CONTOH Laporan FMEA Farmasi
August 18, 2022 | Author: Anonymous | Category: N/A
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ZFEF^C ZFEF^COQ OQGM GM IGN/IHQG ...... ACOG[ IF[FMGQGO
VZQA ZV[IF[EG[ ......... G`gegt 4 ......................... .........................
BGC@V^F EHAF GOA FBB FBBFKQ FKQ GOG@S[C[ GOG@S[C[ (BEFG)
VOCQ IF^DG
4 Bgregsc
QCE BEFG
Zcepcogo Qce
4 Iftug Qce IZ
Gollhtg
4 Gphtfifr,Gscstfo Gphtfifr
Zftulgs Oh Ohtu`f u`fo
4 Gscstfo Gphtfif ifrr
Qudugo Zfenfotuigo Qce BEFG
Ef`giuigo cafotcbcigsc, pfoc`gcgo, gog`cscs ago efoyusuo rfihefoagsc pfrngc pfrngcigo igo tfrmgagp prhsfaur Zf`gygogo Hngt
Qgolluol Dgwgn Qce
g. Cafotcbcigs Cafotcbcigscc ( efoyusuo efoyusuo rflcst rflcstfr fr rcscih rcscih ac Bgregsc Bgregsc)) n. Ef`giuigo gog`cscs (BEFG) k. Efoyusu Efoyusuo o rfihef rfihefoag oagsc sc pfrngc pfrngcigo igo a. Ef`gisgogigo Ef`gisgogigo prhsfaur prhsfaur mgsc` mgsc` pfrngcigo pfrngcigo ( Cep`fefotg Cep`fefotgsc sc prhsfaur prhsfaur ngru mgsc` mgsc` pfrngcigo) pfrngcigo) f. Ef`giu Ef`giuigo igo fvg`ugsc fvg`ugsc cep`fe cep`fefot fotgsc gsc Zrhsfa Zrhsfaur ur ygol ygol ngru ngru
C.
G@V^ Z^ Z^H[F[ SGOL AC ACGOG@C[G4 Zf`gygogo Zf`gygogo Hngt 7. Ahitfr efou`cs ^fsf
> ^fsfp actfrceg Zgscfo/if`ugrlg Zgscfo
6 Zgscfo/if`ugrlg pgscfo efofrceg hngt
; ^fsfp
1 Zftulgs ^ugol Bgregsc
1g Efepfrscgpigo hngt
1n Efenugt Ftcift
1k Efefrcisg ifsfsugcgo rfsfp, hngt, ftcift
^fsfp `upg acsfrgmigo CAFOQCBCIG[C BG BGC@V^F EH EHAAc`ftgiigo F nuigo pgag tfepgtoyg ^fsfp dgtum/mc`gol agrc wgagmoyg
CC.
Qu`csgo tcagi df`gs ac ngkg Zfrecotggo cokhep`ftf Hngt tcagi sfsugc bhreu`grcue Zfolluoggo scoligtgo ygol tcagi df`gs
Ifsg`gmgo tf`ggm rfsfp Ifsg`gmgo efrgkci
1g Efepfrscgpigo hngt
7. Ahitfr efou`cs ^fsfp
> ^fsfp actfrceg Zgscfo/if`ugrlg Zgscfo
6 Zgscfo/if`ugrlg pgscfo efofrceg hngt
; ^fsfp Zfou`csgo ftcift sg`gm
1 Zftulgs ^ugol Bgregsc
Efoyfrgmigo pgag hrgol ygol sg`gm Cobhregsc hngt ygol tcagi df`gs
CC CCC. C.
1n Efenugt Ftcift
1k Efefrcisg ifsfsugcgo rfsf rfsfp, p, hngt, ftcift
QVDV QVDVGO GO EF@ EF@GI GIVI VIGO GO GOG@C OG@C[C [C[ [ BEFG BEFG Gog`cscs BEFG ac Bgregsc ac`giuigo uotui efolfog`c/efoaftfisc iflglg`go/ifsg`gmgo
ygol euolico gigo tcenu` tcenu` sfrtg sfrtg gicngtoyg gicngtoyg ago efolfog`c efolfog`c pfoyfngn tfrdgacoyg sfnf`ue efodgac egsg`gm ygol nfrngmgyg ac bgregsc nglc pgscfo ago igrygwgo. CAFOQCBCIG[C GICNGQ DCIG QF^DGAC BGC@V^F EHAF VOQVI QCGZQCGZ BGC@V^F EHAF
CR.
Oh.
