Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf ·...

28
GPQ-MAN-07 MSM-GP/27 APR 2001 Product Assurance Audit Checklist GPQ-MAN-07

Transcript of Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf ·...

Page 1: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

GPQ

-MA

N-0

7

MS

M-G

P/27 A

PR

2001

Pro

du

ct A

ssu

ran

ceA

udit

Ch

ecklist

GP

Q-M

AN

-07

Page 2: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 2 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sI.

Gen

era

l P

rodu

ct

Ass

ura

nce

1.

Org

an

isati

on

an

d S

taff

1.1

Doe

s th

e co

ntr

act

or h

ave

a for

mally

esta

blish

ed P

Aor

gan

isati

on w

ith

th

e el

emen

ts o

f S

afe

ty, R

elia

bilit

y,M

ain

tain

abilit

y, S

/W

PA

, Q

uality

Part

s, M

ate

rials

an

dPro

cess

es, C

onfigu

rati

on M

an

age

men

t?1.2

Are

th

e Pro

du

ct A

ssu

ran

ce fu

nct

ion

s in

dep

enden

t of

Man

ufa

ctu

rin

g, E

ngi

nee

rin

g an

d o

ther

org

an

isati

on?

1.3

Are

th

ere

form

ula

ted o

bje

ctiv

es o

f th

e or

gan

isati

on?

1.4

Is m

an

age

men

t em

ph

asi

s on

“pre

ven

tion

” ra

ther

th

an

det

ecti

on o

f qu

ality

pro

ble

ms?

1.5

Are

th

e re

spon

sibilit

ies

of s

uper

viso

rs a

nd m

an

age

rs,

etc.

for

mally

def

ined

?1.6

Doe

s th

e per

son

res

pon

sible

for

Pro

du

ct A

ssu

ran

ce o

na p

roje

ct h

ave

acc

ess

to h

igh

er m

an

age

men

t fo

r th

efo

cuss

ing

on a

nd r

esol

uti

on o

f pro

ble

ms?

1.7

Are

th

e PA

fu

nct

ion

s st

affed

to

the

pro

per

com

ple

men

t?1.8

Doe

s th

e Pro

du

ct A

ssu

ran

ce o

rgan

isati

on h

ave

suffic

ien

t fa

ciliti

es, eq

uip

men

t an

d t

ools

for

appro

pri

ate

evalu

ati

on o

f m

ate

rials

an

d h

ard

ware

qu

ality

?2

.P

roced

ure

s2.1

Doe

s th

e co

ntr

act

or h

ave

a P

rodu

ct A

ssu

ran

ce M

an

ual

or a

set

of pro

cedu

res

cove

rin

g Pro

du

ct A

ssu

ran

ce?

2.2

Do

pro

cedu

res

iden

tify

“w

ho”

doe

s “w

hat”

, “w

hen

”,“h

ow”

an

d “

wh

ere”

?2.3

Are

PA

fu

nct

ion

s an

d r

espon

sibilit

ies

per

form

ed b

yot

her

gro

ups

iden

tified

?2.4

Do

pro

cedu

res

iden

tify

in

form

ati

on flo

w, fo

rms

an

din

stru

ctio

ns

for

com

ple

tin

g th

e fo

rms?

2.5

Do

pro

cedu

res

con

tain

man

age

men

t appro

val

sign

atu

res,

date

s of

iss

ue

an

d r

evis

ion

s an

d c

han

ge

Page 3: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 3 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sdes

ign

ato

rs?

2.6

Is t

he

dis

trib

uti

on c

ontr

olle

d a

nd o

bso

lete

pro

cedu

res

rem

oved

fro

m u

se?

2.7

Are

pro

cedu

res

ava

ilable

at

the

appro

pri

ate

wor

kst

ati

ons?

2.8

Are

pro

cedu

res

kep

t u

pdate

d?

2.9

Do

det

ailed

pro

cedu

res

exis

t fo

r th

e per

form

an

ce o

fin

spec

tion

s an

d t

ests

?3

.Q

A a

udit

s3.1

Are

sys

tem

ati

c in

tern

al an

d e

xter

nal au

dit

s per

form

ed?

3.2

Are

au

dit

s per

form

ed?

a)

Acc

ordin

g to

an

est

ablish

ed p

lan

?b)

Usi

ng

chec

klist

s?3.3

Are

in

tern

al au

dit

s co

ndu

cted

on

an

im

part

ial basi

s by

qu

alified

per

son

nel

?4

.R

eceiv

ing I

nsp

ecti

on

4.1

Is t

he

con

tract

or's

rec

eivi

ng

insp

ecti

on flo

w a

nd

act

ivit

ies

doc

um

ente

d?

4.2

Are

faci

liti

es c

lean

, pro

per

lig

hti

ng

exis

t, a

nd s

tora

gean

d h

an

dlin

g pra

ctic

es fol

low

ed?

4.3

Are

all in

com

ing

supplies

in

spec

ted a

nd t

este

d p

rior

to

use

aga

inst

th

e re

qu

irem

ents

of pro

cure

men

tdoc

um

ents

? (a

ppro

pri

ate

dra

win

gs, sp

ecific

ati

ons

an

dte

chn

ical in

stru

ctio

ns)

4.4

Are

rec

eivi

ng

insp

ecti

ons

per

form

ed in

acc

ordan

ce w

ith

esta

blish

ed p

roce

du

res

an

d in

stru

ctio

ns?

4.5

Is t

he

follow

ing

veri

fied

?a)

Iden

tifica

tion

/ c

onfigu

rati

on?

b)

Su

pplier

’s d

ocu

men

tati

on?

4.6

Wh

en s

upplies

are

acc

epte

d o

n t

he

basi

s of

cer

tifica

tion

or t

est

repor

t:a)

Are

tes

t re

por

ts c

hec

ked

100%

aga

inst

pro

cure

men

t

Page 4: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 4 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sdoc

um

ents

req

uir

emen

ts?

b)

Are

rep

orts

an

d c

erti

fica

tion

ret

ain

ed?

4.7

Wh

en s

upplies

are

acc

epte

d o

n t

he

basi

s of

cer

tifica

tion

or t

est

repor

t, a

re c

hec

ks

per

form

ed t

o co

nfirm

con

form

an

ce?

4.8

Do

rece

ivin

g in

spec

tion

rec

ords

indic

ate

date

of re

ceip

t,in

spec

tion

s, t

ests

, doc

um

ents

uti

lise

d, n

um

ber

acc

epte

d/re

ject

ed?

4.9

Is t

race

abilit

y m

ain

tain

ed b

etw

een

mate

rials

an

dce

rtific

ate

s, r

epor

ts a

nd r

ecei

vin

g in

spec

tion

doc

um

ents

?4.1

0A

re t

her

e se

para

ted s

tora

ge a

reas

for

mate

rials

wait

ing

rece

ivin

g in

spec

tion

an

d m

ate

rials

alr

eady

insp

ecte

dan

d a

ccep

ted?

5.

Pack

agin

g a

nd H

an

dli

ng

Pack

agin

g5.1

Are

part

s, a

ssem

blies

an

d m

ate

rials

ver

ifie

d for

clea

nlin

ess

bef

ore

pack

agi

ng

an

d p

roper

ly p

ack

age

d?

5.2

Are

part

s h

avi

ng

crit

ical or

hig

hly

fin

ish

ed s

urf

ace

spro

tect

ed a

gain

st d

am

age

?5.3

Are

lea

ds

of e

lect

rica

l part

s pro

tect

ed fro

mco

nta

min

ati

on w

hic

h w

ill ef

fect

sol

der

abilit

y?5.4

Are

pack

agi

ng

oper

ati

ons

cove

red b

y w

ritt

enpro

cedu

res

/ in

stru

ctio

ns,

wh

ich

in

clu

de

at

least

th

efo

llow

ing:

a)

Sel

ecti

on o

f pack

agi

ng

mate

rials

?b)

Inn

er p

rote

ctio

n?

c)

Mec

han

ical pro

tect

ion

?d)

Cle

an

lin

ess

an

d c

onta

min

ati

on c

ontr

ol?

5.5

Are

pack

agi

ng

oper

ati

ons

insp

ecte

d a

nd a

re ite

ms

con

trol

led b

efor

e sh

ippin

g fo

r pro

per

pack

agi

ng,

mark

ing

an

d a

ccom

pan

yin

g doc

um

enta

tion

?

Page 5: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 5 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sH

an

dli

ng

5.6

Do

han

dlin

g pro

cedu

res

an

d in

stru

ctio

ns

exis

t?5.7

Are

ite

ms

leavi

ng

a c

ontr

olle

d a

rea o

r bei

ng

tran

spor

ted

bet

wee

n w

ork/te

st a

reas

carr

ied in

appro

pri

ate

con

tain

ers

or fix

ture

s to

pro

vide

adeq

uate

pro

tect

ion

from

dam

age

or

con

tam

inati

on?

