Amaphutha Ama-5 Abizayo Aphezulu Awenza Abasabalalisi Lapho Ushintsha Abahlinzeki Be-Orthopedic

Ukushintsha abahlinzeki bamathambo kungaba isinyathelo esihlakaniphile. Ukufakwa okungcono, amanani angcono, ama-backorder ambalwa.

Kodwa abasabalalisi abavamile ukulimala ngengxenye abaxoxisane ngayo. Balinyazwa ingxenye abangazange bayiqinisekise: izindleko zokufika, imininingwane yendawo yokuthobela, ukuhlukahluka kwesikhathi esiholayo, kanye neqiniso lesevisi yansuku zonke uma i-oda lokuqala lifika.

Lesi sihloko siwuhlaka lokuqala engozini lwabasabalalisi bemishini yezokwelapha abahlola ngokuqhubekayo iswishi. Umgomo ulula: gwema izimanga ezibizayo, vikela ukwethenjwa kodokotela abahlinzayo, futhi ugcine amathenda ehamba.

Okuthathwayo okubalulekile

• Phatha 'intengo' njengenani eliphelele lezindleko zokufika , okuhlanganisa amabhafa, ama-expedites, umonakalo/ukubuyiselwa, kanye nesihloko samadokhumenti.

• Izitifiketi azifani nokwamukelwa kwemakethe yendawo. Qinisekisa izidingo zokungenisa nokulebula kusenesikhathi, ikakhulukazi ezinhlelweni zamazwe amaningi.

• Ungazamukeli izikhathi zokuhola ezinethemba. Cela amamethrikhi asesikhathini nokuhlukahluka, kanye nokuhlola ngaphambi kokuthi uzibophezele.

• Ukulandeleka kanye nokuphendula kwe-CAPA kubaluleke kakhulu njengokucaciswa komkhiqizo.

• Ukushintsha ukuphatha ushintsho. Hlela amathreyi, ukuqeqeshwa, kanye nembuyiselo ehlanzekile/ukushintsha ukuhamba komsebenzi.

Iphutha #1: Ukuphatha inani leyunithi njengezindleko zangempela (kanye nokuziba izindleko zokufika)

Iphutha elivame kakhulu lokushintsha ukuxoxisana ngenani elikhulu leyunithi, bese uthola ukuthi amamajini ayanyamalala ngemva kwekota yokuqala.

Abashayeli bezindleko ezifihliwe ngesikhathi sokushintsha komnikezeli bavame ukuhlangana ezindaweni ezifanayo:

• Amabhafa we-Inventory : uphethe isitoko esengeziwe ngoba awusithembi isikhathi sokuhola esisha okwamanje.

• I-Expedites : ukhokha ukulungisa amaphutha okubikezela nokubambezeleka kokuthunyelwa.

• Ukulimala, ingcuphe yesithiyo sokuvimbela inzalo, kanye nembuyiselo : izinkinga zokupakisha nezokuphatha aziveli kukhwothi.

• Isihloko samadokhumenti : ithimba lakho lichitha isikhathi lijaha izitifiketi ezingekho, ukuhumusha, nezibuyekezo.

• Ukuvuza kwemali engenayo (uma amadokhumenti angezansi emahle): amaphepha angafani kanye namaphutha amakhulu ento angadala ukungqubuzana kwenkokhelo nokusebenza kabusha.

Isexwayiso : Uma ungakwazi ukumodela izindleko zokufika, awukwazi ukuqhathanisa abahlinzeki. Uqhathanisa izingcaphuno nje.

Okufanele ukwenze esikhundleni salokho: yakha ishidi lokusebenzela elinezindleko zokufika ngaphambi kokuthi usayine

Sebenzisa ishidi lokusebenzela elilula langaphambi komklomelo futhi ulenze into yokufaka isango kuswishi yakho yomphakeli.

Ubuncane bezinto zomugqa ezizofaka:

• Impahla, umshwalense, imisebenzi, izimali zomthengisi, kanye nesitoreji

• Isitoko sokuphepha (amaviki) ozosibamba ngesikhathi soshintsho

• Isilinganiso sokusheshisa esilindelwe (ngisho noma 'kubi kakhulu') kanye nezindleko ngokusheshisa ngakunye

• Ukubuyisela/ukubuyisela izindleko zokuhamba komsebenzi (isikhathi + impahla)

• Umzamo wokwenza amadokhumenti (amahora we-QA/RA) wezinsuku zokuqala ezingu-90

Yini okufanele uyibuze noma yimuphi umhlinzeki wamathambo

• Imaphi ama-Incoterms ovame ukuwasebenzisa, futhi yini efakiwe?

