Ebook Quản lý chất lượng sản xuất thuốc Phần 1

a

'

A

TRUONG DAI HOC Y TE CONG CONG

QUAN LY CHAT LlfflNG
SAN XUAT THUOC

NHA XUAT BAN Y HOC


TRUONG DAI
HOC
Y TE CONG CONG
•
•
•

QUAN LY CHAT LLfdNG

SAN XUAT THUOC

NHA XUAT BAN Y HOC
HA NOI - 2001


Quart ly chat IUPrig san xuat thuoc

Tritdng dai hocY te cong cong

Chu bien
Le Tien
Pham Tri Dung

Cac tac gia
Pham Tri Dung
Nguyen Thanh HiCcfng
Le Tien
Pham Van Tien

Thif ky bien soan
Pham PhiCdng Lien


Quan ly chat luqng san xuS't thu6c

Trudng dai hocY te cong cdng

Ldi NOIDAU

Cuoc each mang lchoa hoc cong nghe tren the gi6i ngay nay dang lam
bien doi sau sac tinh hinh kinh te cua hau bet cac nUcfc tren the gidi.
NhOng hoat dong kinh te mang tinh loan can, cuoc canh tranh tren thi
tracing ngay cang trd nen quyet liet.
'I'rong cuoc canh tranh do, ngUdi ta nhan thay: chat hfdng san pham cao,
gia thanh ha, toe do va dich vu thuan l ien la nhutng nhan to" quyet dinh sii
thanh cong cua moi quoc gia, cua moi cong ty trong viec chiem llnh thi
trUdng va duy tri anh hUOng tren pham vi quoc te.

Su phat trien cua nen kinh te nhieu thanh phan clnnh la tien de lam cho
nhung cuoc canh tranh ngay cang trd nen gay gat tren quy mo 16n.
'Prong nhutng nhan to" do, quan trong nhat la nhflng van de lien quan den
chat liWng. Chinh vi vay, ngay nay tren the gidi, van de chat litdng s.an
pham khong phai chi’ ditdc dat ra 0 cap do cong ty, ma con la moi quan tam
cua cac quoc gia.
GATT/WTO da cong bo lliep dinh rao can trong ky thuat thUdng mai quoc
te (ARGEEMENrr ON TICCCHNICAL BARI ERRS TO INTERNATIONAL
TRy\DE - TBT), day la rao can phi (hue quan rat quan trong trong thi
trudng quoc te. Tat ca moi san pham deu hi chi phol bdi cac dieu khoan cua
hiep dinh nay. 'I'rong hoi canh cluing cua nen kinh te toan cau do thi cac sail
pham co chdng nhan chat hfdng phu hdp se rat thuan tien trong viec vifdt
qua rao can ky thuat trong tlnfdng mai quoc te.
"Chat hfdng la mot yea to quyet dinh de doanh nghicp thanh cong". Chat
lifting san pham da va dang trd thanh vu khi canh tranh chu yen cua moi
loai hinh doanh nghicp trong moi llnh vile san xuat kinh doanh, la mot
trong nln'ing muc lieu co tam chien ludc quan trong cac ke hoach va phat
trien cua doanh nghicp, trong do co doanh nghiep Ditdc.

(3

Nude ta, chat lUdng hang hoa noi cluing, chat litdng tlnioc noi rieng da
dude the che hang: "Phdp 10nh chat lifting hang hod" da dUdc Hoi dong Nha
nu’dc Nifdc Cong hoa xa hoi chu ngliia Viet Nam thong qua ngay 27 tliang 12
mini 1990 va da dude ban hanh ngay 02 thang 01 nam 1991. Muc tieu dam
bao chat hfdng thuoc da difdc Clifnh sach (Juoc gia ve tliuoc cua Viet Nam
khang dinh.

3

Tri/dng dai hocY te cdng cdng___________________________ Quan ly chSit lUOng san xu£t thuoc

"Quan ly chat liiOng san xuat thuoc " ditdc soan thno nh&m thUc hign sM
chi dao cua Ho Y te tgi cong van so' 1954 YT - K2DT ngay 30 thang 3 nam
2000 ve viec bien soan cac thi lieu giang day cho cac ldp chuyen nganh cua
TrUdng Can bo quan ly Y te (nay la trUOng Dai hoc Y te Cong cong). Cuon
sach ndy nhftm phuc vu viec hoc tfip vh nghien cttu cho cac hoc vien sau dai
hoc chuyen nganh quan ly Difdc noi chung vft can bo quan ly chat lifdng san
xuat thuoc noi rieng.
Chfic chhn cuon sach nay con co nhicu thieu sot va ban che, cluing toi
inong muon nhan difdc sif dong gop y kien cua ban doc gan xa.

Tnrctag Dai hoc Y t€ cdng c6ng xin chan thanh cam on!

-

Ha noi, ngay 20 l/idng 5 nam 2001
TRUONG DAI HOC Y TE CONG CONG


Trudng dai hocY te cdng cdng

Quan ly chat iuong san xuat thuoc

1.2. Nguyen tac
Viec phan cong thuc hien nhiem vu, quyen han quan ly Nha nUdc ve chat
lu'dng hang hoa theo cac nguyen tac sau:
-

Bao dam viec quan ly tap trung thong nhat trong ca nUdc, dong
thdi phan cong trach nhiem hop ly doi vdi cac Bo, Nganh, cd quan
true thuoc Chmh phu va dia phUdng nh&m tranh chong cheo hoac
bo sot doi tUdng quan ly.

-

Can cut vao chufc nang, nhiem vu, dong thdi c6 sU dieu chm h phu
hdp vdi kha nang, nghiep vu ky thuat chuyen sau cua tting Bo,
Nganh, cd quan trUc thuoc Chfnh phu de khac phuc nhiing ton tai
trong cac qui dinh trUdc day.

-

Doi vdi cac hang hoa dac thu co anh hudng trUc tiep den siic khoe
ngUdi tieu dung, den an toan ve moi trUdng san xuat dUdc giao
cho cac Bo quan ly chuyen nganh.

-

Cac Bo, cd quan trUc thuoc Chinh phu va dia phUdng phai cu the
hoa viec quan ly chat lufdng hang hoa do minh phu trach.

1.3. Phan cong cu the
Viec phan cong quan ly Nha nUdc ve chat liidng hang hoa gii3a cac Bo,
Nganh dUdc thuc hien nhu sau:
-

Bo khoa hoc, cong nghe va moi trUdng la cd quan chiic nang giup
Chinh phu chi dao va thong nhat quan ly Nha nUdc ve chat lUdng

hang hoa, de ra cac chu trUo'ng chinh sach chung, quan ly thong
nhat ve nghiep vu va kiem tra cac Bo quan ly chuyen nganh, cac
cd quan true thuoc Chinh phu va cac dia phUdng trong viec chap
hanh cac qui dinh quan ly Nha nUdc ve chat lifdng hang hoa

-

Bo quan ly chuyen nganh, cac cd quan trUc thuoc Chinh phu va
cac dia phu'dng nghien ciiu xay dung cac van ban hudng d^n, cac
qui dinh ve bao dam va kiem soat chat lifdng hang hoa thuoc
pham vi quan ly cua minh tiT san xuat den tieu dung.

-

Cac Bo quan ly chuyen nganh, cac cd quan trUc thuoc Chmh phu
va cac dia phUdng phol hdp chat che vdi Bo khoa hoc, cong nghe
va moi trUdng trong viec to chilc thuc hien cac chiic nang, nhiem
vu quan ly Nha nifdc ve chat lifdng hang hoa difdc phan cong.

-

Bo y te co trach nhiem quan ly Nha nUdc ve: Dude pham. dude lieu,
trang thiet bi, dung cu y te, cac loai my pham anh hUdng trUc tiep
den su'c khoe cua con ngUdi, ve sinh an toan doi vdi thuc pham
(tudi song, da qua che bien cong nghiep), cac loai nUdc uong, nfdu
\-a thuoc la.

