{"id":26350,"date":"2025-12-27T11:29:37","date_gmt":"2025-12-27T04:29:37","guid":{"rendered":"https:\/\/base.vn\/blog\/?p=26350"},"modified":"2026-01-26T11:11:31","modified_gmt":"2026-01-26T04:11:31","slug":"capa-la-gi","status":"publish","type":"post","link":"https:\/\/base.vn\/blog\/capa-la-gi\/","title":{"rendered":"CAPA l\u00e0 g\u00ec? \u1ee8ng d\u1ee5ng th\u1ef1c t\u1ebf trong s\u1ea3n xu\u1ea5t v\u00e0 d\u01b0\u1ee3c ph\u1ea9m"},"content":{"rendered":"\n

CAPA (Corrective and Preventive Action) l\u00e0 m\u1ed9t trong nh\u1eefng h\u1ec7 th\u1ed1ng quan tr\u1ecdng nh\u1ea5t trong l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t v\u00e0 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng. N\u1ebfu doanh nghi\u1ec7p \u0111ang t\u00ecm hi\u1ec3u CAPA l\u00e0 g\u00ec<\/strong> v\u00e0 nh\u1eefng \u1ee9ng d\u1ee5ng c\u1ee7a CAPA trong th\u1ef1c t\u1ebf, h\u00e3y c\u00f9ng Base.vn<\/a> theo d\u00f5i n\u1ed9i dung sau \u0111\u00e2y.<\/p>\n\n\n\n

1. CAPA l\u00e0 g\u00ec?<\/h2>\n\n\n\n

CAPA<\/strong> l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a Corrective and Preventive Action<\/strong>, \u0111\u01b0\u1ee3c hi\u1ec3u l\u00e0 h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba. \u0110\u00e2y l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng trong qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng gi\u00fap doanh nghi\u1ec7p x\u1eed l\u00fd s\u1ef1 c\u1ed1 m\u1ed9t c\u00e1ch c\u00f3 h\u1ec7 th\u1ed1ng, kh\u00f4ng ch\u1ec9 s\u1eeda l\u1ed7i tr\u01b0\u1edbc m\u1eaft m\u00e0 c\u00f2n ng\u0103n l\u1ed7i t\u00e1i di\u1ec5n trong t\u01b0\u01a1ng lai. Hai th\u00e0nh ph\u1ea7n ch\u00ednh c\u1ee7a CAPA bao g\u1ed3m:<\/p>\n\n\n\n

– Corrective Action<\/strong>, hay h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c, t\u1eadp trung v\u00e0o vi\u1ec7c t\u00ecm v\u00e0 lo\u1ea1i b\u1ecf nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 c\u1ee7a c\u00e1c v\u1ea5n \u0111\u1ec1 \u0111\u00e3 x\u1ea3y ra, ch\u1eb3ng h\u1ea1n nh\u01b0 s\u1ea3n ph\u1ea9m l\u1ed7i ho\u1eb7c quy tr\u00ecnh kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u.<\/p>\n\n\n\n

– Preventive Action<\/strong>, hay h\u00e0nh \u0111\u1ed9ng ph\u00f2ng ng\u1eeba, \u0111\u1ec1 c\u1eadp \u0111\u1ebfn vi\u1ec7c nh\u1eadn di\u1ec7n v\u00e0 lo\u1ea1i b\u1ecf c\u00e1c nguy\u00ean nh\u00e2n ti\u1ec1m \u1ea9n c\u00f3 th\u1ec3 g\u00e2y ra s\u1ef1 c\u1ed1 trong t\u01b0\u01a1ng lai, ngay c\u1ea3 khi l\u1ed7i \u0111\u00f3 ch\u01b0a x\u1ea3y ra.<\/p>\n\n\n\n

\u0110i\u1ec3m kh\u00e1c bi\u1ec7t l\u1edbn nh\u1ea5t gi\u1eefa CAPA v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng th\u00f4ng th\u01b0\u1eddng l\u00e0 CAPA kh\u00f4ng d\u1eebng l\u1ea1i \u1edf vi\u1ec7c \u201cch\u1eefa ch\u00e1y\u201d. Thay v\u00e0o \u0111\u00f3, CAPA y\u00eau c\u1ea7u doanh nghi\u1ec7p ph\u1ea3i ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n c\u1ed1t l\u00f5i, \u0111i\u1ec1u ch\u1ec9nh quy tr\u00ecnh v\u00e0 x\u00e2y d\u1ef1ng c\u01a1 ch\u1ebf ki\u1ec3m so\u00e1t \u0111\u1ec3 h\u1ec7 th\u1ed1ng v\u1eadn h\u00e0nh t\u1ed1t h\u01a1n v\u1ec1 l\u00e2u d\u00e0i. Nh\u1edd v\u1eady, doanh nghi\u1ec7p c\u00f3 th\u1ec3 c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c thay v\u00ec l\u1eb7p \u0111i l\u1eb7p l\u1ea1i c\u00f9ng m\u1ed9t l\u1ed7i.<\/p>\n\n\n

\n
\"CAPA
CAPA l\u00e0 g\u00ec?<\/em><\/figcaption><\/figure><\/div>\n\n\n

CAPA \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng d\u1ef1a tr\u00ean c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf uy t\u00edn. Trong ti\u00eau chu\u1ea9n ISO 9001:2015, \u0111i\u1ec1u kho\u1ea3n 10.2 y\u00eau c\u1ea7u t\u1ed5 ch\u1ee9c ph\u1ea3i th\u1ef1c hi\u1ec7n h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c nh\u1eefng y\u1ebfu t\u1ed1 kh\u00f4ng ph\u00f9 h\u1ee3p v\u00e0 \u00e1p d\u1ee5ng t\u01b0 duy d\u1ef1a tr\u00ean r\u1ee7i ro \u0111\u1ec3 ph\u00f2ng ng\u1eeba. T\u1ea1i Hoa K\u1ef3, C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m (FDA) c\u0169ng quy \u0111\u1ecbnh r\u1ea5t r\u00f5 v\u1ec1 CAPA t\u1ea1i m\u1ee5c 820.100 trong 21 CFR Part 820<\/a>. Quy \u0111\u1ecbnh n\u00e0y \u0111\u1eb7c bi\u1ec7t b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n

Ti\u00eau chu\u1ea9n<\/strong><\/td>Y\u00eau c\u1ea7u ch\u00ednh<\/strong><\/td>Ph\u1ea1m vi \u00e1p d\u1ee5ng<\/strong><\/td><\/tr>
ISO 9001:2015<\/td>H\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 t\u01b0 duy r\u1ee7i ro<\/td>T\u1ea5t c\u1ea3 ng\u00e0nh ngh\u1ec1<\/td><\/tr>
FDA 21 CFR 820<\/td>CAPA cho thi\u1ebft b\u1ecb y t\u1ebf<\/td>Thi\u1ebft b\u1ecb y t\u1ebf l\u01b0u h\u00e0nh t\u1ea1i M\u1ef9<\/td><\/tr>
GMP-WHO <\/td>CAPA trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c <\/td>D\u01b0\u1ee3c ph\u1ea9m to\u00e0n c\u1ea7u<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Th\u1ef1c t\u1ebf cho th\u1ea5y, CAPA th\u1ef1c s\u1ef1 c\u00f3 \u00fd ngh\u0129a v\u1edbi c\u00e1c ng\u00e0nh nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 th\u1ef1c ph\u1ea9m xu\u1ea5t kh\u1ea9u. V\u00ed d\u1ee5, n\u1ebfu m\u1ed9t nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t thu\u1ed1c ph\u00e1t hi\u1ec7n l\u00f4 h\u00e0ng kh\u00f4ng \u0111\u1ea1t \u0111\u1ed9 tinh khi\u1ebft, CAPA kh\u00f4ng ch\u1ec9 y\u00eau c\u1ea7u lo\u1ea1i b\u1ecf l\u00f4 s\u1ea3n ph\u1ea9m \u0111\u00f3, m\u00e0 c\u00f2n bu\u1ed9c doanh nghi\u1ec7p ph\u1ea3i \u0111i\u1ec1u tra nguy\u00ean nh\u00e2n s\u00e2u xa, ch\u1eb3ng h\u1ea1n nh\u01b0 thi\u1ebft b\u1ecb l\u1ecdc g\u1eb7p s\u1ef1 c\u1ed1 hay quy tr\u00ecnh v\u1ec7 sinh ch\u01b0a \u0111\u1ea1t chu\u1ea9n, v\u00e0 sau \u0111\u00f3 \u0111\u01b0a ra bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba \u0111\u1ec3 l\u1ed7i t\u01b0\u01a1ng t\u1ef1 kh\u00f4ng l\u1eb7p l\u1ea1i.<\/p>\n\n\n\n

\u0110\u1ecdc th\u00eam:<\/strong> TQM l\u00e0 g\u00ec? Gi\u1ea3i ph\u00e1p n\u00e2<\/a>n<\/a>g cao ch\u1ea5t l\u01b0\u1ee3ng to\u00e0n di\u1ec7n cho doanh nghi\u1ec7p<\/a><\/p>\n\n\n\n

2. Ph\u00e2n bi\u1ec7t Corrective Action (CA) v\u00e0 Preventive Action (PA) trong CAPA<\/h2>\n\n\n\n

\u0110\u1ec3 hi\u1ec3u \u0111\u00fang v\u1ec1 CAPA, tr\u01b0\u1edbc h\u1ebft ch\u00fang ta c\u1ea7n ph\u00e2n bi\u1ec7t r\u00f5 2 kh\u00e1i ni\u1ec7m: Corrective Action v\u00e0 Preventive Action. C\u1ea3 hai \u0111\u1ec1u nh\u1eb1m m\u1ee5c ti\u00eau n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng, nh\u01b0ng kh\u00e1c nhau \u1edf th\u1eddi \u0111i\u1ec3m \u00e1p d\u1ee5ng v\u00e0 c\u00e1ch ti\u1ebfp c\u1eadn. C\u1ee5 th\u1ec3:<\/p>\n\n\n\n

