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quản lý chất lượng sản xuất thuốc: phần 2

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nối tiếp nội dung phần 1, phần 2 cuốn sách "quản lý chất lượng sản xuất thuốc" giới thiệu tới người đọc các kiến thức cơ bản về quản lý phòng thí nghiệm, những yếu tổ ảnh hưởng đến chất lượng thuốc trong sản xuất thuốc và phân tích các điểm trọng yếu cần kiểm soát,... mời các bạn cùng tham khảo.

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Nội dung Text: quản lý chất lượng sản xuất thuốc: phần 2

  1. Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc NHLTNG KIEN THITC CO BAN VE QUAN LY PHONG THI NGHIEM MUC • TIEU HOC • TAP • Sau khi hoc xong bdi nay, hoc vien co the: 1. Trinh bay diicic cac yeu cau chung cua phong thi nghiem phu hdp vdi cac chuan miic quoc te. 2. Van dung de dinh hudng viec hoan thien va tien t6i xin cong nhan phong thi nghiem tai cd sci. NOI • DUNG HOC • TAP • I. GlCfl THIEU TAl LIEU VE QUAN LY PHONG THI NGHIEM 1. Phan mof dau Tai lieu nay neu cac yeu cau chinh yeu lien quan he thong quan ly va cac yeu cau ve nang liic ky thuat ma theo do neu mot phong thii nghiem (PTN) cd kha nang dap iing cho nhiing loai phep thii va/hoac hieu chuan nao do thi no se dUdc cac to chiic cong nhan thiia nhan nhii la dap iing chuan miic cua viec cdng nhan theo tieu chuan quoc te ISO/IEC17025 ve cac loai phep thii/ hieu chuan tUdng iing do. He thong quan ly neu d day la mot bo phan cua he thong quan ly chung cua to chiic co phong thii nghiem nay hoac ciia chinh phong thii nghiem. Noi rieng he thong to chiic quan ly do neu dUdc xay diing theo nhiing chuan muc doi hoi ciia tieu chuan IS09001 thi no co the diidc cac cd quan cong nhan xem nhii thoa man cac yeu cau ve he thong to chiic nhiing dieu do chiia du de minh chiing no co du kha nang ky thuat de cung cap cac ket qua va dti lieu co gia tri ve mat ky thuat. Tham chi vao cuol nam 2000, khi cac tieu chuan IS09001 va ISO 9002 da diidc stia doi, hdp nhat thanh tieu chuan IS 0 9 0 0 1:2000 mang tinh day dti hdn thi du he thong to chtic quan ly ciia phong thti nghiem hieu chuan co dap ting chuan miic nay, neu muon dUdc cong nhan, no cung phai dap ting cac yeu cau ve mat ky thuat. 2. Pham vi ap dung Tai lieu nay diidc ap dung cho moi to chtic hoac bo phan cua mot to chtic 122
  2. Trudng dai hoc Y te cong cong Quan ly chat lupng san xuat thuoc co thac hien cac phep thti nghiem/ hieu chuan. Nhting yeu cau nay khong phu thuoc vao so' liidng nhan vien, khong phu thuoc vao pham vi va linh viic thti nghiem/hieu chuan. Khi mot phong thti nghiem hieu chuan khong thac hien mot hoac nhieu hoat dong co neu trong tai lieu nay thi ho chi c£n tuyen bo' ho khong ap dung cac yeu cau doi vdi nhting pham vi loai trti do. Moi phong thti nghiem/ hieu chuan co the sti dung tai lieu nay nha la mot chi d in de xay diing cho minh mot he thong quan ly hanh chmh, quan ly ky thuat, quan ly chat lu’dng de hoan thien hon moi tac nghiep cua ho, can nh&c cac yeu cau ky thuat de tu so sanh, xac dinh duoc thuc trang cua minh so vdi chuan mile nay va tti dd de ra cac giai phap hoan thien thich ting ca ve to chtic quan ly cua he thong chat liidng lan tinh trang trang thiet bi nang liic. Mat khac khach hang cua phong thti nghiem, cd quan cd tham quyen va dac biet cd quan cong nhan co the sti dung tai lieu hudng dan nay nhu la cd sd de xac nhan hoac thtia nhan nang liic cua phong thti nghiem. 3. Ldi ich cua viec ap dung Moi phong thti nghiem co the diing tai lieu nay nhu mot chi dan cho viec xay diing va trien khai cac hoat dong quan ly phu hdp va hieu qua vdi tinh trang thac tai cua minh. Hdn the cac phong thti nghiem/hieu chuan ap dung day du cac hudng d in cua tai lieu nay cd the xay diing va minh chting cho cd quan cdng nhan rfing ho cd he thong quan ly va nang liic ky thuat thoa man cac yeu cau cua tieu chuan ISO/IEC17025. Nhting phong thti nghiem/ hieu chuan neu diidc cd quan cong nhan thtia nhan se cd dUdc uy tin va ldi the trong tiep thi, ket qua thti nghiem/hieu chuan cua ho se dUdc Uu tien sti dung cho cac hoat dong danh gia, giam dinh hay phan xti mang tinh trong tai. Nen liiu y rin g , khi cac to chtic cong nhan cua moi nUdc tham gia thoa lidc thtia nhan da phiidng vdi cac to chtic tUdng dudng cua cac quoc gia khac cd sti dung tieu chuan nay de cdng nhan, thi ket qua thti nghiem va hieu chuan gitia cac phong thi nghiem tuan thu tieu chuan nay se de dang dUdc dong thtia nhan.Viec nay tao dieu kien cho sii phat trien hdp tac thudng mai va ky thuat, hai hoa cac tieu chuan, thu tuc va se tao dieu kien cho chinh hoat dong va quan he cua mdi phong thti nghiem iuai nay. II. NOI DUNG TAI LIEU De tien cho viec tra ctiu, phan diidi day chting toi se trinh bay mot cach tong quan cac yeu cau ve he thdng to chtic quan ly chat liidng va cac yeu cau ve nang liic cua phong thti nghiem theo tuan tii cac hang muc chinh da dUdc neu trong IS 017025 1. Ve cd cau to chtic Phong thti nghiem hoac cd quan chu quan cua PTN phai la mot thiic the 123
  3. Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc co kha nang chiu trach nhiem ve mat phap ly, dap iing duoc tat ca cac yeu cau cua tieu chuan nay va thoa man cac yeu cau cua khach hang, cua cac cd quan co tham quyen hoac cac cd quan cong nhan. Ngoai kha nang thiic hien cac cong viec tai tru sd, PTN cung phai co kha nang thuc hien cac hoat dong tai hien triidng, tai cac dia diem lien ket tam thdi vdi cd sd hay tren cac phudng tien di dong ma ban chat cong viec doi hoi. Neu PTN chi la mot bo phan cua mot to chiic co thiic hien cac hoat dong khac vdi cdng viec thu nghiem va/hoac hieu chuan thi ve cd cau to chiic, phai dinh rd trach nhiem cua moi nhan vien chu chot co lien quan hoac co anh hudng t6i cac hoat dong thii nghiem va/hoac hieu chuan cua PTN de nhan biet cac mau thuan co the ve quyen ldi. Dieu nay nh&m dam bao tinh trach nhiem va khach quan trong hoat dong cua no. Cac bo phan co lien quan ve quyen ldi nhii: San xuat kinh doanh, tiep thi hoac tai chinh se khdng gay ra anh hudng bat ldi den sii tuan thu cua PTN theo cac yeu cau cua tieu chuan nay. Neu mot PTN mong muon dUdc thiia nhan la PTN cua ben thii ba thi ta phai chiing minh rang PTN dd la khach quan, rang nhan vien cua PTN do khong chiu mot ap liic nao ve thudng mai, tai chinh hay ap liic khac