{"id":4402,"date":"2024-02-25T08:52:18","date_gmt":"2024-02-25T08:52:18","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/service\/equipment-management-at-stem-cell-bankscell-therapy-centers\/"},"modified":"2025-09-29T13:07:34","modified_gmt":"2025-09-29T06:07:34","slug":"quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao","status":"publish","type":"service","link":"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/","title":{"rendered":"Qu\u1ea3n L\u00fd Thi\u1ebft B\u1ecb T\u1ea1i C\u00e1c Ng\u00e2n H\u00e0ng T\u1ebf B\u00e0o G\u1ed1c\/ Trung T\u00e2m Tr\u1ecb Li\u1ec7u T\u1ebf B\u00e0o"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Hien_nay_ngay_cang_nhieu_thiet_bi_lab_duoc_phat_trien_hoac_duoc_dieu_chinh_phu_hop_de_su_dung_trong_san_xuat_cac_san_pham_tri_lieu_te_bao_tai_cac_ngan_hang_te_bao_goc_trung_tam_tri_lieu_te_bao\" >Hi\u1ec7n nay, ng\u00e0y c\u00e0ng nhi\u1ec1u thi\u1ebft b\u1ecb lab \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n ho\u1eb7c \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh ph\u00f9 h\u1ee3p \u0111\u1ec3 s\u1eed d\u1ee5ng trong s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o.&nbsp;<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Chat_luong_thiet_bi_tai_cac_ngan_hang_te_bao_goc_trung_tam_tri_lieu_te_bao\" >Ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Tham_dinh_thiet_ke_DQ\" >Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (DQ)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Tham_dinh_lap_dat_IQ\" >Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t (IQ)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Tham_dinh_van_hanh_OQ\" >Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Tham_dinh_hieu_nang_PQ\" >Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (PQ)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Tham_dinh_lai_thiet_bi\" >Th\u1ea9m \u0111\u1ecbnh l\u1ea1i thi\u1ebft b\u1ecb<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Kiem_soat_chat_luong_thiet_bi_tai_cac_ngan_hang_te_bao_goc_trung_tam_tri_lieu_te_bao\" >Ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Danh_sach_thiet_bi_chu_yeu\" >Danh s\u00e1ch thi\u1ebft b\u1ecb ch\u1ee7 y\u1ebfu<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Hieu_chuan_va_kiem_tra_chat_luong_thiet_bi\" >Hi\u1ec7u chu\u1ea9n v\u00e0 ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Bao_tri_thiet_bi_PM\" >B\u1ea3o tr\u00ec thi\u1ebft b\u1ecb (PM)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Thiet_bi_bi_hong_hoac_het_duoc_ho_tro_dich_vu_ky_thuat\" >Thi\u1ebft b\u1ecb b\u1ecb h\u1ecfng ho\u1eb7c h\u1ebft \u0111\u01b0\u1ee3c&nbsp;h\u1ed5 tr\u1ee3 d\u1ecbch v\u1ee5 k\u1ef9 thu\u1eadt<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Duy_tri_ho_so_quan_ly_thiet_bi\" >Duy tr\u00ec h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd thi\u1ebft b\u1ecb<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/biogroupvietnam.com\/vi\/dich-vu\/quan-ly-thiet-bi-tai-cac-ngan-hang-te-bao-goc-trung-tam-tri-lieu-te-bao\/#Cac_thiet_bi_dieu_khien_bang_may_tinh\" >C\u00e1c thi\u1ebft b\u1ecb \u0111i\u1ec1u khi\u1ec3n b\u1eb1ng m\u00e1y t\u00ednh<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Hien_nay_ngay_cang_nhieu_thiet_bi_lab_duoc_phat_trien_hoac_duoc_dieu_chinh_phu_hop_de_su_dung_trong_san_xuat_cac_san_pham_tri_lieu_te_bao_tai_cac_ngan_hang_te_bao_goc_trung_tam_tri_lieu_te_bao\"><\/span>Hi\u1ec7n nay, ng\u00e0y c\u00e0ng nhi\u1ec1u thi\u1ebft b\u1ecb lab \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n ho\u1eb7c \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh ph\u00f9 h\u1ee3p \u0111\u1ec3 s\u1eed d\u1ee5ng trong s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o.&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>C\u00e1c thi\u1ebft b\u1ecb n\u00e0y c\u00f3 m\u1ee9c \u0111\u1ed9 ph\u1ee9c t\u1ea1p kh\u00e1c nhau, t\u1eeb thi\u1ebft b\u1ecb \u0111\u01a1n gi\u1ea3n nh\u01b0 m\u00e1y ly t\u00e2m \u0111\u1ebfn thi\u1ebft b\u1ecb ph\u1ee9c t\u1ea1p nh\u01b0 m\u00e1y s\u00e0ng l\u1ecdc t\u1ebf b\u00e0o (cell sorter). <strong>T\u1ea5t c\u1ea3 nh\u1eefng thi\u1ebft b\u1ecb n\u00e0y \u0111\u1ec1u c\u00f3 y\u00eau c\u1ea7u chung l\u00e0 \u0111\u01b0\u1ee3c l\u1ef1a ch\u1ecdn ph\u00f9 h\u1ee3p v\u00e0 \u0111\u1ee7 ti\u00eau chu\u1ea9n tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t.