Imibuzo eyi-10 ebuzwa ngabaXhasi baMabhobho xa beXhasa abaBoneleli boMfakelo woMzabalazo (Baphendulwe)

Ukufumana izifakelo zokwenzakala akufani nokukhangela izinto ezilahlwayo. Nokuba wongeza umthombo wesibini okanye ulungele umenzi omtsha wokufakelwa komonzakalo wamathambo, 'umboneleli' wakho uyinxalenye yenkqubo yakho ethembekileyo yotyando-kuba yonke i-backorder, itreyi engafaniyo, okanye utshintsho olungabhalwanga ekugqibeleni luhlala kwiqela lakho.

Eli nqaku lijika inkqubo yesiqinisekiso esithe saa ibe yimibuzo eli-10 elungele umthengisi onokuyisebenzisa kwii-RFIs, iifowuni zababoneleli, kunye nophicotho.

Izinto eziphambili ezithathwayo

• Umnikezeli we-trauma kuphela 'njengolungile' njengamaxwebhu abo: ISO 13485 ububanzi, ukulandeleka, ukulawula utshintsho, i-CAPA , kunye nokucaciswa kwendima.

• E-US, qinisekisa ukuba ngubani umenzi/isibhengezo esisemthethweni , kunye nendlela i-FDA 510(k) , ubhaliso/uluhlu, kunye noxanduva lwe-UDI lusingathwa ngayo.

• Cela i- traceability drill kunye nomthetho obhaliweyo wokutshintsha-isaziso (ngexesha elikhokelayo) ngaphambi kokuba ulinganise.

• Iinkqubo zokwenzakala zidala umngcipheko owongezelelekileyo kwiitreyi zesixhobo/iiseti zababolekisi : ukugqiba, isantya sokubuyisela, kunye nomcimbi wokugcinwa kwekhonkco lokugcinwa kangangoko.

• Tshixa okulindelweyo ngesivumelwano somgangatho + i-SLA ebotshelelwe kwii-KPIs ezinokulinganiswa (OTD, izinga lokuzalisa, i-backorder yesaziso sokukhokela ixesha).

1) Ngubani umenzi osemthethweni kunye nomenzi werekhodi wezi zixhobo zokwenzakala?

Impendulo: Phambi kokuba uthethe ngexabiso okanye ipotfoliyo, qinisekisa ukuba ngoobani ngokusemthethweni uxanduva lokubhala iilebhile kunye nolawulo. Ukuba iindima azicacanga, yonke imisebenzi esezantsi (i-UDI, ukuphatha isikhalazo, ukutshintshwa kwezaziso, ukukhumbula) iba yinto engcolileyo.

Yintoni onokuyicela

• Ingxelo yendima ecacileyo: umenzi, umphuhlisi wenkcazelo, umenzi wekhontrakthi, ongenisa ngaphandle, umthengisi/umthengisi kwakhona.

• Uxanduva lwematriksi ebonisa ukuba ngubani umnini:

• ulawulo lokuleyibhela

• izingeniso zolawulo (apho kufanelekileyo)

• Ukuphathwa kwesikhalazo emva kwemarike kunye namanyathelo endle

• utshintsho ulawulo kunye nezaziso zabathengi

Ijongeka njani into entle

• Iqumrhu elinye elibizwa ngokuba liziko linoxanduva lokuleyibhile kunye neefayile zokulawula, kwaye uxanduva lubhaliwe-hayi 'siza kuyiqonda kamva.'

Iiflegi ezibomvu

• 'Singabeka naliphi na igama kwileyibhile' ngaphandle komgangatho/ingcaciso yolawulo.

• Ukuthatha uxanduva olumfiliba kwiinkampani ezininzi.

2) Sithini isimo sakho se-US esilawulayo kule ntsapho yemveliso-kwaye unokungqina oko?

Impendulo: Kwizixhobo ezininzi ze-orthopedic, ukufikelela kwimarike kuxhomekeke kwindlela yokulawula echanekileyo kunye nobungqina bobungqina. Ubuncinci, kufuneka uqonde ukuba ngaba isixhobo sifuna i-FDA 510(k) imvume yokufakelwa kwe-trauma, ikhululiwe (kunye nemida), okanye inikezelwa phantsi kwelungiselelo elithile.