• Kuyini ukucushwa kwakho okujwayelekile kwephakeji, futhi ubuqinisekisa kanjani ubuqotho besithiyo oyinyumba ngesikhathi sokuthutha?

• Ithini inqubo yakho uma ukuthunyelwa kubambezelekile noma kungaphelele?

Lapho i-XC Medico ingena khona

Uma ufuna ukwenza izindleko zokufika zibikezelwe, udinga ukubonakala kokusebenza. Indlela ye-XC Medico iwukwenza ukusebenza kokunikezwayo kulinganiseke (isibonelo, ngokuqondanisa izindawo zokuhlola isimo se-oda kanye nama-KPI womhlinzeki afana nokulethwa ngesikhathi kanye nokuphelela), ukuze 'izindleko zangempela' zingafiki njengesimanga kamuva.

Kubasabalalisi abathengisa kuwo wonke amazwe aseMelika, i-XC Medico ingase futhi isekele izinketho zokugcwalisa ezilungele i-LATAM, okuhlanganisa umzila osuselwe e-Mexico lapho kufanele khona, ukuze kuncishiswe ukungqubuzana kwemingcele. Phatha lokhu njengento efanelekile: cela umzila othize, imigomo, kanye nezibopho ngokubhala.

Iphutha #2: Ukuthatha ukuhamba kwezitifiketi (i-CE/FDA ayifani nokugunyazwa kwendawo)

Umsabalalisi angase aqinisekise i-CE, abone inombolo yemvume ye-FDA, futhi acabange ukuthi umsebenzi wokuthobela umthetho wenziwe. Bese ithenda yokuqala icela idokhumenti ongenayo, noma izidingo zokulebula zendawo ziphoqelela iphrojekthi yokulebula kabusha ongazange uyihlelele ibhajethi.

Izikhumbuzo ezimbili ezisebenzayo:

• E-US, i-FDA ingase iqinisekise ukubhaliswa/ukufakwa kuhlu kwesikhungo kanye (lapho kufanele) ulwazi lokuhanjiswa kwemakethe phakathi nokubuyekezwa kokungenisa. Okungafani kungahamba kancane noma kumise ukungena. Bona ukubuka konke kwemishini yezokwelapha engenisayo ye-FDA ngalokho okuhloliwe emngceleni.

• E-Mexico, izindlela ze-COFEPRIS zivame ukudinga umnikazi wendawo wokubhalisa kanye nokulindelwe kwe-Spanish ilebula/IFU. Iphuzu lokuqala ukubuka konke kokubhaliswa kwe-Emergo COFEPRIS.

I-Key Takeaway : 'Ithobelana nomhlaba wonke' ayiyona isethi yedokhumenti. Kuyinqubo. Izidingo ziyahlukahluka ngezwe nangezigaba zomkhiqizo.

Okufanele ukwenze esikhundleni salokho: cela iphekhi yamadokhumenti elungele imakethe

Ngaphambi kokufaka i-oda elibucayi, dinga iphekhi yamadokhumenti elawulwayo, enenguqulo ithimba lakho le-QA/RA elingakwazi ukuliqinisekisa.

Okungenani, cela:

• Isitifiketi se-ISO 13485 (yamanje)

• Izitifiketi ze-CE kanye nemininingwane yobubanzi (lapho kufanele)

• Imininingwane yereferensi ye-FDA 510(k) (lapho kufanele)

• Ukulandeleka/Indlela ye-UDI (uzolandelela kanjani inqwaba/inqwaba)

• Ukulebula kanye namafayela e-IFU anokulawulwa kokubuyekeza nohlelo lokuhumusha

• Shintsha inqubomgomo yesaziso (uzokwaziswa kanjani uma okuthile kushintsha)

Lapho i-XC Medico ingena khona

I-XC Medico izibeka njengemibhalo elungele abasabalalisi abadinga ubufakazi bokuthobelana, hhayi iziqubulo. Izinto ezishicilelwe zenkampani zigcizelela i-ISO 13485 kanye nokufakwa kwezitifiketi zamazwe ngamazwe, kanye nezinqubo zokulandeleka (okuhlanganisa nokumaka nge-laser ye-UDI yokulandelela inqwaba).

Uma ufuna indawo yokuqala ehlelekile yokuqinisekisa umhlinzeki, ungaphinda ubhekisele ku I-XC Medico orthopedic OEM/ODM umhlahlandlela wokuthenga , obhalelwe amaqembu okuthenga adinga ukuhlolwa kwesitayela sohlu lokuhlola, hhayi incwajana.