13

Quan ly chat hrpng san xuat thuoc

Trudng dai hocY te cong cdng

2. Nhufng bien phap chu yeu quan ly Nha ntfdc ve chat ltfcfng san pham
2.1. Thong nhat quan ly Nha niidc ve chat luang hang hod trong
pham vi cd niidc
Tai nUdc ta, trong Phap lenh chat lifdng hang hoa ban hanh ngay
27/12/1990 va trong Phap lenh chat lifdng hang hoa sUa doi difdc Uy ban
thifdng vu Quoc hoi ky ban hanh ngay 24/12/1999 qui dinh ro: "Nha nUdc
thong nhat quan ly chat lUdng hang hoa theo qui dinh cua Phap lenh chat
lifdng hang hoa va cac qui dinh khac cua phap luat". Thong nhat quan ly
Nha nUdc ve chat lifdng hang hoa trong pham vi ca nUdc dUdc thuc hien
tren cd sd co sU phan cong trach nhiem hdp ly doi vdi cac Bo, Nganh, cd
quan thudc Chmh phu va dia phUdng de co sU phoi hdp va chiu trach
nhiem thUc hien trong cac llnh vUc quan ly cu the cua minh. Ch&ng han:
-

Bo khoa hoc, cong nghe, va moi trUdng chiu trach nhiem trUdc
Chinh phu thuc hien viec thong nhat quan ly Nha nUdc ve chat
lifdng hang hoa. Chinh phu qui dinh cu the trach nhiem cua cac
Bo, cd quan ngang Bo, cd quan thuoc Chinh phu trong viec thifc
hien quan ly Nha nUdc ve chat lifdng hang hoa.

-

Bo khoa hoc cong nghe moi trUdng phoi hdp vdi Bo thUdng m ai,
cac Bo, cac cd quan ngang Bo, cd quan thuoc Chinh phu trong viec
thuc hien quan ly Nha nUdc ve chat lUdng hang hoa theo sU phan
cong cua Chinh phu.

-

Uy ban nhan dan cac cap trong pham vi nhiem vu, quyen han cua
minh thuc hien quan ly Nha nUdc ve chat lifdng hang hoa theo sU
phan cong cua Chinh phu.

9

r

Phap lenh cung neu ro: To chifc ca nhan san xuat kinh doanh phai
chiu trach nhiem ve chat lifdng hang hoa khong dam bao chat lifdng theo
qui dinh cua phap luat. Nghiem cam san xuat kinh doanh han g hoa
khong dam bao chat lifdng thee qui dinh cua luat phap hoac neu thong
tin quang cao sai sif that va cac hanh vi gian doi khac khac ve chat
lifdng hang hoa.

2.2. Kien toan va phat huy vai trd quan ly Nha nude cua he thong cac
cd quan chitc nang
a. He thong cua Tong cue tieu chuan - do lUdng - chat lifdng thuoc Bo
cong nghe khoa hoc va moi trifdng. Day la true chinh trong mang ludi
to chtic quan ly chat lUdng trong ca nUdc; trUc tiep giup Nha nifdc
thuc thi ca viec chi dao, hudng dan, to chilc cac hoat dong co lien quan
tdi quan ly chat lUdng doi vdi nen kinh te ; la ndi hoi tu moi to chuc va
ca nhan co lien quan (ca trong va ngoai nUdc) trong sU phan con g
trach nhiem va phoi hdp chat che vdi nhau nham thuc hien tot nhat

14

Trudng dai hocY te cdng cong

Quan ly chat luong san xuat thuoc

cac ke hoach, chUdng trinh dam bao va nang cao chat lifdng hang hoa
va dich vu theo nhiem vu va quyen han Nha nUdc giao cho. Cd cau to
chiic cua Tong cuc tieu chuan - do lUdng - chat lifdng gom cd quan chi
dao d Trung Udng (Lanh dao Tong cuc va cac bo phan chiic nang giup
viec de dieu hanh chung cong viec); cac Trung tam ky thuat dat tai
cac khu viic de tien hanh cac hoat dong nghiep vu va ky thuat phuc
vu cho quan ly chat lifdng; cac cd quan chuyen sau ve nghiep vu va ky
thuat cua cac nganh: Do lifdng, tieu chuan, thong tin- tU lieu, dao tao,
nang suat, chting nhan va cong nhan.
b. He thong cac cd quan Tieu chuan - do lUdng - chat lifdng tinh - thanh
pho trUc thuoc Trung Udng (nay la cac Chi cuc tieu chuan - do lifdng chat lUdng). Day la he thong to chiic do chinh quyen tinh - thanh pho
trUc thuoc Trung Udng quan ly toan dien nhUng chiu sii chi dao,
hudng dan cua Tong cuc tieu chuan - do lUdng - chat lifdng ve noi
dung hoat dong va ve nghiep vu va ky thuat. Ngoai ra, tai cac cd quan
chiic nang giup cac Bo quan ly nganh kinh te ve quan ly chat lifdng,
tuy theo dac diem va yeu cau cu the ma d moi Bo co nhutng hinh thiic
to chiic thich hdp khac nhau. Vdi cac Bo quan ly nganh san xuat thi
chufc nang quan ly chat lifdng thUdng dUdc giao cho Vu khoa hoc ky
thuat hay Vu quan ly cong nghe san xuat va chat lifdng san pham. O
mot so' Bo dUdc Nha nUdc phan cong triic tiep quan ly chat lifdng doi
vdi mot so' hang hoa, cong trinh, dich vu (y te, xay diing, giao thong
van tai, thuy san, nong nghiep va phat trien nong thon, thUdng mai
...) thi ngoai cd quan chiic nang theo doi, dieu pho'i chung, con co
nhufng cd quan thiic hien nhUng cong viec cu the ve nghiep vu va ky
thuat trong quan ly chat lifdng theo nhCfng nhiem vu va quyen han

nhat dinh do Bo quan ly nganh kinh te qui dinh tren cd sd thoa thuan
v6i Bo khoa hoc, cong nghe, moi trUdng
c. Tai cac ddn vi cd scl (goi chung la doanh nghiep) co nhQng to chifc giup
Giam doc doanh nghiep thuc thi nhQng nhiem vu cu the ve quan ly
chat lifdng nhU: Xay dung cac tieu chuan va dinh miic, hieu chuan va
sUa chiia cac phUdng tien do lUdng, theo doi va kiem tra chat lifdng,
nghiem thu san pham. Day la cac to chiic chifc nang quan ly chat
lUdng cua ban than doanh nghiep. Cac to chifc nay co quan he trUc
tiep vdi he thong Tong cuc tieu chuan - do lUdng - chat lifdng va he
thong chiic nang cua cac Bo hay tinh - thanh pho' trong viec tif van,
trao doi thong tin, dao tao can bo va cac van de cu the ve nghiep vu va
ky thuat.

2.3. Ban hanh va dp dung tieu chuan chat luong hang hod
Tieu chuan chat lifdng hang hoa dUdc the hien dudi hinh thtic van ban
ky thuat, de cap den cac qui dinh ve chi tieu, yeu cau ky thuat, phUdng phap
15


Truong dai hocY te cong cong

Quan ly chat iuong san xuat thuoc

thii nghiem, bao goi, ghi nhan, van chuyen, bao quan hang hoa va ca ve cac
yeu cau cua he thong quan ly chat lifdng va moi van de lien quan den ch a t
lifdng hang hoa. Nhd cac tieu chuan nay, cac cd quan chiic nang Nha nifdc
hay cac to chiic danh gia co dUdc nhiing chuan mUc doi vdi cac linh vUc lien
quan den chat lifdng hang hoa va do do co cd sd neu dUdc cac quyet dinh
quan ly. Ngoai cac tieu chuan Viet Nam ve chat lifdng hang hoa, cac nha san
xuat co the sii dung cac tieu chuan chat lifdng cua nUdc ngoai, tieu chuan

quoc te hoac tieu chuan nganh lam chuan cii cho viec san xuat, xem xet,
danh gia chat lifdng san pham cua minh mien rang cac tieu chuan do khong
trai vdi vdi cac qui dinh luat phap. Cac to chiic, ca nhan san xuat kinh
doanh phai cong bo" tieu chuan cd sd ve chat lifdng hang hoa ma ho ap dung
va chiu trach nhiem ve chat lifdng hang hoa do minh cong bo. M at khac, vi
thong thUdng cac tieu chuan deu mang tinh tu nguyen trong khi do cd
nhiing loai hang hoa lien quan den thuc pham, an toan ve sinh siic khoe con
ngUdi, moi trUdng lai doi hoi sU tuan thu theo nhiing yeu cau nhat dinh
mang tinh b it buoc cua cac tieu chuan chat lifdng cu the. Vi ly do nay, trong
bien phap quan ly chat lifdng, Nha nUdc qui dinh "Danh muc hang hoa thuoc
dien bat buoc phai ap dung tieu chuan chat lifdng Viet Nam". M oi to chiic,
ca nhan san xuat kinh doanh hang hoa thuoc dien qui dinh tren phai cong
bo" va dam bao hang hoa cua minh phu hdp vdi cac yeu cau chat lifdng neu
trong cac tieu chuan tUdng ling do. Ngoai "Danh muc hang hoa thuoc dien
b it buoc ap dung" dUdc Nha nUdc neu trong tiing thdi ky, de phii hdp vdi doi
hoi ve mifc chat lifdng, Bo trudng, Thii trudng cd quan ngang bo, thu trUdng
cac cd quan thuoc Chmh phu cung cd trach nhiem qui dinh danh muc hang
hoa b it buoc phai ap dung tieu chuan nganh hoac tieu chuan khac thuoc
trach nhiem quan ly cua Bo / Nganh minh.

