Corrective and Preventive Action Basics - PathWise · 2015. 1. 14. · Corrective and Preventive...
Transcript of Corrective and Preventive Action Basics - PathWise · 2015. 1. 14. · Corrective and Preventive...
Corrective and Preventive Action Basics
November 4, 2014
Joseph TartalPostmarket and Consumer Branch Chief
Division of Industry and Consumer EducationOffice of Communication and Education
Center for Devices and Radiological HealthU.S. Food and Drug Administration
2
Lear
ning
Obj
ectiv
es•
Kno
w th
e pu
rpos
e of
Cor
rect
ive
and
Pre
vent
ive
Act
ion
•H
ave
the
abilit
y to
dis
tingu
ish
betw
een
each
def
ined
te
rm
•U
nder
stan
d th
e re
quire
men
ts in
21
CFR
820
Qua
lity
Sys
tem
Reg
ulat
ion
•Id
entif
y va
rious
type
s of
dat
a an
d to
ols
•R
ecog
nize
exa
mpl
es a
nd b
est p
ract
ices
•B
e aw
are
of c
ompl
ianc
e co
ncer
ns
3
Purp
ose
of th
e C
orre
ctiv
e an
d Pr
even
tive
Act
ion
Subs
yste
m•
To c
olle
ct a
nd a
naly
ze in
form
atio
n to
iden
tify
actu
al
and
pote
ntia
l pro
duct
and
qua
lity
prob
lem
s•
To in
vest
igat
e pr
oduc
t and
qua
lity
prob
lem
s an
d ta
ke a
ppro
pria
te a
nd e
ffect
ive
corr
ectiv
e or
pr
even
tive
actio
n•
To v
erify
or v
alid
ate
the
effe
ctiv
enes
s of
cor
rect
ive
and
prev
entiv
e ac
tions
4
Purp
ose
of th
e C
orre
ctiv
e an
d Pr
even
tive
Act
ion
Subs
yste
m
•To
com
mun
icat
e co
rrec
tive
and
prev
entiv
e ac
tions
to
the
appr
opria
te p
eopl
e •
To p
rovi
de in
form
atio
n fo
r man
agem
ent r
evie
w•
To d
ocum
ent a
ctiv
ities
5
Def
initi
on: C
orre
ctio
n“C
orre
ctio
n”ac
tion
to e
limin
ate
a de
tect
ed
nonc
onfo
rmity
.1.
A c
orre
ctio
n ca
n be
mad
e in
con
junc
tion
with
a
corr
ectiv
e ac
tion.
2. A
cor
rect
ion
can
be, f
or e
xam
ple,
rew
ork
or
regr
ade
ISO
900
0:20
05(E
)
6
Def
initi
on: C
orre
ctiv
e A
ctio
n“C
orre
ctiv
e ac
tion”
actio
n to
elim
inat
e th
e ca
use
of a
de
tect
edno
n-co
nfor
mity
or o
ther
und
esira
ble
situ
atio
n.1.
Th
ere
can
be m
ore
than
one
cau
se fo
r a
nonc
onfo
rmity
.2.
C
orre
ctiv
e ac
tion
is ta
ken
to p
reve
nt re
curr
ence
.3.
Th
ere
is a
diff
eren
ce b
etw
een
corr
ectio
n an
d co
rrec
tive
actio
n.IS
O 9
000:
2005
(E)
7
Def
initi
on: P
reve
ntiv
e A
ctio
n“P
reve
ntiv
e ac
tion”
actio
n to
elim
inat
eth
e ca
use
of a
pot
entia
l non
-con
form
ity o
r oth
er u
ndes
irabl
e si
tuat
ion
1.
Ther
e ca
n be
mor
e th
an o
ne c
ause
for a
pote
ntia
l non
conf
orm
ity.
2.
Pre
vent
ive
actio
n is
take
n to
pre
vent
oc
curr
ence
.IS
O 9
000:
2005
(E)
8
21 C
FR 8
20 R
egul
ator
y R
equi
rem
ent -
Proc
edur
es
Est
ablis
han
d m
aint
ain
proc
edur
esfo
r im
plem
entin
g co
rrec
tive
and
prev
entiv
e ac
tion
21 C
FR 8
20.1
00(a
)
9
The
Prea
mbl
e on
Pro
cedu
res
The
proc
edur
es (f
or im
plem
entin
g co
rrect
ive
and
prev
entiv
e ac
tion)
mus
t pro
vide
for c
ontro
l an
d ac
tion
to b
e ta
ken
on d
evic
es d
istri
bute
d,
and
thos
e no
t yet
dis
tribu
ted,
that
are
su
spec
ted
of h
avin
g po
tent
ial n
onco
nfor
miti
es.
