Alesi Nàtrɔ Ƒumeŋuɖui Dɔwɔƒewo Evɔ Màgblẽ Wò Mama Dɔwɔƒe O

Afɔku gbãtɔ ƒe ɖoɖo si woatsɔ ada ƒumeŋuɖui ƒe atikewɔƒe aɖe kpɔ hafi atrɔ.

Ƒumeŋutinunyalawo ƒe tɔtrɔ ate ŋu ana adzɔnuwo ƒe agbɔsɔsɔme, asixɔxɔ, OEM ƒe asitɔtrɔ le nɔnɔmewo ŋu, alo woƒe tsɔtsɔ yi na amewo ƒe dɔwɔwɔ nanyo ɖe edzi. Ate ŋu ana atikewɔnuwo mamala hã nakpɔ gazazã ɣaɣlawo, nuŋlɔɖiwo ƒe vovototowo, ɣeyiɣi siwo woatsɔ awɔ dɔe si meli ke o, dɔwɔnuwo ƒe hatsotso siwo mede blibo o, kple tɔtɔ si woate ŋu aƒo asa na na kɔdzi ƒe asisiwo.

Eyata menye nyayɔyɔ ɖeɖeko dzie wotu nyametsotso si le dedie wu ɖo o. Wotue ɖe ƒumeŋutinunyalawo ƒe nudzralawo ƒe numekuku si wowɔ ɖe ɖoɖo nu dzi si doa gazazã bliboa, asi ƒe dzadzraɖo, nuzazãwo ƒe kakaɖedzi, wo yometiti, nyatoƒoetotowo gbɔ kpɔkpɔ, kple tɔtrɔ ƒe kpekpeɖeŋu kpɔ hafi wodzidzea ƒomedodo yeyea.

Mamãlawo ƒe nyametsotso ŋuti mɔfiame sia ɖe vodada atɔ̃ siwo xɔa ga geɖe siwo wòle be woaƒo asa na ne wole ƒumeŋuɖui ƒe dɔwɔƒe trɔm me eye wòna dodokpɔ ŋutɔŋutɔ siwo nuƒlelawo, nyonyome, ɖoɖowɔwɔ, ganyawo, kple nudzadzra ƒe ƒuƒoƒowo ate ŋu azã ɖekae.

Nusita Ƒumeŋutinunyalawo Bua Nudzralawo Trɔtrɔ Ŋu

Zi geɖe la, nya geɖe gbɔe nudzralawo ƒe tɔtrɔ tsona tsɔ wu be kuxi ɖeka si sa ɖe aga. Nusiwo ʋãa ame zi geɖe dometɔ aɖewoe nye portfolio ƒe goglome si seɖoƒe li na, megbeɖoɖo siwo gbugbɔna, nuŋlɔɖiwo ƒe kpekpeɖeŋu blewu, kadodo si mewɔa tɔtrɔ o, ame ŋutɔ ƒe ŋkɔ ƒe tiatia siwo metrɔna o, kple ŋutetemanɔamesi be woado alɔ kekeɖenudɔ ɖe asi yeyewo me.

Gake ƒumeŋutinunyala aɖe ɖɔliɖɔli kpɔa ŋusẽ ɖe nu geɖe dzi wu nuƒle. Ate ŋu akpɔ ŋusẽ ɖe amewo ƒe ŋkɔ dede agbalẽ me, ŋkɔ dede wo dzi, dɔbiagbalẽviwo, nudzraɖoƒewo, dɔwɔnuwo ƒe agbawo, nudzadzra ƒe hehenana, kɔdzi ƒe dɔwɔwɔ ƒe ɖoɖowo, kple nudzadzra megbe subɔsubɔdɔ dzi. Bu tɔtrɔa abe nuzazãwo ƒe kɔsɔkɔsɔ ƒe dɔ si wowɔna le wo nɔewo dome ene, ke menye nudzrala ɖɔliɖɔli bɔbɔe o.

Vodada #1: Bubu Unit Price abe Gazazã Ŋutɔŋutɔ ene

Nyayɔyɔ si bɔbɔ ate ŋu adze nusi adze ame ŋu eye wòana dɔwɔwɔ ƒe gazazã si lolo wu nado mo ɖa le nudɔdɔ gbãtɔwo megbe. Ga si woatsɔ akpɔ nuawo tsoe ŋutɔŋutɔ lɔ gazazã ɖesiaɖe si hiã be woatsɔ axɔ nuawo, adze, adzra wo ɖo, ado alɔ wo, ahagbugbɔ wo ade wo me ɖe eme.