2.4. Chiing nhan chat lUOng va cong nhan he thong quan ly chat litcfng
Viec ban hanh va ap dung cac tieu chuan chat lUdng cho san pham va
he thong, le tU nhien se dan den nhu cau va hoat dong danh gia xac dinh
tinh trang dap ling cac tieu chuan do. Nha nUdc xem cac hoat dong chiing
nhan chat lifdng hang hoa, chiing nhan he thong quan ly chat lifdng, hoat
dong cong nhan he thong quan ly chat lifdng, hoat dong cong nhan he
thong quan ly chat lUdng cua cac phong thii nghiem , cua cac to chiic giam
dinh chat lUdng hang hoa, cac to chifc chiing nhan he thong quan ly v. v...
la mot trong cac bien phap tfch cifc dong vien thuc day cac doanh nghiep,
to chiic lam tot hdn chifc nang quan ly chat lifdng cua minh, hoi nhap vdi

phifdng thiic quan ly tren the gidi. Mac du, nhiing hoat dong nay do cac to
chiic hoat dong dich vu ky thuat thUc hien nhUng cac dieu kien hoat dong
cua cac to chiic dich vu ky thuat do se dUdc Chinh phu can cii tren cac dieu
kien cu the cua nifdc ta va cac yeu cau ma cac thong le quoc te doi h oi de
qui dinh va nhd do quan ly difdc no.

16


Trudng dai hocY te cdng cdng

Quan ly chat luong san xuat thuoc

2.5. Kiem tra, thanh tra ve chat litcfng hang hod
Can cii yeu cau quan ly chat lifdng hang hoa trong tu!ng thdi ky, Chinh
phu qui dinh Danh muc hang hoa phai dUdc kiem tra ve chat lifdng va to
chiic thuc hien kiem tra ve chat lUdng hang hoa.
Viec thanh tra chat lifdng hang hoa do Thanh tra chuyen nganh ve chat
lifdng hang hoa thuc hien, cd cau to chiic va hoat dong cua cac cd quan thanh
tra do se do Chinh phu qui dinh. De khuyen khlch nhiing cd sd thiic hien tot
cong tac quan ly chat lifdng, Phap lenh chat lUdng hang hoa qui dinh". Hang
hoa nh..
.n xuat, kinh doanh da dUdc chiing nhan co he thong quan ly chat
lifdng phu hdp tieu chuan Viet Nam hoac tieu chuan nu6c ngoai, tieu chuan
quoc te dUdc mien kiem tra chat lifdng trif trUdng hdp phat hien co dau hieu
vi pham phap luat ve chat lifdng hang hoa"

2.6. Khen thiidng va xii ly vi pham
To chiic ca nhan co thanh ti'ch trong hoat dong ve chat lifdng hang hoa

hoac co cong phat hien cac vi pham phap luat ve chat lifdng hang hoa thi
dUdc khen thUdng theo qui dinh cua phap luat.
NgUdi nao san xuat, kinh doanh hang hoa khong dam bao chat lifdng
theo tieu chuan da cong bo", san xuat kinh doanh hang hoa thuoc danh
muc hang hoa phai ap dung tieu chuan Viet Nam ma hang hoa khong phu
hop vdi tieu chuan do, vi pham qui dinh ve chiing nhan chat lifdng, cong
nhan he thong quan ly chat lifdng hoac vi pham cac qui dinh mang tinh
phap luat ve chat lu'dng hang hoa thi tuy theo tinh chat, miic do vi pham
ma bi xii phat hanh chinh hoac truy ciiu trach nhiem hinh sii theo qui
dinh cua phap luat.

II. DINH Hl/CiNG CUA NGANH Y TE VA Cd S6 PHAP LY DE QUAN
LY CHAT L l/d N G DU’dC PHAM
Trong ban dii thao "PhUdng hUo'ng, nhiem vu ke hoach phat trien kinh
te. xa hoi 5 nam 2001-2005", d muc "Dinh hu'dng phat trien cac linh viic xa
hoi", co neu: Phat trien cong nghiep du'dc, nang cao chat lifdng san xuat
thuoc chlia benh; bao dam 40% nhu cau thuoc chiia benh dUdc san xuat tii
trong nu'dc vdi chat lifdng cao. Do la nhiing dinh hu'6ng vo cung quan trong
cho Nganh dude trong nhung nam tcfi.
De quan ly chat lifdng dUdc pham, Bo y te da co nhieu van ban mang
tinh phap qui. qui dinh cac dieu khoan lien quan den chat lifdng thuoc dung
trong cong tac BVSK nhan dan. Chinh sach Quoc gia ve thuoc cua Viet Nam
da dua ra cac giai phap n h im quan ly chat lifdng thuoc sU dung trong
Nganh v te.

T2 • Q LC LSXT

17

Trudng dai hocY te cong cong

Quan ly chat luong san xuat thuoc

1. Muc tieu dam bao chat litfcfng thuoc d Viet Nam
-

Dam bao thuoc tdi tay ngudi benh an toan, co hieu lUc, dap ling
dUdc cac tieu chuan chat lUdng va cac chi tieu ky thuat

-

Xac dinh tieu chuan de dang ky, ban hanh cac thuoc co chat lifdng

2. Noi dung dam bao chat lvfofng thuoc d Viet Nam
2.1. Tieu chuan hoa
•

Bo y te ban hanh va quan ly toan bo tieu chuan ve thuoc. Co 2 cap
tieu chuan ap dung doi vdi thuoc:

Tieu chuan cap Nhd niidc va tieu chuan cap cd sd
•

DUdc dien Viet Nam bao gom cac tieu chuan cap Nha nUdc: Ve thuoc
va nguyen lieu lam thuoc phong benh va chifa benh cho ngUdi, xuat
ban theo dinh ky 5 nam.

•

Danh muc chuyen luan DUdc dien phai phu hdp vdi dudng loi quoc gia
ve thuoc va sU phat trien dUdc hoc tren the gidi. Danh muc bao gom
thuoc co truyen va thuoc hien dai.

•

Cung co" Hoi dong DUdc dien de dam nhiem viec bien soan, giup Bo
trUdng Bo y te ban hanh DUdc dien Viet Nam theo dung dinh ky.

•

De viec giao lUu quoc te ve thuoc dUdc thuan ldi, DUdc dien Viet Nam
bien soan phan dau trinh do tUdng dUdng cac nUdc (trUdc mkt la khu
vtfc ASEAN) va Bo y te quy dinh nhQng DUdc dien nUdc ngoai dUdc ap
dung d Viet Nam.

•

Tieu chuan cd sd ve thuoc san xuat trong nUdc phai qua th am dinh,
xet duyet cua Bo y te trUdc khi ban hanh. ap dung va khong dUdc
thap hdn tieu chuan cap Nha nUdc (neu cd).

•

Tieu chuan cac thuoc nhap vao Viet Nam phai dang ky va qua tham
dinh cua cd quan chuyen mon trUdc khi Bo y te duyet, cong nhan.

•

Tieu chuan thuoc dUdc dinh ky xem xet, bo sung cho phu hop vdi tinh

hinh chung.

2.2. Kiem nghiem chat litang thuoc
•

Bo y te ban hanh, quy dinh ve he thong tu kiem tra chat lUdng d cac
ddn vi.

18

-

Cac cd sd san xuat thuoc thuoc bat ctf thanh phan kinh te nao deu
phai cd bo phan tu kiem tra chat ltfdng. cd kha nang kiem nghiem
chat lifdng thuoc san xuat theo tieu chuan quy dinh.

-

Cac cd sd ton trif, phan phoi dUdc phai cd bo phan kiem nghiem.
kiem soat chat lUdng thuoc va phai cung cap ho sd dat chat luong
cua tifng lo san pham khi xuat thuoc (ban buon).


Trudng dai hocY te cdng cong

-

•

Quan ly chat luong san xuat thuoc

Khoa difdc benh vien pha che thuoc tiem, dich tiem truyen, co bo
phan kiem nghiem danh gia chat lifdng thuoc ve ly hoa, sinh vat,
vi sinh vat hoc.