Yintoni onokuyicela

• Kwizixhobo ezifuna ukucocwa: i-510(k) echaphazelekayo iinkcukacha zesalathiso kunye nendlela ii-SKUs ezizimaphu ngazo.

• Kwizixhobo ezibangwayo 'ikhululiwe': isiseko esibhaliweyo kunye nemida (yintoni ekhululweyo, engeyiyo).

• Ubhaliso lokusekwa kunye neenkcukacha zoluhlu lwesixhobo apho kufanelekileyo.

Ijongeka njani into entle

• Umthengisi unokuchaza i-510(k) ngokucacileyo kwaye akubonise kwinkcazo esemthethweni ye-FDA. Isaziso seMarike ePhakamileyo 510(k).

• Baphatha ubhaliso/uluhlu njengemfuno esisiseko yolawulo, hayi ibheji esemgangathweni, ehambelanayo Ukubhaliswa kwesixhobo se-FDA kunye noluhlu.

Iiflegi ezibomvu

• 'ivunyiwe i-FDA' isetyenziswe ngokungaqhelekanga kwizixhobo zeClass II.

• Akukho sixhobo-zinkcukacha zosapho ('Inkampani yethu ibhalisiwe' ngaphandle kwemephu yale nto uyithengayo).

3) Kubaxhasi bokufakelwa komothuko: ngaba isiqinisekiso sakho se-ISO 13485 sofakelo lokwenzakala singoku-kwaye ngaba umda wokugquma ukufakwa kunye nezixhobo?

Impendulo: I-ISO 13485 sisignali yokuqala eyomeleleyo, kodwa kuphela ukuba yeyangoku kwaye ububanzi buhambelana nenyani (ukufakelwa, izixhobo, iinkqubo). Musa ukwamkela ilogo kwiwebhusayithi njengobungqina.

Yintoni onokuyicela

• Isiqinisekiso se-ISO 13485 sePDF esibonisa:

• umzimba okhuphayo

• imihla yokuqinisekisa

• ingxelo yobubanzi

• iidilesi zesiza (apho ukuveliswa kwenzeka)

• Ushwankathelo olufutshane 'lokulungela uphicotho-zincwadi': indlela abalulawula ngayo uphicotho-zincwadi lwangaphakathi, ukungathotyelwa, kunye neCAPA.

Ijongeka njani into entle

• Umda wesatifikethi uhambelana ngokucacileyo nokufakelwa kwe-orthopedic / izixhobo kunye neenkqubo ezifanelekileyo.

• Umthengisi unokukuhamba ngendlela abalawula ngayo ukungathotyelwa kwaye bathintele ukuphinda-hayi nje 'sine-QC.'

Iiflegi ezibomvu

• Umda awucacanga ('urhwebo' okanye 'usasazo' kuphela) xa ufuna umenzi.

• Izatifikethi eziphelelwe lixesha okanye amaqumrhu akhuphayo angacacanga.

I-4) Ngaba unokubonisa ukulandelwa kokuphela kokuphela kunye ne-UDI / ulawulo lokulebula (kungekhona nje ukuyibanga)?

Impendulo: Ukulandeleka yinto eyenza ukukhumbula kwenziwe utyando endaweni yentlekele. Ufuna ubungqina bokuba umthengisi unokulandelela ukufakelwa kwezinto ezigqityiweyo abuyele kwimpahla ekrwada kunye namanyathelo enkqubo engundoqo-kwaye iilebhile zilawulwa kwaye zihlaziywe.

Yintoni onokuyicela

• Isishwankathelo sokulandelelwa: iqashiso/ibhetshi/imigaqo yothotho, into erekhodiweyo, izenzo zokugcina.

• Isicwangciso se-UDI kunye nolawulo lokubhala (ukuhamba kokuvunywa komsebenzi, ulawulo loguqulelo, imigaqo yokutshintsha iilebhile).