• Inventory buffers: extra stock si wolé ɖe asi esime nudzrala yeyea ƒe nudɔdɔ ƒe dɔwɔwɔ meɖo kpe edzi haɖe o.

• Tɔdziʋuɖoɖo kabakaba: agbatsɔtsɔ kpata si wozãna tsɔ haya tso ewɔwɔ alo nyagblɔɖi ƒe megbetsitsi me.

• Gazazã siwo do ƒome kple nyonyome: ŋkuléle ɖe nu ŋu, tɔtrɔgbɔ, ɖɔliɖɔli, nyatoƒoetoto ŋuti numekuku, kple nubablɛ siwo gblẽ.

• Nuŋlɔɖidɔwo ƒe agba: QA/RA ɣeyiɣi si wozãna tsɔ biaa ɖaseɖigbalẽwo, gbegɔmeɖeɖewo, nɔnɔme tɔxɛwo, kple asitɔtrɔwo.

• Dɔwɔwɔ ƒe tɔtɔ: nudɔdɔ siwo mede blibo o alo nuawo ƒe aƒetɔ ƒe vodada siwo gblẽa nu le dɔbiagbalẽviwo, kɔdziwo, kple nudzralawo ƒe ƒuƒoƒowo ŋu.

Gɔmeɖose vevitɔ: Menye nudzrala si ƒe asi bɔbɔ wue nye nudzrala si ƒe gazazã bliboa bɔbɔ wu kokoko o.

Tu Dɔwɔgbalẽvi Si Wozãna le Anyigba Dzi Hafi Nàna Asitsatsa

Ne mede ɖeke o la, tsɔ adzɔnuwo ƒe asi, nudɔdɔ ƒe agbɔsɔsɔ suetɔ, ​​agbatsɔtsɔ, nugblẽfexeɖoɖo, adzɔwo, dukɔmeviwo ƒe fewo, nudzraɖoƒe, dedienɔnɔ ƒe nudzraɖoƒe, gazazã siwo wokpɔ mɔ na kabakaba, tɔtrɔgbɔ, agbatsɔtsɔ ɖɔliɖɔli, kple nuŋlɔɖi gaƒoƒo sɔ kple wo nɔewo. Zã susu mawo ke na nudzrala ɖesiaɖe si woɖo ɖe ŋkɔ kpui me.

Hafi nàtrɔ la, de tɔtrɔ ƒe nudzraɖoƒe, ŋkɔ ŋɔŋlɔ ake, kpeɖodzinana, hehenana kple agbatsɔtsɔ kpata ɖe wò nudzrala ƒe tɔtrɔ ƒe gazazã ƒe kpɔɖeŋu.

Tsɔ nudzralawo sɔ kple gazazã bliboa ƒe kpɔɖeŋu ɖeka kple susu ɖeka.

Nya Siwo Woabia

• Incoterm kawoe wotsɔna naa amewo, eye akpa kae nye gazazã kple afɔku ɖesiaɖe tɔ?

• Aleke wokpɔa nubablɛwo ƒe nyonyome kple wo ɖoɖoɖa takpɔkpɔ dzii?

• Nukae dzɔna ne nudɔdɔ aɖe tsi megbe, mewu enu o, alo gblẽ?

• Dedienɔnɔ ƒe agbɔsɔsɔme nenie wokafu le ŋkeke 90 gbãtɔawo me?

Vodada #2: Etsɔe be Ðaseɖigbalẽwo Trɔna Le Asiwo Dome Le Wo Si

ISO 13485 ƒe ɖaseɖigbalẽ, CE ƒe nuŋlɔɖi, alo nyatakaka si ku ɖe FDA ŋu ate ŋu asɔ, gake mele be woabu wo dometɔ aɖeke be enye mɔɖeɖe le eɖokui si be woadzra atike ɖesiaɖe le asi ɖesiaɖe me o. Nudidiwo ate ŋu ato vovo le mɔ̃a ƒe hatsotsowo me toto, alesi woɖoe be woazãe, dukɔ, gbe si wotsɔ dea dzesi woe, akpa si nudzrala wɔna, kple mɔ si dzi woato aŋlɔ ŋkɔ ɖe nutoa me nu.