Corrective Action (h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c) l\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n sau khi s\u1ef1 c\u1ed1 \u0111\u00e3 x\u1ea3y ra. M\u1ee5c ti\u00eau c\u1ee7a CA l\u00e0 t\u00ecm v\u00e0 lo\u1ea1i b\u1ecf nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 c\u1ee7a v\u1ea5n \u0111\u1ec1, nh\u1eb1m tr\u00e1nh l\u1ed7i t\u01b0\u01a1ng t\u1ef1 l\u1eb7p l\u1ea1i trong t\u01b0\u01a1ng lai. \u0110\u1ec3 l\u00e0m \u0111\u01b0\u1ee3c \u0111i\u1ec1u n\u00e0y, doanh nghi\u1ec7p ph\u1ea3i th\u1ef1c hi\u1ec7n ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n c\u1ed1t l\u00f5i, hay Root Cause Analysis. M\u1ed9t s\u1ed1 c\u00f4ng c\u1ee5 ph\u1ed5 bi\u1ebfn g\u1ed3m s\u01a1 \u0111\u1ed3 x\u01b0\u01a1ng c\u00e1 nguy\u00ean nh\u00e2n – k\u1ebft qu\u1ea3 (Fishbone Diagram) v\u00e0 ph\u01b0\u01a1ng ph\u00e1p 5 Whys<\/a> (5 c\u00e2u h\u1ecfi \u201ct\u1ea1i sao\u201d).<\/p>\n\n\n\n

Ng\u01b0\u1ee3c l\u1ea1i, Preventive Action (h\u00e0nh \u0111\u1ed9ng ph\u00f2ng ng\u1eeba) \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u01b0\u1edbc khi s\u1ef1 c\u1ed1 x\u1ea3y ra. PA t\u1eadp trung v\u00e0o vi\u1ec7c nh\u1eadn di\u1ec7n c\u00e1c r\u1ee7i ro ti\u1ec1m \u1ea9n v\u00e0 ch\u1ee7 \u0111\u1ed9ng lo\u1ea1i b\u1ecf ch\u00fang, d\u1ef1a tr\u00ean ph\u00e2n t\u00edch d\u1eef li\u1ec7u, xu h\u01b0\u1edbng l\u1ed7i trong qu\u00e1 kh\u1ee9 ho\u1eb7c c\u00e1c c\u1ea3nh b\u00e1o t\u1eeb b\u00ean ngo\u00e0i. \u0110\u00e2y l\u00e0 c\u00e1ch ti\u1ebfp c\u1eadn mang t\u00ednh ch\u1ee7 \u0111\u1ed9ng v\u00e0 th\u1ec3 hi\u1ec7n t\u01b0 duy d\u00e0i h\u1ea1n trong qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng.<\/p>\n\n\n\n

D\u01b0\u1edbi \u0111\u00e2y l\u00e0 b\u1ea3ng so s\u00e1nh nhanh 2 th\u00e0nh ph\u1ea7n c\u1ee7a CAPA:<\/p>\n\n\n\n

Ti\u00eau ch\u00ed so s\u00e1nh<\/strong><\/td>Corrective Action (CA)<\/strong><\/td>Preventive Action (PA)<\/strong><\/td><\/tr>
Th\u1eddi \u0111i\u1ec3m \u00e1p d\u1ee5ng<\/td>Sau khi s\u1ef1 c\u1ed1 x\u1ea3y ra<\/td>Tr\u01b0\u1edbc khi s\u1ef1 c\u1ed1 x\u1ea3y ra<\/td><\/tr>
M\u1ee5c ti\u00eau<\/td>Kh\u1eafc ph\u1ee5c v\u00e0 ng\u0103n s\u1ef1 c\u1ed1 t\u00e1i di\u1ec5n<\/td>Ph\u00f2ng ng\u1eeba r\u1ee7i ro ti\u1ec1m \u1ea9n<\/td><\/tr>
C\u00f4ng c\u1ee5 ch\u00ednh<\/td>RCA, 5 Whys, Fishbone<\/td>Risk Assessment, FMEA<\/td><\/tr>
\u0110\u1eb7c \u0111i\u1ec3m<\/td>X\u1eed l\u00fd, b\u1ecb \u0111\u1ed9ng<\/td>Ch\u1ee7 \u0111\u1ed9ng, d\u1ef1 \u0111o\u00e1n<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Ch\u1eb3ng h\u1ea1n, trong ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m, m\u1ed9t nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t vi\u00ean thu\u1ed1c h\u1ea1 s\u1ed1t ph\u00e1t hi\u1ec7n m\u1ed9t l\u00f4 s\u1ea3n ph\u1ea9m c\u00f3 h\u00e0m l\u01b0\u1ee3ng ho\u1ea1t ch\u1ea5t th\u1ea5p h\u01a1n ti\u00eau chu\u1ea9n. V\u1edbi Corrective Action, nh\u00e0 m\u00e1y s\u1ebd d\u1eebng s\u1ea3n xu\u1ea5t, \u0111i\u1ec1u tra nguy\u00ean nh\u00e2n v\u00e0 ph\u00e1t hi\u1ec7n m\u00e1y tr\u1ed9n nguy\u00ean li\u1ec7u b\u1ecb l\u1ed7i do kh\u00f4ng \u0111\u01b0\u1ee3c b\u1ea3o tr\u00ec \u0111\u00fang l\u1ecbch. Bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c l\u00fac n\u00e0y l\u00e0 s\u1eeda ch\u1eefa m\u00e1y v\u00e0 si\u1ebft ch\u1eb7t quy tr\u00ecnh b\u1ea3o tr\u00ec \u0111\u1ecbnh k\u1ef3.<\/p>\n\n\n\n

Song song \u0111\u00f3, nh\u00e0 m\u00e1y c\u0169ng tri\u1ec3n khai Preventive Action. Qua ph\u00e2n t\u00edch d\u1eef li\u1ec7u, nh\u00e0 m\u00e1y nh\u1eadn ra l\u1ed7i th\u01b0\u1eddng x\u1ea3y ra v\u00e0o cu\u1ed1i tu\u1ea7n, khi ca l\u00e0m vi\u1ec7c thay th\u1ebf ca ch\u00ednh. Bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba c\u00f3 th\u1ec3 bao g\u1ed3m \u0111\u00e0o t\u1ea1o b\u1ed5 sung cho nh\u00e2n s\u1ef1 thu\u1ed9c ca l\u00e0m vi\u1ec7c n\u00e0y, x\u00e2y d\u1ef1ng checklist ki\u1ec3m tra ri\u00eang cho ca thay th\u1ebf v\u00e0 thi\u1ebft l\u1eadp h\u1ec7 th\u1ed1ng c\u1ea3nh b\u00e1o t\u1ef1 \u0111\u1ed9ng khi ph\u00e1t hi\u1ec7n d\u1ea5u hi\u1ec7u b\u1ea5t th\u01b0\u1eddng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t.<\/p>\n\n\n\n

Khi \u0111\u01b0\u1ee3c tri\u1ec3n khai \u0111\u1ed3ng th\u1eddi, CA v\u00e0 PA t\u1ea1o n\u00ean gi\u00e1 tr\u1ecb c\u1ed1t l\u00f5i c\u1ee7a h\u1ec7 th\u1ed1ng CAPA. CA gi\u00fap x\u1eed l\u00fd tri\u1ec7t \u0111\u1ec3 c\u00e1c v\u1ea5n \u0111\u1ec1 \u0111\u00e3 x\u1ea3y ra, c\u00f2n PA gi\u00fap doanh nghi\u1ec7p ch\u1ee7 \u0111\u1ed9ng ng\u0103n ng\u1eeba r\u1ee7i ro trong t\u01b0\u01a1ng lai. \u0110\u00e2y ch\u00ednh l\u00e0 n\u1ec1n t\u1ea3ng \u0111\u1ec3 doanh nghi\u1ec7p duy tr\u00ec ch\u1ea5t l\u01b0\u1ee3ng \u1ed5n \u0111\u1ecbnh v\u00e0 th\u00edch \u1ee9ng t\u1ed1t trong m\u00f4i tr\u01b0\u1eddng kinh doanh lu\u00f4n thay \u0111\u1ed5i.<\/p>\n\n\n

\n
\"Ph\u00e2n
Ph\u00e2n bi\u1ec7t Corrective Action (CA) v\u00e0 Preventive Action (PA) trong CAPA<\/em><\/figcaption><\/figure><\/div>\n\n\n

3. Quy tr\u00ecnh 7 b\u01b0\u1edbc tri\u1ec3n khai CAPA theo chu\u1ea9n ISO\/FDA<\/h2>\n\n\n\n

CAPA th\u01b0\u1eddng \u0111\u01b0\u1ee3c tri\u1ec3n khai d\u1ef1a tr\u00ean c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf nh\u01b0 ISO 9001 v\u00e0 FDA 21 CFR 820, sau \u0111\u00f3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh \u0111\u1ec3 ph\u00f9 h\u1ee3p v\u1edbi \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh c\u1ee7a t\u1eebng doanh nghi\u1ec7p. Quy tr\u00ecnh n\u00e0y c\u00f3 th\u1ec3 tri\u1ec3n khai theo 7 b\u01b0\u1edbc nh\u01b0 sau.<\/p>\n\n\n\n

B\u01b0\u1edbc 1: X\u00e1c \u0111\u1ecbnh v\u00e0 ghi nh\u1eadn v\u1ea5n \u0111\u1ec1 (Non-conformance report – b\u00e1o c\u00e1o s\u1ef1 kh\u00f4ng ph\u00f9 h\u1ee3p)<\/strong><\/p>\n\n\n\n