Pre
ambl
e, C
omm
ent 1
58
10
Whe
re to
Sta
rt?
Pla
nnin
gP
lans
sho
uld
incl
ude…
I. E
stab
lishi
ng D
ata
Sou
rces
and
Crit
eria
II. M
easu
ring
and
Ana
lysi
s of
Dat
a S
ourc
esIII
. Im
prov
emen
t Pla
nsIV
. Inp
ut to
Man
agem
ent
11
Esta
blis
hing
Dat
a So
urce
s
Exte
rnal
So
urce
sSo
urce
sIn
tern
al
12
Exam
ples
of I
nter
nal D
ata
Sour
ces
•P
roce
ss C
ontro
l D
ata
•Te
st/In
spec
tion
data
•D
evic
e H
isto
ry
Rec
ords
•In
tern
al A
udits
•N
onco
nfor
min
g m
ater
ial r
epor
ts•
Rew
ork
and
S
crap
/Yie
ld D
ata
•Tr
aini
ng re
cord
s
13
Exam
ples
of E
xter
nal D
ata
Sour
ces
•A
dver
se E
vent
R
epor
ting
(MD
R)
•FD
A
•E
ven
sim
ilar
devi
ces
from
co
mpe
titor
s
•S
uppl
ier C
ontro
ls
•C
usto
mer
s
•C
ompl
aint
s
•S
ervi
cing
repa
irs
14
Dat
a A
naly
sis
Ana
lyze
proc
esse
s, w
ork
oper
atio
ns, c
once
ssio
ns,
qual
ity a
udit
repo
rts, q
ualit
y re
cord
s, s
ervi
ce re
cord
s,
com
plai
nts,
retu
rned
pro
duct
, and
oth
er s
ourc
es o
f qu
ality
dat
a to
iden
tify
exis
ting
and
pote
ntia
l cau
ses
of
nonc
onfo
rmin
g pr
oduc
t, or
oth
er q
ualit
y pr
oble
ms.
21
CFR
820
.100
(a)(
1)
15
App
roac
h to
Dat
a A
naly
sis
Non
-sta
tistic
al &
Sta
tistic
al T
echn
ique
s●
Use
aris
k-ba
sed
appr
oach
to ra
nk a
reas
, S
elec
t ite
ms
with
maj
or im
pact
, i.e
. Pro
duct
rela
ted
or
Pro
cess
rela
ted
Pro
ceed
with
item
s fro
m h
igh
to lo
w im
pact
and
ev
entu
ally
ass
ure
all a
reas
are
add
ress
ed•
Use
of S
tatis
tical
Met
hodo
logy
; 21
CFR
820
.100
(a)(
1)
App
ropr
iate
sta
tistic
al m
etho
dolo
gy s
hall
be e
mpl
oyed
w
here
nec
essa
ry to
det
ect r
ecur
ring
qual
ity p
robl
ems
16
Inve
stig
ate
to D
eter
min
e R
oot C
ause
Inve
stig
ate
the
caus
e of
non
conf
orm
ities
re
latin
g to
pro
duct
, pro
cess
es, a
nd th
e qu
ality
sys
tem
21 C
FR 8
20.1
00(a
)(2)
17
The
Prea
mbl
e on
Inve
stig
atio
nsTh
e re
quire
men
t in
this
sec
tion
is b
road
er th
an th
e re
quire
men
t for
inve
stig
atio
ns u
nder
Sec
. 820
.198
, be
caus
e it
requ
ires
that
non
conf
orm
ing
prod
uct
disc
over
ed b
efor
e or
afte
r dis
tribu
tion
be
inve
stig
ated
to th
e de
gree
com
men
sura
te w
ith th
e si
gnifi
canc
e an
d ris
k of
the
nonc
onfo
rmity
. M
ore
. . .