Hafi woawɔ asitsatsa ƒe nudɔdɔ la, ele be numamãla ƒe sedzikpɔha naɖo kpe nudidi siwo sɔ na asi ɖesiaɖe si ŋu woɖo taɖodzinu ɖo kple adzɔnuwo ƒe ƒome ɖesiaɖe dzi. Ele be nudzrala la nana nuŋlɔɖi siwo dzi wokpɔna siwo dzi woate ŋu ato akpɔe ɖa be woƒe lolome, woƒe nyateƒenyenye, woƒe nɔnɔme si wogbugbɔ trɔ asi le, kple woƒe ɖekawɔwɔ hã.

Bia Nuŋlɔɖiwo ƒe Agbalẽvi si Woate Ŋu Adzra Ðo Ðe Asi Ŋu

• Fifia ƒe nyonyome-dzikpɔkpɔ ƒe ɖaseɖigbalẽwo kple afisi woawɔ dɔ le ŋuti nyatakaka siwo sɔ

• Adzɔnuwo ƒe ŋkɔ dede agbalẽ me alo nuŋlɔɖi siwo ku ɖe nusiwo sɔ ŋu

• Adzɔnuwo ŋuti nyatakakawo kple mɔ̃ɖaŋu ŋuti nuŋlɔɖi siwo li be woalé ŋku ɖe wo ŋu

• Nusiwo wotsɔ wɔe kple ŋkuléle ɖe nu ŋu ŋuti nuŋlɔɖiwo, le afisi wòsɔ le

• Labeling kple IFU files kple revision kple gbegɔmeɖeɖe dzikpɔkpɔ

• UDI, batch, alo lot traceability mɔnu

• Adzɔnuwo ƒe tɔtrɔ ŋuti nyatakaka nana ƒe ɖoɖo

Ðo kpe edzi be woate ŋu azãe kple sedzikpɔla bibiwo le asi ɖesiaɖe si ŋu woɖo taɖodzinu ɖo me.

Ne èdi dzeside ƒe ɖoɖo si keke ta wu la, to... ƒumeŋutinunya OEM kple ODM nudzrala ƒe dodokpɔ mɔfiame.

Vodada #3: Mɔkpɔkpɔbuɖeame ƒe Ɣeyiɣiwo Dzixɔxɔse Kpeɖodzi Manɔmee

Ɣeyiɣi si woatsɔ awɔ dɔe ƒe liƒo le vevie wu ŋugbedodo ɖeka si me mɔkpɔkpɔ le be woatsɔe ayi na amewo.

Nudzrala ate ŋu ayɔ ɣeyiɣi si woatsɔ awɔ dɔe si hea ame eye wòahe dɔwɔwɔ ƒe afɔku gã aɖe vɛ kokoko. Dɔwɔwɔ ŋutɔŋutɔ nɔ te ɖe nusiwo wotsɔ wɔe ƒe amesinɔnɔ, ŋutete ƒe ɖoɖowɔwɔ, ŋkuléle ɖe nu ŋu, nubablɛwo, nudzraɖoƒewo, ɖoɖowɔwɔ, kple alesi wokpɔa nusiwo to vovo gbɔe dzi.

Nuwo tsɔtsɔ yi na amewo si meli ke o naa dedienɔnɔ ƒe nudzraɖoƒe geɖe wu, agbatsɔtsɔ kpata, nusiwo woatsɔ aɖo wo teƒe, nudɔdɔwo megbe, dɔwɔnuwo ƒe hatsotso siwo mede blibo o, kple asisiwo ƒe dzimaɖitsitsi. Nyabiase si sɔ la menye 'Aleke gbegbee nàte ŋu atsɔ nudɔdɔwo aɖo ɖe amewo kabakabae?' ko o ke boŋ 'Aleke gbegbee nàte ŋu atsɔ nudɔdɔ blibowo aɖo ɖe amewo ɣesiaɣi?' o.

