Amakosa 5 yambere ahenze abatanga ibicuruzwa bakora mugihe uhinduye abatanga amagufwa

Guhindura abatanga amagufwa birashobora kuba intambwe yubwenge. Gukwirakwiza neza, ibiciro byiza, inyuma yinyuma.

Ariko abadandaza ntibakunze kubabazwa nigice baganiriye. Bababazwa nigice batigeze bemeza: igiciro cyubutaka, ibisobanuro byubahirizwa byaho, kuyobora-igihe cyo guhinduka, hamwe na serivise yumunsi-kuwundi iyo itegeko ryambere ryihutirwa rigeze.

Iyi ngingo ningaruka-yambere kubaganga bakwirakwiza ibikoresho byubuvuzi basuzuma byimazeyo. Intego iroroshye: irinde gutungurwa bihenze, kurinda ikizere cyo kubaga, no gukomeza amasoko agenda.

Ibyingenzi

• Fata 'igiciro ' nkigiciro cyose cyubutaka , harimo buffers, yihuta, ibyangiritse / kugaruka, hamwe ninyandiko hejuru.

• Impamyabumenyi ntabwo ari kimwe no kwemerera isoko ryaho. Kwemeza ibicuruzwa bitumizwa hamwe nibirango hakiri kare, cyane cyane kuri gahunda y'ibihugu byinshi.

• Ntukemere ibihe byiza byo kuyobora. Baza ku gihe cyagenwe no guhinduka, hamwe na pilote mbere yo kwiyemeza.

• Gukurikirana hamwe na CAPA gusubiza bifite akamaro nkibicuruzwa byihariye.

• Guhindura ni imiyoborere ihinduka. Tegura inzira, imyitozo, hamwe no kugaruka / gusimbuza akazi.

Ikosa # 1: Gufata igiciro cyibiciro nkigiciro nyacyo (no kwirengagiza igiciro cyubutaka)

Ikosa rikunze guhinduka ni kuganira ku giciro kinini, hanyuma kuvumbura ama marike azimira nyuma yigihembwe cya mbere.

Abashoferi bahishe mugihe cyo gutanga ibicuruzwa bakunda guhurira ahantu hamwe:

• Ibarura ryibikoresho : utwara ububiko bwinyongera kuko utizeye igihe gishya cyo kuyobora.

• Expedites : wishyura kugirango ukosore amakosa yo guhanura no gutinda kohereza.

• Ibyangiritse, inzitizi yinzitizi, kandi igaruka : gupakira no gukemura ibibazo ntibigaragara kuri cote.

• Inyandiko hejuru : itsinda ryanyu rimara umwanya mukurikirana ibyemezo byabuze, ibisobanuro, hamwe no gusubiramo.

• Amafaranga yinjira (iyo inyandiko yo hasi yinyandiko irimo akajagari): impapuro zidahuye hamwe nibintu byingenzi amakosa ashobora gutera fagitire no kongera gukora.

Icyitonderwa : Niba udashobora kwerekana ikiguzi cyubutaka, ntushobora kugereranya abatanga isoko. Urimo kugereranya amagambo.

Icyo wakora ahubwo: kubaka urupapuro rwakazi-rwakazi mbere yuko usinya

Koresha urupapuro rwabanjirije ibihembo hanyuma ukore ikintu cyinjira mumasoko yawe.

Ibintu ntarengwa byo gushyiramo:

• Ibicuruzwa, ubwishingizi, imisoro, amafaranga ya broker, hamwe nububiko

• Umutekano wumutekano (ibyumweru) uzifata mugihe cyinzibacyuho

• Ikigereranyo cyihuta cyateganijwe (niyo cyaba 'kibi-kibaye ') nigiciro kuri yihuta

• Garuka / gusimbuza igiciro cyakazi (igihe + imizigo)

• Imbaraga zinyandiko (amasaha ya QA / RA) muminsi 90 yambere

Icyo wabaza uwaguhaye amagufwa yose

• Ni ubuhe bwoko bwa Incoterms ukoresha, kandi harimo iki?

