Vodada 5 Siwo Xɔasi Siwo Mamãlawo Wɔna Ne Wole Ƒumeŋutinunyalawo Trɔm

Ƒumeŋutinunyalawo ƒe tɔtrɔ ate ŋu anye afɔɖeɖe si me nunya le. Kpekpeɖeŋunana nyuie wu, asixɔxɔ nyuitɔ, megbenyawo ƒe nudɔdɔ ʋɛ aɖewo.

Gake ƒã hafi akpa si ŋu wowɔ ɖoɖo ɖo la wɔa nuvevi mamalawo. Akpa si dzi womeda asi ɖo o la wɔa nuvevi wo: anyigba ƒe gazazã, nutoa me ƒe sedziwɔwɔ ŋuti nyatakakawo, ɣeyiɣi si woatsɔ awɔ dɔe ƒe tɔtrɔ, kple gbesiagbe subɔsubɔ ƒe nyateƒenyenye ne sedede kpata gbãtɔ nya dze.

Nyati sia nye afɔku gbãtɔ ƒe ɖoɖo na atikewɔnuwo mamalawo siwo le tɔtrɔ aɖe me tom vevie. Taɖodzinua le bɔbɔe: ƒo asa na nu xɔasi siwo wɔ nuku, kpɔ amekola ƒe kakaɖedzi ta, eye nàna dɔbiagbalẽviwo nayi edzi.

Nu vevi siwo woatsɔ ayi teƒe bubuwo

• Bu 'asi' abe anyigba ƒe gazazã bliboa ene , si me buffers, expedites, damage/returns, kple documentation overhead hã le.

• Ðaseɖigbalẽwo mesɔ kple nutoa me asitsalawo ƒe lɔlɔ̃ ɖe edzi o. Da asi ɖe nusiwo wotsɔ tso duta vɛ kple dzesidede nu ƒe nudidiwo dzi kaba, vevietɔ na dukɔ geɖe ƒe ɖoɖowo.

• Mègaxɔ mɔkpɔkpɔ ƒe ɣeyiɣi siwo woatsɔ awɔ dɔe o. Bia metriks siwo le ɣeyiɣi dzi kple tɔtrɔwo, eye nàdoe kpɔ hafi nàtsɔ ɖokuiwò ana.

• Traceability kple CAPA ƒe ŋuɖoɖo le vevie abe alesi adzɔnuwo ƒe specs le vevie ene.

• Trɔtrɔ nye tɔtrɔwo dzikpɔkpɔ. Wɔ ɖoɖo ɖe traywo, hehenana, kple dɔwɔwɔ si le dzadzɛ si woatsɔ atrɔ ayi/ɖɔliɖɔli ŋu.

Vodada #1: Bubu ɖeka ƒe asi be enye gazazã ŋutɔŋutɔ (kple aɖabaŋeŋe ƒu anyigba dzi gazazã dzi) .

Vodada si bɔ wu le tɔtrɔ me enye be woawɔ ɖoɖo ɖe nu ɖeka ƒe asi gã aɖe ŋu, emegbe woake ɖe eŋu be vovototoawo nu yina le ƒe etɔ̃ gbãtɔ megbe.

Gazazã ɣaɣla ƒe ʋukulawo le nudzralawo ƒe tɔtrɔɣi dina be yewoaƒo ƒu ɖe teƒe ɖeka mawo ke:

• Inventory buffers : ètsɔa stock bubuwo ɖe asi elabena mèka ɖe ɣeyiɣi yeye si woatsɔ awɔ dɔe dzi haɖe o.

• Expedites : èxea fe be yeaɖɔ vodada siwo le nyagblɔɖi me kple dɔdɔ ƒe megbetsitsiwo ɖo.

• Damage, sterility barrier risk, and returns : nubablɛ kple wo ŋudɔwɔwɔ ƒe nyawo medzena le nyayɔyɔ me o.

