Kushishino lwezixhobo zonyango, ukuqinisekiswa komgangatho (QA) akuyomfuneko yolawulo nje; kukuzibophelela okusisiseko kukhuseleko lwesigulane kunye nokuthembeka kwemveliso. Njengabavelisi, sibeka phambili umgangatho kuwo wonke umba wemisebenzi yethu, ukusuka kuyilo ukuya kwimveliso. Esi sikhokelo sibanzi siya kuphonononga iindlela ezifanelekileyo zokuqinisekisa umgangatho wokwenziwa kwezixhobo zonyango, ukubonelela ngezimvo ezixabisekileyo kubasebenzi beshishini.
Ukuqonda uQinisekiso loMgangatho kwiMveliso yeZixhobo zoNyango
Ukuqinisekiswa komgangatho kwimveliso yezixhobo zonyango kubandakanya uluhlu lweenkqubo ezicwangcisiweyo kunye neenkqubo ezilungiselelwe ukuqinisekisa ukuba iimveliso zihlangabezana neemfuno ezichaziweyo kunye nemigangatho yolawulo. Oku kubandakanya imisebenzi ecwangcisiweyo kuyo yonke inkqubo yokwenziwa kwemveliso, ukusuka kuyilo lokuqala ukuya kucupho lwasemva kokuthengisa.
1. Ukuthotyelwa kweMimiselo
Ukuthotyelwa kwemigangatho yolawulo sisiseko soqinisekiso lomgangatho wokwenziwa kwezixhobo zonyango. Kwimimandla emininzi, izixhobo zonyango kufuneka zithobele izikhokelo ezingqongqo ezibekwe ngamaqumrhu alawulayo afana ne-US Food and Drug Administration (FDA) kunye ne-European Medicines Agency (EMA).
Abavelisi mabaziqhelanise nale migaqo baze baqinisekise ukuba iinkqubo zabo zolawulo lomgangatho (quality management systems (QMS)) zingqinelana nayo. Oku kuquka ukugcina amaxwebhu acokisekileyo, ukwenza uphicotho rhoqo, kunye nokuphumeza amanyathelo okulungisa xa kuyimfuneko. Ngokwenza oko, abavelisi abathobeli kuphela imimiselo kodwa bakha ukuthembana kubathengi babo.
2. Ulawulo loMngcipheko
Ulawulo olusebenzayo lomngcipheko lubalulekile kushishino lwezixhobo zonyango. Indlela esebenzayo yokuchonga, yokuvavanya, kunye nokunciphisa imingcipheko enxulumene neemveliso ibalulekile. Oku kubandakanya ukwenza uvavanyo lomngcipheko ngexesha lesigaba soyilo kunye nakuwo wonke umjikelo wobomi bemveliso.
Ukusebenzisa izixhobo ezifana neMode yokungaphumeleli kunye noHlalutyo lweMpembelelo (FMEA) inceda ukuchonga iindawo ezinokuthi zingaphumeleli kunye nefuthe labo ekukhuseleni isigulane. Ngokujongana nale mingcipheko kwangethuba kwinkqubo yophuhliso, abavelisi banokuphucula umgangatho uwonke kunye nokuthembeka kwezixhobo zabo.
3. Ulawulo loyilo
Ulawulo loyilo yinkalo ebalulekileyo yoqinisekiso lomgangatho kwimveliso yezixhobo zonyango. Ibandakanya indlela ecwangcisiweyo yoyilo lwemveliso, eqinisekisa ukuba zonke iinkcukacha kunye neemfuno zifezekisiwe.
Izinto eziphambili zolawulo loyilo ziquka:
Isicwangciso soyilo:Ukuseka isicwangciso esicacileyo esichaza inkqubo yoyilo, kubandakanywa amaxesha kunye noxanduva.
Igalelo loyilo:Ukuqokelela kunye nokubhala iimfuno zabasebenzisi kunye neemfuno zolawulo.
UQinisekiso loYilo kunye noQinisekiso:Ukuqinisekisa ukuba imveliso idibana neenkcukacha zoyilo kwaye isebenze njengoko kucetyiwe ngovavanyo olungqongqo.
Ngokuphumeza iinkqubo zolawulo loyilo elomeleleyo, abavelisi banokunciphisa umngcipheko wemiba enxulumene noyilo enokuthi ibeke esichengeni umgangatho wemveliso.
4. ULawulo loMgangatho woMboneleli
Umgangatho wemathiriyeli ekrwada kunye namalungu achaphazela kakhulu imveliso yokugqibela. Ke ngoko, ukuseka ubudlelwane obuluqilima nababoneleli kunye nokuphumeza inkqubo yolawulo lomgangatho wababoneleli kubalulekile.
Abavelisi kufuneka baqhube uphononongo olucokisekileyo lwabo banokuba ngababoneleli-nkonzo, kubandakanywa uphicotho-zincwadi kunye novavanyo lweenkqubo zabo zomgangatho. Ukubekw'esweni okuqhubekekayo kunye novandlakanyo lwentsebenzo lunceda ekuqinisekiseni ukuba abaniki-nkonzo bahlala behlangabezana nemigangatho yomgangatho.
5. Uphuculo oluqhubekayo
Ukuqinisekiswa komgangatho asingomzamo wexesha elinye; kufuna ukuzibophelela ekuphuculeni okuqhubekayo. Ukukhuthaza inkcubeko yomgangatho ngaphakathi kwintlangano ikhuthaza abasebenzi ukuba bachonge iindawo zokuphucula kunye nokwabelana ngezona ndlela zilungileyo.
Ukuphumeza iindlela ezifana ne-Lean kunye neSix Sigma inceda ukulungelelanisa iinkqubo, ukunciphisa inkunkuma, kunye nokuphucula umgangatho wemveliso. Uqeqesho lwarhoqo kunye neenkqubo zophuhliso lwabasebenzi zenza igalelo kubasebenzi abanolwazi oluthe kratya oluzinikele ekuqinisekiseni umgangatho.
Ukuqukumbela
Ukuqinisekiswa komgangatho kwimveliso yezixhobo zonyango yinkqubo eneenkalo ezininzi efuna indlela ebanzi. Ngokuthobela imilinganiselo yokulawula, ukuphumeza izicwangciso ezisebenzayo zokulawula umngcipheko, ukugcina ulawulo loyilo oluqinileyo, ukulawula umgangatho wababoneleli, kunye nokukhuthaza inkcubeko yokuphucula okuqhubekayo, abavelisi banokuqinisekisa ukhuseleko kunye nokusebenza kakuhle kweemveliso zabo.
Ukuhlala unolwazi malunga neendlela ezingcono zokuqinisekisa umgangatho kubalulekile ukugcina umda wokhuphiswano. Ngokubeka phambili umgangatho, abavelisi abakhuseli abaguli kuphela kodwa baphucula isidima sabo kunye nempumelelo kwindawo yentengiso.
Ukuphumeza ezi ndlela zilungileyo zokuqinisekisa umgangatho kwimveliso yezixhobo zonyango kunokukhokelela kwiziphumo eziphuculweyo zesigulane kunye nekamva elizinzileyo loshishino. Sikunye, sinokwenza indawo yokhathalelo lwempilo ekhuselekileyo nethembekileyo.
Ixesha lokuposa: Oct-16-2024