Ukukhokha kakhulu kumfanekiso ukuba yindlu enkulu yokuphila kwisikweleti esinjalo, lapho izikhathi nezidingo zokulungile ekwakhiweni kuyathatha indlela ebalulekile kumsindleko wobumnandi nembulelo yezenzo. Kufanele izinkampani ezidumezelwe ekwakhiweni kwezixhumanisi zomdlalo zenzela izinhlelo zokukhokha okubalulekile ezingaqedi elinye ngalinye lwesimo sokwakha, kuqala kuseto lwempahla eya kuthinta impahla emva kokwakha. Umthombo omkhulu wokulawula okudonsayo olunxuswa nokwakha kwezixhumanisi zomdlalo kudinga ukuthi izinkampani ziphile ngeminyaka engaphezu kweminyaka yokukhokha, ukuqinisekisa ukuthi ngalunye ulwazi lukhetha noma lukhetha phansi imitholampilo yesimo nemigaqo.
Iziseko zokwakha izixhobo zokugcina ngendidiyo ziyaphakama ngamandla amakhulu ekugcineni ubumfihlelo obulungileyo ngelishwa kuba kunezidingo ezinzima kakhulu kwizixhobo zokugcina eziphuculiweyo. Ubuncinane bezindlela zokugcina ngendidiyo kufuneka zixhobe zibonise ubukhoko, ubuchanekako obuphambene kakhulu, nokutholakala kwegazi. Abayakhi kumele bahlale imithetho emangalisayo yokuphatha ubumfihlelo eyenzela ukhetho lwemithi, iindlela zokuhlaga, iintonga zentliziyo, nemifulo yezixhobo ukuze kugcinwe ubume obuhle kumzimba wokugcina.
Ukusekelo kwezinhlelo yokuphatha ubumfihlelo
Ukusebenzisa kanye nokuziphilisa kwi-ISO 13485
Ukusebenzisa kwezinhlobo zokuphatha ubumnandi ze-ISO 13485 kuyisisekelo sobuchwepheshe obunembuso bempahla yokulungisa imiphakathi. Leli qhaza eliqashelwe khona libhekisa izidingo ezihlukileyo zokwenza izixhobo zomdlalo, nika indlela yokuphatha ubumnandi ngendlela ethile. Kufanele izikhala zenze amathuluzi akhangelwayo okuphatha ukudizwa, ukuhlawula umsindo, nokuthatha izenzo zokulungisa nezokukhokha ezingqinisekile ukuthi ziyalingana nezidingo zokulawula emazweni onke.
Ukuxhasana ne-ISO 13485 kudinga ukudokolwa okuhlelwe yonke into yokwenza, kuqala kususelwa ekwakhiweni kuya kuhlaziywa kwendawo yokugcina. Kufanele izinhlelo zokuphatha ubumnandi zifakwe phakathi ukubuyekezwa kwezinqumo ngemaqondana, uhlola phakade, nokuthuthukisa okuphathelene nobumnandi obonakalayo ukuthi kukhona umyalo wokuphatha ubumnandi. Isiphumo esihlukile kuyadinga amagunya afunxwe ngezinye izigaba eziqukethe abasebenzi basebenza ngobumnandi, ababhangeleli bezenzo, nabasemthethweni abasebenzana ngokuxhasana ukugcina izimo zokuxhasana.
Ukukhokha Kwesaphulelo Ngokulandela Inhloso
Iindlela ezifundisa kwindima zokubaluleka zenhloso zokukhokha izaphulelo kumakhemikhali okwenza iistileti ezenziwa ngabantu abangamandla ukuguqulela izidingo zokulungiswa kwizaphulelo ngokulinganisa nokuba kuzobangelani into ekhethekileyo kumntu ofuna inyaniso nesimo sezaphulelo. Le ndlela ibandakanya nokubala ngokuhle kwezinto ezibalulekileyo zoluntu, iiparamitha zomthetho, neendimana ezinokuthi zibophelela isebenza sezaphulelo. Abakhethi basebenzisa iizixhobo ezifana ne-Failure Mode and Effects Analysis (FMEA) ukuchazela iindima kwaye bakwazi imisebenzi enjalo yokuphatha ngendlela efanelekileyo phantsi komthetho wokwenza.