cd the anh hUdng den quyet dinh co tinh ky thuat. Phong thii nghiem hoac hieu chuan cua ben thii ba khdng dUdc tham gia bat cii cac hoat dong nao co the ton hai den do tin cay, tinh doc lap ciia cac quyet dinh va tinh trung thiic lien quan den hoat dong thii nghiem hoac hieu chuan ciia no. PTN phai xac dinh cd cau to chiic va vi tri ciia no trong to chiic chii quan va cac moi quan he giiia quan ly chat liidng, hoat dong ky thuat va dich vu ho trd. Phai quy dinh trach nhiem, quyen han va moi quan he qua lai ciia tat ca cac nhan vien quan ly, thiic hien hoac kiem tra cong viec co anh hudng den chat ludng ciia phep thii nghiem va/hoac hieu chuan. Phong cung phai giam sat mot cach thich hdp trinh do ky nang va thao tac ciia cac nhan vien thii nghiem va hieu chuan, bao gom ca cac nhan vien dang tap sii. De lam viec nay, chang han can co can bo quan ly ky thuat chiu trach nhiem toan bo cac hoat dong ky thuat. NgUdi nay phai dUdc cung cap cac nguon liic can thiet de dam bao chat liidng cac hoat dong ciia PTN. Phong se phai bo nhiem dich danh mot can bo giii vai trd quan ly chat liidng, ngoai cac nhiem vu va cac trach nhiem khac, ngUdi nay co trach nhiem va quyen han rd rang dam bao sao cho he thong chat liidng luon du'dc thiic hien va tuan thu, diidc phep lien he triic tiep v6i cap quan ly cao nhat co tham quyen diia ra cac quyet dinh ve chinh sach va nguon liic ciia PTN. Phong phai xem xet viec bo nhiem cac cap pho thay the ngiidi phu trach quan ly chii chot khi ho di vang. 2. He thong chat lu’dng Nhii da neu he thong chat liidng la cd cau to chiic, thu tuc, qua trinh va nguon liic can thiet de thiic hien cong tac quan ly chat liidng. He thong nay 124
  4. Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc la mot phan cau thanh trong he thong quan ly chung cua ban than phong thii nghiem va luan diem xay diing cua he thong chat lifdng trong phong thii nghiem cung tuan thu 8 nguyen tac: 1. D inh hudng khach hang va thi trUdng 2. Vai tro lanh dao 3. Su tham gia cua moi thanh vien 4. Phudng phap qua trinh 5. Phudng thiic tiep can mang tinh he thong 6. Cai tien lien tuc 7. Quyet dinh diia tren sii kien 8. Phat trien quan he hdp tac PTN phai thiet lap, thiic hien va duy tri mot he thong chat liidng phu hdp v6i quy md hoat dong cua no. Phong phai lap thanh van ban cac chinh sach, he thong, chUdng trinh, thu tuc, hucfng dan trong pham vi can thiet de dam bao chat lifdng cho ket qua thii nghiem va/hoac hieu chuan. Cac chinh sach va muc tieu ve chat lifdng ciia PTN phai dUdc xac dinh trong so tay chat lifdng va phai dUdc lanh dao cam ket. Moi tai lieu sii dung trong he thong chat lifdng phai dUdc pho bien, hieu rd, luon san co va dUdc cac nhan vien co trinh do thich iing sii dung. 3. Kiem soat tai lieu PTN phai thiet lap va duy tri cac thii tuc kiem soat tat ca cac tai lieu cua he thong chat lifdng (cac tai lieu noi bo hoac co nguon goc tii ben ngoai) nhif: Cac quy dinh, tieu chuan, tai lieu tieu chuan khac, phudng phap thii va/hoac hieu chuan cung nhif cac ban ve, phan mem, qui dinh ky thuat, hu6ng d in va so tay. Tat ca cac tai lieu phai difdc bien soan, xem xet, phe chuan ca ve noi dung chuyen mon cung nhu cach trinh bay dinh dang thong nhat trifdc khi sii dung. V iec ban hanh, phan phoi, cap nhat, siia doi, thu hoi, thay the hay loai bo moi tai lieu loi thdi deu phai theo mot thii tuc da dinh. Nhiing dieu nay cung difdc ap dung cho cac tai lieu dUdc liiu giuf trong he thong may tinh. 4. Xem xet cac yeu cau, de nghi va hdp dong Phan nay de cap viec PTN co lap va duy tri thu tuc xem xet cac yeu cau, de nghi va hdp dong ciia khach hang qua dd dam bao hieu dung cac yeu cau ciia khach hang, co kha nang va chuan bi day du cac dieu kien de dap iing cac yeu c iu do. Vi du nang liic va nguon liic, phudng phap thu va/hdac hieu chuan thich hdp difdc liia chon va co kha nang dap iing yeu cau ciia khach hang. Yeu cau nay cung k h in g dinh rin g bat cii sii khac biet nao giiia yeu 125
  5. Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc cau hoac de nghi va hop dong phai duoc giai quyet trudc khi b it dau cong viec. Moi hdp dong phai diidc ca hai ben PTN va khach hang chap nhan. Phong thii nghiem phai bao cho khach hang ve moi thay doi neu co cua hdp dong. Tham chi neu hdp dong can thay doi sau khi cdng viec da b it dau thiic hien thi phai lap lai qua trinh xem xet hdp dong nhu trudc dd va moi thay doi phai dUdc thong bao cho tat ca cac nhan vien lien quan. 5. Ho?p dong phu ve thvf nghiem va hieu chuan Trudng hdp cd bat cii cong viec nao do ngUdi thau phu cua PTN tien hanh, phong thii nghiem cung phai ap dung viec xem xet nay doi vdi ho va phai bao b in g van ban cho khach hang ve viec dd cung nhu phai dUdc sii dong y cua khach hang ve viec nay. PTN chiu trach nhiem doi vdi khach hang ve cong viec ciia nha thau phu ngoai tru: trudng hdp khi khach hang hoac cO quan cd tham quyen chi dinh nha thau phu can dUdc sii dung. PTN phai cd mot so dang ky tat ca cac nha thau phu sii dung cho cac phep thii va/hoac hieu chuan va phai cd ho sd chiing minh cac nha thau phu phu hdp vdi tieu chuan nay doi vdi cong viec dUdc yeu c iu . 6. Dich vu mua sam va nguon cung cap PTN phai cd chinh sach, thii tuc ve liia chon va sii dung dich vu mua sim dung cu, thiet bi, thuoc thii va cac hoa chat, vat lieu can sii dung co lien quan den hoat dong thii nghiem va hieu chuan. PTN phai dam bao r in g cac nha cung iing, cac thuoc thii va vat lieu tieu thu dude mua cd anh hiidng tdi chat liidng ciia cac phep thii va/hoac hieu chuan se khdng diidc sii dung cho den khi chung diidc kiem tra va hieu chuan hoac phai dUdc xac nhan la da phu hdp vdi quy dinh ky thuat tieu chuan hoac cac yeu cau diidc quy dinh trong cac phudng phap thii nghiem va/hoac hieu chuan lien quan. Cac dich vu va hang cung cap diidc sii dung phai tuan thii theo yeu cau da qui dinh. Phai cd va liiu giii ho sd minh chiing ve hoat dong kiem tra sii phu hdp nay. Tai lieu mua s im ndi chung hay cac ddn dat hang cu the cho nhiing hang muc cd anh hudng tdi chat lifdng thu nghiem hieu chuan phai md ta rd, chang han chiing loai, cap, hang, nhan dang chinh xac, qui dinh ky thuat, hudng dan kiem tra, so lieu ky thuat khac bao gom viec chap nhan cac ket qua thii nghiem, chat liidng yeu cau va chuan miic he thong chat lifdng cua cd sd san xuat cung cap cac san pham dd. PTN phai danh gia nang liic cac nha cung cap vat tu, dich vu chu yeu cd anh hudng den chat lifdng ciia thii nghiem va hieu chuan va phai duy tri, cap nhat cac ho sd danh gia, danh sach nha cung cap dUdc phe chuan nay. 126