<\/strong><\/p>\n<p>Sau khi thi\u1ebft b\u1ecb \u0111\u00e3 \u0111\u01b0\u1ee3c l\u1eafp \u0111\u1eb7t v\u00e0 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh, c\u00f3 l\u1ecbch tr\u00ecnh b\u1ea3o tr\u00ec (PM) v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng (QC) ph\u1ea3i \u0111\u01b0\u1ee3c vi\u1ebft theo quy tr\u00ecnh v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n (SOP) theo h\u01b0\u1edbng d\u1eabn c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 \u0111\u01b0\u1ee3c tu\u00e2n th\u1ee7 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng <strong>c\u00e1c ch\u1ee9c n\u0103ng c\u1ee7a thi\u1ebft b\u1ecb ho\u1ea1t \u0111\u1ed9ng \u1ed5n \u0111\u1ecbnh<\/strong> <strong>trong c\u00e1c gi\u1edbi h\u1ea1n \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp<\/strong>.<\/p>\n<p>Quy tr\u00ecnh SOP n\u00eau r\u00f5 c\u00e1c b\u01b0\u1edbc c\u1ea7n tu\u00e2n th\u1ee7 khi thi\u1ebft b\u1ecb h\u1ecfng ho\u1eb7c kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng b\u00ecnh th\u01b0\u1eddng c\u0169ng ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 tr\u01b0\u1edbc khi c\u00f3 th\u1ec3 cho ph\u00e9p d\u00f9ng thi\u1ebft b\u1ecb thay th\u1ebf. T\u00f9y thu\u1ed9c v\u00e0o \u1ee9ng d\u1ee5ng c\u1ee7a thi\u1ebft b\u1ecb, ph\u00f2ng lab tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o ho\u1eb7c nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ch\u1ee9ng minh s\u1ef1 tu\u00e2n th\u1ee7 theo c\u00e1c quy \u0111\u1ecbnh v\u00e0 ti\u00eau chu\u1ea9n hi\u1ec7n h\u00e0nh.<\/p>\n<p>M\u1ed9t k\u1ebf ho\u1ea1ch \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf ch\u1ea5t l\u01b0\u1ee3ng ph\u1ea3i bao g\u1ed3m c\u00e1c quy tr\u00ecnh v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n SOP nh\u01b0: ki\u1ec3m so\u00e1t, hi\u1ec7u chu\u1ea9n, b\u1ea3o tr\u00ec, l\u00e0m s\u1ea1ch, v\u1ec7 sinh v\u00e0 gi\u00e1m s\u00e1t c\u00e1c thi\u1ebft b\u1ecb quan tr\u1ecdng. Ngh\u0129a l\u00e0, c\u00e1c thi\u1ebft b\u1ecb c\u00f3 kh\u1ea3 n\u0103ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m, \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t ho\u1eb7c d\u1ecbch v\u1ee5 tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o. Do v\u1eady, c\u1ea7n c\u00f3 m\u1ed9t quy \u0111\u1ecbnh v\u00e0 ch\u00ednh s\u00e1ch l\u1ef1a ch\u1ecdn thi\u1ebft b\u1ecb v\u00e0 quy tr\u00ecnh chu\u1ea9n \u0111\u1ec3 qu\u1ea3n l\u00fd c\u00e1c thi\u1ebft b\u1ecb n\u00e0y.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Chat_luong_thiet_bi_tai_cac_ngan_hang_te_bao_goc_trung_tam_tri_lieu_te_bao\"><\/span><strong>Ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Sau khi x\u00e1c \u0111\u1ecbnh c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a thi\u1ebft b\u1ecb \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ee7a ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o, b\u01b0\u1edbc ti\u1ebfp theo trong qu\u1ea3n l\u00fd thi\u1ebft b\u1ecb l\u00e0 ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng. M\u1ee5c \u0111\u00edch c\u1ee7a vi\u1ec7c \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng l\u00e0 \u0111\u1ec3 ch\u1ee9ng minh r\u1eb1ng thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 v\u1eadn h\u00e0nh \u0111\u00fang c\u00e1ch. Ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb th\u01b0\u1eddng bao g\u1ed3m c\u00e1c ho\u1ea1t \u0111\u1ed9ng sau: th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (DQ), th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t (IQ), th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ) v\u00e0 th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (PQ).