Iimpazamo ezi-5 eziPhakamileyo eziNgcaciso zeNgxowa-mali Enzayo xa Utshintsha ababoneleli be-Orthopedic

Ukutshintsha ababoneleli be-orthopedic kunokuba yintshukumo ehlakaniphile. Ukhuseleko olungcono, amaxabiso angcono, iiodolo zasemva ezimbalwa.

Kodwa abasasazi abafane benzakaliswe yinxenye abathe bathethathethana ngayo. Benza ukwenzakala ngenxa yecandelo abangaliqinisekisanga: iindleko ezifikelweyo, iinkcukacha zokuthotyelwa kwendawo, ukuguquguquka kwexesha elikhokelayo, kunye nenyaniso yenkonzo yemihla ngemihla xa iodolo yokuqala engxamisekileyo ibetha.

Eli nqaku liyinkqubo-sikhokelo yomngcipheko wokuqala kubasasazi bezixhobo zonyango abaphonononga iswitshi. Injongo ilula: thintela izinto ezothusayo ezibiza imali eninzi, khusela ukuthembela koogqirha botyando, kwaye ugcine iithenda zihamba.

Izinto eziphambili ezithathwayo

• Phatha 'ixabiso' ​​njengexabiso lilonke elifunyenweyo , kubandakanywa izithinteli, ii-expedites, umonakalo/imbuyekezo, kunye namaxwebhu aphezulu.

• Izatifikethi azifani nokwamkelwa kweemarike zendawo. Qinisekisa iimfuno zokungenisa nokuleyibheli kwangoko, ngakumbi kwizicwangciso zamazwe amaninzi.

• Musa ukwamkela amaxesha anethemba lokukhokela. Cela i-metrics ngexesha kunye nokuguquguquka, kunye nomqhubi wenqwelomoya ngaphambi kokuba uzibophelele.

• Ukulandeleka kunye nokuphendula kweCAPA kubaluleke kakhulu njengeenkcazo zemveliso.

• Ukutshintsha kulawulo lotshintsho. Cwangcisa iitreyi, uqeqesho, kunye nembuyekezo ecocekileyo/ukutshintshwa kokuhamba komsebenzi.

Impazamo #1: Ukuphatha ixabiso leyunithi njengexabiso lokwenyani (kunye nokungahoywa kweendleko zokuhlala)

Eyona mpazamo ixhaphakileyo yokutshintsha kukuthethathethana ngexabiso elikhulu leyunithi, emva koko ufumanise ukuba imida iyanyamalala emva kwekota yokuqala.

Abaqhubi beendleko ezifihlakeleyo ngexesha lotshintshiselwano lomthengisi badla ngokuhlanganisana kwiindawo ezifanayo:

• I-Inventory buffers : uphethe isitokhwe esongezelelweyo kuba awukalithembi ixesha lokukhokela elitsha okwangoku.

• I-Expedites : uhlawula ukulungisa iimpazamo zokubikezela kunye nokulibaziseka kokuthunyelwa.

• Umonakalo, umngcipheko wokuthintela inzala, kunye nembuyekezo : ukupakishwa kunye nemiba yokuphatha ayibonakali kwisicatshulwa.

• Umphezulu woxwebhu : iqela lakho lichitha ixesha lileqa izatifikethi ezingekhoyo, iinguqulelo kunye nohlaziyo.

• Ukuvuza kwengeniso (xa uxwebhu olusezantsi lungcolisekile): amaphepha angahambelaniyo kunye neempazamo zomphathi wento zinokudala ukungqubana kwetyala kunye nokusebenza kwakhona.

Isilumkiso : Ukuba awukwazi ukwenza imodeli yeendleko zokuhlala, awukwazi ukuthelekisa ababoneleli. Uthelekisa izicatshulwa.

Yintoni omawuyenze endaweni yoko: yakha iphepha lomsebenzi elineendleko zokuhlala phambi kokuba usayine

Sebenzisa iphepha lomsebenzi elilula langaphambili kwaye ulenze libe yinto yokungena kwiswitshi yakho yomthengisi.

Ubuncinci bezinto zomgca zokubandakanya:

• Uthutho, i-inshurensi, imisebenzi, imirhumo yomthengisi, kunye nokugcinwa

• Isitokhwe sokhuseleko (iiveki) oya kusibamba ngexesha lotshintsho

• Umlinganiselo olindelekileyo wesantya (nokuba 'imbi kakhulu') kunye neendleko ngokukhawuleza

• Ukubuyiswa/ukutshintsha iindleko zokuhamba komsebenzi (ixesha + nomthwalo)

• Umzamo wokubhala (iiyure ze-QA / RA) kwiintsuku zokuqala ze-90

Yintoni onokuyibuza nawuphi na umthengisi wamathambo

• Zeziphi ii-Incoterms odla ngokuzisebenzisa, kwaye zibandakanya ntoni?

