AB-512 (B) Integrity Management Requirements Checklist

OWNERUSER INTEGRITY MANAGEMENT SYSTEM
QUALITY MANUAL CHECKLIST

AB-512(b) 2007-01
Company Name:
Qualiy Manual Tile an! Re"i#ion Sau#:
$e%#on &'o i# %e#pon#i(le )o% p%epa%in* 'e o&ne%+# ,ualiy #y#em manual:
Name: Title:
Telephone No.: ( ) Fax No.: ( )
Cell No.: ( ) E-Mail:
The Owner-User Integrity Management Requirements (!M") # AB-512 $o%&ment' ha( been i((&e$ b)
the Albe*ta p*e((&*e e+&ipment (a,et) A$mini(t*ato* to (pe%i,) *e+&i*ement( ,o* o-ne*( -ho a*e *e+&i*e$
to hol$ +&alit) mana.ement Ce*ti,i%ate o, A&tho*i/ation pe*mit &n$e* the 0E1" 1e%tion 11(2).
Thi( %he%3li(t -AB-512(b) ha( been $e4elope$ to a((i(t in en(&*in. that the +&alit) ()(tem man&al('
(&bmitte$ b) o-ne*( -ho appl) ,o* Ce*ti,i%ate( o, A&tho*i/ation pe*mit(' a*e $o%&mente$ in a%%o*$an%e
-ith AB-512.
5-ne*( -ho appl) ,o* a +&alit) mana.ement Ce*ti,i%ate o, A&tho*i/ation pe*mit (hall p*o4i$e an AB-512(b)
-ith the -*itten $e(%*iption o, thei* +&alit) mana.ement ()(tem (+&alit) man&al) to (ho- -he*e ea%h
*e+&i*e$ AB-512 element i( %o4e*e$ in thei* +&alit) man&al.
Application for Registration of Quality Management System ,o*m AB-26 an$ OwnerUser ressure
!quipment Integrity Management System (!M1) ,o*m AB-512(a)' (hall be (&bmitte$ -ith the +&alit)
man&al an$ AB-512(b) %he%3li(t' pe* 0E1" 1e%tion 12(1).
AB1A *e4ie-e*7( %omment(:

1i.nat&*e an$ $ate ------------------------------------------------------------------------------------------------------------
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INTEGRITY MANAGEMENT ELEMENT
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0/1 O&ne%2U#e% Ine*%iy Mana*emen Sy#em Manual
0/3 Tile $a*e
The title pa.e (hall i$enti,):
Title o, the $o%&ment that $e(%*ibe( the o*.ani/ation7( !M1.
The name an$ %o*po*ate a$$*e(( o, the o*.ani/ation.
!$enti,) the *e4i(ion (tat&( o, the $o%&ment.

"e4ie-e*7( Comment(:

0/0 S-ope an! Appli-aion
Thi( (e%tion (hall:
!n%l&$e a 0oli%) 1tatement that i$enti,ie( the 3e) p&*po(e o, the
man&al an$ %on,i*m( %omplian%e -ith the 1a,et) Co$e( A%t.
9e,ine the (%ope o, the p*o.*am.
0*o4i$e an o4e*4ie- o, the o*.ani/ation an$ the t)pe o, ,a%ilitie(
that a*e ope*ate$.
:i(t o, ma;o* ope*atin. %ente*( (,a%ilitie().
!$enti,) ,a%ilitie( &n$e* the (%ope o, the !M1 that a*e ope*ate$ on
behal, o, othe* o-ne*(.
9e,ine the *e(pon(ibilit) ,o* 3e) a%ti4itie( b) &tili/in. Table 1 o*
e+&i4alent.


0/4 Ta(le o) Conen#
Thi( (e%tion (hall:
1ho- a table o, %ontent( that li(t( the n&mbe* an$ title o, ea%h
(e%tion an$ it( lo%ation in the man&al.


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0/5 O%*ani6aion
Thi( (e%tion (hall in%l&$e:
A (tatement that mana.ement -ill en(&*e that *e(pon(ibilitie( an$
a&tho*itie( a*e $e,ine$ an$ a*e %omm&ni%ate$ -ithin the
o*.ani/ation.
5*.ani/ation %ha*t(() that i$enti,) 3e) po(ition( an$ thei*
*elation(hip -ith the *epo*tin. (t*&%t&*e ,o* inte.*it) a((e((ment
pe*(onnel ill&(t*ate$.
A (tatement that ;ob $e(%*iption( (hall be maintaine$ a( *e+&i*e$
to en(&*e the !M1 i( e,,e%ti4e.


0/7 8e)iniion# o) Te%m# an! A-%onym#
Gui!e
All te*m( an$ a%*on)m( &(e$ -ith the !M1 -*itten +&alit) ()(tem
(ho&l$ be $e,ine$.


0/9 Saemen o) Au'o%iy an! Re#pon#i(iliy
Thi( (e%tion (hall in%l&$e:
A (tatement that the -*itten +&alit) ()(tem %o4e*( the in,o*mation
(pe%i,ie$ in the !M" an$ a%%&*atel) $e(%*ibe( the !M1 &(e$ b) the
%ompan).
A (tatement that the +&alit) ()(tem ha( the ,&ll (&ppo*t o,
mana.ement -ho -ill en(&*e that a$e+&ate *e(o&*%e(' in%l&$in.
%ompetent pe*(onnel' a*e p*o4i$e$ to implement the p*o.*am.

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0/9 Saemen o) Au'o%iy an! Re#pon#i(iliy Con+!
Title o, pe*(on $e(i.nate$ a( the mana.ement *ep*e(entati4e to
be *e(pon(ible ,o* the !M1 p*o.*am< -ith an explanation that thi(
pe*(on' i**e(pe%ti4e o, othe* $&tie(' ha( the $e,ine$ a&tho*it) an$
*e(pon(ibilit) ,o* the implementation o, the !M1 an$ ha( $i*e%t
a%%e(( to' an$ (&ppo*t ,*om' top mana.ement to *e(ol4e an)
implementation ba**ie*(.
1i.nat&*e o, (enio* (exe%&ti4e) mana.ement.