Bo y te dau tu can bo co trinh do, trang thiet bi cho cac cd quan kiem
nghiem thuoc he quan ly Nha nude ve thuoc, cu the la:
-

Hien dai hoa n h im nang cao trinh do va kha nang kiem nghiem
cua cac ddn vi kiem tra chat lifdng tuyen Trung Udng de lam tot
chiic nang kiem nghiem, phuc vu xet cap dang ky lUu hanh thuoc,
giam sat chat lifdng thuoc trong qua trinh lUu thong tren thi
trUdng, lam trong tai khi co tranh chap, khieu nai ve chat lifdng
thuoc, tU van ve chinh sach quoc gia ve chat lifdng thuoc.

•

-

Xac dinh Vien kiem nghiem la cd quan duy nhat quan ly cac chat
doi chieu dung trong kiem nghiem thuoc.

-

Quy hoach va dau tu nang cap mot so tram kiem nghiem d mot so
dia ban trong diem thanh Trung tam kiem nghiem khu vUc de
cung vdi Vien kiem nghiem va Phan vien kiem nghiem hinh
thanh mot he thong kiem nghiem tuyen Trung Udng trong viec
danh gia, xac dinh chat lifdng thuoc.

-

Tao dieu kien de cac tram (Trung tam) kiem nghiem tuyen tinh
thuc hien tot nhiem vu tham gia giam sat, kiem nghiem, kiem
soat, phat hien thuoc kem chat lifdng, thuoc gia, gop phan tlch cUc
vao thanh tra dUdc.

K huyen khfch nh&m tang cUdng viec trao doi kinh nghiem , dao tao,
boi dudng doi ngu can bo vdi cac nUdc khu vUc ASEAN va cac nUdc
khac tren the gidi trong llnh vUc kiem tra chat lUdng thuoc va cung
cap chat doi chieu dung trong kiem tra chat lifdng thuoc.

•

•

•

Bo y te nghien ciiu, xay diing, ban hanh:
-

Tieu chuan: Phong kiem tra chat lifdng thuoc dUdc cong nhan.

-

Tieu chuan:

+

ThUc hanh tot kiem nghiem thuoc.

+

Thuc hanh tot thii lam sang thuoc.

Cac quy che can dUdc hudng d&n thuc hien nghiem tuc. Cac tieu
chuan trUdc mat khuyen khich thuc hien va tien tdi b it buoc thuc
hien trong mot thdi gian xac dinh cua Nha nUdc.
Kien quyet khong cho phep lUu hanh cac thuoc khong dam bao chat
lUdng, khong gia han cho phep sii dung cac loai thuoc da het han, xu
ly nghiem k h ic nhiing ddn vi, ca nhan vi pham ve chat lifdng thuoc.

2.3. Thii nghiem, danh gia thuoc
•

Bo y te nghien ciiu, siia doi, hoan chinh va ban hanh quy che thu
nghiem lam sang doi vdi cac thuoc mdi.
19


Trudng dai hocY te cdng cdng

•

Quan ly chat luong san xuat thuoc_

Bo y te chi dinh mot so" cd sd y hoc va y te co dieu kien ve can bo
chuyen mon co trinh do va co trang thiet bi hien dai dUdc giao n h ie m
vu thii nghiem thuoc tren ngUdi. Thu tradng cac ddn vi nay khi difdc

giao nhiem vu phai cti can bo co trinh do, co trach nhiem va dao diic
thuc hien dung cac phUdng phap ky thuat thu nghiem va danh gia ve
thuoc, co ky ket hdp dong thu nghiem vdi ndi dua thu.

•

Bo y te thanh lap Hoi dong danh gia thuoc, tu van cho Bo trong viec
xem xet ket qua thii lam sang de quyet dinh cho phep sii dung hay
khong doi vdi thuoc m6i.

•

Thuoc nUdc ngoai xin thii lam sang tai Viet Nam phai theo quy che
thii lam sang cua Viet Nam.

•

Bo y te se quy dinh che do bao ho quyen ldi cua ngUdi benh dUdc thii
thuoc.

•

Bo y te khuyen khich viec danh gia cac thuoc trong va ngoai nUdc
dang lUu thong va sii dung, nhat la cac thuoc m6i.

2.4. Loai bo thuoc trong dieu tri va liiu thong
•

Bo y te quy dinh cap co tham quyen ra lenh thu hoi thuoc trong cac
trUdng hdp binh thUdng, trUdng hdp khan cap doi v6i nhiing lo thuoc

co van de ve chat lifdng, nhiing thuoc khong an toan trong dieu tri,
quy dinh nguyen tac xii ly doi v6i cac thuoc da thu hoi.

•

Qua qua trinh giam sat thuoc lUu thong tren thi trUdng cung nhu
trong dieu tri, phat hien nhiing thuoc khong dat tieu chuan chat
lifdng, khi c6 quyet dinh thu hoi hoac tu phat hien, nha cung cap co
trach nhiem phai thu hoi nhanh, gon va triet de cac thuoc do va chiu
toan bo phi ton.

• Viec xii ly huy bo cac loai thuoc phai thu hoi, cam lUu hanh, can
difdc tien hanh co sii giam sat chat che nhfim dam bao an toan,
tranh sai sot.
•

Tang ciidng cong tac thanh tra, kiem tra, xii ly nghiem khac cac
triidng hdp vi pham ve chat liidng thuoc.

CAU HOI
1. Phan tich cac bien phap quan ly Nha nu'dc ve chat ltidng hang hoa noi
chung va van dung trong quan ly chat luong thuoc?
2. Trinh bay va cho vl du minh hoa ve viec dam bao chat lifdng thuoc
cua Viet Nam?

20


Truong dai hocY te cdng cong

Quan ly chat luong san xuat thuoc

NHAN THLTC VE CHAT Ll/ONG VA
QUAN LY CHAT LlTONG
■

■

MUC
TIEU HOC
TAP
•
•
•
Sau khi hoc xong bai nay, hoc vien co kha nang:
1. Trinh bay dUdc mot cach co he thong cac kien thiic cd ban ve chat
lUdng. quan ly chat lu'dng, cac mo hinh quan ly chat lifdng, vai trd
va y nghia cua viec chiing nhan san pham, chiing nhan he thong
quan ly.
2. Van dung dUdc cac kien thiic da dUo'c hoc de danh gia va tifng budc
cai tien he thong quan ly chat lu'dng tai cd sd

NOI DUNG HOC TAP
I.

NHAN THtfC VE CHAT Ll/dN G

1. Chat lufcfng la gi ?
Chat lifdng la mot khai niem quen thuoc vdi tat ca moi ngUdi tuy nhien
quan niem ve chat lifdng lai rat da dang va tham chi con co nhieu tranh cai.

Tuy theo doi tUdng va muc dich sii dung, tii "chat lifdng" co y nghia khac
nhau. Nhiing ngUdi cdng nhan, ngUdi thd coi chat lifdng la nhiing gi ho phai
lam de dap ling cac quy dinh ky thuat “chat lifdng la sU phu hdp vdi cac quy
dinh ky thuat - Crosby”, trUdng hdp nay chat lifdng dUdc the hien qua nhom
cac gia tri cua nhung chi tieu ky thuat cu the ma phan thiet ke da de ra cho
san pham. Tuy nhien do su da dang cua khach hang va sU khac biet cua thi
truo'ng noi dia, thi trUdng khu vUc, thi trUdng tai cac nUdc tren the gidi nen
nhung quy dinh ky thuat cu the da dUdc xem la tol Uu cho mot loai san
pham tai mot thi trUdng nay lai khong dUdc chap nhan tai mot thi trUdng
khac. Tinh trang nay xay ra do thi hieu, sd thich, tap quan. ton giao hoac do
nhung dieu kien thdi tiet, dia ly. Ngu'di sii dung dac biet la nhiing ngUdi tieu
dung binh thUdng nhieu khi khong quan tam hoac khong cd kha nang de xet
doan cac tinh nang ky thuat cua san pham, doi vdi ho “chat lUdng la sii phu
hdp vdi cac nhu cau sii dung cua ho va la thii ma vi no, ho da phai bo tien ra
de mua san pham nao do“ . Nhieu khi khai niem chat liidng cua moi ngUdi
con g in lien vdi nhiing nhan thiic hay cam giac vo hinh nhu ve dep, tinh Uu

21


Tri/dng dai hocY te cong cdng

Quan ly chat luong san xuat thuoc_

viet hoac tinh nguyen ban, doc dao cua san pham . N hiing cam nhan nav rat
kho minh hoa, giai thich nhung “ ta biet dUdc dieu do khi ta nhin thay no”,
ta chap nhan chi tra cho dieu ma ta quan niem nhu vay la co chat luong va
thoa m an m ong doi cua ta.