• Luthini ulungiselelo lwakho olusemgangathweni lokupakisha, kwaye uqinisekisa njani ingqibelelo yomqobo onyumba ngexesha lothutho?

• Ithini inkqubo yakho xa ukuthunyelwa kulibaziseka okanye kungagqitywanga?

Apho i-XC Medico ingena khona

Ukuba ufuna ukwenza ixabiso lokuhlala liqikeleleke, udinga ukubonakala kokusebenza. Indlela ye-XC Medico kukwenza unikezelo lulinganiseke ukusebenza (umzekelo, ngokulungelelanisa iindawo zokujonga ubume be-odolo kunye nee-KPIs zomboneleli njengonikezelo ngexesha kunye nokugqibelela), ukuze 'indleko yokwenyani' ifike ngokumangalisayo kamva.

Kubathengisi abathengisa kulo lonke elaseMelika, i-XC Medico inokuxhasa kwakhona ukhetho lokuzaliseka kwe-LATAM, kubandakanywa umzila waseMexico apho kufanelekileyo, ukunciphisa ukungqubuzana kwemida. Kuthathe oku njengento efunekayo: cela indlela ethile, imigaqo kunye noxanduva ngokubhaliweyo.

Impazamo #2: Ukuthatha uhambo lwezatifikethi (CE / FDA ayifani nokuvunywa kwendawo)

Umsasazi unokuqinisekisa i-CE, abone inombolo yemvume ye-FDA, kwaye acinge ukuba umsebenzi wokuthotyelwa wenziwe ngokwesiseko. Emva koko ithenda yokuqala icela uxwebhu ongenalo, okanye iimfuno zokuleyibhile zengingqi zinyanzelise iprojekthi yokufakela iileyibhile ngokutsha ongakhange uyisebenzisele ibhajethi.

Izikhumbuzo ezibini ezisebenzayo:

• E-US, i-FDA inokuqinisekisa ubhaliso/uluhlu lweziko kunye (apho kufanelekileyo) ulwazi lokungeniswa kwentengiso kwangaphambili ngexesha lophononongo lokungenisa elizweni. Ukungahambelani kunokucotha okanye kumise ukungena. Jonga i-FDA yokungenisa izixhobo zonyango isishwankathelo malunga noko kujongwe emdeni.

• EMexico, iindlela ze-COFEPRIS zidla ngokufuna umnikazi wobhaliso wasekhaya kunye nokulindelwe kwe-IFU yeSpanishi. Indawo yokuqala lushwankathelo lobhaliso lwe-Emergo lwe-COFEPRIS.

I-Key Takeaway : 'ihambelana nehlabathi jikelele' ayisoseti yoxwebhu. Yinkqubo. Iimfuno ziyahluka ngokwelizwe kunye nokuhlelwa kwemveliso.

Yintoni omawuyenze endaweni yoko: cela ipakethe yamaxwebhu esele ilungile

Phambi kokuba ufake iodolo enzima, funa ipakethi yamaxwebhu elawulwayo, eguqulelweyo enokuqinisekiswa yiqela lakho le-QA/RA.

Ubuncinci, cela:

• Isatifikethi se-ISO 13485 (yangoku)

• Izatifikethi zeCE kunye neenkcukacha zobubanzi (apho kufanelekileyo)

• I-FDA 510(k) iinkcukacha zesalathiso (apho kufanelekile)

• Ukulandeleka / indlela ye-UDI (indlela ozakulandela ngayo ibhetshi/iqashiso)

• Ukuleyibhile kunye neefayile ze-IFU ezinolawulo lokuhlaziya kunye nesicwangciso sokuguqulela

• Guqula umgaqo-nkqubo wesaziso (indlela oza kwaziswa ngayo xa kukho into etshintshileyo)

Apho i-XC Medico ingena khona

I-XC Medico izimisa njengamaxwebhu alungele abasasazi abafuna ubungqina bokuthotyelwa, hayi izilogeni. Izixhobo ezipapashiweyo zenkampani zigxininisa i-ISO 13485 kunye nokhuseleko lwesatifikethi samazwe ngamazwe, kunye nezenzo zokulandeleka (kubandakanya ukuphawulwa kwelaser ye-UDI yokulandela ibhetshi).

