Regula’on, Cer’fica’on, and Industry Standards · Regula’ons And Cer’fica’on o...
Transcript of Regula’on, Cer’fica’on, and Industry Standards · Regula’ons And Cer’fica’on o...
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Regula'on,Cer'fica'on,andIndustryStandardsModule6AImpactonProductDesignandQuality
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Mo'va'on
Whydoregula'ons,cer'fica'ons,andindustrystandardsma<er?o Toselltocertainmarkets,manyproductsneedtomeetgovernmentregula@ons(environment,consumersafety,etc.)andindustryteststandards,orrequirespecificcer@fica@ons
o Thesetopicsareimportantforstartupstounderstandthebarriersimposedbyspecificindustries,whetheritisregula@ons,cer@fica@ons,orstandardrequirements
Whyisthismoduleimportant?
“Thereisnosuchthingasfreeregula8on.”–JohnHu>on
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Mo'va'on
o Overlookingimportantindustryrequirementsthatwillrequirechangesinyourproduct’sdesign,capabili@es,and/ormanufacturingprocess
o Assumingthatregula@ons,cer@fica@ons,andindustrystandardsarethesame
o Losingsightofindustrystandardsfordevelopmentthatcanderailyourcommercializa@onefforts
Commonmistakesandmisconcep8ons
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ModuleOutline
o Learningobjec@veso Determininglevelofregula@onbasedonindustryo Differencesbetweenregula@on,cer@fica@on,andindustrystandards
o Industryregula@onsandteststandardso Resourcesforregula@ons,cer@fica@on,andindustrystandardso Industrycasestudies
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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LearningObjec'ves
o LO1.Differencesbetweenregula@ons,cer@fica@on,andindustrystandards
o LO2.Theimpactofregula@ons,cer@fica@on,andindustrystandardsonyourbusinessplanandabilitytoscale-up
o LO3.Howtodefinetheregula@ons,cer@fica@ons,andindustrystandardsforyourbusinessandproducts
o LO4.Bestprac@cesformee@ngregula@ons,cer@fica@on,andindustrystandards
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'onsAndCer'fica'onsWheredoesthisfitintothedevelopmentcycle?
Conceptand
FeasibilityDefini'on Productand
ProcessDesignImplementandValidate
Produc'onandStock
LaunchandClosure
Pre-alpha Alpha Beta Pilot Ramp Scale
PHAS
ES
BUILDS
EngineeringValida8on
DesignValida8on
ProcessValida-on
ConceptValida8on
PRODUCTDESIGNOBJECTIVESMarketResearch
DesignResearchFeasibility
DevelopmentQualifica@on
FieldReadinessLaunch
ManufacturingCapacity
MANUFACTURINGREADINESSLEVELSLevels: 109987654321
MfgDevelopmentManufacturingResearch
MfgCapability
Produc'on
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(MRL)ManufacturingReadinessLevels
MaterialSolu'onsAnalysis TechnologyDevelopment EngineeringandManufacturingDevelopment
Produc'onandDeployment
Opera'onsandSupport
BasicmanufacturingImplica@onsiden@fied
ManufacturingConceptsiden@fied
ManufacturingProofofConceptdeveloped
Capabilitytoproducethe
technologyinalaboratoryenvironment
Capabilitytoproduceaprototypecomponents
inaproduc@on-relevant
environment
Capabilitytoproduceaprototypesystemor
subsysteminaproduc@on-relevant
environment
Capabilitytoproducesystems,
subsystemsorcomponentsinaproduc@on-
relevantenvironment
Pilotlinecapability
demonstrated.Readytobegin
Low-Rateproduc'on
LowRateProduc'on
demonstrated.Capabilityinplacetobegin
Full-RateProduc'on
Full-RateProduc'on
demonstratedandleanproduc'onprac'cesin
place
1 2 3 4 5 6 7 8 9 10
Thismodule’scontentisrelevantattheseMRLs
Pre-alpha Alphaprototypes Beta
prototypes Pilotprototypes
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HeavilyRegulatedIndustries
o Researchyourwell-establishedcompe@@ontoiden@fyrelevantstandards,regula@ons,andcer@fica@ons(leveragetheirknowledge,researchandinvestmentinlegalwork)
o Askyourcustomerstoiden@fyrelevantregula@onsandcer@fica@ons
o Becomefamiliarwithandjoincommi\eesandotherorganiza@onsthatleadthedevelopmentandpublica@onofindustrystandards,regula@ons,andcer@fica@on
Howtobeginyoursearch
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HeavilyRegulatedIndustries
o Energyo Transporta@ono Medical/Healthcareo Foodo DefenseAmarketismorelikelytobeheavilyregulatedif:o Consumersafety/protec@oniskeyo Li@ga@onpoten@alofproductfailuresishigho Corporateabuseofrulesandregula@onsisprevalento Governmentpoliciesfavorprotec@onofconsumersandprivateci@zensoverthatofmanufacturers
Examples
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KeyQues'ons
o Howaretheydifferent?o Howdotheyimpactmyabilitytosellintomarkets?o Dotheycreateariskoranopportunityformyproduct?o Howdotheyimpactmyabilitytoscale-upproduc@on?