Chat lifdng gan lien vdi gia tri sii dung, gia ca va vi vay chat lUdng cung

gan lien vdi nhiing doi tUdng sii dung khac nhau cung kha nang tai chinh
cua ho “chat lu’dng khong chi la thii ma ngUdi sii dung bo tien ra mua no ma
con phai la thii ma ho co the va xiing dang de bo tien mua no” ; Chat lifdng
la sii vifa van de sii dung no”(Juran). Chat luong khong dong nghia vdi sii
hoan hao tuyet doi. Viec chu trong vao cac san pham sieu hang, lo hoan
thien no mot cach thai qua ma khong quan tam den thi trUdng va kha nang
tieu thu ch ic h in khong phai la mot cach nhin nhan dung ve chat liidng
theo nghia dong.
C h in g han, doi vdi nha san xuat, xet ve m at ky th u at va kinh te thi chat
lifdng cua san pham va dich vu cua ho trUdc het phai dap iing muc dich va
chien lUdc kinh doanh cua ho, dap iing nhu cau cua khach hang, cac quy
dinh ve phap ly ma san pham / dich vu cua ho cd lien quan dong thdi no phai
cd siic canh tranh vdi cac san pham va dich vu tUdng iing. D e thiic hien kinh
doanh lau dai, nha san xuat phai can nhac tat ca cac yeu to" tren.

Do sii phat trien cua khoa hoc va cdng nghe, cac san pham ngay nay
ngay cang trd nen phiic tap. Nha san xuat gid day khong chi cd trach nhiem
ve tinh trang chat liidng cua san pham khi xuat xUdng ma con phai chiu
trach nhiem ve tinh trang chat liidng cua san pham do trong suot qua trinh
khai thac, sii dung, van chuyen, lap dat, dao tao, hudng d in sii dung, bao
tri, siia chiia, cung iing phu tiing va tham chi phai chiu trach nhiem xii ly
chung khi chung het kha nang hoac thdi han sii dung. Tinh trang nay tu no
da lam cho khai niem chat liidng san pham hang hoa g in lien vdi nhiing
khia canh nhat dinh cua chat liidng dich vu va trong nhieu trudng hdp,
chinh khia canh ve chat liidng ciia dich vu di kem san pham do lai la chi tieu
chinh yeu giup cho san pham do cd siic tieu thu ldn.
Thiic ra, ngay nay ranh gidi giGa san pham mang tinh hang hoa va san
pham mang tinh dich vu cang ngay cang bi lu md. Cac san pham hang hoa
gid day deu kem theo "dich vu sau khi ban" va ngUdc lai mot san pham
mang tinh dich vu lai thUdng kem theo viec cung iing hang hoa, nhu hoat

dong cua cac ciia hang may do, sUa chiia, ciia hang an... Hau nhu trong moi
nganh deu cd miic do pha tap nao do giiia tinh hang hoa va dich vu va do
vay noi den chat liidng cua mot san pham ta khong the khong xet tdi cac dac
triing ve dich vu cua no.
Neu hieu dich vu la "ket qua cua cac hoat dong nay sinh tii cac moi q uan
he tiidng tac giGa ben cung iing va khach hang cung nhu cac hoat dong nay
sinh trong noi bo cua ben cung iing nham dap iing nhu cau ciia khach hang"

22


Trudng dai hocY te cdng cong

Quan ly chat li/png san xuat thuoc

(IS08402) thi chat lifdng khong chi con la sii hoan thien ddn thuan cac d^c
tinh ky thuat ma san pham phai co neu no dUdc sii dung theo muc dich cua
no (Mizuno). Chat lifdng con la sif hoan thien va gia tang gia tri cua san
pham tai tat ca cac giai doan co the cua no. Chat lifdng khong chi mang tinh
ky thuat ma con mang tinh nghe thuat. Dac diem nay cua chat lifdng lai lam
cho cac nha san xuat rat kho the hien nhiing tinh nang Uu viet do qua
nhiing thong so ky thuat hoac qua " mot sif dinh lifdng, hay vat chat hoa "
nao do giup khach hang nhan biet them ve chat lifdng san pham cua ho. De
bu lai, ho phai lUu y tdi cac khia canh tam ly, sd thich cua khach hang,
nhanh chong nSm bat dUdc nhiing mong muon cung nhu nhiing nhan dinh
cua ho de phuc vu.

Tit nhitng luqin diem tren, ta co the neu mot so nhan xet sau
1. Chat lifdng la mot khai niem rat chung vi vay phai xet no gan lien vdi
muc dich sii dung. Hieu theo nghia tinh nang ky thuat, khi danh gia

chat lifdng ciia mot san pham ta phai xet va chi xet nhiing dac tinh
ky thuat nao cd lien quan den sif thoa man nhiing nhu cau cu the do.
2. Chat lifOng luon dUdc bieu thi, do lUdng danh gia qua sii thoa m an
nhu cau ciia ngUdi sii dung ma ngudi sU dung rat da dang va ban
than nhu cau ciia tifng ngUdi sii dung cung luon thay doi nen chat
lu’dng cung luon luon bien dong theo thdi gian, khong gian, dieu kien
sii dung.
3.

N hu cau cd the dUdc cdng bo" ro rang dudi dang cac qui dinh, tieu
chuan nhUng cung cd nhiing nhu cau khong the m ieu ta ro rang, cd
nhiing nhu cau chi nay sinh trong qua trinh khai thac sii dung san
pham va do vay ngUdi sii dung chi co the cam nhan chung hoac cd khi
chi phat hien dUdc chung trong hoac sau qua trinh sii dung. N h u vay
chat lu’dng ciia san pham con the hien qua cac kha nang dap iing cac
nhu cau tiem an .

Vdi nhiing nhan xet tren, trong tieu chuan thuat ngii ISO 8402 ve chat
lUdng va quan ly chat lifdng, To chiic quoc te ve Tieu chuan hoa ISO da dua
ra dinh nghia dUdc dong dao cac quoc gia chap nhan dudi day:
"Chat litcfng la toan bo cac dac tinh cua mot thitc the tao cho thitc the do
kha nang thoa man cac nhu cau da cong bo hay con tiem an".

2. Miic chat lifdng
Chat lifdng luon g in vdi nhu cau sU dung. Nhiing san pham cd cac dac
tinh cung lien quan den cac nhu cau sii dung giong nhau cd the cd cac kha
nang dap iing nhiing nhu cau nay d nhiing miic rat khac nhau do nha san
xuat da thiet ke va hoan thien cac tinh nang nay d nhiing miic khac nhau.
Moi dac tinh ciia san pham luon cd the bieu thi qua mot dac trUng dinh
ltfdng nhu ve cdng suat. ve lifdng tieu hao nang lUdng/nhien lieu, toe do, tai,

23


Trudng dai hoc Y te cdng cong__________________________ Quan ly chat luong san xuat thuoc_
dip ben (tuoi tho).v.v., mot so dac tinh nhif ve dep, tao dang, sii hai hoa giiia
san pham va con ngtfdi hay mot so dac tinh cam quan n h u m au sac m iii vi,
sii tinh te cua san pham . v.v ve nguyen tie cung deu difdc bieu thi qua mot
tri so dinh ltfdng thfch iing (vl du theo he thang diem ). Viec xem xet m ot
cach dong thdi tat ca cac dac tinh do theo cung mot nguyen tac hay cong
thiic tinh toan nao do se cho ta mot tri so tUdng doi bieu thi “ miic chat
lifdng” cua no. N hiing san pham cung loai dung cho cung m ot m uc dich sU
dung giong nhau nhung co tri so tUdng doi nay khac nhau se co miic chat
lifdng khac nhau va dUdng nhien chung co gia ban va thi trUdng tieu thu
khac nhau.
N h iin g san p h a m m a n gay sau san x u a t cac chi tieu ch at lUdng cua
no khong dap iing cac nhu cau sU dung hoac cac san p h a m k h o n g dUdc
cai tien nen sau m ot thdi gian bi cac san p h a m canh tra n h cu n g lo a i day
lu i, khong con dUdc thi trUdng chap n h an dUdc gpi la san p h a m co “miic
chat lifdng lac hau

Miic chat lUdng
hap dan

/

Miic chat lUdng lac hau

Trai ngUdc v6i san p h a m co miic chat lifdng lac h au la san p h a m co
“miic chat lifdng h ap d^n - "a ttr a c tiv e q u ality le v e l” . D o th u d n g la n h lin 0
san p h a m co n h iin g dac tin h da dUdc th ie t ke va h oan th ien k h o n g chi ^

dap ling nhu cau sii d u n g th on g th u d n g cua no m a con co cac tin h n a n G
m 6i la, Uu viet hdn h an so v6i n h iin g san p h a m thong th u d n g v a thu'dn^
n h iin g tinh n an g n ay m a n g tinh doi m di, dot pha tron g cong n g h e san

24


Trudng dai hocY te cong cong

Quan ly chat luong san xuat thuoc

xuat. trong sii dung nguyen nhien vat lieu hay chinh trong qua trinh khai
thac sii dung no.
San pham co miic chat lUdng lac hau khong dUdc ngUdi sii dung chap nhan.