Ukuba ufuna isiqalo esicwangcisiweyo sokuqinisekisa umboneleli, unokubhekisa kwi I-XC Medico orthopedic OEM/ODM isikhokelo sokuthengwa kwempahla , ebhalelwe amaqela okuthengwa kwempahla afuna uvavanyo lwendlela yokutshekisha, hayi incwadana.

Impazamo #3: Ukukholelwa kumaxesha anethemba lokukhokela xa utshintshela ababoneleli be-orthopedic

Umthengisi angadibana nexesha lokukhokela elicatshulweyo kwaye abe engalunganga.

Imowudi yokungaphumeleli enexabiso elikhulu kukuguquguquka: amaxesha okukhokelela ekujikeni, ukuthunyelwa ngokuyinxenye kuyavela, kwaye iqela lakho liphela libaleka ngokukhawuleza kunye nokuxolisa.

Oko kuguquguquka kunyanzela abasasazi ukuba bazikhusele:

• Isitokhwe esingakumbi sokhuseleko (inkunzi ibotshelelwe)

• Umthwalo ongxamisekileyo ngakumbi

• Okunye okutshintshileyo kunye nemiyalelo yangasemva

• Udano olungakumbi logqirha wotyando xa iiseti zingagqitywanga

Kuluhlu lwezibalo emva koku, jonga ingcaciso yendlela ukuguquguquka kwexesha elikhokelayo kuqhuba ngayo isitokhwe sokhuseleko kunye namanqanaba eenkonzo.

Omawukwenze endaweni yoko: chaza iseti ye-KPI kwaye uyiqabe

Sukucela 'unikezelo olukhawulezayo.' Cela ukusebenza okunokumetwa.

Abasasazi be-KPIs banokusebenzisa kwikhadi lamanqaku lomthengisi ziquka:

• I-OTIF (ngexesha, igcwele)

• Ukuthembeka kwexesha lokukhokela kunye nokuhluka

• Ireyithi ye-backorder

• Ukukhawulezisa umlinganiselo

• Izinga lesikhalazo kunye nexesha lokuvalwa kweCAPA

Uluhlu lolwimi olucacileyo lweemetric zababoneleli abaqhelekileyo lushwankathelwa liZiko loLawulo lweeNtengo kumboneleli walo we-OTIF kunye nokuthembeka kwexesha elikhokelayo kushwankathelo lwe-KPI.

Apho i-XC Medico ingena khona

Le yenye indawo apho ukwenza izinto elubala kubetha izithembiso. I-XC Medico inokulungelelaniswa nabasasazi kwii-KPIs ezisebenzayo, emva koko ibonakalise intsebenzo kwirempu ehleliweyo (ii-SKU zolingo, iindawo ezilinganiselweyo, iindawo zokucwangcisa ngokutsha ezichaziweyo) phambi kokwandisa.

Ukuba uceba ukutshintsha, cela i-KPI cadence (iveki nganye ngexesha lotshintsho, emva koko ngenyanga) kunye nendlela ecacileyo yokunyuka xa ukuthunyelwa kumngcipheko kuphosa ifestile.

Impazamo #4: Ukutshintsha ii-SKU ngaphandle kokuqinisekisa ukulandeleka, izikhalazo, kunye nokuphendula kweCAPA

Abasasazi bahlala bejolisa kwiinkcazo zemveliso, emva koko bafumanise kade ukuba inkqubo yokusebenza esemgangathweni ayihambelani nokusasaza.

Uluhlu olusebenzayo lokutshintsha kufuneka lubandakanye:

• Zichongiwe kwaye zilandelelwa njani amaqashiso/iibhetshi

• Kwenzeka ntoni xa kungena isikhalazo

• Zivulwa ngokukhawuleza kangakanani iiCAPAs, zixelwe, kwaye zivalwe

• Utshintsho lwemveliso lulawulwa njani (kunye nendlela oza kwaziswa ngayo)

Ukuba umboneleli omtsha akakwazi kuxhasa ukulandeleka okukhawulezileyo, okucocekileyo kunye nokuhamba komsebenzi wokulungisa, iindleko zakho zokusebenza ziyanyuka nokuba isifakelo ngokwaso sisebenza kakuhle.

Yintoni omawuyenze endaweni yoko:vavanya isixokelelwano somgangatho njengokuba uya kusisebenzisa

Ngexesha lesiqinisekiso, sebenzisa 'isiganeko setafile' kunye nomthengisi:

• Cela umzekelo wokulandeleka kwi-SKU enye (ukusuka kwimathiriyeli ekrwada ukuya kwisixhobo esigqityiweyo, kwinqanaba abanokwabelana ngalo)

• Buza ixesha le-CAPA kwaye ngubani ongabanini bonxibelelwano lwabasasazi

• Buza amaxwebhu achanekileyo owafumanayo xa utshintsho lwenziwa (kwaye kude kangakanani ngaphambili)

Apho i-XC Medico ingena khona

Isikhundla esipapashiweyo se-XC Medico siquka iinkqubo zokulandeleka ezifana nokumakishwa kwe-laser ye-UDI yokulandela umkhondo webhetshi, nto leyo enxulumene nokulungela uphicotho-zincwadi kunye nokusingatha izikhalazo.

