product development cycle

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COMPANY PROPRIEARY AND CON!IDENIAL

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able of Contents

Table of Contents....................................................................................................................................................1

1.0 Purose..............................................................................................................................................................!

!.0 "#oe..................................................................................................................................................................!

$.0 Definitions.........................................................................................................................................................!

$.1 %&e#uti'e Mana(ement Team )%MT*....................................................................................................!$.! +usiness Plan..........................................................................................................................................!$.$ Customer.................................................................................................................................................!$., Desi(n Inut Re'ies.............................................................................................................................!$. Maretin( Reuirements Do#ument )MRD*..........................................................................................!$. Feasibilit2 Team.....................................................................................................................................!$.3 Manufa#turin( Pro#ess Desi(n Re'ies................................................................................................!

$.4 Pro5u#t....................................................................................................................................................$$.6 Pro5u#t De'eloment C2#le...................................................................................................................$$.10 Pro5u#t De'eloment...........................................................................................................................$$.11 Pro5u#t De'eloment Feasibilit2 "tu52 )PDF"*..................................................................................$$.1! Pro5u#t Mana(er..................................................................................................................................$$.1$ Pro5u#t De'eloment Phase.................................................................................................................$$.1, Pro5u#t De'eloment Plan...................................................................................................................$$.1 Pro5u#t De'eloment Re'ies.............................................................................................................$$.1 Pro5u#t De'eloment Tas...................................................................................................................,$.13 Pro7e#t...................................................................................................................................................,$.14 8ualit2...................................................................................................................................................,$.16 "ub-Plan................................................................................................................................................,$.!0 "2stem Desi(n Re'ies........................................................................................................................,$.!1 Tas Team............................................................................................................................................,

$.!! Pro5u#t De'eloment Team )PDT*......................................................................................................,$.!$ Te#hni#al Desi(n Re'ies....................................................................................................................,

,.0 Resonsibilities..................................................................................................................................................,

,.1 %&e#uti'e Mana(ement Team )%MT*....................................................................................................,,.! Feasibilit2 Team.....................................................................................................................................,.$ Pro5u#t Mana(er.....................................................................................................................................,., Re(ulator2 Affairs/8ualit2 "2stems Dire#tor.........................................................................................,. Tas Teams.............................................................................................................................................,. Pro5u#t De'eloment Team )PDT*........................................................................................................

.0 Referen#es an5 Ali#able Do#uments.............................................................................................................

.0 Pro#e5ure............................................................................................................................................................1 Con#et Phase..........................................................................................................................................! Feasibilit2 Phase.....................................................................................................................................3.$ Plannin( Phase.......................................................................................................................................6., De'eloment Phase...............................................................................................................................10. Pre-Pro5u#tion Phase............................................................................................................................1$. Pilot Pro5u#tion Phase..........................................................................................................................1.3 Full Pro5u#tion an5 "uort Phase......................................................................................................13

3.0 Aen5i&.........................................................................................................................................................14

3.1 9lossar2 of Te#hni#al Terms................................................................................................................14

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&'( Purpose

The Pro5u#t De'eloment C2#le 5efines :Coman2 Name;e5= #omrehensi'e (ui5e ali#able to both simle an5 #omle&5e'eloment ro(rams. Deen5in( on the #omle&it2 of the ro5u#t an5 the e&tent of the 5esi(nreuirements= the 5e'eloment lan ma2 not e&a#tl2 follo this res#ribe5 ro#ess= but must still al2the essential elements of effe#ti'e 5esi(n #ontrol an5 s2stemati# ro5u#t 5e'eloment.

)'( *cope

The Pro5u#t De'eloment C2#le alies to all ro5u#t 5e'eloment ro(rams fun5e5 an5 mana(e5 b2:Coman2 Name;.

+'( Definitions

+'& E,ecutive Mana-ement eam .EM

A mana(ement team that lans= 5ire#ts= an5 mana(es #oman2 a#ti'ities= in#lu5in(manufa#turin( oerations an5 ro5u#t 5e'eloment. It has the authorit2 an5 resonsibilit2 to#arr2 out the #oman2


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+'8 Pro%uct

@nless otherise se#ifie5= the or5 ro5u#tB in this ro#e5ure is use5 in the more (lobal senseto refer to #omonents= materials= stru#tures= ma#hines= 5e'i#es= s2stems= ro#esses= softare= orser'i#es.

+'9 Pro%uct Development C#cleAn i5eali>e5= #omrehensi'e 5es#rition of a #ontrolle5 5esi(n an5 5e'eloment ro#ess ithin aualit2 s2stem. Its urose is to 5eli'er a ualit2 ro5u#t that is aroriate for its inten5e5 use.The #2#le 5efines the ma7or hases= a#ti'ities= milestones= resonsibilities= an5 5eli'erablesreuire5 in a #on#urrent= inte(rate5= ro5u#t 5e'eloment ro#ess. The fi'e )* hases of thePro5u#t De'eloment C2#le are Con#et= Feasibilit2= Plannin(= De'eloment= an5 Pro5u#tion. Are'ie follos ea#h hase of the ro5u#t 5e'eloment to 'erif2 attainment of ob7e#ti'es for that

arti#ular hase an5 to authori>e #ontinuation into the ne&t hase.

+'&( Pro%uct Development

The s2stemati# 5e'eloment ro#ess for otimi>in( a ro5u#te#ontinuation into the ne&t hase. The ob7e#ti'e of the re'ies is a #omrehensi'e= s2stemati#e&amination of the 5esi(n to e'aluate the a5eua#2 of the 5esi(n reuirements= to e'aluate the#aabilit2 of the 5esi(n to meet the reuirements= an5 to i5entif2 roblems.

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+'&6 Pro%uct Development as4

A Pro5u#t De'eloment Plan reuirement or a#ti'it2 ne#essar2 for the su##essful #omletion ofthe 5e'eloment ro(ram.

+'&7 Pro:ect

In essen#e= a ro7e#t is the resear#h hases= Con#et an5 Feasibilit2= of the Pro5u#t De'elomentC2#le. The ob7e#ti'e of a ro7e#t is to 5emonstrate throu(h tests or anal2sis the s#ientifi# 'ali5it2of a #on#et )a ne te#hnolo(2 or ro5u#t* an5 the te#hnolo(i#al feasibilit2 of imlementin( it asa ro5u#t.

+'&8 ;ualit#

The totalit2 of features an5 #hara#teristi#s that bears on the abilit2 of a ro5u#t to satisf2 fitness-for-use= in#lu5in( safet2 an5 erforman#e.

+'&9 *ub


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1') !easibilit# eam

A Feasibilit2 Team aointe5 b2 the %MT reares a +usiness Assessment an5 a Pro5u#tDe'eloment Feasibilit2 "tu52 at the start of the Feasibilit2 Phase to 5etermine if the otential

ro5u#t reresents a finan#ial oortunit2.

1'+ Pro%uct Mana-erThe Pro5u#t Mana(er bears o'erall resonsibilit2 for su##essful mana(ement of the 5e'eloment

ro(ram an5 is resonsible for lea5in( an5 fa#ilitatin( the efforts of the Pro5u#t De'elomentTeam. As the lea5er of the Pro5u#t De'eloment Team= the Pro5u#t Mana(er is resonsible for#oor5inatin( an5 inte(ratin( their a#ti'ities an5 a#tin( as liaison ith the %&e#uti'eMana(ement Team.

1'1 Re-ulator# Affairs/;ualit# *#stems Director

The Dire#tor of Re(ulator2 Affairs/8ualit2 "2stems is resonsible for assurin( the ualit2 of thero5u#t 5esi(n ro#ess= the Manufa#turin( Pro#ess= the ro5u#t= an5 all hases of the Pro5u#tDe'eloment C2#le.

