Embonini yemishini yezokwelapha, ukuqinisekiswa kwekhwalithi (QA) akuyona nje imfuneko yokulawula; kuwukuzibophezela okuyisisekelo ekuphepheni kwesiguli nokuthembeka komkhiqizo. Njengabakhiqizi, sibeka phambili ikhwalithi kuzo zonke izici zokusebenza kwethu, kusukela ekuklanyeni kuya ekukhiqizeni. Lo mhlahlandlela ophelele uzohlola izinqubo ezihamba phambili zokuqinisekisa ikhwalithi ekukhiqizeni amathuluzi ezokwelapha, ohlinzeka ngemininingwane ebalulekile kochwepheshe bemboni.
Ukuqonda Ukuqinisekiswa Kwekhwalithi Ekwenziweni Kwedivayisi Yezokwelapha
Ukuqinisekiswa kwekhwalithi ekukhiqizweni kwemishini yezokwelapha kuhlanganisa uchungechunge lwezinqubo nezinqubo eziklanyelwe ukuqinisekisa ukuthi imikhiqizo ihlangabezana nezidingo ezishiwo kanye namazinga okulawula. Lokhu kuhlanganisa imisebenzi ehleliwe kuyo yonke inqubo yokukhiqiza, kusukela ekuklanyweni kokuqala kuya ekugadweni kwangemva kwemakethe.
1. Ukuthobela Umthetho
Ukuhambisana nezindinganiso zokulawula kuyisisekelo sokuqinisekisa ikhwalithi ekukhiqizweni kwemishini yezokwelapha. Ezifundeni eziningi, izisetshenziswa zezokwelapha kufanele zithobele izinkombandlela eziqinile ezibekwe izinhlangano ezilawulayo ezifana ne-US Food and Drug Administration (FDA) kanye ne-European Medicines Agency (EMA).
Abakhiqizi kufanele bazijwayeze le mithetho futhi baqinisekise ukuthi izinhlelo zabo zokuphatha ikhwalithi (i-QMS) zihambisana nayo. Lokhu kuhlanganisa ukugcinwa kwamadokhumenti aphelele, ukucwaningwa kwamabhuku okuvamile, nokusebenzisa izinyathelo zokulungisa lapho kudingeka. Ngokwenza kanjalo, abakhiqizi abagcini ngokuthobela imithetho kuphela kodwa futhi bakhe ukwethembana kumakhasimende abo.
2. Ukulawulwa Kwengozi
Ukulawulwa kobungozi okusebenzayo kubalulekile embonini yemishini yezokwelapha. Indlela esebenzayo yokuhlonza, yokuhlola, kanye nokunciphisa ubungozi obuhlobene nemikhiqizo ibalulekile. Lokhu kubandakanya ukuhlola ubungozi ngesikhathi sesigaba sokuklama kanye nakuwo wonke umjikelezo wempilo womkhiqizo.
Ukusebenzisa amathuluzi afana ne-Failure Mode and Effects Analysis (FMEA) kusiza ukukhomba amaphuzu angaba khona okuhluleka kanye nomthelela wawo ekuphepheni kwesiguli. Ngokubhekana nalezi zingozi ekuqaleni kwenqubo yokuthuthukiswa, abakhiqizi bangathuthukisa ikhwalithi yonke nokuthembeka kwamadivayisi wabo.
3. Ukulawula Ukuklama
Ukulawulwa kwedizayini kuyisici esibalulekile sokuqinisekiswa kwekhwalithi ekukhiqizweni kwemishini yezokwelapha. Kubandakanya indlela ehlelekile yokuklama umkhiqizo, ukuqinisekisa ukuthi yonke imininingwane nezidingo ziyahlangatshezwa.
Izinto ezibalulekile zokulawula ukwakheka zihlanganisa:
Ukuhlela Ukuklama:Ukusungula uhlelo olucacile oluchaza inqubo yokuklama, okuhlanganisa izikhathi nezibopho.