Regula8on,cer8fica8on,andindustrystandards
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Regula'onsAndCer'fica'on
o Regula'on:Ingovernment,aregula@onisapieceofthedelegatedlegisla@ondracedbysubject-ma\erexpertstoenforceastatutoryinstrument.Insomecases,thelegisla@onisspecificallydesignedtoregulateindustries.Inprivateindustry,regula@onisdrivenbyself-regulatoryorganiza@onsandtradeassocia@onsthatallowindustriestosetruleswithlessgovernmentinvolvement.
o Cer'fica'on:Forproductcer@fica@on,thisreferstoprocessesintendedtodetermineifaproductmeetsminimumstandards,similartoqualityassurance.Eachcountryhasitsowncer@fica@onsystemsandorganiza@ons.
Basics
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IndustryStandards
o Industrystandard:Anindustrystandardmodelisasetofuniversalopera@onalprocessmethodsortoolsthatapplytomostcompanieswithinaspecificindustry.Itiden@fiesthecoredimensions,materials,andmethodologiesthosecompaniesmayuseandsupportsbusinessbestprac@ces.Thelanguageorstyleofthemodeliswidelyaccepted.Standardsareocenself-imposedbyindustryinana\empttoreducevariabilityandloweroverallcost.
Basics
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Regula'onsAndCer'fica'on
o Regula'on:U.S.regula@onrequiresautomakerstoincreasefueleconomyto54.5milespergallonforcarsandlight-dutytrucksbymodelyear2025
o Cer'fica'on:TheEPAisresponsibleforcalcula@ngtheaveragefueleconomyforeachmanufacturer— CorporateAverageFuelEconomy(CAFE)cer@fica@onisdoneoneoftwoways:• EitherthemanufacturerprovidesitsownfueleconomytestdataandauditedbyEPA,or• TheEPAobtainsaspecificmake-and-modelvehicleandtestsitinitsowntestfacility
Examples–Automo8veindustry
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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IndustryStandards
o Standards:CodeofFederalRegula'ons(CFR)Title40,Part1066—Vehicle-Tes@ngProceduresindustrystandardrequiredtes@ngproceduresformeasuringexhaust,evapora@ve,andrefuelingemissions
o SocietyofAutomo'veEngineers(SAE)interna@onalstandardincorporatesdrivingcyclesthatproducefuelconsump@ondatarela@ngtourban,suburban,andinterstatedrivingpa\erns
Examples–Automo8veindustry
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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DesignAndManufacturingDrivers
Todeterminewhichregula'onsandteststandardswilldriveyourproductdesignandmanufacturingprocesses:o Researchthe“drivers”behindtheregula@onsandteststandardso Understandgovernmentandindustryinfluenceonregula@onsandcer@fica@onstandards
o Iden@fykeyproduct-failurepointswithcompe@ngproductso Researchconsumerreportsandwarrantyclaimso Researchthetes@ngrequirementsoforganiza@onsthatdevelopandpublishindustrystandards
Regula8onsandstandards
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DesignAndManufacturingDrivers
o Determinewhattes@ngcanbedonein-houseversusexternally(i.e.,throughindependenttestlabs).Whentestsarerequiredbyanindependentthirdpartyinternally,confirmyourproductpasttestpriortosendingforthirdpartytes@ng.Thiswillsaveyou@meandmoney.
o Determinehowtes@ngandcer@[email protected]@onsofprototypesand/orseveralproductvaria@ons?
o Understandlead@mesneededfortes@ngandcer@fica@onandhowthisimpacts@me-to-marketforthelaunchofyourproduct
Regula8onsandstandards(cont.)
