sustaining quality and warranty - build4scale · mi9ga9on acvi9es should not aﬀect subsequent...

PreparingfortheProduc1onRampU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org www.build4scale.org

SustainingQualityandWarrantyModule7BPreparingfortheProduc1onRamp

PreparingfortheProduc1onRampU.S. DEPARTMENT OF ENERGY • OFFICE OF ENERGY EFFICIENCY & RENEWABLE ENERGY www.build4scale.org

Mo2va2on

2

o Scalingac1vi1escanaffectproductqualityandreliability,butquickiden1fica1onofproblemskeepscorrec1veac1oncostslow

o Scalingtheprocessfrombetaprototypebuildsintoactualdeliveredpilotandproduc1onbuildswiththefollowinggoals:— Catchproductreliabilityproblemsquicklyandearlyonintheproduc1onprocess

— Ensurethatwarrantyandservicestrategiesareappropriateandcosteffec1ve

— Priori1zerisk-mi1ga1oneffortsbasedonimpactstototalcostonthebillofmaterials,customersa1sfac1on,and1metomarket

Whyisthismoduleimportant?


3

PilotAndScalingWheredoesthisfitintothedevelopmentcycle?

Conceptand

FeasibilityDefini2on

ProductandProcess

Design

Implementand

Validate

Produc2onandStock

Launchand

Closure

Pre-alpha Alpha Beta Pilot Ramp Scale

PHAS

ES

BUILDS

EngineeringValida9on

DesignValida9on

ProcessValida-on

ConceptValida9on

PRODUCTDESIGNOBJECTIVESMarketResearch

DesignResearchFeasibility

DevelopmentQualifica2on

FieldReadinessLaunch

ManufacturingCapacity

MANUFACTURINGREADINESSLEVELSLevels: 109987654321

ManufacturingDevelopmentManufacturingResearch

Mfg.Capability

Produc2on


ModuleOutline

4

o Learningobjec1veso Reliabilityoverview— Keydriversandlifecyclereview— Scale-upobjec1ves

o Produc1onscale-upandriskmi1ga1ono Transi1onto“screening”testmethodso Ini1a1onofdatamonitoringandfeedbackloopprocedures


LearningObjec2ves

5

o LO1.Understandac1vi1esandop1onsinvolvedwithscale-upforsustainingquality,warranty,service,andrepair

o LO2.Understandhowtousefailuremodeandeffectsanalysis(FMEA)outputstopriori1zeac1vi1esanddecisions


6

ReliabilityOverviewKeydriversandlifecyclereview

ConceptandFeasibility Defini2on

ProductandProcessDesign

ImplementandValidate

Produc2onandStock

LaunchandClosure

EstablishPreliminaryReliabilityPlans

PHAS

ES

RELIAB

ILITY Setthe

ReliabilityGoalsfortheProduct(s)

DesignandImplement

theReliabilityCasefortheProduct(s)to

Support

VerifytheProductReliabilityfromIni2alProductBuilds.

RefinetheReliability

Case

ValidateProductReliabilityfromIni2alProduc2on

ValidateProductReliability

fromProduc2on

andCustomerFeedback

o Reliabilityandqualityac1vi1esshouldoccuratallstagesoftheproductlifecycle

o Reliabilitypredic1onsandFMEAoutputsdrivepriori1za1onofac1vi1es:— E.g.,impactson1metomarket,totalcost,andcustomersa1sfac1on


ReliabilityOverview

7

Reliabilitytes2ngobjec2vesbybuildversion:o Pre-alphates2ng:establishreliabilitygoalso Alphates2ng:testandrefinementofproductdesigno Betates2ng:testandrefinementofmanufacturingprocesso Pilottes2ng:validatedesignandmanufacturingpriortoproduc1on

o Produc2onramp:validatewarrantyandserviceimpacts

Scale-upbuildobjec9ves


Produc2onScale-Up

8

Ensurethatoverallprogramimplementa2onmeetsgoalsfor2metomarket,cost,andcustomersa2sfac2onwithunifica2onacrossthefollowingteams:o Marke1ng/saleso Quality/reliabilityo Productdesigno Newproductintroduc1on(NPI)o Manufacturingo Serviceandrepairo Technicalpublica1onso Supplychain

Cross-func9onalteamengagement


Produc2onScale-Up

9

Betatopilottoramptransi9ons

Tip:NPIandotherteamsmayneedtostayinvolvedinthepilotandproduc1onrampto

maintainaccountabilitytothesegoals

o Usereliabilitygoalsandconfidencemetricsasgates

Decisiontradeoffswhengoalsarenotmet:o Costtoachievehigherreliabilityorconfidence

o Costofdelayedlauncho Costofwarrantyandserviceimplica1ons


Produc2onScale-Up

10

o Transi1onfrombeta“usesimula1on”tofinalproduct“screening”testmethods:— Allpilotbuildsandbeyondareintendedasdeliverableproducts

o Ini1ateappropriatetest,datacollec1on,andfeedbackloopprocedures

o Iden1fypilotcustomersanddevelopafeedbackplano Setuseagreements,warranty,andserviceplansinmo1ono Releasesupportdocumenta1on