5.8

Do

the

oper

ato

rs h

ave

th

e pro

per

too

ls t

o su

ppor

t th

eass

embly

wh

ile

per

form

ing

wor

k/te

st o

n it?

6.

Cle

an

lin

ess

an

d C

on

tam

inati

on

Con

trol

6.1

Are

th

ere

pro

cedu

res

ava

ilable

sys

tem

ati

cally

cove

rin

gcl

ean

lin

ess

an

d c

onta

min

ati

on c

ontr

ol a

spec

ts?

6.2

Are

th

ere

spec

ific

in

stru

ctio

ns

for:

a)

En

teri

ng

an

d lea

vin

g cl

ean

roo

ms

(per

son

nel

an

deq

uip

men

t)?

b)

Cle

an

ing

of c

lean

roo

ms,

in

clu

din

g:1. C

lean

ing

mate

rials

?2. C

lean

ing

met

hod

s?c)

C

lean

ing

of e

qu

ipm

ent

to b

e en

tere

d in

th

e cl

ean

room

s?d)

Cle

an

roo

ms’

main

ten

an

ce?

e)

Con

trol

of cl

ean

roo

m p

ara

met

ers?

f)

Act

ion

s in

case

of ala

rm in

clu

din

g:1.

Sto

p w

ork?

2.

Sh

ield

cri

tica

l it

ems?

6.3

Are

ite

ms

test

ed a

nd in

spec

ted for

cle

an

lin

ess

such

as

(vis

ual ex

am

inati

ons,

wip

e te

sts,

ch

eck for

alk

alin

e an

daci

ds)

an

d a

re t

he

appro

pri

ate

met

hod

s u

sed?

6.4

Are

acc

ess

con

trol

in

stru

ctio

ns

pos

ted, vi

sito

rs s

ign

in

log

pro

per

ly d

ate

d a

nd e

nfo

rced

as

appro

pri

ate

?6.5

Are

sm

ock r

eten

tion

are

as

pro

vided

?6.6

Are

cle

an

sm

ocks

ava

ilable

?6.7

Are

flo

or m

ats

pla

ced a

t all e

ntr

an

ces?

Page 6: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 6 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s6.8

Are

flo

or c

oati

ngs

pee

lin

g or

gen

erati

ng

du

st p

art

icle

savo

ided

?6.9

Is t

he

shed

din

g of

spon

ge, m

op o

f cl

oth

mate

rial

evid

ent?

6.1

0A

re s

moc

ks

bu

tton

ed a

nd w

orn

by

all p

erso

nn

elin

clu

din

g vi

sito

rs?

6.1

1Is

th

ere

food

, bev

erage

s or

sm

okin

g?6.1

2A

re p

erso

nal bel

ongi

ngs

ou

t of

sig

ht

an

d s

tore

dpro

per

ly?

6.1

3Is

th

e u

se o

f w

ooden

con

tain

ers

wit

h u

ntr

eate

d in

teri

oran

d e

xter

ior

surf

ace

s or

card

boa

rd b

oxes

min

imis

ed?

6.1

4A

re p

erio

dic

part

icle

cou

nts

per

form

ed t

o ve

rify

if

wit

hin

req

uir

ed lim

its?

6.1

5A

re g

love

s, c

aps,

boo

ties

an

d m

ask

s appro

pri

ate

to

the

are

a a

nd w

orn

by

all p

erso

nn

el?

6.1

6Is

th

e in

tegr

ity

of t

he

envi

ron

men

t an

d c

onta

min

ati

onco

ntr

ol m

ain

tain

ed in

rel

ati

on t

o th

e su

rrou

ndin

g are

as

or t

o m

ate

rial an

d m

obile

equ

ipm

ent

ente

rin

g th

e are

a?

6.1

7A

re o

ther

req

uir

emen

ts s

uch

as:

lam

inar

air

flow

,va

cuu

m s

hoe

cle

an

ers,

air

bath

en

tran

ces,

spec

ial

wast

e dis

pos

als

, et

c. e

nfo

rced

?6.1

8A

re c

lean

roo

m e

nvi

ron

men

t co

ndit

ion

s, t

emper

atu

re,

hu

mid

ity,

pre

ssu

re c

ontr

olle

d a

nd r

ecor

ded

?6.1

9Is

tem

per

atu

re m

ain

tain

ed n

omin

ally

at

20ºC

+/-2

ºC o

rm

eet

a s

pec

ific

pro

du

ct s

pec

ific

ati

on?

6.2

0A

re p

osit

ive

pre

ssu

re d

iffe

ren

tials

main

tain

ed b

etw

een

clea

n r

oom

an

d s

urr

oun

din

g are

a a

t 6m

m H

g an

dbet

wee

n c

lean

roo

m a

nd e

ntr

an

ce loc

k a

t 2m

m H

g w

ith

pre

ssu

re m

onit

ors?

6.2

1Is

hu

mid

ity

main

tain

ed, pre

fera

bly

at

30-5

0%

or

as

spec

ifie

d in

a p

rodu

ct s

pec

ific

ati

on a

nd m

onit

ored

wit

ha h

ygro

met

er p

erio

dic

ally

calibra

ted?

Page 7: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 7 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s7

.M

an

ufa

ctu

rin

g a

nd

Test

ing

Man

ufa

ctu

rin

g a

nd

Test

ing

7.1

Are

man

ufa

ctu

rin

g op

erati

ons

an

d in

spec

tion

s pla

nn

edan

d d

escr

ibed

in

man

ufa

ctu

rin

g doc

um

ents

? (S

hop

trave

ller

s, w

ork o

rder

s)?

7.2

Do

shop

tra

veller

s in

clu

de:

a)

Rev

isio

n s

tatu

s / d

ate

, re

lease

date

?b)

Item

iden

tifica

tion

an

d c

onfigu

rati

on?

c)

Mate

rials

/ p

art

s to

be

use

d?

7.3

Are

sh

op t

rave

ller

s id

enti

fied

/ t

race

able

to

the

con

tract

no.

/ p

urc

hase

ord

er?

7.4

Are

su

ppor

t doc

um

ents

to

be

use

d r

efer

ence

d?

(e.g

.dra

win

gs, w

ork in

stru

ctio

ns)

?7.5

Are

rew

ork /

rep

air

pla

ns

use

d t

o doc

um

ent

rew

ork /

repair

man

ufa

ctu

rin

g / in

spec

tion

s op

erati

ons?

A

reth

ey a

deq

uate

? A

re t

hey

arc

hiv

ed?

Man

ufa

ctu

rin

g C

on

trol

7.6

Is s

hop

tra

veller

kep

t w

ith

pro

du

ct d

uri

ng

man

ufa

ctu

rin

g / in

spec

tion

oper

ati

ons?

7.7

Are

in

spec

tion

, fa

bri

cati

on a

nd a

ssem

bly

oper

ati

ons

trace

able

to

the

indiv

idu

al per

form

ing

the

oper

ati

on?

7.8

Are

all a

rtic

les

insp

ecte

d t

o applica

ble

/ c

ontr

olle

ddoc

um

ents

an

d a

re t

he

doc

um

ents

ava

ilable

at

the

insp

ecto

r’s

wor

kst

ati

on?

7.9

Are

un

au

thor

ised

, m

ark

ed-u

p, ille

gible

or

def

ace

ddra

win

gs o

r w

ork in

stru

ctio

ns

bei

ng

use

d?

7.1

0Is

th

e se

qu

ence

of op

erati

ons

bei

ng

follow

ed a

s def

ined

in t

he

pla

nn

ing?

7.1

1A

re a

ccep

ted a

nd r

ejec

ted ite

ms

pro

per

ly iden

tified

an

dta

gged

?7.1

2A

re p

art

lis

ts c

omple

te for

ass

embly

wor

k?

7.1

3A

re a

deq

uate

in

spec

tion

rec

ords

gen

erate

d a

nd

Page 8: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 8 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sm

ain

tain

ed a

nd d

o th

ey in

dic

ate

th

e st

atu

s of

art

icle

san

d in

spec

tion

s per

form

ed?

7.1

4A

re a

ssem

bly

oper

ati

ons

per

form

ed in

seq

uen

ce w

ith

insp

ecti

on o

per

ati

ons?

7.1

5A

re t

orqu

ing

oper

ati

ons

sati

sfact

ory?

C

alibra

ted t

ools

?T

est

Docu

men

ts7.1

6D

oes

the

con

tract

or h

ave

sta

ndard

ised

pro

cedu

res

an

dm

eth

ods

for

the

pre

para

tion

, fo

rmat,

con

ten

t, r

evie

wan

d c

ontr

ol o

f te

st p

roce

du

res?