<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Tham_dinh_thiet_ke_DQ\"><\/span><strong>Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (DQ)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf (DQ) <strong>x\u00e1c \u0111\u1ecbnh c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt v\u1ec1 ho\u1ea1t \u0111\u1ed9ng v\u00e0 ch\u1ee9c n\u0103ng c\u1ee7a thi\u1ebft b\u1ecb m\u1ed9t c\u00e1ch chi ti\u1ebft<\/strong> \u0111\u1ec3 quy\u1ebft \u0111\u1ecbnh l\u1ef1a ch\u1ecdn thi\u1ebft b\u1ecb, l\u1ef1a ch\u1ecdn nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb, nh\u00e0 cung c\u1ea5p, v\u00e0 \u0111\u00e1nh n\u0103ng l\u1ef1c nh\u00e0 cung c\u1ea5p (theo b\u1ea3ng 1).<\/p>\n<p>T\u00f9y v\u00e0o nguy\u00ean t\u1eafc ho\u1ea1t \u0111\u1ed9ng v\u00e0 \u0111\u1eb7c t\u00ednh c\u1ee7a thi\u1ebft b\u1ecb, tr\u00ecnh \u0111\u1ed9 chuy\u00ean m\u00f4n c\u1ee7a nh\u00e0 cung c\u1ea5p c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u t\u01b0\u01a1ng \u0111\u1ed1i d\u1ec5 \u0111\u1ed1i v\u1edbi c\u00e1c thi\u1ebft b\u1ecb kh\u00f4ng c\u1ea7n l\u1eafp \u0111\u1eb7t (ch\u1ec9 c\u1eafm \u0111i\u1ec7n s\u1eed d\u1ee5ng), nh\u01b0ng \u0111\u01b0\u1ee3c <strong>y\u00eau c\u1ea7u kh\u1eaft khe v\u1edbi thi\u1ebft b\u1ecb c\u00f3 y\u00eau c\u1ea7u l\u1eafp \u0111\u1eb7t ph\u1ee9c t\u1ea1p v\u00e0 c\u00f3 ph\u1ea7n m\u1ec1m v\u1eadn h\u00e0nh qua m\u00e1y t\u00ednh<\/strong>. N\u0103ng l\u1ef1c chuy\u00ean m\u00f4n c\u1ee7a nh\u00e0 cung c\u1ea5p ph\u1ea3i bao g\u1ed3m c\u1ea3 vi\u1ec7c th\u1ea9m \u0111\u1ecbnh v\u00e0 h\u1ed7 tr\u1ee3 ch\u1ecdn thi\u1ebft b\u1ecb (b\u1ea3ng 2). Th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf th\u01b0\u1eddng \u00e1p d\u1ee5ng cho thi\u1ebft b\u1ecb m\u1edbi.<\/p>\n<p><strong>B\u1ea3ng 1: N\u1ed9i dung c\u1ee7a th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf<\/strong><\/p>\n<ol>\n<li>X\u00e1c \u0111\u1ecbnh c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt ch\u1ee9c n\u0103ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o thi\u1ebft b\u1ecb ph\u00f9 h\u1ee3p v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 s\u1ef1 \u0111\u00e1p \u1ee9ng c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb.<\/li>\n<li>X\u00e1c \u0111\u1ecbnh c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt ho\u1ea1t \u0111\u1ed9ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u1ec7c \u0111o l\u01b0\u1eddng v\u00e0 ki\u1ec3m tra s\u1ef1 \u0111\u00e1p \u1ee9ng c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb.<\/li>\n<li>Gi\u00e1 thi\u1ebft b\u1ecb.<\/li>\n<li>C\u00e1c \u0111i\u1ec1u kho\u1ea3n b\u1ea3o h\u00e0nh v\u00e0 th\u1eddi gian b\u1ea3o h\u00e0nh thi\u1ebft b\u1ecb.<\/li>\n<li>H\u1ee3p \u0111\u1ed3ng b\u1ea3o tr\u00ec, t\u00ednh s\u1eb3n s\u00e0ng th\u1ef1c hi\u1ec7n c\u00e1c d\u1ecbch v\u1ee5 h\u1ed5 tr\u1ee3, chi ph\u00ed d\u1ecbch v\u1ee5 v\u00e0 kho\u1ea3ng th\u1eddi gian ph\u1ea3i b\u1ea3o tr\u00ec thi\u1ebft b\u1ecb. Li\u1ec7u nh\u00e2n vi\u00ean c\u1ee7a ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o c\u00f3 th\u1ec3 t\u1ef1 th\u1ef1c hi\u1ec7n b\u1ea3o tr\u00ec hay ph\u1ea3i th\u1ef1c hi\u1ec7n b\u1edfi c\u00e1c k\u1ef9 s\u01b0 c\u1ee7a nh\u00e0 cung c\u1ea5p thi\u1ebft b\u1ecb?<\/li>\n<li>Quy \u0111\u1ecbnh v\u1eadn h\u00e0nh s\u1ea3n xu\u1ea5t tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o hi\u1ec7n t\u1ea1i.<\/li>\n<li>Danh ti\u1ebfng c\u1ee7a nh\u00e0 cung c\u1ea5p &#8211; c\u00f3 \u0111\u00e1ng tin c\u1eady, d\u1ecbch v\u1ee5 h\u1ed5 tr\u1ee3 kh\u00e1ch h\u00e0ng, h\u1ed7 tr\u1ee3 k\u1ef9 thu\u1eadt.<\/li>\n<li>Ki\u1ec3m so\u00e1t nh\u1eefng thay \u0111\u1ed5i c\u00f3 th\u1ec3 c\u00f3 &#8211; c\u1eadp nh\u1eadt ph\u1ea7n m\u1ec1m, thu h\u1ed3i s\u1ea3n ph\u1ea9m v\u00e0 c\u00e1c th\u00f4ng b\u00e1o \u0111\u01b0\u1ee3c cung c\u1ea5p nh\u01b0 th\u1ebf n\u00e0o?<\/li>\n<li>C\u00e1c y\u00eau c\u1ea7u l\u1eafp \u0111\u1eb7t thi\u1ebft b\u1ecb &#8211; kh\u00f4ng gian \u0111\u1eb7t thi\u1ebft b\u1ecb, c\u00e1c y\u00eau c\u1ea7u v\u1ec1 h\u1ec7 th\u1ed1ng \u1ed1ng n\u01b0\u1edbc v\u00e0 ngu\u1ed3n \u0111i\u1ec7n, h\u1ec7 th\u1ed1ng b\u00e1o \u0111\u1ed9ng, ph\u1ea7n m\u1ec1m v\u00e0 ph\u1ea7n c\u1ee9ng m\u00e1y t\u00ednh, \u0111i\u1ec1u ki\u1ec7n nhi\u1ec7t \u0111\u1ed9 v\u00e0 \u0111\u1ed9 \u1ea9m c\u1ee7a n\u01a1i \u0111\u1eb7t thi\u1ebft b\u1ecb.