0/: Mana*emen Re#pon#i(iliie#
Thi( (e%tion (hall %on,i*m mana.ement7( %ommitment an$ 3e)
*e(pon(ibilitie( to the !M1. !t (hall in%l&$e:
$lannin*
A (tatement that mana.ement -ill en(&*e that the*e i( an
app*op*iate plannin. p*o%e(( to a((&*e e,,e%ti4e $e4elopment an$
maintenan%e o, the !M1.
Mana*emen Commimen
A (tatement an$ e4i$en%e that mana.ement i( %ommitte$ to the
$e4elopment an$ implementation o, a (&%%e((,&l !M1 an$ to
%ontin&all) imp*o4e it( e,,e%ti4ene((.
E(tabli(h that top mana.ement -ill *e4ie- the !M1 at app*op*iate
inte*4al( to en(&*e it( %ontin&e$ (&itabilit) an$ e,,e%ti4ene((' an$
that *e%o*$( o, (&%h *e4ie-( -ill be maintaine$.

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0/: Mana*emen Re#pon#i(iliie# Con+!
A (tatement that mana.ement (hall en(&*e that app*op*iate
%omm&ni%ation p*o%e((e( a*e e(tabli(he$ -ithin the o*.ani/ation
to a((&*e %omplian%e -ith the le.i(lation an$ the e,,e%ti4ene(( o,
the !M1. The(e p*o%e((e( (hall in%l&$e in,o*mation on the
le.i(lation an$ i((&e( that ma) impa%t the (a,et) o, the p*e((&*e
e+&ipment.
A (tatement that the o*.ani/ation (hall $ete*mine an$ p*o4i$e
a$e+&ate %ompetent h&man *e(o&*%e(' an$ the ne%e((a*)
,a%ilitie( an$ e+&ipment to e,,e%ti4el) implement the !M1. Al(o'
tho(e -*itten %ont*a%t( that $e,ine *e(pon(ibilitie( an$ (%ope (hall
be maintaine$ ,o* %ont*a%te$ !M1 (e*4i%e( (&%h a( $e(i.n'
ope*ation' inte.*it) a((e((ment' an$ !M1 $e4elopment.


0/; Qualiy Sy#em 8o-umenaion
Thi( (e%tion (hall e(tabli(h that the*e -ill be a $o%&mente$
p*o%e$&*e ,o* %ont*ollin. the !M1 +&alit) ()(tem man&al'
*e,e*en%e$ p*o%e$&*e(' %o$e( an$ (tan$a*$(' *e%o*$( an$ othe*
$o%&ment( *ele4ant to the !M1.
1tate that the(e $o%&ment( (hall be maintaine$' *ele4ant an$
%&**ent &n$e* the *e(pon(ibilit) o, the mana.ement
*ep*e(entati4e.
1tate that the*e -ill be $o%&mente$ %ont*ol( an$ i$enti,) the p*o%e$&*e
&(e$ to en(&*e that:
The %&**ent i((&e( o, the app*op*iate $o%&mentation a*e a4ailable
at all *ele4ant lo%ation( an$ to all *ele4ant pe*(on(.
All %han.e( o, $o%&ment( o* amen$ment( to $o%&ment( a*e
%o4e*e$ b) the %o**e%t a&tho*i/ation an$ p*o%e((e$ in a manne*'
-hi%h -ill en(&*e timel) a4ailabilit) at the app*op*iate lo%ation.

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Thi( (hall in%l&$e en(&*in. that %&**ent 4e*(ion( o, the +&alit)
man&al a*e p*o4i$e$ an$ a%%epte$ b) AB1A.
1&pe*(e$e$ $o%&ment( a*e *emo4e$ ,*om &(e th*o&.ho&t the
o*.ani/ation o* a*e app*op*iatel) i$enti,ie$ a( (&pe*(e$e$
$o%&ment(.
5the* pa*tie(' a( ne%e((a*)' a*e noti,ie$ o, %han.e(.
The %&**ent *e4i(ion (tat&( o, $o%&ment( i( i$enti,ie$.
9o%&ment( *emain le.ible' *ea$il) i$enti,iable' an$ *et*ie4able.
9o%&ment( o, exte*nal o*i.in a*e i$enti,ie$ an$ thei* $i(t*ib&tion
%ont*olle$.
The %ont*ol( nee$e$ ,o* the i$enti,i%ation' (to*a.e' p*ote%tion'
*et*ie4al' *etention time' an$ $i(po(ition o, *e%o*$( a*e a$$*e((e$.
That all %han.e( to $o%&ment( a*e han$le$ th*o&.h an
app*op*iate mana.ement o, %han.e p*o%e((.


0/< Compeen-y an! T%ainin*
Thi( (e%tion (hall $e,ine the ()(tem ,o* en(&*in. the *e+&i*e$
%ompeten%e o, pe*(onnel -ho pe*,o*m -o*3 that %an impa%t on the
e,,e%ti4ene(( o, the !M1.
>e) a%ti4itie( that (hall be %ont*olle$:
!$enti,i%ation o, expe*ien%e' +&ali,i%ation an$ t*ainin. *e+&i*ement(
,o* in$i4i$&al ;ob po(ition( that a*e %*iti%al to !M1 implementation.
!$enti,i%ation o, the t*ainin. p*o.*am( o* othe* t*ainin. *e(o&*%e(
that a*e &(e$ ,o* t*ainin..
0*o%e(( ,o* en(&*in. that pe*(onnel' -ho ope*ate p*e((&*e
e+&ipment' a((e(( the inte.*it) o, in-(e*4i%e e+&ipment o* pe*,o*m
p*e((&*e -el$in.' hol$ the app*op*iate Ce*ti,i%ate( o, Competen%)
a( *e+&i*e$ &n$e* the 1a,et) Co$e( A%t an$ *e.&lation(.
A((e((ment' *ea((e((ment an$ %e*ti,i%ation o, %ompeten%e.

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0/< Compeen-y an! T%ainin* Con+!
Contin&ation t*ainin. to en(&*e the *e+&i*e$ le4el o, %ompeten%) i(
maintaine$' an$ to *e,le%t an) %han.e( in le.i(lation' te%hnolo.)'
!M1 be(t p*a%ti%e(' et%.
"e%o*$( o, ;ob ,&n%tion(' t*ainin. an$ %ompeten%) a((e((ment
an$ *ea((e((ment.
0*o%e(( to en(&*e that an) %ont*a%t pe*(on( -ho pe*,o*m !M1
ta(3( meet the *e+&i*e$ t*ainin. an$ %ompeten%e *e+&i*ement(.