7.1

7A

re t

ext

pro

cedu

res

form

ally

rele

ase

d a

nd c

ontr

olle

dw

ith

ch

an

ge a

nd r

evis

ion

page

s?7.1

8D

o pro

cedu

res

incl

ude

as

applica

ble

th

e fo

llow

ing:

a)

Nom

encl

atu

re a

nd iden

tifica

tion

of th

e te

st a

rtic

le?

b)

Ch

ara

cter

isti

cs a

nd d

esig

n c

rite

ria t

o be

insp

ecte

d o

r te

sted

, in

clu

din

g va

lues

an

d t

oler

an

ces

for

a

ccep

tan

ce a

nd r

ejec

tion

?c)

D

etailed

ste

ps

an

d o

per

ati

ons

to b

e ta

ken

in

s

equ

ence

in

clu

din

g ve

rifica

tion

s to

be

made

bef

ore

p

roce

edin

g?d)

Cro

ss-r

efer

ence

of ch

ara

cter

isti

cs w

ith

mea

suri

ng

a

nd/or

ND

T e

qu

ipm

ent

to b

e u

sed, sp

ecifyi

ng

ran

ge a

nd t

ype?

e)

Det

ails

or in

stru

ctio

ns

for

oper

ati

on o

f sp

ecia

l data

r

ecor

din

g eq

uip

men

t of

oth

er a

uto

mate

d t

est

e

qu

ipm

ent?

f)

Layo

ut

an

d in

terc

onn

ecti

on o

f te

st e

qu

ipm

ent

an

d a

rtic

les?

g)

Iden

tifica

tion

of h

aza

rdou

s si

tuati

ons

or o

per

ati

ons?

h)

Pre

cau

tion

to

com

ply

wit

h e

stablish

ed s

afe

ty r

equ

irem

ents

, to

en

sure

safe

ty o

f per

son

nel

an

d t

o p

reve

nt

dam

age

or

deg

radati

on o

f art

icle

s an

d m

easu

rin

g eq

uip

men

t?

Page 9: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 9 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

si)

E

nvi

ron

men

ts a

nd o

ther

con

dit

ion

s to

be

m

ain

tain

ed?

j)

Con

stra

ints

?k)

Inst

ruct

ion

s fo

r re

por

tin

g n

on-c

onfo

rman

ce,

a

nom

alo

us

occu

rren

ces

or r

esu

lts?

7.1

9A

re t

est

pro

cedu

res

form

ally

appro

ved b

y PA

?T

est

Con

trol

7.2

0A

re p

rovi

sion

s m

ade

to p

rote

ct p

erso

nn

el a

nd ite

ms

from

ph

ysic

al dam

age

an

d e

nvi

ron

men

tal h

aza

rds?

7.2

1Is

th

e te

st ite

m in

spec

ted t

o det

erm

ine

evid

ence

of

dam

age

or

loos

e part

s?7.2

2A

re d

iscr

epan

cies

or

an

omalies

res

olve

d p

rior

to

test

ing?

7.2

3A

re t

he

follow

ing

act

ivit

ies

per

form

ed b

y PA

as

applica

ble

:a)

Wit

nes

s ea

ch t

est

an

d v

erify

test

per

form

an

ces?

b)

Obse

rvati

on?

Per

form

su

rvei

llan

ce o

r m

onit

orper

iodic

ally

the

test

bei

ng

per

form

ed a

s dir

ecte

d b

yex

plici

t in

stru

ctio

ns?

c)

Data

rev

iew

? R

evie

w t

he

pro

cedu

re a

nd r

ecor

ded

data

at

the

con

clu

sion

of th

e te

st c

ycle

ver

ifyi

ng

requ

irem

ents

an

d d

ata

en

trie

s are

com

pati

ble

?7.2

4D

o all d

ocu

men

ts b

ear

nec

essa

ry a

ppro

val si

gnatu

res

insp

ecti

on s

tam

ps?

7.2

5Is

rew

ork, re

pair

or

mod

ific

ati

on o

ccu

rrin

g to

th

ete

stin

g pro

per

ly d

ocu

men

ted?

7.2

6A

re t

est

dis

crep

an

cies

, fa

ilu

res

an

d n

on-c

onfo

rman

ce’s

repor

ted, an

aly

sed a

nd c

orre

ctiv

e act

ion

im

ple

men

ted?

8.

Measu

rem

en

ts a

nd

Test

Equ

ipm

en

t8.1

Doe

s th

e co

ntr

act

or h

ave

up-t

o-date

wri

tten

pro

cedu

res

def

inin

g h

is c

alibra

tion

sys

tem

en

com

pass

ing

mea

suri

ng

an

d t

est

equ

ipm

ent,

sta

ndard

s, c

alibra

tion

Page 10: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 10 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

san

d m

ain

ten

an

ce p

resc

ribed

in

terv

als

an

d m

etro

logy

labor

ato

ry e

nvi

ron

men

tal co

ntr

ols

8.2

Doe

s th

e ca

libra

tion

sys

tem

in

clu

de

all e

qu

ipm

ent

use

dto

ver

ify

the

qu

ality

of th

e pro

cess

es a

nd p

rodu

cts

bei

ng

man

ufa

ctu

red?

8.3

Do

calibra

tion

pro

cedu

res

exis

t fo

r ea

ch e

qu

ipm

ent

type

an

d in

clu

de:

a)

Equ

ipm

ent

chara

cter

isti

cs a

nd iden

tifica

tion

?b)

Loc

ati

on?

c)

Fre

qu

ency

of per

iodic

ch

ecks?

d)

Acc

epta

nce

cri

teri

a?

8.4

Is a

ll m

easu

rem

ent

an

d t

est

equ

ipm

ent

subje

cted

to

avi

sual, d

imen

sion

al an

d o

per

ati

onal in

spec

tion

upon

rece

ipt

an

d a

t per

iodic

in

terv

als

th

erea

fter

?8.5

Are

calibra

tion

label

s u

sed a

nd d

o th

ey in

clu

de

at

least

the

follow

ing:

a)

Iden

tifier

?b)

Du

e date

for

re-

calibra

tion

?c)

C

ontr

ol s

tam

p?

8.6

Is t

he

nec

essi

ty for

an

d/or

fre

qu

ency

of per

iodic

insp

ecti

ons

base

d o

n o

bje

ctiv

e ev

iden

ce o

f th

e st

abilit

yan

d c

onti

nu

ed a

ccu

racy

of th

e eq

uip

men

t? Is

th

ere

an

y in

terv

al ex

ceed

ing

1 y

ear

of v

alidit

y?8.7

Is a

ll m

easu

rem

ent

an

d t

est

equ

ipm

ent

chec

ked

aga

inst

a s

tan

dard

of gr

eate

r acc

ura

cy?

8.8

Are

tem

per

atu

re, h

um

idit

y, v

ibra

tion

an

d c

lean

lin

ess

con

trol

led t

o th

e ex

ten

t n

eces

sary

to

ass

ure

calibra

tion

an

d c

onti

nu

ed p

rodu

ct m

easu

rem

ents

of th

e re

qu

ired

acc

ura

cy?

8.9

Is it

ensu

red t

hat

erro

rs o

f m

easu

rin

g an

d t

est

equ

ipm

ent

do

not

exc

eed 1

0%

of th

e h

igh

est

tole

ran

ceof

an

y it

ems

to b

e ch

ecked

wit

h t

hat

equ

ipm

ent?

Page 11: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 11 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s8.1

0A

re s

tan

dard

s aga

inst

wh

ich

tes

t an

d m

easu

rem

ent

equ

ipm

ent

are

per

iodic

ally

chec

ked

tra

ceable

to

Nati

onal or

In

tern

ati

onal S

tan

dard

s?8.1

1A

re s

tan

dard

s su

ppor

ted b

y ce

rtific

ate

s, r

epor

t,va

riable

s data

sh

eets

att

esti

ng

to t

he

date

, acc

ura

cyan

d c

ondit

ion

s u

nder

wh

ich

th

e re

sult

s w

ere

obta

ined

?8.1

2Is

th

e ca

libra

tion

org

an

isati

on s

taffed

wit

h s

uffic

ien

tqu

alified

tec

hn

ical per

son

nel

?8.1

3A

re t

ri-d

imen

sion

al m

easu

rin

g m

ach

ines

an

dla

bor

ato

ry t

esti

ng

mach

ines

per

iodic

ally

calibra

ted b

y a

qu

alified

org

an

isati

on?

9.

Non

-Con

form

an

ce C

on

trol

9.1

Is a

pro

cedu

re a

vailable

wh

ich

des

crib

es t

he

non

-co

nfo

rman

ce s

yste

m?

9.2

Are

non

-con

form

an

ces

init

ially

repor

ted o

n loc

al

reco

rds

(dis

crep

an

cy n

otes

)? W

ho

takes

dec

isio

n for

furt

her

pro

cess

ing?

Is

PA

in

volv

ed?

9.3

Do

NC

R r

ecor

ds

reflec

t ca

use

s an

d r

espon

sibilit

ies

for

the

dis

crep

an

cies

an

d s

how

cor

rect

ive

an

d p

reve

nti

veact

ion

s ta

ken

?9.4

Is t

he

inte

rnal or

gan

isati

on r

espon

sible

for

cau

sin

g th

edis

crep

an

cy in

form

ed?