Produc9onrampac9vi9es


Produc2onScale-Up

11

KeyStepstoRiskManagement:o Iden1fyo Analyzeo Controlo Transfero Reduceo Assess

Ac9vitypriori9za9onandriskmi9ga9on


StepsforEffectAnalysis:o FMEAoutputsbecomeinputsforqualityandwarrantyscale-updecisions

3-DimensionalViewofRisks:o Detectability,Do Probability,Po Severity,So Setascoreof1–3foreachdimension

12

Ac9vitypriori9za9onandriskmi9ga9on(cont.)Produc2onScale-Up

Tip:assigningappropriateFMEAriskscoresof1–3forD,P,andSandmul1plyingthemtogetheriden1fiesthehighest-risk,highest-valueitemsforpriori1za1on

(Severity)

(Probability)

(Detectability)


FailureModeAndEffectsAnalysis

13

Mi9ga9onac9vi9esshouldnotaffectsubsequentriskassessmentscoresunlesssignificantrisksgetlostinrepriori9za9on

Example

Risk D P S Risk Mi2ga2onAc2vity

UselifeforcomponentXislessthantherequiredproductuselife 2 3 2 12

Planforservicestrategytoreplacepartifmorecosteffec1vethanincreasingcomponent

performance

Productdown1mehassignificantimpactoncustomeropera1ons 3 2 1 6

Planforfast-respondingrepairserviceorachievesufficientreliabilityconfidencethroughaddi1onal

testanddatacollec1on

Highinfantmortalityratewilldamagereputa1onandsales 3 1 3 9 Testreliabilitypredic1onsduringscale-upwith

feedbacklooptocorrectimportantrootcauses

Detectability(D)xProbability(P)xSeverity(S)=Risk


14

o Inpreviousbetates1ngstages,usesimula1on(i.e.,acceleratedlifetes2ng[ALT])isconductedwithappropriateseveritytofailtheproductandiden1fypoten1alproblems(adesignqualityexercise)

o TheknowledgegainedfromALTcanbeusedtoreducetheseverityoffailurecondi1onsfordevelopingappropriateproduc1on“screening”tests(amanufacturingqualityexercise)

Reminder:ALTisates1ngstrategywherebytheengineerextrapolatesaproduct’sfailurebehavioratnormalcondi1onsfromlifedataobtainedatacceleratedstresslevels.Sinceproductsfailmorequicklyathigherstresslevels,thisstrategyallowstheengineertoobtainreliabilityinforma1onaboutaproductinashorter1meframe(i.e.,meanlifeexpectancyandprobabilityoffailureataspecific1me)

“Screening”testmethodsTransi2ontoProduc2on


StressScreening

15

o Highlyacceleratedstressscreening(HASS)usesacceleratedstressesbeyondaproduct’sspecifica1onstodetectproductdefectsduringmanufacturingandproduc1on

o Non-destruc2veinspec2onsincludeoutofboxaudit(OBA),func1onaltes1ng,x-ray,andvisualmethods

o Destruc2vetestexamplesincludeongoingreliabilitytests(ORT),teardown,andbreakopen

Anyscreeningtestimplementa9onshouldaddvaluetotheproductbasedonpriorrisk-mi9ga9onorcost-mi9ga9ondecisions.Otherdesignfactorsorservicingplansmightbe

alterna9vestoscreentes9ng.

Highlyacceleratedstressscreening


DataCollec2onandFeedbackLoops

16

Theprimaryobjec2veisensureearlyfailureratesmatchreliabilitypredic2onsandgoals;availabletoolsincludethefollowing:o HASStes1ng,OBAs,andproduc1onlineinspec1ons:— Lastprocessinproduc1onflowbeforeshippingaproducttoensurethatallmanufacturingandtestprocesseshavebeencompleted

— Dataaboutthemanufacturedproductacquiredpriortodelivery

— Couldbeconductedasahigh-percentagecheckearlyinproduc1onandalow-percentagechecklaterinproduc1onramp

Ini9a9onandprocedures


DataCollec2onandFeedbackLoops

17

o ORTs— Periodiccheckpointsanddirec1onresets— Predefinednumberofproductsinthemanufacturinglinearerandomlypickedeachdayofproduc1onandsubjectedtoenvironmentalstressestoinducedamage

o Cumula2vedistribu2onfunc2onanalysis— Actualfielddataforpredic1ngunexpectedfailuretrends

o Rootcauseanalysis(detailedonnextpage)— Analysisforunderstandinganddeterminingcorrec1veac1on

Ini9a9onandprocedures(cont.)