Ukubala kahle kwezimali kufaka phakathi izindlela ezifana nokulinganisa kwamathali, ubuchwepheshe bakho lokwenza, ukusetshenziswa okulandelwayo, nezimpendulo zokuhlengahlenga. Amagunya ezigaba kumele abuyekele ngokushesha kanye kubeke amabizo kwezimali ukuze aqondele izinguquko ezenzekelayo emisebenzini yokwenza, amandla wabhamuza, noma izimpendulo zokuhlengahlenga. Ukuhlanganiswa kweziphindezelo zokuphatha izimali kumphakeliso wesigaba kusinika amandla ukuthi izindlela ziqashelwe ngendlela efanelekile ukuhlasela izinkinga ezibalulekile kakhulu.
Ukulawula Kakhulu Kwamathali Amanzi
Ukubhaliselwa Neqiniso Lwabhamuza
Imithombo emijulile yokukhetha izindiza kuyisahluko esibalulekile ekulinganisweni kakhulu kwemisebenzi yezixoxo zokwenza izixhobo zokumelana. Kumele izithuthi zibuyekelela imikhuba engcono yokuhlola izindiza eziphinde zibe, kufakwe phakathi ukubala kwezinqumo zokulinganisa kakhulu, amandla okwenza, nokuhlanjwa kwezimpendulo zokulawula. Izindiza ezikhethiwe zihlengwa ngemfazwe futhi zihlengwe ngokuphindaphindi ukuqinisekisa ukuba ziqhubeka nokulandela izinhlobo nezimpendulo.
Umthetho wokukhetha izindiza njalo unikeza ukuhlola kusuka endaweni, ukufunda kwezinkomba, nokubuka kwezincwadi zokulinganisa kakhulu ukuqinisekisa ukuthi izindiza zingasebenza ngokuphambene nezimpendulo. Aba wenza izixhobo zokumelana zidlula ukugcina uhlu lwezindiza ezivunyelwe ngezimpendulo ezitholakaleyo yokukhethwa, izindlela zokusebenza, nezimemo zokubuyiselwa. Umgwaqo ophathekayo wezindiza ohlanganisa ubungako obuphelele uyakhiqiza kakhulu ekulinganisweni kakhulu kwezinto futhi kungenzima yokuwenza.
Ukubhengezela Kwamathiphu Nokuphima
Izinhlelo zokukhokha nokubhengezela kwamathiphu ekufakweni kunciphisa ukuthi izithuthi zokwakha zihlaziywa ngemithetho etholakele kabefore yokungena emshineni. Konke okuthunyelwayo kwezimpendulo ezibalinkanye kufa ukuphima okuhlelekile ukuqinisekisa umthombo wokugcina, iziphawu zomlando, neziphawu zomfanekiso. Kudingeka ukuthi izibhangezo zamathiphu kusuka kumthengi ziqinisekiswe ngokuphima okuphambili ukuqinisekisa ukulandelana nemithetho ephathekayo njengo-ASTM namathiphu ase-ISO.
Izinhlelo ezahlukene zokuphima kungase kufaka phakathi ukuchaneka kwegxesha, ukuphima komlando, nokulinganisa kokulungile kwebiology ngempela kuyimpendulo yezimpendulo zamathiphu nemithetho. Iziphumo zokuphima zibhalwe futhi zilondoloziwe njengencwadi yobuchwepheshe bokulinganisa ngezindlela zokulandela. Lokhu kufa ukulahlekelwa kumthetho kufa kuhlukaniswa futhi kugcinelwe ngemvume yokulahlekelwa okungaba yisiphinde sithunyelwe kumthengi, kubuyiselwa, noma kucindezelwa ngokomthetho otholakele.