An

d d

oes

it c

oncu

r to

iden

tify

pre

ven

tive

act

ion

s?9.5

Are

log

s an

d r

ecor

ds

main

tain

ed o

f all N

CR

iss

ued

an

dM

RB

mee

tin

gs?

9.6

Are

th

ere

adeq

uate

pro

visi

ons

for

segr

egati

on, re

mov

al

an

d iden

tifica

tion

of n

on-c

onfo

rmin

g m

ate

rials

? I

s th

eacc

ess

to h

oldin

g are

as

con

trol

led?

9.7

Are

NC

Rs

iden

tified

on

rel

evan

t sh

op t

rave

ller

s an

dqu

ality

rec

ords?

9.8

Are

NC

Rs

pro

per

ly fille

d o

ut

an

d c

omple

te?

9.9

Are

NC

Rs

clos

ed b

y PA

aft

er v

erific

ati

on o

f su

cces

sfu

l

Page 12: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 12 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sre

med

ial act

ion

s im

ple

men

tati

on?

9.1

0A

re p

reve

nti

ve a

ctio

ns

imple

men

tati

on t

rack

ed?

(Cor

rect

ion

of te

chn

ical doc

um

ents

, m

odific

ati

on o

fto

ols

an

d w

ork in

stru

ctio

n?)

9.1

1A

re n

on-c

onfo

rman

ces

class

ifie

d a

ccor

din

g to

applica

ble

pro

ject

ru

les?

9.1

2A

re t

he

follow

ing

dis

pos

itio

ns

applied

?a)

Use

-as-

is?

b)

Rew

ork?

c)

Rep

air

?d)

Scr

ap?

e)

Ret

urn

to

supplier

?9.1

3A

re m

ajo

r n

on-c

onfo

rman

ces

not

ifie

d t

o E

SA

wit

hin

1w

orkin

g day

aft

er t

he

revi

ew b

y th

e lo

cal M

RB

?9.1

4Is

a R

FW

iss

ued

if th

e n

on-c

onfo

rman

ce d

ispos

itio

naffec

ts t

he

pro

du

ct c

onfigu

rati

on?

10

Pro

cess

Con

trol

10.1

Are

sta

ndard

/ e

stablish

ed p

roce

sses

cla

ssifie

d in

acc

ordan

ce t

o Pro

ject

ru

les?

10.2

Is e

ach

pro

cess

cov

ered

by

a s

pec

ific

ati

on?

10.3

Do

pro

cess

spec

ific

ati

ons

incl

ude

QA

pro

visi

ons,

met

hod

s fo

r in

spec

tion

an

d t

est,

nu

mber

of sa

mple

s,acc

ept

/ r

ejec

t cr

iter

ia?

10.4

Doe

s th

e co

mpan

y m

ain

tain

doc

um

ente

d e

viden

ce o

fpro

cess

es v

alidati

on s

tatu

s?10.5

Are

ch

an

ges

to p

roce

ss im

ple

men

ted t

hro

ugh

esta

blish

ed C

onfigu

rati

on C

ontr

ol p

roce

du

res?

10.6

Are

th

e per

son

nel

wh

o per

form

cri

tica

l pro

cess

es o

rev

alu

ate

pro

cess

per

form

an

ce n

um

eric

ally

adeq

uate

,tr

ain

ed a

nd c

erti

fied

?10.7

Are

mate

rials

, eq

uip

men

t, c

ompu

ter

syst

ems

an

dso

ftw

are

an

d p

roce

du

res

invo

lved

in

th

e per

form

an

ce o

f

Page 13: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 13 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

scr

itic

al pro

cess

es v

alidate

d?

10.8

Are

non

-des

tru

ctiv

e-in

spec

tion

s (N

DI)

tre

ate

d in

th

esa

me

way

of c

riti

cal pro

cess

es?

10.9

Are

rep

rese

nta

tive

ND

I st

an

dard

s ava

ilable

for

equ

ipm

ent

calibra

tion

an

d t

o m

onit

or e

qu

ipm

ent

per

form

an

ce?

10.1

0A

re N

DI

insp

ecti

on r

ecor

ds

main

tain

ed?

10.1

1A

re p

roce

ss e

qu

ipm

ent

per

iodic

ally

chec

ked

(as

applica

ble

) fo

r:a)

Tem

per

atu

re u

nifor

mit

y?b)

Inte

grit

y / p

reci

sion

of

ther

mo-

cou

ple

lin

es?

c)

Inte

grit

y of

vacu

um

rel

ate

d fea

ture

s (lin

es, et

c.)?

d)

En

d-t

o-en

d in

stru

men

ts c

alibra

tion

?e)

E

ffec

tive

nes

s of

con

tam

inati

on c

ontr

ol m

ean

s?10.1

2F

or e

ach

pro

cess

per

form

ed a

re r

ecor

ds

main

tain

ed o

fm

ain

pro

cess

para

met

ers

an

d o

f re

late

d labor

ato

rysa

mple

s te

sts

resu

lts?

10.1

3A

re t

her

e pro

visi

ons

in c

ase

of in

terr

upti

on o

f m

ain

pow

er s

upply

du

rin

g op

erati

on?

11

Pro

cu

rem

en

t C

on

trol

11.1

Doe

s th

e co

ntr

act

or m

ain

tain

a lis

t of

appro

ved

subco

ntr

act

ors

an

d s

upplier

s su

ppor

ted w

ith

qu

alita

tive

an

d q

uan

tita

tive

data

?11.2

Has

form

al ass

essm

ent

incl

udin

g per

iodic

fol

low

-up

bee

n a

ccom

plish

ed o

n s

ubco

ntr

act

ors

an

d s

upplier

s?11.3

Doe

s th

e co

ntr

act

or c

onti

nu

ally

evalu

ate

su

bco

ntr

act

or/ s

upplier

’s h

isto

ry /

res

ult

s an

d im

ple

men

t co

rrec

tive

act

ion

s w

hen

appro

pri

ate

?11.4

Are

pro

ject

pec

uliar

requ

irem

ents

iden

tified

in

ord

erth

at

qu

ality

per

son

nel

rev

iew

ing

pu

rch

ase

doc

um

ents

have

adeq

uate

pro

ject

an

d t

ech

nic

al data

to

per

form

the

revi

ew?

Page 14: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 14 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s11.5

Doe

s th

e co

ntr

act

or m

ain

tain

an

d im

ple

men

t a s

yste

mof

effec

tive

ly p

ass

ing

on c

ontr

act

/ p

roje

ct q

uality

requ

irem

ents

to

the

subco

ntr

act

ors

an

d s

upplier

s?11.6

Do

pro

cure

men

t doc

um

ents

con

tain

Pro

du

ct A

ssu

ran

cepro

visi

ons

for

the

follow

ing

as

appro

pri

ate

:a)

Applica

ble

ES

A c

ontr

act

or P

A s

pec

ific

ati

ons?

b)

Ch

emic

al an

d/or

ph

ysic

al te

st r

esu

lts

(raw

mat.

)?c)

A

ccom

pan

yin

g sp

ecim

en for

in

com

ing

test

s?d)

Age

con

trol

of lim

ited

life

pro

du

cts?

e)

Ch

ara

cter

isti

cs t

o be

insp

ecte

d o

r te

sted

?f)

R

equ

irem

ents

for

in

spec

tion

an

d t

est

reco

rds?

g)

Pro

cess

ing

of n

on-c

onfo

rmin

g m

ate

rials

?h

) R

equ

irem

ents

for

sou

rce

insp

ecti

on a

nd M

IPs?

i)

Rig

ht

of a

cces

s an

d p

lan

ned

su

rvei

llan

ce a

ctiv

itie

s?j)

C

lean

lin

ess

an

d c

onta

min

ati

on c

ontr

ol?

k)

Acc

epta

nce

data

pack

age

an

d d

eliv

ery?

l)

Pre

serv

ati

on, pack

agi

ng

an

d s

hip

pin

g?m

) C

riti

cal pro

cess

req

uir

emen

ts?

11.7

Are

pu

rch

ase

doc

um

ents

rev

iew

ed a

nd a

ppro

ved b

yPA

?11.8

Doe

s th

e co

ntr

act

or h

ave

a p

olic

y or

ru

les

for

sou

rce

insp

ecti

on?

11.9

Are

adeq

uate

ly t

rain

ed p

erso

nn

el a

vailable

for

sou

rce

insp

ecti

on?

11.1

0D

oes

the

con

tract

or m

ain

tain

rec

ords

of s

ourc

eact

ivit

ies,

sta

tus

def

icie

nci

es a

nd a

ctio

n ite

ms?

12

Tra

inin

g a

nd

Cert

ific

ati

on

12.1

Are

per

son

nel

per

form

ing

crit

ical pro

cess

es a

nd n

on-

des

tru

ctiv

e te

stin

g tr

ain

ed a

nd c

erti

fied

acc

ordin

g to

adoc

um

ente

d t

rain

ing

pro

gram

me?

12.2

Are

nati

onal or

in

tern

ati

onal tr

ain

ing

pro

gram

mes

an

dst

an

dard

s applied

?