0/31 8e#i*n Con%ol
Thi( (e%tion (hall $e(%*ibe the ()(tem ,o* en(&*in. that p*e((&*e
e+&ipment i( $e(i.ne$ in a%%o*$an%e -ith the 1a,et) Co$e( A%t' an$
that the $e(i.n a$$*e((e( the (e*4i%e %on$ition( an$ othe* p*o%e((
*elate$ *e+&i*ement( nee$e$ to p*e4ent &nintentional *elea(e o, ,l&i$
%ontaine$ in the p*e((&*e ()(tem.
>e) a%ti4itie( that (hall be %o4e*e$:
En(&*in. that the*e i( a $e(i.n ba(i( memo*an$&m (9BM) that
i$enti,ie( the $e(i.n an$ ope*atin. %on$ition(' the (e*4i%e
*e+&i*ement( an$ othe* in,o*mation nee$e$ to ,a%ilitate the (a,e
$e(i.n' %on(t*&%tion' an$ in(pe%tion o, the e+&ipment.
@e*i,)in. that pe*(onnel a((i.ne$ to $e(i.n en.inee*in. a%ti4itie(
a*e %ompetent an$ meet the appli%able %o$e expe*ien%e an$
+&ali,i%ation *e+&i*ement(' -he*e (&%h *e+&i*ement( exi(t.
0*epa*ation' 4e*i,i%ation an$ app*o4al o, $e(i.n $o%&ment( #
((pe%i,i%ation(' $*a-in.( e.. 0A!9(' 0*o%e(( Flo- 9ia.*am('
%al%&lation(' et%.) ,*om the 9BM.
En(&*in. that the late(t %o$e e$ition an$ a$$en$a o, the
appli%able %on(t*&%tion %o$e( an$ (tan$a*$( an$ othe* *elate$
$o%&ment( a*e a4ailable to $e(i.n pe*(onnel an$ a*e &(e$ ,o*
p*e((&*e e+&ipment $e(i.n.

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0/31 8e#i*n Con%ol -on+!
En(&*in. that all $e(i.n $o%&ment(' in%l&$in. an) *e4i(ion(' ha4e
the *e+&i*e$ app*o4al an$ that the late(t *e4i(ion( a*e a4ailable
an$ a*e &(e$.
En(&*in. that the*e i( app*op*iate mana.ement o, %han.e
p*o%e((e( in pla%e ,o* all $e(i.n a%ti4itie(.
En(&*in. that the $e(i.n *e.i(t*ation an$ othe* 1a,et) Co$e( A%t
(1CA) *e+&i*ement( ha4e been met.
En(&*in. that $e(i.n in,o*mation an$ alte*ation p*o%e$&*e( ,o*
alte*ation( to boile*(' p*e((&*e 4e((el(' an$ the*mal ,l&i$ heate*('
in%l&$in. ,itne(( ,o* p&*po(e e4al&ation( -hen appli%able' a*e
(&bmitte$ to AB1A 9e(i.n 1&*4e) ,o* a%%eptan%e p*io* to the (ta*t
o, -o*3.
@e*i,)in. that man&,a%t&*e*( an$ pipin. %ont*a%to*( a*e +&ali,ie$
an$ %ompetent to %on(t*&%t p*e((&*e e+&ipment in a%%o*$an%e
-ith the $e(i.n. "etention o, all appli%able en.inee*in. $e(i.n
$o%&ment(.
Con,i*min. that the p*e((&*e pipin. in(tallation i( in a%%o*$an%e
-ith the Safety Codes Act.


0/33 $u%-'a#in* an! Mae%ial Con%ol
Thi( (e%tion (hall e(tabli(h the ()(tem &(e$ to en(&*e that p&*%ha(e$
mate*ial( an$ (e*4i%e( ,o* !M1 a%ti4itie( %on,o*m to the 1a,et) Co$e(
A%t an$ meet the (pe%i,ie$ p&*%ha(e *e+&i*ement(.
>e) A%ti4itie( that (hall be %o4e*e$:
E4al&ation an$ (ele%tion o, (&pplie*(
9e,ine the p*o%e(( &(e$ ,o* (ele%tin. (&pplie*( ba(e$ on thei*
abilit) to (&ppl) e+&ipment' mate*ial(' an$ (e*4i%e( in a%%o*$an%e
-ith the 1a,et) Co$e( A%t an$ o-ne*7( *e+&i*ement(. C*ite*ia ,o*
(ele%tion' e4al&ation an$ *e-e4al&ation o, (&pplie*( (hall be
e(tabli(he$. "e%o*$( o, e4al&ation *e(&lt( an$ an) ne%e((a*)
%han.e( to 4en$o* app*o4al a*i(in. ,*om the e4al&ation (hall be
maintaine$.
Maintain a %&**ent app*o4e$ 4en$o*( li(t that i( a4ailable to' an$
&(e$ b)' all pe*(onnel in4ol4e$ -ith p&*%ha(in. a%ti4itie(.

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0/33 $u%-'a#in* an! Mae%ial Con%ol Con+!
0&*%ha(in.
En(&*e p&*%ha(in. in,o*mation ,o* the p*o$&%t an$ (e*4i%e( to be
p&*%ha(e$ in%l&$e(' a( appli%able:
B&alit) 1)(tem Ce*ti,i%ation *e+&i*ement(.
!$enti,i%ation o, the appli%able i((&e( o, the Co$e( an$ 1tan$a*$(
to -hi%h the p*o$&%t m&(t %ompl).
Mate*ial (pe%i,i%ation( an$ othe* *e+&i*e$ in,o*mation.
The extent an$ t)pe o, (e*4i%e *e+&i*e$.
5-ne*7( (pe%i,ie$ *e+&i*ement(.


Cont*a%t(
Maintain a -*itten %ont*a%t ,o* in(pe%tion' $e(i.n' N9E' an$ othe*
(e*4i%e( that %an impa%t the e,,e%ti4ene(( o, the !M1.
En(&*e that the*e a*e -*itten %ont*a%t( ,o* all e+&ipment that i(
ope*ate$ on behal, o, othe* o-ne*(. The(e %ont*a%t( (hall $e,ine
-ho -ill be *e(pon(ible ,o* the ope*ation' maintenan%e' (e*4i%in.
p*e((&*e *elie, 4al4e( (e*4i%in.' in(pe%tion' *epai*' an$ othe* !M1
a%ti4itie(.