Da Dɔwɔwɔ ƒe Dɔwɔwɔ kpɔ kple KPIwo

Dze egɔme kple SKU tiatia aɖewo, anyigba ƒe nɔnɔme si seɖoƒe li na, teƒe siwo dzi wolɔ̃ ɖo be woagbugbɔ aɖo wo ɖe ɖoɖo nu, kple mɔ si dzi woato adzi ɖe edzi si woŋlɔ ɖi. Ne nudzrala la ɖe nyonyome si li ke kple nudɔdɔ ƒe dɔwɔwɔ fia vɔ ko hafi nàkekee ɖe enu.

Vodada #4: Aɖabaŋeŋe ƒu Traceability, Quality Systems, kple CAPA Response dzi

Adzɔnuwo ƒe nɔnɔmewo nye dzeside ƒe akpa ɖeka ko. Ne nyatoƒoetoto alo nyonyome ƒe nyabiase aɖe do mo ɖa la, ehiã be mamala nakpɔ batch ŋuti nyatakaka siwo de pɛpɛpɛ kabakaba, numekuku ƒe afɔɖeɖe siwo woŋlɔ ɖi, kadodo siwo ŋu agbanɔamedzi le, kple ɖɔɖɔɖodɔ siwo dzi wokpɔ ŋusẽ ɖo.

Ele be ƒumeŋuɖuiwɔƒe si ŋu kakaɖedzi le nate ŋu aɖe alesi wòkpɔa nusiwo wotsɔ wɔe, ewɔwɔ ŋuti nuŋlɔɖiwo, dodokpɔ me tsonu, batch release, nyatoƒoetoto, CAPA, kple adzɔnuwo ƒe tɔtrɔ dzi me. Le dzedzeɣi la, ƒu du le kplɔ̃dzi nudzɔdzɔ aɖe tsɔ wu be nàɖo ŋu ɖe nuƒo aɖe ŋu.

• Bia kpɔɖeŋu traceability nuŋlɔɖi na SKU teƒenɔla ɖeka.

• Bia amesi tɔe nye mamala ƒe kadodo le nyatoƒoetotoɣi.

• To lɔlɔ̃ ɖe edzi, numekuku, kple CAPA ƒe ɣeyiɣiɖoɖo siwo wokpɔ mɔ na me.

• Ðo kpe nuŋlɔɖi siwo wona dzi ne adzɔnu alo dɔwɔwɔ aɖe trɔ.

• Doe kpɔ be woate ŋu axɔ nuŋlɔɖiwo kaba eye woawɔe ɣesiaɣi hã.

Ele be afɔɖeɖe ɖesiaɖe nado ka kple nuŋlɔɖi siwo woate ŋu axɔ kple agbanɔamedzi siwo woɖe fia.

Be nàto alesi woate ŋu ada ewɔwɔ kple eƒe nyonyome dzi kpɔkpɔ ƒe ŋutetewo kpɔ la, kpɔ XC Medico tɔ ƒumeŋuɖui ƒe atikewo wɔwɔ ƒe ŋutetewo . Ne èdi mɔkpɔkpɔwo le vidzidzi megbe la, lé ŋku ɖe esiwo wota ŋu kpekpeɖeŋunana le nudzadzra megbe ƒe ɖoɖo.

Vodada #5: Tɔtrɔwo Dzikpɔkpɔ Nu Bubu Le Nudzralawo ƒe Trɔtrɔɣi

Amedede ƒe ɖoɖo si dzi woda asi ɖo le mɔ̃ɖaŋununya me ate ŋu ado kpo nu le asitsatsa me kokoko ne womekpɔ tɔtrɔa dzi nyuie o. Ðewohĩ amekolawo menya nu tso dɔwɔnu yeyeawo ŋu o, ate ŋu anye be traywo made blibo o, ɖewohĩ nudzralawo ƒe ƒuƒoƒowo mase vovototo siwo le atikeawo me gɔme o, eye se siwo ku ɖe nusiwo woatsɔ atrɔ asi le wo ŋu alo wo ɖɔliɖɔli ŋu me mekɔ o.