Ukubophezela Kwezenzo Yokwakha
Ukufakwa kwezindlela zokuhlola ukusuka
Izindlela zokubophezela izimo (SPC) zabelana nezixhobo ezinhle ngokukhathalela nokubophezela izimo zokwakha ku isifungo sezixhobo ze-orthopedic izinyeke. Ukusebenzisa kwe-SPC kuthatha ukubala kwemiphefumulo ebalulekile yesenzo, ukufaka izimali zokubophezela, nokukhathalela ngqo kwezenzo ngokuzivocavoca ngokulandelana. Izigaba zokubophezela nezibalo zokwaziwa kusiza abasebenzisi ukuthola izinguquko zesimo ngaphambi kokuba zithole izinhlotshane ezingavumelekile.
Izinkampani eziphatha SPC zidinga ukufundisa izisebenziso zezemfundo kumkonco wokubala nokuchaza kwamathuba okuphatha. Kumele kube khona ukuqonda kwabasebenzi ngendlela yokuthintana nokuthinta amanqaku akhiwe kuququzelelo kanye ngenye indlela lokwenza izilungiselelo zemfundo. Izivikeli ezihlanjwayo zombono zibonise indlela yombono ngokulinganayo kuzimpendulo zakho kanye nokunika idatha yokuthuthukisa ubungako. Ukuhlanganiswa kwedatha ye-SPC negama lezemfundo likhuthaza ukubuka kuye ngemizuzu yonke kanye nezinhlelo zokuphepha ngokuzenzakalelayo kumaqoshelo angaphandle kokuphatha.
Amathuluzi Okuhlola Emehlweni
Amaphrothokholi okuhlola aphelele ngesikhathi senqubo aqinisekisa ukuthi izindinganiso zekhwalithi ziyagcinwa kuyo yonke imisebenzi yokukhiqiza. Amaphuzu okuhlola atholakala endaweni efanelekile ezigabeni ezibucayi zenqubo lapho kungavela khona amaphutha noma lapho isenzo sokulungisa sisebenza kahle kakhulu ngezindleko. Izinqubo zokuhlola kumelwe zibhalwe ngokucacile ngezinqubo ezithile, izindlela zokulinganisa, namazinga okwamukelwa okuvimbela ukuhunyushwa komuntu siqu.
Ukuhlolwa kwesimanje kwenqubo kungahlanganisa izinhlelo zokulinganisa ezizenzakalelayo, imishini yokulinganisa ehlanganisiwe, nobuchwepheshe bokuhlola obubonakalayo ukuze kuthuthukiswe ukunemba nokusebenza kahle. Idatha yokuhlola iyaqoqwa futhi ihlaziywe ukuze kutholakale ukuthambekela, amakhono enqubo namathuba okuthuthuka. Ukuhlolwa okujwayelekile kwemishini yokuhlola kuqinisekisa ukunemba kokulinganisa nokulandeleka kwamazinga kazwelonke. Abasebenzi abenza ukuhlolwa kufanele baqeqeshwe futhi bafaneleke ngokuhambisana nezidingo ezibekwe zamakhono.
Ukuhlaziywa nokuvikela kwezimboni zakhele
Ukubona kwebandla nokusebenza
Ukuhlaziywa kwesigaba sokugcina kufaka phakathi ukubona kabangqi kwebandla nokusebenza ukuqinisekisa ukuthi izixhobo ezimbalwa zihlukile konke okudingekayo. Ukuhlola kwebandla kusebenzisa izixhobo zokuphindaphinda ngokucophele kanye nezibhalo, izahluko zeziphazamiso, nezigidi ezithile ezidolophiwe ngokwemithetho yezixhobo. Izingxenye eziphambili ezingathintana nesiseko senzenzo noma ukuthi kuyini esifayisayo sengcali ziqashelwa kakhulu ngexesha lokuhlola.