San pham co “mite chat liidng hap dan' thudng dinh hudng cho thi
trudng hep, chung thudng cd gia thanh cao nen liidng khach hang cung
han che.
Tai tu'ng thdi diem, tiing thi trUdng, moi chung loai san pham luon cd
“miic chat liidng tdi tiu". Do la miic chat liidng dap ling viia van nhu cau sU
dung cua khach hang chinh yeu ma muc tieu kinh doanh da hoach dinh.
Phai nhac lai rang, chat lUdng la mot khai niem tUOng doi va do vay miic
chat lu'dng cung cd y nghia tUo'ng doi. “Chat lu'dng la sii dap ung cac yeu cau
cua ngudi sU dung hien tai va tUdng lai” (Dem ing) nen miic chat lu'dng tdi Uu
hom nay cd the la miic chat liidng lac hau cua ngay mai. N hiing san pham
hien cd miic chat liidng hap dan hom nay thi ngay mai cd the chi dUdc xem
la dap ung dung nhu cau cua thi trUdng, nen nhieu ngUdi van goi chung la
nhiing san pham cd “miic chat liidng don dau\
Khai niem miic chat liidng khong chi giup ta danh gia va so sanh dinh
luong tinh trang chat liidng cua cac san pham cung loai ma con la phUdng

thiic dinh hudng cho cac nha san xuat trong chuan bi ke hoach. cd san cac
san pham ddn dau de thich iing vdi sii thay doi cua thi tru'dng.

Khi phan tich ve miic chat liidng ta da thay quan niem chat lu’dng la tren
het khong cd nghia la vdi moi gia ta phai phan dau de tao ra san pham cd
chat lu o n g cao nhat, lam chat lu'dng vdi moi gia. Le dudng nhien chat liidng
cang cao. chi phi de thiet ke, san xuat no cang cao. Chat liidng luon lien
quan den gia thanh va do do lien quan den su liia chon cua ngUdi tieu thu.
Luan diem "chat lu'dng la tren het" the hien d cho khi tiep nhan yeu cau cua
khach hang cu the hay cua thi trudng noi chung, trUdc het doanh nghiep
phai Uu tien phan dau de dat miic chat lu'dng theo veu cau cua no va chi dat
van de rut giam chi phi neu da dat miic chat lu'dng da neu. Tii nhiing nam
cua thap ky bay mUdi W.Edward Deming da noi “vao cuol thap ky nay, chi
cd cac cdng ty thudng xuyen dam bao muc tieu chat lu'dng, nang suat va cd
kha nang cung cap dich vu thi mdi ton tai dude” . Trong nhieu yeu to" canh
tranh, cac doanh nghiep deu thay yeu to" chat lu'dng luon mang tinh chien
lu'dc lau dai“ khach hang luon doi hoi chat lUdng va tUdng lai cua to chiic
phu thuoc vao dieu do.”
Trong noi bo cua moi to chiic, chat lUdng luon g&n lien vdi nghia vu va
quyen lo'i cua mdi thanh vien vi:

•

Ai cung inuon cd cdng viec on dinh, an toan

•

Ai cung muon gan bo, thoa man cdng viec

•

Ai cung muon dude ton trong

25


Trudng dai hocY te cdng cong

Quan ly chat luong san xuat thuoc_

• Ai cung muon dUdc tu hao ve cong viec ma minh da lam cho to chiic
cua minh

II. QUAN LY CHAT LU’dNG
Hoat dong quan ly da co tii khi con ngudi hdp tac vdi nhau de trong trot
san ban, de tu bao ve minh trUdc nhiing de doa cua thu du va thien
nhien.Tuy nhien dinh nghia ve quan ly rat da dang. Ngudi ta quan niem
quan ly la viec sU dung mot cach hufu ich nguon luc de dat dUdc nhiing muc
tieu cu the nao do. Vi nguon luc bao gom cac nguon tai chinh, nguon tai
nguyen cua cai va mot yeu to' rat quan trong khac do la nguon nhan liic nen
quan ly khong don thuan la viec khai thac sii dung ma con mang tinh chat
kiem soat, dieu khien con ngudi. "Quan ly la cach de dat diitfc nhiing ket qua
thong qua to chiic va dieu phoi hoat dong cua con ngiidi” ] tao dUdc sii hop
tac, giidng mau tich cUc di dau, dong vien thuc day moi ngudi lam viec de
phuc vu cho muc tieu da de ra tiic la da lam quan ly. Hoat dong quan ly lien
quan den con ngudi nen Uquan ly la mot nghe thuat iing xu?'. Mot ngudi quan
ly tot la ngudi biet hoa minh, biet thuc day sU dong gop, sang tao, biet cach
danh gia va iing xii phu hdp vdi moi ngUdi. Qua thuc cd nhiing ngudi bam
sinh da cd tai quan ly nhung hau het moi ngudi hoc dUdc nghe thuat quan ly
thong qua kinh nghiem, cdng viec va cac mo hinh, nhieu ngudi hoc quan ly

thong qua qua trinh dao tao chinh thong. l‘Quan ly la mot nghe nghiep, hon
the cac quyet dinh quan ly deu phai diia tren viec phan tich mot cach he
thong va logic moi thong tin kinh te, ky thuat thu diidc theo nhiing phiidng
thiic khac nhau nen Uquan ly la mot nganh khoa hoc thiic thu \ Du xet theo
khia canh nao thi tUu trung lai, quan ly la viec can doi thdi gian, nguon luc
nham hoan thien va phat trien tot hon cac muc tieu nao do cua moi to chiic
Quan ly cung cd the dUdc quan niem ddn gian nhu tien si N oriaki Kano
cd dUa mot vi du: Neu ban shn tien va muon ngay lap tiic cd mot ngoi nha,
ban chi viec bo tien ra mua no. Trong trudng hdp nay ban c h in g can gi tdi
hoat dong quan ly. Nhung neu ban chua cd du tien ma ban m uon co mot
ngoi nha theo mot cach tiet kiem, dap iing dung y dinh cua ban hdn. luc do
ban phai “lam quan ly“ de thuc hien y dinh do. TrUdc het ban phai len ke
hoach tiing budc cho y dinh do, thiic hien no, kiem tra xem xet xem lieu no
tien trien ra sao va khi can ban phai cd cac giai phap hieu chinh kh&c phuc
de ke hoach cua ban dUdc thuc hien nhu ban da de ra.
Nhiing quan niem khac nhau ve quan ly cung nay sinh do doi tUdng
quan ly khac nhau. Ngay trong llnh ^ c dUdc pham da cd hoat dong quan ly
san xuat thuoc. quan ly phan phoi thuoc, quan ly van chuyen, quan ly kho
bai bao quan, quan ly thuoc tai cac cd sd y te, quan ly doi ngu nhan vien
trong cac linh vUc cdng viec lien quan nhiing van de tren. .v.v.
Ro rang quan ly chat liidng noi chung cung nhu quan ly chat luong cua

26


Trudng dai hocY te cdng cdng

Quan ly chat luong san xuat thuoc

nhiing dang hinh hoat dong khac nhau trong lmh vUc san xuat cung iing

thuoc noi rieng chi la mot trong so" rat nhieu nhiing doi tUdng cua hoat dong
quan ly. Tuy nhien vi chat liidng dUdc hinh thanh hoac bi anh hudng tai tat
ca cac khau ma no co lien quan nen dudng nhu khi noi den quan ly chat
liidng la chung ta da noi den hau het cac khia canh quan ly khac. Tieu
chuan IS08402 dinh nghia “quan ly chat liidng la toan bo cac hoat dong cua
chiic nang quan ly de xac dinh chinh xac cac muc tieu, trach nhiem va viec
trien khai ap dung no thong qua cac phUdng phap nhu lap ke hoach chat
liidng, kiem soat chat liidng, dam bao chat liidng va cai tien chat liidng”
Trong trUdng hdp dang de cap cua chung ta, de co the canh tranh va ton
tai, moi doanh nghiep deu mong muon san xuat va cung iing dUdc cac san
pham co chat liidng dap iing mot cach tot nhat nhu cau cua khach hang va
do vay ho deu phai quan ly chat liidng. Hieu mot cach ddn gian doanh
nghiep phai de ra nhiing hoat dong can thiet va thuc hien chung trong
nhiing dieu kien xac dinh de sau mot giai doan nao do dat dUdc mot cach
hiiu ich va hieu qua nhiing muc tieu cu the cua ho . TrUdc khi phan tich
ban chat va dac diem cua quan ly chat liidng chung ta hay neu va phan
t ic ^ m o t sd" hoat dong cu the cd lien quan mat thiet cua no.