• Documentation overhead : wò ƒuƒoƒoa zãa ɣeyiɣi tsɔ tia ɖaseɖigbalẽ siwo bu, gbegɔmeɖeɖewo, kple asitɔtrɔwo yome.

• Gakpɔkpɔ ƒe sisi (ne nuŋlɔɖi siwo le anyime tɔtɔ): agbalẽ siwo mesɔ o kple nusiwo ƒe aƒetɔ ƒe vodadawo ate ŋu ahe fexexe ƒe masɔmasɔ vɛ eye woagawɔ dɔ ake.

Nuxlɔ̃ame : Ne màte ŋu awɔ model landed cost o la, màte ŋu atsɔ nudzralawo asɔ kple wo nɔewo o. Ðeko nèle nyayɔyɔwo tsɔm sɔ kple wo nɔewo.

Nusi nàwɔ boŋ: tu dɔwɔgbalẽvi si dzi nàto awɔ dɔ le anyigba dzi hafi nàde asi ete

Zã dɔwɔgbalẽvi bɔbɔe aɖe si woŋlɔ do ŋgɔ na kafukafu eye nàwɔe wòanye gating item le wò nudzrala ƒe tɔtrɔ me.

Fli suetɔ kekeake siwo woatsɔ ade eme:

• Agbatsɔtsɔ, nugblẽfexeɖoɖo, adzɔwo, asitsalawo ƒe fewo, kple nudzraɖoƒe

• Dedienɔnɔ ƒe nudzraɖoƒe (kwasiɖawo) si nàlé ɖe asi le tɔtrɔɣia

• Kpata ƒe xexlẽme si wokpɔ mɔ na (ne enye 'vɔ̃ɖitɔ kekeake' gɔ̃ hã) kple ga si woatsɔ awɔ kaba ɖesiaɖe

• Trɔtrɔ/ɖɔliɖɔli dɔwɔwɔ ƒe gazazã (ɣeyiɣi + agbatsɔtsɔ) .

• Agbagbadzedze be woawɔ nuŋlɔɖiwo (QA/RA gaƒoƒo) le ŋkeke 90 gbãtɔawo me

Nusi woabia ƒumeŋutinunyala ɖesiaɖe

• Incoterm kawoe nèzãna zi geɖe, eye nukae le eme?

• Nukae nye wò nubablɛ ƒe ɖoɖo si sɔ, eye aleke nèwɔna ɖoa kpe mɔxenu si me dɔlékui mele o ƒe blibonyenye dzi le ʋuɖoɖo me?

• Nukae nye wò dɔwɔwɔ ne nudɔdɔ aɖe tsi megbe alo mede blibo o?

Afisi XC Medico sɔ le

Ne èdi be yeana anyigbadzinɔnɔ ƒe gazazã nanye nusi woate ŋu agblɔ ɖi la, ehiã be woakpɔ dɔwɔwɔ ƒe dzedzeme. XC Medico ƒe mɔnu enye be wòana woateŋu adzidze nuzazãwo ƒe dɔwɔwɔ (le kpɔɖeŋu me, to ɖoɖowɔwɔ ɖe nudɔdɔ ƒe nɔnɔme ƒe ɖaseɖigbalẽwo kple nudzralawo ƒe KPIwo abe nudɔdɔ ɖe game dzi kple blibodede ene ŋu me), ale be 'gazazã ŋutɔŋutɔ' meva ɖo abe nusi wɔ nuku ene emegbe o.

Le mamala siwo dzraa nu le Amerika-dukɔwo katã me gome la, XC Medico ate ŋu ado alɔ LATAM-xɔlɔ̃wɔwɔ ƒe emevava ƒe tiatiawɔblɔɖe hã, siwo dometɔ aɖewoe nye mɔzɔzɔ si wotu ɖe Mexico le afisi wòsɔ le, be woaɖe liƒowo dome masɔmasɔ dzi akpɔtɔ. Bu esia abe veviedodonu si sɔ ene: bia mɔ tɔxɛa, sewo, kple agbanɔamedziwo to agbalẽ me.

