DFMEA ReportWord下载.docx

DFMEA ReportWord下载.docx

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3.dFMEATables4

4.Summary4

5.Conclusion5

（ToUpdateTable,ClickonTableArea,PressF9）

1.

GENERAL

1.1.Objective

DocumentandReporttheresultsoftheDesignFMEA（dFMEA）conductedonthedevicesubassembliesand/orcomponents.

1.2.Scope

TheUpgradeprojectisadesignchangeonWZ-50C6andWZ-50C6TMicroinfusionPumpSystems,whichwerereleasedintheyear2005andstillinsalesnow.

ThedFMEAisconductedonadeviceanditssubassembliesand/orcomponents.

1.3.Definitions

Term

dFMEA

DesignFailureModesandEffectsAnalysis

HA

HazardAnalysis–primaryproductriskanalysisdocument

1.4.CitedDocuments

Number

Revision

RD052

100

SmithsMedicalDesignFMEAProcedure

2.Methods（GeneralInstructions）

2.1.Team

IdentifythedFMEAteam.

Name

Title

2.2.Configuration

Thedevice,subassembliesand/orcomponentsthatwereanalyzedmustbeclearlyidentified.Partnumbersandrevisionsshallbenoted.

Restrictor

Footpad

Color

LCD

Label

Washer

Frontcase

Clamp

Switchsaddle

Buzzer

5ppmRisistor

Software

IFU

PressHandle

Cluchnetscrew

Leadscrew

Baseclutchscrew

Motor

Bearing

Battery

Transformer

Presstransducer

2.3.SystemEffectsListing

AlistingofallidentifiedSystemEffectsiscreatedduringtheanalysisinordertoserveasinputtothedeviceHazardAnalysis（HA）.

Item

SystemEffect

Thepumpcannotstandstably

2.

Usernotsatisfied

3.

Losepartoffunctions

4.

Cannotcontinuetoprocess

5.

Shortcurcuit

6.

Difficulttoassemble

7.

Assemblyfails

8.

Safetyfunctionloses

9.

Incorrectalarm

10.

Usershutdowsthepumpaccidently

11.

Saftyissuewillbepossibletohappen

12.

Notuser-friendly

13.

Wrongoperation

14.

Thesyringecannotbefixed

15.

Thesyringcannotbeidentified

16.

Accuracyislow

17.

Reduecethelifetimeofcluchandleadscrews

18.

Thepumpcannotbeused

19.

Under-DeliveryofFluid

20.

Over-DeliveryofFluid

21.

NoDeliveryofFluid

22.

Leadandcluchscrewsarenotengagedwell

23.

ReducethepumpworktimewithoutACpower

2.4.ManufacturingControlsListing

AlistingofallidentifiedMfgControlsiscreatedduringtheanalysisinordertoserveasinputtothemanufacturingprocesses.NotethatrequirementsshouldbereferencedwhereassumedunderlyingfunctionalityispartoftheMfgControl（deviceselftestsetc.）.

MfgControl

Reference

Addavisualinspectionstep

AdditionalIQC

PCBAFCT

AdditionalIQCandFQC

DetailedproductionWI

PCBICTandadditionaltraining

Supplierqualitycontrol

3.dFMEATables

SeeAppendixAforthedFMEATable（s）.

4.Summary

[willbeaddedfinally]

5.Conclusion

AppendixA

dFMEATables

DFMEATables

Part

FailureMode

LocalEffect

PotentialCause

MfgControls

Comments

Screwlooses

Infusionlinecannotbefixedcorrectly

Noeffecttomainfunctions

ThetorqueofScrewdriverisnotenoughandbadqualityofscrew

Hookbroken

Infusionlinecannotbefixed

Lowqualityofhookandincorrectoperations

Footpadsarenotonthesameplane

Lowqualityoffootpadorwrongmaterial

Footpadsloose

Thescrewisnotfixed

Colorisnotconsistent

Rawmaterialcolorisnotright

Colorfades

Nodisplay

Cannotoperatebodyweightmode

LowqualityofLCD

brokenbyexternalforce

Nopower

Nodatacommunication

Nobacklight

Wrongcontents（includingcolorandword）

Usernotsatisfiedandnon-regulatorycompliance

Lowqualityoflabels

Stickinessisnotstrongenough

Cornerisbending

Lowqualityoflabelsandthelabelisnotadheredwell

Rearlabelandprintcodelabelarenotaligned

Codecannotbeidentified

Notgoodoperation

AdditionalFQC

Washerdoesn’tfunction

ThetorqueofScrewdriverisnotenough

Deformed

Pushrodisnotoperatedsmoothly

Difficulttoassemble,inaccuratepressure

Lowqualityoffrontcase

Dimensionofguidedblockisnotright

Clampisnotoperatedsmoothly

Mouldagingorpoormanufacturingprocesscontrol

AdditionalIQC?

Missinglocationofthebuzzerhole

PCBcannotbemounted

Jigfails

Changethemoldtomaketheholebysupplier

Dimensionofguidinggroove

AdditionalIQC

微动开关套

Screwholemislocation

Hardtomountmicroswitch

Thebuzzerismountedtoohigh

Impactfrontpanelstickprocess

Frontcasedeformed

Buzzerisnotinrightpositionwhenwelded

Buzzerdeosnotwork

Noalarmfunction

Safetyfunctionslose

Weldedwrongpin

24.

Componentdefect

25.

Positionisnotright

None

Volumeislower

26.

Lowqualityofbuzzersound

Lowqualityofbuzzer

27.

Sealedpaperisnottakenoff

ProductionWIandFQC

28.

Outoftolerence

Temperaturedrifttoomuch

Wrongalarm

Componentquality

29.

Pressingpowerkeytoshutdownthepumpevenduringinfusion

Thepumppowersoffdirectlynomatterifitisduringinfusion

Unclearspecification

30.

Syringesizechanedoesn’tcausethepumptostop

Thepumpcontinuestoinfuseevenifthesyringesizechanges

31.

Whileinfusingremovalofthesyringewillnotcauseanaudibleandvisiblealarm

Anaudibleandvisiblealarmdon’thappenevenifthesyringeisremovedwhileinfusing

32.

Whileinfusinganalarmwillnotcausethepumptostop

Thepumpcannotstopevenifanalarmhappenswhileinfusing

23.

Thepumpstartsaninfusionwhileanalarmisactive

Whenanalarmisactivethepumpstartsaninfusion

24

Thepumpdoesn’trestrictthevolumeoffluidduringasingleI/Vlinepurgeto2ml

25

DuringPOSTthepumpwill,withtheexceptionoftheon/offkey,testallkeystocheckwhetherakeyisstuckon

Somekeysarestuckon

26

Digitsafterthedecimalpointarenotonlycontrolledbysinglechevronkeys

Singleanddoublechevronkeyscontroldigitsafterthedecimalpoint

27

Notallofalarmsarebothaudibleandvisual

Somealarmsarenotbothaudibleandvisual

28

Keysarenotcheckediftheyarestuckoninbodyweightmode

Somekeysarepossibletobestuckon

29

Wrongversion

Difficultto/cannotunderstand

Carelessoperation

FQCandtraining

30

Ribweared

Holeofpresshandlebecomesbigger

Syringe