1'3 as4 eams

Tas Teams ha'e resonsibilit2 an5 authorit2 to lan an5 e&e#ute "ub-Plans an5 other Pro5u#tDe'eloment Tass assi(ne5 b2 the Pro5u#t De'eloment Team.

1'6 Pro%uct Development eam .PD

The Pro5u#t De'eloment Team has #olle#ti'e resonsibilit2 an5 authorit2 to lan= 5ire#t= an5mana(e the a#ti'ities an5 5eli'erables of a 5e'eloment ro(ram an5 to #arr2 out the ob7e#ti'esof the %&e#uti'e Mana(ement Team. It is resonsible for a5'isin(= #oor5inatin(= an5 inte(ratin(the a#ti'ities of the Tas Teams.

3'( References an% Applicable Documents

Desi(n Control 9ui5an#e for Me5i#al De'i#e Manufa#turersB= FDA Center for De'i#es an5Ra5iolo(i#al ?ealth= Mar#h 11= 1663 %n(ineerin( "ta(es of Ne Pro5u#t De'elomentB= National "o#iet2 of Professional%n(ineers= 1660 The FDA an5 orl5i5e 8ualit2 "2stem Reuirements 9ui5eboo for Me5i#al De'i#es=imberl2 Trautman= A"8 8ualit2 Press De'eloment of Desi(n Inut Reuirements Prearation of a Pro5u#t De'eloment Plan De'eloment of Desi(n Eutut Desi(n Re'ie Desi(n erifi#ation Desi(n ali5ation Desi(n Transfer Desi(n ?istor2 File

6'( Proce%ure

The Pro5u#t De'eloment C2#le #onsists of fi'e )* inte(rate5 ro5u#t 5e'eloment hases. For ea#h

ro5u#t 5e'eloment hase= there is a #on(ruous series of a#ti'ities= 5eli'erables= an5 milestonesoriente5 toar5 a#hie'in( the ob7e#ti'e)s* of that arti#ular hase. The en5 of a hase is an otimum5e#ision oint in the ro(ression toar5 reali>ation of a ro5u#t. The (oal of ea#h hase is to establishthe ertinent information )te#hni#al= e#onomi#= ualit2= an5 ris assessment* ne#essar2 to mae the5e#ision to ro#ee5 or not to ro#ee5 to the ne&t hase of the 5e'eloment #2#le. The summation of these'en hases is a su##essful ro5u#t 5e'eloment ro(ram that otimi>es a ro5u#tGs time to maret=#ost= erforman#e= ualit2= #ustomer satisfa#tion= an5 ris mana(ement= b2 simultaneousl2 inte(ratin(all ro5u#t nole5(e an5 e&ertise from #on#et= throu(h manufa#turin( an5 #ustomer satisfa#tion= tothe en5 of the ro5u#t life #2#le. ?oe'er= ea#h ro5u#t an5 5e'eloment ro(ram is 5ifferent. The5e'eloment #2#le for a se#ifi# ro5u#t or 5e'eloment ro(ram ma2 not en#omass all hases of thePro5u#t De'eloment C2#le. These hases are Con#et= Feasibilit2= Plannin(= De'eloment= an5Pro5u#tion.

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6'& Concept Phase

hen Maretin(= or an2 other (rou or in5i'i5ual= i5entifies a #on#et )a ne te#hnolo(2 orro5u#t* ith otential ali#ation as a ro5u#t= Resear#h initiates a Pro7e#t to 5emonstrate thes#ientifi# 'ali5it2 of the #on#et. This is the Con#et Phase of the Pro5u#t De'eloment C2#le.If the #on#et is shon 'ali5 an5 it reresents a otential finan#ial oortunit2= it enters the

Feasibilit2 Phase.

6'&'& Definition

The Con#et Phase of ro5u#t 5e'eloment is that erio5 5urin( hi#h a #on#et isro'en s#ientifi#all2 'ali5 or is shon to be otentiall2 'ali5 b2 the ali#ation of atest-of-rin#ile mo5el)s*.

6'&') Ob:ective

The ob7e#ti'e of the Con#et Phase is to 5emonstrate throu(h tests an5/or anal2sis theerforman#e an5 imlementation otential of a #on#et.

6'&'+ Activities an% Responsibilities

The a#ti'ities #ommon to this hase are those ne#essar2 to 5es#ribe an inno'ation=

initiate a ro7e#t to in'esti(ate the inno'ation= i5entif2 its otential utilit2= an55emonstrate its otential for a#hie'in( erforman#e an5 imlementation. In (eneral=the folloin( shoul5 o##urH

Full2 arti#ulate the #on#et an5 assumtions. )Resear#h* Comlete an5 submit a Pro7e#t Alloan#e Reuest to the %MT. )Resear#h* Aro'e the Pro7e#t Alloan#e Reuest alon( ith a ro7e#t resour#e bu5(etan5 s#he5ule. )%MT* Confirm that the #riti#al assumtions uon hi#h erforman#e is base5 arereasonable. )Resear#h* Demonstrate the #on#et is 'ali5 or otentiall2 'ali5 ith tests an5/or anal2sis.Present results in Te#hni#al Reorts. )Resear#h* I5entif2 an5 assess barriers to 5e'eloment an5 manufa#turin(. )Resear#h* Comlete a state-of-the-art sur'e2. )Resear#h*

Comlete a Pro5u#t Con#et Reort. )Resear#h* Con5u#t a 5esi(n re'ie of the a5eua#2 of the in'esti(ation= aroriatenessof the results= an5 'ali5it2 of the #on#et. )Resear#h* Aro'e Authori>ation to Continue De'eloment. )%MT*

6'&'1 Deliverables

"e#ifi# 5eli'erables result from the #omletion of the a#ti'ities #ommon to the Con#etPhase of 5e'eloment.

6'&'1'& Pro:ect Allo2ance Re5uest

The Pro7e#t Alloan#e Reuest ro'i5es a brief 5es#rition of the #on#etan5 ob7e#ti'es. If aroriate= the %MT aro'es the reuest an5 authori>esa finan#ial an5 human resour#e bu5(et to #omlete the resear#h ortion of

5e'eloment.6'&'1') echnical Reports

Te#hni#al Reorts resent the results an5 erforman#e 5ata from testin( orthe results of mathemati#al anal2sis.

6'&'1'+ Pro%uct Concept Report

The Pro5u#t Con#et Reort ro'i5es the ertinent te#hni#al 5ata= e#onomi#assessment= an5 #on#et anal2sis information ne#essar2 to mae a 5e#ision to

ro#ee5 or not to ro#ee5 to the ne&t 5e'eloment hase.

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Pro'i5es 5es#rition of the #on#et ith set#hes= 5rain(s= an5/ormo5el)s*. Pro'i5es a tar(et set of erforman#e se#ifi#ations for the #on#et. Presents test results an5 5ata here ne#essar2. Presents results of the state-of-the-art sur'e2.

9i'es a reliminar2 i5entifi#ation an5 5is#ussion of the otentialbarriers to 5e'eloment= manufa#turin(= an5 maretin( of a nero5u#t. 9i'es a statement of ho the #oman2 ill use the #on#et as a

ro5u#t.

6'&'3 Milestones

Milestones 5esi(nate si(nifi#ant oints of ro(ress in the #omletion of a#ti'ities#ommon to the Con#et Phase of 5e'eloment.

