrequested.TheSupplierisresponsibleforallmaterialsandchemicalsthatwillbereceivedbyGEConsumer&Industrialandincludedintheirproducts.Thisincludesmaterialspassedonfromsub-tiersuppliers.

ThesupplierisresponsibletonotifyGEofanychangetothesuppliedmaterial.

DE.TechnicalServices

TechnicalServicesshallobtainareviewofallpotentialcode3orcode4findingsbyaqualifiedindividualandadvisetheresponsibleEngineerofthetoxicrisk,ifany,ofallmaterials,parts,andfinishessubmittedforreview.AreportontheconclusionswillbecompletedandrecordsretainedpertheGEConsumer&Industrial’slegaldepartmentfileretentionschedule

EF.SeniorCounsel,ProductSafety

TheSeniorCounsel,ProductSafetyshallrespondtoanyquestionsontheinterpretationandapplicationoflegalstandardstoanymaterialidentifiedasaPossibleToxicityConcern.

FG.ProductLineSafetyCouncil

TheProductLineSafetyCouncilwillreviewanytoxicityorhazardissuesthatcannotberesolvedthroughthenormalprocessofcommunicationbetweentheSystemsManagerorTechnicalLeader,Engineer,LegalCounsel,andtheProductSafetyProgramManager.

H.ReviewPersonnel

TheSafetyProgramManager(SPM),GlobalSafetyLeader(GSL),ProductLineSafetyLeader(PLSL)orSeniorConsultingEngineer(SCE)isresponsibletoreviewtheEngineers’workinassigningtheappropriatecodelevel.TheSCEisresponsiblefordocumentingthetoxicitystatusontheappropriateNPIchecklists,seeSI900001S001.TherolesoftheSPM,GSL,andPLSLaredefinedinSI900000S002,SafetyReviewProcess.

HI.ChiefEngineer

TheChiefEngineerisresponsibleforinterpretationandoversightofthisPolicy.

V.ProcessFlowChart

APPENDIXA:

MaterialofConcernList(MOC)

Antimony

Arsenic

Barium(watersoluble)

Cadmium

Hexavalentchromium

Lead

Mercury

Selenium

Asbestos

Fiberglass(exceptglassreinforcedplastics)

Flameretardants

Polybrominatedbiphenyls(PBB)

Polybrominateddiphenylethers(PBDE)

Anti-fungaladditives

Pigments

Colorants

Refrigerants

Foamblowingagents

Residualmonomercontentinpolymers

Radioactiveisotopes

APPENDIXB: MaterialInformationRequest–(MIR)–RawMaterialsandParts

Date

SupplierName

SupplierAddress

GEConsumer&IndustrialToxicityComplianceProcedure

Dear:

InordertoconformtoGEConsumer&Industrial’sToxicityCompliancePolicy,itisrequiredthateachsupplierfullydiscloseanytoxicmaterialsasdefinedinStandingInstruction900000,Section4,“ToxicityProcedure”(copyenclosed).Ifnoneofthematerialsdefinedinthepolicyareusedinthecomponentsyouaresupplying,orinanyprocessesusedtomakethosecomponents,youstillmustsocertifyinanofficiallettertoGEConsumer&Industrial.PleasereadtheentireInstruction.

Pleasemakesuretoincludeallofthefollowinginformationinyourletter.

Lettertobedraftedoncompanyletterhead(itmaybesentasahardcopyletterorelectronicallyviae-mail)

GEConsumer&IndustrialPartnumber(s)

Partname(s)

GEConsumer&Industrialusingsite(s)

IfaMOCispresent,listspecificmaterial(manufacturer,grade),oriftherearenoMOC'spresent,thenstate“NoMaterialsofConcern”.

IfaMOCispresent,provideMSDSsheetoranequivalentmaterialcertificationandquantifythepercentage.

Thispartcontactsfood,iceorwater,provideaMSDSsheetoranequivalentmaterialcertificationofallmaterials.

(NOTETOENGINEER,DELETEABOVELINEIFNOTAPPLICABLE)

Indicateifyouaremakinganychangestothematerial,addingcolor,anyotheradditives,oranyprocessingchanges,includingchangeinmanufacturingsitethatcouldaffectthematerialinanyway.

IndicatetherevisionofSI900000S004youusedtodetermineifanMOCispresent.

Sendthelettertomyattention,withacopytoyourGEConsumer&Industrialbuyer.

Lettershallbesignedbyanauthorizedrepresentativeofthecompany.