• ophilayo Umzobo wokulandela umkhondo kwi-SKU/iqashiso elinye:

• iziqinisekiso zemathiriyeli ekrwada → ukwenza umhambi/indlela → iirekhodi zokuhlola → ukukhutshwa kokugqibela → irekhodi yokuthunyelwa

Ijongeka njani into entle

• Inkqubo yabo ye-UDI / umkhondo ixhasa ukuthotyelwa kunye nemihla ngemihla yokusabalalisa i-ops (ukuchaneka kwe-inventory, ukukhumbula okujoliswe kuyo).

• Baqonda ulindelo lwe-biocompatibility kwaye banokubhekisa kwisakhelo esamkelweyo esinje Isikhokelo se-FDA kwi-ISO 10993-1 biocompatibility (PDF) yovavanyo lwesixhobo esifakelwayo.

Iiflegi ezibomvu

• Ukulandeleka kuhlala kwiispredishithi ezingekho sikweni kungekho tshintsho.

• 'Singanikezela ngeeleyibhile' kodwa akukho nkqubo yeleyibhile ebhaliweyo yemvume/yokukhutshwa.

I-5) Uthini umgaqo wakho wokulawula utshintsho-kwaye unika isaziso esingakanani ngaphambi kokuba utshintsho lusebenze?

Impendulo: Ukuba umthengisi unokutshintsha imathiriyeli, imizobo, unyango olungaphezulu, okanye ukupakishwa ngaphandle kwenkqubo yesaziso esiqeqeshekileyo, uyabhencwa-ingakumbi kwiithenda kunye namaxesha amade obhaliso.

Yintoni onokuyicela

• Isaziso esibhaliweyo sokutshintsha kweSOP sigquma:

• luluphi utshintsho olubangela isaziso (uyilo/izinto eziphathekayo/inkqubo/ukufaka iilebhile/ukupakishwa)

• amaxwebhu afunekayo (ingqiqo, impembelelo yomngcipheko, impembelelo yokuqinisekisa)

• isaziso sexesha lokukhokela kunye nokuba ungabeka okanye ubambe

• Imizekelo yezaziso zotshintsho lwangaphambili (ezineenkcukacha ezibuthathaka zenziwe ngokutsha).

Ijongeka njani into entle

• Ulawulo lotshintsho lubotshelelwe kwingcinga yolawulo lomngcipheko (umzekelo, imigaqo ye-ISO 14971).

• Ixesha elikhokelayo lesaziso licacile kwaye liyasebenza (abaninzi abasasazo bacela iwindow yesaziso esincinci), ngokufanayo nendlela echazwe kwindlela yokuhambisa isiqinisekiso seentsuku ezingama-30.

Iiflegi ezibomvu

• 'Siza kukuxelela ukuba kukho into etshintshileyo' ngaphandle kwenkqubo.

• Utshintsho oluqhutywa ngotshintshiselwano lwababoneleli ngaphandle kokuqinisekiswa kovavanyo lwempembelelo.

6) Uzisingatha njani izikhalazo, iCAPA, kunye nokulungela ukukhumbula-kwaye ngawaphi amaxesha akho okuphendula?

Impendulo: Awudingi mfezeko; ufuna umboneleli onokuphanda, uxwebhu lwengcambu yesizathu, kwaye avale i-loop ngokukhawuleza. Inkqubo ecothayo okanye ebalekayo yeCAPA iba yingxaki yegama lomsasazi.

Yintoni onokuyicela

• Isikhalazo sokuhamba komsebenzi kwaye yeyiphi idatha efakiweyo.

• Ukuhamba komsebenzi weCAPA (uphando, ukugcinwa, unobangela, isenzo sokulungisa, ukujonga ukusebenza kakuhle).

• Uphononongo lwenkqubo yokukhumbula/umsebenzi kunye nesicwangciso sonxibelelwano.

• Ulindelo lwexesha lokuphendula olubhalwe kwizivumelwano.

Ijongeka njani into entle

• I-CAPA imiselwe ixesha kwaye inomlinganiselo.

• Bangabonisa indlela ukulandeleka kuxhasa ngayo iintshukumo zentsimi ekujoliswe kuzo.

Iiflegi ezibomvu

• Akukho ndlela ichaziweyo yokunyuka.

• Hayi 'ujongo olusebenzayo' inyathelo (ulungiso aluqinisekiswanga).

