Quality Audit Report Notes

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s pecttn ualityAudi

Selt to
t o
e valuat
evauate

a
inspection i alll apee
apec
puspose ObSet- a
ts çmp
Compkance
manutacturers
the
should be desghed
cet tnspectio) piammed
The
the
implamenla tibn
iplamenlatibn

detec the shost Comings Commectiveacion


Comective act ons
the necessay
ommend
MP to houdd
Should be doumelad
dowetad.
e spectian
h prodedure t
toe s e h inspected

pecoe
premsee fncuding peconalfadiies
Maintainance o buidigs Cquipmet
etoxa Startiog mateials mished prduct
q pmenl
productin pnCess Contms
> pcumeita ti
Santatin nyaiee
Caloratin ot nnmunit
Selt ipection tCa
Managemal Sheud appoint a el mpectien t e a
Constub epezts w hev Tespectire lds E
Constut
o
a as th Smp
he memberc h the teamb b e appointed
om fnse Out srde

trea y ca Selt ipec tion


Deperds Cea remenls bl sha
Prcferably be l least OnCe a
year
ualif Catims c udtors
Audi toc must have Spechc nowudae
al
al
tps o malib audit
The muct be a aina
?1
STk lepastment in
Jhich he canleto Ca Qut audt

e
otDina s an examp oChecx oh esetel
Donenl3

4eneral ities
Are Operatons
tersad wisio epoale G) delad

areas oacdea/uale sz
used So as to minímce
Are ckangek 0ome
ganed
C o n l a m n a t i op

ware tousina reas


Sepeatin b Arpoved g
Ae kere
kene physfcal
reected materalstore3

eeAAs stores
gtores a materals,
Are
There Seperale
abels iniinis hed prduclt
Pockaaing
* Organrgatio G Mawagnsnt
inslnucted tn
Santation $ healta
re personal
perconal

earem enls
anmalM eConds
Are speci{fed t e s t repcated

Kept
Cadures

C e l t - nspection P
inspectHonAchedule
Cover all apec
Cover all aspec

Does
Does the Sel
p d u ct 6, $ 9
Claan, neot der4
Js Area
Toos o -ud to
C DOCumenl stanchods &guidelines
Gmp requlaions
Sualihy , eporls
epols
Aud?t
olbo tup
Orerous re Cods
doumensGepeH

Ouon
on
-Audteos

iaa
memoire s
Audit Chect Wst

C2 audt pla
ist to auditing
Check
(3
Olosevation
Audit
general Compay pmatiom

plant kocatioo enronment

Management
Cmpa
Ogat abona infemnati
aina melwds

stot rendos
ut-sourcing Qevices
- DeasmerlalCndtiot pvactices

System, OCumeulation doCnai


Guallty
C n , Ckause CenloCystem, uA c wrerSpy
Seico etc
d i t Repo
A ugested seture o awd epo
He 6 Drea Audrted
Dak time oAudit
ODyectires upose of fAudi t
persomn el endouered
ChangCs inCa an previous aud(
Obsevating

Comrective me res Tsuasd


Ofal auditce
final Csndsions

etcvwa,udrt Renet Drokwa


TGAN
Dat
No ooomanc
abcewatio
Dscpto)
Continue ovesa f haLessn
d
t e a auditr Slanature o Auditea
p o aced Cemectine Amet)

Shwature o ditec
Canplution dala

ollb Dfudit vid N o yes


Con imdtwn d Acion

Audtte Dat

Tollow oective ctin Re pat


ollo cP
&Oto- 6 hore Choul be effe tire

Piamme
er atte e inSpeotisn rpot Coreotine
acbonL noceD Can
udrt
phase O
inal
Repol
Actio actin Tepot
Comective
S i m p l e C o m e c b e

reest actiBa
ne OCe of
actin tten

infomuaton
ol lou P
meceivi auy
ack o
aity
udit
dit

Stacla
Dhas@s

Succescul
Auditi os)

Preparation

oeg aet LCoa non- venutin o


Select m
Cofmancas Csrectve
aliMa
Mana Stervaona Preventine
Resut acb)
Cualuatos
xamnattoy
enauatun
t u d i t Schedue
Diecusim
Ra audit
omatim
cosin Kopot
distouton
udt uoutio
o d a y eyauztics New Eaale

orgaatm AVlabi ol proCs dala


Ma als onoa efft
Docunalatuon
Compiau Ce Ustomar auwa renaNs
Cutumer Sappe
nveut

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