Zã Dɔwɔnu si Dzi Wokpɔna, si Woaɖe Ðe Go le Vivime

1. Dzesidede: to adzɔnuwo ƒe lolome, nuŋlɔɖiwo, kpɔɖeŋuwo, dɔwɔnuwo, kple asitsatsa ŋuti nyawo me.

2. Kpɔɖeŋu dodokpɔ: ɖo kpe nɔnɔme tɔxɛwo, nubablɛwo, tray ƒe ɖoɖowɔwɔ, kple ƒuƒoƒoa ƒe nyaŋuɖoɖowo dzi.

3. Dodokpɔ ƒe ɖoɖo: do SKU ƒe hatsotso si seɖoƒe li na kple anyigba ƒe nɔnɔme kpɔ kple KPI siwo dzi wolɔ̃ ɖo.

4. Hehenana: dzra nudzralawo ƒe ƒuƒoƒowo, mɔ̃ɖaŋudɔwɔlawo, nudzraɖoƒedɔwɔlawo, kple ezãla siwo sɔ ɖo.

5. Kekeɖenudɔwɔwɔ: dzidzeme le eɖoɖo vɔ megbe ko, nyonyome, nu gbugbɔgade, kple nyatoƒoetoto ƒe dɔwɔwɔwo li ke.

Ne kpeɖodziwo kple agbanɔamedziwo me kɔ ko hafi nàʋu ayi akpa si kplɔe ɖo dzi.

Supplier Switching Checklist na Ƒumeŋutinunyalawo

Alesi XC Medico Doa Alɔ Nudzralawo ƒe Numekuku

Ne wole XC Medico alo ƒumeŋutinunyala bubu ɖesiaɖe me dzrom la, ele be emamalawo nazã dzesidemɔnu ma ke si wotu ɖe kpeɖodzi dzi. Dzro adzɔnuwo ƒe hatsotso si sɔ, adzɔnuwo wɔwɔ dzi kpɔkpɔ, nuŋlɔɖi siwo li, OEM/ODM ƒe lolome, kadodo ƒe kpɔɖeŋu, nudɔdɔ ƒe ɖoɖo, kple nudzadzra megbe ɖoɖowo me hafi nàtsɔ wo ɖokui ana be yeaɖee ɖe go ɣeyiɣi didi aɖe.

XC Medico wɔa dɔ kple xexeame katã ƒe mamalawo le nuveviwɔame, akɔta, ƒunukpeƒewo gbugbɔgatu, kamedefefewo ƒe atikewɔwɔ, amekoko dɔwɔnuwo, kple ƒumeŋuɖui ƒe hatsotso siwo do ƒome kplii me. Nuƒlela siwo le nuveviwɔame ƒe atikewo me tom hã ate ŋu azã... trauma implant supplier tiatia mɔfiame abe hatsotso-koŋ ƒe nufiame ene.

Afɔɖeɖe si kplɔe ɖo si sɔ enye numedzodzro si woŋlɔ ɖi si ƒo nu tso asi si ŋu wole taɖodzinu ɖo, adzɔnuwo ƒe ŋkɔwo, mɔ̃ɖaŋununya ƒe nudidiwo, ŋkɔ ŋɔŋlɔ ƒe hiahiãwo, nubablɛwo, dodokpɔ ƒe ɖoɖo, subɔsubɔdɔ si wokpɔ mɔ na, ​​kple nyametsotso ƒe agbowo ŋu. Ele be kpɔɖeŋu dodokpɔ kple yameʋuɖoɖo ƒe sededewo naɖo kpe nya siwo wogblɔ le nyayɔyɔ me dzi.

Nya Siwo Wobiaa Enuenu Ku Ðe Ƒumeŋutinunyalawo Trɔtrɔ Ŋu

Nukae wòle be mamalawo nalé ŋku ɖe eŋu hafi atrɔ ƒumeŋutinunyalawo?

To gazazã bliboa, adzɔnuwo ƒe nyonyome, asi tɔxɛ ŋuti nuŋlɔɖiwo, nuwɔwɔ ƒe ŋutete, nudɔdɔ ƒe kakaɖedzi, kplɔkplɔ, nyatoƒoetotowo gbɔ kpɔkpɔ, tɔtrɔwo dzi kpɔkpɔ, dɔwɔnuwo ƒe ɖekawɔwɔ, hehenana ƒe hiahiãwo, nudzraɖoƒewo ƒe ɖeɖefia, kple nudzadzra megbe kpekpeɖeŋu me.

Ðe asixɔxɔ si bɔbɔ ɖe anyi wue nye nu vevitɔ kekeake si woatsɔ atia nudzralawoa?