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U.S.Government:mul8-layeredinfrastructureIssues/risks:o Uncertaintyabout@mingo Dura@on(adminchange)o Nego@a@onofincumbentso Interac@ons/responsesof“layers”
Regula'onDrivers
Federal
State
Regional
Local
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Example1–Automo8veindustryRegula'onDrivers
Federal:CarbonDioxide(CO2),Emissions,Safety
State:CaliforniaAirResourcesBoard(CARB)
Regional:HighOccupancyVehicle
(HOV)
Local:Fees
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'ons
Federal:o CAFErequirementsdrivingvehiclesdesignforbe\erfueleconomy
o RenewableFuelStandard(RFS)pushingdevelopmentofbiofuelvehicles
o Electricvehiclepurchaseincen@vestoconsumersStates:o EVincen@vesdriveregionaldemand(e.g.,$6,000inColorado)o CaliforniaandNewYorkstateclean-truckvoucherso Moresubtle:Gaspricesandtaxes;road,bridge,andhighwayinfrastructurespending;parkingfees,tollandHOVwaivedforcleanvehicles;speciallanedesigna@onforcleanvehicles
Example1– Automo8veindustry(cont.)
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'ons
Regional:o SouthCoastAirQualityManagementDistrictoff-roaddieselNOxclean-upfundsinregionalarea
Local:o DriveCleanChicagoelectric-truckvoucherprogramo Europeancity“conges@on”chargestoreducetrafficconges@onandemission(e.g.,Londonnotallowingvehiclesotherthanmasstransitinthecity)
Example1– Automo8veindustry(cont.)
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Regula'onsExample1– Automo8veindustry(cont.)
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Example2–EnergyindustryRegula'onDrivers
Federal:EnvironmentalProtec'onAgency(EPA)
State:RenewablePorfolioStandards
Regional:HighOccupancyVehicle
(HOV)Local:Permits
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'ons
Federal:o CleanPowerPlanestablishingcarbonpollu@onemissionguidelinesforexis@ngsta@onarysources
o Investment/Produc@onTaxCredits(ITC/PTC)forrenewable-energygenera@onprojects
States:o Renewableporroliostandards(RPS)–Requiresstateu@li@estoincludespecificpercentagesofrenewablepowergenera@on
o Energyefficiencystandardsforu@li@eso Netmeteringlawsestablishinglimitsonusersofrenewablestosellbackpowertothegrid
o Rebatesandincen@vesforconsumerstoadoptrenewableenergyorenergyefficientproductsandefficiencymeasures
Example2–Energyindustry(cont.)
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'ons
Regional:o Grid-interconnec@vityrules,fees,andpermitso County-levelenergy-genera@onzoningandsi@nglawsLocal:o Power-genera@onsi@nglaws,fees,andpermitso Transporta@onrou@ngandroad-buildingrequirements
Example2– Energyindustry(cont.)
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Resources
o EnvironmentalProtec@onAgency(EPA): h\ps://www.epa.gov/laws-regula@ons
o EnvironmentalProtec@onAgency(EPA): h\ps://www.epa.gov/laws-regula@ons
o FederalEnergyRegulatoryCommission(FERC): h\ps://www.ferc.gov/
o DepartmentofTransporta@on(DOT): h\ps://[email protected]/regula@ons
o FederalMotorCarrierSafetyAdministra@on(FMCSA):h\ps://www.fmcsa.dot.gov/regula@ons
o ConsumerProductSafetyCommission(CPSC):h\ps://www.cpsc.gov/
o Occupa@onalSafetyandHealthAdministra@on(OSHA):h\ps://www.osha.gov
Governmentregula8ons
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Resources
Hazardousmaterials:o Employeehandling:OSHAh\ps://www.osha.govo Disposal:EPAh\ps://www.epa.gov/hw,Restric@onofHazardousSubstances(RoHS)h\p://[email protected]/RoHS.aspx
o Transporta@on:DOTh\ps://www.phmsa.dot.gov/hazmat/outreach-training/training-modules
Consumerproducts:o ConformitéEuropéenne(CE)h\ps://en.wikipedia.org/wiki/CE_marking,NSFh\p://www.nsf.org/services/by-industry/consumer-products/,CPSCh\ps://www.cpsc.gov/Business--Manufacturing/Tes@ng-Cer@fica@on/
Cer8fica8on
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Resources
Productandprocessquality:(cont.)o QSh\p://cer@[email protected]/cer@fica@ons/glossary/quality-cer@fica@ons/automo@ve-industry/qs-9000/ISO9000h\ps://www.iso.org/iso-9001-quality-management.html
Environmental:o ISO14000h\ps://www.iso.org/iso-14001-environmental-management.html
EnergyEfficiency:o EnergyStarh\ps://www.energystar.gov/
Cer8fica8on(cont.)