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0/33 $u%-'a#in* an! Mae%ial Con%ol -on+!
Cont*ol o, 0*e((&*e E+&ipment an$ Mate*ial( at 1ite
En(&*e that e+&ipment an$ mate*ial( *e%ei4e$ on (ite meet (pe%i,ie$
p&*%ha(in. *e+&i*ement( an$ the appli%able %o$e( an$ (pe%i,i%ation(.
Thi( (hall in%l&$e:
1)(tem ,o* en(&*in. *e%ei4e$ mate*ial( %on,o*m to the %o**e%t
(pe%i,i%ation( an$ +&antit).
1)(tem ,o* i$enti,)in. mate*ial( -ith the %o**e%t (pe%i,i%ation an$
othe* *e+&i*e$ in,o*mation -hene4e* mate*ial( i$enti,i%ation -ill
not be *etaine$ to the point o, &(e.
1)(tem ,o* i$enti,)in. an$ $i(po(in. o, non-%on,o*min. item(.
1)(tem ,o* en(&*in. that the e+&ipment o* mate*ial( i((&e$
%omplie( -ith the Co$e an$ the $e(i.n (pe%i,i%ation(.


0/30 Con#%u-ion an! In#allaion o) $%e##u%e E,uipmen
Thi( (e%tion (hall e(tabli(h the metho$( &(e$ to en(&*e that p*e((&*e
e+&ipment i( %on(t*&%te$ an$ in(talle$ in a%%o*$an%e -ith the 1a,et)
Co$e( A%t an$ the appli%able Co$e( o, Con(t*&%tion an$ meet( the
$e(i.n *e+&i*ement(.
Coo*$ination an$ %ont*ol o, p*e((&*e e+&ipment man&,a%t&*e*(
an$ o*.ani/ation( that in(tall p*e((&*e e+&ipment (*e4ie- o,
$e(i.n).
1&*4eillan%e o, %ont*a%to*( +&alit) %ont*ol ()(tem(.
9ete*minin. nee$ an$ extent o, an) (o&*%e ((hop) in(pe%tion.
@e*i,)in. that %ont*a%t o*.ani/ation( ha4e the *e+&i*e$ %apabilitie(
an$ a*e app*o4e$ 4en$o*(.
En(&*in. that the (&pplie* i( p*o4i$e$ -ith the %&**ent 4e*(ion( o,
*e+&i*e$ (pe%i,i%ation( an$ $*a-in.( an$ the in,o*mation i( %lea*l)
$e,ine$ an$ i( &n$e*(too$ b) the (&pplie*.

0/30 Con#%u-ion an! In#allaion o) $%e##u%e E,uipmen Con+!
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in Manual
Appointment o, %ompetent pe*(on( to a%t a( the o-ne*7(
in(pe%to*( ,o* %o$e p*e((&*e pipin. %on(t*&%tion (*e,e* to T*ainin.
an$ Competen%) (e%tion).
The p*o%e(( ,o* *e4ie-in. an$ *etainin. %omplete$ p*o;e%t
pa%3a.e( *e+&i*e$ ,o* en(&*in. the man&,a%t&*e*7( $ata *epo*t(
a*e *et&*ne$ an$ that Albe*ta 0ipin. Con(t*&%tion $ata *epo*t(
(AB-82) a*e p*o4i$e$ an$ a*e %omplete$ %o**e%tl).
@e*i,)in. that the $e(i.n ha( been *e.i(te*e$ in a%%o*$an%e -ith
the 1a,et) Co$e( A%t' -hen appli%able' an$ that Completion o,
Con(t*&%tion 9e%la*ation ,o*m( (AB-81)' a*e p*o4i$e$ to AB1A ,o*
*e.i(te*e$ pipin. $e(i.n(.
Noti,i%ation to AB1A o, in(tallation in(pe%tion( a( *e+&i*e$.
C*itten p*o%e$&*e( that meet AB1A *e+&i*ement( a*e maintaine$
,o* ne- %on(t*&%tion a%ti4itie( that a*e %omplete$ $i*e%tl) b) the
o-ne*.

"e4ie-e*7( Comment(

0/34 Con%ol o) Monio%in* an! Mea#u%in* 8e"i-e#
Thi( (e%tion (hall $e,ine the p*o%e$&*e to %ont*ol' %alib*ate' an$
maintain monito*in. an$ mea(&*in. $e4i%e(.
>e) a%ti4itie( that (hall be %o4e*e$ a*e:
En(&*in. that ea%h mea(&*in. $e4i%e i( %alib*ate$ o* 4e*i,ie$' at
(pe%i,ie$ inte*4al( o* p*io* to &(e' a.ain(t mea(&*ement (tan$a*$(
t*a%eable to inte*national o* national mea(&*ement (tan$a*$(<
-he*e no (&%h (tan$a*$( exi(t' the ba(i( &(e$ ,o* %alib*ation o*
4e*i,i%ation (hall be *e%o*$e$.
En(&*in. that ea%h item o, mea(&*in. e+&ipment i( i$enti,ie$ to
enable the %alib*ation (tat&( to be $ete*mine$.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 11 o, 22
AB-512(b) 2007-01
IMR
Se-ion
Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/34 Con%ol o) Monio%in* an! Mea#u%in* 8e"i-e# Con+!
Cont*ol o, i((&e o, e+&ipment to en(&*e that it i( (&itable ,o*
inten$e$ &(e' the %alib*ation i( %&**ent< an$ that it i( examine$
a,te* &(e.
Mea(&*e( to en(&*e that 4e*i,i%ation( a%%epte$ ba(e$ on
e+&ipment that i( ,o&n$ to be o&t o, %alib*ation *emain 4ali$.


0/35 Ope%aion
Thi( (e%tion (hall $e,ine the ()(tem &(e$ to en(&*e that p*e((&*e
e+&ipment i( ope*ate$ (a,el) in a%%o*$an%e -ith the 1a,et) Co$e( A%t.
>e) a%ti4itie( that (hall be %o4e*e$ a*e:
0*o%e(( ,o* $e,inin. the (a,e ope*atin. limit( o, the e+&ipment an$
en(&*in. the e+&ipment i( ope*ate$ -ithin the(e limit(.
En(&*in. the*e a*e a$e+&ate p*o%e$&*e( to $o%&ment %*iti%al
ta(3(.
En(&*in. the*e a*e (&itable in(t*&%tion( ,o* the (a,e ope*ation o,
the e+&ipment.
En(&*in. that the *e+&i*e$ ope*atin. hi(to*) ,o* e+&ipment i(
*e%o*$e$ an$ %ont*olle$ to en(&*e the $e(i.n limitation( o, the
e+&ipment a*e not ex%ee$e$. Thi( (hall in%l&$e item( $e(i.ne$ to
A1ME 1e%tion @!!!' 9i4i(ion 2 o* 2 %o$e *&le( an$ othe* %)%li%
(e*4i%e e+&ipment.
En(&*in. that the pe*(onnel ope*atin. the e+&ipment a*e
%ompetent.
Maintenan%e o, app*op*iate t*ainin. an$ %ompeten%) a((e((ment
*e%o*$(.
"e(pon(ibilitie( o, the %hie, po-e* en.inee* an$ *ole in the !M1.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 12 o, 22
AB-512(b) 2007-01
IMR
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Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/35 Ope%aion Con+!
@e*i,)in. that the ope*ato*7( ob(e*4ation( that ma) impa%t the
inte.*it) o, the p*e((&*e e+&ipment a*e %omm&ni%ate$ to the
app*op*iate inte.*it) a((e((ment pe*(onnel.
Noti,i%ation to en.inee*in. an$ in(pe%tion pe* M5C p*o%e((e(
-hen e+&ipment i( ope*ate$ o&t(i$e o, $e(i.n %on$ition(.