Imithetho yokuqhubeka kwezinhlelo ngokuphatha izikhathi ezingcono ezenza ukuthi kusebenze njengoba kusetyenziswa ekliniki. Lokhu kungaba yiqhophho lezinqamuzana, ukuvikela izici, ubunzima bezinhlango, nokulinganisa okubheke kakhulu kumfanekiso weshayidi nesilingo sokusetshenziswa. Kufanele kube yilungiselelo lwezinhlelo zokuchazwa ukuqinisekisa ukuthi zihlambulukile ngokuphatha kakhulu futhi zinike amathiphu akhangeleka emsebenzi wokulungiswa. Izimpendulo zokulinganisa nokuphatha kwezinhlelo zibhalwe futhi zilondolozeke njengenxenye eyiqeda kwirekodi yokhokelo.
Ukungcolandelayo Kwemithwalo Nokugcina Ukuthintana
Ukuhlaziywa kwebiyo-ukutholakala kusidla ukuthi izixhobo zokulungisa ububi bezintambo zisafethiwe ekuthinteni kwabo ngomthwalo futhi azikhiqizi imiphumela engcono yebiyo. Izinhilo zokuhlaziywa zilandela amava alandelayo njenge ISO 10993 isilondo, esinikeza inqaku yokubala ngobuchwepheshe bezixhobo zomedical. Ngokweziphi ezinhlo zokuthinta nomthwalo, ukuhlaziywa kungaphakathi kokuhlazwa kwezithixo, ukuqhathaniswa, ukuhlaselwa, nokuhlaziywa kwebhodhi yonke.
Amathuluzi okugcina ububi kusheshayo ayakha ukuthi izindlela zokucima amathambo akhuphuka ngempela amathambo angenabubi futhi aqaphele ubunzima nobusebenzi bomfanekiso. Ukubalwa kokucima kufaka phakathi ukuchazwa kwesibonelo sezibi, ukuchazwa kobubi kusheshayo, nokucinga kwebumba eliqinile emva kwekhasimende yocingo. Ukuhlola kanye kwezixhobo zokucima kusheshayo kunciphisa ukusebenza kakhona nokwemukelwa kwiingxenye ezivikilwayo. Ukwaziswa kwebhuyekhodi nesibonelo sobubi kusheshayo kunciphisa umbono omuhle wokungena kwezimali kanye nembulelo yomkhakha.
Izinkomba Nezinhlelo Zokulandeleka
Ukulondoloza Kwemfundo Yezigaba
Imithombo yesikhwama esigcwele siphinde sifakazela konke ukudokolwa kwezinyathelo zokwakha kwesikhala ngasinye sokwakha kwezixhumanisi ze-orthopedic. Izincwadi zesikhala ziqukethe imininingwane yezimboni ezasetshenziswa, iziqondiso zokuchitha, imiphumo yokuhlola, namuntu ophathelene nezinyathelo zokwakha. Lokhu kudokolwa kumisebenzisa ukuqashwa kabusha okuphelele kusukela emva kwezinhlelo ezigcineneyo kuze kube khona izimboni zakamuva futhi kuncike mininingwane ebalulekileyo ekulondolozeni iingxaki zobumnandi noma izimbi zokhokhela.
Imithombo ye-elekthroniki yesikhala iyathelela ubalulekile nokusebenza kahle ngaphandle kokunakekela ubuqiniso be-data kungeza kwezinhlelo zebhuku. Le mithombo ingachitha ukusabela okuzenzakalelayo kwe-data kusuka kumendini wokwakha, ukubamba isimo ngemizuzu, neziqingo ze-elekthroniki ukuze kugcinwe ubuqiniso bazo futhi kuthintwe ukuthinta okungavumelekile. Ukuxhasa okujwayelekile nokugcina imithombo ivikela idatha yesikhala futhi iqinisekise ukufinyelela kudinga kwezimali nangabakhokhelayo.