7) Kwiimveliso eziziintsholongwane okanye ukupakishwa okungenazintsholongwane: ngaba ungabonelela ngokuvala inzala kunye nezishwankathelo zokuqinisekisa ukupakishwa (ISO 11607 umxholo)?

Impendulo: Ukuba imveliso ibonelelwe ngobunyumba, ukupakishwa kunye nokuqinisekisa ukuvalwa kokuvalwa kwentsholongwane akunyanzelekanga—zibubungqina obungundoqo.

Yintoni onokuyicela

• Isishwankathelo sokuqinisekisa ukupakishwa (ingqibelelo yesithintelo esingenazintsholongwane, uvavanyo lokuhambisa/lokuthumela, isiseko sobomi beshelufa) xa kufanelekile.

• Isishwankathelo sokuqinisekiswa kokuqinisekisa kunye nobungqina bokukhululwa kwebhetshi xa kufanelekile.

• Ingxelo ecacileyo yoxanduva: ngubani oqinisekisa ukuba yintoni, kwaye yintoni oyifumanayo kwiqashiso ngalinye.

Ijongeka njani into entle

• Amaxwebhu okuqinisekisa akhona kwaye kwabelwana ngawo ngendlela elawulwayo.

• Umthengisi unokuchaza ukuba loluphi utshintsho olunokuthi luqalise ukuqinisekiswa kwakhona.

Iiflegi ezibomvu

• 'Oyinyumba' amabango angenasishwankathelo sokuqinisekisa.

• Utshintsho lokupakisha luphathwa njengezithambiso (alukho).

8) Ngawaphi amaxesha okukhokela, amandla, kunye nemodeli yoluhlu onokuthi uzibophelele kuyo-kwaye kwenzeka ntoni xa uphoswa?

Impendulo: Ixesha lokukhokela alikho inani elinye. Udinga iinkcazo ngentsapho yemveliso, umbono ocacileyo wokuthintelwa kwamandla, kunye nemithetho yokwabiwa ngexesha le-spikes.

Yintoni onokuyicela

• Ixesha lokukhokela ngosapho/ibhendi ye-SKU (ubungakanani obuqhelekileyo vs non-standard).

• Ingxelo yesakhono kunye nesicwangciso sotyando.

• Iinketho zoluhlu: isitokhwe, ukuthunyelwa, umhlanganiselwa, okanye iVMI.

• I-cadence yonxibelelwano ngasemva kunye nendlela yokunyuka.

Ijongeka njani into entle

• Umniki-nkonzo uzibophelele kumanqanaba enkonzo anokumetwa (OTD, ireyithi yokuzalisa, i-backorder yesaziso sexesha lokukhokela), ngokuhambelana nendlela ye-KPI yomthengisi (kwaye hayi nje izithembiso zomlomo).

Iiflegi ezibomvu

• Amaxesha okukhokela okuthenjiswa ngokugqithisileyo kungekho datha okanye ingqiqo yolwabiwo.

• 'Singenza nantoni na ngokukhawuleza' ngaphandle kokubonakala kwe-inventri.

9) Uziqhuba njani iiseti zetreyi zesixhobo se-orthopedic isixhobo somboleki-ukugqiba, ukugcinwa kwakhona, kunye nekhonkco-lokugcina?

Impendulo: Iinkqubo zomonzakalo ziyasilela ekusebenzeni rhoqo kunokuba zisilela ngoomatshini. Eyona ntlungu yakho inkulu iya kuba zizikhewu zetreyi, izixhobo ezingekhoyo, kunye nokujika kancinci.

Yintoni onokuyicela

• Imephu yokumisela itreyi kunye noluhlu lokupakisha ngeseti nganye.

• Inkqubo yokukhangela ukugqibelela kwetreyi (ngubani ojonga, nini, kwaye imiba isingathwa njani).

• Uguqulo ekujoliswe kulo lokubuyisela isitokhwe, ukulungiswa, kunye nokutshintshwa.

• Ulindelo lwekhonkco lokugcinwa kwabo babolekisa ngemali (amanqaku e-handoff, imida yoxanduva).