0/37 Mana*emen o) C'an*e =MOC>
Thi( (e%tion (hall in%l&$e a Mana.ement o, Chan.e (M5C) ()(tem ,o*
pe*manent an$ tempo*a*) ph)(i%al an$ ope*ational %han.e( to
p*e((&*e e+&ipment' %han.e( to p*o%e$&*e(' (tan$a*$( an$ othe* !M1
$o%&mentation an$ o*.ani/ational %han.e( to a((&*e that the inte.*it)
o, the p*e((&*e ()(tem i( not a$4e*(el) a,,e%te$ b) (&%h %han.e(.
The M5C p*o%e$&*e (hall be $o%&mente$ an$ in%l&$e:
!$enti,i%ation o, -hat a%ti4itie( a*e (&b;e%t to M5C an$ -hat a*e
%on(i$e*e$ *epla%ement in 3in$.
The te%hni%al in,o*mation to (&ppo*t the *ea(on ,o* the %han.e.
9ete*minin. an) impa%t the %han.e ma) ha4e on health an$
(a,et).
0*o%e(( to en(&*e the M5C p*o%e$&*e ha( been %o**e%tl) applie$.
9&*ation o, the %han.e' (pe*manent o* time i, tempo*a*)).
0*o%e(( to en(&*e that the *e+&i*e$ a&tho*i/ation ,*om all *ele4ant
$i(%ipline( i( obtaine$.
T*ainin. o, ope*atin. an$ othe* pe*(onnel' -ho(e ;ob ta(3( -ill be
a,,e%te$ b) the %han.e' p*io* to implementin. %han.e. Dp$atin.
o, p*o%e(( (a,et) in,o*mation an$ p*o%e$&*e( -hen the %han.e
*e(&lt( in a %han.e in the p*o%e((e( $e(%*ibe$ in the
p*o%e$&*e(().


!((&e$: 2007-01-08 "e4i(ion 1 0a.e 12 o, 22
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IMR
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Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/39 Ine*%iy A##e##men $%o*%am
Thi( (e%tion (hall $e(%*ibe the ()(tem ,o* en(&*in. that the *e+&i*e$
in(pe%tion( an$ othe* inte.*it) a((e((ment a%ti4itie( a*e $one' to
a((&*e the ,itne(( ,o* p&*po(e o, the p*e((&*e e+&ipment th*o&.ho&t
it( ,&ll li,e %)%le' an$ %omplian%e -ith the 1a,et) Co$e( A%t.
A((i.nin. "e(o&*%e(
Appointin. the pe*(on -ho i( *e(pon(ible ,o* the inte.*it)
a((e((ment p*o.*am an$ $e(i.natin. the in$i4i$&al( -ho -ill
a((&me the(e *e(pon(ibilitie( in thi( pe*(onE( ab(en%e.
En(&*in. that:
All pe*(onnel an$ o*.ani/ation( a((i.ne$ to inte.*it) a((e((ment
a%ti4itie(' in%l&$in. %ont*a%te$ (e*4i%e(' meet the *e+&i*ement(
e(tabli(he$ b) the A$mini(t*ato*.
A -*itten %ont*a%t i( maintaine$ ,o* all %ont*a%t in(pe%tion an$
non$e(t*&%ti4e examination a%ti4itie(.
The*e i( e,,e%ti4e (&pe*4i(ion o, in(pe%tion pe*(onnel b)
%ompetent in$i4i$&al(.
!n(pe%tion pe*(onnel a*e ,*ee o, an) %omme*%ial' ,inan%ial an$
othe* p*e((&*e( that mi.ht a,,e%t thei* ;&$.ment.
That an) in$i4i$&al( o* o*.ani/ation( %annot in,l&en%e the *e(&lt(
o, in(pe%tion( %a**ie$ o&t.
Con,i$entialit) o, in,o*mation obtaine$ in the %o&*(e o, in(pe%tion
a%ti4itie( i( maintaine$.

"e4ie-e*7( Comment(

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 1= o, 22
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IMR
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Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/39 Ine*%iy A##e##men $%o*%am Con+!
lanning
Maintainin. a (&itable plannin. p*o%e(( to en(&*e that inte.*it)
a((e((ment a%ti4itie( a*e $one in a%%o*$an%e -ith *e+&i*ement(
e(tabli(he$ b) the A$mini(t*ato*' an$ a*e app*op*iate to en(&*e
the (a,et) an$ ,itne(( ,o* p&*po(e o, the e+&ipment.
0*e((&*e E+&ipment A((et( an$ "e%o*$(
E(tabli(hin. an$ maintainin. an a%%&*ate in4ento*) o, all p*e((&*e
e+&ipment.
Maintainin. *e%o*$( o,: $e(i.n an$ man&,a%t&*in. in,o*mation'
maintenan%e' in(pe%tion' (e*4i%in.' te(t(' alte*ation o* *epai* ,o*
ea%h item o, p*e((&*e e+&ipment o* ()(tem.
0*o4i$in. AB1A -ith *e+&i*e$ in4ento*) in,o*mation an$ othe*
*e%o*$( a( *e+&i*e$ &n$e* the 1a,et) Co$e( A%t.
0*o4i$in. the p*e((&*e e+&ipment *e%o*$( to ne- o-ne*( -hen
p*e((&*e e+&ipment i( (ol$ o* othe*-i(e $i(po(e$ o,' a( *e+&i*e$
&n$e* the 1a,et) Co$e( A%t.
Noti,)in. AB1A in -*itin. -hen a boile* p*e((&*e 4e((el' ,i*e$
heate* o* the*mal li+&i$ heate* i( bo&.ht' (ol$' *ente$' *elo%ate$ o*
othe*-i(e $i(po(e$ o,' a( *e+&i*e$ b) the 1a,et) Co$e( A%t. Thi(
(hall in%l&$e e+&ipment that ha( been $e%ommi((ione$ ,o* late*
&(e.
E(tabli(hin. a (&itable ()(tem ,o* *etainin. an$ $i(pla)in.
Ce*ti,i%ate( o, !n(pe%tion.