<\/li>\n<li>H\u1ed7 tr\u1ee3 l\u1eafp \u0111\u1eb7t thi\u1ebft b\u1ecb &#8211; cung c\u1ea5p c\u00e1c ch\u1ee9ng nh\u1eadn n\u0103ng l\u1ef1c l\u1eafp \u0111\u1eb7t, v\u1eadn h\u00e0nh v\u00e0 hi\u1ec7u chu\u1ea9n thi\u1ebft b\u1ecb.<\/li>\n<li>Kh\u1ea3 n\u0103ng t\u01b0 v\u1ea5n, \u0111\u00e0o t\u1ea1o s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb v\u00e0 chi ph\u00ed \u0111\u00e0o t\u1ea1o.<\/li>\n<\/ol>\n<p><strong>B\u1ea3ng 2: C\u00e1c c\u00e2u h\u1ecfi quan tr\u1ecdng v\u1ec1 n\u0103ng l\u1ef1c nh\u00e0 cung c\u1ea5p thi\u1ebft b\u1ecb<\/strong><\/p>\n<ol>\n<li>Nh\u00e0 cung c\u1ea5p c\u00f3 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng \u0111\u01b0\u1ee3c l\u1eadp th\u00e0nh v\u0103n b\u1ea3n v\u00e0 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn ho\u1eb7c \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn kh\u00f4ng?<\/li>\n<li>Ph\u1ea7n c\u1ee9ng c\u1ee7a thi\u1ebft b\u1ecb v\u00e0 ph\u1ea7n m\u1ec1m m\u00e1y t\u00ednh c\u00f3 \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n v\u00e0 x\u00e1c nh\u1eadn theo quy tr\u00ecnh v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n (SOP) c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t c\u0169ng nh\u01b0 c\u00f3 c\u00e1c ti\u00eau chu\u1ea9n c\u00f4ng nh\u1eadn v\u00e0 h\u01b0\u1edbng d\u1eabn theo quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh kh\u00f4ng?<\/li>\n<li>Nh\u00e0 cung c\u1ea5p c\u00f3 th\u1ec3 cung c\u1ea5p h\u1ed3 s\u01a1\/ ch\u1ee9ng nh\u1eadn ch\u1ea5t l\u01b0\u1ee3ng, xu\u1ea5t x\u1ee9 s\u1ea3n ph\u1ea9m t\u1eeb c\u00e1c t\u1ed5 ch\u1ee9c c\u00f4ng nh\u1eadn kh\u00f4ng?<\/li>\n<li>Nh\u00e0 cung c\u1ea5p c\u00f3 cung c\u1ea5p x\u00e1c nh\u1eadn l\u00e0 thi\u1ebft b\u1ecb \u0111\u00e1p \u1ee9ng c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a kh\u00e1ch h\u00e0ng kh\u00f4ng?<\/li>\n<li>Nh\u00e0 cung c\u1ea5p c\u00f3 h\u1ec7 th\u1ed1ng ti\u1ebfp nh\u1eadn v\u00e0 ph\u00fac \u0111\u00e1p nh\u1eefng ph\u1ea3n h\u1ed3i c\u1ee7a kh\u00e1ch h\u00e0ng \u0111\u1ec3 th\u00f4ng b\u00e1o nh\u1eefng s\u1ef1 c\u1ed1 ho\u1eb7c y\u00eau c\u1ea7u h\u1ed5 tr\u1ee3 thi\u1ebft b\u1ecb kh\u00f4ng?<\/li>\n<li>Nh\u00e0 cung c\u1ea5p c\u00f3 cung c\u1ea5p h\u1ed3 s\u01a1 n\u0103ng l\u1ef1c l\u1eafp \u0111\u1eb7t v\u00e0 v\u1eadn h\u00e0nh thi\u1ebft b\u1ecb kh\u00f4ng?<\/li>\n<li>C\u00f3 h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t s\u1ef1 thay \u0111\u1ed5i \u0111\u1ec3 th\u00f4ng b\u00e1o cho ng\u01b0\u1eddi d\u00f9ng v\u1ec1 nh\u1eefng thay \u0111\u1ed5i c\u00f3 th\u1ec3 c\u00f3 c\u1ee7a thi\u1ebft b\u1ecb?<\/li>\n<\/ol>\n<h4><span class=\"ez-toc-section\" id=\"Tham_dinh_lap_dat_IQ\"><\/span><strong>Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t (IQ)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t (IQ &#8211; Installation Qualification) <strong>\u0111\u1ea3m b\u1ea3o thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c l\u1eafp \u0111\u1eb7t tu\u00e2n theo ti\u00eau chu\u1ea9n thi\u1ebft k\u1ebf<\/strong> (v\u00ed d\u1ee5: c\u00f4ng su\u1ea5t v\u00e0 ch\u1ee9c n\u0103ng c\u1ee7a thi\u1ebft b\u1ecb, \u0111\u01b0\u1ee3c k\u1ebft n\u1ed1i v\u00e0 hi\u1ec7u chu\u1ea9n \u0111\u00fang c\u00e1ch) v\u00e0 v\u1eadn h\u00e0nh trong m\u00f4i tr\u01b0\u1eddng ph\u00f9 h\u1ee3p. Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi nh\u00e0 cung c\u1ea5p ho\u1eb7c ng\u01b0\u1eddi d\u00f9ng. Tuy nhi\u00ean, s\u1ebd h\u1eefu \u00edch khi t\u1eadn d\u1ee5ng n\u0103ng l\u1ef1c c\u1ee7a nh\u00e0 cung c\u1ea5p v\u00e0 s\u1eed d\u1ee5ng c\u00e1c m\u1eabu th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn.<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Tham_dinh_van_hanh_OQ\"><\/span><strong>Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh (OQ &#8211; Operation Qualification) <strong>\u0111\u1ea3m b\u1ea3o thi\u1ebft b\u1ecb ho\u1ea1t \u0111\u1ed9ng ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c y\u00eau c\u1ea7u c\u1ee7a quy tr\u00ecnh trong c\u00e1c ph\u1ea1m vi ho\u1ea1t \u0111\u1ed9ng d\u1ef1 ki\u1ebfn t\u1ea1i ph\u00f2ng lab<\/strong>. C\u00e1c \u0111\u1eb7c \u0111i\u1ec3m c\u1ee7a th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh bao g\u1ed3m lo\u1ea1i v\u00e0 s\u1ed1 l\u01b0\u1ee3ng m\u1eabu c\u1ea7n th\u1eed nghi\u1ec7m, t\u1ea7n su\u1ea5t th\u1eed nghi\u1ec7m, lo\u1ea1i thi\u1ebft b\u1ecb tham chi\u1ebfu \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u, x\u00e1c nh\u1eadn ch\u1ee9c n\u0103ng c\u1ee7a thi\u1ebft b\u1ecb v\u00e0 c\u00e1c ph\u01b0\u01a1ng ph\u00e1p th\u1ed1ng k\u00ea \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 gi\u1ea3i th\u00edch d\u1eef li\u1ec7u. Thi\u1ebft b\u1ecb c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o s\u1eed d\u1ee5ng sau qu\u00e1 tr\u00ecnh th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh. N\u1ebfu thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho nhi\u1ec1u \u1ee9ng d\u1ee5ng kh\u00e1c nhau, t\u1ea5t c\u1ea3 \u0111\u1ec1u c\u00f3 th\u1ec3 y\u00eau c\u1ea7u ch\u1ee9ng ch\u1ec9 hi\u1ec7u su\u1ea5t \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf ri\u00eang, th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh OQ c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi nh\u00e0 cung c\u1ea5p ho\u1eb7c ng\u01b0\u1eddi d\u00f9ng.<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Tham_dinh_hieu_nang_PQ\"><\/span><strong>Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (PQ)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng (PQ &#8211; Performance Qualification) <strong>\u0111\u1ea3m b\u1ea3o thi\u1ebft b\u1ecb ho\u1ea1t \u0111\u1ed9ng \u1ed5n \u0111\u1ecbnh\/ nh\u1ea5t qu\u00e1n theo c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt \u0111\u00e3 thi\u1ebft l\u1eadp \u0111\u1ec3 s\u1eed d\u1ee5ng th\u01b0\u1eddng xuy\u00ean<\/strong>. C\u00e1c y\u1ebfu t\u1ed1 c\u1ee7a th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng c\u00f3 th\u1ec3 bao g\u1ed3m th\u1eed nghi\u1ec7m song song v\u1edbi m\u1ed9t thi\u1ebft b\u1ecb c\u00f3 th\u1ec3 so s\u00e1nh \u0111\u01b0\u1ee3c, kh\u1ea3 n\u0103ng \u0111\u1ecdc v\u00e0 \u0111\u1ed9 ch\u1eafc ch\u1eafn c\u1ee7a thi\u1ebft b\u1ecb khi v\u1eadn h\u00e0nh trong c\u00e1c \u0111i\u1ec1u ki\u1ec7n kh\u00e1c nhau (bao g\u1ed3m c\u1ea3 vi\u1ec7c can thi\u1ec7p t\u1eaft m\u00e1y v\u00e0 kh\u1edfi \u0111\u1ed9ng l\u1ea1i) v\u00e0 b\u1edfi nh\u1eefng ng\u01b0\u1eddi v\u1eadn h\u00e0nh kh\u00e1c nhau v\u00e0 c\u00e1c th\u00f4ng s\u1ed1 th\u1eed nghi\u1ec7m c\u00f3 xu h\u01b0\u1edbng chuy\u1ec3n \u0111\u1ed9ng (drift). Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u n\u0103ng c\u0169ng bao g\u1ed3m vi\u1ec7c xem x\u00e9t hi\u1ec7u chu\u1ea9n, b\u1ea3o tr\u00ec (PM) v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng (QC) thi\u1ebft b\u1ecb \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c bi\u1ebfn \u0111\u1ed9ng v\u1ec1 hi\u1ec7u su\u1ea5t c\u1ee7a thi\u1ebft b\u1ecb l\u00e0 kh\u00f4ng \u0111\u00e1ng k\u1ec3.<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Tham_dinh_lai_thiet_bi\"><\/span><strong>Th\u1ea9m \u0111\u1ecbnh l\u1ea1i thi\u1ebft b\u1ecb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>Th\u1ea9m \u0111\u1ecbnh l\u1ea1i thi\u1ebft b\u1ecb (Requalification) l\u00e0 <strong>y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c khi c\u00f3 nh\u1eefng thay \u0111\u1ed5i c\u1ea5u h\u00ecnh thi\u1ebft b\u1ecb, c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn hi\u1ec7u su\u1ea5t thi\u1ebft b\u1ecb<\/strong> (v\u00ed d\u1ee5: c\u00e1c s\u1eeda ch\u1eefa quan tr\u1ecdng ho\u1eb7c di chuy\u1ec3n thi\u1ebft b\u1ecb) ho\u1eb7c nh\u1eefng thay \u0111\u1ed5i \u0111\u00e1ng ch\u00fa \u00fd v\u1ec1 hi\u1ec7u su\u1ea5t thi\u1ebft b\u1ecb ho\u1eb7c ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o. H\u1ed3 s\u01a1 ho\u1ea1t \u0111\u1ed9ng c\u1ee7a thi\u1ebft b\u1ecb c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t theo c\u00e1c kho\u1ea3ng th\u1eddi gian n\u00e0y, \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh xem c\u00f3 c\u1ea7n ph\u1ea3i th\u1ef1c hi\u1ec7n th\u1ea9m \u0111\u1ecbnh l\u1ea1i thi\u1ebft b\u1ecb hay kh\u00f4ng? Bi\u1ec3u m\u1eabu c\u00e1c m\u1ee5c c\u1ea7n ki\u1ec3m tra thi\u1ebft b\u1ecb s\u1ebd \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n b\u1edfi nh\u00e0 cung c\u1ea5p thi\u1ebft b\u1ecb c\u00f3 n\u0103ng l\u1ef1c.