Iphutha #3: Ukukholelwa izikhathi zokuhola ezinethemba lapho ushintsha abahlinzeki bamathambo

Umphakeli angahlangabezana nesikhathi sokuhola esicashuniwe futhi aqhubeke engalingani kahle.

Imodi yokwehluleka ebizayo iwukuhlukahluka: izikhathi zokuhola, ukuthunyelwa kwengxenye kuyavela, futhi ithimba lakho ligcina lisebenza ngokusheshisa nokuxolisa.

Lokho kuhlukahluka kuphoqelela abasabalalisi ekuziphatheni kokuzivikela:

• Isitokwe sokuphepha esengeziwe (imali eboshiwe)

• Izimpahla eziphuthumayo ezengeziwe

• Ukushintshwa okwengeziwe nama-backorders

• Ukukhungatheka okwengeziwe kodokotela abahlinzayo lapho amasethi engaphelele

Ukuze uthole izibalo ze-inventory ngemuva kwalokhu, bona incazelo yokuthi ukuhlukahluka kwesikhathi sokuhola kusiqhuba kanjani isitoko sokuphepha namaleveli esevisi.

Okufanele ukwenze esikhundleni salokho: chaza isethi ye-KPI futhi uyihlole

Ungaceli 'ukulethwa okusheshayo.' Cela ukusebenza okulinganisekayo.

Abasabalalisi be-KPIs bangasebenzisa ekhadini lesikolo lomphakeli bahlanganisa:

• I-OTIF (ngesikhathi, ngokugcwele)

• Ukwethenjwa kwesikhathi sokuhola nokuhluka

• Izinga le-oda elingemuva

• Sheshisa isilinganiso

• Izinga lesikhalazo kanye nesikhathi sokuvalwa kwe-CAPA

Uhlu lolimi olulula lwamamethrikhi abahlinzeki abavamile lufinyezwa yi-Institute for Supply Management kumnikezeli wayo we-OTIF kanye nokuhlola konke kwe-KPI yokuthembeka kwesikhathi esiphambili.

Lapho i-XC Medico ingena khona

Lena indawo eyodwa lapho ukubeka izinto obala kwedlula izithembiso. I-XC Medico ingaqondana nabasabalalisi kuma-KPIs asebenzayo, bese ifakazela ukusebenza kumpambuko osesiteji (ama-SKU okuhlola, izindawo ezilinganiselwe, izindawo zokuhlela kabusha ezichaziwe) ngaphambi kokunwetshwa.

Uma uhlela ukushintsha, cela i-KPI cadence (isonto ngalinye ngesikhathi soshintsho, bese kuba nyanga zonke) kanye nendlela ecacile yokukhuphuka lapho ukuthunyelwa sengozini yokuphuthelwa yiwindi.

Iphutha #4: Ukushintsha ama-SKU ngaphandle kokuqinisekisa ukulandeleka, izikhalazo, kanye nokusabela kwe-CAPA

Abasabalalisi bavamise ukugxila ekucacisweni komkhiqizo, bese bathola sekwephuzile kakhulu ukuthi ukugeleza kwesistimu yekhwalithi akunabungane bokusabalalisa.

Uhlu lokuhlola olusebenzayo ludinga ukumboza:

• Zikhonjwa futhi zilandelelwa kanjani inkatho/amaqoqo

• Kwenzekani uma kungena isikhalazo

• I-CAPA ivulwa, ixhunywe, futhi ivalwe ngokushesha kangakanani

• Zilawulwa kanjani izinguquko zomkhiqizo (nokuthi uzokwaziswa kanjani)

Uma umphakeli omusha engakwazi ukusekela ukulandeleka okusheshayo, okuhlanzekile nokugeleza komsebenzi wokulungisa, izindleko zakho zokusebenza ziyakhuphuka ngisho noma isifakelo ngokwaso sisebenza kahle.

Okufanele ukwenze esikhundleni salokho: hlola isistimu yekhwalithi njengokuthi uzoyisebenzisa

Ngesikhathi sokufaneleka, qalisa 'isigameko se-tabletop' nomphakeli:

• Cela isibonelo sokulandeleka se-SKU eyodwa (kusuka kokusetshenziswayo kuya kudivayisi eqediwe, ezingeni abangabelana ngalo)

• Buza umugqa wesikhathi we-CAPA nokuthi ubani ongumnikazi wezokuxhumana zabasabalalisi

• Cela amadokhumenti aqondile owatholayo lapho kwenziwa ushintsho (nokuthi kusekude kangakanani)

Lapho i-XC Medico ingena khona

Ukuma kwe-XC Medico okushicilelwe kuhlanganisa izinqubo zokulandeleka ezifana nokumaka ngelaser ye-UDI ukuze kulandelelwe iqoqo, okuhlobene nokulungela ukucwaningwa kwamabhuku kanye nokusingatha izikhalo.