Vodada #2: Etsɔe be ɖaseɖigbalẽwo zɔ mɔ (CE/FDA mesɔ kple nutoa me ƒe mɔɖeɖe o) .

Numamãla ate ŋu aɖo kpe CE dzi, akpɔ FDA ƒe xexlẽdzesi si dzi woɖe mɔ ɖo, eye wòatsɔe be wowɔ sedziwɔwɔ ƒe dɔa koŋ. Emegbe tender gbãtɔ bia be woatsɔ agbalẽ aɖe si mele asiwò o, alo nutoa me ƒe dzesidede nudidiwo zia ŋkɔ gbugbɔgaŋlɔ ƒe dɔ aɖe si mèwɔ gazazã ƒe ɖoɖo na o la dzi.

Ŋkuɖodzinya nyui eve:

• Le U.S.A. la, FDA ate ŋu aɖo kpe dɔwɔƒea ƒe ŋkɔ ŋɔŋlɔ/ŋlɔɖi kple (afisi wòhiã le) nyatakaka siwo wotsɔ ɖo ɖa do ŋgɔ na asitsatsa dzi le nusiwo wotsɔ tso duta vɛ me toto me. Nusiwo mesɔ o ate ŋu ana gege ɖe eme blewu alo atɔ te. Kpɔ FDA ƒe atikewɔmɔ̃ siwo wotsɔ tso duta vɛ ƒe wɔwɔfia hena nusiwo wokpɔ le liƒoa dzi.

• Le Mexico la, zi geɖe la, COFEPRIS ƒe mɔwo bia be woaxɔ ŋkɔ le nutoa me kple Spaingbe me dzeside/IFU ƒe mɔkpɔkpɔwo. Gɔmedzedze aɖee nye Emergo ƒe COFEPRIS ƒe ŋkɔ ŋɔŋlɔ ƒe wɔwɔfia.

Key Takeaway : 'Xexeame katã ƒe sedziwɔwɔ' menye nuŋlɔɖi ƒe ƒuƒoƒo o. Enye nusi yia edzi. Nudidiwo toa vovo le dukɔwo kple adzɔnuwo ƒe hatsotsowo nu.

Nusi nàwɔ boŋ: bia nuŋlɔɖiwo ƒe agbalẽvi si sɔ na asi

Hafi nàwɔ nudɔdɔ vevi aɖe la, bia nuŋlɔɖiwo ƒe agbalẽvi si dzi wokpɔna, si ƒe tɔtrɔwo le, si dzi wò QA/RA ƒuƒoƒoa ate ŋu aɖo kpee.

Ne mede ɖeke o la, bia be:

• ISO 13485 ƒe ɖaseɖigbalẽ (fifia) .

• CE ɖaseɖigbalẽ(wo) kple afisi wòakeke ɖo ŋuti nyatakakawo (afisi wòsɔ le) .

• FDA 510(k) ƒe mɔfiame ŋuti nyatakakawo (afisi wòsɔ le) .

• Traceability/UDI mɔnu (alesi nàkplɔ batch/lot ɖo) .

• Labeling kple IFU files kple revision control kple gbegɔmeɖeɖe ƒe ɖoɖo

• Trɔ nyatakaka nana ƒe ɖoɖo (alesi woana nànya ne nane trɔ)

Afisi XC Medico sɔ le

XC Medico tsɔ eɖokui ɖo nɔƒe si sɔ na nuŋlɔɖiwo na mamala siwo hiã kpeɖodzi be wowɔ ɖe seawo dzi, ke menye nyagbɔgblɔwo o. Adzɔha la ƒe nusiwo wota te gbe ɖe ISO 13485 kple dukɔwo dome ɖaseɖigbalẽwo ƒe kpekpeɖeŋunana dzi, tsɔ kpe ɖe traceability nuwɔnawo ŋu (siwo dometɔ aɖewoe nye UDI laser dzesidede hena batch tracking).