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Kiem_soat_chat_luong_thiet_bi_tai_cac_ngan_hang_te_bao_goc_trung_tam_tri_lieu_te_bao\"><\/span><strong>Ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<h4><span class=\"ez-toc-section\" id=\"Danh_sach_thiet_bi_chu_yeu\"><\/span><strong>Danh s\u00e1ch thi\u1ebft b\u1ecb ch\u1ee7 y\u1ebfu<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd thi\u1ebft b\u1ecb c\u1ea7n \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp t\u1ea1i c\u00e1c ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c\/ trung t\u00e2m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o. M\u1ed7i thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 s\u1ea3n xu\u1ea5t ho\u1eb7c th\u1eed nghi\u1ec7m c\u1ea7n \u0111\u01b0\u1ee3c g\u1eafn nh\u00e3n nh\u1eadn d\u1ea1ng \u0111\u1ec3 c\u00f3 th\u1ec3 theo d\u00f5i hi\u1ec7u chu\u1ea9n, b\u1ea3o tr\u00ec, c\u0169ng nh\u01b0 theo d\u00f5i, ki\u1ec3m so\u00e1t nh\u1eefng thay \u0111\u1ed5i c\u1ee7a thi\u1ebft b\u1ecb. Khi h\u1ec7 th\u1ed1ng thi\u1ebft b\u1ecb c\u00f3 c\u00e1c th\u00e0nh ph\u1ea7n ri\u00eang bi\u1ec7t, m\u1ed7i th\u00e0nh ph\u1ea7n s\u1ebd nh\u1eadn d\u1ea1ng b\u1eb1ng m\u1ed9t m\u00e3 duy nh\u1ea5t. H\u1ec7 th\u1ed1ng \u0111\u00e1nh s\u1ed1 thi\u1ebft b\u1ecb n\u00ean \u0111\u01b0\u1ee3c l\u1eadp sao cho c\u00f3 \u00fd ngh\u0129a v\u00e0 c\u00f3 th\u1ec3 m\u1edf r\u1ed9ng khi trung t\u00e2m\/ ng\u00e2n h\u00e0ng t\u1ebf b\u00e0o g\u1ed1c ph\u00e1t tri\u1ec3n h\u01a1n. C\u1ea7n duy tr\u00ec m\u1ed9t danh s\u00e1ch thi\u1ebft b\u1ecb ch\u1ee7 y\u1ebfu c\u00f3 c\u00e1c th\u00f4ng tin c\u01a1 b\u1ea3n sau:<\/p>\n<ul>\n<li>S\u1ed1 nh\u1eadn d\u1ea1ng thi\u1ebft b\u1ecb<\/li>\n<li>Nh\u00e0 s\u1ea3n xu\u1ea5t<\/li>\n<li>S\u1ed1 serial\/ model<\/li>\n<li>Ch\u1ec9 \u0111\u1ecbnh quan tr\u1ecdng ho\u1eb7c kh\u00f4ng quan tr\u1ecdng.<\/li>\n<li>C\u00e1c y\u00eau c\u1ea7u hi\u1ec7u chu\u1ea9n.<\/li>\n<li>C\u00e1c y\u00eau c\u1ea7u \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng.<\/li>\n<li>C\u00e1c y\u00eau c\u1ea7u b\u1ea3o tr\u00ec.<\/li>\n<li>Ng\u00e0y mua<\/li>\n<li>Ng\u00e0y \u0111\u01b0a v\u00e0o s\u1eed d\u1ee5ng<\/li>\n<li>V\u1ecb tr\u00ed \u0111\u1eb7t thi\u1ebft b\u1ecb<\/li>\n<\/ul>\n<h4><span class=\"ez-toc-section\" id=\"Hieu_chuan_va_kiem_tra_chat_luong_thiet_bi\"><\/span><strong>Hi\u1ec7u chu\u1ea9n v\u00e0 ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>C\u00e1c thi\u1ebft b\u1ecb quan tr\u1ecdng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u hi\u1ec7u chu\u1ea9n theo ti\u00eau chu\u1ea9n c\u00f3 th\u1ec3 x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c. C\u00e1c thi\u1ebft b\u1ecb y\u00eau c\u1ea7u hi\u1ec7u chu\u1ea9n ho\u1eb7c QC ph\u1ea3i \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh r\u00f5 r\u00e0ng, v\u00e0 quy tr\u00ecnh SOP ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n khi n\u00e0o thi\u1ebft b\u1ecb ph\u1ea3i th\u1ef1c hi\u1ec7n hi\u1ec7u chu\u1ea9n hay QC (v\u00ed d\u1ee5: khi s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb l\u1ea7n \u0111\u1ea7u ho\u1eb7c sau khi s\u1eeda ch\u1eefa c\u00f3 n\u00ean th\u1ef1c hi\u1ec7n hi\u1ec7u chu\u1ea9n ho\u1eb7c QC kh\u00f4ng? Quy \u0111\u1ecbnh trong bao l\u00e2u ph\u1ea3i th\u1ef1c hi\u1ec7n hi\u1ec7u chu\u1ea9n ho\u1eb7c QC c\u00e1c thi\u1ebft b\u1ecb n\u00e0y? \u2026). Quy tr\u00ecnh SOP c\u0169ng bao g\u1ed3m ph\u01b0\u01a1ng ph\u00e1p, ti\u00eau ch\u00ed ch\u1ea5p nh\u1eadn, c\u00e1c h\u1ed3 s\u01a1 l\u01b0u, c\u00e1c thao t\u00e1c x\u1eed l\u00fd s\u1ef1 c\u1ed1 k\u1ef9 thu\u1eadt v\u00e0 ti\u00eau chu\u1ea9n x\u00e1c \u0111\u1ecbnh (traceable standard). Sau khi hi\u1ec7u chu\u1ea9n ho\u1eb7c QC, thi\u1ebft b\u1ecb ph\u1ea3i \u0111\u01b0\u1ee3c b\u1ea3o v\u1ec7 kh\u1ecfi c\u00e1c \u0111i\u1ec1u ch\u1ec9nh tr\u00e1i ph\u00e9p v\u00e0 c\u00e1c thao t\u00e1c v\u1eadn h\u00e0nh, b\u1ea3o tr\u00ec v\u00e0 b\u1ea3o qu\u1ea3n kh\u00f4ng \u0111\u00fang c\u00e1ch. Nh\u00e2n vi\u00ean s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb c\u00f3 th\u1ec3 truy