Bgc`urf Ehaf
Fbfkt/Gicngt
7
Qu`csgo tcagi df`gs acngkg
[g`gm hngt, ahscs, brfiwfosc ago rutf
>
Zfrecotggo cokhep`ft
[g`gm ahscs, brfiwfosc ago rutf
;
Hngt tcagi sfsugc Bhreu`grcue
Zgscfo efenf`c hngt ac `ugr
1
Zfolluoggo [coligtgo ygol tcagi df`gs
[g`gm hngt, ahscs
6
^fsfp `upg acsfrgmigo
Qcagi efoagpgt hngt
2
^fsfp ac`ftgiigo nuigo pgag tfepgtoyg
Qcagi efoagpgt hngt, efolgotrc `fncm `geg
<
^fsfp dgtum/mc`gol agrc wgagmoyg
Qcagi efoagpgt hngt, efolgotrc `fncm `geg, mgrus efecotg rfsfp agrc rugol pf`gygogo ifeng`c
=
Ifsg`gmgo tf`ggm rfsfp
[g`gm hngt, ahscs, agpgt efocenu`igo Fbfi [gepcol
3
Ifsg`gmgo efrgkci
[g`gm hngt ago ahscs
7:
Zfou`csgo ftcift sg`gm
[g`gm ahscs, brfiwfosc ago rutf
77
Efoy Efoyfr frgm gmig igo o hng hngtt pga pgagg pgs pgscf cfo/ o/hr hrgo gol l ygo ygol l ssg` g`gm gm
[g [g`g `gm mh hng ngt, t, Ifrg Ifrgku kuog ogo,I o,IQA QA,, IQK IQK,, IOK ago IZK
7>
Cobhregsc hngt ygol tcagi df`gs
[g`gm kgrg efolihosuesc hngt, mgsc` tcagi ngci
VZGSG CAFOQCBCIG[C ZFOSFNGN AG^C ZFOSFNGN AG^C QCGZ BGC@V^F EHAF AGO VZGSG SGOL QF@GM AC@GIVIGO VOQVI EFOLGQG[C EFOLGQG[C BGC@V^F BGC@V^F EHAF
R.
O h
Bgc`urf Ehaf
Zfoyfngn
Vpgyg ygol gag
7
Qu` u`cs csgo go tc tcag agi i df`g df`gss ac acng ngkg kg
Ef Efou ou`c `css tfrn tfrnur uruu-nu nuru ru
Ef Efol olmu munu nuol olcc ahit ahitfr fr pf pfou ou`c `css rfsfp uotui ihobcregsc
>
Zfrecotggo cokhep`ft
Efou`cs tfrnuru-nuru ago sthki hngt nf`ue ac shscg`csgcig shscg`csgcigo o
Efolmunuolc ahitfr pfou`cs rfsfp uotui ihobcregsc ago shscg`csgsc sthi hngt.agrc Bgregsc if Voct> Zf`gygogo
;
Hngt tcagi sfsugc Bhreu`grcue
Ahitfr efenutumigo hngt sfsugc -[hscg`csgsc sthki hngt agrc af afol olgo go coac coacig igsc sc tftg tftgpc pc tcag tcagi i Nlgcgo Bgregsc if Voct> tfrkgotue ag`ge bhreu`grcue Zf`gygogo
1
Zfolluoggo [coligtgo ygol tcagi df`gs
Efou`cs tfrnuru-nuru, tcagi tfrsfacg agbtgr scoligtgo ac efdg ifrdgoyg
Efolmunuolc ahitfr pfou`cs rfsfp uotui ihobcregsc
6
^fsfp `upg acsfrgmigo
Zgscfo tcagi bhkus igrog sgict
- Efoagmu`uigo pgcsfo `goscg gtgu ^fsfp acenc`igo h`fm pftulgs
2
^fsfp ac ac`ftgiig igo on nu uigo pgag tfepgtoyg
Zgscfo tfrnuru-nuru tfrnuru-nuru ago tcagi gag gag pftuodui pfoycepgogo rfsf rfsfp p ac Zusifsegs
Efenugt pftuodui pfoycepgo rfsfp ago Efolcolgtigo pgscfo uotui ef`ftgiigo ac tfepgtoyg
<
^fsfp dg dgtum/mc`gol a aggrc wgagmoyg
\gagm tcagi efodgeco ifgegogo rfsfp ( rusgi)
Efoyfacgigo ihtgi uotui efoycepgo rfsfp
=
Ifsg`gmgo tf`ggm rfsfp
Zftulgs bgregsc tfrnuru-nuru igrog due`gm pgscfo yl yl nogygi
Efefrcisg u`gol hngt sfnf`ue acsfrgmigo if pgscfo
3
Ifsg`gmgo efrgkci
Zftulgs iurgol tf`ctc
Efefrcisg u`gol hngt sfnf`ue acsfrgmigo
7:
Zfou`csgo ftcift sg`gm
Zftulgs iurgol tf`ctc
Efefrcisg u`gol hngt sfnf`ue acsfrgmigo
77
Ef Efoy oyfr frgm gmig igo o hngt hngt pgag pgag pgscfo/hrgol ygol sg`gm sg`gm
Zgscfo tcagi efoafolgr pgollc`go afolgo df`gs
Efegstcigo ecoceg` > cafotctgs pgscfo, ( ogeg , ueur ago if`umgo)
7>
Co Cobh bhre regs gscc hn hngt gt yg ygol ol tca tcagi gi df`gs
Zftulgs tfrnuru-nuru
-Efenugt Kgp agbtgr tc`ci ZCH ygol ac tfrgpigo ac nf`gigol ifrtgs rfsfp
RC.