Quy tr\u00ecnh x\u00e2y d\u1ef1ng CAPA b\u1eaft \u0111\u1ea7u khi doanh nghi\u1ec7p ph\u00e1t hi\u1ec7n m\u1ed9t v\u1ea5n \u0111\u1ec1 c\u1ea7n x\u1eed l\u00fd. V\u1ea5n \u0111\u1ec1 n\u00e0y c\u00f3 th\u1ec3 \u0111\u1ebfn t\u1eeb c\u00e1c ngu\u1ed3n nh\u01b0 khi\u1ebfu n\u1ea1i c\u1ee7a kh\u00e1ch h\u00e0ng, k\u1ebft qu\u1ea3 audit (\u0111\u00e1nh gi\u00e1) n\u1ed9i b\u1ed9, ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng, ho\u1eb7c ph\u00e2n t\u00edch d\u1eef li\u1ec7u cho th\u1ea5y d\u1ea5u hi\u1ec7u b\u1ea5t th\u01b0\u1eddng.<\/p>\n\n\n\n

\u1ede b\u01b0\u1edbc n\u00e0y, doanh nghi\u1ec7p c\u1ea7n ghi nh\u1eadn \u0111\u1ea7y \u0111\u1ee7 c\u00e1c th\u00f4ng tin: v\u1ea5n \u0111\u1ec1 x\u1ea3y ra khi n\u00e0o, \u1edf \u0111\u00e2u, \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn b\u1ed9 ph\u1eadn n\u00e0o, m\u1ee9c \u0111\u1ed9 nghi\u00eam tr\u1ecdng ra sao. Vi\u1ec7c ghi nh\u1eadn c\u00e0ng r\u00f5 c\u00e0ng gi\u00fap \u0111\u00e1nh gi\u00e1 \u0111\u00fang m\u1ee9c \u0111\u1ed9 \u01b0u ti\u00ean v\u00e0 tr\u00e1nh b\u1ecf s\u00f3t c\u00e1c v\u1ea5n \u0111\u1ec1 tr\u1ecdng \u0111i\u1ec3m.<\/p>\n\n\n\n

B\u01b0\u1edbc 2: Ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 (Root Cause Analysis)<\/strong><\/p>\n\n\n\n

\u0110\u00e2y l\u00e0 b\u01b0\u1edbc quan tr\u1ecdng nh\u1ea5t c\u1ee7a to\u00e0n b\u1ed9 quy tr\u00ecnh CAPA. M\u1ee5c ti\u00eau kh\u00f4ng ph\u1ea3i ch\u1ec9 bi\u1ebft s\u1ef1 c\u1ed1 \u0111\u00e3 x\u1ea3y ra, m\u00e0 l\u00e0 hi\u1ec3u v\u00ec sao n\u00f3 x\u1ea3y ra.<\/p>\n\n\n\n

Doanh nghi\u1ec7p c\u00f3 th\u1ec3 \u00e1p d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p 5 Whys \u0111\u1ec3 \u0111i s\u00e2u v\u00e0o nguy\u00ean nh\u00e2n c\u1ed1t l\u00f5i. Ngo\u00e0i ra, s\u01a1 \u0111\u1ed3 x\u01b0\u01a1ng c\u00e1 s\u1ebd gi\u00fap ph\u00e2n t\u00edch v\u1ea5n \u0111\u1ec1 t\u1eeb nhi\u1ec1u g\u00f3c \u0111\u1ed9 nh\u01b0 con ng\u01b0\u1eddi, m\u00e1y m\u00f3c, v\u1eadt li\u1ec7u, ph\u01b0\u01a1ng ph\u00e1p, \u0111o l\u01b0\u1eddng v\u00e0 m\u00f4i tr\u01b0\u1eddng.<\/p>\n\n\n\n

Ch\u1ec9 khi l\u00e0m t\u1ed1t b\u01b0\u1edbc n\u00e0y, th\u00ec doanh nghi\u1ec7p m\u1edbi c\u00f3 th\u1ec3 tr\u00e1nh \u0111\u01b0\u1ee3c t\u00ecnh tr\u1ea1ng x\u1eed l\u00fd b\u1ec1 m\u1eb7t, s\u1eeda l\u1ed7i t\u1ea1m th\u1eddi v\u00e0 v\u1ea5n \u0111\u1ec1 v\u1eabn l\u1eb7p l\u1ea1i.<\/p>\n\n\n\n

B\u01b0\u1edbc 3: \u0110\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 quy\u1ebft \u0111\u1ecbnh h\u00e0nh \u0111\u1ed9ng<\/strong><\/p>\n\n\n\n

Sau khi x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5, doanh nghi\u1ec7p c\u1ea7n \u0111\u00e1nh gi\u00e1 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro \u0111\u1ec3 quy\u1ebft \u0111\u1ecbnh h\u01b0\u1edbng x\u1eed l\u00fd h\u1ee3p l\u00fd.<\/p>\n\n\n\n

M\u1ed9t c\u00f4ng c\u1ee5 th\u01b0\u1eddng d\u00f9ng l\u00e0 FMEA (Failure Mode and Effects Analysis – ph\u00e2n t\u00edch d\u1ea1ng l\u1ed7i v\u00e0 t\u00e1c \u0111\u1ed9ng), gi\u00fap \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng x\u1ea3y ra, m\u1ee9c \u0111\u1ed9 \u1ea3nh h\u01b0\u1edfng v\u00e0 kh\u1ea3 n\u0103ng ph\u00e1t hi\u1ec7n l\u1ed7i. K\u1ebft h\u1ee3p v\u1edbi ma tr\u1eadn \u0111\u00e1nh gi\u00e1 r\u1ee7i ro (Risk Assessment Matrix), doanh nghi\u1ec7p c\u00f3 th\u1ec3 bi\u1ebft \u0111\u01b0\u1ee3c l\u00e0 n\u00ean th\u1ef1c hi\u1ec7n h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c, h\u00e0nh \u0111\u1ed9ng ph\u00f2ng ng\u1eeba hay k\u1ebft h\u1ee3p c\u1ea3 hai.<\/p>\n\n\n\n

Ngo\u00e0i ra, \u1edf b\u01b0\u1edbc n\u00e0y c\u0169ng c\u1ea7n c\u00e2n nh\u1eafc \u0111\u1ebfn ngu\u1ed3n l\u1ef1c, th\u1eddi gian tri\u1ec3n khai v\u00e0 t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn c\u00e1c quy tr\u00ecnh kh\u00e1c.<\/p>\n\n\n\n

B\u01b0\u1edbc 4: L\u1eadp k\u1ebf ho\u1ea1ch v\u00e0 tri\u1ec3n khai h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c\/ph\u00f2ng ng\u1eeba<\/strong><\/p>\n\n\n\n

K\u1ebf ho\u1ea1ch CAPA c\u1ea7n \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng chi ti\u1ebft. M\u1ed7i h\u00e0nh \u0111\u1ed9ng ph\u1ea3i c\u00f3 m\u1ee5c ti\u00eau \u0111o l\u01b0\u1eddng \u0111\u01b0\u1ee3c, ng\u01b0\u1eddi ch\u1ecbu tr\u00e1ch nhi\u1ec7m, th\u1eddi h\u1ea1n ho\u00e0n th\u00e0nh v\u00e0 ngu\u1ed3n l\u1ef1c \u0111i k\u00e8m.<\/p>\n\n\n\n

Trong qu\u00e1 tr\u00ecnh tri\u1ec3n khai, doanh nghi\u1ec7p n\u00ean c\u00f3 c\u00f4ng c\u1ee5 theo d\u00f5i ti\u1ebfn \u0111\u1ed9 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o c\u00e1c b\u00ean ph\u1ed1i h\u1ee3p ch\u1eb7t ch\u1ebd, c\u00e1c h\u00e0nh \u0111\u1ed9ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u00fang k\u1ebf ho\u1ea1ch v\u00e0 kh\u00f4ng b\u1ecb b\u1ecf s\u00f3t.<\/p>\n\n\n\n

B\u01b0\u1edbc 5: X\u00e1c minh hi\u1ec7u qu\u1ea3 (ki\u1ec3m tra, audit n\u1ed9i b\u1ed9)<\/strong><\/p>\n\n\n\n

Sau khi ho\u00e0n t\u1ea5t c\u00e1c h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c\/ph\u00f2ng ng\u1eeba, doanh nghi\u1ec7p c\u1ea7n ki\u1ec3m tra xem gi\u1ea3i ph\u00e1p c\u00f3 th\u1ef1c s\u1ef1 hi\u1ec7u qu\u1ea3 hay kh\u00f4ng. Vi\u1ec7c n\u00e0y th\u01b0\u1eddng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n sau m\u1ed9t kho\u1ea3ng th\u1eddi gian nh\u1ea5t \u0111\u1ecbnh \u0111\u1ec3 c\u00f3 \u0111\u1ee7 d\u1eef li\u1ec7u \u0111\u00e1nh gi\u00e1.<\/p>\n\n\n\n

Doanh nghi\u1ec7p s\u1ebd so s\u00e1nh c\u00e1c ch\u1ec9 s\u1ed1 tr\u01b0\u1edbc v\u00e0 sau khi tri\u1ec3n khai CAPA, \u0111\u1ed3ng th\u1eddi c\u00f3 th\u1ec3 th\u1ef1c hi\u1ec7n audit n\u1ed9i b\u1ed9 \u0111\u1ec3 ki\u1ec3m tra m\u1ee9c \u0111\u1ed9 tu\u00e2n th\u1ee7 quy tr\u00ecnh m\u1edbi. N\u1ebfu k\u1ebft qu\u1ea3 ch\u01b0a \u0111\u1ea1t y\u00eau c\u1ea7u, CAPA c\u1ea7n \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh ho\u1eb7c b\u1ed5 sung th\u00eam bi\u1ec7n ph\u00e1p.<\/p>\n\n\n\n

B\u01b0\u1edbc 6: C\u1eadp nh\u1eadt t\u00e0i li\u1ec7u v\u00e0 \u0111\u00e0o t\u1ea1o li\u00ean quan<\/strong><\/p>\n\n\n\n

