【正文】 Design and Process FMEA F M E A ailure ode ffects nalysis HANDBOOK By Samuel Chung Head of Quality Reference 1 2 Design FMEA Checklist No . De si g n F MEA Ch e ck li st Ye s No1 A li st of de lega tes w it h na m e s,d e p a rtmen ts, jo b t itl e (t o he l p us tou n d e rstand the na t u re ofre sp o n sibil ity wi t h cross fun ctionaltea m.)2 Hi stori cal wa rra n ty da ta w ith de s ign,a s the roo t ca u s e .3 Hi stori cal de s ig n / pro c e ssco mp a ti b ility pro h ib it o p timu m res u lt.3 Design FMEA Checklist No . De si g n F MEA C h e ck li st Ye s No4 De si g n ch a r a cteri stics th a t a ff e ct h ig hrisk ?5 De si g n requi r e s ne w m a teri a l?6 De si g n requi r e s spe ci a l tooli n g ? 7 Ha s a sse m b ly b u ild va ria ti o n a n a lys isb e e n con s id e re d ? 8 Ha s De s ig n o f Exp e riment b e e nco n si d e re d ?4 Design FMEA Checklist No . De si g n F MEA C h e ck li st Ye s No9 Is the re a pl a n f o r pro totyp e in pl a ce?10 Ha s a d e s ign FMEA be e nco mp l e ted? (Simi la r produ ct)11 Ha ve serv ice and ma i n tenan ceiss u e s b e e n con si d e r e d ? 12 Ha ve t h e D e sign Ve rifi ca tion Planb e e n ple ted? (Sim i la r produ ct) 13 If yes, wa s it p le ted by a crossfun ctio n a l tea m?5 Design FMEA Checklist No . De si g n F MEA Ch e ck li st Ye s No14 Are a ll speci fi e d tests, me tho d s, a n de q u ip ment a n d a cce p t a n ce cri ter iacle a rly d e fined a n d u n d e rstoo d ?15 Ha ve speci a l Cha ra cteri sti cs b e e nse le cte d ?16 Are sp e ci a l ch a ra cteri stics p ro p e rlyd o cu m e n te d ?17 Ha ve d im e n s io n th a t a ff e cts form, fita n d fu n ctio n ( . p la ce m e n t b y thecu stom e r in the m a n u f a cturi n g su cha s co p l a n a ry p lane , lead d im e n sion ,p a ckage siz e or o the r co n strai n t ? )6 Design FMEA Checklist No . De si g n F MEA Ch e ck li st Ye s No18 Is t e st loa d ing su ff ici e n t to p ro vide allco n d itio n s, . produ cti o n a n d e n d u se r?19 Ha ve p a rts man u fact u re d atmi n im u m a n d max im u msp e cifi c a tions b e e n t e sted?20 Is the sp e cifi e d test sa mp ling sizea n d f re q u e n cy fea si b le?21 Are sp e ci a l ma ter ia l chara cter isti csid e n tifie d ?7 Design FMEA Checklist No . De si g n F MEA Ch e ck li st Ye s No22 Wil l ma teri a l su p p liers p ro v id ece rtifica tion wi th e a ch sh ip ment?23 Is Bil l o f Ma teri a l c o mp l e te?24 The refe re n c e standa rd s i d e n tifiedwi th a p p ro p ria te re v ision le v e l? . AN SI G D T25 Are t h e refe re n ce d im e n s ionsid e n tifie d t o a d d l a youtme a su r e me n t ?8 Design FMEA Checklist No . De si g n F MEA Ch e ck li st Ye s No26 Are t h e con tro l p o i n ts and da tumsu rface s iden tifi e d t o enable designo f fun ctio n a l g a g e s for si g n ific a n tch a ra cter isti cs?27 The ap p r o p r ia te d e sign t o le r a n c e su se d p a ti b le w ith indu stryma n u factu r ing sta n d a rd s?28 The go ve r n me n t sa f e ty,e n vir o n mental , e rg o n o mi c a n de mi ssi o n con str a in ts a d d re ss e d i nthe de si g n f e a tu re s?29 The DFMEA ad d r e sse d t h e hi g h ris ka ff e ct seve rity 8?9 Design FMEA Checklist No . De si g n F MEA C h e ck li st Ye s No30 The de si g n re q u ir e s new tech n o l o g ya n d pr e cis i o n equ ip ment?If yes, id e n tify t h e spe cifi c..31 The pro d u ct de si g n e d re q u ir e dsp e ci a l? Ha n d ling?? Stora g e ?? En vironm e n t a l co n tro ltemp e ra tur e s?32 Sp e ci a l traini n g r e q u ired forma n u factu r ing p e rs o n n e l ?10 Design FMEA Checklist No . De si g n F MEA Ch e ck li st Ye s No33 Mi stake p r o o fing? I .e. Key e d f o r symme trica l part sucha s le ft an d ri g h t to a vo i d mista kea sse mbly?34 Ch a r a cteri stics re q u ir e d sp e cial too lso r f ixtu re t o en su r e custo me r saf e tyo r satis factio n ?35 Co n ti n u o u s imp r o ve m e n t for…11 Design FMEA Checklist No . De si g n F MEA C h e ck li st Ye s No363738 39 4012 DESIGN FMEADevelopment Flow Charts and Block Diagrams are used to establish: ? input information ? process (function) ? the deliverables or output They demonstrate primary relationships and logical order and are attached to the FMEA 13 Workshop 1 Block Diagram ?You are going to be split into teams ?The teams will be multidisciplined ? Nominate a team leader, “Engineer Responsible” ?Use the “Block Diagram Blank” to develop a block flow diagram to represent the design considerations for ... 14 Workshop 1 Block Diagram A Company174。 Switch for XXXXX Some points you might wish to consider ? who is going to use it? ? where is it going to be used? ? how is it to be powered? ? expected life? 15 Workshop 1 Block Diagram Did you plete the key details at the top? Any areas where you need help? Any additional information required ? 16 THE FMEA FORM _ _ SystemPOTENTIALFAILUR E MODE A ND EFF EC TSAN ALYS IS(DE SIGN FMEA )FMEA Nu mb e r __ _ _ _ _ _ _Pa g e _ _ _ _ _ _ o f __ _ _ _ __ _ Sub system_ _ Co mp o n e n t __ _ _ _ _Cu stome r:De sig n Re sp o n sib il ity ____ ___Re vie we d by: __ _ _ _ _ _ _ _ _ _ _ _ _ _Pre p a re d By __ _ _ _ _ _ _ _Ap p ro ve d By: _ _ _ _ _ _ _ _ _Mo d e l Ye a r(s)/ Veh icl e (s) __Ke y Da te ___ _____ _____ _FMEA Da te ( o rig ) _ (Re v) _Co re T e a m __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _