IMPROVEMENT OF THE PROCESS OF IMPLEMENTATION OF NEW PRODUCT FOR EUROPEAN MARKET - CASE STUDY

Production Engineering

-A st a t:

A i sepa a le ele e t of i tellige t p o esses is the effe ti e use of k o ledge gai ed f o e te al sou es a d the a ilit to ha ge u de the i flue e of e te al fa to s. A e a ple of this a e fou d i the p o ess of i t odu i g a e o st u tio p odu t to the EU a ket. It has to ea t to the e e - ha gi g EU legislatu e a d the atio al egula-tio s that adapt to it. The f e ue tl asked uesegula-tio s f o a ufa tu e s a d i po te s i di ate the e essit of e-ati g a p o edu e that ould allo fo p e isel e plai i g hat the algo ith of the p o ess looks like a d hat ite ia

ust e et to i t odu e the e p odu t i to the o st u tio p odu t a ket. The o ple it a d ultitude of egu-latio s as ell as the la guage a ie also ause othe o pli atio s ith the u de sta di g of the p o ess p o edu e of o du t. The g aphi al p ese tatio of the algo ith should fa ilitate follo i g the path of o du t i the ase of i t odu i g a e o st u tio p odu t i to the EU a ket. The g aphi al fo should allo fo i tuiti e o e e t i the p o ess a d a o stitute a asis fo eati g a i te a ti e fo .

IMPROVEMENT OF THE PROCESS OF IMPLEMENTATION

OF NEW PRODUCT FOR EUROPEAN MARKET

-

CASE STUDY

INTRODUCTION

Regulatio EU No / of the Eu opea Pa lia-e t a d of thlia-e Cou il of Ma h la i g do ha -o ised -o diti-o s f-o the a keti g -of -o st u ti-o p - o-du ts is u e tl o side ed a ke o e ithi the Eu opea U io a d sta ds a o e atio al la . It is efe ed to i sho t as Co st u tio P odu t Regulatio CPR . F o the da the afo e e tio ed egulatio a e i to fo e, the a ufa tu e s i t odu i g o st u tio p odu ts i to i ulatio ithi the Eu opea s ste e e put u de o ligatio to:

 d a up a d deli e alo g ith the at h of p odu ts i te ded fo a si gle e ipie t a op of a e do

u-e t – a du-e la atio of pu-e fo a u-e,

 a ki g the p odu ts ith the CE a ki g ith addi-tio al i fo aaddi-tio [ ].

These o ligatio s a e losel o e ted ith the eed to o du t the p o ess of assess e t a d e ifi atio of the o siste of fu tio al p ope ties a d d a i g up te h i al do u e tatio . A o di g to the CPR, the p o-du t is to e a o pa ied ope ati g i st u tio s a d safet i fo atio , as ell as i fo atio esulti g f o a t. o of the Regulatio EC No / of the Eu opea Pa lia e t a d of the Cou il of De e e o e i g the Regist atio , E aluatio , Autho isatio a d Rest i tio of Che i als REACH [ ].

A o di g to A t. se t. of the CPR, a ufa tu e s de la e the fu tio al p ope ties of the esse tial ha a

te-isti s ith efe e e to the i te ded use of the p odu t a o di g to the ha o ised te h i al spe ifi atio . The

CPR si ulta eousl e ui es the fu tio al p ope t to e de la ed ith efe e e to at least o e esse tial ha a te i-sti , a d i the ase of a p odu t fo hi h a Eu opea Te h i al App o al has ee issued it is e essa to de

la-e all thla-e p opla-e tila-es i ludla-ed i thla-e ETA Eu opla-ea Tla-e h i-al App o i-als . At the sa e ti e, the s ope a d le el of the p ope ties de la ed eeds to take i to a ou t the te h

i-al egulatio s pe tai i g to the use of the p odu t i the lo atio of its p ospe ti e appli atio .

Regulatio EU No / ha ges the esta lished ea i g of the CE a ki g. A CE a ki g o a o st u tio p odu t u e tl se es to p o e its o plia e ith the fu tio al p ope ties de la ed. It is the s ope a d le el of those p ope ties that de ide hethe the p odu t a e ade a aila le i the a ket of a EU e e ou t , a d the e e states gai the ight to ithd a f o thei a kets p odu ts hose p ope ties do ot o pl ith thei te h i al e ui e e ts. The CE a ki g is, the e-fo e, o lo ge a passpo t hi h allo s e-fo the p odu t to

e sold i the EU a ket; it si pl o stitutes a o fi a-tio of the de la aa-tio ’s edi ilit [ ].

The a o e o ditio s ause the a ufa tu e ’s de i-sio s ega di g pla i g the t pe of o st u tio p odu t des i ed a set of fu tio al p ope ties of the esse tial ha a te isti s to e o e espe iall i po ta t. It is a ti e-o su i g a d e-ostl task hi h e ui es detailed a d up-to-date k o ledge i te s of oth the te h i al e ui e-e ts of the-e Eu ope-ea U io ou t ie-es a d the-e p o e-edu e-e fo setti g a d o te ts of te h i al spe ifi atio s ha o i-sed ith the CPR.

Mi hał ZASADZIEŃ Silesia U i ersity of Te h ology

Zofia NOWROT Buildi g Resear h I stitute

Key ords: o stru tio produ t, the EU arket, CE, har o ized sta dards, la eli g

DOI . /MSPE- -

Of ou se, alo gside CPR e should also a al se o-e isti g o plo-e o-e ta o-egulatio s. Espo-e iall o th of

ote a e:

 Regulatio EC No / of the Eu opea Pa lia-e t a d of thlia-e Cou il of Jul setti g out the e ui e e ts fo a editatio a d a ket su eilla -e -elati g to th-e a k-eti g of p odu ts,

 De isio No / /EC of the Eu opea Pa lia-e t a d of thlia-e Cou il of Jul o a o o f a e o k fo the a keti g of p odu ts,

 Regulatio EC No / of the Eu opea Pa -lia e t a d of the Cou il of De e e o -e i g th-e R-egist atio , E aluatio , Autho isatio a d Rest i tio of Che i als REACH ,

 Eu opea Te h i al App o als Guideli es ETAG . A o di g to the Regulatio EU No. / , the tools used fo de la i g fu tio al p ope ties a e ha o i-sed Eu opea sta da ds hEN a d Eu opea Te h i al As-sess e ts. The Eu opea Co issio pu lishes i fo atio o gi i g the Eu opea Sta da ds the status of sta -da ds ha o ised ith the di e ti e i fo of o u i a-tio s hi h appea i the Offi ial Jou al of the EU.

I the ase of i o ati e p odu ts hi h do ot fall ithi the o je ti e s ope of ha o ised sta da ds o o es fo hi h the o is ot a ade uate assess e t tool, the o e t efe e e do u e t he de la i g thei fu tio-al p ope ties is a olu ta Eu opea Te h i tio-al App o tio-als ETA do u e t. It is a do u e ted assess e t of fu

tio-al p ope ties issued the Te h i tio-al Assess e t Bod TAB a d ag eed o the Eu opea O ga isatio fo Te h i al Assess e t EOTA .

To su up, a o di g to the CPR all usi ess e tities i the hai of suppl a d dist i utio should u de take ea-su es to gua a tee that the a e i t odu i g i to i ulatio

o st u tio p odu ts i o plia e ith the e ui e e ts set fo th i the CPR ai ed at e su i g the fu tio al p o-pe ties of o st u tio p odu ts a d eeti g the asi

e ui e e ts fo st u tu es. I po te s a d dist i uto s of p odu ts should e a a e hi h esse tial ha a te isti s a e egulated i the EU a ket a d hat spe ial e ui

e-e ts a e-e i pla e-e i the-e e-e e Cou t ies.

The a ufa tu e o i po te dist i uto is the efo e o liged to:

 pe fo a o plia e assess e t,

 issue a de la atio of pe fo a e a d ake it a ai-la le i a o da e ith the ele a t eguai-latio s a d o the asis of:

 i itial t pe testi g,

 fa to p odu tio o t ol,

 tests of fi al p odu ts o du ted the a ufa -tu e i a o da e ith the testi g pla ,

 a ki g of the p odu t i a o da e ith the e-gulatio s,

 o du ti g tests o the fi al p odu ts.

PROCESS IMPROVEMENT – ASSUMPTIONS

The p o ess of i t odu i g a e o st u tio i dust p odu t is e o pli ated fo the a ufa tu e s. The legislatio i this ega d is a iguous, ulti-le eled a d o ple . Apa t f o the u e t legal situatio , p odu t sta da ds a d testi g sta da ds as ell as ei g a uai ted ith the te i olog , the a ufa tu e ust also k o thei espo si ilities esulti g f o the la a d ide tif the egulatio s hi h pe tai to thei , ofte ti es spe ifi , p o-du t. The e a e, ad ittedl , tools hi h aid a ufa tu e s, ut fo a o pa ies the a e ot suffi ie t o do ot fu tio as e pe ted.

A a al sis of data fo the Ge e al Offi e of Buildi g Co t ol a d the Eu opea Co issio [ , ] ade possi le the ide tifi atio of the ost i po ta t a eas of k o led-ge hi h the p o ess pa ti ipa ts ha e p o le s ith. The a e p ese ted i Ta le .