Ukulawula Ukuguquka kanye Nezimodi Zokulungiselela
Imithetho yesimo yombuthano ihlanza ukuthi izinguquko kumzimba, imbono noma izinhlelo zihlaziywe ngempela, zivunyelwe futhi zisekelwe ngaphandle kokulahla ubumnandi noma ukuhlangana nokuhlaziywa. Imbono yokubuyisela kumbuthano kufanele ibuyeke impikiswano yezinguquko eziphawula ekuphileni komzimba, ukusebenza kwayo, nokuhlaziywa kwayo. Lokhu kubuyekeza ukubala kwesikhulumi, izidingo zokuvikela, nokuchaza izibopho zokukhombisa kuzinhlelo zokuhlaziywa noma abathengi.
Imisebenzi yokuqasha umlando wembono yamanje ebekwe kumzimba, imbono yokwenza, nezidingo zokulavulwa kwabakhokhi. Izinhlelo zokuphatha uhlelo lukhuni kuthintela ukusetshenziswa kwezindima ezidala futhi zihluphele ukuthi wonke umuntu alifinyelele imbono yamanje, evunyelwe. Ukubuyekeza okujulile nokubuyekeza kwezindima ezilondoloziwe kuhamba ngesikhathi ngezindlela zokwenza izinto kanye nezinkathi zokuhlaziywa ngemuva kwalokho kuhlale kushisayo ubumnandi bezinhlelo zokulavulwa.
Ukusabela kakhulu nokubuyekeza kwezimali
Izikhombiso Zobuchwepheshe Nokubona Kwezenzo Ezikhethekileyo
Ukuphatha ubuchwepheshe kufanele kube ngendlela ethembekile yokukhombisa nokulandela izenzo ezikhethekileyo ebonisa ububi bezinhlelo zobufakazi nezimali. Izikhombiso zobuchwepheshe zingafaka izilinganiso zemiphumela engalungileyo, izimpendulo zomthengi, impendulo yezahluko, nesizathu sokulungisa. Lezi zikhombiso zinika amathambo okulinganisa izenzo zabuchwepheshe futhi ukuthola izikhathi zokuthutha.
Ukunquma kwamathuba ebuchwepheshe kunikeza izigaba futhi kuncoma ukuthi kuzothinta izinkinga zobufakazi ngaphambi kokuba kube khona inkimbinkimbi. Ukubuka okudala kwezithathu nguqobo olusebenzisa izibonelo zezimali ukuqinisekisa ukuthi izilwane zobuchwepheshe zifinyelelwa futhi amathuba afakelwe ngendlela efanelekileyo ekulungiseni izinkinga. Ukulinganisa ngezibonelo zezimali nezirhwedvwa ezilungileyo zinikeza uhlelo olusha oluthile oluthola izikhathi zokuthutha.
Inhlelo Yokulungisa Nokuvikela Izimpendulo
Imithetho ephambili yokulungisa nokukhuthaza (CAPA) ihlinzekelwa ngendlela eyisisekelo ekulungiseni izinkinga zokh quality nokukhuthazela ukuba kuzoze kube khona futhi. Imigomo ye-CAPA kumele ifakwe phakathi ukhlolwa okuhle kwezizathu, ukuthuthuka kwemiphumela efanelekile yokulungisa, nokwakhiwa kwebephondo lokulungiswa. Imiphumela yokukhuthaza egcwaliswe kuhlola imithombo nokulinganisa isimo sokulima kusiza ekuboneni nokulungiseni izinkinga ezinokwenzeka ngaphambi kokuba zibakhona izinhlanzi ezingavumelekile noma izimbi zokugcwala.
Imithetho efanele ye-CAPA iyihlanganiso yezinhlangano eziphathelene nezidingo zokhlolwa kwezinkinga ezinhlekeleleyo zokh quality nokuthuthuka kwemiphumela embalwa. Ukuhlolwa kahle kwebephondo lokulungiswa kusiza ekuboneni ukuthi izenzo ezifakelwe zifinyelela iziphumo ezifanele futhi azikwazi ukudala iziphumo ezingafanele. Ukuhlolwa kwezimali kwezinqubo ze-CAPA kusiza ekulondolozeni futhi kusizeka ukuthi kunezindlela ezifanele zokuthuthuka kwezinkinga zokh quality.