Uma ufuna ukuhlola ukuphendula, ungaqageli. Qala ngezinga lesevisi: I-XC Medico ishicilela i-SLA yempendulo kanye nenqubomgomo yosekelo kuyo Ukusekelwa kwangemuva kokuthengisa kanye nekhasi le-SLA lokuphendula . Yisebenzise njengesisekelo salokho okulindele kunoma yimuphi umphakeli.

Iphutha #5: Ukubukela phansi umsebenzi wokuphatha ushintsho (ukwethenjwa kodokotela abahlinzayo, amathreyi, ukuqeqeshwa, izimbuyiselo)

Ukushintsha umphakeli akusona nje isenzo sokuthenga. Ishintsha indlela izibhedlela ezikuthola ngayo.

Uma weqa ukuphathwa koshintsho, izindleko zivela kanje:

• Ukutholwa kancane kancane kodokotela abahlinzayo abakhetha isethi endala

• Ukungqubuzana kosuku lapho amathreyi engaphelele noma engajwayelekile

• Ukwanda kwezicelo 'ezincane' eziphuthumayo ezephula uhlelo lwakho lokuhamba

• Ukubuya okungcolile kanye nokushintshwa okukhipha isikhathi

Okufanele ukwenze esikhundleni salokho: sebenzisa iswishi njengokukhishwa kwezigaba

Uhlelo olusebenzayo lokukhishwa lubukeka kanje:

1. I-Pilot scope : khetha isethi eqinile yama-SKU kanye nendawo eyodwa.

2. Ukuqeqeshwa : chaza ukuhambisana kwezinsimbi kanye nezidingo zokuqeqeshwa.

3. Setha ukuphelela : qinisekisa ukucushwa kwethreyi nokugeleza komsebenzi wokugcwalisa.

4. Ukubuyisela/okushintshwayo : bhala indlela esheshayo yezinsuku zokuqala ezingu-90.

5. Isikali : nweba kuphela uma i-OTIF nokugeleza komsebenzi wesikhalazo kuzinzile.

Lapho i-XC Medico ingena khona

Kubasabalalisi abadinga ububanzi, iphothifoliyo yokukhiqiza ye-XC Medico kanye nokuma kwesikali kungasekela ukuhlelwa kwezinhlelo eziningi. Isiqalo esihle siwukujula kwesigaba sabo sokuqukethwe, okufana ne trauma locking plates guide guide kanye Ukubuka konke kwesistimu yokukhiqiza nekhwalithi , bese usebenzisa umshayeli wakho ukuze uqinisekise iqiniso lesevisi.

Uhlu lokuhlola lokushintsha umhlinzeki olulula (kopisha/unamathisela)

Sebenzisa lokhu njengohlu lwakho lokuhlola lwangaphakathi ngaphambi kokuthi uzibophezele:

• Ishidi lokusebenza lezindleko ezitholakalayo liqediwe futhi libuyekezwa yizimali

• Izidingo zokuthobela imakethe ngemakethe ziqinisekisiwe (amalebula/ulimi lwe-IFU, indlela yokubhalisa)

• Iphekhi yamadokhumenti alawulwa ngenguqulo yamukelwe futhi yaqinisekiswa yi-QA/RA

• Ikhadi lomphumela le-KPI livunyelwene (OTIF, ukuhluka kwesikhathi sokuhola, ama-backorder, impendulo ye-CAPA)

• Kuchazwe umshayeli wendiza (ama-SKU, ijografi, izindawo zokuhlela kabusha, imithetho yokukhuphuka)

• Inqubo yokubuyisela/yokushintsha okuvunyelwene ngayo futhi yahlolwa

Izinyathelo ezilandelayo

Uma ufuna iphekhi elisebenzayo lokuqinisekisa lokushintsha abahlinzeki bezifo zamathambo (uhlu lokuhlola lwemibhalo + isifanekiso sekhadi lesikolo le-KPI), licele kwa-XC Medico futhi uliqalise ngokumelene nomphakeli wakho wamanje kanye nohlu lwakho olufushane.

(Kugcine kuyisicefe. Okuyisicefe kuhle ekuthotshelweni nasekuthengeni izinto.)