1. Kiem tra chat lifdng
Kiem tra chat liidng la viec “do, xem xet, thii nghiem mot hay nhieu dac
tinh cua san pham va so sank ket qua vdi cac yeu cau de ket luan ve sii phu
hdp hay khong phu hdp” .
PhUdng phap nay ton tai ngay khi cd hoat dong san xuat san pham va
trao doi hang hoa. Ngay trong qua trinh san xuat thii cdng, khi hoan thanh
mot budc cdng viec nao do hay khi hoan thanh mot san pham, ngudi thd lam
ra san pham do da phai do dac, xem xet hay thii nghiem mot so" tinh chat
nao do de quyet dinh xem san pham hay cdng viec minh lam ra cd thoa man
hay khong trUdc khi chuyen sang budc cdng viec tiep theo. Trong san xuat
cdng nghiep, hoat dong kiem tra tai cac cdng doan cang cd y nghia vi ta se
kip thdi tach loc cac ban pham, thanh pham khong dat cac yeu cau chat

liidng ra khoi day chuyen san xuat de xU ly, han che cac ton hai do sii lln
Ion cua chung se gay ra nhiing hong hoc trong nhiing cdng doan tiep theo
cung nhu han che" nhiing ton hao kinh te khong can thiet cua viec tiep tuc
gia cdng, xii ly chung.
Ro rang phu'dng phap nay la can thiet va nhieu khi la bat buoc. Tuy
nhien phUdng phap nay chi cd tac dung phan loc cac san pham xau va san
pham tot khi tinh trang chat lUdng cua chung da hinh thanh con ban than
hoat dong kiem tra tii no khong lam tang them hay cai thien tinh trang chat
liidng da hinh thanh do. NgUdi ta noi “kiem tra la mot hoat dong mang tinh
thu dong, doi p h o ".

27


Trudng dai hocY te cdng cong

Quan ly chat luong san xuat thuoc

Mat khac do han che ve thdi gian kiem tra, do nhiing gidi han ve chi
phi danh cho no va vi ban than hoat dong kiem tra co the lam suy giam
tham chi pha huy chat liidng cua san pham nen viec kiem tra chi co the
dUdc thiic hien theo mot ty le dai dien nao do trong cac lo hay me san
pham. Cach kiem tra theo kieu dai dien nhu vay ro rang khong the dam
bao tinh trang chung cho chat lifdng cua tat ca cac san pham da dUdc san
xuat. Vi vay, vdi cac chi tiet hay cac san pham phiic tap ma viec de lot liidi
tinh trang hong hoc cua chung ra thi trUdng hay sang cac cong doan sau co
the gay nhiing ton hai nghiem trong, ngUdi ta b^t buoc phai kiem tra toan
bo 100% cac san pham do neu tinh chat cua hoat dong kiem tra cho phep.
Dang lUu y la ngay viec kiem tra 100% cung khong dam bao tinh chinh
xac tuyet doi trong phan loc hay noi khac di, ta van phai chiu sii lot ludi nao

do cua cac san pham sai hong. Dieu nay thoat nghe co ve phi ly nhung thuc
te la vay. Hoat dong kiem tra von ddn dieu lai phai lap lai thudng xuyen nen
du can than den dau, tinh ddn dieu, sii met moi se lam nhan vien kiem tra
co sU nham lan trong cac budc thao tac, trong doc cac tri so". Vdi nhiing lo
san pham ldn, dac biet la cac san pham “t&m tam” nghia la miic do hong hoc
cung nhu tinh nguy hai cua no khong hoac kho the hien ro, nhiing ngudi lam
cdng tac kiem tra tham chi con cd tam ly sau mot quang thdi gian kiem tra
nao do, the" nao cung phai phat hien dUdc nhiing san pham sai hong va vi
vay choc choc lai phai “viit mot vai san pham sang thim g sai hong” de minh
chiing cho tinh hieu qua trong cong viec cua minh.

2. Kiem soat chat lifc/ng
Vi kiem tra chat liidng chi quan tam cuc bo tdi chinh san pham do va
mang tinh thu dong, ngudi ta thay can phai cd phUdng thiic chu dong, mang
tinh phong ngUa nh&m kip thdi xem xet va khong che, dieu chinh dUdc moi
yeu to" cd the anh hudng den tinh nang chat lUdng cua no trUdc va trong qua
trinh cac tinh nang do dude hinh thanh va thuc hien. PhUdng thiic do la hoat
dong kiem soat chat liidng.
Kiem soat chat liidng la cac hoat dong va ky thuat m ang tinh tac nghiep
diidc sit dung de dap iing cac yeu cau chat liidng
^ Kiem soat chat lUdng la viec xac dinh va khong che", dieu chinh dUdc moi
yeu to co anh hudng triic tiep den qua trinh tao ra chat liidng de cac yeu to
do dUdc duy tri hoac chi bien dong trong nhiing dung sai xac dinh va nhd do
chat liidng cua san pham se dUdc dam bao. Cac yeu to lien quan thudng la:
a. Nguon nhan liic: Du sif dung cdng nghe san xuat ddn gian hay hien
dai thi trinh do thong hieu ve nghiep vu, thao tac cua con ngudi van
luon la yeu to quyet dinh den chat liidng san pham. NgUdi thao tac
phai dUdc dao tao de thong hieu nghiep vu chuyen mon, ky nang
thanh thao trong cong viec, cd du siic khoe va nhiing chuan muc cu

28


Trudng dai hocY te cdng cong

Quan ly chat luong san xuat thuoc

the theo tiing nghe nghiep. Kiem soat nguon nhan liic la viec neu
dung va du cac chuan mUc cho nhiing cong viec cu the dong thdi cd
dUdc phuong thiic de giup ho tuan thu, dat cac chuan miic do. Dao tao
tham xet kha nang cua nhiing ngudi lam viec theo nhiing chuan miic
va nhiing noi dung dUdc dao tao, danh gia kha nang thiic hien cua ho
qua cac cdng viec va qua cac qua trinh dao tao la nhiing giai phap
thong thudng de kiem soat con ngudi. Phan quan ly nguon nhan liic
se trinh bay ky hon van de nay.
b. Thiet bi va phUdng tien san xuat: Thiet bi va phUOng tien san xuat
phai du, cd san, phu hdp vdi nhung yeu cau cu the cd lien quan den
cac chi tieu chat liidng san pham. Tren cO sd cua cac yeu cau chat
lu'dng da dUdc the hien qua cac chi tieu ky thuat, ta can nam dUdc
thiic trang cac thiet bi hien cd, tinh nang ky thuat, do chinh xac hay
kha nang duy tri cac tham sd" cdng nghe, gia cdng cua chung va quan
trong hdn phai neu dUdc cac phUdng thiic, phUdng phap de do dac,
theo doi cac thong sd" do cua chung. Phai lap dUdc lich bao tri, bao
dudng thay the phu tiing, dung cu ga lap, cac chi tiet phu trd.
c.

PhUdng phap, quy trinh, quy pham thiic hien: PhUdng phap, quy
trinh. quy pham la nhiing hudng dan thao tac cu the cho tiing cdng
viec. Kiem soat chung khong chi la viec nghien ciiu xay diing chung
mot cach khoa hoc, thich iing nhat vdi tinh trang thiet bi va kha nang

quan ly ma chung con phai tuan thu nhiing quy dinh nhu tinh thong
nhat, tinh ddn gian. tinh cd san va dude cap nhat kip phuc vu cho
ngudi thao tac. Viec xay diing cac quy trinh. quy pham, hudng d in
phai tuan thu mot thu tuc chung bao gom lap va neu dUdc cd sd cho
nhung danh muc cac tai lieu can xay dung, khuon m lu de xay dung
nham dam bao tinh thong nhat, phan cdng ngUdi chuan bi, ngUdi
tham xet, phe duyet. viec in an, cap phat, theo doi cac noi dung sUa
doi hay viec thay the" huy bo chiing.

d. Tinh trang nguyen nhien lieu: Chat ludng san pham phu thuoc vao
nguyen nhien lieu. De kiem soat tinh trang chat lu'dng nguyen
nhien lieu ta can biet du'o’c moi dac tinh cd lien quan den tinh trang
chat lu'o'ng san pham cua minh va cd dude phudng thiic va phudng
phap kiem tra chung. Trong rat nhieu cdng nghe san xuat va che
bien, tinh trang nguyen nhien lieu khong chi can duoc kiem soat
khi ta mua chung ma con can du'qc kiem soat tu' khau nuoi trong,
van chuyen... Nguon goc va su on dinh ve chat ludng cua nguyen
nhien lieu vi vay rat quan trong. Cac loai nguyen nhien vat lieu
chu chot, phai mua thudng xuyen thudng cd the dude kiem soat qua
viec mua chung tii nhiing nha thau phu da dude phe duyet theo
mot vai chuan miic thich iing nhu:

29


Trudng dai hocY te cong cong

Quan ly chat luong san xuat thuoc

-

Tinh trang on dinh cua chat liidng qua cac dot giao hang (so, ty le
san pham sai hong).