18
The
Prea
mbl
e on
Inve
stig
atio
ns…
the
requ
irem
ent i
n th
is s
ectio
n ap
plie
s to
pr
oces
san
d qu
ality
sys
tem
nonc
onfo
rmiti
es, a
s w
ell a
s pr
oduc
t non
conf
orm
ities…
if a
mol
ding
pr
oces
s w
ith it
s kn
own
capa
bilit
ies
has
a no
rmal
5
perc
ent r
ejec
tion
rate
and
that
rate
rise
s to
10
perc
ent,
an in
vest
igat
ion
into
the
nonc
onfo
rman
ce
of th
e pr
oces
s m
ust b
e pe
rform
ed.
Pre
ambl
e, C
omm
ent 1
61
19
Iden
tify
Cor
rect
ive
and
Prev
entiv
e A
ctio
nsId
entif
y th
e ac
tion(
s) n
eede
d to
cor
rect
and
prev
entr
ecur
renc
eof
non
conf
orm
ing
prod
uct a
nd o
ther
qua
lity
prob
lem
s
21 C
FR 8
20.1
00(a
)(3)
20
Iden
tify
Act
ion(
s) to
be
take
n
•N
o fu
rther
act
ion
nece
ssar
y•
Cor
rect
ion
•C
orre
ctiv
e A
ctio
n•
Pre
vent
ativ
e A
ctio
n
21
The
Prea
mbl
e on
Ris
k an
d D
egre
e of
C
orre
ctiv
e an
d Pr
even
tive
Act
ion
…th
e de
gree
of c
orre
ctiv
e an
d pr
even
tive
actio
n ta
ken
to e
limin
ate
or m
inim
ize
actu
al o
r pot
entia
l no
ncon
form
ities
mus
t be
appr
opria
te to
the
mag
nitu
de o
f the
pro
blem
and
com
men
sura
te w
ith
the
risks
enc
ount
ered
. . .
P
ream
ble,
Com
men
t 159
22
Verif
y/Va
lidat
e C
orre
ctiv
e an
d Pr
even
tive
Act
ions
Ver
ify o
r val
idat
e th
e co
rrect
ive
and
prev
entiv
e ac
tion
to e
nsur
e th
at s
uch
actio
n is
effe
ctiv
e an
d do
es n
ot a
dver
sely
affe
ct th
e fin
ishe
d de
vice
21
CFR
820
.100
(a)(
4)
23
The
Prea
mbl
e on
Ver
ifica
tion
and
Valid
atio
n
FDA
has
revi
sed
Sec
. 820
.100
(a)(
4) to
re
flect
that
pre
vent
ive,
as
wel
l as
corr
ectiv
e,
actio
n m
ust b
e ve
rifie
d or
val
idat
ed.
Pre
ambl
e, C
omm
ent 1
63
24
Impl
emen
t Cor
rect
ive
and
Prev
entiv
e A
ctio
ns
Impl
emen
t and
reco
rd c
hang
es in
met
hods
an
d pr
oced
ures
nee
ded
to c
orre
ct a
nd
prev
ent i
dent
ified
qua
lity
prob
lem
s21
CFR
820
.100
(a)(
5)
25
Com
mun
icat
ing
CA
PA In
form
atio
n•
Dis
sem
inat
e in
form
atio
n re
late
d to
qua
lity
prob
lem
s or
no
ncon
form
ing
prod
ucts
to th
ose
dire
ctly
resp
onsi
ble
for a
ssur
ing
the
qual
ity o
f suc
h pr
oduc
t or t
he
prev
entio
n of
suc
h pr
oble
ms.
21 C
FR 8
20.1
00(a
)(6)
•S
ubm
it re
leva
nt in
form
atio
n on
iden
tifie
d qu
ality
pr
oble
ms,
as
wel
l as
corre
ctiv
e an
d pr
even
tive
actio
ns,
for m
anag
emen
t rev
iew
.21
CFR
820
.100
(a)(
7)
26
The
Prea
mbl
e on
CA
PA A
ctiv
ities
for
Man
agem
ent R
evie
w. .
. O
nly
certa
in in
form
atio
n ne
ed b
e di
rect
ed to
m
anag
emen
t. Th
e m
anuf
actu
rer’s
pro
cedu
res
shou
ld
clea
rly d
efin
e th
e cr
iteria
to b
e fo
llow
ed to
det
erm
ine
wha
t inf
orm
atio
n w
ill be
con
side
red
“rele
vant
” to
the
actio
n ta
ken
and
why
. FD
A e
mph
asiz
es th
at it
is a
lway
s m
anag
emen
t’s re
spon
sibi
lity
to e
nsur
e th
at a
ll no
ncon
form
ity is
sues
are
han
dled
app
ropr
iate
ly.