B\u1ea5t k\u1ef3 thay \u0111\u1ed5i n\u00e0o trong quy tr\u00ecnh c\u0169ng c\u1ea7n \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt v\u00e0o h\u1ec7 th\u1ed1ng t\u00e0i li\u1ec7u nh\u01b0 SOP (Standard Operating Procedures), h\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c v\u00e0 s\u1ed5 tay ch\u1ea5t l\u01b0\u1ee3ng.<\/p>\n\n\n\n

\u0110\u1ed3ng th\u1eddi, doanh nghi\u1ec7p c\u1ea7n t\u1ed5 ch\u1ee9c c\u00e1c bu\u1ed5i \u0111\u00e0o t\u1ea1o \u0111\u1ec3 gi\u00fap nh\u00e2n vi\u00ean hi\u1ec3u v\u00e0 \u00e1p d\u1ee5ng \u0111\u00fang c\u00e1c thay \u0111\u1ed5i. Vi\u1ec7c l\u01b0u tr\u1eef \u0111\u1ea7y \u0111\u1ee7 h\u1ed3 s\u01a1 CAPA l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c \u0111\u1ec3 ph\u1ee5c v\u1ee5 cho c\u00e1c \u0111\u1ee3t audit ISO ho\u1eb7c thanh tra c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd.<\/p>\n\n\n\n

B\u01b0\u1edbc 7: Theo d\u00f5i d\u00e0i h\u1ea1n v\u00e0 \u0111\u00f3ng l\u1ea1i CAPA<\/strong><\/p>\n\n\n\n

B\u01b0\u1edbc cu\u1ed1i c\u00f9ng l\u00e0 theo d\u00f5i CAPA trong d\u00e0i h\u1ea1n \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o v\u1ea5n \u0111\u1ec1 kh\u00f4ng t\u00e1i di\u1ec5n. C\u00e1c KPI (Key Performance Indicators) li\u00ean quan c\u1ea7n \u0111\u01b0\u1ee3c gi\u00e1m s\u00e1t li\u00ean t\u1ee5c trong m\u1ed9t kho\u1ea3ng th\u1eddi gian \u0111\u1ee7 d\u00e0i.<\/p>\n\n\n\n

Ch\u1ec9 khi c\u00f3 b\u1eb1ng ch\u1ee9ng cho th\u1ea5y gi\u1ea3i ph\u00e1p ho\u1ea1t \u0111\u1ed9ng hi\u1ec7u qu\u1ea3 v\u00e0 b\u1ec1n v\u1eefng, th\u00ec CAPA m\u1edbi \u0111\u01b0\u1ee3c \u0111\u00f3ng l\u1ea1i. Cu\u1ed1i c\u00f9ng, doanh nghi\u1ec7p n\u00ean l\u1eadp b\u00e1o c\u00e1o t\u1ed5ng k\u1ebft \u0111\u1ec3 r\u00fat kinh nghi\u1ec7m v\u00e0 c\u1ea3i thi\u1ec7n c\u00e1c CAPA trong t\u01b0\u01a1ng lai.<\/p>\n\n\n\n

\u0110\u1ecdc th\u00eam:<\/strong> Six Sigma l\u00e0 g\u00ec? Ph\u01b0\u01a1ng ph\u00e1p qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng hi\u1ec7u qu\u1ea3<\/a><\/p>\n\n\n\n

4. \u1ee8ng d\u1ee5ng CAPA t\u1ea1i Vi\u1ec7t Nam: S\u1ea3n xu\u1ea5t, d\u01b0\u1ee3c ph\u1ea9m v\u00e0 Cleanroom<\/h2>\n\n\n\n

Trong qu\u00e1 tr\u00ecnh h\u1ed9i nh\u1eadp chu\u1ed7i cung \u1ee9ng to\u00e0n c\u1ea7u, nhi\u1ec1u doanh nghi\u1ec7p Vi\u1ec7t Nam \u0111\u00e3 coi CAPA l\u00e0 m\u1ed9t c\u00f4ng c\u1ee5 qu\u1ea3n l\u00fd ch\u1ee7 \u0111\u1ea1o, kh\u00f4ng ch\u1ec9 \u0111\u1ec3 x\u1eed l\u00fd s\u1ef1 c\u1ed1 m\u00e0 c\u00f2n \u0111\u1ec3 n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf ng\u00e0y c\u00e0ng nghi\u00eam ng\u1eb7t.<\/p>\n\n\n\n

4.1 Ng\u00e0nh s\u1ea3n xu\u1ea5t c\u00f4ng nghi\u1ec7p<\/h3>\n\n\n\n

T\u1ea1i c\u00e1c khu c\u00f4ng nghi\u1ec7p tr\u1ecdng \u0111i\u1ec3m t\u1ea1i \u0110\u1ed3ng Nai, B\u00ecnh D\u01b0\u01a1ng hay H\u1ea3i Ph\u00f2ng, CAPA \u0111\u01b0\u1ee3c t\u00edch h\u1ee3p tr\u1ef1c ti\u1ebfp v\u00e0o h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd s\u1ea3n xu\u1ea5t c\u1ee7a nhi\u1ec1u nh\u00e0 m\u00e1y. C\u00e1c t\u1eadp \u0111o\u00e0n l\u1eafp r\u00e1p \u0111i\u1ec7n t\u1eed l\u1edbn nh\u01b0 Samsung hay Foxconn th\u01b0\u1eddng k\u1ebft h\u1ee3p CAPA v\u1edbi ERP (h\u1ec7 th\u1ed1ng ho\u1ea1ch \u0111\u1ecbnh ngu\u1ed3n l\u1ef1c doanh nghi\u1ec7p) v\u00e0 MES (h\u1ec7 th\u1ed1ng \u0111i\u1ec1u h\u00e0nh s\u1ea3n xu\u1ea5t) \u0111\u1ec3 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng theo th\u1eddi gian th\u1ef1c.<\/p>\n\n\n\n

Ti\u00eau bi\u1ec3u, m\u1ed9t nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t linh ki\u1ec7n \u0111i\u1ec7n t\u1eed t\u1ea1i B\u1eafc Ninh sau khi tri\u1ec3n khai CAPA \u0111\u00e3 th\u1ea5y t\u1ef7 l\u1ec7 l\u1ed7i s\u1ea3n ph\u1ea9m gi\u1ea3m t\u1eeb 2,8% xu\u1ed1ng c\u00f2n 0,6% ch\u1ec9 trong v\u00f2ng 12 th\u00e1ng. T\u1eeb vi\u1ec7c ph\u00e2n t\u00edch d\u1eef li\u1ec7u s\u1ea3n xu\u1ea5t h\u00e0ng ng\u00e0y, nh\u00e0 m\u00e1y ph\u00e1t hi\u1ec7n \u0111\u1ed9 \u1ea9m m\u00f4i tr\u01b0\u1eddng c\u00f3 li\u00ean quan \u0111\u1ebfn l\u1ed7i h\u00e0n linh ki\u1ec7n. Bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c l\u00e0 c\u1ea3i thi\u1ec7n h\u1ec7 th\u1ed1ng \u0111i\u1ec1u h\u00f2a kh\u00f4ng kh\u00ed v\u00e0 t\u0103ng c\u01b0\u1eddng quy tr\u00ecnh ki\u1ec3m tra m\u00f4i tr\u01b0\u1eddng \u0111\u1ecbnh k\u1ef3, \u0111\u1ec3 l\u1ed7i kh\u00f4ng t\u00e1i di\u1ec5n.<\/p>\n\n\n\n

Trong ng\u00e0nh d\u1ec7t may, CAPA c\u0169ng \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng \u0111\u1ec3 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u ch\u1ea5t l\u01b0\u1ee3ng t\u1eeb c\u00e1c th\u01b0\u01a1ng hi\u1ec7u qu\u1ed1c t\u1ebf. M\u1ed9t s\u1ed1 doanh nghi\u1ec7p l\u1edbn nh\u01b0 Vinatex \u0111\u00e3 x\u00e2y d\u1ef1ng h\u1ec7 th\u1ed1ng CAPA t\u1ed5ng h\u1ee3p, cho ph\u00e9p c\u00e1c nh\u00e0 m\u00e1y th\u00e0nh vi\u00ean chia s\u1ebb nguy\u00ean nh\u00e2n v\u00e0 c\u00e1ch x\u1eed l\u00fd c\u00e1c l\u1ed7i th\u01b0\u1eddng g\u1eb7p nh\u01b0 nhu\u1ed9m m\u00e0u kh\u00f4ng \u0111\u1ec1u, co r\u00fat v\u1ea3i hay l\u1ed7i \u0111\u01b0\u1eddng may.<\/p>\n\n\n\n

4.2 Ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m v\u00e0 ti\u00eau chu\u1ea9n GMP<\/h3>\n\n\n\n

Ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m l\u00e0 l\u0129nh v\u1ef1c \u00e1p d\u1ee5ng CAPA r\u1ea5t ch\u1eb7t ch\u1ebd do ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t t\u1eeb C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c Vi\u1ec7t Nam v\u00e0 c\u00e1c c\u01a1 quan qu\u1ed1c t\u1ebf nh\u01b0 FDA (C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3).<\/p>\n\n\n\n