Ne èdi be yeakpɔ gɔmedzeƒe si woɖo ɖi na nudzralawo ƒe kpeɖodzi la, àte ŋu akpɔe ɖa be XC Medico orthopedic OEM/ODM procurement guide , si woŋlɔ na nuƒlelawo ƒe ƒuƒoƒo siwo hiã be woawɔ dodokpɔ abe ɖaseɖigbalẽ ƒe atsyã ene, ke menye agbalẽ gbadza o.

Vodada #3: Ɣeyiɣi siwo woatsɔ awɔ dɔe si me mɔkpɔkpɔ le dzixɔxɔse ne èle ƒumeŋutinunyalawo trɔm

Nudzrala ate ŋu aɖo ɣeyiɣi si wogblɔ be woatsɔ awɔ dɔe gbɔ eye wòaganye amesi sɔ nyuie kokoko.

Dodokpɔ ƒe nɔnɔme si xɔa ga geɖee nye tɔtrɔ: ɣeyiɣi siwo woatsɔ awɔ dɔe la trɔna, nusiwo woɖona ɖe amewo ƒe akpa aɖewo dzena, eye wò ƒuƒoƒoa va nɔa du dzi kabakaba eye wòɖea kuku.

Tɔtrɔ ma zi mamalawo dzi be woawɔ ametakpɔkpɔ ƒe nuwɔna:

• Dedienɔnɔ ƒe nudzraɖoƒe geɖe wu (wobla fiadu) .

• Agbatsɔtsɔ si hiã kpata wu

• Nusiwo woatsɔ aɖo eteƒe kple megbedede geɖe wu

• Amekola ƒe dziɖeleameƒo geɖe wu ne sets mewu enu o

Ne èdi nudzraɖoƒe ƒe akɔntabubu si le megbe na esia la, kpɔ alesi ɣeyiɣi si woatsɔ awɔ dɔe ƒe tɔtrɔ ʋãa dedienɔnɔ ƒe nudzraɖoƒe kple subɔsubɔdɔ ƒe agbɔsɔsɔme ƒe numeɖeɖe.

Nusi nàwɔ boŋ: ɖe KPI ƒe ɖoɖoa gɔme eye nàdoe kpɔ

Mègabia 'ɖoɖo kabakaba.' Bia dɔwɔwɔ si woate ŋu adzidze.

KPI siwo mamalawo ate ŋu azã le nudzralawo ƒe dzesidegbalẽvi me dometɔ aɖewoe nye:

• OTIF (le game dzi, bliboe) .

• Lead-time kakaɖedzi kple vovototo

• Backorder ƒe agbɔsɔsɔme

• Wɔ ratio kabakaba

• Nyatoƒoetoto ƒe agbɔsɔsɔme kple CAPA ƒe nuwuwu ƒe ɣeyiɣi

Gbegbɔgblɔ si me kɔ ƒe xexlẽdzesi si nye nudzralawo ƒe metriks siwo bɔ la nye esi Nudzralawo Dzikpɔƒe ƒo nu tsoe kpuie le eƒe nudzralawo ƒe OTIF kple ŋgɔyiyi ƒe ɣeyiɣi ƒe kakaɖedzi KPI ƒe wɔwɔfia me.

Afisi XC Medico sɔ le

Esia nye nuto ɖeka si me nuwɔwɔ le gaglãgbe ƒo ŋugbedodowo ta. XC Medico ateŋu awɔ ɖeka kple mamalawo le dɔwɔwɔ ƒe KPI siwo le vevie dzi, emegbe aɖo kpe dɔwɔwɔ dzi le afɔɖeɖe si woɖo ɖe ɖoɖo nu (pilot SKUs, limited geographies, defined reorder points) hafi akeke ɖe enu.