ZF^MCQVOLGO ^ZO Qgmgpgo prhsfs
Bgc`urf ehaf
Ahitfr 7. Qu` u`cs csgo go tcag tcagi i efou`cs ^fsfp df`gs ac ngkg
gicngt
[ ([fvfrcty)
H (ifeuolic ogo tfrdgac)
A Ifeuagmg o acaftfisc
^ZO ([xHxA)
[g`gm hngt, ahscs, brfiwfosc ago rutf
7:
2
>
7>:
>. Zfre Zfreco cotg tggo go cokhep`ftf
[g`gm ahscs, brfiwfosc ago rutf
=
2
>
32
;. Hn Hngt gt tca tcagi gi sfsugc bhreu`grcue
Zgscfo efenf`c hngt ac `ugr
7
>
>
1
1. Zf Zfol ollu luog oggo go scoligtgo ygol tcagi df`gs
[g`gm hngt, ahscs
=
7
>
72
6. ^fsfp `upg acsfrgmigo
Qcagi efoagpgt hngt
>
7
>
2. Ac Ac`f `ftg tgii iigo go nuigo pgag tfepgtoyg
Qcagi efoagpgt hngt, efolgotrc `fncm `geg
>
7:
>
1:
6
>
>:
=. Ifsg Ifsg`g `gmg mgo o tf`ggm rfsfp
[g`gm hngt, ahscs, agpgt efocenu`igo Fbfi [gepcol
7:
6
;
76:
Ifsg`gmgo efrgkci
[g`gm hngt ago ahscs
=
>
>
;>
7:.
Zfou`csgo ftcift sg`gm
[g`gm ahscs, brfiwfosC ago rutf
=
1
>
21
77.
Efoyfrgm igo hngt pgag pgscfo/hrg ol ygol sg`gm
[g`gm hngt, Ifrgkuogo, IZK, IOK
7:
;
;
3:
^fsfp actfrceg Zgscfo/if`ugrl g Zgscfo
^fsfp
Zftulgs ^ugol Bgregsc
3.
1
Efepfrscgpig o hngt
Efenugt Ftcift
Efefrcisg ifsfsugcgo rfsfp, hngt, ftcift Zgscfo/if`ugrl g pgscfo efofrceg hngt
7>.
RCC. RC C.
Cobhregsc hngt ygol tcagi df`gs
[g`gm kgrg efolihosuesc hngt, mgsc` tcagi ngci
>
;
>
7>
BGC@V^ GC@V^F F EHAF EHAF SGO SGOL L GIG GIGO O AC[F@ AC[F@F[ F[GC GCIG IGO O
Nfragsgrigo oc`gc ^ZO acgenc` kut hbb phcot ygctu phcot 7 sgepgc afolgo 6 Oh.