M\u1ed9t tr\u01b0\u1eddng h\u1ee3p \u0111i\u1ec3n h\u00ecnh l\u00e0 x\u1eed l\u00fd s\u1ef1 c\u1ed1 OOS (Out of Specification – k\u1ebft qu\u1ea3 ngo\u00e0i gi\u1edbi h\u1ea1n ti\u00eau chu\u1ea9n) t\u1ea1i m\u1ed9t nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t kh\u00e1ng sinh. Khi ph\u00e1t hi\u1ec7n m\u1ed9t l\u00f4 s\u1ea3n ph\u1ea9m c\u00f3 \u0111\u1ed9 tinh khi\u1ebft th\u1ea5p h\u01a1n y\u00eau c\u1ea7u, quy tr\u00ecnh CAPA \u0111\u01b0\u1ee3c k\u00edch ho\u1ea1t ngay. Qu\u00e1 tr\u00ecnh ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 k\u00e9o d\u00e0i 15 ng\u00e0y, v\u1edbi s\u1ef1 tham gia c\u1ee7a nhi\u1ec1u b\u1ed9 ph\u1eadn, v\u00e0 nguy\u00ean nh\u00e2n \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u00e0 do h\u1ec7 th\u1ed1ng l\u1ecdc kh\u00f4ng kh\u00ed trong khu v\u1ef1c s\u1ea3n xu\u1ea5t b\u1ecb t\u1eafc m\u1ed9t ph\u1ea7n.<\/p>\n\n\n\n

Bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c l\u00e0 thay m\u1edbi to\u00e0n b\u1ed9 b\u1ed9 l\u1ecdc v\u00e0 thi\u1ebft l\u1eadp quy tr\u00ecnh ki\u1ec3m tra \u00e1p su\u1ea5t vi sai h\u00e0ng ng\u00e0y. \u0110\u1ed3ng th\u1eddi, h\u00e0nh \u0111\u1ed9ng ph\u00f2ng ng\u1eeba \u0111\u01b0\u1ee3c tri\u1ec3n khai bao g\u1ed3m: \u0111\u00e0o t\u1ea1o l\u1ea1i nh\u00e2n vi\u00ean v\u1ec1 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng, l\u1eafp \u0111\u1eb7t h\u1ec7 th\u1ed1ng c\u1ea3nh b\u00e1o t\u1ef1 \u0111\u1ed9ng khi \u00e1p su\u1ea5t kh\u00f4ng kh\u00ed xu\u1ed1ng d\u01b0\u1edbi ng\u01b0\u1ee1ng an to\u00e0n.<\/p>\n\n\n\n

4.3 Ng\u00e0nh Cleanroom v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf<\/h3>\n\n\n\n

C\u00f9ng v\u1edbi s\u1ef1 ph\u00e1t tri\u1ec3n c\u1ee7a ng\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf, nhi\u1ec1u doanh nghi\u1ec7p Vi\u1ec7t Nam \u0111\u00e3 \u0111\u1ea7u t\u01b0 m\u1ea1nh v\u00e0o Cleanroom (ph\u00f2ng s\u1ea1ch) \u0111\u1ec3 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u s\u1ea3n xu\u1ea5t v\u00f4 tr\u00f9ng. Trong m\u00f4i tr\u01b0\u1eddng n\u00e0y, CAPA gi\u1eef vai tr\u00f2 then ch\u1ed1t trong vi\u1ec7c ki\u1ec3m so\u00e1t \u00f4 nhi\u1ec5m v\u00e0 duy tr\u00ec ti\u00eau chu\u1ea9n v\u1eadn h\u00e0nh.<\/p>\n\n\n\n

T\u1ea1i Khu c\u00f4ng ngh\u1ec7 cao TP.HCM, m\u1ed9t s\u1ed1 doanh nghi\u1ec7p \u0111\u00e3 x\u00e2y d\u1ef1ng Cleanroom \u0111\u1ea1t chu\u1ea9n ISO 14644 (ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 ph\u00f2ng s\u1ea1ch) v\u00e0 s\u1eed d\u1ee5ng CAPA \u0111\u1ec3 x\u1eed l\u00fd c\u00e1c s\u1ef1 c\u1ed1 nh\u01b0 v\u01b0\u1ee3t ng\u01b0\u1ee1ng h\u1ea1t b\u1ee5i ho\u1eb7c nhi\u1ec5m vi sinh.<\/p>\n\n\n\n

M\u1ed9t v\u00ed d\u1ee5 c\u1ee5 th\u1ec3 l\u00e0 m\u1ed9t c\u00f4ng ty s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf d\u00f9ng m\u1ed9t l\u1ea7n. Khi ghi nh\u1eadn s\u1ed1 l\u01b0\u1ee3ng vi khu\u1ea9n trong m\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t t\u0103ng b\u1ea5t th\u01b0\u1eddng, c\u00f4ng ty n\u00e0y \u0111\u00e3 ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra nguy\u00ean nh\u00e2n trong 3 tu\u1ea7n. K\u1ebft qu\u1ea3 cho th\u1ea5y nguy\u00ean nh\u00e2n xu\u1ea5t ph\u00e1t t\u1eeb vi\u1ec7c thay \u0111\u1ed5i nh\u00e0 cung \u1ee9ng h\u00f3a ch\u1ea5t t\u1ea9y r\u1eeda m\u00e0 ch\u01b0a th\u1ef1c hi\u1ec7n validation (x\u00e1c nh\u1eadn t\u00ednh ph\u00f9 h\u1ee3p) \u0111\u1ea7y \u0111\u1ee7.<\/p>\n\n\n\n

Gi\u1ea3i ph\u00e1p tr\u01b0\u1edbc m\u1eaft l\u00e0 quay l\u1ea1i h\u1ee3p t\u00e1c v\u1edbi nh\u00e0 cung \u1ee9ng c\u0169 \u0111\u1ec3 \u1ed5n \u0111\u1ecbnh s\u1ea3n xu\u1ea5t. V\u1ec1 l\u00e2u d\u00e0i, doanh nghi\u1ec7p thi\u1ebft l\u1eadp quy tr\u00ecnh validation nghi\u00eam ng\u1eb7t cho m\u1ecdi thay \u0111\u1ed5i li\u00ean quan \u0111\u1ebfn v\u1eadt t\u01b0, h\u00f3a ch\u1ea5t ho\u1eb7c nh\u00e0 cung \u1ee9ng.<\/p>\n\n\n

\n
\"\u1ee8ng
\u1ee8ng d\u1ee5ng CAPA t\u1ea1i Vi\u1ec7t Nam: S\u1ea3n xu\u1ea5t, d\u01b0\u1ee3c ph\u1ea9m v\u00e0 Cleanroom<\/em><\/figcaption><\/figure><\/div>\n\n\n

5. L\u1ee3i \u00edch, v\u00ed d\u1ee5 th\u1ef1c t\u1ebf v\u00e0 c\u00f4ng c\u1ee5 h\u1ed7 tr\u1ee3 tri\u1ec3n khai CAPA<\/h2>\n\n\n\n

Vi\u1ec7c tri\u1ec3n khai CAPA \u0111\u00fang c\u00e1ch mang l\u1ea1i nh\u1eefng l\u1ee3i \u00edch thi\u1ebft th\u1ef1c v\u00e0 c\u00f3 th\u1ec3 \u0111o l\u01b0\u1eddng \u0111\u01b0\u1ee3c, \u0111i\u1ec1u n\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh qua nhi\u1ec1u nghi\u00ean c\u1ee9u v\u00e0 nh\u1eefng tr\u01b0\u1eddng h\u1ee3p th\u1ef1c t\u1ebf t\u1ea1i c\u00e1c doanh nghi\u1ec7p.<\/p>\n\n\n\n

5.1 L\u1ee3i \u00edch kinh t\u1ebf tr\u1ef1c ti\u1ebfp<\/h3>\n\n\n\n

C\u00e1c doanh nghi\u1ec7p tri\u1ec3n khai CAPA \u0111\u00fang h\u01b0\u1edbng c\u00f3 th\u1ec3 gi\u1ea3m \u0111\u00e1ng k\u1ec3 c\u00e1c l\u1ed7i l\u1eb7p l\u1ea1i. \u0110i\u1ec1u n\u00e0y \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng v\u00ec chi ph\u00ed x\u1eed l\u00fd m\u1ed9t l\u1ed7i ch\u1ea5t l\u01b0\u1ee3ng th\u01b0\u1eddng cao g\u1ea5p nhi\u1ec1u l\u1ea7n so v\u1edbi chi ph\u00ed ph\u00f2ng ng\u1eeba ngay t\u1eeb \u0111\u1ea7u.<\/p>\n\n\n\n

B\u00ean c\u1ea1nh \u0111\u00f3, th\u1eddi gian trung b\u00ecnh x\u1eed l\u00fd khi\u1ebfu n\u1ea1i c\u1ee7a kh\u00e1ch h\u00e0ng c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c r\u00fat ng\u1eafn, t\u1eeb \u0111\u00f3 n\u00e2ng cao m\u1ee9c \u0111\u1ed9 h\u00e0i l\u00f2ng v\u00e0 t\u0103ng kh\u1ea3 n\u0103ng duy tr\u00ec m\u1ed1i quan h\u1ec7 l\u00e2u d\u00e0i v\u1edbi kh\u00e1ch h\u00e0ng.<\/p>\n\n\n\n

CAPA c\u0169ng gi\u00fap doanh nghi\u1ec7p t\u1ed1i \u01b0u chi ph\u00ed v\u1eadn h\u00e0nh b\u1eb1ng c\u00e1ch gi\u1ea3m l\u00e3ng ph\u00ed nguy\u00ean v\u1eadt li\u1ec7u, h\u1ea1n ch\u1ebf s\u1ea3n xu\u1ea5t l\u1ea1i v\u00e0 gi\u1ea3m chi ph\u00ed b\u1ea3o h\u00e0nh.<\/p>\n\n\n\n