c\u1eadp \u0111\u01b0\u1ee3c t\u00e0i li\u1ec7u v\u1ec1 hi\u1ec7u chu\u1ea9n, b\u1ea3o tr\u00ec (PM) v\u00e0 QC \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c th\u00f4ng s\u1ed1 x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c duy tr\u00ec trong qu\u00e1 tr\u00ecnh s\u1eed d\u1ee5ng. Ph\u1ea3i c\u00f3 m\u1ed9t quy tr\u00ecnh \u0111\u1ec3 theo d\u00f5i khi thi\u1ebft b\u1ecb c\u00f3 hi\u1ec7u l\u1ef1c hi\u1ec7u chu\u1ea9n h\u1ebft h\u1ea1n. Quy tr\u00ecnh n\u00e0y n\u00ean bao g\u1ed3m c\u00e1c xem x\u00e9t v\u1ec1:<\/p>\n<ul>\n<li>Hi\u1ec7u l\u1ef1c c\u1ee7a m\u1ed9t l\u1ea7n ki\u1ec3m tra, hi\u1ec7u chu\u1ea9n.<\/li>\n<li>K\u1ebft qu\u1ea3 ki\u1ec3m tra, hi\u1ec7u chu\u1ea9n.<\/li>\n<li>C\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t b\u1eb1ng thi\u1ebft b\u1ecb b\u1ecb l\u1ed7i k\u1ec3 t\u1eeb ng\u00e0y hi\u1ec7u chu\u1ea9n h\u1ebft h\u1ea1n.<\/li>\n<\/ul>\n<h4><span class=\"ez-toc-section\" id=\"Bao_tri_thiet_bi_PM\"><\/span><strong>B\u1ea3o tr\u00ec thi\u1ebft b\u1ecb (PM)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>M\u1ed9t quy tr\u00ecnh SOP ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp b\u1eb1ng v\u0103n b\u1ea3n v\u00e0 c\u00f3 ph\u1ea7n b\u1ea3o tr\u00ec thi\u1ebft b\u1ecb theo h\u01b0\u1edbng d\u1eabn c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t nh\u1eb1m ng\u0103n ng\u1eeba s\u1ef1 c\u1ed1, thi\u1ebft b\u1ecb b\u1ecb nhi\u1ec5m, s\u1ea3n ph\u1ea9m tr\u1ed9n l\u1eabn nhau v\u00e0 nhi\u1ec5m ch\u00e9o. Quy tr\u00ecnh SOP c\u1ea7n bao g\u1ed3m:<\/p>\n<ul>\n<li>V\u1ec7 sinh v\u00e0 b\u1ea3o d\u01b0\u1ee1ng thi\u1ebft b\u1ecb.<\/li>\n<li>V\u1ec7 sinh \u0111\u01b0\u1eddng \u1ed1ng.<\/li>\n<li>Lo\u1ea1i b\u1ecf ho\u1eb7c t\u1ea9y r\u1eeda s\u1ea3n ph\u1ea9m d\u00ednh l\u1ea1i c\u1ee7a l\u00f4 s\u1ea3n xu\u1ea5t tr\u01b0\u1edbc \u0111\u00f3.<\/li>\n<li>C\u00e1c thao t\u00e1c b\u1ea3o v\u1ec7 thi\u1ebft b\u1ecb kh\u00f4ng b\u1ecb nhi\u1ec5m.<\/li>\n<li>Ki\u1ec3m tra \u0111\u1ed9 s\u1ea1ch c\u1ee7a thi\u1ebft b\u1ecb tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng.<\/li>\n<li>Nh\u1eadt k\u00fd s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb.<\/li>\n<\/ul>\n<p>Nh\u1eadt k\u00fd b\u1ea3o tr\u00ec thi\u1ebft b\u1ecb ph\u1ea3i bao g\u1ed3m c\u00e1c th\u00f4ng tin nh\u01b0: c\u00e1c ho\u1ea1t \u0111\u1ed9ng, ng\u00e0y th\u00e1ng v\u00e0 th\u1eddi gian th\u1ef1c hi\u1ec7n; ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n; lo\u1ea1i s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o s\u1ed1 l\u00f4 (n\u1ebfu c\u00f3); v\u00e0 \u0111\u01b0\u1ee3c ki\u1ec3m tra b\u1edfi nh\u00e2n vi\u00ean gi\u00e1m s\u00e1t. \u1ede m\u1ee9c t\u1ed1i thi\u1ec3u, thi\u1ebft b\u1ecb n\u00ean \u0111\u01b0\u1ee3c b\u1ea3o d\u01b0\u1ee1ng theo t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t.<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Thiet_bi_bi_hong_hoac_het_duoc_ho_tro_dich_vu_ky_thuat\"><\/span><strong>Thi\u1ebft b\u1ecb b\u1ecb h\u1ecfng ho\u1eb7c h\u1ebft \u0111\u01b0\u1ee3c&nbsp;h\u1ed5 tr\u1ee3 d\u1ecbch v\u1ee5 k\u1ef9 thu\u1eadt<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>M\u1ed9t quy tr\u00ecnh SOP c\u0169ng c\u1ea7n c\u00f3 v\u1ec1 x\u1eed l\u00fd thi\u1ebft b\u1ecb b\u1ecb tr\u1ee5c tr\u1eb7c, h\u1ecfng h\u00f3c ho\u1eb7c kh\u00f4ng c\u00f2n ho\u1ea1t \u0111\u1ed9ng. Quy tr\u00ecnh bao g\u1ed3m th\u00f4ng b\u00e1o v\u00e0 l\u1eadp h\u1ed3 s\u01a1 v\u1ec1 s\u1ef1 c\u1ed1 c\u1ee7a thi\u1ebft b\u1ecb, vi\u1ec7c thay th\u1ebf thi\u1ebft b\u1ecb kh\u00e1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng, ti\u1ebfp theo l\u00e0 th\u1ef1c hi\u1ec7n hi\u1ec7u chu\u1ea9n v\u00e0 ki\u1ec3m \u0111\u1ecbnh l\u1ea1i thi\u1ebft b\u1ecb, n\u1ebfu c\u1ea7n. N\u1ebfu thay th\u1ebf thi\u1ebft b\u1ecb t\u1ea1m th\u1eddi ho\u1eb7c l\u00e2u d\u00e0i th\u00ec ph\u1ea3i c\u00f3 h\u1ed3 s\u01a1 ghi l\u1ea1i s\u1ef1 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng c\u1ee7a s\u1ef1 thay \u0111\u1ed5i \u0111\u1ed1i v\u1edbi quy tr\u00ecnh s\u1ea3n xu\u1ea5t ho\u1eb7c th\u1eed nghi\u1ec7m \u0111ang \u00e1p d\u1ee5ng hi\u1ec7n t\u1ea1i. T\u00e0i li\u1ec7u n\u00e0y c\u00f3 th\u1ec3 n\u00eau r\u00f5 r\u1eb1ng thi\u1ebft b\u1ecb \u0111\u00e3 \u0111\u01b0\u1ee3c thay th\u1ebf tr\u00ean c\u01a1 s\u1edf \u201ct\u01b0\u01a1ng \u0111\u01b0\u01a1ng\u201d, ho\u1eb7c \u0111\u00e1nh gi\u00e1 l\u00e0 c\u1ea7n ph\u1ea3i th\u1eed nghi\u1ec7m l\u1ea1i.