Bgc`urf ehaf
gicngt
[ ([fvfrcty)
H (ifeuo licogo tfrdgac)
A Ifeua gmgo acaftfi sc
^ZO ([xHx A)
Iueu `gtcb
% Iue u`gtcb
7
Ifsg`gmgo ttff`ggm rfsfp
[g`gm hngt, ahscs, agpgt efocenu`igo Fbfi [gepcol
7:
6
;
76:
76:
>;.7
>
Qu`csgo tcagi df`gs ac ngkg
[g`gm hngt, ahscs, brfiwfosc ago rutf
7:
2
>
7>:
>
32
;22
62.6
1
Efoyfrgmigo h hn ngt pgag pgscfo/hrgol pgscfo/hrgol ygol sg`gm
[g`gm hngt, Ifrgkuogo, IZK, IOK
7:
;
;
3:
162
21
6>:
=:.>
2
Ac`ftgiigo nuigo pgag tfepgtoyg
Qcagi efoagpgt hngt, efolgotrc `fncm `geg
>
7:
>
1:
62:
<
Ifsg`gmgo efrgkci
[g`gm hngt ago ahscs
=
>
>
;>
63>
=
^fsfp dgtum/mc`gol agrc wgagmoyg
Qcagi efoagpgt hngt, efolgotrc `fncm `geg, mgrus efecotg rfsfp agrc rugol pf`gygogo ifeng`c
>
6
>
>:
27>
3
Zfolluoggo scoligtgo ygol tcagi df`gs
[g`gm hngt, ahscs
=
7
>
72
2>=
7:
Cobhregsc hngt ygol tcagi df`gs
[g`gm kgrg efolihosuesc hngt, mgsc` tcagi ngci
>
;
>
7>
21:
77
^fsfp `upg acsfrgmigo
Qcagi efoagpgt hngt
>
7
>
1
211
7>
Hngt tcagi sfsugc bhreu`grcue
Zgscfo efenf`c hngt ac `ugr
7
>
>
1
21=
:.2
RCCC. ^FOKGOG ^FOKGOG QCOAGI @GODVQ @GODVQ VOQVI VOQVI EFOLG EFOLGQG[C BGC@V^F BGC@V^F EHAF Qgmgpgo prhsfs
Ahitfr efou`cs ^fsfp
Bgc`urf ehaf
gicngt
[
H
A
^ZO ([xHxA)
Zfogoll uol dgwgn
\gitu
7;.Qu`csgo tcagi df`gs ac ngkg
[g`gm hngt, ahscs, brfiwfosc ago rutf
7:
2
>
7>:
71. Z Zfftulgs Bgregsc efolfk olfkffi rfs fsfp fp afolgo sfisgeg 76 76.. Dcig Dcig Zft Zftul ulgs gs tcagi tcagi ncsg efengkg egig egig ih ihob obcr creg egsc sc u`gol if ahitfr 72 72.. Ih Ihrf rfis iscc [HZ [HZ
Zfogoll uol Dgwgn Bgregsc
s/a ;: Du`c >:7=
7
32
7=. Zf Zftulgs Bg B gregsc efolfk olfkffi rfs fsfp fp afolgo sfisgeg 73. Zf Zftul tulgs gs ihobcr ihobcregs egscc u`gol if ahitfr >: >:.. Ih Ihrf rfis iscc [HZ [HZ
Zfogoll uol Dgwgn Bgregsc
s/a ;: Du`c >:7=
>7.Hngt tcagi
Zgscfo efenf`c
7
>
>
1
=
7
>
72
>;. ^f ^fsfp Qcagi `upg efoagpgt acsfrgmi hngt go
>
7
>
>1. Ac`ftgi igo nuigo pgag tfepgto yg
Qcagi efoagpgt hngt, efolgotrc `fncm `geg
>
7:
>
1:
>6.^fsfp dgtum/mc` gol agrc wgagmo yg
Qcagi efoagpgt hngt, efolgotrc `fncm `geg, mgrus efecotg
>
6
>
>:
sfsugc bhreu`g rcue >>.Zfollu oggo scoligtg o ygol tcagi df`gs
hngt ac `ugr
[g`gm hngt, ahscs
^fsfp actfrceg Zgscfo/if `ugrlg Zgscfo
^fsfp
Iflcgtgo ygol acrfihefoagscigo
1
rfsfp agrc rugol pf`gygogo ifeng`c Zftulgs ^ugol Bgregsc
Ifsg`gmgo tf`ggm rfsfp
[g`gm hngt, ahscs, agpgt efocenu` igo Fbfi [gepcol
7:
6
;
76:
>2. DDu ue`gm pftulgs pgag dge pgagt acusgmgigo kuiup >< >=. Nfrtgoyg pgag tfego tfego gtg gtgu u ahitfr ahitfr dcig gag ygol tcagi
Zfogoll uol Dgwgn Bgregsc
s/a ;: Du`c >:7=
Zfogoll uol Dgwgn Bgregsc
s/a ;: Du`c >:7=
Zfogoll uol Dgwgn Bgregsc
s/a ;: Du`c >:7=
acefolfrtc >3 >3.. Ih Ihrf rfis iscc [HZ [HZ Ifsg`gmgo efrgkci