  6. Trudng dai hoc Y te cdng cong Quan ly chat li/png san xuat thuoc 7. Dich vu doi vdi khach hang PTN phai tao dieu kien cho khach hang hoac dai dien cua khach hang co dieu kien hdp tac de lam rd cac yeu cau cua khach hang va de theo ddi hoat dong cua PTN n h im dam bao dUdc tmh bao mat doi vdi khach hang khac. Sii hdp tac nay co the the hien qua viec: Tao dieu kien cho khach hang hoac dai dien cua khach hang tiep can mot cach hdp ly vdi cac llnh vUc lien quan cua PTN de chiing kien thuc hien cac phep thii va/hoac hieu chuan cho khach hang, chiing kien viec chuan bi, dong goi va giii cac mau thii va/hoac hieu chuan do khach hang yeu cau vi muc dich tham tra; Thong bao cho khach hang bat cii sii cham tre nao hoac co thay doi ldn lien quan tdi cong viec thii nghiem va/hoac hieu chuan. Quan tam moi thdng tin phan hoi ciia khach hang, ke ca thong tin tich ciic va tieu ciic va sii dung cac thong tin nay de cai tien he thong chat liidng, cac hoat dong thu nghiem va hieu chuan cung nhii cung cach phuc vu khach hang. 8. Khieu nai PTN phai co chinh sach va thii tuc de giai quyet cac khieu nai cua khach hang hoac cac ben khac. PTN phai lUu giut ho sd cua tat ca cac khieu nai, cac lan dieu tra cung nhu ket qua ciia cac hanh dong khac phuc doi vdi cac khieu nai. 9. Kiem soat cong viec thii nghiem va/ hoac hieu chuan khong phu hdp PTN phai co chinh sach va thii tuc de ap dung khi co bat cii cong viec thii nghiem va/hoac hieu chuan ciia PTN hoac ket qua ciia cong viec khong phu hdp vdi cac thii tuc ciia PTN hoac cac yeu cau da thoa thuan vo'i khach hang. Chinh sach va thu tuc nay phai dam bao ring: a. Xac dinh trach nhiem va quyen han de quan ly cong viec khong phu hdp nha tam ngiing cong viec, tut chol khdng lam bao cao thu nghiem, tam ngu'ng cap chung chi hieu chuan khi can thiet b. Danh gia muc do va tinh nghiem trong ciia cong viec khdng phu hdp. c. Phai cd hanh dong k h ic phuc dUdc thuc hien ngay lap tiic cung vdi moi quyet dinh ve kha nang chap nhan cdng viec khdng phii hdp. d. Khi can thiet. PTN phai thdng bao cho khach hang va thu hoi lai ket qua cdng viec khdng phu hdp; e. Dinh rd du'dc trach nhiem ve quyen han cho phep tiep tuc cdng viec. Cac cdng viec khdng phu ho'p hoac cac van de khdng phu hdp phat sinh 127
  7. Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc trong he thong chat liidng hoac trong cac hoat dong thii nghiem va/hoac hieu chuan co the xay ra tai nhieu ndi khac nhau trong he thong chat liidng. Vf du: Khieu nai cua khach hang, viec kiem soat chat liidng, hieu chuan thiet bi, kiem tra cac vat lieu tieu thu, giam sat nhan vien, thanh tra, bien ban va viec kiem tra giay chiing nhan, viec xem xet ciia lanh dao va cac cuoc danh gia noi bo hoac ben ngoai. Khi viec danh gia chi ra r in g cdng viec khdng phu hdp co the lai xay ra hoac co nghi ngd ve sii phu hdp so v6i cac chinh sach va cac thii tuc cua PTN thi phong thii nghiem can ap dung ngay thu tuc hanh dong k h ic phuc du6i day 10. Hanh dong khac phuc PTN phai xay diing chmh sach, thii tuc va phai phan cong cac trach nhiem thich hdp de thiic hien hanh dong k h ic phuc (la hanh dong dUdc tien hanh de loai bo cac nguyen nhan gay ra tinh trang khdng phu hdp von di dang ton tai, dong thdi de ngan chan sii tai d iin tinh trang khong phu hdp do) khi xac dinh dUdc cong viec khdng phu hdp hoac cac sai khac so v6i chinh sach va thu tuc trong he thong chat liidng hoac cac hoat dong ky thuat. V6i nhiing sii khdng phu hdp ma nguyen nhan ciia no da rd ta co the tien hanh ngay cac hanh dong khac phuc nhung vdi cac trUdng hdp nguyen nhan cua no chua rd hoac cd the co nhieu nguyen nhan thi van de phan tich tim ra va xac dinh miic do quan trong cua chung de de ra bien phap khac phuc lai la mot dieu rat can thiet va kho khan. Thdng thiidng thu tuc ve hanh dong khac phuc phai dUdc b it dau bang mot cuoc dieu tra de xac dinh cac nguyen nhan chinh ciia van de. Do cac nguyen nhan chinh lai khdng rd rang nen viec nay doi hoi can phan tich can than tat ca cac nguyen nhan tiem an co the xay ra. Cac nguyen nhan tiem an co the bao gom: Viec lay, xii ly, liiu mau, cac yeu cau cua khach hang, qui dinh ky thuat cua m lu , phudng phap va thii tuc, tay nghe va dao tao nhan vien, chiing loai chat liidng vat lieu tieu thu hoac thiet bi va viec hieu chuan thiet bi. Phong thu nghiem phai xac dinh hanh dong k h ic phuc va phai liia chon, thiic hien hanh dong kh ic phuc co the thiic hien d§ nhat de loai trii van de va ngan chan no tai dien. Vi ly do nay cac hanh dong k h ic phuc phai diidc xem xet sao cho tiidng xiing v6i miic do quan trong va sii nguy hiem cua van de. Sau khi thiic hien cac hanh dong k h ic phuc neu co nhiing thay doi nay sinh tii viec dieu tra nghien ciiu ve hanh dong k h ic phuc thi PTN phai lap van ban de thong bao va cho ap dung nhiing thay doi do. V6i nhiing giai phap k h ic phuc da neu PTN phai kiem soat ket qua de dam bao hanh dong khac phuc da thiic hien la co hieu qua. Trong trUdng hdp can thiet hoac khi phat hien co sii khdng phu hdp hoac sai khac gay nghi ngd ve sii phu hdp ciia PTN thi PTN phai dam bao r in g tai cac linh viic co nghi ngd do se dUdc danh gia xem xet bo sung kip thdi. 128