Resear#h submits a Pro7e#t Alloan#e Reuest to the %MT to initiate thero7e#t an5 otential 5e'eloment ro(ram. The %MT aro'es the Pro7e#t Alloan#e Reuest= a resour#e bu5(et= an5

ro7e#t s#he5ule. Resear#h #omletes Pro5u#t Con#et Reort. Resear#h #omletes a 5esi(n re'ie. The %MT aro'es Authori>ation to Continue De'eloment.

6') !easibilit# Phase

Folloin( the 5esi(n re'ie an5 authori>ation to #ontinue resear#h= Resear#h initiates theFeasibilit2 Phase of the Pro5u#t De'eloment C2#le.

6')'& Definition

The Feasibilit2 Phase of ro5u#t 5e'eloment is that erio5 5urin( hi#h it is ro'enossible ithin the te#hnolo(i#al state of the art to ro5u#e a ne ro5u#t from the#on#et.

6')') Ob:ectivesThe Feasibilit2 Phase has four ),* ob7e#ti'esH

Determine if the roose5 ro5u#t reresents a finan#ial oortunit2. Confirm the tar(et erforman#e of the ne ro5u#t throu(h e&erimentationan5/or a##ete5 en(ineerin( anal2sis. As#ertain there are no te#hni#al or e#onomi# barriers to imlementation that#annot be o'er#ome b2 5e'eloment. Define the ro5u#t 5esi(n reuirements an5 5e'eloment (oals in terms of#ustomer satisfa#tion an5 finan#ial a5'anta(e.

6')'+ Activities an% Responsibilities

The a#ti'ities #ommon to this hase are those ne#essar2 to 5emonstrate ro5u#tfeasibilit2 an5 5etermine if maret #on5itions for the roose5 ro5u#t are #on5u#i'e tofinan#ial (ain. In (eneral= the folloin( shoul5 o##urH

Preare a reliminar2 #on#etual 5es#rition of the ro5u#t an5 a 5efinition ofits fun#tion= erforman#e= an5 interfa#e reuirements in terms of #ustomersatisfa#tion an5 finan#ial (ain. )Resear#h* Aoint members of a Feasibilit2 Team to reare a +usiness Assessment an5a Pro5u#t De'eloment Feasibilit2 "tu52. )%MT* Preare a +usiness Assessment 5es#ribin( the maret #ometition= #urrent an5future marets= e&e#te5 finan#ial erforman#e= an5 business ris asso#iate5 ith5e'eloment an5 maretin( of the ro5u#t. )Feasibilit2 Team*



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Preare a reliminar2 estimate of the otential ro5u#tation to Continue De'eloment. )%MT*

6')'1 Deliverables

"e#ifi# 5eli'erables result from the #omletion of the a#ti'ities #ommon to theFeasibilit2 Phase of 5e'eloment.

6')'1'& Pro%uct Development !easibilit# *tu%#

The Pro5u#t De'eloment Feasibilit2 "tu52 e&amines all ali#able fa#ets ofa roose5 5e'eloment ro(ram. It #ommuni#ates the ros an5 #ons of the

roose5 ro5u#t to the %&e#uti'e Mana(ement Team to fa#ilitate the5e#ision to e&en5 time an5 resour#es in un5ertain( its 5e'eloment. The

PF" resents an imartial +usiness Assessment #learl2 5etailin( an anal2sisof the maret= finan#es= an5 business ris alon( ith a brief 5es#rition ofthe ro5u#t an5 5e'eloment ro#ess.

6')'1') E,perimental Protot#pe

The usual 5eli'erable of the Feasibilit2 Phase is an e&erimental rotot2e)ben#h or brea5boar5 mo5el*. here it is not realisti# to ro5u#e an entiremo5el= 5emonstrate feasibilit2 throu(h an aroriate #ombination of tests ofmaterials= full or artial ro5u#t or ro#ess mo5els= or b2 other a##etableen(ineerin( te#hniues su#h as #omuter simulations.

6')'1'+ echnical Reports

Te#hni#al Reorts resent the results an5 erforman#e 5ata from testin( ofthe a#tual e&erimental rotot2e)s*. The reorts ma2 also in#lu5e

reliminar2 ro5u#t or ro#ess 5esi(n information.

6')'1'1 Mar4etin- Re5uirements Document

This 5o#ument 5efines the ro5u#t 5esi(n inut reuirements= the 5esi(n(oals= an5 the 5e'eloment ro(ram (oals. These #onform to the arameters

resente5 in the Pro5u#t De'eloment Feasibilit2 "tu52 to assure the hi(hestrobabilit2 of #ustomer satisfa#tion an5 finan#ial su##ess.

6')'3 Milestones

Milestones 5esi(nate si(nifi#ant oints of ro(ress in the #omletion of a#ti'ities#ommon to the Feasibilit2 Phase of 5e'eloment.



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The %MT aro'es #ontinuation of resear#h base5 on the Pro5u#t De'elomentFeasibilit2 "tu52. Pro5u#t Mana(er #omletes Desi(n Inut Re'ie)s*. The %MT aro'es the Maretin( Reuirements Do#ument marin( the en5 of

the resear#h ro7e#t )Con#et an5 Feasibilit2 Phases* an5 the be(innin( of thero5u#t 5e'eloment ro(ram. The Pro5u#t Mana(er #omletes a Pro5u#t De'eloment Re'ie an5 the %MTaro'es Authori>ation to Continue De'eloment.

6'+ Plannin- Phase

In the Feasibilit2 Phase= a Feasibilit2 Team #omlete5 the Pro5u#t De'eloment Feasibilit2 "tu52an5 the Pro5u#t De'eloment Team #omlete5 the Maretin( Reuirements Do#ument. Theseto 5o#uments full2 5es#ribe the state of the maret= the ro5u#t 5esi(n reuirements toma&imi>e #ustomer satisfa#tion in the maret= an5 the 5e'eloment ro(ram (oals. Durin( thePlannin( Phase= the Pro5u#t De'eloment Team uses these 5o#uments to ro5u#e the Pro5u#tDe'eloment Plan.

6'+'& Definition

The Plannin( Phase of ro5u#t 5e'eloment is that erio5 5urin( hi#h a 5etaile5ro5u#t 5e'eloment lan an5 a #orreson5in( business lan is #reate5 for attainment ofro5u#t an5 ro(ram (oals.

6'+') Ob:ectives

The Plannin( Phase has to )!* ob7e#ti'esH

Create a 5etaile5 lan an5 s#he5ule for 5e'eloin( the ro5u#t. Create a 5etaile5 business lan for 5e'eloin( the ro5u#t.