Ifthereareanyquestions,pleasefeelfreetocontactmeimmediately.

Sincerely,

Requestor

Requestor’sTitle

Phone:

Fax:

E-Mail:

Enclosure:GEConsumer&IndustrialStandingInstructionNo.900000Sect4

APPENDIXC: MaterialInformationRequest–(MIR)–SourcedProducts

Date

SupplierName

SupplierAddress

GEConsumer&IndustrialToxicityComplianceProcedure

Dear:

InordertoconformtoGEConsumer&Industrial’sToxicityCompliancePolicy,itisrequiredthatoursupplierscertifythattheproductstheyselltoGEConsumer&IndustrialareincompliancewithGEConsumer&Industrial’sStandingInstruction900000Sect.4“ToxicityProcedure”(copyenclosed).PleasereadtheentireInstruction.

Pleasemakesuretoincludeallofthefollowinginformationinyourletter.

Lettertobedraftedoncompanyletterhead(itmaybesentasahardcopyletterorelectronicallyviae-mail)

GEConsumer&IndustrialModelNumbers(s)

Indicateifyouaremakinganychangestothematerial,addingcolor,anyotheradditives,oranyprocessingchanges,includingchangeinmanufacturingsitethatcouldaffectthematerialinanyway.

Lettershouldclearlystateoneofthefollowingcases:

(NOTETOENGINEER,DELETEREFERENCETOFOOD,ICEORWATERIFNOTAPPLICABLE).

AlistofallMOC’sandmaterialsexposedtofood,iceorwater.ProvideMSDSsheetoranequivalentmaterialcertificationforthesematerials.

Astatementthatthisnewmodel(s)hasnoadditionalMOC’sormaterialsexposedtofood,iceorwaterthanexistingGEConsumer&IndustrialModelnumber___________.Substantiallydifferentamounts,concentrations,ortheaccessibilityofMOC’sshouldbeevaluatedasachange,seebelow.

Astatementthatthisnewmodel(s)hasnoadditionalMOC’sormaterialsexposedtofood,iceorwaterthanexistingGEConsumer&IndustrialModelnumber___________,exceptasnoted.ProvideMSDSsheetoranequivalentmaterialcertificationforthesematerials.

IndicatetherevisionofSI900000S004youusedtodetermineifanMOCispresent.

Sendthelettertomyattention,withacopytoyourGEConsumer&Industrialbuyer.

Lettershallbesignedbyanauthorizedrepresentativeofthecompany.

Ifthereareanyquestions,pleasefeelfreetocontactmeimmediately.

Sincerely,

Requestor

Requestor’sTitle

Phone:

Fax:

E-Mail:

Enclosure:GEConsumer&IndustrialStandingInstructionNo.900000Sect.4

APPENDIXD: MaterialInformationRequest–(MIR)–ChangetoSourcedProducts

Date

SupplierName

SupplierAddress

GEConsumer&IndustrialToxicityComplianceProcedure

Dear:

InordertoconformtoGEConsumer&Industrial’sToxicityCompliancePolicy,itisrequiredthatoursupplierscertifythattheproductstheyselltoGEConsumer&IndustrialareincompliancewithGEConsumer&IndustrialStandingInstruction900000Sect.4“ToxicityProcedure”(copyenclosed).PleasereadtheentireInstruction.

Pleasemakesuretoincludetheallofthefollowinginformationinyourletter.

Lettertobedraftedoncompanyletterhead(itmaybesentasahardcopyletterorelectronicallyviae-mail)

GEConsumer&IndustrialModelNumbers(s)impactedbytheproposedchange.

Componentsormaterialsbeingchanged.

IfanMOCispresent,listthespecificmaterial(manufacturer,grade),oriftherearenoMOC'spresent,thenstate“NoMaterialsofConcern”

IfanMOCispresent,provideaMSDSsheetoranequivalentmaterialcertification.

Thispartcontactsfood,iceorwater,provideaMSDSsheetoranequivalentmaterialcertificationofallmaterials.

(NOTETOENGINEER,DELETEABOVELINEIFNOTAPPLICABLE)

Indicateifyouaremakinganychangestothematerial,addingcolor,anyotheradditives,oranyprocessingchanges,includingchangeinmanufacturingsitethatcouldaffectthematerialinanyway.

IndicatetherevisionofSI900000S004youusedtodetermineifanMOCispresent.

Sendthelettertomyattention,withacopytoyourGEConsumer&Industrialbuyer.

Lettershallbesignedbyanau