Ne èle ɖoɖo wɔm ɖe tɔtrɔ ŋu la, bia KPI cadence (kwasiɖa sia kwasiɖa le tɔtrɔɣi, emegbe ɣleti sia ɣleti) kple escalation mɔ si me kɔ ne afɔku le eme be nudɔdɔ aɖe nato fesrea ŋu.

Vodada #4: SKUwo tɔtrɔ evɔ womeɖo kpe traceability, nyatoƒoetoto, kple CAPA ƒe ŋuɖoɖo dzi o

Zi geɖe la, numalawo ƒe susu nɔa adzɔnuwo ƒe nɔnɔmewo ŋu, emegbe wova ke ɖe eŋu wòtsi megbe akpa be nyonyome ƒe ɖoɖoa ƒe dɔwɔwɔwo mesɔ na mamalawo o.

Ele be tɔtrɔ ƒe ɖaseɖigbalẽ nyui aɖe naƒo nu tso:

• Alesi wodea dzesi lots/batches eye wokplɔa wo ɖo

• Nusi dzɔna ne nyatoƒoetoto aɖe va

• Alesi woʋua CAPA-wo kabakabae, ɖoa dze kpli wo, eye wotua woe

• Alesi wokpɔa adzɔnuwo ƒe tɔtrɔwo dzii (kple alesi woana nànyae) .

Ne nudzrala yeyea mete ŋu do alɔ dɔwɔwɔ kabakaba, dzadzɛ kple ɖɔɖɔɖo ƒe dɔwɔwɔ ƒe ɖoɖowo o la, wò dɔwɔwɔ ƒe gazazã dzina ɖe edzi ne nusi wotsɔ de ame me ŋutɔ wɔa dɔ nyuie gɔ̃ hã.

Nusi nàwɔ boŋ: do nyonyome ƒe ɖoɖoa kpɔ abe alesi nàzãe ene

Le dzedzeɣi la, wɔ 'tabletop incident' kple nudzrala la:

• Bia traceability kpɔɖeŋu na SKU ɖeka (tso raw material dzi va ɖo device si wowɔ vɔ dzi, le level si woateŋu ama) .

• Bia CAPA ƒe ɣeyiɣiɖoɖo kple amesi tɔe nye mamalawo ƒe kadodowo

• Bia agbalẽ siwo tututu nèxɔ ne wowɔ tɔtrɔ (kple ɣeyiɣi didi si do ŋgɔ) .

Afisi XC Medico sɔ le

XC Medico ƒe ɖoƒe si wota la lɔ traceability nuwɔnawo abe UDI laser dzesi na batch tracking, si sɔ na distributor audit dzadzraɖo kple nyatoƒoetoto gbɔ kpɔkpɔ.

Ne èdi be yeada alesi wowɔa nui kpɔ la, mègasusui o. Dze egɔme kple subɔsubɔ ƒe dzidzenu: XC Medico ta ŋuɖoɖo SLA kple kpekpeɖeŋunaɖoɖo le eƒe... kpekpeɖeŋunana kple ŋuɖoɖo le nudzadzra megbe SLA ƒe axa . Zãe abe gɔmeɖoanyi ene na nusi nàkpɔ mɔ na tso nudzrala ɖesiaɖe gbɔ.

Vodada #5: Tɔtrɔwo dzi kpɔkpɔ ƒe dɔa bubu nu tsɛe (amekola ƒe kakaɖedzi, traywo, hehexɔxɔ, tɔtrɔgbɔ) .

Menye nuƒle ƒe afɔɖeɖe koe nudzrala ƒe tɔtrɔ nye o. Etrɔa alesi kɔdziwo kpɔa wòe.