6'+'+ Activities an% Responsibilities

The a#ti'ities #ommon to this hase are those ne#essar2 to ro5u#e a Pro5u#tDe'eloment Plan for 5ire#tin( ro5u#t 5e'eloment. In (eneral= the folloin( shoul5

o##urH

"ub5i'i5e the ro(ram into 5istin#t (rous of relate5 reuirements an5a#ti'ities. %a#h sub5i'ision reresents a arti#ular "ub-Plan of the De'elomentPlan. These "ub-Plans are the first le'el of 5i'ision an5 #olle#ti'el2 are inten5e5 toembo52 e'er2 reuirement to 5e'elo the ro5u#t. )Pro5u#t De'eloment Team* Form Tas Teams ith resonsibilit2 an5 authorit2 to e&e#ute "ub-Plans an5other Pro5u#t De'eloment Tass. )PDT* %nsure full inte(ration of all 5eartments an5 (rous into the tas teams an5the 5e'eloment ro(ram. )PDT* I5entif2 in 5etail the tass= a#ti'ities= resonsibilities= 5eli'erables= s#he5ule=timetable= an5 resour#e reuirements of ea#h "ub-Plan ne#essar2 to 5e'elo the

ro5u#t se#ifie5 in the Maretin( Reuirements Do#ument. )Teams* If ne#essar2= further sub5i'i5e ea#h "ub-Plan into more 5etaile5 tass. Aointin5i'i5uals or tas teams ith the resonsibilit2 an5 authorit2 to #omlete ea#htas. )Teams* Comlete a +usiness Plan 5etailin( finan#ial an5 human resour#e bu5(ets uses#he5ules= an5 ro5u#t #ost arameters to 5e'elo the ro5u#t as se#ifie5 in theMaretin( Reuirements Do#ument. )PDT* Comlete a Pro5u#t De'eloment Plan b2 in#ororatin( the +usinessAssessment from the Pro5u#t De'eloment Feasibilit2 "tu52= the De'elomentPlan= an5 the +usiness Plan into a sin(le 5o#ument. @5ate an2 of the informationor reuirements as ne#essar2. )PDT* Re'ie an5 aro'e the Pro5u#t De'eloment Plan. )%MT* Con5u#t a Pro5u#t De'eloment Re'ie. )Pro5u#t Mana(er*



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Aro'e Authori>ation to Continue De'eloment. )%MT*

6'+'1 Deliverables

"e#ifi# 5eli'erables result from the #omletion of the a#ti'ities #ommon to thePlannin( Phase of 5e'eloment.

6'+'1'& 0usiness Plan

The +usiness Plan is the bu5(et= use s#he5ule= an5 ro5u#t #ost arametersaro'e5 b2 the %MT. It is a se#tion of the Pro5u#t De'eloment Plan. The+usiness Plan i5entifies an5 s#he5ules #aital an5 non-#aital e&en5itures=human resour#e usa(e= an5 ro5u#t #ost arameters to 5e'elo the ro5u#t asse#ifie5 in the Maretin( Reuirements Do#ument.

6'+'1') Pro%uct Development Plan

The Pro5u#t De'eloment Plan is the master 5o#ument (ui5in( the5e'eloment ro(ram. It is #ontinuousl2 u5ate5 as the 5e'eloment ro#esse'ol'es an5 more information be#omes a'ailable. The Pro5u#t De'elomentPlan 5etails the tass= a#ti'ities= 5eli'erables= s#he5ule= timetable= an5resour#e reuirements ne#essar2 to 5e'elo the ro5u#t as se#ifie5 in theMaretin( Reuirements Do#ument.

6'+'3 Milestones

Milestones 5esi(nate si(nifi#ant oints of ro(ress in the #omletion of a#ti'ities#ommon to the Plannin( Phase of 5e'eloment.

The %MT aro'es the Pro5u#t De'eloment Plan. Pro5u#t Mana(er #omletes a Pro5u#t De'eloment Re'ie an5 the %MTaro'es Authori>ation to Continue De'eloment.

6'1 Development Phase

In the De'eloment Phase= inte(rate5 #ross-fun#tional teams #on#urrentl2 #arr2 out the #omletero5u#t 5esi(n an5 5e'eloment in a##or5an#e ith the Pro5u#t De'eloment Plan. Teams

5e'elo en(ineerin( rotot2es an5 ilot manufa#turin( ro#esses to 'erif2 the 5esi(n asse#ifie5 in the Maretin( Reuirements Do#ument.

6'1'& Definition

The De'eloment Phase of ro5u#t 5e'eloment is that erio5 5urin( hi#h the nee5e5imro'ements in materials= ro#esses= an5 5esi(n are ma5e an5 5urin( hi#h the

ro5u#t is teste5 an5 'erifie5 to be #ommer#iall2 'iable an5 ro5u#ible.

6'1') Ob:ectives

The De'eloment Phase has three )$* ob7e#ti'esH

Mae the nee5e5 imro'ements in materials= 5esi(ns= an5 ro#esses for thefabri#ation of a ro5u#t as se#ifie5 in the Maretin( Reuirements Do#ument. Confirm that the ro5u#t erforms as se#ifie5 b2 #onstru#tin( an5 testin(en(ineerin( rotot2e)s* an5 ilot manufa#turin( ro#esses. Desi(n 'erifi#ation to #onfirm that the 5esi(n outut meets the 5esi(n inutreuirements of the Maretin( Reuirements Do#ument.

6'1'+ Activities an% Responsibilities

The a#ti'ities #ommon to this hase are those ne#essar2 to #arr2 out the #omletero5u#t 5esi(n 5e'eloment an5 reliminar2 Manufa#turin( Pro#ess 5esi(n5e'eloment a##or5in( to the aro'e5 Pro5u#t De'eloment Plan. In (eneral= thefolloin( shoul5 o##urH

Comlete s2stem le'el ro5u#t se#ifi#ations. )Teams*

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Comlete subs2stem le'el ro5u#t se#ifi#ations. )Teams* Comlete reliminar2 s2stem 5esi(n an5 la2out. )Teams* Initiate Ris Anal2sis. )Teams* I5entif2 #riti#al materials= #omonents= subs2stems= an5 ro#esses. )Teams* De'elo #riti#al materials= #omonents= subs2stems= an5 manufa#turin(

ro#esses to the e&tent reuire5 to meet 5esi(n inut reuirements an5 e#onomi#ob7e#ti'es. )Teams* Comlete 'erifi#ation testin( of #riti#al materials= #omonents= subs2stems= an5manufa#turin( ro#esses. )Teams* Con5u#t Te#hni#al Desi(n Re'ie)s* for materials= #omonents= subs2stems=an5 manufa#turin( ro#esses as reuire5. )Pro5u#t Mana(er* I5entif2 an5 initiate ro5u#t stru#ture 5o#umentation )ro5u#t stru#ture / tree=Manufa#turin( Pro#ess flo= et#.*. )Teams* oa5 MRP ? ro5u#t stru#ture )bills of materials= routin(s= et#.*. )Teams* I5entif2 materials= #omonents= an5 manufa#turin( ro#esses ith lon(

ur#hasin( lea5 times an5/or 'en5or 5e'eloment reuirements. Coor5inateur#hasin( of these items ith the Pro5u#t De'eloment Plan s#he5ule foren(ineerin( rotot2e)s*= manufa#turin( rotot2e)s*= an5 ilot ro5u#tion.)Teams* Comlete "ensiti'it2 Anal2sis an5 Te#hni#al Reort. )Teams* Comlete %rror +u5(et)s* an5 Te#hni#al Reort. )Teams* Comlete s2stem 5esi(n of the en(ineerin( rotot2e. )Teams* Comlete 5esi(n of in5i'i5ual ilot manufa#turin( ro#esses. )Teams* Comlete %n(ineerin( Release of all ro5u#t 5esi(n 5o#umentation )to le'elassembl2 5on* for assembl2 of en(ineerin( rotot2e)s*. )Teams* %n(ineerin( an5 Manufa#turin( 7ointl2 fabri#ate en(ineerin( rotot2e)s* usin(

ilot manufa#turin( ro#esses. )Teams* Comlete Reliabilit2 Test Plan. )Teams* Comlete s2stem le'el erifi#ation Test Plan)s*. )Teams* Comlete ali5ation Test Plan)s*. )Teams* Comlete s2stem le'el 'erifi#ation testin( of the en(ineerin( rotot2e)s* ina##or5an#e ith erifi#ation Test Plan)s*. )Teams*