Page 15: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 15 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s12.3

Are

ND

T p

erso

nn

el t

rain

ed a

nd c

erti

fied

acc

ordin

g to

MIL

-STD

-410 o

r eq

uiv

ale

nt?

12.4

Is r

e-ce

rtific

ati

on p

erfo

rmed

per

iodic

ally

acc

ordin

g to

an

est

ablish

ed p

rogr

am

me

or fol

low

ing

exte

nsi

vein

terr

upti

on o

f w

ork o

r u

nsa

tisf

act

ory

per

form

an

ce?

12.5

Are

qu

an

tita

tive

tes

ts u

sed t

o ve

rify

th

e pro

fici

ency

of

the

train

ed p

erso

nn

el?

12.6

Are

rec

ords

doc

um

enti

ng

per

son

nel

tra

inin

gm

ain

tain

ed?

13

Sta

mp

Con

trol

13.1

Doe

s a d

ocu

men

ted s

yste

m e

xist

for

th

e u

sage

of

stam

ps?

(in

spec

tion

, fa

bri

cati

on, te

st, et

c.)

13.2

Do

reco

rds

exis

t allow

ing

trace

abilit

y to

th

e re

spon

sible

indiv

idu

als

an

d d

efin

ing

the

au

thor

ity

/ lim

itati

ons

inu

se?

14

Desi

gn

Con

trol

14.1

Are

th

ere

stan

dard

s an

d p

roce

du

res

ava

ilable

for

pre

para

tion

an

d m

ain

ten

an

ce o

f en

gin

eeri

ng

dra

win

gsan

d s

pec

ific

ati

ons?

14.2

Are

th

ere

pro

cedu

res

for

track

ing

an

d d

ocu

men

tati

on o

fre

qu

irem

ents

ver

ific

ati

on?

14.3

Do

QA

per

son

nel

part

icip

ate

in

in

tern

al des

ign

rev

iew

sto

en

sure

th

at:

a)

Tec

hn

ical doc

um

ents

com

ply

wit

h p

roce

du

res

an

dst

an

dard

s?b)

Req

uir

ed in

spec

tion

s an

d t

ests

are

appro

pri

ate

an

dfe

asi

ble

?14.4

Is Q

A p

art

icip

ati

on t

o in

tern

al des

ign

rev

iew

sdoc

um

ente

d?

14.5

In s

uppor

t of

for

mal des

ign

rev

iew

s w

ith

th

e cu

stom

erdoe

s th

e PA

fu

nct

ion

en

sure

th

at:

a)

Doc

um

ents

are

com

ple

te a

nd c

onsi

sten

t?

Page 16: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 16 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sb)

An

aly

ses

clea

rly

iden

tify

th

e re

late

d b

ase

lin

e?c)

S

afe

ty, re

liabilit

y an

d m

ain

tain

abilit

y are

fact

ored

into

th

e des

ign

?d)

Th

e des

ign

is

pro

du

cible

, in

spec

table

, te

stable

?

II.

Reli

abil

ity

1.

Reli

abil

ity

1.1

Doe

s a s

yste

m e

xist

for

en

suri

ng

that

des

ign

ers

are

aw

are

of part

der

ati

ng

crit

eria

wit

h w

hic

h t

hey

are

expec

ted t

o co

mply

?1.2

Doe

s a p

roce

du

re e

xist

des

crib

ing

the

FM

EC

A a

ppro

ach

of t

he

con

tract

or?

1.3

Doe

s th

e FM

EC

A a

ppro

ach

foc

us

on:

a.

Iden

tifica

tion

an

d c

ontr

ol o

f si

ngl

e poi

nt

failu

re?

b.

Cri

tica

l in

terf

ace

s?c.

M

eth

ods

by

wh

ich

red

un

dan

cy is

imple

men

ted?

d.

Pro

du

ct d

esig

n (e.

g. layo

ut

of P

CB

s, t

race

wid

th, pad

size

s an

d o

ther

failu

re c

au

ses

rela

ted t

o m

ech

an

ical

con

figu

rati

on?)

1.4

Is a

fu

nct

ion

al FM

EC

A p

erfo

rmed

at

syst

em (payl

oad)

leve

l?1.5

Doe

s th

e FM

EC

A in

clu

de

the

iden

tifica

tion

of m

eth

ods

by

wh

ich

th

e ex

iste

nce

of fa

ilu

re m

odes

can

be

det

erm

ined

du

rin

g op

erati

ons?

1.6

Doe

s th

e FM

EC

A a

deq

uate

ly r

efer

ence

basi

c des

ign

doc

um

enta

tion

su

ch a

s sp

ecific

ati

ons,

des

ign

rep

orts

,dra

win

gs, ci

rcu

it d

iagr

am

s, p

art

lis

ts a

nd o

per

ati

ng

pro

cedu

res?

III.

Main

tain

abil

ity

1.

Main

tain

abil

ity

1.1

Is t

he

con

tract

or a

ware

of basi

c m

ain

tain

abilit

y

Page 17: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 17 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

spri

nci

ple

s an

d t

ech

niq

ues

?1.2

Is t

he

con

tract

or fam

ilia

r w

ith

main

ten

an

ce c

once

pts

,pla

nn

ing

an

d s

uppor

tin

g el

emen

ts?

1.3

Do

pro

cedu

res

exis

t to

per

form

main

tain

abilit

y st

udie

san

d m

ain

tain

abilit

y pre

dic

tion

s?1.4

Is m

ain

tain

abilit

y a d

esig

n p

ara

met

er m

onit

ored

for

com

plian

ce t

hro

ugh

out

the

des

ign

pro

cess

?

IV.

Safe

ty1

.S

afe

ty1.1

Are

NA

SA

an

d E

SA

safe

ty r

elate

d d

ocu

men

ts(s

pec

ific

ati

ons,

sta

ndard

s, h

an

dboo

ks)

ava

ilable

?1.2

Has

an

adeq

uate

pro

gram

of tr

ain

ing,

safe

ty m

otiv

ati

onan

d a

ware

nes

s bee

n in

stit

ute

d?

1.3

Is t

he

con

tract

or a

ble

to

suppor

t h

is s

ubco

ntr

act

ors

for

safe

ty r

elate

d iss

ues

?1.4

Are

th

ere

adeq

uate

safe

ty p

lan

s pro

du

ced c

over

ing:

a.

Sco

pe

of s

afe

ty e

ffor

t?b.

Em

ph

asi

s on

safe

ty a

naly

ses

an

d r

evie

ws?

c.

Haza

rd c

ontr

ol p

roce

du

res?

d.

Invo

lvem

ent

of P

A a

nd s

afe

ty p

erso

nn

el t

hro

ugh

out

des

ign

an

d d

evel

opm

ent?

e.

Safe

ty d

esig

n c

rite

ria?

f.

Safe

ty v

erific

ati

on p

rogr

am

?1.5

Doe

s a d

etailed

pro

cedu

re e

xist

to

esta

blish

an

dm

ain

tain

a s

afe

ty v

erific

ati

on p

rogr

am

? A

nd d

oes

itallow

for

coo

rdin

ati

on o

f all in

tere

sted

con

tract

or's

fun

ctio

ns

so t

o pro

vide

pro

mpt

feed

back

to

ES

A?

1.6

Are

safe

ty r

elate

d in

spec

tion

s an

d t

ests

per

form

ed b

y or

un

der

dir

ect

surv

eillan

ce o

f th

e PA

an

d S

afe

tyfu

nct

ion

?1.7

Doe

s th

e PA

an

d S

afe

ty fu

nct

ion

have

rev

iew

au

thor

ity

Page 18: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 18 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sov

er a

ll t

est

pla

ns

wit

h a

deq

uate

lea

d t

ime

to iden

tify

an

d c

ontr

ol a

ssoc

iate

d h

aza

rds?

1.8

Is t

he

gen

erati

on o

f sa

fety

doc

um

ents

for

a p

roje

ct w

ell

def

ined

an

d s

ched

ule

d?

1.9

Do

the

safe

ty a

naly

ses

make

maxi

mu

m u

se o

f FM

EC

Are

sult

s?

V.

Soft

ware

PA

1.

Org

an

isati

on

al

Str

uctu

re1.1

For

each

pro

ject

in

volv

ing

soft

ware

dev

elop

men

t, is

ther

e a d

esig

nate

d s

oftw

are

man

age

r?1.2

Doe

s th

e pro

ject

sof

tware

man

age

r re

por

t dir

ectl

y to

th

epro

ject

man

age

r?1.3

Is t

her

e a s

oftw

are

PA

fu

nct

ion

for

each

pro

ject

th

at

invo

lves

sof

tware

dev

elop

men

t?1.4

Is t

her

e a s

oftw

are

con

figu

rati

on c

ontr

ol fu

nct

ion

for

pro

ject

s th

at

invo

lve

soft

ware

dev

elop

men

t?1.5

Wh

ich

res

pon

sibilit

ies

are

ass

ign

ed t

o th

e so

ftw

are

PA

fun

ctio

n in

th

e va

riou

s ph

ase

s of

th

e so

ftw

are

life

cycl

e?1.6

How

is

the

indep

enden

ce o

f th

e so

ftw

are

PA

fu

nct

ion

ass

ure

d?