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Resources
RadioFrequency:o FederalCommunica@onsCommission(FCC)h\ps://www.fcc.gov/general/radio-frequency-safety-0
ElectricalProducts:o ULh\p://www.ul.com/code-authori@es/electrical-code/
Cer8fica8on(cont.)
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Resources
Automo've:o SAEh\p://standards.sae.org/automo@ve/
o AIAGh\p://www.aiag.org/o USCARh\p://www.uscar.org/guest/index.phpEnergy:o NAESBh\ps://www.naesb.org/o Oilandgash\p://oilandgasstandards.org/o Windpowerh\p://www.awea.org/standards-development
o Solarpowerh\p://www.seia.org/policy/health-safety/codes-standards
Industrystandards
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'on-DrivenOpportunity
Acompanythattookadvantageofregula8onsasanopportunitytointroducetheirnewproductFederal:o CAFErequirementsallowingentryfornewvehiclesOEM’s
o FederalEVrebatesforconsumersmakeEV’smoreaffordable
o FederalsubsidiesforEVcharginginfrastructurereduceconsumerEVrangeanxiety
Casestudy1–Start-upelectricvehiclecompany
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
31
Regula'on-DrivenOpportunity
State:o CaliforniaZeroEmissionVehicle(ZEV)regula@onrequiringlargevolumeandintermediatevolumecarmanufacturerstobringtoandoperateintheStateacertainpercentofvehicleswithnear-zerotailpipeemissionsandEVcompaniesareabletomone@zeandselltheirextraZEVcreditstootherautoOEM’swhodon’tmeetrequirements.
o Subsidiesforresiden@alsolarinstalla@onsandnetmeteringallowCaliforniahomeownerstochargetheirEVforfreeandsellbackexcesspowerfromEVtogrid
o Somestate’sputupblocksnotallowingEVcompaniestoselltoconsumersdirect(i.e.,stateofMichiganvs.Tesla)
Casestudy1– Start-upelectricvehiclecompany(cont.)
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
32
Regula'on-DrivenOpportunityCasestudy1– Start-upelectricvehiclecompany(cont.)Regional:o SouthCoastAirQualityManagementDistrict(SCAQMD),theairpollu@oncontrolagencyforallofOrangeCountyandtheurbanpor@onsofLosAngeles,RiversideandSanBernardinocoun@es,ins@tutescarrotands@ckpoliciesthatprovidebusinessesandfleetswithincen@vesforinves@nginEV’s
o Coun@esmakeinvestmentsinregionalEVCharginginfrastructuretoreduceEVrangeanxietyforconsumers
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'on-DrivenOpportunity
Local:o LosAngelessustainablecityplanpromisethat50%ofnewcityfleetvehiclespurchasedeachyearwouldbeEVby2017
o Ci@esprovidefreeparkingandfreeEVchargingforEVowners
o City“conges@on”chargesareadoptedtoreducetrafficconges@onandemissionprovidingincen@veforurbanfleetownerstoswitchtoEV’s(i.e.,taxi’s)
Casestudy1– Start-upelectricvehiclecompany(cont.)
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
Naturalgasfrackingequalshugemarketpoten'al:o 2014:TensofthousandsofnewwellstobedrilledinNorthAmerica
o Hundredsofthousandsofexis@ngwellsarehydro-frackingcandidates
JonahGasFieldofWyomingEnCanaGasWellswithFrackingFrackingWellSite
34
Regula'on-DrivenOpportunityCasestudy2–Naturalgasfrackingcompany
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
35
Regula'on-DrivenOpportunity
o Opportuni@esthatcouldbenefitfromacompactLPG-fueledfuelcellpairedwithasolararraycanprovide24/7/365power
Casestudy2– Naturalgasfrackingcompany(cont.)