  8. Trudng dai hoc Y te cdng cdng Quan ly chat luong san xuS't thudc 11. Hanh dong phong ngvfa Khong chi vdi nhting si1 khong phu hdp da xay ra, phong thu nghiem phai xac dinh nhiing cai tien can thiet cho nhiing sii khdng phu hdp tiem an ca ve mat ky thuat lin he thong chat liidng, nghia la phai xac dinh cac hanh dong phong ngiia de loai bo mot sd" nguyen nhan cd kha nang gay ra sii khdng phu hdp, xay dting ke hoach hanh dong, thtic hien va kiem soat hanh dong dd; so v6i hanh dong khac phuc. Hanh dong phong ngiia la mot qua trinh "cd xu the chu dong" de xac dinh cac cd hoi cai tien hdn la mot phan iing ddi pho n iy sinh tii viec xac nhan van de da phat sinh hoac khieu nai. 12. Kiem soat ho sd Ho sd cd the la d bat cii hinh thiic nao vi du ban in may tinh hoac ban lUu dien tii. Ho sd la chiing cd minh chiing cho cac hoat dong cua phong thii nghiem do dd PTN phai thiet lap va duy tri cac thii tuc de ma hoa, tap hdp, danh so, truy cap, lu'u trii, duy tri va thanh ly cac ho sd chat liidng va ky thuat sao cho cd the de dang truy tim va dUdc liiu giuc trong mot mdi triidng thich hdp de ngan chan hu hong hoac xuong cap cung nhu phong ngiia mat mat. Thdi gian lUu giii tiing loai ho sd phai dUdc quy dinh cho phu hdp v6i nhu c iu sii dung hoac cac yeu cau phap ly. Tat ca cac ho sd phai diidc liiu giii an toan va dam bao tinh bao mat. Vdi cac loai ho sd diidc lUu giii trong may tinh, PTN phai co cac thii tuc de bao ve va sao lai sd" lieu va ngan ngiia viec tiep can khdng diidc phep hoac tinh trang sUa doi dii lieu. Vdi cac loai ho sd lien quan dac tinh ky thuat, nhu tap hdp dii lieu va thdng tin co du'dc khi thiic hien cac phep thii va/hoac hieu chuan va chi ra so" lieu thdng so" ciia qua trinh va chat liidng qui dinh cd dat diidc hay khdng. Ho sd ky thuat co the bao gom cac bieu mau, hdp dong, phieu lam viec, so ghi chep. td rdi kiem tra, sd ghi chep cdng viec, do thi kiem soat, bien ban va giay chiing nhan hieu chuan noi bo va ben ngoai, thdng bao ciia khach hang va thdng tin phan hoi .v.v. PTN phai liiu giii ho so ciia cac quan trie goc, so" lieu da truyen d in va thong tin can thiet de thiet lap mot cuoc danh gia, ho sd hieu chuan. ho sd nhan vien va mot ban sao cua mdi bao cao thii nghiem hoac chiing chi hieu chuan da ban hanh trong mot thdi gian nhat dinh. Ho so' doi vo'i moi phep thu' hoac hieu chuan phai liiu giu day dii cac thong tin de tao dieu kien xac dinh cac yeu td" anh hudng den do khdng dam bao do neu co the va de tao dieu kien cho cac phep thu va hieu chuan diidc lap lai du6i dieu kien gan vdi dieu kien ban dau nhat. Cac ho sd phai bao gom ca viec xac dinh ngudi chiu trach nhiem lay m lu, thtic hien tiing phep thii va/hoac hieu chuan va ngudi kiem tra ket qua. Khi trong cac ho sd co sai loi, phai diidc gach ngay len sai loi do, khong du'oc tay xoa, lam cho kho doc hoac phai xoa bo va phai ghi thong tin dung T9 - O L C L S X T 129
  9. Truong dai hoc Y te cong cong Quan ly chat lupng san xuat thuoc ben canh. Tat ca cac thay doi trong cac ho so phai difdc chinh ngiidi sUa chiia ky xac nhan hoac viet ta t ten. Trong triidng hdp ho sd diidc liiu giii trong may tinh, phai co bien phap tUdng xting de tranh mat mat hoac thay doi so" lieu goc. 13. Danh gia noi bo PTN phai dinh ky tuan thu mot ke hoach va thu tuc da xac dinh thiic hien danh gia noi bo cac hoat dong cua PTN nham tham tra xem cac hoat dong cua PTN con tiep tuc tuan thu cac yeu cau cua he thong chat lifdng hay khdng. ChUdng trinh danh gia noi bo phai chi rd tat ca cac yeu td" cua he thong cha"t lifdng, bao gom cac hoat dong thu nghiem va/hoac hieu chuan. Phu trach cha"t lifdng co trach nhiem lap ke" hoach va td chiic danh gia theo ke" hoach va theo yeu c iu cua lanh dao. Viec danh gia nay phai dtidc nhiing ngtidi da qua dao tao va co trinh do chuyen mon, co cac nguon liic cho phep, doc lap vdi linh viic hoac pham vi hoat dong diidc danh gia thiic hien. Tai cac phong thii nghiem 16n, yeu c lu nay thuan ldi hdn vi nhiing ngtidi da dtidc dao tao tai cac bo phan khac nhau co the thtic hien cac cuoc danh gia cheo cho nhau va nhti vay co the dam bao tinh khach quan doc lap. Tai cac phong thii nghiem nho, viec nay co the dtidc thtic hien theo cach linh dong hdn, chang han bd" tri cac trtidng nhom, trtidng cac bo phan danh gia lan nhau. Dieu quan trong la nhting ngtidi danh gia phai am hieu ve cac thu tuc, cac hti6ng dan ma bo phan bi danh gia dang ap dung de tti dd phat hien ra nhting dieu khdng phti hdp, giup ho hoan thien cong viec hdn. 14. Xem xet cua lanh dao Xem xet cua lanh dao ve chat lifdng la cuoc hop do ban lanh dao to chtic de kiem tra viec tuan thii qui dinh trong he thong chat liidng HTCL, sti phti hdp cua HTCL da xay dting do"i v6i yeu cau thtic tien, tinh hieu qua cua viec ap dung he thong chat lifdng hien hanh va cac van de lien quan cac yeu cau ve cha"t lu’dng trong hoat dong kiem tra thti nghiem hieu chuan. Sau hay mtidi hai thang mot lan, lanh dao PTN phai dinh ky thtic hien mot cuoc xem xet he thong cha"t ltidng nhti vay. Cuoc xem xet nay phai de cap t6i: - Sti phu hdp ciia chinh sach va cac thu tuc. - Cac bao cao ciia ngtidi quan ly va giam sat. - Ket qua cua danh gia noi bo gan day. - Hanh dong khac phuc va phong ngtia. - Cac cuoc danh gia cua cac td chtic ben ngoai. - Ket qua so sanh lien phong hoac thii nghiem thanh thao. - Cac thay doi ve khoi ltidng, pham vi cong viec. 130
  10. Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc - Thong tin phan hoi tu! khach hang. - Khieu nai. - Cac yeu to' lien quan khac nhu: Cac hoat dong kiem soat chat ltidng, nguon ltic va dao tao nhan vien. Phai cd ho sd ghi lai moi phat hien tti cuoc xem xet cua lanh dao va cac hoat dong phat sinh tti cuoc xem xet nay. Lanh dao phai dam bao sao cho cac hoat dong nay thtic hien trong khoang thdi gian thi'ch hdp nhti da thoa thuan. III. CAC YEU CAU VE NANG Ll/C KY THUAT 1. Yeu cau chung Co nhieu yeu to' xac dinh mtic do chinh xac va do tin cay cua phep thti va/hoac hieu chuan do PTN thtic hien. Chang han yeu to' con ngtidi; dieu kien tien nghi va mdi trtidng; phtiong phap thti, hieu chuan va hieu ltic cua phuong phap; thiet bi; tinh trang dan xuat chuan do ltidng; cac van de lien quan thu tuc lay mau; cac van de quan ly mau thti nghiem va hieu chuan.v.v Mtic do ma cac yeu to" ndi tren gop phan gay ra do khdng dam bao chung cho cac ket qua thti nghiem, hieu chuan cd sti khac nhau dang ke gitia cac loai phep thu va cac hinh thtic hieu chuan. PTN phai tinh den cac yeu to' nay khi xay dting cac phtidng phap va thu tuc thti nghiem va/hoac hieu chuan, cac yeu to' dao tao va trinh do cua nhan vien cung nhti yeu to' ltia chon, hieu chuan thiet bi ma PTN dang sti dung. 2. Nhan sti Lanh dao PTN phai dam bao de tat ca nhting ngtidi thao tac cac thiet bi cu the. nhting ngtidi thtic hien thti nghiem, hieu chuan, danh gia ket qua phai co trinh do ky nang thich ting. Neu co sti dung nhan vien dang dtidc dao tao thi phai cd su giam sat thich hdp ciia nhting ngu'di da cd kinh nghiem. Cac nhan vien thtic hien cac nhiem vu cu the phai la ngtidi co trinh do, cd cd sd ve trinh do giao due. dao tao, kinh nghiem thich hdp va/hoac cac ky nang co the chting minh dude khi dude yeu cau. Chang han trong mot so' linh vtic nhti thii nghiem khong pha huy, nhting ngtidi thtic hien cac nhiem vu cu the phai la nhting nguoi co chting nhan hanh nghe. PTN phai chiu trach nhiem dap ting cac yeu cau ve chting nhan hanh nghe. Cac yeu cau ve chting nhan hanh nghe cd the la qui dinh hoac cd the bao gom cac tieu chuan ve linh vtic ky thuat cu the hoac do khach hang yeu cau. Nhan vien chiu trach nhiem nhan xet va dien giai trong bao cao thti nghiem phai co trinh do, dtidc dao tao, co kinh nghiem phu hdp va co kien thtic thich hop ve phep thii dtidc thtic hien. Chang han: 131