"a#ar$ Assessment
E(tabli(hin. (&itable p*o%e((e( ,o* i$enti,)in. an$ %ont*ollin.
ha/a*$( at thei* ,a%ilitie(. Thi( (hall in%l&$e 4i(&al a((e((ment o,
the p*e((&*e ()(tem at ea%h ,a%ilit) to i$enti,) me%hani%al inte.*it)
th*eat(' the ,l&i$ (e*4i%e an$ othe* ba(i% in,o*mation nee$e$ to
p*epa*e app*op*iate in(pe%tion plan( ,o* the p*e((&*e e+&ipment
an$ en(&*e (a,et)' ,itne(( ,o* p&*po(e an$ %omplian%e -ith the
1a,et) Co$e( A%t.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 15 o, 22
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IMR
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Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
En(&*in. that app*op*iate a((e((ment( ha4e been $one at
,a%ilitie( that -ill be ope*ate$ on behal, o, othe* o-ne*( an$ -hen
exi(tin. ,a%ilitie( a*e a%+&i*e$.
Inspection roce$ures
9e4elopin. an$ maintainin. app*op*iate in(pe%tion p*o%e$&*e( in
a%%o*$an%e -ith *e+&i*ement( e(tabli(he$ b) the A$mini(t*ato*'
an$ en(&*in. the(e a*e a4ailable' &n$e*(too$ an$ &(e$ b)
pe*(onnel pe*,o*min. the appli%able in(pe%tion(.
Inspection lans
En(&*in. that e+&ipment (pe%i,i% in(pe%tion plan( an$ (t*ate.ie(
a*e e(tabli(he$ ,o* p*e((&*e e+&ipment an$ a*e app*o4e$ b) the
Chie, !n(pe%to*.


Initial Inspection rior to entering ser%ice
@e*i,)in. that an in(pe%tion o, ea%h item o, p*e((&*e e+&ipment i(
%omplete$ a,te* the e+&ipment ha( been in(talle$ an$ p*io* to
ente*in. (e*4i%e.
En(&*in. that all AB1A in(pe%tion( ,o* i((&an%e o, pe*mit(
(Ce*ti,i%ate( o, !n(pe%tion) *e+&i*e$ &n$e* the 1a,et) Co$e( A%t
ha4e been %omplete$ p*io* to the p*e((&*e e+&ipment bein.
pla%e$ in (e*4i%e.
erio$ic Integrity Assessment
En(&*in. that pe*io$i% a((e((ment( a*e $one in a%%o*$an%e -ith
the *e+&i*ement( e(tabli(he$ b) the A$mini(t*ato* an$ in(pe%tion
plan( an$ en(&*e( ,itne(( ,o* p&*po(e o, the p*e((&*e ()(tem.
The(e (hall in%l&$e:
Exte*nal !n(pe%tion(.
Tho*o&.h (inte*nal o* e+&i4alent) in(pe%tion(.
Co**o(ion (&*4e)( (DT 1&*4e)( et%.) an$ othe* %on$ition
monito*in. a%ti4itie( nee$e$ to a((&*e the %ontin&e$ (a,e
ope*ation o, the e+&ipment.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 1? o, 22
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IMR
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Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
"e4ie- an$ app*o4al o, DT an$ othe* monito*in. *e(&lt( b) a
%ompetent in$i4i$&al -ho hol$( the *e+&i*e$ in-(e*4i%e in(pe%to*
%e*ti,i%ate (!1!).
A((i.nin. app*op*iate in(pe%tion inte*4al( in a%%o*$an%e -ith
*e+&i*ement( (et b) the A$mini(t*ato*.


Clo(e 5&t o, !n(pe%tion Fin$in.(
En(&*in. that app*op*iate timel) %o**e%ti4e a%tion i( ta3en ,o*
in(pe%tion ,in$in.( an$ ,o* othe* inte.*it) a((e((ment a%ti4itie(
that *e+&i*e ,ollo--&p.


0/3: Non!e#%u-i"e E?aminaion# an! Te#in*
Thi( (e%tion (hall e(tabli(h the ()(tem ,o* en(&*in. that non$e(t*&%ti4e
examination(' metall&*.i%al te(t(' an$ othe* p*o%e((e( &(e$ to a((e((
the inte.*it) o, p*e((&*e e+&ipment meet thei* inten$e$ p&*po(e.
App*o4al o, (pe%ial p*o%e(( %ont*a%to*( pe* *e+&i*ement( in the
0&*%ha(in. an$ Mate*ial Cont*ol (e%tion o, thi( !M" $o%&ment.
En(&*in. -*itten *e+&i*ement( a*e p*o4i$e$ to %ont*a%to*(.
En(&*in. -*itten p*o%e$&*e( a*e $e4elope$ an$ ,ollo-e$ ,o*
(pe%ial p*o%e((e(.
En(&*in. (pe%ial p*o%e$&*e( a*e 4ali$ate$.
0e*(onnel +&ali,i%ation an$ %e*ti,i%ation *e+&i*ement( a*e 4e*i,ie$.
Coo*$ination o, %ont*a%t a%ti4itie(.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 17 o, 22
AB-512(b) 2007-01
IMR
Se-ion
Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/3: Non!e#%u-i"e E?aminaion# an! Te#in* Con+!
En(&*in. that %o**o(ion monito*in. plan( a*e $e4elope$ b)
%ompetent pe*(onnel' an$ app*o4e$ b) the Chie, !n(pe%to*' an$
that *e(&lt( a*e *epo*te$ an$ a*e on ,ile.
En(&*in. that %ompetent pe*(onnel a((e(( %o**o(ion monito*in.
*e(&lt( an$ that *e(&lt( a*e 4e*i,ie$.


