Uhlu Lokuhlola I-Ethylene Oxide Sterilization Audit (ISO 11135)
Lolu hlu lokuhlola lokuhlola luklanyelwe abakhiqizi bemishini yezokwelapha kanye nabacwaningi mabhuku bekhwalithi ukuthi baluhlole I-Ethylene Oxide (EO) izinqubo zokuvala inzalo. Iqinisekisa ukuhambisana ngokugcwele nayo I-ISO 11135-1 futhi ISO 13485 izindinganiso.
1. Ububanzi
Lolu hlu lokuhlola lusebenza ezinqubweni zokuvala inzalo emikhiqizweni yezokwelapha eyenziwa nge-ethylene oxide. Okwemikhiqizo eyinyumba ye I-Risk Class III, imibhalo yokuklama nokuqinisekiswa kufanele ihlolwe. Ukuhlolwa kokuvala inzalo kufanele kwenziwe ngokusekelwe efayeleni lomkhiqizo okungenani elilodwa.
2. Izibopho kanye Negunya
Umcwaningi mabhuku oholayo
Ubhekene nokuhlolwa kohlelo lwe-QM mayelana ne-ISO 13485 kanye neSiqondiso soMkhandlu 93/42/EWG. Umcwaningi mabhuku oholayo wengamela ithimba labacwaningi mabhuku futhi aqinisekise ukuthotshelwa kwenqubo ye-DQS.
Uchwepheshe Wezobuchwepheshe
Ibophezelekile ekuhloleni okuqondene nomkhiqizo othile, okugxile kakhulu ekubhalweni komklamo kanye nokuqinisekiswa kwezinqubo zokuvala inzalo.
3. Indlela Yokuhlola
Umgomo ukuhlola ukugcwaliseka I-ISO 11135-1. Imiphumela kufanele yenziwe embikweni wocwaningomabhuku ngokubhekiselwa kulolu hlu lokuhlola.
| Umshwana | Audit Umbuzo / Imfuneko | Ukuhlola |
|---|---|---|
| 4. Izinhlelo Zokuphatha Ikhwalithi | ||
| 4.1 Imibhalo | ||
| 4.1.1 | Ingabe izinqubo zokuklama, ukuqinisekiswa, ukulawula okujwayelekile kanye nokukhishwa komkhiqizo ekubulaweni inzalo kucacisiwe? | |
| 4.1.2 | Ingabe yonke imibhalo namarekhodi ngokwe-ISO 11135-1 abuyekeziwe, avunyelwe futhi ayalawulwa? | |
| 4.2 Isibopho Sokuphatha | ||
| 4.2.1 | Ingabe izibopho neziphathimandla zicacisiwe futhi zabelwa abantu abaqeqeshiwe? | |
| 4.2.2 | Ingabe sikhona isivumelwano senkontileka uma kunezinhlangano ezimbalwa ezihilelekile? | |
| 4.3 Ukwenziwa Komkhiqizo | ||
| 4.3.1-2 | Ingabe izinqubo zokuthenga, ukuhlonza nokulandeleka zicacisiwe? | |
| 4.3.3 | Ingabe uhlelo lokulinganiswa kwazo zonke izisetshenziswa namathuluzi okuhlola lucacisiwe? | |
| 4.4 Izilinganiso, Ukuhlaziya kanye Nokuthuthukisa | ||
| 4.4 | Ingabe izinqubo zokulawula umkhiqizo ongavumelani nezenzo zokulungisa/zokuvikela zicacisiwe? | |
| 5. Ukwenziwa kwe-ejenti yokuvala inzalo | ||
| 5.1 | Ingabe ukwakheka, izimo zokugcina nobude bendawo bucaciswe i-ejenti ye-EO? | |
| 5.2 | Ingabe ukusebenza kahle kwe-microbicidal kuyasetshenziswa uma kusetshenziswa izingoma ezingajwayelekile? | |
| 5.3 | Ukuhlolwa kwemiphumela kumkhiqizo ngokweSigaba 7. | |
| 5.4.1 | Ukuhlolwa komphumela wemvelo okubhaliwe kanye nezenzo zokuqapha? | |
| 5.4.2 | Ukugcinwa kwemithetho yendawo/yezwe lonke mayelana nokukhishwa kwe-EO nokulahlwa kwayo? | |
| 6. Inqubo kanye Nezinsimbi Izinhlamvu | ||
| 6.1.2 | Ingabe ukufakwa kwezinhlamvu kufaka phakathi ukulungiswa kwangaphambili, umjikelezo, kanye nokukhipha umoya? | |
| 6.1.3 | Ingabe umjikelezo uhlanganisa ukukhishwa komoya, ukufakwa kwe-EO, ukulungiswa, nokuhlanzwa? | |