  11. Trudng dai hoc Y te cdng cdng Quan ty c h it luong san xuat thuoc - Kien thiic ky thuat thich hdp de che tao cac m lu , vat lieu, cac san pham... difdc thii hoac phudng phap su dung hoac dinh sii dung cac mau, vat lieu, cac san pham sii dung dd hoac phai biet ve cac khiem khuyet va sii giam gia tri co the xay ra trong khi difa vao sii dung. - Kien thiic ve cac yeu c lu chung ma luat phap va cac tieu chuan qui dinh; kien thiic hieu biet ve bieu hien do sai lech dUdc phat hien lien quan den viec sii dung cac mau, vat lieu, cac san pham... Do doi hoi do, lanh dao PTN phai xay diing muc tieu ve huan luyen, dao tao va ky nang cua nhan vien PTN. PTN phai co mot chinh sach va thu tuc de xac dinh nhu cau dao tao, to9 chiic dao tao cho nhan vien PTN. ChUdng trinh dao tao phai phu hdp vdi cac nhiem vu hien nay va trong tUdng lai. PTN phai sii dung nhiing ngUdi lam viec tren cd sd dai han hoac hdp dong v6i PTN. Khi PTN ky hdp dong va sii dung nhan vien ho trd chinh va nhan vien ky thuat bd sung thi PTN phai dam bao nhiing nhan vien nay phai difdc giam sat, co nang luc va nhiing ngUdi nay lam viec phu hdp vdi he thong chat lifdng cua PTN. H inh thiic kha hiiu hieu de biet dUdc nhiem vu chiic n an g cung nhu nhu c lu trinh do ciia mdi ngUdi la viec lap bang mo ta cong viec hien tai cua ngifdi quan ly, ky thuat va nhan vien ho trd chinh th am gia th u nghiem va/hoac hieu chuan. B ang md ta cdng viec dUdc xay dung bang nhieu hinh thiic nhUng thUdng co cac thdng tin sau: - Trach nhiem lien quan den thuc hien thii nghiem va/hoac hieu chuan. - Trach nhiem lien quan den lap ke hoach thii nghiem va/hoac hieu chuan va danh gia ket qua. - Trach nhiem bao cao va dien giai. - Trach nhiem lien quan den siia doi, xay dung va hieu luc ciia cac phudng phap mdi. - Yeu c lu ve ky nang thanh thao va kinh nghiem. - Trinh do va chUdng trinh dao tao. - Trach nhiem ve quan ly. Phu trach phong thii nghiem phai giao trach nhiem cu the cho nhan vien thiic hien lay m lu , dac biet nhan vien thiic hien thii nghiem va/hoac hieu chuan va nhiing ngUdi lien quan viec cap giay chiing nhan thii nghiem va/hoac hieu chuan cung nhif nhiing ngUdi van hanh cac thiet bi dac biet. PTN phai duy tri ho sd ve quyen han, nang liic, trinh do chuyen mon. dao tao va kinh nghiem thich hdp cua tat ca cac nhan vien ky thuat bao gom ca nhan vien hdp dong. Thong tin phai luon s in co va phai bao gom ca ngay xac nhan giao trach nhiem va/hoac nang liic do cho ho. 132
  12. Trudng dai hoc Y t ii cong cong Quan ly chat lupng san xuat thuoc 3. Tien nghi va dieu kien moi trtfcfng Cac yeu to lien quan dieu kien, tien nghi cua phong thii nghiem va/h oac hieu chuan nhu nguon nang liidng, anh sang va cac dieu kien moi trUdng chung sao cho thuan tien de thUc hien chinh xac viec thii nghiem va/h oac hieu chuan. PTN phai dam bao sao cho dieu kien moi trUdng k hong anh hUdng den ket qua hoac anh hUdng nghiem trong den chat lifdng can co ciia bat cii cac phep do nao. PTN phai dac biet quan tam khi lay m lu , thii nghiem va/hoac hieu chuan thuc hien tai vi tri khac vdi vi tri co dinh ciia PTN. PTN phai lap thanh van ban cac yeu cau ky th u a t ve tien nghi va dieu kien moi trudng co the anh hudng den ket qua thii nghiem v a / hoac hieu chuan. Phai theo doi ghi chep cac dieu kien moi trUdng theo yeu cau cua qui dinh ky thuat lien quan cac phudng phap va thii tuc hoac ndi co cac dieu kien co the anh hudng tdi chat liidng ket qua thii nghiem. Chang han cac dieu kien ve vd khuan sinh hoc, bui, nhieu dien tu:, biic xa, do am, nguon cung cap dien, nhiet do va am thanh, miic do rung dong dUdc khong che thich hdp vdi cac hoat dong ky thuat lien quan. Phai diing ngay khi cac dieu kien moi triidng cd the gay anh hudng den ket qua cua phep thii nghiem va/hoac hieu chuan. Phai cd sii ngan cach cd hieu qua giiia cac khu vUc cd cac hoat dong khdng tUdng thich, lay lan gan nhau. va phai thUc hien cac phudng phap ngan chan n h ilm ban. Theo tinh trang cu the cua minh PTN phai kiem soat kha nang tiep can va kiem soat viec sii dung cac khu vUc cd gay anh hudng tdi chat lu’dng thii nghiem va/hoac hieu ch uln, phong thii nghiem phai dua ra cac bien phap dam bao ve sinh cdng nghiep tot, va phai cd thii tuc dac biet de xii ly khi cd sU co nao dd xay ra. 4. Phtfofng phap thuf nghiem/ hieu chuan va viec phe duyet phvfcfng phap PTN phai sii dung cac phiidng phap va cac thii tuc thich hdp cho tat ca phep thii nghiem va/hoac hieu chuan trong linh vUc hoat dong ciia minh. Dieu nay bao gom viec lay m lu, quan ly, van chuyen, luu giii va chuan bi cac m lu de thii nghiem va/hoac hieu chuan, va khi thich hdp. phai xac dinh va cong bo do khong dam bao do cung nhu ap dung ky thuat thong ke de phan tich dii lieu thu nghiem va/hoac hieu chuan. PTN phai cd cac hiidng d in sii dung va thao tac cho tat ca trang thiet bi lien quan cung nhii hiidng d in ve quan ly, chuan bi m lu thii nghiem va/hoac hieu c h u ln hoac hiidng d in ve ca hai viec neu thieu nhiing hiidng d in nay cd the lam anh hiidng den ket qua thii nghiem va/hoac hieu 133