0/3; Repai%# an! Ale%aion# o $%e##u%e E,uipmen
Thi( (e%tion (hall $e,ine the ()(tem &(e$ to en(&*e that *epai*( an$
alte*ation( to item( o, p*e((&*e e+&ipment' both o, a tempo*a*) an$
pe*manent nat&*e' a*e $one in a%%o*$an%e -ith the 1a,et) Co$e( A%t
an$ that the (a,et) o, the e+&ipment -ill not be a$4e*(el) a,,e%te$.
Fene*al *e+&i*ement(
En(&*in. that -o*3 i( $one b) o*.ani/ation( that ha4e a 4ali$
Albe*ta B&alit) 0*o.*am Ce*ti,i%ate o, A&tho*i/ation an$
%apabilitie( ,o* the (%ope o, -o*3.
Coo*$ination o, %ont*a%t an$ in-ho&(e -o*3.
En(&*in. that the *epai*Galte*ation o*.ani/ation i( p*o4i$e$ -ith all
the te%hni%al an$ +&alit) (tan$a*$( nee$e$ to $e4elop the -o*3
p*o%e$&*e an$ %omplete the -o*3 in a%%o*$an%e -ith (pe%i,ie$
*e+&i*ement( an$ the 1a,et) Co$e( A%t.
En(&*in. that the *epai* an$ alte*ation p*o%e$&*e %o4e*( all
*e+&i*e$ te%hni%al an$ +&alit) (tan$a*$( ,o* the (e*4i%e in -hi%h
the item -ill be pla%e$.
App*op*iate in(pe%tion an$ othe* %ompetent *e(o&*%e( a*e
$eplo)e$ to en(&*e the *epai* o* alte*ation -o*3 i( $one (a,el)
an$ in a%%o*$an%e -ith the 1a,et) Co$e( A%t.
0*o4i(ion ,o* $o%&mentation o, the *epai* o* alte*ation' in%l&$in.
an) $e(i.n %han.e(' *epai* an$ alte*ation p*o%e$&*e(' *epo*t(
an$ +&alit) ()(tem *e%o*$(' to be *etaine$ on ,ile.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 18 o, 22
AB-512(b) 2007-01
IMR
Se-ion
Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/3; Repai%# an! Ale%aion# o $%e##u%e E,uipmen Con+!
En(&*in. that the e+&ipment in(pe%tion plan( ,o* the item an$
()(tem a*e *ea((e((e$ an$ in(pe%tion *e+&i*ement( an$
inte*4al( a*e *e4i(e$ a( *e+&i*e$.
0*o4i$in. %ont*ol( to en(&*e that an) hot tap( an$ an) tempo*a*)
en%lo(&*e( in(talle$ to maintain the inte.*it) o, the p*e((&*e
e+&ipment an$ p*e4ent lea3a.e a*e (&itable an$ meet the
*e+&i*ement( o, the 1a,et) Co$e( A%t.

"e4ie-e*7( Comment(

1pe%i,i% *e+&i*ement( ,o* Boile*(' 0*e((&*e 4e((el(' the*mal ,l&i$
heate*( an$ boile* exte*nal pipin.:
En(&*in. that the *epai*Galte*ation p*o%e$&*e ha( p*io* app*o4al
,*om the Chie, !n(pe%to* an$' a( appli%able' AB1A.
En(&*in. that p*opo(e$ alte*ation( a*e a%%epte$ b) AB1A 9e(i.n
1&*4e).
0*o4i(ion( to en(&*e that an AB1A 1a,et) Co$e( 5,,i%e* (1C5) i(
noti,ie$ o, the -o*3 an$ that the 1C57( p*io* a%%eptan%e o, the
p*o%e$&*e i( obtaine$ - a( *e+&i*e$ pe* *e+&i*ement( e(tabli(he$
b) the A$mini(t*ato*.
En(&*in. that *epai*( an$ alte*ation( a*e in(pe%te$ an$ %e*ti,ie$
b) an AB1A 1C5 o* a %ompetent pe*(on -ho hol$( the
app*op*iate Albe*ta !n-(e*4i%e !n(pe%to* Ce*ti,i%ate - pe* the
*e+&i*ement( e(tabli(he$ b) the A$mini(t*ato*.
Ma3in. %e*tain that a %op) o, the Albe*ta "epai* an$ Alte*ation
"epo*t AB-=0 (AB-82 ,o* boile* exte*nal pipin.) i( *etaine$ on ,ile
an$ the o*i.inal ,o*m i( p*o4i$e$ to AB1A.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 16 o, 22
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IMR
Se-ion
Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/3; Repai%# an! Ale%aion# o $%e##u%e E,uipmen Con+!
1pe%i,i% *e+&i*ement( ,o* p*e((&*e pipin.
En(&*in. that the in(pe%tion( *e+&i*e$ &n$e* the appli%able
A1ME B21 pipin. %o$e a*e $one b) a %ompetent o-ne*7(
in(pe%to* -ho meet( the +&ali,i%ation an$ expe*ien%e
*e+&i*ement( o, the %o$e.
En(&*in. that p*e((&*e pipin. AB-82 ,o*m' %e*ti,ie$ b) the
o-ne*7( in(pe%to*' i( 3ept on ,ile.
En(&*in. that the $e(i.n ,o* alte*ation( an$ a$$ition( to pipin.
()(tem( an$ AB-81 ,o*m( a*e (&bmitte$ to AB1A in a%%o*$an%e
-ith 1e%tion 2.10 o, thi( $o%&ment -hen *e+&i*e$ b) the 1a,et)
Co$e( A%t.

"e4ie-e*7( Comment(

0/3< O"e%p%e##u%e $%oe-ion an! $%oe-i"e 8e"i-e#
Thi( (e%tion (hall $e,ine the 3e) a%ti4itie( nee$e$ to en(&*e that
p*e((&*e *elie, 4al4e(' *&pt&*e $i(%( an$ othe* p*ote%ti4e $e4i%e('
a*e $e(i.ne$' in(talle$' maintaine$ an$ 3ept in (e*4i%e (in
a%%o*$an%e -ith the 1a,et) Co$e( A%t) to en(&*e that the $e(i.n
an$ (a,e ope*atin. limit( o, the p*e((&*e e+&ipment ()(tem a*e
not ex%ee$e$.
Maintenan%e o, the appli%able $e(i.n (pe%i,i%ation( ,o* the *elie,
$e4i%e(.
En(&*in. that the o4e* p*e((&*e p*ote%tion ,o* the p*e((&*e
e+&ipment an$ ()(tem i( a$e+&ate.
En(&*in. that p*e((&*e *elie, $e4i%e( a*e (e*4i%e$ in a%%o*$an%e
-ith the *e+&i*ement( e(tabli(he$ b) the A$mini(t*ato* an$ at
inte*4al( that a*e app*op*iate to en(&*e the) -ill ope*ate a(
$e(i.ne$.
En(&*in. that p*e((&*e *elie, $e4i%e( a*e p*ote%te$ ,*om $ama.e
$&*in. thei* *emo4al' (e*4i%in. an$ *e-in(tallation an$ that the)
a*e *e-in(talle$ in thei* %o**e%t lo%ation.