Con5u#t Te#hni#al Desi(n Re'ie)s* for ro5u#t 5esi(n 'erifi#ation of theen(ineerin( rotot2e as reuire5. )Pro5u#t Mana(er* Initiate reliabilit2 testin( in a##or5an#e ith Reliabilit2 Test Plan. )Teams* Etimi>e the ro5u#t 5esi(n throu(h 5esi(n iterations usin( a##etable tests=anal2sis= or #omuter mo5els. )Teams* Etimi>e 5esi(n of the ilot manufa#turin( ro#esses throu(h 5esi(n iterationsusin( a##etable tests= anal2sis= or #omuter mo5els. )Teams* Con5u#t Manufa#turin( Pro#ess Desi(n Re'ie)s* for the in5i'i5ual ilotmanufa#turin( ro#esses as reuire5. )Pro5u#t Mana(er* Comlete 5esi(n of the ilot Manufa#turin( Pro#ess. )Teams* @5ate s2stemle'el erifi#ation Test Plan)s*. )Teams* Comlete reliminar2 Reliabilit2 Testin( of the en(ineerin( rotot2e)s* ina##or5an#e ith Reliabilit2 Test Plan. )Teams* Comlete final s2stem le'el 'erifi#ation testin( of the en(ineerin( rotot2e)s*

after 5esi(n otimi>ation an5 mo5ifi#ations in a##or5an#e ith erifi#ation TestPlan)s*. )Teams* Con5u#t Te#hni#al Desi(n Re'ie)s* for ro5u#t 5esi(n 'erifi#ation of theen(ineerin( rotot2e as reuire5. )Pro5u#t Mana(er* Comlete ilot ualit2 assuran#e ro#esses. )Teams* Comlete reliminar2 Ris Anal2sis an5 Te#hni#al Reort. )Teams* Comlete reliminar2 'ali5ation testin( of the en(ineerin( rotot2e)s* ina##or5an#e ith the ali5ation Test Plan)s*. )Teams* Con5u#t "2stem Desi(n Re'ie)s* for reliminar2 ro5u#t 5esi(n 'ali5ation ofthe en(ineerin( rotot2e as reuire5. )Pro5u#t Mana(er*

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Preare a #he#list to ensure #omletion of 'erifi#ation a#ti'ities for all 5esi(ninut reuirements. )Pro5u#t Mana(er* Comlete the Pro5u#tion Release of all ro5u#t 5esi(n 5o#umentation )to le'elassembl2 5on* for assembl2 of manufa#turin( rotot2e)s*. )Teams* Comlete the %n(ineerin( Release of all Manufa#turin( Pro#ess 5esi(n

5o#umentation )in5i'i5ual ro#esses an5 o'erall Manufa#turin( Pro#ess 5esi(n* forassembl2 of manufa#turin( rotot2e)s*. )Teams* Con5u#t a Pro5u#t De'eloment Re'ie. )Pro5u#t Mana(er* Aro'e Authori>ation to Continue De'eloment. )%MT*

6'1'1 Deliverables

"e#ifi# 5eli'erables result in the #omletion of the a#ti'ities #ommon to theDe'eloment Phase of 5e'eloment.

6'1'1'& En-ineerin- Protot#pe

The essential 5eli'erable of the De'eloment Phase is a teste5 an5 ro'enen(ineerin( rotot2e)s*. Its urose is to #onfirm that the ro5u#t erformsas se#ifie5 an5 'erif2 that 5esi(n outut meets the 5esi(n inutreuirements of the Maretin( Reuirements Do#ument.

6'1'1') Manufacturin- Process Desi-n Documentation

The %n(ineerin( Release of all Manufa#turin( Pro#ess 5esi(n outut5o#umentation #omletel2 5es#ribin( the manufa#turin( an5 testin( of the

ro5u#t.

6'1'1'+ Pro%uct Desi-n Documentation

The Pro5u#tion Release of all ro5u#t 5esi(n outut 5o#umentation full25efinin( the ro5u#t as inten5e5 for the user )#omonent se#ifi#ations=5rain(s= ro5u#t se#ifi#ations= labelin(= a#a(in(= et#.*.

6'1'1'1 Reliabilit# est Plan

The ritten ro#e5ures an5 roto#ol to #on5u#t reliabilit2 an5

maintainabilit2 testin( of the en(ineerin( rotot2e)s*.

6'1'1'3 echnical Reports for Desi-n =ali%ation

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata fromreliminar2 'ali5ation testin( of the en(ineerin( rotot2e)s*.

6'1'1'6 echnical Reports for Desi-n =erification

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata from'erifi#ation testin( an5 'ali5ation testin( of the en(ineerin( rotot2e)s*.

6'1'1'7 echnical Reports on Error 0u%-ets

Te#hni#al Reorts 5etailin( allo#ation of alloable error amon( ossiblesour#es of error to a#hie'e #omlian#e ith 5esi(n reuirements.

6'1'1'8 echnical Reports on Ris4 Anal#sisTe#hni#al Reorts resentin( the reliminar2 results of an in'esti(ation ofthe ro5u#t an5 a'ailable information to i5entif2 ha>ar5s= estimate theirlielihoo5= an5 5etermine the se'erit2 asso#iate5 ith ea#h ha>ar5.

6'1'1'9 echnical Reports on *ensitivit# Anal#sis

Te#hni#al Reorts resentin( the results of an in'esti(ation of #omonents=subs2stems= an5 the ro5u#t to 5etermine outut resonse er unit #han(e ofinut.

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6'1'1'&( echnical Reports on Reliabilit# estin-

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata fromreliminar2 reliabilit2 an5 maintainabilit2 testin( of the en(ineerin(rotot2e)s*.

6'1'1'&& =ali%ation est Plan.sThe ritten ro#e5ures an5 roto#ol to #on5u#t fiel5 testin( or #lini#al trialsof the en(ineerin( rotot2e for 5esi(n 'erifi#ation an5 reliminar2 5esi(n'ali5ation.

6'1'1'&) =erification est Plan.s

The ritten ro#e5ures an5 roto#ol to #on5u#t 'erifi#ation testin( of theen(ineerin( rotot2e for ro5u#t 5esi(n 'erifi#ation.

6'1'3 Milestones

Milestones 5esi(nate si(nifi#ant oints of ro(ress in the #omletion of a#ti'ities#ommon to the De'eloment Phase of 5e'eloment.

Pro5u#t Mana(er #omletes Manufa#turin( Pro#ess Desi(n Re'ie)s* for ilotmanufa#turin( ro#esses. Pro5u#t Mana(er #omletes Te#hni#al Desi(n Re'ie)s* for ro5u#t 5esi(n'erifi#ation an5 of the en(ineerin( rotot2e. Pro5u#t Mana(er #omletes "2stem Desi(n Re'ie)s* for reliminar2 ro5u#t'ali5ation of the en(ineerin( rotot2e. Pro5u#t Mana(er #omletes a Pro5u#t De'eloment Re'ie an5 the %MTaro'es Authori>ation to Continue De'eloment.