Ao, woate ŋu atsɔ nudɔdɔ suetɔ kekeake siwo lolo, nudzraɖoƒe bubuwo, agbatsɔtsɔ kpata, nuŋlɔɖiwo wɔwɔ, tɔtrɔgbɔ, megbedede, alo kpekpeɖeŋu si gbɔdzɔ axe mɔ ɖe unit ƒe asi si bɔbɔ wu nu. Tsɔ anyigbadzinuwo katã kple dɔwɔwɔ ƒe gazazã sɔ kple wo nɔewo.

Ɣeyiɣi didi kae wòxɔna hafi wotrɔa ƒumeŋuɖui ƒe atikewɔlawo?

Ɣeyiɣiɖoɖoa nɔ te ɖe adzɔnuwo ƒe hatsotso, ŋkɔ ŋɔŋlɔ ƒe mɔnu, nuŋlɔɖiwo ƒe dzadzraɖo, kpɔɖeŋu ƒe kpeɖodzi, nudzraɖoƒe ƒe tɔtrɔ, dɔwɔnu ƒe nudidi, kple hehenana dzi. Zi geɖe la, eɖeɖe ɖe go vivivi le dedie wu esi woatsɔ aɖɔli agbalẽdzraɖoƒe bliboa enumake.

Nuŋlɔɖi kawoe wòle be ƒumeŋuɖui nana?

Nusiwo wobia tso ame si la toa vovo le nusiwo wowɔ kple asi nu. Ate ŋu anye nyonyome ƒe ɖaseɖigbalẽwo, ɖoɖowɔɖi siwo sɔ alo ŋkɔ ŋɔŋlɔ ƒe nuŋlɔɖi siwo sɔ, nɔnɔme tɔxɛwo, mɔ̃ɖaŋu ŋuti nyatakakawo, dzesideŋkɔwo, IFUwo, nuŋlɔɖi siwo woate ŋu ake ɖe wo yome, ɖaseɖiɖi siwo wotsɔ léa ŋku ɖe nu ŋu, kple tɔtrɔ ŋuti nyatakaka nana ƒe ɖoɖowo.

Aleke mamalawo ate ŋu aɖo kpe adzɔnuwɔƒe aɖe dzi hafi awɔ nu aduadu?

To nuwo wɔwɔ kple woƒe nyonyome ƒe ŋutetewo me, lé ŋku ɖe nuŋlɔɖi siwo dzi wokpɔna ŋu, do kpɔɖeŋuwo kpɔ, wɔ mɔzɔzɔ ƒe dodokpɔ, wɔ dodokpɔ ƒe nudɔdɔ, dzidze nudɔdɔ ƒe KPIwo, eye nàda kadodo kpɔ le nɔnɔme ŋutɔŋutɔ si to vovo me.

Nyataƒoƒo: Trɔ Nudzralawo Kple Kpeɖodziwo, Ke Menye Nukpɔsusuwo O

Ƒumeŋutinunyalawo ƒe tɔtrɔ nye asitsatsa ƒe tɔtrɔ si me tsonuwo le ɖoɖowɔwɔ, dɔwɔwɔ, ganyawo, kple asisiwo gbɔ. Zi geɖe la, vodada siwo xɔa ga geɖe wu la tsoa susu siwo womedo kpɔ o gbɔ: woƒe susu tsɔtsɔ ɖe asi ŋu, wobua ɖaseɖigbalẽwo be woda asi ɖe wo dzi le xexeame katã, kaka ɖe ɣeyiɣi siwo woatsɔ awɔ dɔe siwo ŋu kakaɖedzi le dzi, aɖabaŋeŋe ƒu dɔwɔwɔ ƒe ɖoɖo nyuiwo dzi, alo woƒe lolome dzi ɖeɖe kpɔtɔ hafi habɔbɔa nasu te.

Dɔwɔwɔ si me woɖɔa ɖo ɖea afɔku siawo dzi kpɔtɔna. Tu nudzrala ƒe dzesidegbalẽvi ɖeka, bia kpeɖodzi siwo dzi wokpɔna, da asi ɖe adzɔnuwo kple nuŋlɔɖiwo dzi, do ƒomedodoa kpɔ to dodokpɔ aɖe dzi, eye ne woɖo nyonyome kple nuzazã ƒe dzidzenu siwo dzi wolɔ̃ ɖo gbɔ ko hafi nàkekee ɖe enu.