• Ni ubuhe buryo busanzwe bwo gupakira, kandi nigute ushobora kwemeza ubudahangarwa bwa sterile mugihe cyo gutwara?

• Nubuhe buryo bwawe mugihe ibyoherejwe bitinze cyangwa bituzuye?

Aho XC Medico ibereye

Niba ushaka gukora ibiciro byubutaka byateganijwe, ukeneye ibikorwa bigaragara. Uburyo bwa XC Medico nugukora imikorere yo gupimwa gupimwa (kurugero, muguhuza ibyateganijwe kuri bariyeri hamwe nabatanga KPI nko gutanga ku gihe no kuzura), bityo 'ikiguzi nyacyo ' ntikigera gitunguranye nyuma.

Ku bagurisha bagurisha hirya no hino muri Amerika, XC Medico irashobora kandi gushyigikira uburyo bwo gusohoza neza LATAM, harimo inzira ya Mexico ikorera aho bikenewe, kugirango igabanye amakimbirane yambukiranya imipaka. Fata ibi nkikintu gikwiye-kubaza: baza inzira yihariye, amagambo, ninshingano mu nyandiko.

Ikosa # 2: Dufashe ingendo zimpamyabumenyi (CE / FDA ntabwo ari kimwe no kwemerwa kwaho)

Umugabuzi arashobora kugenzura CE, reba numero yemewe ya FDA, hanyuma akeka ko imirimo yo kubahiriza ikorwa. Noneho isoko rya mbere risaba inyandiko udafite, cyangwa ibisabwa byanditse byibanze bihatira umushinga wongeyeho utateguye.

Ibintu bibiri byibutsa:

• Muri Reta zunzubumwe za Amerika, FDA irashobora kugenzura iyandikwa ryabakozi / urutonde hamwe (aho bibaye ngombwa) amakuru yoherejwe mugihe cyo gusuzuma ibicuruzwa byatumijwe hanze. Kudahuza birashobora gutinda cyangwa guhagarika kwinjira. Reba ibikoresho byubuvuzi bya FDA bitumiza muri rusange kubigenzurwa kumupaka.

• Muri Mexico, inzira za COFEPRIS mubisanzwe zisaba abafite kwiyandikisha hamwe na label ya Espagne / IFU ibiteganijwe. Intangiriro ni rusange muri Emergo ya COFEPRIS kwiyandikisha.

Ibyingenzi byingenzi : 'Kwubahiriza isi yose ' ntabwo ari inyandiko yashyizweho. Ni inzira. Ibisabwa biratandukanye bitewe nigihugu hamwe nibicuruzwa byashyizwe mubikorwa.

Icyo wakora ahubwo: saba isoko-iteguye inyandiko

Mbere yuko utanga itegeko rikomeye, saba igenzurwa, ryuzuye inyandiko ipaki itsinda rya QA / RA rishobora kwemeza.

Nibura, saba:

• Icyemezo cya ISO 13485 (ikigezweho)

• Icyemezo cya CE hamwe nibisobanuro birambuye (aho bishoboka)

• FDA 510 (k) ibisobanuro birambuye (aho bishoboka)

• Inzira ya Traceability / UDI (uburyo uzakurikirana icyiciro / ubufindo)

• Ikirango na IFU dosiye hamwe no kugenzura no guhindura gahunda

• Hindura politiki yo kumenyesha (uko uzamenyeshwa mugihe hari icyahindutse)

Aho XC Medico ibereye

XC Medico yihagararaho nk'inyandiko-yiteguye kubagabura bakeneye ibimenyetso byubahirizwa, ntabwo ari amagambo. Ibikoresho isosiyete yasohoye byibanda kuri ISO 13485 hamwe no gutanga ibyemezo mpuzamahanga, hiyongereyeho uburyo bwo gukurikirana (harimo na UDI laser marike yo gukurikirana ibyiciro).