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Duy_tri_ho_so_quan_ly_thiet_bi\"><\/span><strong>Duy tr\u00ec h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd thi\u1ebft b\u1ecb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>H\u1ed3 s\u01a1 thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong qu\u00e1 tr\u00ecnh mua s\u1eafm, s\u1eed d\u1ee5ng, b\u1ea3o qu\u1ea3n v\u00e0 ph\u00e2n ph\u1ed1i ph\u1ea3i \u0111\u01b0\u1ee3c duy tr\u00ec theo l\u1ecbch tr\u00ecnh l\u01b0u gi\u1eef h\u1ed3 s\u01a1 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o nh\u1eadn d\u1ea1ng v\u00e0 kh\u1ea3 n\u0103ng thu h\u1ed3i c\u00e1c s\u1ea3n ph\u1ea9m tr\u1ecb li\u1ec7u t\u1ebf b\u00e0o li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb, n\u1ebfu c\u1ea7n thi\u1ebft. H\u1ed3 s\u01a1 thi\u1ebft b\u1ecb bao g\u1ed3m t\u1ea5t c\u1ea3 c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb, ch\u1eb3ng h\u1ea1n nh\u01b0 vi\u1ec7c s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb, hi\u1ec7u chu\u1ea9n, QC, b\u1ea3o tr\u00ec, v\u1ec7 sinh, ki\u1ec3m tra v\u00e0 \u0111\u00e1nh gi\u00e1 \/th\u1ea9m \u0111\u1ecbnh. Vi\u1ec7c l\u01b0u gi\u1eef h\u1ed3 s\u01a1 c\u0169ng c\u1ea7n tu\u00e2n th\u1ee7 theo c\u00e1c quy \u0111\u1ecbnh c\u1ee7a nh\u00e0 n\u01b0\u1edbc v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n c\u00e1c nh\u1eadn.<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Cac_thiet_bi_dieu_khien_bang_may_tinh\"><\/span><strong>C\u00e1c thi\u1ebft b\u1ecb \u0111i\u1ec1u khi\u1ec3n b\u1eb1ng m\u00e1y t\u00ednh<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>Ngo\u00e0i quy tr\u00ecnh SOP \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 nh\u01b0 tr\u00ean, thi\u1ebft b\u1ecb \u0111i\u1ec1u khi\u1ec3n b\u1eb1ng m\u00e1y t\u00ednh \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u c\u00f3 SOP r\u00f5 r\u00e0ng v\u1ec1 m\u1ed9t s\u1ed1 \u0111i\u1ec3m sau:<\/p>\n<ul>\n<li>B\u1ea3o tr\u00ec v\u00e0 v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng.<\/li>\n<li>B\u1ea3o m\u1eadt h\u1ec7 th\u1ed1ng.<\/li>\n<li>Hi\u1ec3n th\u1ecb v\u00e0 x\u00e1c minh d\u1eef li\u1ec7u tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn.<\/li>\n<li>Quy tr\u00ecnh cho vi\u1ec7c b\u1ed5 sung ho\u1eb7c thay \u0111\u1ed5i.<\/li>\n<li>S\u1eeda \u0111\u1ed5i t\u00e0i li\u1ec7u<\/li>\n<li>Sao l\u01b0u b\u1ed9 nh\u1edb d\u1eef li\u1ec7u v\u1edbi quy tr\u00ecnh truy xu\u1ea5t \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c th\u1ef1c.<\/li>\n<li>Quy tr\u00ecnh thay th\u1ebf \u0111\u1ec3 ti\u1ebfp t\u1ee5c ho\u1ea1t \u0111\u1ed9ng trong th\u1eddi gian m\u00e1y t\u00ednh ng\u1eebng ho\u1ea1t \u0111\u1ed9ng.<\/li>\n<\/ul>\n<p><i>(Ngu\u1ed3n tham kh\u1ea3o: Equipment Management in The Cellular Therapy Facility by Tao Wang \u2013 Validation and Quality System Manager, National Cord Blood Program, New York Blood Center. Cellular Therapy: Principles, Methods, and Regulations. 2nd Edition. AABB. P. 139-153).<\/i><\/p>\n","protected":false},"featured_media":5897,"parent":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-4402","service","type-service","status-publish","has-post-thumbnail","hentry","service-category-huong-dan-quan-ly-thiet-bi"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Qu\u1ea3n L\u00fd Thi\u1ebft B\u1ecb T\u1ea1i C\u00e1c Ng\u00e2n H\u00e0ng T\u1ebf B\u00e0o G\u1ed1c\/ Trung T\u00e2m Tr\u1ecb Li\u1ec7u T\u1ebf B\u00e0o<\/title>\n<meta name=\"description\" content=\"T\u1ea5t c\u1ea3 nh\u1eefng thi\u1ebft b\u1ecb n\u00e0y \u0111\u1ec1u c\u00f3 y\u00eau c\u1ea7u chung l\u00e0 \u0111\u01b0\u1ee3c l\u1ef1a ch\u1ecdn ph\u00f9 h\u1ee3p v\u00e0 \u0111\u1ee7 ti\u00eau chu\u1ea9n tr\u01b0\u1edbc khi s\u1eed d\u1ee5ng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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