Ijongeka njani into entle

• Ungaqhuba isampulu 'iseti epheleleyo' yophicotho: ingaba iseti ehanjisiweyo iyahambelana noluhlu lokupakisha olusemthethweni, olunophawu oluchanekileyo kunye nokubekwa?

• Ukubuyisela isitokhwe kunye namaxesha okutshintsha izixhobo kuyachazwa kwaye kulinganiswe.

Iiflegi ezibomvu

• Akukho luhlu lokupakisha olusemgangathweni okanye akukho guqulelo lolawulo.

• 'Siza kongeza izixhobo kamva' njengesiqhelo.

I-10) Ngaba uya kusayina isivumelwano somgangatho kunye ne-SLA-kwaye yiyiphi imigaqo yorhwebo ekhusela macala omabini?

Impendulo: Ukuba ayibhalwanga, asiyonyani. Isivumelwano somgangatho sichaza indlela enisebenza ngayo kunye; i-SLA ichaza ukuba yintoni 'inkonzo elungileyo' ithetha; imigaqo yorhwebo ichaza indlela owabelana ngayo ngomngcipheko.

Yintoni onokuyicela

• Isivumelwano somgangatho (okanye itemplate) esigubungelayo:

• tshintsha izaziso zolawulo

• isikhalazo/ uxanduva lweCAPA kunye namaxesha

• ukulandeleka kunye nokugcinwa kwerekhodi

• amalungelo ophicotho

• Ikhadi lekhadi le-SLA elineesethi ezincinci ze-KPIs (i-OTD, izinga lokuzalisa, ixesha lokukhokela isaziso se-backorder, isixhobo sokutshintsha isixhobo).

• Amagama okurhweba: ii-MOQ, ii-incoterms, iwaranti / imbuyekezo, imida yodwa, kunye nemigaqo ye-IP ye-OEM/ODM.

Kumagqabantshintshi ngolwimi olucacileyo lwento emayibe ngaphakathi, umchazi weGreenlight Guru malunga nokuba isivumelwano somgangatho wesixhobo sonyango kufuneka sigqunywe yintoni sisiqalo esiluncedo (umxholo oluncedo xa uyila isivumelwano sakho somgangatho wesivumelwano soluhlu lwezixhobo zonyango).

Ijongeka njani into entle

• Umthengisi ukulungele ukulinganiswa-kwaye achaze ukuba kwenzekani xa usukelo lulahlekile.

Iiflegi ezibomvu

• Ukwala ukusayina nasiphi na isivumelwano somgangatho.

• Ii-KPI zixoxwa ngomlomo kodwa azizange zibhalwe.

Uqukuqelo olulula lweentsuku ezingama-30 onokuphinda ulusebenzise

Ukuba ufuna inkqubo ephindaphindwayo esebenzela iithenda kunye nophicotho:

• Iintsuku 1-10: Uxwebhu-ukuhlolwa kokuqala (ii-certs, ukulandelelwa, ukulawula utshintsho, i-CAPA, iindima)

• Iintsuku ze-11-20: Ukuqinisekiswa kokuSebenza (iseti yesampulu, ukuzaliseka kwetreyi, ixesha lokukhokela ngokwenene-jonga)

• Iintsuku ezingama-21-30: Tshixa kwimigaqo (isivumelwano somgangatho + SLA, emva koko ulinge ngeseti encinci ethengiswayo)

Uguqulelo oluneenkcukacha ezithe vetshe kulo msebenzi uchazwe kwisikhokelo se-XC Medico ababoneleli bokufakelwa komonzakalo kubanikezeli.

Ukuba ufuna kwakhona uluhlu lokukhangela olubanzi, olungangqalanga ukwenzakala, qala ngale nto isakhelo sovavanyo esinamanqanaba amabini.

Amanyathelo alandelayo

Ukuba uyathanda, ungajika le mibuzo ibe yipakethi ye-RFI yephepha elinye ngoluhlu lokukhangela lwesicelo soxwebhu, itheyibhile ye-SLA KPI, kunye nerubrikhi yamanqaku yeflegi ebomvu elula.

Ungaphinda uqwalasele inkqubo yakho yangoku ngokuchasene noku Uluhlu lokuhlola umthengisi wamathambo ogxile e-US.