Pre
ambl
e, C
omm
ent 1
64
27
Doc
umen
ting
Cor
rect
ive
Act
ion
and
Prev
entiv
e A
ctio
n A
ctiv
ities
Doc
umen
t all
activ
ities
requ
ired
unde
r thi
s se
ctio
n, a
nd th
eir r
esul
ts
21 C
FR 8
20.1
00(b
)
28
The
Prea
mbl
e on
CA
PA a
nd
Inte
rnal
Aud
its a
nd M
gmt R
evie
ws
Two
com
men
ts s
tate
d th
at th
e re
cord
s re
quire
d un
der
Sec
820
.100
(b) s
houl
d be
trea
ted
as p
art o
f the
inte
rnal
au
dit.
FDA
dis
agre
es w
ith th
ese
com
men
ts…
FDA
has
th
e au
thor
ity to
revi
ew s
uch
reco
rds
and
the
oblig
atio
n to
do
so
to p
rote
ct th
e pu
blic
hea
lth. .
. M
anuf
actu
rers
will
be re
quire
d to
mak
e th
is in
form
atio
n re
adily
ava
ilabl
e to
an
FD
A in
vest
igat
or
Pre
ambl
e, c
omm
ents
166
29
FDA
Insp
ectio
n M
anuf
actu
rers
sho
uld
cons
ider
that
thei
r C
orre
ctiv
e Ac
tion
and
Prev
entiv
e Ac
tion
docu
men
tatio
n ca
n de
mon
stra
te to
FD
A th
at th
e m
anuf
actu
rer’s
qua
lity
syst
em is
effe
ctiv
e an
d en
able
s th
e m
anuf
actu
rer t
o id
entif
y pr
oble
ms
quic
kly
and
impl
emen
t effe
ctiv
e co
rrec
tive
and
prev
entiv
e ac
tions
30
Gui
danc
e A
vaila
ble
•G
HTF
: Qua
lity
Man
agem
ent S
yste
m
Med
ical
Dev
ices
–G
uida
nce
on c
orre
ctiv
e a
ctio
n an
d pr
even
tive
actio
n an
d re
late
d Q
MS
pro
cess
es;
SG
3; 2
010
•G
HTF
: Qua
lity
Man
agem
ent S
yste
m
Med
ical
dev
ices
-N
onco
nfor
mity
Gra
ding
Sys
tem
fo
r Reg
ulat
ory
Pur
pose
s an
d In
form
atio
n E
xcha
nge;
S
G3;
201
2
Prov
idin
g In
dust
ry E
duca
tion
1.CD
RH L
earn
–M
ulti-
Med
ia In
dust
ry E
duca
tion
§ov
er 8
0 m
odul
es -
vide
os, a
udio
reco
rdin
gs, p
ower
poi
nt p
rese
ntat
ions
, sof
twar
e-ba
sed
“how
to”
mod
ules
§ac
cess
ible
on
your
por
tabl
e de
vice
s: h
ttp:
//w
ww
.fda.
gov/
Trai
ning
/CDR
HLea
rn
2.De
vice
Adv
ice
–Te
xt-B
ased
Edu
catio
n§
com
preh
ensiv
e re
gula
tory
info
rmat
ion
on p
rem
arke
t and
pos
tmar
ket t
opic
s:ht
tp:/
/ww
w.fd
a.go
v/M
edic
alDe
vice
s/De
vice
Regu
latio
nand
Guid
ance
3.Di
visi
on o
f Ind
ustr
y an
d Co
nsum
er E
duca
tion
(DIC
E)§
If yo
u ha
ve a
que
stio
n -E
mai
l: D
ICE@
fda.
hhs.
gov
§Ph
one:
1(8
00) 6
38-2
014
or (3
01) 7
96-7
100
(Liv
e Ag
ents
9am
–4:
30 p
m E
ST)
§W
eb H
omep
age:
ht
tp:/
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w.fd
a.go
v/M
edic
alDe
vice
s/De
vice
Regu
latio
nand
Guid
ance
/Con
tact
Us-
-Di
visi
onof
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stry
andC
onsu
mer
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atio
n/de
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t.htm
31