5.2 V\u00ed d\u1ee5 th\u1ef1c t\u1ebf: T\u1eeb kh\u1ee7ng ho\u1ea3ng \u0111\u1ebfn th\u00e0nh c\u00f4ng<\/h3>\n\n\n\n

M\u1ed9t tr\u01b0\u1eddng h\u1ee3p \u0111i\u1ec3n h\u00ecnh l\u00e0 c\u00f4ng ty d\u01b0\u1ee3c ph\u1ea9m ABC (t\u00ean \u0111\u00e3 \u0111\u01b0\u1ee3c thay \u0111\u1ed5i), chuy\u00ean s\u1ea3n xu\u1ea5t thu\u1ed1c gi\u1ea3m \u0111au. N\u0103m 2023, doanh nghi\u1ec7p n\u00e0y g\u1eb7p kh\u1ee7ng ho\u1ea3ng khi FDA ph\u00e1t hi\u1ec7n 3 l\u00f4 thu\u1ed1c xu\u1ea5t kh\u1ea9u c\u00f3 h\u00e0m l\u01b0\u1ee3ng t\u1ea1p ch\u1ea5t v\u01b0\u1ee3t ti\u00eau chu\u1ea9n.<\/p>\n\n\n\n

Thay v\u00ec ch\u1ec9 thu h\u1ed3i s\u1ea3n ph\u1ea9m, c\u00f4ng ty tri\u1ec3n khai quy tr\u00ecnh CAPA to\u00e0n di\u1ec7n. Giai \u0111o\u1ea1n ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 k\u00e9o d\u00e0i 6 tu\u1ea7n, v\u1edbi s\u1ef1 tham gia c\u1ee7a chuy\u00ean gia qu\u1ed1c t\u1ebf. Nguy\u00ean nh\u00e2n c\u1ee7a s\u1ef1 c\u1ed1 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u00e0 do quy tr\u00ecnh l\u00e0m s\u1ea1ch thi\u1ebft b\u1ecb gi\u1eefa c\u00e1c batch (m\u1ebb s\u1ea3n xu\u1ea5t) ch\u01b0a \u0111\u01b0\u1ee3c \u0111\u1ea3m b\u1ea3o, g\u00e2y \u00f4 nhi\u1ec5m ch\u00e9o.<\/p>\n\n\n\n

H\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c bao g\u1ed3m thi\u1ebft k\u1ebf l\u1ea1i quy tr\u00ecnh CIP (Clean-in-Place – l\u00e0m s\u1ea1ch t\u1ef1 \u0111\u1ed9ng t\u1ea1i ch\u1ed7), n\u00e2ng c\u1ea5p h\u1ec7 th\u1ed1ng gi\u00e1m s\u00e1t t\u1ef1 \u0111\u1ed9ng v\u00e0 thay th\u1ebf m\u1ed9t s\u1ed1 thi\u1ebft b\u1ecb c\u0169. Song song \u0111\u00f3, c\u00e1c h\u00e0nh \u0111\u1ed9ng ph\u00f2ng ng\u1eeba \u0111\u01b0\u1ee3c tri\u1ec3n khai nh\u01b0 l\u1eafp c\u1ea3m bi\u1ebfn IoT (Internet v\u1ea1n v\u1eadt) \u0111\u1ec3 c\u1ea3nh b\u00e1o s\u1edbm, \u0111\u00e0o t\u1ea1o l\u1ea1i nh\u00e2n vi\u00ean v\u1eadn h\u00e0nh v\u00e0 \u00e1p d\u1ee5ng quy tr\u00ecnh validation ch\u1eb7t ch\u1ebd cho m\u1ecdi thay \u0111\u1ed5i trong s\u1ea3n xu\u1ea5t.<\/p>\n\n\n\n

Sau 12 th\u00e1ng, k\u1ebft qu\u1ea3 r\u1ea5t t\u00edch c\u1ef1c: kh\u00f4ng ph\u00e1t sinh l\u1ed7i trong 15 l\u00f4 s\u1ea3n ph\u1ea9m li\u00ean ti\u1ebfp, th\u1eddi gian s\u1ea3n xu\u1ea5t m\u1ed7i batch gi\u1ea3m 15%, v\u00e0 quan tr\u1ecdng nh\u1ea5t l\u00e0 c\u00f4ng ty l\u1ea5y l\u1ea1i \u0111\u01b0\u1ee3c s\u1ef1 tin t\u01b0\u1edfng t\u1eeb FDA c\u00f9ng c\u00e1c \u0111\u1ed1i t\u00e1c qu\u1ed1c t\u1ebf.<\/p>\n\n\n\n

5.3 C\u00f4ng c\u1ee5 h\u1ed7 tr\u1ee3 tri\u1ec3n khai CAPA<\/h3>\n\n\n\n

C\u00f4ng ngh\u1ec7 s\u1ed1 4.0 \u0111\u00e3 gi\u00fap vi\u1ec7c tri\u1ec3n khai CAPA tr\u1edf n\u00ean d\u1ec5 d\u00e0ng h\u01a1n bao gi\u1edd h\u1ebft. Tr\u00ean th\u1ebf gi\u1edbi, nhi\u1ec1u doanh nghi\u1ec7p l\u1edbn s\u1eed d\u1ee5ng c\u00e1c ph\u1ea7n m\u1ec1m QMS (h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng) nh\u01b0 MasterControl, Veeva Vault QMS hay TrackWise. Tuy nhi\u00ean, c\u00e1c gi\u1ea3i ph\u00e1p n\u00e0y th\u01b0\u1eddng c\u00f3 chi ph\u00ed cao v\u00e0 kh\u00e1 ph\u1ee9c t\u1ea1p \u0111\u1ed1i v\u1edbi c\u00e1c doanh nghi\u1ec7p v\u1eeba v\u00e0 nh\u1ecf t\u1ea1i Vi\u1ec7t Nam.<\/p>\n\n\n\n

V\u00ec v\u1eady, nhi\u1ec1u doanh nghi\u1ec7p trong n\u01b0\u1edbc l\u1ef1a ch\u1ecdn c\u00e1c n\u1ec1n t\u1ea3ng qu\u1ea3n tr\u1ecb t\u00edch h\u1ee3p nh\u01b0 Base.vn<\/a>. Base.vn cung c\u1ea5p module CAPA v\u1edbi giao di\u1ec7n ti\u1ebfng Vi\u1ec7t, d\u1ec5 s\u1eed d\u1ee5ng, chi ph\u00ed h\u1ee3p l\u00fd v\u00e0 c\u00f3 th\u1ec3 t\u00f9y ch\u1ec9nh theo t\u1eebng ng\u00e0nh. H\u1ec7 th\u1ed1ng c\u00f2n h\u1ed7 tr\u1ee3 ph\u00e2n t\u00edch d\u1eef li\u1ec7u, nh\u1eadn di\u1ec7n xu h\u01b0\u1edbng v\u00e0 \u0111\u1ec1 xu\u1ea5t bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba r\u1ee7i ro d\u1ef1a tr\u00ean d\u1eef li\u1ec7u th\u1ef1c t\u1ebf.<\/p>\n\n\n\n

V\u1edbi nh\u1eefng doanh nghi\u1ec7p m\u1edbi b\u1eaft \u0111\u1ea7u, vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c m\u1eabu Excel chu\u1ea9n \u0111\u1ec3 qu\u1ea3n l\u00fd CAPA v\u1eabn c\u00f3 th\u1ec3 ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c. Tuy nhi\u00ean, khi s\u1ed1 l\u01b0\u1ee3ng CAPA t\u0103ng l\u00ean, vi\u1ec7c chuy\u1ec3n sang h\u1ec7 th\u1ed1ng s\u1ed1 h\u00f3a l\u00e0 c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u00ednh minh b\u1ea1ch, d\u1ec5 theo d\u00f5i v\u00e0 thu\u1eadn ti\u1ec7n khi audit.<\/p>\n\n\n\n

Trong t\u01b0\u01a1ng lai, CAPA s\u1ebd ti\u1ebfp t\u1ee5c ph\u00e1t tri\u1ec3n theo h\u01b0\u1edbng t\u00edch h\u1ee3p s\u00e2u v\u1edbi IoT, Machine Learning (h\u1ecdc m\u00e1y) v\u00e0 Predictive Analytics (ph\u00e2n t\u00edch d\u1ef1 \u0111o\u00e1n). Khi \u0111\u00f3, CAPA kh\u00f4ng nh\u1eefng x\u1eed l\u00fd s\u1ef1 c\u1ed1 \u0111\u00e3 x\u1ea3y ra m\u00e0 c\u00f2n gi\u00fap doanh nghi\u1ec7p ch\u1ee7 \u0111\u1ed9ng ph\u00e1t hi\u1ec7n v\u00e0 ng\u0103n ng\u1eeba r\u1ee7i ro t\u1eeb r\u1ea5t s\u1edbm.<\/p>\n\n\n

\n
\"L\u1ee3i
L\u1ee3i \u00edch, v\u00ed d\u1ee5 th\u1ef1c t\u1ebf v\u00e0 c\u00f4ng c\u1ee5 h\u1ed7 tr\u1ee3 tri\u1ec3n khai CAPA<\/em><\/figcaption><\/figure><\/div>\n\n\n

6. C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p (FAQ) v\u1ec1 CAPA<\/h2>\n\n\n\n

6.1 C\u00f3 b\u1eaft bu\u1ed9c ph\u1ea3i \u00e1p d\u1ee5ng CAPA kh\u00f4ng?<\/h3>\n\n\n\n

Theo quy \u0111\u1ecbnh c\u1ee7a ISO 9001:2015, c\u00e1c t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn b\u1eaft bu\u1ed9c ph\u1ea3i c\u00f3 c\u01a1 ch\u1ebf x\u1eed l\u00fd h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba. V\u1edbi nh\u1eefng ng\u00e0nh \u0111\u1eb7c th\u00f9 nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf hay th\u1ef1c ph\u1ea9m, CAPA l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c t\u1eeb c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd nh\u01b0 FDA, EMA v\u00e0 C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c Vi\u1ec7t Nam. Ngay c\u1ea3 khi kh\u00f4ng b\u1ecb b\u1eaft bu\u1ed9c theo quy \u0111\u1ecbnh ph\u00e1p l\u00fd, CAPA v\u1eabn mang l\u1ea1i l\u1ee3i \u00edch r\u00f5 r\u1ec7t v\u1ec1 m\u1eb7t chi ph\u00ed, ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 uy t\u00edn th\u01b0\u01a1ng hi\u1ec7u.<\/p>\n\n\n\n