Okokufaka Kwedizayini:Ukuqoqa kanye nokubhala phansi izidingo zabasebenzisi kanye nezidingo zokulawula.
Ukuqinisekiswa Kwedizayini Nokuqinisekisa:Ukuqinisekisa ukuthi umkhiqizo uhlangabezana nokucaciswa kwedizayini futhi usebenza njengokuhlosiwe ngokuhlolwa okunzima.
Ngokusebenzisa izinqubo zokulawula idizayini eqinile, abakhiqizi banganciphisa ubungozi bezinkinga ezihlobene nomklamo ezingase zibeke engcupheni ikhwalithi yomkhiqizo.
4. Ukuphathwa Kwekhwalithi Yomhlinzeki
Izinga lempahla yokusetshenziswa kanye nezingxenye zalo linomthelela omkhulu kumkhiqizo wokugcina. Ngakho-ke, ukusungula ubudlelwano obuqinile nabahlinzeki-mpahla nokusebenzisa uhlelo lokuphatha ikhwalithi yabahlinzeki kubalulekile.
Abakhiqizi kufanele benze ukuhlola okuphelele kwabangase babe ngabahlinzeki, okuhlanganisa ukucwaningwa kwamabhuku kanye nokuhlolwa kwezinhlelo zabo zekhwalithi. Ukuqapha okuqhubekayo nokuhlolwa kokusebenza kusiza ukuqinisekisa ukuthi abahlinzeki bahlangabezana nezindinganiso zekhwalithi ngokungaguquki.
5. Ukuthuthukiswa Okuqhubekayo
Ukuqinisekisa ikhwalithi akuwona umzamo wesikhathi esisodwa; kudinga ukuzibophezela ekwenzeni ngcono okuqhubekayo. Ukukhuthaza isiko lekhwalithi ngaphakathi kwenhlangano kukhuthaza abasebenzi ukuthi bakhombe izindawo okumele bazithuthukise futhi babelane ngemikhuba engcono kakhulu.
Ukusebenzisa izindlela ezifana ne-Lean ne-Six Sigma kusiza ukuqondisa izinqubo, ukwehlisa ukungcola, futhi kuthuthukise ikhwalithi yomkhiqizo. Izinhlelo ezivamile zokuqeqesha nokuthuthukiswa kwabasebenzi zinegalelo kubasebenzi abanolwazi oluthe xaxa abazinikele ekuqinisekiseni ikhwalithi.
Isiphetho
Ukuqinisekiswa kwekhwalithi ekukhiqizweni kwemishini yezokwelapha kuyinqubo enezici eziningi edinga indlela ebanzi. Ngokunamathela ezindinganisweni zokulawula, ukusebenzisa amasu okulawula ubungozi asebenzayo, ukugcina izilawuli zedizayini eziqinile, ukuphatha ikhwalithi yabahlinzeki, kanye nokugqugquzela isiko lokuthuthuka okuqhubekayo, abakhiqizi bangaqinisekisa ukuphepha nokusebenza ngempumelelo kwemikhiqizo yabo.
Ukuhlala unolwazi mayelana nezinqubo ezingcono kakhulu zokuqinisekisa ikhwalithi kubalulekile ekugcineni umkhawulo wokuncintisana. Ngokubeka phambili ikhwalithi, abakhiqizi abavikeli iziguli kuphela kodwa futhi bathuthukisa isithunzi nempumelelo yazo ezimakethe.
Ukusebenzisa lezi zinqubo ezingcono kakhulu zokuqinisekisa ikhwalithi ekukhiqizweni kwemishini yezokwelapha kungaholela emiphumeleni ethuthukisiwe yesiguli kanye nekusasa elizinzile lemboni. Ngokubambisana, singakha indawo yokunakekelwa kwezempilo ephephile nethembekile.
Isikhathi sokuthumela: Oct-16-2024