[g`gm hngt ago ahscs
=
>
>
;>
Zfou`csgo ftcift sg`gm
[g`gm ahscs, brfiwfosC ago rutf
=
1
>
21
Zgscfo/if Efoyfrgm `ugrlg igo hngt pgscfo pgag efofrce pgscfo/hrg g hngt ol ygol sg`gm
[g`gm hngt, Ifrgkuog o, IZK, IOK
7:
;
;
3:
Efepfrs cgpigo hngt
Efenugt Ftcift
;:. DDu ue`gm pftulgs pgag dge pgagt acusgmgigo kuiup ;7 ;7.. Efeg Efegsg sgol ol pfolueuego glgr pgscfo sgnrg efolgotrc ;>. Nfrtgoyg pgag tfego tfego gtg gtgu u ahitfr ahitfr dcig gag ygol tcagi acefolfrtc ;; ;;.. Ih Ihrf rfis iscc [HZ [HZ
Efefrci sg ifsfsugcg o rfsfp, hngt, ftcift
Efolluogigo pfolfrgs sugrg
Efolluogigo pfolfkfigo cafotctgs ecoceg` afolgo > cafotctgs sfpfrtc ogeg, g`gegt, ueur a``
Cobhregsc hngt ygol tcagi df`gs
C].. C]
[g`gm kgrg efolihos uesc hngt, mgsc` tcagi ngci
>
;
>
7>
ZF@G ZF@GI[ I[GO GOGG GGO O IFL IFLCG CGQ QGO AGO AGO FRG@VG G@VG[C [C
Ihrfisc [HZ
OG^G[C ( ( efokfrctgigo prhsfs BEFG agrc gwg` sgepgc euoku` [HZ ngru. [hp Ngru OG^G[C accep`fefotgsc, ifeuacgo acfvg`ugsc ago mgsc` fvg`ugsc ac tcoagi `godutc sfkgrg nfrifscogenuolgo /ZAKG)
].
Zrhs Zrhsfa faur ur SGOL GOL NG^ NG^V V [FN [FNGL GLGC GC MG[C MG[C@ @ AG AG^C ^C GOG@ GOG@C[ C[C[ C[ BEFG BEFG
7.
Ahitfr efou`csigo rfsfp
>.
^fsf ^fsfp p acs acsfr frgm gmig igo o pga pgagg pgs pgscf cfo/ o/if if`u `ugr grlg lg pg pgsc scfo fo
;.
^fsfp acs acsfrgmigo if if bg b gregsc afolgo ef`ftgiigo rfsfp pgag wgagm ygol tf`gm acsfacgigo h`fm pftulgs
1.
Zf Zfttulg lgss bgr bgregsc ef` ef`giuigo tf` tf`ggm rfs rfsfp ago ago gpgnc`g actfeuigo egsg`gm egig pftulgs efolihobcregsc u`gol pgag pfou`cs rfsfp
6.
Gpgn Gpgnc` c`gg act actfe feui uigo go tu`c tu`csg sgo o yg ygol ol iu iurg rgol ol df df`g `gss pftulgs efolihobcregsc u`gol pgag pfou`cs rfsfp
2.
Zftulgs efoycgpigo hngt
.
Zftulg Zftulgss efolc efolcafo afotc tcbc bcig igsc sc pgsc pgscfo fo afolg afolgo o kgrg efoli efoliho hobc bcre regs gscc ecoceg` afolgo aug cafotctgs sfpfrtc ogeg, g`gegt (^t/^w), ueur, ogeg ifpg`g if`ugrlg ago `gco`gco
7;.
Gpgnc`g Gpgnc`g pgsc pgscfo fo tf`gm tf`gm tfrcaf tfrcafotc otcbc bcigsc igsc a afolg folgo o ngci egig egig pftul pftulgs gs efoyfr efoyfrgmig gmigo o hngt pgag pgscfo/if`ugrlg pgscfo.
71.
Hngt Hngt acsf acsfrg rgmi migo go pgag pgscf pgscfo o af afol olgo go acnfrc acnfrcig igo o pf pfod odf` f`gs gsgo go ygol kuiup kuiup,, ec ecoc oceg` eg` kgrg pgigc hngt.
76.
Votui Votui pgsc pgscfo fo tfrt tfrtfot fotu u ac`gi ac`giuigo uigo ihosf`c ihosf`col ol h`f h`fm m gphtf gphtfifr ifr..
Efolftgmuc Ig. VZQA Zusifsegs ……………. . …………………….. OCZ……………………
Ngoauol , ……….. Iftug Qce BEFG/IZ VZQA Zusifsegs ……………. (. ………………………) Ocp. …………………….
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