6'3 Pre


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Manufa#turin( ersonnel fabri#ate manufa#turin( rotot2e)s* usin( ro5u#t5esi(n 5o#umentation )Pro5u#tion Release* an5 Manufa#turin( Pro#ess 5esi(n5o#umentation )%n(ineerin( Release*. )Manufa#turin(* Comlete 'ali5ation testin( of in5i'i5ual manufa#turin( ro#esses an5 o'erallManufa#turin( Pro#ess 5esi(n. )Teams*

Con5u#t Manufa#turin( Pro#ess Desi(n Re'ie)s* for 'ali5ation of ro#essesan5 o'erall Manufa#turin( Pro#ess 5esi(n. )Pro5u#t Mana(er* Comlete Reliabilit2 Testin( of the manufa#turin( rotot2e)s* in a##or5an#eith Reliabilit2 Test Plan. )Teams* Comlete s2stem le'el 'erifi#ation testin( of manufa#turin( rotot2e)s* ina##or5an#e ith erifi#ation Test Plan)s*. )Teams* Con5u#t Te#hni#al Desi(n Re'ie)s* for ro5u#t 5esi(n 'erifi#ation of themanufa#turin( rotot2e as reuire5. )Pro5u#t Mana(er* Comlete Ris Anal2sis an5 te#hni#al reort. )Teams* Con5u#t Desi(n Re'ie)s* for Ris Anal2sis as reuire5. )Pro5u#t Mana(er* Comlete 'ali5ation testin( of the manufa#turin( rotot2e)s* in a##or5an#eith the ali5ation Test Plan)s*. )Teams* Con5u#t "2stem Desi(n Re'ie)s* for ro5u#t 5esi(n 'ali5ation of themanufa#turin( rotot2e as reuire5. )Pro5u#t Mana(er* Comlete ualit2 assuran#e ro#esses. )Teams* Comlete Pro5u#tion Release of all ualit2 assuran#e 5o#umentation. )Teams* Con5u#t Desi(n Re'ie)s* of ualit2 assuran#e ro#esses for the ro5u#t an5manufa#turin( ro#esses. )Pro5u#t Mana(er an5 8ualit2 "2stems* Comlete #he#list for ensurin( #omletion of 'erifi#ation a#ti'ities for all5esi(n inut reuirements )Pro5u#t Mana(er* @5ate the Pro5u#tion Release of all ro5u#t 5esi(n 5o#umentation )to le'elassembl2 5on* for start of Pilot Pro5u#tion. )Teams* Comlete the Pro5u#tion Release of all Manufa#turin( Pro#ess 5esi(n5o#umentation )in5i'i5ual ro#esses an5 o'erall Manufa#turin( Pro#ess 5esi(n* forstart of Pilot Pro5u#tion. )Teams* Comlete the Manufa#turabilit2 Reort. )PDT* Comlete De'eloment Reort. )PDT*

Comlete a Te#hni#al File in #omlian#e ith the Me5i#al De'i#es Dire#ti'e6$/,!1%%C if reuire5. )PDT* Con5u#t Te#hni#al File Re'ie)s*. )Pro5u#t Mana(er* Con5u#t a Pro5u#t De'eloment Re'ie. )Pro5u#t Mana(er* Aro'eAuthori>ation to Continue De'eloment. )%MT*

6'3'1 Deliverables

"e#ifi# 5eli'erables result from the #omletion of the a#ti'ities #ommon to thePre-Pro5u#tion Phase of 5e'eloment.

6'3'1'& Development Report

Reort summari>in( the 5e'eloment an5 erforman#e of the ro5u#t 5esi(n=#omlian#e ith the 5esi(n reuirements= roblems en#ountere5 in5e'eloment= an5 re#ommen5ations for future 5e'eloment an5

imro'ements.

6'3'1') Manufacturabilit# Report

Reort summari>in( 5e'eloment an5 erforman#e of the Manufa#turin(Pro#ess 5esi(n= #omlian#e ith the 5esi(n reuirements= roblemsen#ountere5 in 5e'eloment= an5 re#ommen5ations for future 5e'elomentan5 imro'ements.

6'3'1'+ Manufacturin- Protot#pe

The essential 5eli'erable of the Pre-Pro5u#tion Phase is a teste5 an5 ro'enmanufa#turin( rotot2e)s*. Its urose is to 'ali5ate the 5esi(n of the



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ro5u#t an5 ro#esses an5 #onfirm that ro5u#t se#ifi#ations #onform touser nee5s an5 inten5e5 use)s* as se#ifie5 in the Maretin( ReuirementsDo#ument.

6'3'1'1 Manufacturin- Process Desi-n Documentation

The Pro5u#tion Release of all Manufa#turin( Pro#ess 5esi(n outut5o#umentation #omletel2 5es#ribin( the manufa#turin( of the ro5u#t )testse#ifi#ations= assembl2 instru#tions= test ro#e5ures= bills of materials=routin(s= et#.*.

6'3'1'3 echnical !ile

A #omilation of 5o#uments an5 te#hni#al files 5emonstratin( 5e'elomentof a ro5u#t in a##or5an#e ith the I"E-6001 International "tan5ar5= "e#tion,., )Desi(n Control*= an5 #omlian#e to the Jessential reuirementsJ setforth in the Me5i#al De'i#es Dire#ti'e= 6$/,!/%%C= Anne& 1.

6'3'1'6 echnical Reports for Desi-n =ali%ation

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata from'ali5ation testin( of the manufa#turin( rotot2e)s*.

6'3'1'7 echnical Reports for Desi-n =erification

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata from'erifi#ation testin( an5 'ali5ation testin( of the manufa#turin( rotot2e)s*.

6'3'1'8 echnical Reports for Process =ali%ation

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata from testin(of the manufa#turin( ro#esses.

6'3'1'9 echnical Reports on Reliabilit# estin-

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata fromreliabilit2 an5 maintainabilit2 testin( of the manufa#turin( rotot2e)s*.

6'3'1'&( >p%ate% Pro%uct Desi-n DocumentationThe u5ate5 Pro5u#tion Release of all ro5u#t 5esi(n outut 5o#umentationfull2 5efinin( the ro5u#t as inten5e5 for the user )#omonent se#ifi#ations=5rain(s= ro5u#t se#ifi#ations= labelin(= a#a(in(= et#.*.

6'3'1'&& >p%ate% Reliabilit# est Plan

The ritten ro#e5ures an5 roto#ol to #on5u#t reliabilit2 an5maintainabilit2 testin( of the manufa#turin( rotot2e)s*.

6'3'1'&) >p%ate% =ali%ation est Plan.s

The ritten ro#e5ures an5 roto#ol to #on5u#t fiel5 testin( or #lini#al trialsof the manufa#turin( rotot2e for ro5u#t 5esi(n 'erifi#ation an5 ro5u#t5esi(n 'ali5ation.

6'3'1'&+ >p%ate% =erification est Plan.sThe ritten ro#e5ures an5 roto#ol to #on5u#t 'erifi#ation testin( of themanufa#turin( rotot2e for ro5u#t 5esi(n 'erifi#ation an5 'ali5ation ofmanufa#turin( ro#esses.

6'3'3 Milestones

Milestones 5esi(nate si(nifi#ant oints of ro(ress in the #omletion of a#ti'ities#ommon to the Pre-Pro5u#tion Phase of 5e'eloment.

Pro5u#t Mana(er #omletes Manufa#turin( Pro#ess Desi(n Re'ie)s* for'ali5ation of manufa#turin( ro#esses an5 Manufa#turin( Pro#ess 5esi(n.

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Pro5u#t Mana(er #omletes Te#hni#al Desi(n Re'ie)s* for ro5u#t 5esi(n'erifi#ation of the manufa#turin( rotot2e. Pro5u#t Mana(er #omletes "2stem Desi(n Re'ie)s* for ro5u#t 5esi(n'ali5ation of the manufa#turin( rotot2e. Pro5u#t Mana(er #omletes a Pro5u#t De'eloment Re'ie an5 the %MT

aro'es Authori>ation to Continue De'eloment.