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 20 o, 22
AB-512(b) 2007-01
IMR
Se-ion
Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/3< O"e%p%e##u%e $%oe-ion an! $%oe-i"e 8e"i-e# Con+!
That (e*4i%in. o, p*e((&*e *elie, 4al4e( i( $one b) an
o*.ani/ation that ha( a 4ali$ Albe*ta B&alit) 0*o.*am Ce*ti,i%ate
o, A&tho*i/ation ,o* the (%ope o, -o*3 an$ i( an app*o4e$ 4en$o*.
"e,e* to 1e%tion 2.11 o, thi( man&al.
En(&*in. that p*e((&*e *elie, ()(tem $e(i.n( that ha4e i(olatin.
4al4e( in the path o, p*e((&*e *elie, $e4i%e( a*e app*o4e$ b) the
A$mini(t*ato* p*io* to thei* in(tallation.
Maintainin. a -*itten implemente$ p*o%e$&*e that meet( A1ME
1e%tion @!!! 9i4i(ion ! Appen$ix M *e+&i*ement(' ,o* %ont*ollin.
i(olatin. 4al4e( in(talle$ in the path o, p*e((&*e *elie, $e4i%e(.
Maintainin. *e%o*$( o, the (e*4i%in. an$ *epla%ement o, p*e((&*e
*elie, $e4i%e(.
A((i.nin. app*op*iate (e*4i%in. inte*4al( ba(e$ on the (e*4i%in.
%on$ition *epo*t( an$ othe* ope*atin. in,o*mation.
Maintainin. te(tin. *e%o*$( ,o* othe* p*ote%ti4e $e4i%e(' (&%h a(
eme*.en%) (h&t$o-n (E19) an$ o4e* p*e((&*e an$ %*iti%al
tempe*at&*e (h&t $o-n %ont*ol(.

"e4ie-e*7( Comment(

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 21 o, 22
AB-512(b) 2007-01
IMR
Se-ion
Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/01 Ine%nal Au!i#
Thi( (e%tion (hall $e(%*ibe the a&$it p*o%e(( &(e$ to $ete*mine the
e,,e%ti4ene(( o, the !M1 an$ to i$enti,) a*ea( -he*e the !M1 %an be
imp*o4e$.
An a&$it p*o%e$&*e (hall be $e4elope$ -hi%h (hall in%l&$e:
E(tabli(hin. an a&$it (%he$&le.
The a&$it %*ite*ia (%ope an$ ,*e+&en%) o, the a&$it(.
Metho$( an$ *e(pon(ibilitie( ,o* plannin. an$ %on$&%tin. the
a&$it(.
9o%&ment( &(e$ ,o* %on$&%tin. an$ *epo*tin. the a&$it ,in$in.(
an$ maintainin. a&$it *epo*t( an$ othe* *elate$ $o%&ment(.
En(&*in. timel) a%tion i( ta3en ,o* the a&$it ,in$in.(.
Follo--&p a%tion to 4e*i,) the (&%%e(( o, that a%tion ta3en' i(
$e,ine$.
The mana.e* *e(pon(ible ,o* the a*ea bein. a&$ite$ (hall en(&*e
that a%tion( a*e bein. ta3en -itho&t &n$&e $ela) to eliminate
$ete%te$ non-%on,o*mitie( an$ thei* %a&(e(. Follo--&p a%ti4itie(
in%l&$e the 4e*i,i%ation o, the a%tion( ta3en an$ $o%&mentation o,
the 4e*i,i%ation *e(&lt(.


!((&e$: 2007-01-08 "e4i(ion 1 0a.e 22 o, 22
AB-512(b) 2007-01
IMR
Se-ion
Re).
Re)/. W'e%e
Elemen i# Co"e%e!
in Manual
0/03 Co%%e-i"e an! $%e"enai"e A-ion#@ A--i!en# an! In-i!en#
Thi( (e%tion (hall $e,ine the ()(tem &(e$ to en(&*e that i((&e(' that
ma) ne.ati4el) impa%t on the (a,et) o, the p*e((&*e e+&ipment' *e(&lt
in non-%omplian%e to the 1a,et) Co$e( A%t' o* ;eopa*$i/e !M1
*e+&i*ement(' a*e in4e(ti.ate$' %o**e%te$' an$ *epo*te$' an$ (&itable
a%tion i( ta3en to p*e4ent thei* *e%&**en%e.
En(&*in. that a%%i$ent( an$ &n(a,e %on$ition( a*e *epo*te$ to
AB1A' a( *e+&i*e$ b) the 1a,et) Co$e( A%t.
To e(tabli(h a ,o*mali/e$ p*o%e(( ,o* $ete*minin. the *oot %a&(e
o, an in%i$ent' nea* mi((' o* non-%omplian%e i((&e an$ ta3in.
app*op*iate a%tion to p*e4ent it( *e%&**en%e.
To en(&*e that a%ti4itie( a*e *epo*te$ to the app*op*iate
a&tho*itie( -ithin the o*.ani/ation.
0*o4i$e ,o* *epo*t( an$ othe* $o%&ment( &(e$ to *e%o*$ the
(it&ation(' the %o**e%ti4e a%tion an$ p*e4entati4e a%tion( ta3en.
9o%&ment( (hall in%l&$e the *e+&i*e$ app*o4al( o, the Chie,
!n(pe%to*' othe* *ele4ant pe*(onnel an$' -hen appli%able' AB1A.
T*a%3in. an$ %ont*ollin. the %ompletion o, the %o**e%ti4e an$
p*e4entati4e a%tion an$ 4e*i,)in. it( e,,e%ti4ene((. "e4ie- o, an
in%i$ent' nea* mi((' non-%omplian%e an$ othe* *ele4ant
in,o*mation' to $ete*mine an$ implement the a%tion nee$e$ to
p*e4ent a *e%&**en%e an$ imp*o4e e,,e%ti4ene(( o, the !M1.

"e4ie-e*7( Comment(

!((&e$: 2007-01-08 "e4i(ion 1 0a.e 22 o, 22

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