1.7

Is t

he

test

org

an

isati

on in

dep

enden

t fr

om t

he

dev

elop

men

t? (u

nit

, in

tegr

ati

on, sy

stem

)1.8

Wh

o dec

ides

in

case

of co

nflic

t bet

wee

n d

iffe

ren

tor

gan

isati

onal u

nit

s?1.9

Is P

rodu

ct A

ssu

ran

ce a

ppro

val m

an

dato

ry p

rior

to

soft

ware

rel

ease

?2

.R

eso

urc

es,

pers

on

nel

an

d t

rain

ing

2.1

Doe

s ea

ch s

oftw

are

dev

elop

er h

ave

pri

vate

com

pu

ter-

suppor

ted w

orkst

ati

on/te

rmin

al?

2.2

Are

pro

ject

man

age

rs fam

ilia

r w

ith

sof

tware

pro

ject

Page 19: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 19 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sm

an

age

men

t dis

ciplin

es?

2.3

Is t

her

e a r

equ

ired

sof

tware

en

gin

eeri

ng

train

ing

pro

gram

for

sof

tware

dev

elop

ers?

3.

Soft

ware

en

gin

eeri

ng e

xperi

en

ce

3.1

Wh

at

is t

he

med

ian

nu

mber

of ye

ars

of applica

ble

exper

ien

ce o

f so

ftw

are

pro

ject

man

age

rs?

3.2

Wh

at

is t

he

med

ian

nu

mber

of ye

ars

of applica

ble

exper

ien

ce o

f so

ftw

are

in

tegr

ati

on a

nd t

est

man

age

rs?

3.3

Wh

at

is t

he

med

ian

nu

mber

of ye

ars

of so

ftw

are

dev

elop

men

t ex

per

ien

ce o

f th

e so

ftw

are

sta

ff?

3.4

Wh

at

per

cen

tage

of th

e so

ftw

are

sta

ff h

as

at

least

on

eye

ar

of d

evel

opm

ent

exper

ien

ce w

ith

th

e des

ign

an

dim

ple

men

tati

on lan

guage

s to

be

use

d?

3.5

Of th

ose

wit

h e

xper

ien

ce, w

hat

is t

he

med

ian

nu

mber

of y

ears

of ex

per

ien

ce w

ith

th

ose

lan

guage

s?3.6

Wh

at

is t

he

med

ian

siz

e, in

sou

rce

lin

es o

f co

de,

of

soft

ware

dev

elop

men

t pro

ject

s co

mple

ted in

th

e la

st fiv

eye

ars

?3.7

Wh

at

is t

he

size

of th

e sm

alles

t pro

ject

?3.8

Wh

at

is t

he

size

of th

e la

rges

t pro

ject

?4

.D

ocu

men

ted

sta

nd

ard

s an

d p

rocedu

res

4.1

Doe

s th

e so

ftw

are

org

an

isati

on u

se a

sta

ndard

ised

an

ddoc

um

ente

d s

oftw

are

dev

elop

men

t pro

cess

on

each

pro

ject

?4.2

Doe

s th

e st

an

dard

sof

tware

dev

elop

men

t pro

cess

doc

um

enta

tion

des

crib

e th

e u

se o

f to

ols

an

dte

chn

iqu

es?

4.3

Is a

for

mal pro

cedu

re u

sed t

o ass

ure

per

iodic

man

age

men

t re

view

of th

e st

atu

s of

each

sof

tware

dev

elop

men

t pro

ject

?4.4

Is t

her

e a m

ech

an

ism

for

ass

uri

ng

that

soft

ware

subco

ntr

act

ors,

if an

y, fol

low

a d

isci

plin

ed s

oftw

are

Page 20: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 20 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sdev

elop

men

t pro

cess

?4.5

Are

sta

ndard

s u

sed t

o sp

ecify

the

con

ten

t of

sof

tware

doc

um

ents

(file

s/fo

lder

s)?

4.6

Are

in

spec

tion

s co

ndu

cted

du

rin

g th

e so

ftw

are

dev

elop

men

t pro

cess

?4.7

Are

cod

ing

stan

dard

s applied

to

the

soft

ware

dev

elop

men

t pro

cess

?4.8

Are

sta

ndard

s applied

to

the

pre

para

tion

of

un

it/in

tegr

ati

on/sy

stem

tes

t ca

ses?

4.9

Are

cod

e m

ain

tain

abilit

y st

an

dard

s applied

?4.1

0A

re in

tern

al des

ign

rev

iew

sta

ndard

s applied

?4.1

1A

re c

ode

insp

ecti

on s

tan

dard

s applied

?4.1

2A

re s

oftw

are

cla

ssific

ati

on r

ule

s applied

?4.1

3Is

a for

mal pro

cedu

re a

pplied

to

esti

mate

sof

tware

siz

e?4.1

4Is

a for

mal pro

cedu

re a

pplied

to

pro

du

ce s

oftw

are

dev

elop

men

t sc

hed

ule

s?4.1

5A

re for

mal pro

cedu

res

applied

to

esti

mati

ng

soft

ware

dev

elop

men

t co

st?

4.1

6Is

a m

ech

an

ism

use

d for

en

suri

ng

that

the

soft

ware

des

ign

tea

ms

are

fam

ilia

r w

ith

th

e so

ftw

are

requ

irem

ents

?4.1

7A

re m

an

-mach

ine

inte

rface

sta

ndard

s applied

to

each

appro

pri

ate

sof

tware

dev

elop

men

t pro

ject

?5

.P

rocess

metr

ics

5.1

Are

sof

tware

sta

ffin

g pro

file

s m

ain

tain

ed (act

ual

staffin

g ve

rsu

s pla

nn

ed s

taffin

g)?

5.2

Are

pro

file

s of

sof

tware

siz

e m

ain

tain

ed for

each

soft

ware

con

figu

rati

on ite

m, ov

er t

ime?

5.3

Are

sta

tist

ics

on s

oftw

are

cod

e an

d t

est

erro

rsga

ther

ed?

5.4

Are

des

ign

/co

din

g er

rors

pro

ject

ed a

nd c

ompare

d t

oact

ual?

Page 21: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 21 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s5.5

Are

pro

file

s m

ain

tain

ed o

f act

ual ve

rsu

s pla

nn

eddes

ign

ed s

oftw

are

un

its,

ove

r ti

me?

5.6

Are

pro

file

s m

ain

tain

ed o

f act

ual ve

rsu

s pla

nn

ed t

este

dso

ftw

are

un

its,

ove

r ti

me?

5.7

Are

pro

file

s m

ain

tain

ed o

f act

ual ve

rsu

s pla

nn

edin

tegr

ate

d s

oftw

are

un

its,

ove

r ti

me?

5.8

Are

pro

cess

or m

emor

y u

tilisa

tion

est

imate

s ve

rsu

sact

ual si

ze t

rack

ed?

(siz

ing

figu

res)

5.9

Are

targ

et p

roce

ssor

th

rou

ghpu

t u

tilisa

tion

est

imate

sve

rsu

s act

ual u

sed, tr

ack

ed?

(tim

ing

figu

res)

5.1

0A

re d

esig

n a

nd c

ode

revi

ew c

over

age

mea

sure

d a

nd

reco

rded

?5.1

1Is

tes

t co

vera

ge m

easu

red a

nd r

ecor

ded

for

each

ph

ase

of fu

nct

ion

al te

stin

g?5.1

2A

re t

he

act

ion

ite

ms

resu

ltin

g fr

om s

oftw

are

rev

iew

str

ack

ed t

o cl

osu

re?

5.1

3A

re s

oftw

are

pro

ble

m r

epor

ts r

esu

ltin

g fr

om t

esti

ng

track

ed t

o cl

osu

re?

5.1

4A

re t

he

act

ion

ite

ms

resu

ltin

g fr

om d

esig

n/co

de

insp

ecti

ons

track

ed t

o cl

osu

re?

5.1

5Is

tes

t pro

gres

s tr

ack

ed for

each

del

iver

able

sof

tware

un

it/co

mpon

ent?

6.

Data

man

agem

en

t an

d a

naly

sis

6.1

Has

a m

an

age

d a

nd c

ontr

olle

d p

roce

ss d

ata

base

bee

nes

tablish

ed t

o pro

cess

met

rics

data

acr

oss

all p

roje

cts?

6.2

Are

th

e re

view

data

gath

ered

du

rin

g so

ftw

are

rev

iew

san

aly

sed?

6.3

Is t

he

erro

r data

fro

m c

ode

insp

ecti

ons

an

d t

ests

an

aly

sed t

o det

erm

ine

the

likel

y dis

trib

uti

on a

nd

chara

cter

isti

cs o

f th

e re

main

ing

erro

rs in

th

e pro

du

ct?