As a e see , % of the ue ies elate to the Othe a d P odu t a ki g atego ies. These atego ies i lu-des uestio s pe tai i g to the p o edu es o e ted ith

a ki g p odu ts ith the B a d CE a ki gs as ell as othe s, ot elated to atego ies - . The efo e, it see s i po ta t to eate a u i e sal tool that is eas to i te p et a d hi h ould fa ilitate the p o ess of i t odu i g e o st u tio p odu ts i to the Eu opea U io ou t ies’ a ket. As i t odu i g a e p odu t i to the a ket has ee t eated as a p o ess, the easiest solutio is to illust a-te it ith a g aphi algo ith a d de elop ele a t p o e-du es. Su h ate ial a e the sta ti g poi t fo eati g a utilita ia IT tool hi h a e i ple e ted i a p odu -tio o pa . Due to the highl o pli ated egula-tio s of the EU legislati e s ste i this ega d a d the e iste e of a g eat u e of o st u tio p odu ts, the algo ith is e o ple a d a ot e p ese ted i full i this a ti le. Si fu tio all sepa ate p o esses paths of o du t

hi h a e utilised ha e ee ide tified. Path

This path is used he the e is a ha o ised p odu t sta da d a d the p odu t is su je t to said sta da d. It is the efo e e essa fo the p odu t to e e tified ith a CE a ki g. The supe io egulatio i this ase is the CPR. E e pted f o o ligato a ki g a e p odu ts:

 a ufa tu ed i di iduall ,  a ufa tu ed t aditio all ,  p odu ed fo a spe ifi use.

Ta le 1 1 State U i ersities i the Silesia Voi odeship hi h offer the Produ tio E gi eeri g a d Ma age e t ourse

Que y topi Pe entage sha e of the atego y in all ue ies

Ge e al ue a out i fo atio esulti g f o the CPR %

De la atio of pe fo a e %

Duties of the pa ties %

P odu t a ki g %

Path

This path is used he the e is a p odu t sta da d, ut it is ot ha o ised e.g. Polish Sta da d . It is the efo e e essa fo the p odu t to e a ked ith the B o -st u tio a ki g. the p o edu e is des i ed i the Regula-tio of the Mi iste of I f ast u tu e of th August o ethods of de la i g o plia e of o st u tio p o-du ts a d ethods of a ki g the ith the o st u tio

a ki g Jou al of La s, No. , ite as a e ded . Path

To use this path, the p odu t ust eet the follo i g e ui e e ts: the e is a ha o ised p odu t sta da d, ut the p odu t is ot full su je t to the e isti g ha o ised sta da d. I o de to i t odu e the p odu t i to the a ket, it eeds to e a ked ith the B o st u tio a ki g. Path

This path is used he the e is o p odu t sta da d, ut the e e ist Eu opea Te h i al App o als. It is the efo e e essa fo the p odu t to e a ked ith the B o -st u tio a ki g.

Path

This algo ith a e applied he the e is o p odu t sta da d ut the e e ists a Eu opea Assess e t Do

u-e t – EAD. It is possi lu-e to olu ta il a k thu-e p odu t ith the CE a ki g. Path , the efo e, is si ila to the fi st o e.

Path

This path is i te ded fo p odu ts fo hi h the e is o p odu t sta da d o a othe efe e e do u e t. I this ase o e should get i tou h ith the sele ted TAB a d appl fo a EAD. Follo i g that, the p o edu e o ti ues as i the ase of path . All the hile it should e e e

e-ed that the p o e-edu e of eati g a Eu opea Assess e t Do u e t is u e tl st aite ed a d ostl . It is, ho e e , possi le fo the p o edu e to e fi a ed se e al o

pa-ies si ulta eousl .

ALGORITHM OF CONDUCT – EXAMPLE

Taki g i to a ou t the o ple it of the algo ith s de eloped, o l o e of the - the o e ost t pi al fo a-ses he the p odu t is su je t to a ha o ised sta da d

hEN – is sho elo . I su h a ase CE a ki g is e-essa , i a o da e ith the Regulatio EU No / of the Eu opea Pa lia e t a d of the Cou il of Ma h . G aphi al ep ese tatio of the p o edu e has ee sho i Figu e .

The su se ue t stages of path a e e e uted i the follo i g o de :

. Does a p odu t sta da d e ist – YES a s e

I o de to a s e this uestio o e should apa l ide tif the p odu t a d the he k the sou es a

aila-le to see hethe su h a do u e t e ists. This a e do e usi g the sea h e gi e a aila le o the e site of the Polish Co ittee fo Sta da disatio ; e.g. fa to -ade St ofoa p odu ts EPS ha e thei sta da d

desig ated as PN-EN +A : - .

. Is the sta da d ha o ised? – YES a s e

Helpful i fi di g a a s e to this uestio ill e the o u i atio of the Eu opea Co issio hi h lists the sta da ds ha o ised ith the CPR, e.g. the PN-EN +A : - sta da d is listed as ha o ised ith CPR i the u e t o u i atio of the Eu opea Co issio .