CorrosionProtec'onContainmentPondMonitoring
SupervisoryControlAndDataAcquisi'on(SCADA)
+
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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Regula'on-DrivenOpportunity
SiteRegula'onsatanaturalgaswellhead:o Class1.Zone1/Division1.HazardousLoca@on— Gas,vapor,ormistwillbepresentorexpectedtobepresentforlongperiodsof@meundernormalopera@[email protected],thiscanbedefinedas10-1,000hours/yearor0.1–10percentofthe@me
Casestudy2– Naturalgasfrackingcompany(cont.)
Installloca-on
NextEnergyandUniversityofMichiganCenterforEntrepreneurshipI-CorpsEnergy&Transporta@onh\ps://nextenergy.org/icorps/
+
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
Requirements:o WellHeadSites— HazardousLoca@on,Class1,Zone1
o ProductCer@fica@on— CSAAmericaFC3-2004PortableFuelCellPowerSys
— CSAAmericaFC1-2014FuelCellPowerSys
o ProductIntegra@on— IEEE,NFPA,ASME,ANSI
o QualitySystem— ISO9001
37
Regula'on-DrivenOpportunityCasestudy2– Naturalgasfrackingcompany(cont.)
Regula'onDrivenMarkets:o SCADAo Corrosiono Pondmonitoring
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ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org
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References
o SAEInterna@onal:FuelEconomy–Automo@veStandardsh\p://topics.sae.org/fuel-economy/standards/automo@ve/
o EPA:VehicleCer@fica@onandComplianceTes@ngh\ps://www.epa.gov/vehicle-and-fuel-emissions-tes@ng/vehicle-cer@fica@on-and-compliance-tes@ng
o SAEInterna@onal:FuelEconomyMeasurementRoadTestProcedureh\p://standards.sae.org/j1082_200802/
o NextEnergyandUniversityofMichiganCenterforEntrepreneurshipI-CorpsEnergyandTransporta@onh\ps://nextenergy.org/icorps/
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Glossary
Module 6A-C
Field Readiness is critical process during product development when a company determines
their product’s readiness for release. This process takes place after learning market’s problems,
building a solution and preliminary testing is successfully completed and release is anticipated.
(Repeat from 2B)
Launch is the stage of development when all testing is so the company can vet the reception of
the product before a full go-to-market investment is made. Market entry/commercialization is
the stage in which the product is introduced to the target market. (Repeat from 5A)
Manufacturing Capability process is a unique combination of tools, materials, methods, and
people engaged in producing a measurable output; for example a manufacturing line for
machine parts. All processes have inherent statistical variability which can be evaluated by
statistical methods. (Repeat from 2B)
Production is the processes and methods used to transform tangible inputs (raw materials,
semi-finished goods, subassemblies) and intangible inputs (ideas, information, knowledge) into
goods or services.
Regulation is an abstract concept of management of complex systems according to a set of
rules and trends.
Certification refers to the confirmation of certain characteristics of an object, person, or
organization. This confirmation is often, but not always, provided by some form of external
review, education, assessment, or audit.
Industry Standard is the generally accepted requirements followed by the members of an
industry.
Corporate Average Fuel Economy (CAFE) are regulations in the United States, first enacted by
the United States Congress in 1975, after the 1973-74 Arab Oil Embargo, to improve the
average fuel economy of cars and light trucks (trucks, vans and sport utility vehicles) produced
for sale in the United States.
Code of Federal Regulations (CFR) is the codification of the general and permanent rules and
regulations (sometimes called administrative law) published in the Federal Register by the
executive departments and agencies of the federal government of the United States.
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Society of Automotive Engineers (SAE) is a US-based, globally active professional association
and standards developing organization for engineering professionals in various industries.
Renewable Fuel Standard (RFS) is an American federal program that requires transportation
fuel sold in the United States to contain a minimum volume of renewable fuels.
SAE International initially established as the Society of Automotive Engineers, is a US-based,
globally active professional association and standards developing organization for engineering
professionals in various industries.
EPA is an agency of the federal government of the United States which was created for the
purpose of protecting human health and the environment by writing and enforcing regulations
based on laws passed by Congress.