Ukuba ufuna ukuvavanya ukuphendula, musa ukuqikelela. Qala ngomgangatho wenkonzo: I-XC Medico ipapasha impendulo ye-SLA kunye nomgaqo-nkqubo wenkxaso kuyo inkxaso emva kwentengiso kunye nempendulo SLA page . Yisebenzise njengesiseko sento oyilindele kuye nawuphi na umboneleli.

Impazamo #5: Ukujongela phantsi umsebenzi wokulawula utshintsho (ithemba lotyando, iitreyi, uqeqesho, ukubuya)

Ukutshintsha umthengisi ayilonyathelo lokuthenga kuphela. Iyatshintsha indlela izibhedlele ezikufumana ngayo.

Ukuba utsiba ulawulo lotshintsho, iindleko zivela ngolu hlobo:

• Ukwamkelwa okucothayo koogqirha abakhetha iseti endala

• I-Case-day friction xa iitreyi zingaphelelanga okanye ziqhelekile

• Ukwanda kwezicelo ezingxamisekileyo 'ezincinci' ezophula isicwangciso sakho solungiselelo

• Ukubuya okumdaka kunye nokutshintshwa okuchitha ixesha

Yintoni omawuyenze endaweni yoko: sebenzisa iswitshi njengokukhutshwa kwezigaba

Isicwangciso esisebenzayo sokukhutshwa sijongeka ngolu hlobo:

1. Umda wokulingwa : khetha isethi eqinileyo yee-SKU kunye nejografi enye.

2. Uqeqesho : chaza ukuhambelana kwesixhobo kunye neemfuno zoqeqesho.

3. Cwangcisa ukugqibelela : qinisekisa ubumbeko lwetreyi kunye nokuzaliswa komsebenzi.

4. Ukubuyisela / ukutshintshwa : bhala indlela ekhawulezayo kwiintsuku zokuqala ezingama-90.

5. Isikali : ukwandisa kuphela xa i-OTIF kunye ne-workflows yesikhalazo zizinzile.

Apho i-XC Medico ingena khona

Kubasasazi abadinga ububanzi, ipotifoliyo yokuvelisa ye-XC Medico kunye nokubekwa kwesikali kunokuxhasa ucwangciso lwenkqubo ezininzi. Isiqalo esihle sisiqulatho sobunzulu bodidi lwabo, njenge trauma lokutshixa iipleyiti isikhokelo umenzi kunye Uveliso kunye nomgangatho wenkqubo , emva koko sebenzisa i-pilot yakho ukuqinisekisa ubunyani benkonzo.

Uluhlu olulula lomthengisi-tshintsha (khuphela/uncamathisele)

Sebenzisa oku njengoluhlu lwakho lokukhangela lwangaphakathi ngaphambi kokuba uzinikele:

• Iphepha lokusebenzela elineendleko zokufika ligqityiwe kwaye lihlaziywe yimali

• Iimfuno zokuthotyelwa kwemarike-ngentengiso ziqinisekisiwe (iilebhile/ulwimi lwe-IFU, indlela yokubhalisa)

• Ipakethi yamaxwebhu alawulwa yinguqulelo efunyenweyo kwaye yaqinisekiswa yi-QA/RA

• Ikhadi lamanqaku le-KPI livunyelwene (OTIF, ukuhluka kwexesha elikhokelayo, ii-backorders, impendulo yeCAPA)

• Umqhubi wenqwelomoya uchaziwe (ii-SKU, ijografi, iindawo zokucwangcisa ngokutsha, imigaqo yokunyuka)

• Inkqubo yokubuyiswa/yokutshintsha kuvunyelwene kwaye yavavanywa

Amanyathelo alandelayo

Ukuba ufuna ipakethe yokuqinisekisa esebenzayo yokutshintsha ababoneleli ngamathambo (uluhlu lokukhangela amaxwebhu + itemplate yekhadi lamanqaku e-KPI), yicele kwi-XC Medico kwaye uyiqhube ngokuchasene nomthengisi wakho wangoku kunye noluhlu lwakho olufutshane.

(Yigcine ikruqula. Ukukruqula kulungile ekuthotyelweni nasekuboneleleni ngetsheyini.)