6'6 Pilot Pro%uction Phase

In the Pilot Pro5u#tion Phase= Manufa#turin( installs the #omlete Manufa#turin( Pro#ess an5maes trial ro5u#tion runs of the ro5u#t un5er full ro5u#tion #on5itions. At this hase of5e'eloment= the entire Manufa#turin( Pro#ess an5 ro5u#t are maret-rea52= ro5u#tionrelease5= an5 fro>en ith rese#t to ma7or 5esi(n #han(es.

6'6'& Definition

The Pilot Pro5u#tion Phase of ro5u#t 5e'eloment is that erio5 5urin( hi#h theManufa#turin( Pro#ess is installe5 an5 trial ro5u#tion runs are ma5e un5er full-s#ale ro5u#tion #on5itions.

Eb7e#ti'esThe Pilot Pro5u#tion Phase has three )$* ob7e#ti'esH

Etimi>e the Manufa#turin( Pro#ess #onsistent ith maret 5eman5s. ali5ate the #omlete Manufa#turin( Pro#ess 5esi(n. Demonstrate rea5iness for #ommer#ial ro5u#tion un5er full-s#ale #on5itions.

6'6') Activities an% Responsibilities

The a#ti'ities #ommon to this hase are those ne#essar2 to install the Manufa#turin(Pro#ess= #on5u#t ilot ro5u#tion run)s*= an5 'ali5ate the #omlete Manufa#turin(Pro#ess 5esi(n. In (eneral= the folloin( shoul5 o##urH

Comlete final Pro5u#tion Release of ro5u#t 5esi(n an5 Manufa#turin(Pro#ess 5esi(n for #ommer#ial ro5u#tion. )Teams* Comlete final Pro5u#tion Release of all ualit2 assuran#e 5o#umentation forall le'els of ro#urement= manufa#turin(= an5 assembl2. )Teams* Finali>e the 5istribution s2stem in#lu5in( shiment= arehousin(= an5#ustomer ser'i#e ro#ess. )Teams* Install the Manufa#turin( Pro#ess. )Teams* Mae ilot run)s* un5er full ro5u#tion #on5itions. )Manufa#turin(* Con5u#t final Manufa#turin( Pro#ess Desi(n Re'ie)s* for 'ali5ation of theManufa#turin( Pro#ess 5esi(n. )Pro5u#t Mana(er* @5ate Manufa#turabilit2 Reort. )PDT* Con5u#t a Final Pro5u#t De'eloment Re'ie. )Pro5u#t Mana(er* Aro'e Release to Full Pro5u#tion an5 "uort. )%MT*

6'6'+ Deliverables

"e#ifi# 5eli'erables result from the #omletion of the a#ti'ities #ommon to the PilotPro5u#tion Phase of 5e'eloment.

6'6'+'& Mar4et Rea%# Pro%uct

The essential 5eli'erable of the Pilot Pro5u#tion Phase is a #ommer#ial unitof ro5u#t rea52 for maret intro5u#tion.

6'6'+') echnical Reports for Process =ali%ation

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata from testin(an5 'ali5ation of the #omlete Manufa#turin( Pro#ess 5esi(n.



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6'6'+'+ >p%ate% Manufacturabilit# Report

@5ate5 reort summari>in( 5e'eloment an5 erforman#e of theManufa#turin( Pro#ess 5esi(n= #omlian#e ith the 5esi(n reuirements=

roblems en#ountere5 in 5e'eloment= an5 re#ommen5ations for future5e'eloment an5 imro'ements.

6'6'1 Milestones

Milestones 5esi(nate si(nifi#ant oints of ro(ress in the #omletion of a#ti'ities#ommon to the Pilot Pro5u#tion Phase of 5e'eloment.

Pro5u#t Mana(er #omletes final Manufa#turin( Pro#ess Desi(n Re'ie)s* for'ali5ation of the Manufa#turin( Pro#ess 5esi(n. Pro5u#t Mana(er #omletes Final Pro5u#t De'eloment Re'ie an5 the %MTaro'es Release to Full Pro5u#tion an5 "uort.

6'7 !ull Pro%uction an% *upport Phase

In the Full Pro5u#tion an5 "uort Phase= Manufa#turin( maes full-s#ale ro5u#tion runs of thero5u#t for #ommer#ial sale an5 the ro5u#t reali>es a useful life as an otimum= #ometiti'e

ro5u#t.

6'7'& Definition

The Full Pro5u#tion an5 "uort Phase of ro5u#t 5e'eloment is that erio5 5urin(hi#h the ro5u#t reali>es a useful life.

6'7') Ob:ective

The ob7e#ti'e of the Full Pro5u#tion an5 "uort Phase is to maintain ma&imum 'alueof the ro5u#t throu(h #ontinue5 #onsi5eration of ro5u#t 5esi(n an5 Manufa#turin(Pro#ess 5esi(n imro'ements.

6'7'+ Activities an% Responsibilities

The a#ti'ities #ommon to this hase are those ne#essar2 to suort= maintain= an5otimi>e the ro5u#t in the maret an5 ee it #ometiti'e. In (eneral= the folloin(

shoul5 o##urH

Pro'i5e on site )ro5u#t use lo#ation* te#hni#al instru#tions an5 u5ates forsafe an5 effe#ti'e use of the ro5u#t. )Te#hni#al "uort* Desi(n an5 intro5u#e timel2 but minor imro'ements in materials=#omonents= s2stems= an5 softare. )"uort %n(ineerin(* Pro5u#e an5 5istribute sare arts. )Manufa#turin(* Pro'i5e arrant2 ser'i#es. )Customer "er'i#e* Intro5u#e ne ali#ations 5e'eloe5 for the ro5u#t. )"uort %n(ineerin(* Disseminate alerts an5 un5ertae reme5ial a#tion for unlanne5 ro5u#t5efi#ien#ies or #han(in( safet2 reuirements. )8ualit2 "2stems*

6'7'1 Deliverables

"e#ifi# 5eli'erables result from the #omletion of the a#ti'ities #ommon to the FullPro5u#tion an5 "uort Phase of 5e'eloment.

6'7'1'& Pro%uct

The essential 5eli'erable of this hase is an otimum= #ometiti'e ro5u#t.

6'7'1') echnical Reports on Pro%uct *upport

Te#hni#al Reorts resentin( the results an5 erforman#e 5ata on reliabilit2=maintainabilit2= ser'i#eabilit2= mo5ifi#ations= imro'ements= 5efi#ien#ies=safet2= #ustomer interfa#in(= et#. 5urin( suort of the ro5u#t in the fiel5.



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6'7'3 Milestones

Milestones 5esi(nate si(nifi#ant oints of ro(ress in the #omletion of a#ti'ities#ommon to the Full Pro5u#tion an5 "uort Phase of 5e'eloment.

The %&e#uti'e Mana(ement Team maes the 5e#ision to terminate ro5u#tion

an5 sale of the ro5u#t.

7'( Appen%i,

7'& ?lossar# of echnical erms

7'&'& Acceptance Criteria

Define5 limits la#e5 on #hara#teristi#s= materials= or ro5u#ts.

7'&') Desi-n @istor# !ile .D@!

A #omilation of re#or5s= hi#h 5es#ribes the 5esi(n histor2 of a finishe5 ro5u#t.

7'&'+ Desi-n Input

The h2si#al an5 erforman#e reuirements of a ro5u#t use5 as a basis for ro5u#t5esi(n an5 5e'eloment.

7'&'1 Desi-n Output

The results of a 5esi(n effort at ea#h 5esi(n hase an5 at the en5 of the total 5esi(neffort. The finishe5 5esi(n outut is the basis for the De'i#e Master Re#or5. The totalfinishe5 5esi(n outut #onsists of the ro5u#t= its a#a(in( an5 labelin(= an5 theDe'i#e Master Re#or5.