  13. Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc chuan. Tat ca hudng dan, tieu chuan. sd tay va cac dut lieu tham khao lien quan den cong viec cua PTN phai dUdc duy tri cap nhat va luon san co cho cac nhan vien sii dung. Cac thay doi so vdi phudng phap thii nghiem va/hoac hieu chuan chi difdc ap dung khi cac thay doi nay da dUdc lap thanh van ban, difdc chiing minh linh dung d in ve mat ky thuat va dUdc khach hang chap nhan. Vdi cac tieu chuan quoc gia, khu vUc hoac quoc te hoac cac qui dinh ky thuat khac difdc thiia nhan da bao gom thong tin day du ve cach thiic thuc hien cac phep thu va/hoac hieu ch u in thi phong thu nghiem khdng can phai bd sung hoac viet lai thanh thu tuc noi bo neu tieu chuan tren da dUdc lap thanh van ban theo mot hinh thiic cd the dem ban hanh va nhan vien cua PTN cd the sii dung dUdc. Tuy nhien cd the xay diing tai lieu bd sung hoac cac ban md ta chi tiet cho cac budc thiic hien neu viec lam dd la can thiet. Liia chon phiidng phap: PTN phai sii dung cac phudng phap thii nghiem va/hoac hieu chuan, ke ca phUdng phap lay mau, dap iing theo veu cau ciia khach hang va thich hdp doi vdi phep thii va/hoac hieu chuan ma PTN thiic hien; tot nhat la sii dung phudng phap thii da dUdc ban hanh dudi hinh thiic la tieu chuan quoc te, quoc gia hoac khu viic. PTN phai dam bao sii dung tieu chuan mdi nhat trii khi tieu chuan nay khong phu hdp hoac khdng the thiic hien. Khi can thiet, tieu chuan phai difdc bd sung them cac chi tiet de dam bao ap dung phu hdp. Khi khach hang khdng xac dinh rd phUdng phap sii dung thi PTN phai liia chon cac phudng phap thich hdp da difdc cdng bo' trong tieu chuan quoc te, quoc gia hoac khu viic, hoac dUdc cac td chiic ky thuat cd ten tuoi ban hanh, hoac trong cac tap chi, bai bao khoa hoc thich hdp hoac dUdc cac nha san xuat qui dinh. Cac phudng phap do PTN thiet lap hoac phuong phap dUdc PTN ap dung cung cd the diidc sii dung neu cac phifdng phap nay la thich hdp vdi muc dich sii dung va neu phudng phap nay cd hieu liic Khach hang phai dUdc thdng bao ve phudng phap sii dung. PTN phai k h in g dinh cd the ap dung hdp ly phifdng phap tieu chuan trudc khi b it dau thii nghiem va/hoac hieu chuan. Neu phudng phap tieu chuan thay doi thi PTN phai lap lai viec xac nhan. PTN phai thdng bao cho khach hang khi cac phifdng phap thii do khach hang yeu cau la khdng phu hdp hoac het hieu liic. Cac phiidng phap do P T N xay diing: Viec difa cac phifdng phap thii va hieu chuan do PTN xay diing de sii dung noi bo phai la mot hoat dong cd ke hoach va phai phan cdng cho nhan vien cd nang liic, dUdc trang bi cac nguon liic c in thiet chuan bi. 134
  14. Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc Cac ke hoach phai dUdc cap nhat thudng xuyen va PTN phai dam bao sao cho viec truyen dat giiia toan the nhan vien tham gia duoc tien hanh cd hieu qua 9 Cac phiidng phap khong tieu chuan: Khi can sii dung cac phUOng phap khdng phai la phUdng phap tieu chuan, thi cac phUdng phap nay phai dUdc thoa thuan vdi khach hang va P T N phai cd cac yeu c lu rd rang ciia khach hang ve qui dinh ky thuat va muc dich ciia phep thii nghiem /hieu chuan. Phudng pliap xay dung phai cd hieu luc thich hdp trUdc khi sii dung. Doi vdi cac phUdng phap thii nghiem va/hoac hieu chuan mdi thi thii tuc thii nghiem va/h oac hieu chuan phai thiet lap trudc khi thuc hien phep thii nghiem va/h oac hieu chuan va thu tuc dd phai bao gom it nhat cac thdng tin sau: a. Nhan biet thich hdp. b. Pham vi ap dung. c. M ieu ta chiing loai m au dUdc thii nghiem hoac hieu chuan. d. Xac dinh thdng so", sd" lifdng va pham vi. e. Dung cu va thiet bi bao gom ca cac yeu cau ve dac tinh ky thuat. f. Yeu cau ve chuan chinh, mau chuan. g. Y eu cau ve dieu kien mdi trUdng va mot sd" yeu cau ve thdi gian o’n dinh. h. Mieu ta thii tuc bao gom: - Viec ma hoa mau, bao quan, van chuyen, lUu giii va chuan bi m lu thii. - Thuc hien kiem tra trudc khi bat dau cdng viec. - K iem tra de dam bao r in g thiet bi lam viec la thich hdp va khi difdc yeu cau, thiet bi phai dUdc hieu chuan va dieu chinh trudc mdi lan sii dung. - Phifdng phap ghi lai cac dii lieu va ket qua. i. Chuan mifc va/hoac yeu cau de xet duyet/bac bo. j. Ghi lai dii lieu, phifdng phap phan tich va cach trinh bay. k. Do khdng dam bao do va thii tuc de tinh do khdng dam bao do. Phe duyet phUcfng phap thii: Phe duvet la viec xac nhan bang cach kiem tra va cung cap b in g chiing khach quan la da thiic hien cac yeu cau chi tiet ddi vdi muc dich sii dung cu the. PTN phai phe duyet de xac dinh sii phu hdp vdi muc dich sii dung cua 135
  15. Tri/dng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc phiidng phap khdng tieu chuan, cac phudng phap do PTN xay diing hoac thiet ke, cac phiidng phap tieu chuan nhung cd sii md rong vUdt qua pham vi dii dinh ban dau. PTN phai ghi lai ket qua dat dUdc, thu tuc sii dung de phe duyet va ra cong bd" ve viec phiidng phap nay cd phu hdp vdi muc dich su dung khdng Ky thuat sii dung de xac dinh viec ap dung mot phuong phap cd phu hdp hay khdng phai lien quan mot hoac mot sd" cac thdng tin sau: - Sii dung chuan chinh hoac mau chuan de hieu chuan; - So sanh ket qua dat duoc vdi cac phiidng phap khac; - So sanh lien phong; - Danh gia co he thong cac yeu to" tac dong den ket qua; Viec danh gia do khdng dam bao do cua ket qua phai diia vao hieu biet khoa hoc ve nguyen t ic m ang tinh ly thuyet ciia cac phudng phap va kinh nghiem thiic te". TrUdng hdp cd mot sd" thay ddi trong cac phUdng phap khdng tieu chuan dUdc phe duyet thi anh hudng ciia cac thay doi nay phai dUdc lap thanh van ban va neu can se phai co sii phe duyet lai. Pham vi va cap chinh xac ciia gia tri co the dat dUdc tH phudng phap phe duyet khi dUdc danh gia vi muc dich du dinh sii dung phai phu hdp vdi cac yeu cau cua khach hang. VI du: Do khdng dam bao ciia ket qua do. ngUdng phat hien, liia chon phudng phap, miic do tuyen tinh, sai so" tho do tac dong tii ben ngoai, gidi han lap lai, do tai lap.v.v Do vay viec phe duyet mot phudng phap can can nhac giiia chi phi, rui ro va cac kha nang ky thuat lien quan den phudng phap dd ciia phong thii nghiem. Tinh do khong dam bao do: Phong hieu chuan hoac phong thii nghiem thuc hien hieu chuan phai co va phai ap dung thu tuc tinh toan do khdng dam bao do cho tat ca cac phep hieu chuan va hinh thiic hieu chuan. Vdi cac phep thii nghiem, ve nguyen tic , phong thii nghiem phai co va phai ap dung thii tuc de tinh do khdng dam bao do. Vdi nhiing trUdng hdp cu the, nhd tinh chat ciia phudng phap thu ma cac gia tri do co the duoc xem tuan thii theo mot quy luat phan bo" xac dinh va nhd neu trudc do tin cay thdng ke, ta cd the tinh dUdc do dam bao do. Trong nhiing trUdng hdp nav. PTN It nhat phai thu xac dinh thanh phan do khdng dam bao do, thuc hien tinh toan hdp ly va phai dam bao r in g hinh thiic thdng bao ket qua cd kem do khdng dam bao do khdng gay hieu nham cho ngUdi sii dung. Muc do nghiem ngat can thiet khi tinh do khdng dam bao do tuy thuoc vao yeu cau ciia phiidng phap thii, yeu cau ciia khach hang, do rong ciia cac gidi han diing lam cd sd de quyet dinh ve sii phu hdp vdi qui dinh ky thuat. 136