6.2 Doanh nghi\u1ec7p nh\u1ecf c\u00f3 n\u00ean tri\u1ec3n khai CAPA kh\u00f4ng?<\/h3>\n\n\n\n

Doanh nghi\u1ec7p nh\u1ecf ho\u00e0n to\u00e0n c\u00f3 th\u1ec3, v\u00e0 n\u00ean tri\u1ec3n khai CAPA. Tuy nhi\u00ean, c\u00e1ch l\u00e0m c\u1ea7n \u0111\u01a1n gi\u1ea3n v\u00e0 ph\u00f9 h\u1ee3p v\u1edbi ngu\u1ed3n l\u1ef1c s\u1eb5n c\u00f3. Doanh nghi\u1ec7p c\u00f3 th\u1ec3 b\u1eaft \u0111\u1ea7u b\u1eb1ng c\u00e1c SOP (quy tr\u00ecnh thao t\u00e1c chu\u1ea9n) \u0111\u01a1n gi\u1ea3n \u0111\u1ec3 ghi nh\u1eadn s\u1ef1 c\u1ed1 v\u00e0 khi\u1ebfu n\u1ea1i t\u1eeb kh\u00e1ch h\u00e0ng. Sau \u0111\u00f3, t\u1eebng b\u01b0\u1edbc b\u1ed5 sung c\u00e1c ho\u1ea1t \u0111\u1ed9ng nh\u01b0 ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 v\u00e0 theo d\u00f5i hi\u1ec7u qu\u1ea3 h\u00e0nh \u0111\u1ed9ng. Vi\u1ec7c \u0111\u00e0o t\u1ea1o nh\u00e2n vi\u00ean v\u1ec1 t\u01b0 duy t\u00ecm nguy\u00ean nh\u00e2n c\u1ed1t l\u00f5i th\u01b0\u1eddng mang l\u1ea1i hi\u1ec7u qu\u1ea3 nhanh, chi ph\u00ed th\u1ea5p v\u00e0 gi\u00fap gi\u1ea3m \u0111\u00e1ng k\u1ec3 l\u1ed7i l\u1eb7p l\u1ea1i.<\/p>\n\n\n\n

6.3 CAPA kh\u00e1c g\u00ec v\u1edbi Deviation v\u00e0 OOS?<\/h3>\n\n\n\n

Deviation (sai l\u1ec7ch) v\u00e0 OOS (k\u1ebft qu\u1ea3 v\u01b0\u1ee3t ngo\u00e0i gi\u1edbi h\u1ea1n ti\u00eau chu\u1ea9n) l\u00e0 c\u00e1c s\u1ef1 c\u1ed1 ho\u1eb7c s\u1ef1 ki\u1ec7n c\u1ee5 th\u1ec3 ph\u00e1t sinh trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t ho\u1eb7c ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng. Trong khi \u0111\u00f3, CAPA l\u00e0 m\u1ed9t quy tr\u00ecnh qu\u1ea3n l\u00fd mang t\u00ednh h\u1ec7 th\u1ed1ng \u0111\u1ec3 x\u1eed l\u00fd c\u00e1c s\u1ef1 c\u1ed1 \u0111\u00f3.<\/p>\n\n\n\n

M\u1ed9t deviation c\u00f3 th\u1ec3 kh\u00f4ng c\u1ea7n CAPA n\u1ebfu ch\u1ec9 x\u1ea3y ra m\u1ed9t l\u1ea7n v\u00e0 kh\u00f4ng nghi\u00eam tr\u1ecdng. Tuy nhi\u00ean, n\u1ebfu s\u1ef1 c\u1ed1 c\u00f3 nguy c\u01a1 t\u00e1i di\u1ec5n ho\u1eb7c t\u00e1c \u0111\u1ed9ng l\u1edbn \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng, n\u00f3 s\u1ebd k\u00edch ho\u1ea1t m\u1ed9t CAPA. T\u01b0\u01a1ng t\u1ef1, m\u1ed9t tr\u01b0\u1eddng h\u1ee3p OOS sau khi \u0111i\u1ec1u tra nguy\u00ean nh\u00e2n th\u01b0\u1eddng s\u1ebd d\u1eabn \u0111\u1ebfn CAPA nh\u1eb1m ng\u0103n ch\u1eb7n s\u1ef1 c\u1ed1 t\u01b0\u01a1ng t\u1ef1 trong t\u01b0\u01a1ng lai.<\/p>\n\n\n\n

6.4 L\u00e0m sao \u0111\u1ec3 b\u1eaft \u0111\u1ea7u tri\u1ec3n khai CAPA hi\u1ec7u qu\u1ea3?<\/h3>\n\n\n\n

B\u01b0\u1edbc quan tr\u1ecdng nh\u1ea5t l\u00e0 x\u00e2y d\u1ef1ng v\u0103n h\u00f3a xem tr\u1ecdng ch\u1ea5t l\u01b0\u1ee3ng, n\u01a1i nh\u00e2n vi\u00ean hi\u1ec3u r\u1eb1ng b\u00e1o c\u00e1o v\u1ea5n \u0111\u1ec1 l\u00e0 \u0111\u1ec3 c\u1ea3i ti\u1ebfn, kh\u00f4ng ph\u1ea3i \u0111\u1ec3 quy tr\u00e1ch nhi\u1ec7m. Khi con ng\u01b0\u1eddi s\u1eb5n s\u00e0ng chia s\u1ebb s\u1ef1 c\u1ed1, CAPA m\u1edbi th\u1ef1c s\u1ef1 ph\u00e1t huy t\u00e1c d\u1ee5ng. Ti\u1ebfp theo, doanh nghi\u1ec7p n\u00ean \u0111\u00e0o t\u1ea1o \u0111\u1ed9i ng\u0169 c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 b\u1eb1ng 5 Whys v\u00e0 Fishbone Diagram. Cu\u1ed1i c\u00f9ng, c\u1ea7n l\u1ef1a ch\u1ecdn c\u00f4ng c\u1ee5 tri\u1ec3n khai CAPA ph\u00f9 h\u1ee3p, c\u00f3 th\u1ec3 l\u00e0 file Excel \u0111\u01a1n gi\u1ea3n ho\u1eb7c ph\u1ea7n m\u1ec1m qu\u1ea3n l\u00fd chuy\u00ean d\u1ee5ng.<\/p>\n\n\n\n

6.5 C\u00f3 nh\u1eefng t\u00e0i li\u1ec7u ch\u00ednh th\u1ed1ng n\u00e0o v\u1ec1 CAPA?<\/h3>\n\n\n\n

M\u1ed9t s\u1ed1 ngu\u1ed3n tham kh\u1ea3o uy t\u00edn bao g\u1ed3m: FDA Guidance for Industry \u201cQuality Systems Approach to Pharmaceutical CGMP Regulations\u201d, ti\u00eau chu\u1ea9n ISO 9001:2015 v\u00e0 ICH Q10 (Pharmaceutical Quality System). T\u1ea1i Vi\u1ec7t Nam, c\u00e1c h\u01b0\u1edbng d\u1eabn v\u1ec1 GMP (Good Manufacturing Practice)<\/a> v\u00e0 y\u00eau c\u1ea7u li\u00ean quan \u0111\u1ebfn CAPA do C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c ban h\u00e0nh l\u00e0 t\u00e0i li\u1ec7u tham kh\u1ea3o c\u00f3 gi\u00e1 tr\u1ecb cho c\u00e1c doanh nghi\u1ec7p trong ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n\n\n\n

7. Base Work+ \u2013 Gi\u1ea3i ph\u00e1p s\u1ed1 h\u00f3a quy tr\u00ecnh CAPA hi\u1ec7u qu\u1ea3 cho doanh nghi\u1ec7p Vi\u1ec7t<\/h2>\n\n\n\n

Tri\u1ec3n khai CAPA (Corrective and Preventive Action) \u0111\u00f2i h\u1ecfi s\u1ef1 ph\u1ed1i h\u1ee3p li\u1ec1n m\u1ea1ch gi\u1eefa con ng\u01b0\u1eddi, quy tr\u00ecnh v\u00e0 d\u1eef li\u1ec7u. N\u1ebfu qu\u1ea3n l\u00fd CAPA b\u1eb1ng Excel, email r\u1eddi r\u1ea1c hay gi\u1ea5y t\u1edd th\u1ee7 c\u00f4ng, doanh nghi\u1ec7p r\u1ea5t d\u1ec5 g\u1eb7p t\u00ecnh tr\u1ea1ng ch\u1eadm ti\u1ebfn \u0111\u1ed9, thi\u1ebfu truy v\u1ebft, kh\u00f3 ch\u1ee9ng minh tu\u00e2n th\u1ee7 khi audit ISO ho\u1eb7c FDA.<\/p>\n\n\n\n

Base Work+ – B\u1ed9 gi\u1ea3i ph\u00e1p qu\u1ea3n tr\u1ecb c\u00f4ng vi\u1ec7c<\/a>, quy tr\u00ecnh v\u00e0 d\u1ef1 \u00e1n do Base.vn ph\u00e1t tri\u1ec3n \u2013 \u0111\u00f3ng vai tr\u00f2 nh\u01b0 m\u1ed9t tr\u1ee5c v\u1eadn h\u00e0nh s\u1ed1, gi\u00fap doanh nghi\u1ec7p qu\u1ea3n l\u00fd to\u00e0n b\u1ed9 v\u00f2ng \u0111\u1eddi CAPA m\u1ed9t c\u00e1ch minh b\u1ea1ch v\u1edbi chi ph\u00ed ph\u00f9 h\u1ee3p cho doanh nghi\u1ec7p Vi\u1ec7t.<\/p>\n\n\n\n