| 6.1.4 | Ingabe (ngaphambi) ukwelashwa kwenziwa ngaphansi kokuswakama okulawulwayo nezinga lokushisa? | |
| 6.1.5-6 | Ingabe izinqubo eziguquguqukayo (izinga lokushisa, umswakama, i-EO conc, isikhathi) zicaciswe ngokubekezelela? | |
| 6.2.1-2 | Ukucaciswa kwezinto zokusebenza okubhalwe phansi okuhlanganisa nencazelo yawo wonke amathuluzi okuqapha? | |
| 6.2.3 | Ubufakazi be-software bokuxhumana nemininingwane (ISO 9000-3)? | |
| 6.2.4 | Ingabe ukwehluleka kokulawula AKUTHI kuthinti umsebenzi wokurekhoda? | |
| 7. Incazelo Yomkhiqizo | ||
| 7.1.1-2 | Izinyathelo ezithathiwe zemikhiqizo emisha/eshintshiwe noma ukulayisha ukucupha? Ukulingana kubhaliwe? | |
| 7.1.3-5 | Ukufakwa/ukususwa kwe-EO ezingxenyeni okunzima kakhulu ukuvala inzalo kufakazelwe? | |
| 7.2.1-5 | Ukuphepha komkhiqizo: umthelela wokuvala inzalo okuningi, ukuphepha kwebhayoloji (ISO 10993), nezinsalela ze-EO? | |
| 7.3.1-2 | Ukulinganisa kwe-Bioburden (ISO 11737-1) nokuhlola ukusebenza kahle kokuhlanza (ISO 17664)? | |
| 8. Incazelo Yenqubo | ||
| 8.1-4 | Inqubo yokuvala inzalo ecaciswe futhi isekelwa imibhalo ye-IQ/PQ? | |
| 8.5-7 | Ukusebenza kwe-Microbial kunqunyiwe (Isijobelelo A/B)? Izinkomba ze-BI ziyahambisana ne-ISO 11138? | |
| 8.8-9 | Ukuthobela izinkomba zamakhemikhali (ISO 11140) kanye nezivivinyo zokuthi sterility (ISO 11737-2)? | |
| 9. Ukuqinisekisa (IQ, OQ, PQ) | ||
| 9.1 Ukufaneleka Kokufaka (IQ) | ||
| 9.1.1-6 | Ukuthotshelwa kwezisetshenziswa, izikimu zobuchwepheshe, kanye nemininingwane yendawo yokufaka isunguliwe? | |
| 9.2 Ukufaneleka Kokusebenza (OQ) | ||
| 9.2.1-2 | Ubufakazi bekhono lemishini yokusebenza ngaphakathi kokubekezelelana; ukulinganisa kuqinisekisiwe? | |
| 9.3 Iziqu Zokusebenza (PQ) | ||
| 9.3.1-3 | Ubufakazi bokusebenza obufanayo, i-PQ ye-microbiological, kanye ne-PQ yomzimba (imigijimo emi-3 elandelanayo)? | |
| 9.4 | Izinguquko ekucushweni kokulayisha zihlolwe umthelela we-SAL? | |
| 9.5.1-6 | Ukubuyekezwa kombiko wokuqinisekisa nokuvunywa; Imibandela yokukhishwa kwepharamethikhi icacisiwe? | |
| 10. Ukuqapha Nokulawula Umjikelezo | ||
| 10.1 | Ukuqapha izinga lokushisa, ingcindezi, umswakama, ukugxila kwe-EO, nokujikeleza kwegesi? | |
| 10.2 | Ukukhishwa kwe-Parametric: ukulinganisa izinga lokushisa kwamaphoyinti angu-2 nokuhlaziywa kwe-EO okuqondile? | |
| 11. Ukukhishwa koMkhiqizo eNzalweni | ||
| 11.1 | Imibandela ebhaliwe yokuvumelana (amarekhodi edatha uma iqhathaniswa nokucaciswa)? | |
| 11.2 | Ukuphatha imikhiqizo engavumelani (ISO 13485) uma okuguquguqukayo noma i-BI yehluleka? | |
| 12. Ukugcina Inqubo Esebenzayo | ||
| 12.1-2 | Ubufakazi bokusebenza kahle ngezikhathi ezithile kanye nokuhlelwa kokulungisa okuvimbelayo? | |
| 12.3.1-8 | Inqubo yokuhlola kabusha (iminyaka yonke yokukhululwa kwe-parametric); Ukuhlolwa kokufaneleka kwe-BI? | |
| 12.4.1-3 | Ukuhlolwa kwezinguquko (impahla/umkhiqizo/umenzeli) nencazelo yezinga lokuqinisekisa? | |
Umshwana wokuzihlangula: Lolu hlu lokuhlola luyinkomba. Ngaso sonke isikhathi bheka izinga elisemthethweni le-ISO 11135:2014 mayelana nokuhanjiswa okulawulwayo.