-

Thdi han giao hang theo hdp dong (dung han, sdm. muon 1, 2, 3, 4
ngay).

-

Gia ca canh tranh, dieu kien thanh toan (tra trUdc, tra sau. lai
suat)

-

Dia diem giao hang, phudng thiic van chuyen boc dd

e. PhUdng tien do ludng thu nghiem: De kiem tra nguyen vat lieu, ban
san pham, thanh pham, theo doi cac thong sd thiet bi, thong so qua
trinh ta can cd cac dung cu do ludng thii nghiem thich iing. Kiem soat
trang thiet bi do ludng thii nghiem la viec trang bi (bao gom ca viec tu
thiet ke, che tao) du va phu hdp cac phudng tien do va thu nghiem, he
thong chuan1, chat chuan do ludng can thiet; hdp ly va kinh te phu
hdp vdi nhu cau sii dung va tiem liic cua doanh nghiep/ to chiic.
Trang thiet bi phai du de thiic hien moi phep do dung trong thiet ke,
che thii, trong san xuat, trong kiem tra, thu nghiem xuat xUdng cung
nhu nhiing tinh huong phai kiem tra do dac xay ra trong qua trinh sU
dung cua khach hang. Neu trang thiet bi thieu chung ta khong dam
bao cac phep do tren nhung chung ta lai trang bi cac dung cu do

ludng thu nghiem du thiia tinh nang, cdng suat ma nhu cau hien tai
va ca nhu cau khi md rong san xuat cung khong khai thac het thi se
rat lang phi. Kiem soat trang thiet bi do ludng con nham dam bao
chung luon d trang thai lam viec va dat do chinh xac can thiet. De
lam viec nay can lap ke hoach siia chua, bao tri bao dudng va dac biet
phai tuan thu lich hieu chuan , kiem dinh thich hdp cho moi dung cu
do ludng thii nghiem hien cd
f.

Thiet lap phUdng thuc trao doi thong tin: Can phai thiet lap va
kiem soat moi quan he thong tin giUa cac khach hang va doanh
nghiep de nam bat dUdc moi nhu cau, khieu nai tit ho. M oi quan he
nay khong chi the hien qua cac ddn dat hang, qua cac dich vu ma
con the hien trong suot qua trinh khach hang khai thac sU dung
san pham hay dich vu cua to chiic\doanh nghiep. Can lap he thong
thu hoi y kien phan anh cua khach hang khong chi tii cac phong
chiic nang cua doanh nghiep ma con tu! cac dai ly, cac ciia hang tieu
thu d cac khu viic, dia diem khac nhau. De dieu hanh tot hoat dong
trong doanh nghiep, can kiem soat kip thdi va chinh xac moi thong

1 chuan: la vat do, phudng tien do, mau chuan hoac he thong do de dinh nghia. the
hien, duy tri hoac tai tao don vi hoac mot hay nhieu gia tri cua dai luong va duoc
dung de lam moc so sanh

30


Quan ly chat lugng san xuat thuoc

Trudng dai hocY te cong cdng

tin noi bo. Muon vay c ln lap va duy tri moi quan he thong tin theo
chiic nang ngang cung nhu cac moi thong tin dieu hanh theo cd cau
to chiic.
g. Moi trUdng ly hoc va moi trUdng lam viec: Kiem soat moi yeu to lien
quan moi trUdng ly hoc nhu cac nguon xa thai nUdc, khi, mui hoi
thdi, bui hay cac chat doc hai, o nhiem khong chi la kiem soat cac
yeu to" trUc tiep tac dong tdi chat liidng cua san pham ma con la
nhiing dieu kien rang buoc ve trach nhiem cua doanh nghiep doi
vdi ngUdi lao dong va xa hoi. Doanh nghiep phai chi ro moi khia
canh mdi trUdng, moi nguon phat thai de nhan biet cac tac dong cd
the cua chung tdi tinh trang mdi trudng, cd bien phap loai bo, han
che hoac xii ly chung tdi mot miic dUdc cac quy dinh phap luat lien
quan kiem soat mdi trUdng chap nhan dong thdi cung dam bao an
toan, siic khoe cho ngUdi lao dong. Pham vi kiem soat mdi trUdng
con mang y nghia rong hdn. Do la tao mdi trUdng ve tinh th in de
tai do ngUdi lao dong cam thay gan bo va cd kha nang dong gop
nhieu hdn cho doanh nghiep.
Nhiing yeu to" ma hoat dong kiem soat chat liidng phai quan tam den
dUdc the hien trong hinh ve sau:

M di tru d n g ly h o c va tinh than

T hiet bi va ph ira n g tien san xu a t
N g u o n lire

3. He thong quan ly chat liidng
Khi quy mo san xuat md rong, viec dieu hanh san xuat noi chung cung
nhu quan ly chat lu’dng san pham noi rieng se trd nen phiic tap doi hoi viec
hinh thanh cac bo phan phong ban rieng biet de thuc hien cac nhiem vu

31


Trudng dai hocY te cong cong

Quan ly chat luong san xuat thuoc

chiic nang v6i sii phan cong trach nhiem ro rang. Cd cau to chiic chuyen
quyen menh lenh cua ngudi chu da phai dUdc thay the bang cd cau to chiic
hdp tac thong qua quan he hdp tac giiia cac phong ban, bo phan chiic nang.
Cd cau do khong con mang tinh doc lap, chuyen quyen ma cung hoat dong
trong mot moi quan he phu thuoc lan nhau. Quyen quyet dinh va xem xet
cua ca nhan da phai can cii tren xem xet quyet dinh cua nhom nhieu ngUdi.
Dac biet trach nhiem cua chat lUdng san pham khdng chi cdn la trach nhiem
cua cac bo phan chuyen trach ve kiem tra, kiem soat chat lUdng ma la trach
nhiem cua tat ca mei ngUdi trdng ddanh nghiep/ td chiic.

Neu nhu cac muc tieu chat ludng triicic kia mang tinh chat ngan han,
cuc b6 thi gid day n6 phai dUdc xay diing tren cd sd muc tieu chung, dung
hoa mdi muc tieu cu the mang tinh cuc bo cua cac phong ban, bo phan va
chung phai la nhiing muc tieu lau dai, lien quan den sii ton tai va phat
trien cua doanh nghiep. Nhiing su thay doi nay doi hoi hoat dong quan ly
chat ludng phai c6 cac bd phan chiic nang chuyen biet de cung phdl hdp
thiic hien nhiing hdach dinh cu the ve cac muc tieu chat liidng cua ddanh
nghiep. Nhu c lu nay da buec cac heat d6ng quan ly chat ludng phai dUdc
thiic hien tren cd sd he thdng, nghia la co mot cd cau to chiic vdi sii phan
cong quy dinh ro rang ve trach nhiem, quyen han va diidc dieu hanh theo
mot he thong cac quy dinh da diidc xac lap. Hinh ve du6i day ve chu trinh
chat ludng da n6i len m6i lien he va nhu cau cua viec kiem sdat, dieu phdl

cac mdi lien he giiia cac qua trinh.
Thed hinh ve ta thay chat ludng dUdc hinh thanh va phai dUdc kiem soat
tai tat ca cac khau. Khai niem va thiic chat viec quan ly chat ludng mang
tinh he thdng von da hinh thanh va dUdc thiic hien tu: lau nhung vi ban than
hoat dong va he thong quan ly chat liidng luon la mot bo phan cau thanh
khong tach biet vdi he thong to chiic va quan ly san xuat noi rieng cua moi
doanh nghiep, nen nhieu khi ngiidi ta khong xem xet chung mot cach tach
biet. Ngay nay ngiidi ta quan niem "He thong quan ly chat littfng la co cau
32