  16. Trudng dai hoc Y te cdng cdng Quan ly chat luong san xuat thuoc Triidng hdp, mot phiidng phap thii nghiem da dUdc cong nhan rong rai va da chi rd gia tri gidi han cua cac nguyen nhan chu yeu hinh thanh nen do khdng dam bao do va chi rd hinh thiic trinh bay ket qua da tinh, thi PTN dUdc coi la dap iing yeu cau ve do khdng dam bao ket qua cua phep do thii do neu no tuan thu dUdc phUdng phap thii dd cung nhu tuan thu cach lap bao cao ciia no. Khi tinh toan do khdng dam bao do, ta can can nhac cac yeu td" lien quan nhu chuan chinh va mau chuan sii dung, phUdng phap va thiet bi sii dung, dieu kien mdi trUdng, dac tinh va dieu kien cua m iu thii hoac hieu chuan va thao tac ciia nhan vien. Kiem soat dd lieu: Moi dii lieu, cach tinh toan, truyen dii lieu phai dUdc kiem tra thich hdp, co he thong. Khi sii dung may tinh hoac trang thiet bi til dong hoa de thu nhan, xii ly, ghi chep, bao cao, luu trii, giii lai cac dii lieu thii nghiem hoac hieu chuan thi PTN phai dam bao: Phan mem may tinh sii dung phai dUdc lap van ban day du, chi tiet va cd: a. Hieu liic phu hdp de sii dung. b. Phai thiet lap va ap dung thu tuc de bao ve dii lieu, thu tuc dd phai bao gom, nhung khong dUdc gidi han d: tinh toan ven, tinh bao mat khi nhap dii lieu, lUu giii dii lieu, truyen va xii ly dii lieu. c. May tinh va cac thiet bi tu dong hoa phai dUdc bao tri de dam bao hoat dong tot trong cac dieu kien mdi trUdng va dieu kien hoat dong can thiet de duy tri tinh toan ven cua dii lieu thii nghiem va hieu chuan. Ph^n mem dUdc mua tii cac nha san xuat, nhu chUdng trinh xii ly tii ngii. cd sd dii lieu, chu'dng trinh thdng ke.v.v co the dUdc coi nhii phudng phap da dilo'c phe duyet de sii dung. Tuy nhien, nhiing gi co lien quan den viec siia doi hay thay cau hinh trong cac phan mem ciia PTN deu phai diidc phe duyet lai. Thiet bi phong thu nghiem phai dUdc trang bi day dii moi dung cu de lay m lu . do liidng va thii nghiem can thiet de thuc hien chinh xac cong viec thii nghiem va hieu chuan. Trong trUo'ng hdp can sU dung thiet bi nam ngoai pham vi kiem soat thudng xuyen thi phong thi nghiem phai dam bao nhiing yeu cau ciia tieu chuan nay van dUdc dap iing. Thiet bi va phan mem cua thiet bi dUdc sii dung de thii nghiem. hieu chu^n va lay mau phai co kha nang dat dUdc do chinh xac can thiet va phai phu ho'p vdi qui dinh ky thuat lien quan den thii nghiem hoac hieu c h u in tiidng iing. Thiet bi phai diidc kiem tra va/hoac dUdc hieu ch u in truo'c khi sii dung. 137
  17. Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc Chi nhiing ngiidi diidc phep mdi cd quyen sif dung thiet bi. Phong thu nghiem phai co s in cac hudng dan ve sii dung va bao tri trang thiet bi da cap nhat de nhan vien thich hdp cua PTN sii dung. Moi hang muc cua thiet bi va phan mem cua thiet bi sii dung de thu nghiem va hieu ch u in va co y nghia quan trong doi vdi ket qua thi PTN phai ma hoa thong nhat de quan ly. Moi hang muc thiet bi va phan mem cd y nghia quan trong doi vdi phep thu hoac hieu chuan thiic hien deu phai cd ho sd rieng. Ho sd phai neu toi thieu cac thong tin sau: a. Ma hoa hang muc thiet bi va phan mem cua thiet bi dd. b. Ten cua nha san xuat, sd" seri hoac nhan biet thong nhat khac. c. Kiem tra thiet bi phu hdp vdi qui dinh ky thuat. d. Vi tri hien nay cua thiet bi, neu thich hdp. e. Hudng dan cua nha san xuat neu cd, hoac th am chieu tdi ndi cd the tim dUdc hudng dan cua nha san xuat. f. Ngay, ket qua va ban sao cua bien ban hoac giay chiing nhan cua tat ca cac lan hieu chuan va dieu chinh, chuan miic chap nhan, ngay thang hieu chuan lan tdi. g. Ke hoach bao tri neu thich hdp va viec bao tri da thiic hien theo ke hoach. h. Moi hu hong, sii co", siia chiia, thay doi doi vdi thiet bi. PTN phai cd cac thu tuc ve quan ly an toan, van chuyen (khi thiet bi do c in dua di ndi khac de thii nghiem, hieu chuan hoac lay mau) luu giii, sii dung va bao tri theo ke hoach de dam bao cho thiet bi hoat dong tot va nham de ngan ngiia sii nhiem ban hoac tranh hu hong. Thiet bi phai chiu sii qua tai, bi quan ly tdi hoac cung cap cac ket qua dang nghi ngd, hoac da cho thay cd khuyet tat hoac nam ngoai gidi han qui dinh cho phep thi phai bi loai bo ngay khdi danh sach sii dung. Thiet bi phai dUdc de rieng de tranh viec sii dung hoac dan nhan rd rang hay danh dau la khdng dUdc sii dung cho den khi thiet bi tren dUdc sua chiia va diidc minh chiing la viec thii nghiem va hieu chuan se dUdc thiic hien chinh xac. PTN phai kiem tra anh hiidng cua cac nhiidc diem hoac sai khac so vdi gidi han da qui dinh ve phep thii nghiem va/hoac hieu chuan trudc dd va PTN phai ap dung thii tuc “kiem soat cdng viec khdng phu hdp” Khi vi mot ly do nao dd, thiet bi nam ngoai tam kiem soat triic tiep cua PTN thi PTN phai dam bao rang chiic nang va tinh trang hieu chuan cua thiet bi da du’dc kiem tra va cho thay yeu cAu ve chiic nang va tinh trang hieu chuan da thoa man trudc khi thiet bi nay dUdc sii dung lai. Khi can thiet, PTN phai cd kiem tra giiia ky hieu chuan de duy tri miic do tin cay ve tinh trang hieu chuan ciia thiet bi thi viec kiem tra giiia ky nay phai diidc thiic hien theo mot thu tuc da qui dinh. 138
  18. Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc Neu viec hieu chuan phat sinh mot loat cac yeu to can khac phuc thi PTN phai co cac thu tuc dam bao sao cho khong gay sii sai lech nao khac cua thiet bi cung nhu phan mem cua no. 5. Dan xuat chuan do ltfcfng Tat ca cac thiet bi sii dung cho cong viec thii nghiem /hieu chuan, ke ca cac thiet bi dung cho phep do phu (vi du: de xac dinh dieu kien moi trUdng) co anh hudng dang ke den do chinh xac hoac hieu luc cua ket qua hieu chuan/ thu nghiem hoac lay mau phai dUdc hieu chuan trudc khi dUa vao sii dung. PTN phai xay diing mot chUdng trinh hang nam va thu tuc de hieu chuan thiet bi. ChUdng trinh hieu chuan phai bao gom cach liia chon, sii dung, hieu chuan, kiem tra, kiem soat, ban tri cac chuan do lUdng. Ddn xuat chuan do liidng doi vdi cac hoat dong hieu chuan: Doi vdi cac phong hieu chuan, PTN phai xay diing va thiic hien chUdng trinh hieu chuan thiet bi de dam bao cac phep hieu chuan va cac phep do do PTN thiic hien dUdc dan xuat tdi he ddn vi quoc te (SI). Mot phong hieu