Ne èdo kpo tɔtrɔwo dzikpɔkpɔ la, gazazãwo adze abe:

• Amekola siwo lɔ̃a hatsotso xoxoa ƒe vixɔxɔ blewu

• Case-day friction ne trays mede blibo alo nya nu tso eŋu o

• 'sue' biabia kpata siwo gblẽa wò ɖoɖowɔwɔ ƒe ɖoɖoa me ƒe dzidziɖedzi

• Messy returns kple replacements siwo gblẽa ɣeyiɣi

Nusi nàwɔ boŋ: ƒu du switch la abe phased rollout ene

Ðoɖo si woate ŋu awɔ atsɔ aʋui la le abe esia ene:

1. Pilot scope : tia SKUwo ƒe hatsotso sesẽ aɖe kple anyigbaŋutinunya ɖeka.

2. Hehenana : ɖe dɔwɔnu ƒe sɔsɔ kple hehenana ƒe hiahiãwo me.

3. Set completeness : ɖo kpe tray ƒe ɖoɖowɔwɔ kple replenishment dɔwɔwɔ dzi.

4. Trɔtrɔ/ɖɔliɖɔli : ŋlɔ mɔ si dzi woato kabakaba la ɖi na ŋkeke 90 gbãtɔawo.

5. Scale : keke ɖe enu ne OTIF kple nyatoƒoetoto ƒe dɔwɔwɔwo li ke ko.

Afisi XC Medico sɔ le

Le mamala siwo hiã kekeme gome la, XC Medico ƒe adzɔnuwo wɔwɔ ƒe agbalẽdzraɖoƒe kple dzidzenu ƒe ɖoƒe ate ŋu ado alɔ ɖoɖo geɖe wɔwɔ. Gɔmedzedze nyui aɖee nye woƒe hatsotso ƒe goglome me nyawo, abe... trauma locking plates dɔwɔƒea ƒe mɔfiame kple manufacturing and quality system overview , emegbe zã wò yameʋukulaa nàtsɔ aɖo kpe subɔsubɔ ƒe nyateƒenyenye dzi.

Nudzralawo ƒe tɔtrɔ ƒe ɖaseɖigbalẽ bɔbɔe aɖe (kɔpi/tsɔe de eme) .

Zã esia abe wò ememe gating checklist ene hafi nàtsɔ ɖokuiwò ana:

• Anyigbadzi-gazazã ŋuti dɔwɔgbalẽvi si wokpe ɖo eye ganyawo to eme

• Woɖo kpe asi ɖesiaɖe ƒe sedziwɔwɔ ƒe nudidiwo dzi (labels/IFU gbegbɔgblɔ, ŋkɔ ŋɔŋlɔ ƒe mɔ)

• Version-controlled documentation pack si woxɔ eye QA/RA da asi ɖe edzi

• KPI ƒe dzesidegbalẽvi si dzi wolɔ̃ ɖo (OTIF, ŋgɔyiyi-ɣeyiɣi ƒe vovototo, megbeɖoɖowo, CAPA ƒe ŋuɖoɖo)

• Pilot defined (SKUs, anyigba ƒe nɔnɔme, teƒe siwo wogbugbɔ ɖoa ​​ɖoɖo nu, se siwo ku ɖe dzidziɖedzi ŋu) .

• Wolɔ̃ ɖe tɔtrɔgbɔ/ɖɔliɖɔli ƒe ɖoɖoa dzi eye wodoe kpɔ

Afɔɖeɖe siwo kplɔe ɖo

Ne èdi be yeakpɔ kpeɖodzinu si wɔa dɔ nyuie na ƒumeŋutinunyalawo ƒe tɔtrɔ (nuŋlɔɖiwo ƒe ɖaseɖigbalẽ + KPI ƒe dzesidegbalẽvi ƒe nɔnɔmetata), biae tso XC Medico gbɔ eye nàwɔe ɖe wò nudzrala si li fifia kple wò xexlẽdzesi kpui la nu.

(Na wòanye nusi tea ɖeɖi ame ŋu. Kuviawɔwɔ nyo le sedziwɔwɔ kple nuzazãwo ƒe kɔsɔkɔsɔ me.)