Regula’on, Cer’ﬁca’on, and Industry Standards · Regula’ons And Cer’ﬁca’on o...

ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org www.build4scale.org

Regula'on,Cer'fica'on,andIndustryStandardsModule6AImpactonProductDesignandQuality

ImpactonProductDesignandQualityU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org

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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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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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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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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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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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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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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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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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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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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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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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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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Regula'on-DrivenOpportunity

Acompanythattookadvantageofregula8onsasanopportunitytointroducetheirnewproductFederal:o CAFErequirementsallowingentryfornewvehiclesOEM’s

o FederalEVrebatesforconsumersmakeEV’smoreaffordable

o FederalsubsidiesforEVcharginginfrastructurereduceconsumerEVrangeanxiety

Casestudy1–Start-upelectricvehiclecompany


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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.)


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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Local:o LosAngelessustainablecityplanpromisethat50%ofnewcityfleetvehiclespurchasedeachyearwouldbeEVby2017

o Ci@esprovidefreeparkingandfreeEVchargingforEVowners

o City“conges@on”chargesareadoptedtoreducetrafficconges@onandemissionprovidingincen@veforurbanfleetownerstoswitchtoEV’s(i.e.,taxi’s)

Casestudy1– Start-upelectricvehiclecompany(cont.)


Naturalgasfrackingequalshugemarketpoten'al:o 2014:TensofthousandsofnewwellstobedrilledinNorthAmerica

o Hundredsofthousandsofexis@ngwellsarehydro-frackingcandidates

JonahGasFieldofWyomingEnCanaGasWellswithFrackingFrackingWellSite

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Regula'on-DrivenOpportunityCasestudy2–Naturalgasfrackingcompany


35


o Opportuni@esthatcouldbenefitfromacompactLPG-fueledfuelcellpairedwithasolararraycanprovide24/7/365power

Casestudy2– Naturalgasfrackingcompany(cont.)

CorrosionProtec'onContainmentPondMonitoring

SupervisoryControlAndDataAcquisi'on(SCADA)

+


36


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/

+


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


38

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/

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.

https://www.marsdd.com/mars-library/is-the-product-ready-for-release/

https://www.marsdd.com/mars-library/identifying-market-problems/

https://www.marsdd.com/mars-library/product-testing-methods/

https://www.businessnewsdaily.com/6030-product-launch-tips.html

https://en.wikipedia.org/wiki/Process_capability

https://en.wikipedia.org/wiki/Process_(engineering)

https://en.wikipedia.org/wiki/Statistical_variability

http://www.businessdictionary.com/definition/production.html

https://en.wikipedia.org/wiki/Regulation

https://en.wikipedia.org/wiki/Certification

http://www.businessdictionary.com/definition/industry-standard.html

https://en.wikipedia.org/wiki/Corporate_average_fuel_economy

https://en.wikipedia.org/wiki/Code_of_Federal_Regulations

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.

https://en.wikipedia.org/wiki/SAE_International

https://en.wikipedia.org/wiki/Renewable_Fuel_Standard_(United_States)

https://en.wikipedia.org/wiki/SAE_International

https://en.wikipedia.org/wiki/United_States_Environmental_Protection_Agency

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