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

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age:

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tp:/

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a.go

v/M

edic

alDe

vice

s/De

vice

Regu

latio

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Guid

ance

/Con

tact

Us-

-Di

visi

onof

Indu

stry

andC

onsu

mer

Educ

atio

n/de

faul

t.htm

31