Niba ushaka intangiriro yuburyo bwo gutanga isoko, urashobora kandi kwifashisha XC Medico orthopedic OEM / ODM itanga amasoko , yandikiwe amakipe atanga amasoko akeneye isuzuma ryuburyo bwo kugenzura, ntabwo ari agatabo.

Ikosa # 3: Kwizera ibihe byiza byo kuyobora mugihe uhindura abatanga amagufwa

Utanga isoko arashobora guhura nigihe cyo kuyobora kandi agakomeza kuba mubi.

Uburyo bwo gutsindwa buhenze burahinduka: kuyobora ibihe swing, ibyoherejwe igice biragaragara, kandi itsinda ryanyu ryarangije kwiruka byihuse no gusaba imbabazi.

Ihinduka rihatira abakwirakwiza imyitwarire yo kwirwanaho:

• Ibigega byinshi byumutekano (imari shingiro)

• Ibicuruzwa byihutirwa

• Abasimbuye benshi ninyuma

• Abaganga benshi bababajwe mugihe amaseti atuzuye

Kubiharuro bibarwa inyuma yibi, reba ibisobanuro byukuntu kuyobora-igihe bihindagurika bitera ububiko bwumutekano nurwego rwa serivisi.

Icyo gukora ahubwo: gusobanura KPI gushiraho no kuyigerageza

Ntubaze 'gutanga byihuse. ' Baza imikorere yapimwe.

Abagabuzi ba KPI barashobora gukoresha mubitanga amanota arimo:

• OTIF (ku gihe, cyuzuye)

• Kuyobora-igihe cyo kwizerwa no gutandukana

• Igipimo cyinyuma

• Ikigereranyo cyihuse

• Igipimo cyo kurega hamwe nigihe cyo gufunga CAPA

Ururimi rwumvikana urutonde rwibisanzwe rusanzwe rutangwa mu ncamake n'Ikigo gishinzwe gucunga amasoko mu batanga OTIF hamwe no kuyobora-igihe cyo kwizerwa KPI.

Aho XC Medico ibereye

Aka ni kamwe aho gukorera mu mucyo gukubita amasezerano. XC Medico irashobora guhuza nabagabuzi kuri KPI ikora ifite akamaro, hanyuma ikerekana imikorere mumurongo wateguwe (pilote SKUs, geografiya ntoya, ibisobanuro byerekana reord) mbere yo kwaguka.

Niba uteganya guhinduranya, saba KPI cadence (buri cyumweru mugihe cyinzibacyuho, hanyuma buri kwezi) n'inzira isobanutse neza mugihe ibyoherejwe bishobora kubura idirishya.

Ikosa # 4: Guhindura SKU utiriwe wemeza gukurikirana, ibirego, hamwe na CAPA

Abatanga ibicuruzwa bakunze kwibanda kubicuruzwa, hanyuma bakavumbura bitinze ko sisitemu nziza yimikorere idakwirakwiza.

Urutonde rufatika rwo guhinduranya rugomba gukurikiza:

• Nigute ubufindo / ibyiciro byamenyekanye kandi bigakurikiranwa

• Bigenda bite iyo ikirego kije

• Nigute byihuse CAPAs ifungura, ikamenyeshwa, kandi igafungwa

• Uburyo impinduka zicuruzwa zigenzurwa (nuburyo uzabimenyeshwa)

Niba utanga ibintu bishya adashobora gushyigikira byihuse, bisukuye neza kandi bikosora ibikorwa, ibikorwa byawe byiyongera nubwo uwatewe ubwayo akora neza.