Imibuzo Evame Ukubuzwa
Kutheni izikhundla ezibalulekile kakhulu zokulawula ubunzima ngokwenza izixhobo ze-orthopedic
Izikhundla ezibalulekile kakhulu zokulawula ubunzima ziphakamisa ukukhangela kwemvelo yokufika ukuqinisekisa imithetho yomthwalo wesimilo, ukubheka phakathi kweziphumo ezibalulekile zokwenza njengezilinganiso zokugaya kanye nezindlela zokuphatha ngokwesibhedlela, nokuchazwa komsebenzi wokugcina kuhleliwe ngenqanaba kanye nokulinganisa okusebenzayo. Ngaphezu koko, ubungakanani bokupakiya kanye nokubonakala kokuhlambuluka kuyizikhundla eziphathelene ngqo nokulawula ubunzima obuzenzekelayo nokusebenza kwezixhobo emsheneshini yezici.
Ukuthi izimvo zokulawula zihlaza kanjani izinhlelo zokulawula ubunzima ezindlini zokwenza izixhobo ze-orthopedic
Izimfuneko zokulawula zihlukumeza kakhulu izinhlelo zokuphatha ubunzima ngokuletha izimali ezingaphansi kwezigaba zokuphatha izinhlelo zokubona ubunzima, izibopho zokwakha, nokuchazwa kwemvelo. Ukulandela izimfuneko ezifana ne-FDA Quality System Regulation, i-European Medical Device Regulation, ne-ISO 13485 kudinga izinhlelo ezitholakale, izinzo eziqinisekisiwe, nokugcina amabhuku okuqukethwe kabonke. Lezi zimfuneko zihlinza ukuthi izenzo zokuphatha ubunzima zibe yisistimu, zilungile, zingahlaziyeki futhi zinikeze inkinobho yokulandela ngemva kokuhlola ngokulawula.
Ukufundisa abasebenzi kwenza yini indima ekuphatheni izigaba zokubona ubunzima
Ukufundisa kwezomnotho kwenza indima eyisisekelo ekugcineni izinhlobo ngokuthinta ukuthi abasebenzi bahlaziye izilungiso zabo, babe nenxelelo efunekayo ukwenza izimemo zabo ngokwempilo, kanye nobubekezelwa kuzidingo nezindlela ezishintshashintsha. Izinhlangano zokufundisa kumele zihlinze izinhlobo, izinketho ezithile zomsebenzi, izidingo zokulawula, nokubaluleka kokulandela izinhlobo eziphathelene nazo. Ukuhlaziywa kohlelo oluphelele nokulinganisa izinselelo kusiza ekugcineni izinselelo zokusebenza futhi kuhlolwe ukusebenza okuphathelene nokuphathelene kwezinye zonke izenzo eziphathelene nokulingana.
Kani abakhankasi bangalinganisa ububi bezinhlelo zabo zokulawula ubomi?
Amadoda amakhelwa angalima uhlelo lokulawula ubumnandi ngemisebenzi engaphezu kwezinkinga zokukhula, izimpendulo zomthengi, izimpendulo zokuhlola, nezinkinga zokulungisa izenzo. Kunezinye izibalo ezifana nokulinganiswa kokuqala, izilinganiso zokuphinda kokuhlola, nokusebenza kwesivikeli sobumnandi. Ukuhlolwa kohlelo lwezinqumo ngokushesha, ngokuhlanganisa nokuhlola phakathi nokuchazwa kwezimpendulo zomthengi, kunciphisa ukulinganisa kwezenzo yobumnandi balesi hlelo bethu futhi kubonisa amandla okuthutha ngokuphindaphindi.