1. Qu\u1ea3n l\u00fd CAPA theo t\u1eebng \u0111\u1ea7u vi\u1ec7c, r\u00f5 ng\u01b0\u1eddi – r\u00f5 deadline – r\u00f5 ti\u1ebfn \u0111\u1ed9<\/strong><\/p>\n\n\n\n

M\u1ed7i CAPA c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp nh\u01b0 m\u1ed9t d\u1ef1 \u00e1n ho\u1eb7c chu\u1ed7i c\u00f4ng vi\u1ec7c tr\u00ean Base Work+:<\/p>\n\n\n\n

– Ghi nh\u1eadn s\u1ef1 c\u1ed1, deviation ho\u1eb7c OOS.<\/p>\n\n\n\n

– Th\u1ef1c hi\u1ec7n RCA (ph\u00e2n t\u00edch nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5).<\/p>\n\n\n\n

– L\u1eadp k\u1ebf ho\u1ea1ch Corrective Action v\u00e0 Preventive Action.<\/p>\n\n\n\n

– Theo d\u00f5i ti\u1ebfn \u0111\u1ed9 tri\u1ec3n khai CAPA theo th\u1eddi gian th\u1ef1c qua c\u00e1c ch\u1ebf \u0111\u1ed9 Gantt, Kanban, b\u1ea3ng danh s\u00e1ch ho\u1eb7c l\u1ecbch bi\u1ec3u.<\/p>\n\n\n\n

– Truy xu\u1ea5t b\u00e1o c\u00e1o, x\u00e1c minh hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u00f3ng CAPA.<\/p>\n\n\n\n

2. Chu\u1ea9n h\u00f3a v\u00e0 t\u1ef1 \u0111\u1ed9ng h\u00f3a quy tr\u00ecnh CAPA li\u00ean ph\u00f2ng ban<\/strong><\/p>\n\n\n\n

Base Work+ cho ph\u00e9p doanh nghi\u1ec7p x\u00e2y d\u1ef1ng lu\u1ed3ng quy tr\u00ecnh CAPA chu\u1ea9n tr\u00ean to\u00e0n b\u1ed9 t\u1ed5 ch\u1ee9c:<\/p>\n\n\n\n

– T\u1ef1 \u0111\u1ed9ng chuy\u1ec3n b\u01b0\u1edbc t\u1eeb ghi nh\u1eadn, \u0111i\u1ec1u tra, ph\u00ea duy\u1ec7t \u0111\u1ebfn tri\u1ec3n khai v\u00e0 \u0111\u00e1nh gi\u00e1.<\/p>\n\n\n\n

– Li\u00ean k\u1ebft d\u1eef li\u1ec7u gi\u1eefa c\u00e1c b\u1ed9 ph\u1eadn QA, S\u1ea3n xu\u1ea5t, B\u1ea3o tr\u00ec, Kho, Nh\u00e2n s\u1ef1.<\/p>\n\n\n\n

– Gi\u1ea3m ph\u1ee5 thu\u1ed9c v\u00e0o trao \u0111\u1ed5i th\u1ee7 c\u00f4ng v\u00e0 h\u1ea1n ch\u1ebf b\u1ecf s\u00f3t th\u00f4ng tin.<\/p>\n\n\n\n

3. \u0110\u1ec1 xu\u1ea5t & ph\u00ea duy\u1ec7t CAPA nhanh ch\u00f3ng, r\u00f5 r\u00e0ng:<\/strong><\/p>\n\n\n\n

C\u00e1c h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba th\u01b0\u1eddng c\u1ea7n ph\u00ea duy\u1ec7t t\u1eeb nhi\u1ec1u c\u1ea5p. Base Work+ gi\u00fap:<\/p>\n\n\n\n

– S\u1ed1 h\u00f3a ho\u00e0n to\u00e0n \u0111\u1ec1 xu\u1ea5t CAPA, k\u1ebf ho\u1ea1ch h\u00e0nh \u0111\u1ed9ng, ng\u00e2n s\u00e1ch.<\/p>\n\n\n\n

– Ph\u00ea duy\u1ec7t \u0111\u1ec1 xu\u1ea5t linh ho\u1ea1t m\u1ecdi l\u00fac, m\u1ecdi n\u01a1i tr\u00ean m\u00e1y t\u00ednh ho\u1eb7c \u0111i\u1ec7n tho\u1ea1i.<\/p>\n\n\n\n

– Thi\u1ebft l\u1eadp r\u00f5 th\u1ea9m quy\u1ec1n ph\u00ea duy\u1ec7t theo vai tr\u00f2 (QA Manager, Plant Manager, Ban Gi\u00e1m \u0111\u1ed1c).<\/p>\n\n\n\n

– L\u01b0u v\u1ebft to\u00e0n b\u1ed9 l\u1ecbch s\u1eed ph\u00ea duy\u1ec7t, h\u1ed7 tr\u1ee3 truy xu\u1ea5t khi c\u1ea7n audit ISO, GMP ho\u1eb7c FDA.<\/p>\n\n\n\n

Khi CAPA \u0111\u01b0\u1ee3c s\u1ed1 h\u00f3a v\u00e0 v\u1eadn h\u00e0nh tr\u00ean Base Work+, doanh nghi\u1ec7p kh\u00f4ng ch\u1ec9 x\u1eed l\u00fd s\u1ef1 c\u1ed1 t\u1ed1t h\u01a1n m\u00e0 c\u00f2n x\u00e2y d\u1ef1ng \u0111\u01b0\u1ee3c m\u1ed9t h\u1ec7 th\u1ed1ng c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c theo th\u1eddi gian.<\/p>\n\n\n

\n
\"Base<\/a>
Base Work+<\/a> | B\u1ed9 gi\u1ea3i ph\u00e1p c\u00f4ng vi\u1ec7c v\u00e0 hi\u1ec7u su\u1ea5t<\/em><\/figcaption><\/figure><\/div>\n\n\n

H\u01a1n 10.000+ doanh nghi\u1ec7p Vi\u1ec7t \u0111\u00e3 l\u1ef1a ch\u1ecdn Base.vn \u0111\u1ec3 n\u00e2ng cao n\u0103ng l\u1ef1c qu\u1ea3n tr\u1ecb. Li\u00ean h\u1ec7 Base.vn ngay h\u00f4m nay \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n gi\u1ea3i ph\u00e1p qu\u1ea3n l\u00fd CAPA ph\u00f9 h\u1ee3p cho doanh nghi\u1ec7p c\u1ee7a b\u1ea1n.<\/p>\n\n\n\n

8. K\u1ebft b\u00e0i<\/h2>\n\n\n\n

Qua nh\u1eefng th\u00f4ng tin gi\u1ea3i \u0111\u00e1p \u201cCAPA l\u00e0 g\u00ec\u201d, ch\u00fang ta c\u00f3 th\u1ec3 th\u1ea5y h\u1ec7 th\u1ed1ng n\u00e0y kh\u00f4ng ch\u1ec9 l\u00e0 m\u1ed9t y\u00eau c\u1ea7u tu\u00e2n th\u1ee7 m\u00e0 \u0111\u00e3 tr\u1edf th\u00e0nh chi\u1ebfn l\u01b0\u1ee3c c\u1ed1t l\u00f5i gi\u00fap doanh nghi\u1ec7p Vi\u1ec7t Nam n\u00e2ng cao n\u0103ng l\u1ef1c c\u1ea1nh tranh trong b\u1ed1i c\u1ea3nh to\u00e0n c\u1ea7u h\u00f3a. V\u1edbi s\u1ef1 ph\u00e1t tri\u1ec3n m\u1ea1nh m\u1ebd c\u1ee7a c\u00f4ng ngh\u1ec7 s\u1ed1 v\u00e0 c\u00e1c gi\u1ea3i ph\u00e1p qu\u1ea3n tr\u1ecb t\u00edch h\u1ee3p nh\u01b0 Base.vn, vi\u1ec7c tri\u1ec3n khai CAPA gi\u1edd \u0111\u00e2y tr\u1edf n\u00ean d\u1ec5 d\u00e0ng v\u00e0 kh\u1ea3 thi h\u01a1n bao gi\u1edd h\u1ebft. \u0110i\u1ec1u quan tr\u1ecdng l\u00e0 doanh nghi\u1ec7p c\u1ea7n c\u00f3 t\u1ea7m nh\u00ecn d\u00e0i h\u1ea1n v\u00e0 quy\u1ebft t\u00e2m \u0111\u1ea7u t\u01b0 \u0111\u00fang m\u1ee9c \u0111\u1ec3 thu \u0111\u01b0\u1ee3c nh\u1eefng th\u00e0nh qu\u1ea3 x\u1ee9ng \u0111\u00e1ng.<\/p>\n","protected":false},"excerpt":{"rendered":"

CAPA (Corrective and Preventive Action) l\u00e0 m\u1ed9t trong nh\u1eefng h\u1ec7 th\u1ed1ng quan tr\u1ecdng nh\u1ea5t trong l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t v\u00e0 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng. N\u1ebfu doanh nghi\u1ec7p \u0111ang t\u00ecm hi\u1ec3u CAPA l\u00e0 g\u00ec v\u00e0 nh\u1eefng \u1ee9ng d\u1ee5ng c\u1ee7a CAPA trong th\u1ef1c t\u1ebf, h\u00e3y c\u00f9ng Base.vn theo d\u00f5i n\u1ed9i dung sau \u0111\u00e2y. 1. CAPA l\u00e0 g\u00ec? […]<\/p>\n","protected":false},"author":20,"featured_media":26360,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[20],"tags":[],"ppma_author":[64],"class_list":["post-26350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kien-thuc-san-xuat"],"acf":[],"yoast_head":"\nCAPA l\u00e0 g\u00ec? \u1ee8ng d\u1ee5ng th\u1ef1c t\u1ebf trong s\u1ea3n xu\u1ea5t v\u00e0 d\u01b0\u1ee3c ph\u1ea9m<\/title>\n<meta name=\"description\" content=\"CAPA l\u00e0 g\u00ec? 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