Icyo wakora ahubwo: gerageza sisitemu yubuziranenge nkuko uzayikoresha

Mugihe cyo kuzuza ibisabwa, koresha 'ibyabaye kuri tabletop ' hamwe nuwabitanze:

• Saba urugero rwakurikiranwa kuri SKU imwe (kuva mubikoresho fatizo kugeza igikoresho cyarangiye, kurwego bashobora kugabana)

• Baza ingengabihe ya CAPA ninde ufite itumanaho

• Baza inyandiko nyazo wakiriye mugihe habaye impinduka (hamwe nigihe kingana iki)

Aho XC Medico ibereye

Imyanya XC Medico yashyize ahagaragara ikubiyemo imyitozo yo gukurikirana nka UDI laser ikimenyetso cyo gukurikirana ibyiciro, bifitanye isano nabagenzuzi biteguye kugenzura no gukemura ibibazo.

Niba ushaka gusuzuma ibisubizo, ntukeke. Tangira hamwe na serivise ya serivisi: XC Medico itangaza igisubizo SLA hamwe na politiki yo gushyigikira muriyo nyuma yo kugurisha no gusubiza urupapuro rwa SLA . Koresha nk'ibanze kubyo utegereje kubitanga.

Ikosa # 5: Gupfobya umurimo wo gucunga impinduka (kwizerana kubaga, tray, amahugurwa, kugaruka)

Guhindura ibicuruzwa ntabwo ari ibikorwa byamasoko gusa. Irahindura uko ibitaro bikubona.

Niba usibye guhindura imiyoborere, ibiciro byerekana nka:

• Kwakira buhoro kubaganga babaga bakunda seti ishaje

• Umunsi wo guterana amagambo mugihe inzira zituzuye cyangwa zimenyerewe

• Kwiyongera muri 'bito ' ibyifuzo byihutirwa bica gahunda yawe y'ibikoresho

• Messy aragaruka nabasimbuye bitwara igihe

Icyo wakora ahubwo: koresha switch nka feri yo gutangira

Gahunda ifatika yo gutangiza isa nkiyi:

1. Urwego rwindege : hitamo urutonde rukomeye rwa SKUs hamwe na geografiya imwe.

2. Amahugurwa : gusobanura guhuza ibikoresho nibikenewe mumahugurwa.

3. Shiraho ibyuzuye : genzura iboneza rya tray no kuzuza akazi.

4. Garuka / abasimbuye : andika inzira yihuse muminsi 90 yambere.

5. Igipimo : kwagura gusa mugihe OTIF nibibazo byakazi bihagaze neza.

Aho XC Medico ibereye

Ku bagabuzi bakeneye ubugari, XC Medico yo gukora portfolio hamwe nu mwanya uhagaze irashobora gushyigikira igenamigambi rya sisitemu nyinshi. Intangiriro nziza nicyiciro cyimbitse cyibirimo, nka ihahamuka rifunga amasahani yakozwe nuyobora gukora nubuziranenge bwa sisitemu , hanyuma ukoreshe umuderevu wawe kugirango wemeze ukuri kwukuri.

Urutonde rworoshye rutanga-uhindura urutonde (kopi / paste)

Koresha ibi nkurutonde rwimbere rwimbere mbere yo kwiyemeza:

• Urupapuro rwakazi-rwuzuye rwuzuye kandi rusubirwamo nubukungu

• Ibisabwa kubahiriza isoko-by-isoko byemejwe (ibirango / ururimi IFU, inzira yo kwiyandikisha)

• Impapuro zagenzuwe na verisiyo yakiriwe kandi yemejwe na QA / RA

• Ikarita ya KPI yemeye (OTIF, kuyobora-igihe cyo gutandukana, inyuma, igisubizo CAPA)

• Umuderevu yasobanuwe (SKUs, geografiya, ingingo zisubiramo, amategeko yo kuzamura)

• Garuka / gusimbuza inzira byemeranijwe kandi byageragejwe

Intambwe ikurikira

Niba ukeneye paki yemewe yo guhinduranya abaguzi ba orthopedic (inyandiko zerekana urutonde + KPI scorecard template), saba muri XC Medico hanyuma uyikoreshe kubatanga ubu hamwe nurutonde rwawe.

(Komeza kurambirana. Kurambirwa nibyiza kubahiriza no gutanga amasoko.)