6.4

Are

an

aly

ses

of e

rror

s co

ndu

cted

to

det

erm

ine

thei

rpro

cess

rel

ate

d c

au

ses?

Page 22: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 22 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s6.5

Is a

mec

han

ism

use

d for

err

or c

au

se a

naly

sis?

6.6

Are

th

e er

ror

cau

ses

revi

ewed

to

det

erm

ine

the

pro

cess

chan

ges

requ

ired

to

pre

ven

t th

em?

6.7

Is a

mec

han

ism

use

d for

in

itia

tin

g er

ror

pre

ven

tion

act

ion

?7

.P

rocess

con

trol

7.1

Doe

s m

an

age

men

t h

ave

a m

ech

an

ism

for

th

e re

gula

rre

view

of th

e st

atu

s of

sof

tware

dev

elop

men

t pro

ject

s?7.2

Is a

mec

han

ism

use

d for

per

iodic

ally

ass

essi

ng

the

soft

ware

en

gin

eeri

ng

pro

cess

an

d im

ple

men

tin

gim

pro

vem

ents

?7.3

Is a

mec

han

ism

use

d for

iden

tify

ing

an

d r

esol

vin

gsy

stem

en

gin

eeri

ng

issu

es t

hat

cou

ld a

ffec

t so

ftw

are

?7.4

Is a

mec

han

ism

use

d for

reg

ula

r te

chn

ical in

terc

han

ges

wit

h t

he

cust

omer

?7.5

Is a

mec

han

ism

use

d for

en

suri

ng

com

plian

ce w

ith

th

eso

ftw

are

en

gin

eeri

ng

stan

dard

s?7.6

Is a

mec

han

ism

use

d for

en

suri

ng

trace

abilit

y bet

wee

nth

e so

ftw

are

req

uir

emen

ts a

nd t

op-l

evel

des

ign

?7.7

Is a

mec

han

ism

use

d for

con

trol

lin

g ch

an

ges

to t

he

soft

ware

req

uir

emen

ts?

7.8

Is c

onfigu

rati

on m

an

age

men

t im

ple

men

ted?

(Base

lin

es,

Iden

tifica

tion

, Lib

rari

es, R

elea

se a

nd v

ersi

on c

ontr

ol)

7.9

Is a

mec

han

ism

use

d for

en

suri

ng

trace

abilit

y bet

wee

nth

e so

ftw

are

top

-lev

el a

nd d

etailed

des

ign

s?7.1

0A

re in

tern

al so

ftw

are

des

ign

rev

iew

s co

ndu

cted

?7.1

1Is

a m

ech

an

ism

use

d for

con

trol

lin

g ch

an

ges

to t

he

soft

ware

des

ign

?7.1

2Is

a m

ech

an

ism

use

d for

en

suri

ng

trace

abilit

y bet

wee

nth

e so

ftw

are

det

ailed

des

ign

an

d c

ode

un

its

/co

mpon

ents

?7.1

3Is

a m

ech

an

ism

use

d for

en

suri

ng

trace

abilit

y bet

wee

n

Page 23: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 23 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sth

e so

ftw

are

det

ailed

des

ign

an

d c

ode

un

its/

com

pon

ents

?7.1

4A

re s

oftw

are

cod

e re

view

s co

ndu

cted

?7.1

5Is

a m

ech

an

ism

use

d for

con

trol

lin

g ch

an

ges

to t

he

code?

(W

ho

can

make

chan

ges

an

d u

nder

wh

ich

circ

um

stan

ces?

)7.1

6Is

a m

ech

an

ism

use

d for

con

figu

rati

on m

an

age

men

t of

the

soft

ware

too

ls u

sed in

th

e dev

elop

men

t pro

cess

?7.1

7Is

a m

ech

an

ism

use

d for

ver

ifyi

ng

that

the

sam

ple

sex

am

ined

by

Sof

tware

Pro

du

ct A

ssu

ran

ce a

re t

ruly

repre

sen

tati

ve o

f th

e w

ork p

erfo

rmed

?7.1

8Is

th

ere

a m

ech

an

ism

for

ass

uri

ng

that

regr

essi

onte

stin

g is

rou

tin

ely

per

form

ed?

7.1

9Is

th

ere

a m

ech

an

ism

for

ass

uri

ng

the

adeq

uacy

of

regr

essi

on t

esti

ng?

7.2

0A

re for

mal te

st c

ase

rev

iew

s co

ndu

cted

?7.2

1D

o th

e co

mpan

y's

pro

cedu

res

des

crib

e ta

sks

an

dre

spon

sibilit

ies

for

diffe

ren

t te

st t

ypes

?7.2

2Is

mod

ule

(in

tegr

ati

on, sy

stem

) le

vel te

stin

g co

vere

d b

yth

ese

pro

cedu

res?

7.2

3A

re t

est

cove

rage

mea

sure

men

ts d

efin

ed?

7.2

4Is

th

ere

an

appro

ach

for

for

mal qu

alifica

tion

tes

tin

g?7.2

5A

re n

onco

nfo

rman

ces

pro

per

ly d

ocu

men

ted, in

clu

din

gdis

pos

itio

ns

an

d r

etes

tin

g?8

.T

ools

an

d T

ech

nolo

gy

8.1

Is a

uto

mate

d c

onfigu

rati

on c

ontr

ol a

nd t

rack

ch

an

geact

ivit

y th

rou

ghou

t th

e so

ftw

are

dev

elop

men

t pro

cess

?8.2

Are

com

pu

ter

tool

s u

sed t

o ass

ist

in t

raci

ng

soft

ware

requ

irem

ents

to

soft

ware

des

ign

?8.3

Are

des

ign

met

hod

olog

ies

use

d in

pro

gram

des

ign

?8.4

Are

com

pu

ter

tool

s u

sed t

o ass

ist

in t

raci

ng

the

soft

ware

des

ign

to

the

code?

Page 24: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 24 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s8.5

Wh

ich

lan

guage

s are

use

d in

sof

tware

dev

elop

men

ts?

8.6

Wh

at

is t

he

per

cen

tage

of so

ftw

are

dev

elop

men

tsim

ple

men

ted in

hig

h-o

rder

lan

guage

?8.7

Wh

at

is t

he

per

cen

tage

of so

ftw

are

dev

elop

men

tsim

ple

men

ted in

ass

emble

r la

ngu

age

?8.8

Are

au

tom

ate

d t

est

inpu

t data

gen

erato

rs u

sed for

test

ing?

8.9

Are

com

pu

ter

tool

s u

sed t

o m

easu

re t

est

cove

rage

? (t

ool

for

dyn

am

ic a

naly

ses)

8.1

0A

re c

ompu

ter

tool

s u

sed t

o tr

ack

eve

ry r

equ

ired

fun

ctio

n a

nd a

ssu

re t

hat

it is

test

ed/ve

rified

?8.1

1A

re a

uto

mate

d t

ools

use

d t

o an

aly

se t

he

size

an

dch

an

ge a

ctiv

ity

in s

oftw

are

com

pon

ents

?8.1

2A

re a

uto

mate

d t

ools

use

d t

o an

aly

se s

oftw

are

com

ple

xity

? (to

ols

for

stati

c an

aly

ses)

8.1

3A

re in

tera

ctiv

e so

urc

e-le

vel deb

ugg

ers

use

d?

8.1

4A

re c

ompu

ter

tool

s u

sed for

tra

ckin

g an

d r

epor

tin

g th

est

atu

s of

th

e so

ftw

are

in

th

e so

ftw

are

dev

elop

men

tlibra

ry?

8.1

5A

re p

roto

typin

g m

eth

ods

use

d in

des

ign

ing

the

crit

ical

elem

ents

of th

e m

an

-mach

ine

inte

rface

?8.1

6W

hic

h o

ther

SD

E t

ools

are

cu

rren

tly

use

d?

9.

Pro

cu

rem

en

t of

CO

TS

9.1

Is t

her

e a p

roce

du

re for

CO

TS

pro

cure

men

t?9.2

Is t

he

supplier

's c

apabilit

y or

en

suri

ng

CO

TS

main

ten

an

ce t

aken

in

to a

ccou

nt

wh

en p

rocu

rin

gso

ftw

are

?9.3

Are

lic

ensi

ng

arr

an

gem

ents

taken

in

to c

onsi

der

ati

onw

hen

pro

curi

ng

soft

ware

9.4

Wh

at

is t

he

doc

um

enta

tion

pol

icy

for

pro

cure

d C

OTS

to

be

use

d t

oget

her

wit

h c

ompan

y's

dev

elop

ed s

oftw

are

?