o Rootcauseanalysisisusedtoiden1fytherootcausesoffaultsorproblems:— e.g.,asking‘why’five1mes

o Afactorisconsideredarootcauseifitsremovalfromtheproblem-faultsequencepreventsthefaultfromrecurring

o Acausalfactorisonethataffectsanevent'soutcome,butitisnotarootcause.Removingacausalfactorcanbenefitanoutcome,butitdoesnotpreventitsrecurrencewithcertainty

18

RootCauseAnalysis

Allowsforproperdetermina9onoffailure

source,impacttoreliability,andcorrec9veac9onop9ons


PilotCustomers

19

o Considernon-disclosureagreementsifproduct-launchschedulewillbeprolongedtoavoidprematurereleaseofsensi1veinforma1ontothepublic

o Encouragethecustomertoprovidefeedbacko Definearangeofcustomerusecases(e.g.,industryorgloballoca1on)togeneratethemostusefulfeedback

o Seekcustomerswhoarewillingtohostonsiteinstalla1onandusageac1vi1es

o Considerdiscountedpricingforearlyadop1onandaccesstodata

Bestprac9ces

Glossary

Module 7B

Ongoing Reliability test (ORT) is a hardware test process usually used in manufacturing to

ensure that quality of the products is still of the same specifications as the day it first went to

production or general availability.

Process Validation is the analysis of data gathered throughout the design and manufacturing of

a product in order to confirm that the process can reliably output products of a determined

standard.

Bill of Materials (BOM) is a list of the raw materials, sub-assemblies, intermediate assemblies,

sub-components, parts and the quantities of each needed to manufacture an end product.

Failure Mode and Effects Analysis (FMEA) was one of the first highly structured, systematic

techniques for failure analysis. It was developed by reliability engineers in the late 1950s to

study problems that might arise from malfunctions of military systems. An FMEA is often the

first step of a system reliability study.

Pre-alpha Testing refers to testing associated with concept validation. This validation could be

customer discovery based of could require documented evidence that establishes a high degree

of certainty that a particular product or process will consistently meet established criteria for

concept success and reliability goals.

Alpha Testing is in-house testing of a pre-production model or version, to locate or estimate

design flaws or deficiencies.

Beta Testing is second level, external pilot-test of a product (usually a software) before

commercial quantity production. At the beta test stage, the product has already passed through

the first-level, internal pilot-test (alpha test) and glaring defects have been removed.

Pilot Testing is a small-scale campaign, survey, or test-plant commissioned or initiated to check

the conditions and operational details before full scale launch.

Production Ramp-Up is the start or increase in production ahead of anticipated increases in

product demand and also in an effort to confirm all production assumptions.

Detectability is the ability to detect a failure before it causes harm. The purpose of

considering detection in any scenario is to ensure that potential or actual failures can be

identified with enough time to take action before the user is adversely affected.

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

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

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

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

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

http://www.businessdictionary.com/definition/alpha-test.html

http://www.businessdictionary.com/definition/beta-test.html

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

https://www.maketime.io/blog/best-practices-production-age-advanced-manufacturing/

http://www.brighthubpm.com/risk-management/88566-tool-for-assessing-project-risk/

Probability is the likelihood of the hazard occurring and is ranked on a point scale.

Severity is the amount of damage or harm a hazard could create and is usually ranked on point

scale.

Accelerated Life Testing (ALT) is the process of testing a product by subjecting it to conditions

(stress, strain, temperatures, voltage, vibration rate, pressure etc.) in excess of its normal

service parameters in an effort to uncover faults and potential modes of failure in a short

amount of time

Highly Accelerated Stress Screening (HASS) uses accelerated stresses beyond a product’s

specifications to detect product defects during manufacturing and production

Non-Destructive Inspections or non-destructive testing (NDT) is a wide group of analysis

techniques used to evaluate the properties of a material, component or system without causing

damage.

Destructive Tests on-going reliability tests (ORT), tear down, break-open, etc. the product to

test for its compliance to specification.

Root Cause Analysis is a method of problem solving used for identifying the root causes of

faults or problems

Cumulative Distribution Function (CDF) is the cumulative distribution function (CDF) of a real-

valued random variable X, or just distribution function of X, evaluated at x, is the probability

that X will take a value less than or equal to x.

Root Cause is an initiating cause of either a condition or a causal chain that leads to an outcome

or effect of interest.

Causal Factor is those elements that lead to variation in the quality of the finished product. The

Events and Causal Factors (ECF) chart depicts the necessary and sufficient events and causal

factors for accident occurrence.

Non-Disclosure Agreements - is a legal contract between at least two parties that outlines

confidential material, knowledge, or information that the parties wish to share with one

another for certain purposes, but wish to restrict access to or by third parties.



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

https://www.qualmark.com/whatishalthass/whyhassworks

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

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

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

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

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

http://www.riceconsulting.com/public_pdf/charting_for_root_cause_analysis.pdf

https://en.wikipedia.org/wiki/Non-disclosure_agreement

sustaining quality and warranty - build4scale · mi9ga9on acvi9es should not aﬀect subsequent...

Documents