. Is the p odu t full o e ed the hEN? – YES a s e To a s e this uestio o e eeds to ha e a ess to the pa ti ula p odu t’s sta da d. E a t i fo atio a e fou d i the fi st poi t of the sta da d i the hapte titled S ope .

If the p odu t is full o e ed the ha o ised o , it a dato il has to e a ked ith the CE a ki g i o de to e i t odu ed i to the Eu opea a ket. The efo e, the o pa ust follo the guideli es of the CPR, i.e. o plete the follo i g steps of the p o e-du e.

. Ve ifi atio of the esse tial ha a te isti s a d dete i-i g the o pli-ia e assess e t s ste

I the ase of e t uded pol st e e, the e essa i fo -atio a e fou d i Ta le ZA. of the PN-EN

+A : - sta da d. The o plia e assess-e t s stassess-e ill i this asassess-e dassess-epassess-e d o thassess-e dassess-e la assess-ed ea tio to fi e. The St ofoa s ost o o i the a ket ha e a ea tio to fi e lass desig ated as E, a d the efo e thei o plia e assess e t s ste is

S ste .

. P odu t T pe Dete i atio PTD

The assess e t of the fu tio al p ope ties of a p o-du t is do e th ough p oo-du t t pe testi g. Depe di g o the o plia e assess e t s ste , these tests a e o du ted eithe the a ufa tu e the sel es o i oope atio ith a otified esea h u it.

P odu t t pe dete i atio PTD of e t uded pol st e-e is a ie-ed out a Te-e h i al Asse-ess e-e t Bod . The-e esult of the la o ato tests o du ted is a test Repo t, hi h ill e a pa t of the do u e tatio kept the Fa to P odu tio Co t ol.

. Assig i g the p odu t ith a u i ue ide tifi atio u -e

. D a i g up de la atio s of pe fo a e

The de la atio do u e t ust e i o plia e ith the CPR. the de la atio ust e kept fo ea s f o the date the p odu t as last ade a aila le i the a -ket. Its op a e pla ed o a e site, i hi h ase a pape op is deli e ed to the usto e o l upo a e pli it e uest.

. Desig i g the CE la el

The la el should e pla ed i the p odu t i a o da e ith the CPR guideli es.

. C eati g a ope ati g a ual

Befo e eleasi g the p odu t i to the a ket it should e appe ded ith a ope ati g a ual a d i fo atio

pe tai i g to the haza dous su sta es the p odu t o -tai s i a o da e ith the REACH egulatio s.

. I t odu i g the p odu t i to the Eu opea a ket Afte ha i g i t odu ed the p odu t i to the a ket, the

a ufa tu e is o liged to o du t fa to p odu tio o t ol a d a out o t ol tests i a o da e ith the e ui e e ts of the p odu t’s sta da d. I ase he : the sta da d is ha ged, epla ed o e pi es, the FPC i di ates a ha ge i the fu tio al p ope ties of the p odu t o the p odu tio p o ess gets odified, it is e essa to a al se the ha ges, a d i ost ases go th ough the p o edu e agai sta ti g ith poi t o e [ ].

CONCLUSIONS

As a esult of the esea h o du ted, e a o lude that:

. The e is o p o le ith a essi g i fo atio sou es, ut thei s ope a d the a the a e put togethe a ause p o le s ith thei a al sis. The p o ess is o -ple , the p o edu es of o du t ela o ate, ofte u lea to thei a to s.

. The a al sis of data f o elia le sou es EC, GOBC has sho hi h issues a e the ost p o le ati fo the p o ess pa ti ipa ts. The ost f e ue tl asked uestio s pe tai to a ki g p odu ts ith the B o -st u tio a ki g hi h is o-st likel a esult of the

atio al egulatio s ei g o sta tl adjusted fo o -plia e ith the CPR . Also isi l p o le ati fo the a e the issues o e ted ith usi g the CE a ki g a d fulfilli g the o ligatio s put upo the a ufa tu e the CPR.

. A g aphi al ep ese tatio of the p o ess algo ith has ee p oposed as a solutio to the p o le . I fo a-tio gathe ed i the lite atu e pa t has ee p ese ted usi g a dedi ated p og a i fo of a p o edu e. The p o edu e is o p ehe si le a d the o de of a tio s

lea l defi ed.

. The p o edu e a d algo ith de eloped a se e as a sta ti g poi t fo desig i g a fu tio al IT tool hi h ould fa ilitate the p o ess of i t odu i g a e o -st u tio p odu t i to the Eu opea a ket.

This arti le as prepared ithi the statutory resear h titled Produ tio e gi eeri g ethods a d tools

for de elop e t of s art spe ializatio s ,

ork sy ol / /BK_ 6/ perfor ed

at Silesia U i ersity of Te h ology, I stitute of Produ tio E gi eeri g.

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