Page 25: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 25 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sV

I.C

on

figu

rati

on

Man

agem

en

t1

.O

rgan

isati

on

1.1

Is a

con

figu

rati

on M

an

age

r th

e si

ngl

e-poi

nt

con

tact

for

all m

att

ers

rela

tin

g to

CM

?1.2

Is t

her

e a c

lear

state

men

t of

res

pon

sibilit

ies

an

dau

thor

ity

for

the

CM

fu

nct

ion

?1.3

Is t

he

orga

nis

ati

onal pla

cem

ent

of C

M a

t appro

pri

ate

leve

l?2

.S

ubcon

tracto

r's

CM

2.1

Do

pro

cedu

res

pro

vide

for

the

applica

tion

of C

Mre

qu

irem

ents

to

subco

ntr

act

ors?

2.2

Doe

s th

e ch

an

ge c

ontr

ol s

yste

m p

rovi

de

for

inpu

t of

subco

ntr

act

or-i

nit

iate

d c

han

ges,

pro

cess

ing

an

dch

an

ge a

uth

oris

ati

on?

3.

Fu

ncti

on

of

CM

off

ice

3.1

Doe

s th

e C

MO

per

form

th

e fo

llow

ing

fun

ctio

ns:

a.

Pre

para

tion

an

d m

ain

ten

an

ce o

f C

M p

roce

du

res

an

dpla

ns?

b.

Rel

ease

au

thor

ity

for

engi

nee

rin

g doc

um

ents

?c.

O

per

ati

on o

f th

e C

CB

?d.

Su

ppor

t to

des

ign

rev

iew

s?e.

Pro

cess

ing

an

d r

elea

se o

f ch

an

ges

an

d w

aiv

ers?

4.

Con

figu

rati

on

id

en

tifi

cati

on

4.1

Is t

he

con

cept

of C

onfigu

rati

on I

tem

use

d a

nd

imple

men

ted?

(CI-

spec

ific

ati

on-d

raw

ing

list

-des

ign

revi

ews-

qu

alifica

tion

)4.2

Are

cri

teri

a for

sel

ecti

on o

f C

Is p

rovi

ded

?4.3

Do

pro

cedu

res

esta

blish

a s

tan

dard

iden

tifica

tion

syst

em for

dra

win

gs, sp

ecific

ati

ons,

hard

ware

an

dS

/W

?5

.C

on

figu

rati

on

data

man

agem

en

t5.1

Do

pro

cedu

res

or m

an

ual pro

vide

inst

ruct

ion

s fo

r

Page 26: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 26 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

sfo

rmat

an

d c

onte

nt

of d

raw

ings

an

d s

pec

ific

ati

ons?

5.2

Do

pro

cedu

res

or m

an

uals

est

ablish

met

hod

s fo

ram

endm

ents

an

d r

evis

ion

s to

spec

ific

ati

ons

an

ddra

win

gs?

5.3

Is t

he

CM

O fu

nct

ion

res

pon

sible

for

iden

tifica

tion

nu

mber

s ass

ign

men

t?5.4

Are

en

d-i

tem

ser

ial n

um

ber

s pro

vided

by

CM

O for

con

figu

rati

on a

nd c

han

ge t

race

abilit

y?5.5

Are

th

ere

pre

scri

bed

pro

cedu

res

for

rele

ase

of

con

figu

rati

on d

ocu

men

tati

on t

hat

pro

vide,

as

am

inim

um

, es

tablish

men

t of

rec

ords

an

d im

pou

nd o

for

igin

als

?5.6

Is t

her

e a d

efin

ed a

ppro

val pro

cedu

re for

con

figu

rati

ondoc

um

enta

tion

pri

or t

o re

lease

?5.7

Is r

elea

se o

f co

nfigu

rati

on d

ocu

men

tati

on b

y th

eapplica

ble

rel

ease

sys

tem

req

uir

ed p

rior

to

man

ufa

ctu

re o

r pro

cure

men

t?5.8

Do

pro

cedu

res

pro

vide

for

rele

ase

of so

ftw

are

doc

um

enta

tion

?5.9

Is t

he

S/W

Lib

rary

use

d a

s th

e re

lease

fu

nct

ion

an

d is

ther

e an

est

ablish

ed p

roce

du

re for

its

oper

ati

on?

5.1

0D

oes

the

impou

nd s

yste

m p

rovi

de

adeq

uate

sec

uri

ty t

opre

ven

t u

nau

thor

ised

ch

an

ges

an

d p

rovi

de

dis

ast

erpro

tect

ion

?5.1

1D

o pro

cedu

res

pro

vide

for

a S

/W

rep

osit

ory

for

per

man

ent

rete

nti

on o

f del

iver

ed s

oftw

are

?5.1

2Is

CM

applied

to

CA

D/C

AM

sof

tware

an

d s

oftw

are

tool

s?6

.C

on

figu

rati

on

Con

trol

6.1

Are

th

ere

pro

cedu

res

for

applica

tion

of base

lin

eid

enti

fica

tion

an

d c

ontr

ol?

6.2

Are

base

lin

es e

stablish

ed a

t sy

stem

, su

bsy

stem

an

d

Page 27: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 27 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

seq

uip

men

t le

vel?

7.

Con

figu

rati

on

Con

trol

Board

7.1

Doe

s th

e sy

stem

pro

vide

for

a C

CB

wit

h m

ember

ship

that

will en

sure

a c

ompre

hen

sive

im

pact

an

aly

sis?

7.2

Is a

Sof

tware

CC

B p

rovi

ded

wit

h a

ppro

pri

ate

mem

ber

ship

to

evalu

ate

an

d d

ispos

itio

n S

/W

ch

an

ges?

7.3

Are

cle

arl

y def

ined

in

terf

ace

s bet

wee

n t

he

syst

em C

CB

an

d S

/W

CC

B h

ard

ware

/so

ftw

are

ch

an

ges?

7.4

Is t

he

CC

B in

ch

arg

e of

rev

iew

ing

an

d c

ontr

ollin

g th

edes

ign

base

lin

es?

7.5

Are

CC

B D

irec

tive

s is

sued

?8

.C

han

ge E

valu

ati

on

8.1

Doe

s th

e sy

stem

pro

vide

for

impact

an

aly

sis

pri

or t

oappro

val/

dis

appro

val?

8.2

Doe

s ch

an

ge im

pact

an

aly

sis

incl

ude

all a

spec

ts o

fen

gin

eeri

ng,

man

ufa

ctu

rin

g, log

isti

cs c

osts

, sc

hed

ule

?8.3

Are

ch

an

ges

an

d im

ple

men

tati

on d

ocu

men

ts m

ark

edw

ith

th

e cl

ass

?8.4

Are

ch

an

ges

an

d w

aiv

ers

subm

itte

d t

o th

e appro

val

au

thor

ity

esta

blish

ed b

y th

e co

ntr

act

, bef

ore

imple

men

tati

on?

8.5

Are

ch

an

ges

an

d w

aiv

ers

rele

ase

d b

y th

e sa

me

rele

ase

syst

em u

sed for

in

itia

l dra

win

g an

d s

pec

ific

ati

onre

lease

?8.6

Is t

he

inte

rch

an

geabilit

y st

atu

s m

ark

ed o

n t

he

chan

ges?

8.7

Is t

her

e a p

roce

du

re for

th

e re

-iden

tifica

tion

of n

on-

inte

rch

an

geable

ite

ms?

8.8

Doe

s th

e sy

stem

pro

vide

for

the

pre

para

tion

an

dpre

sen

tati

on o

f w

aiv

er?

8.9

Are

waiv

ers

pro

cess

ed t

hro

ugh

th

e cu

stom

er's

CC

B?

9.

Con

figu

rati

on

Sta

tus

Accou

nti

ng

Page 28: Product Assurance Audit Checklist MSM-GP/27 APR 2001perondi/10.11.2008/GPQ-MAN-07-Issue1.pdf · GPQ-MAN-07 ... Product Assurance Audit Checklist ... QA audits 3.1 Are systematic internal

C =

Com

plian

t

N

C =

Not

Com

plian

tPag

e 28 o

f 28

PC

= P

arti

al C

omplian

t

N/A

= N

ot A

pplica

ble

Item

No.

Au

dit

Ele

men

tC

PC

NC

N/A

Rem

ark

s9.1

Doe

s th

e C

M s

yste

m p

rovi

de

for

the

doc

um

enta

tion

of

the

'as-

des

ign

ed' s

tan

dard

by

mea

ns

of a

CID

L(C

onfigu

rati

on I

tem

Data

Lis

t)?

9.2

Do

pro

cedu

res

pre

scri

be

the

fun

ctio

n r

espon

sible

for

CID

L in

pu

ts?

9.3

Doe

s th

e C

IDL c

onta

in a

s a m

inim

um

th

e list

of

rele

ase

d:

a.

Dra

win

gs?

b.

Spec

ific

ati

on?

c.

Tes

t pro

cedu

res?

d.

EE

E p

art

s list

?e.

M

ate

rial list

?f.

Pro

cess

es lis

t?9.4

Doe

s th

e sy

stem

pro

vide

for

the

pre

para

tion

of 'a

s-bu

ilt'

list

s an

d e

stablish

th

e re

spon

sibilit

y fo

r pre

para

tion

an

d d

ata

in

pu

t?