chuan co the thiet lap tinh dan xuat chuan cua cac chuan do ludng va phudng tien do tdi he SI bang mot chuoi hieu chuan hoac so sanh theo kieu ndi mot cach lien tuc chuan hoac phudng tien do dd vdi chuan goc tUdng iing cua he ddn vi do lifdng SI. PTN phai dan xuat tdi he SI qua viec vien dan tdi cac chuan do ludng quoc gia. Cac chuan do ludng quoc gia cd the la chuan dau va dUdc thiia nhan la hang dau cua he ddn vi SI hoac dUdc thiia nhan trong he don vi SI diia vao cac hang sd" vat ly cd ban cung nhu cac chuan quoc gia cd the la chuan thii ma du'dc cac Vien do lUdng quoc gia khac hieu chuan. PTN phai dam ban sii dung cac dich vu hieu chuan chi tii cac PTN cd the chiing minh duoc nang liic. kha nang do va tinh d in xuat chuan. Giay chiing nhan hieu chuan uo ca^ phong thii nghiem ndi tren ca'p phai ghi ket qua do gom do khdng darn bao do vc/'hoac mot cdng bo" phu hdp vdi mot qui dinh ve do ludng da xac dinh 5.1. Mot so diem liiu y Cac PTN hieu chuan dap iing nhiing yeu cau cua tieu chuan nay dUdc xem la cd nang liic. Giay chiing nhan hieu chuan mang bieu tUdng cua cd quan cdng nhan do mot phong hieu chuan dUdc cdng nhan thee tieu chuan nay ve cac phep hieu chuan tiidng iing la bang chiing day du ve tinh d in xuat chuan cua dii lieu hieu chuan da bao cao. - Tinh d in xuat tdi cac ddn vi do ludng SI cd the dat dUdc bang viec vien d in tdi mot chuan dau phu hdp (xem VIM 1993. 6.4) hoac vien dan tdi mot hang so tii nhien cd gia tri la hang sd" da biet 139
  19. Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc trong he SI tiidng iing va diidc Uy ban quoc te ve do liidng va khoi liidng (CIPM) va Hoi nghi chung ve do ludng va khdi liidng (CGPM) khuyen nghi. - Cac PTN hieu chuan duy tri chuan dau hoac chuan dai dien cua he don vi SI diia vao h ln g sd vat ly cd ban cd the yeu cau dan xuat vdi he SI chi sau khi cac chuan nay dUdc so sanh triic tiep hoac gian tiep vdi cac chuan tUdng diidng khac cua m ot Vien do ludng quoc gia. - T huat ngii "qui dinh ky thuat do ludng da xac dinh" cd nghia la dac tinh nay phai diidc de cap rd trong giay chiing nhan hieu chuan ma qui dinh ky thuat cua phep do phai dUdc so sanh b ln g cach neu len hoac dua ra vien d in rd rang ve qui dinh ky thuat. - Thuat ngii “chuan quoc te ’ hoac “chuan quoc gia” dUdc sii dung lien quan vdi tinh d in xuat chuan, gia thiet r in g chuan quoc gia va chuan quoc te nay dap iing dUdc dac tinh ky thuat cua cac chuan dau diidc thiia nhan trong he ddn vi SI. - D in xuat den chuan do ludng quoc gia khdng nhat thiet yeu cau sii dung Vien do liidng quoc gia cua quoc gia dd tai ndi PTN dat tru sd. - Neu mot phong hieu chuan mong muon hoac can dan xuat tdi mot Vien do lifdng quoc gia khac hdn dan xuat tdi chinh quoc gia cua minh thi PTN phai liia chon mot Vien do ludng quoc gia tham gia tich cilc vao cac hoat dong cua BIPM hoac triic tiep hoac thdng qua cac nhom khu vile. - PTN cd the dat diidc chuoi hieu chuan hoac so sanh khdng gian doan bang mot so" budc dUdc thiic hien do cac PTN khac nhau cd kha nang chiing m inh dUdc kha nang dan xuat chuan. Trong ddn vi SI cd mot vai phep hieu chuan hien tai PTN khdng the tuan thu hoan toan. Trong cac triidng hdp dd viec hieu chuan phai chiing minh miic do tin cay trong phep do b&ng viec thiet lap dan xuat den cac chuan do lUo'ng phu hdp nhU: - Sii dung cac mau chuan difdc chiing nhan do nha cung ling cd nang liic cung cap de cd difdc tinh chat hoa hoc, vat ly tin cav cua vat lieu. - Sii dung phifdng phap da qui dinh va/hoac cac tieu chuan tUdng dudng difdc mieu ta rd rang va difdc tat ca cac ben lien quan chap nhan. - Yeu cau PTN tham gia chUdng trinh so sanh lien phong phu hdp neu cd the. 140
  20. Trudng dai hoc Y te cdng cdng Quan ly chat li/png san xuat thuoc Ddn xuat chuan do liidng doi vdi cac phep do, thii nghiem : Cac phong thii nghiem phai dam bao viec dan xuat chuan do ludng cho cac phep do, trii khi chiing minh diidc rin g viec hieu chuan g in kem co tac dong khong dang ke so vdi do khong dam bao do tong cua ket qua thii nghiem. Khi phat sinh tinh huong nay, PTN phai dam bao rin g thiet bi sii dung co the cung cap do khong dam bao do can thiet. Neu viec hieu chuan la yeu to' anh hudng ldn thi cac yeu c iu tren phai difdc tuan thu nghiem ngat. Khi d in xuat cua phep do den cac don vi SI la khdng the va/hoac khdng thich hop thi phong thu nghiem phai chiing minh miic do tin cay trong phep do bang viec : - Sii dung cac mau chuan diidc chiing nhan do nha cung iing cd nang liic cung cap de cd dUdc tinh chat hoa hoc, vat ly tin cay cua vat lieu. - Sii dung phiidng phap da qui dinh va/hoac cac tieu chuan tudng dUdng dUdc mieu ta rd rang va diidc tat ca cac ben lien quan chap nhan. - Tham gia chiidng trinh so sanh lien phong phu hdp neu cd the. Chuan chinh vd mau chuan: PTN phai cd chiidng trinh va thu tuc ve hieu chuan cac chuan chmh, cac chuan chinh phai dUdc hieu chuan bdi mot td chiic cd kha nang d in xuat tdi cac ddn vi do lu'dng he SI. PTN phai lUu giii chuan chinh va chi diidc sii dung de hieu chuan, khdng sii dung cho cac muc dich khac, trii phi PTN cd the chi ra r in g viec dung no nhu ch u in chinh cd the khdng cd hieu liic. Cac chuan chinh phai duoc hieu chuan trudc va sau khi cd bat cii hieu chinh nao. Khi cd the. cac mau chuan phai dan xuat tdi cac ddn vi do lifdng SI hoac den cac mau ch u in diidc chiing nhan. Cac mau chuan noi bo phai diidc kiem tra cho den khi dat miic do phu hdp ve kinh te va ky thuat. PTN phai tien hanh kiem tra can thiet theo cac thu tuc va ke hoach da qui dinh de duy tri sii tin cay ve tinh trang hieu chuan cua chuan chinh, ch u in dau, chuan trao doi. ch u in cdng tac, va chat ch u in . Trong trifd'ng hop phai van chuyen, liiu giii PTN phai cd thu tuc quan ly an toan, van chuyen, liiu giii va sii dung cac ch u in chinh va m lu ch u in de phong ngua nhiem ban hoac hu hong va de bao ve tinh nguyen ven. Phong thii nghiem cd the phai xay diing cac thu tuc khi cac chuan chinh, chat ch u in difdc sif dung ben ngoai vi tri co' dinh cua PTN. 5.2. Lay mau PTN phai cd ke hoach va thu tuc lay m lu khi PTN thiic hien lay m lu vat chat, vat lieu hoac san p h im dung de thu nghiem/hieu chuan tiep theo. Ke hoach lay m lu cung nhif thu tuc lay m lu phai cd s in tai vi tri thiic hien viec 141
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