7'&'3 Desi-n =ali%ation

%stablishin( b2 ob7e#ti'e e'i5en#e that ro5u#t se#ifi#ations #onform to user nee5s an5inten5e5 use)s*.

7'&'6 En-ineerin- Protot#pe

An a#tual orin( 'ersion of a ro5u#t= hi#h is use5 to (ather en(ineerin( informationon the oeration= erforman#e to se#ifi#ations= an5 manufa#turin( reuirements. Man2times it is one of a in5 an5 #ommonl2 fitte5 ith se#ial instrumentation to #onfirmthat the ro5u#t erforms as se#ifie5 an5 'erif2 that 5esi(n outut meets the 5esi(ninut reuirements. The mo5el is of suffi#ient te#hni#al ualit2 to 5etermine hether amanufa#turin( rotot2e shoul5 be built.

7'&'7 Error 0u%-et

An allo#ation )or bu5(et* of alloable error amon( ossible sour#es of error to a#hie'e#omlian#e ith 5esi(n reuirements.

7'&'8 E,perimental Protot#pe

This ben#h or brea5boar5 mo5el)s* is one le'el of sohisti#ation hi(her than the

test-of-rin#ile mo5el. It is use5 to ro'e that a ne ro5u#t #an be 5e'eloe5 from as#ientifi# #on#et to erform as e&e#te5 an5 ro'i5e 5ata to ro'e same.

7'&'9 !unctional Re5uirements

"e#if2 hat the ro5u#t 5oes= fo#usin( on its oerational #aabilities an5 thero#essin( of inuts an5 resultant oututs.

7'&'&( Interface Re5uirements

"e#if2 #hara#teristi#s of the ro5u#t= hi#h are #riti#al to #omatibilit2 ith e&ternals2stems. More se#ifi#all2= these are #hara#teristi#s man5ate5 b2 e&ternal s2stems an5



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outsi5e the #ontrol of the 5e'eloers. Ene interfa#e= hi#h is imortant in e'er2 #ase= isthe user an5/or #ustomer interfa#e.

7'&'&& Manufacturin- Processes

An2 a#tion or oeration that is a 5istin#t ste in the manufa#ture of a ro5u#t ith a

5efine5 be(innin( an5 a 5efine5 en5.

7'&'&) Manufacturin- Process Desi-n

The 5esi(n of the total= #omrehensi'e oeration to manufa#ture a ro5u#t )theManufa#turin( Pro#ess*. It in#lu5es material lo(isti#s= in5i'i5ual ro#esses= tools=euiment= an5 all other reuirements to manufa#ture a ro5u#t in #omlian#e ith5esi(n se#ifi#ations.

7'&'&+ Manufacturin- Protot#pe

A full s#ale= #omletel2 oerational mo5el built to #onfirm manufa#turin( an5fabri#ation reuirements for the manufa#turin( of the ro5u#t. It is use5 to (enerateen(ineerin( 5ata an5 information on the oeration= ualit2= an5 reliabilit2 of the re-

ro5u#tion mo5el to 'ali5ate the 5esi(n of the ro5u#t an5 ro#esses an5 #onfirm thatro5u#t se#ifi#ations #onform to user nee5s an5 inten5e5 use)s*.

7'&'&1 Performance Re5uirements

"e#if2 ho mu#h or ho ell the ro5u#t must erform= a55ressin( su#h issues assee5= stren(th= resonse times= a##ura#2= limits of oeration= et#. This in#lu5es auantitati'e #hara#teri>ation of the use en'ironment= in#lu5in( temerature= humi5it2=sho#= 'ibration= ele#troma(neti# #omatibilit2= et#. Pro5u#t reliabilit2 an5 safet2reuirements also fit in this #ate(or2.

7'&'&3 Process =ali%ation

%stablishin( b2 ob7e#ti'e e'i5en#e that a ro#ess #onsistentl2 ro5u#es a result orro5u#t meetin( its re5etermine5 se#ifi#ations.

7'&'&6 Pro%uct

@nless otherise se#ifie5= the or5 Jro5u#tJ is use5 in the more (lobal sense to referto #omonents= materials= stru#tures= ma#hines= 5e'i#es= s2stems= ro#esses= softare= orser'i#es.

7'&'&7 Pro%uct Desi-n

The 5esi(n of the ro5u#t itself lus the 5esi(n of the s2stem in hi#h it is oerate5 an5maintaine5 )user interfa#e= suortin( euiment= oeratin( instru#tions= et#.*. Pro5u#t5esi(n is inten5e5 to in#lu5e the 5esi(n of e'er2thin( about the ro5u#t an5 its useeet the Manufa#turin( Pro#ess 5esi(n.

7'&'&8 Pro%uct *tructure

The formal #onfi(uration of all the materials= #omonents= subs2stems= ro#esses=5o#umentation= et#. use5 to manufa#ture the ro5u#t. All elements of the ro5u#tstru#ture 5eri'e from the Manufa#turin( Pro#ess flo.

7'&'&9 Pro%uction *pecifications

A #omilation of 5o#uments su#h as assembl2 5rain(s= #omonent se#ifi#ations=manufa#turin( instru#tions= test se#ifi#ations= ormanshi stan5ar5s= et#.= or an2other euall2 a##etable means= ritten an5 unritten= to #ommuni#ate an5 #on'e25esi(n information to Manufa#turin( for the urose of reeate5l2 an5 reliabl2manufa#turin( a ro5u#t.

7'&')( Reliabilit# est Plan

The ritten ro#e5ures an5 roto#ol to #on5u#t reliabilit2 an5 maintainabilit2 testin( ofthe en(ineerin( an5/or manufa#turin( rotot2e. This testin( 5etermines te#hni#al



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#omlian#e ith reliabilit2 an5 maintainabilit2 ob7e#ti'es in the Maretin(Reuirements Do#ument. It i5entifies real an5 otential 5efi#ien#ies an5 se#ifi# areasfor imro'ement.

7'&')& Ris4 Anal#sis

The in'esti(ation an5 assessment of a'ailable information to i5entif2 ha>ar5s )aotential sour#e of harm* an5 to estimate their ris )the robable rate of o##urren#e of aha>ar5 an5 the se'erit2 of the harm*.

7'&')) *cientificall# =ali%

"#ientifi#all2 'ali5 means there are no (eneral truths or h2si#al las= as obtaine5 an5teste5 throu(h the use of the s#ientifi# metho5 that 5o or #oul5 ren5er the #on#etinfeasible.

7'&')+ *ensitivit# Anal#sis

The in'esti(ation of #omonents= subs2stems= an5 the ro5u#t to 5etermine oututresonse er unit #han(e of inut.

7'&')1 *tate of the Art

An en(ineerin( term normall2 iml2in( the state of nole5(e a'ailable in a fiel5 ofs#ien#e or en(ineerin(. It is often 5eri'e5 from a sur'e2 of the oen s#ientifi# literatureor= in the #ase of ro5u#ts= a atent sear#h of in'entions in the (eneral sub7e#t area. The

urose is not to Jrein'ent the heelJ an5 to a'oi5 atent infrin(ement battles at a later5ate of ro5u#t 5e'eloment.

7'&')3 echnical !ile

A #omilation of 5o#uments an5 te#hni#al files 5emonstratin( 5e'eloment of a ro5u#tin a##or5an#e ith the I"E-6001 International "tan5ar5= "e#tion ,., )Desi(n Control*=an5 #omlian#e to the Jessential reuirementsJ set forth in the Me5i#al De'i#esDire#ti'e= 6$/,!/%%C= Anne& 1.

7'&')6 est