Department: Quality Assurance Issue Date: 01.12.06 Su !

ect Internal Au"it REVISIONS Revision Description

DOC. No. : AV/IA/SOP/001 Page No. : Page 1 of 8 Revision No. & Date : (02)01.12.06

Revisi Revis on No. ed Pages 00 0 01 4 02 2-6

Date of Revision 01.03.06 28.09.06 01.12.06

Original Issue Addition in Inter Auditors Criteria Revision for Responsi ilit! and pro"edure

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Department: Quality Assurance Issue Date: 01.12.06 Su !ect Internal Au"it

DOC. No. : AV/IA/SOP/001 Page No. : Page 2 of 8 Revision No. & Date : (02)01.12.06

1.0

Purpose:

#o develop $tandard Operating %ro"edure for internal Audit and e&pertise 'it(in t(e fa"ilit! so t(at %lant "an perfor) selfassess)ents periodi"all! to ensure produ"ts* pro"esses and fa"ilities )eet Co)pan! re+uire)ents. 2.0 Scope: #(is is appli"a le for t(e internal audit of %lant. 3.0Responsi i!ities: 1. ,a"tor! -anager . A--/ualit! Assuran"e is responsi le to identif! auditor and t(e audit tea). 2. Responsi ilit! of Auditor0 Audit %lanning Representing t(e tea) -anaging t(e tea) %reparing audit Report Condu"t opening . "losing )eeting $u )ission of Report Agreeing on Corre"tive A"tion Revie' Corre"tive A"tion %lan ,ollo'-up of Corre"tive A"tion %lan 3. Audit tea) responsi le for "ondu"ting /uarterl! audit on a presele"ted topi" and re"ording t(e audit findings in a 'ritten paper follo'ing 'ill e s"ope of audit in t(e )ention )ont(. 4. Auditee is responsi le for ta1ing "orre"tive a"tion )easures on t(e non "onfor)an"es o served. 2. /A 3&e"utive is responsi le for ensuring t(at "orre"tive a"tion ta1es pla"e 'it(in t(e spe"ified ti)e. ".0 Definitions 4.1 #udit- Appraisal 4.2 Revie$ 4 Inspe"tion 4.3 #ssess%ent- evaluation

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Department: Quality Assurance Issue Date: 01.12.06 Su !ect Internal Au"it &.0 Procedure &.1 Infor%ation' Supp!ies and E(uip%ent Audit C(e"1lists* Co)pan! spe"ifi"ations. &.2 )re(uenc* 2.2.1 /uarterl!

DOC. No. : AV/IA/SOP/001 Page No. : Page , of 8 Revision No. & Date : (02)01.12.06

&.3 Step+ *+Step Instructions P!anning of audit: #(e internal auditor0 Revie's t(e previous audit reports. 5e"ides '(o) to )eet during t(e audit. Colle"ts and revie's appropriate do"u)ents. Deter%ine if ,o%pan* standards are %et#(e internal auditor0 3nsures t(at t(e plant6s progra)s and pro"edures satisfa"toril! address ea"( standard of t(e +ualit! s!ste). 7erifies t(at t(e re+uired ele)ents spe"ified in 58, are refle"ted in t(e "orresponding plant progra) . pro"edures. ,o%pare current p!ant practices to docu%ented procedures. #(e internal auditors0 7erif! t(at t(e "urrent pra"ti"es are "arried out as spe"ified in 'ritten plant $O%s. Intervie's personnel . o serve a"tivities and "onditions. 9ses "(e"1lists to re"ord t(e eviden"es regarding plant pra"ti"es. Eva!uate progra% effectiveness: #(e Internal auditor0 8ases "on"lusions on t(e o :e"tive eviden"e gat(ered during t(e audit to evaluate ea"( progra)6s effe"tiveness. ,o%%unicate #udit Resu!ts: #(e audit "(e"1list* relevant o :e"tive eviden"e* and audit findings are "o)piled into an audit report. #(e report serves as t(e re"ord of Prepare" #y Document Controller Approve" #y Management e!re"entat#$e
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Department: Quality Assurance Issue Date: 01.12.06 Su !ect Internal Au"it

DOC. No. : AV/IA/SOP/001 Page No. : Page - of 8 Revision No. & Date : (02)01.12.06

t(e audit. Internal audit re"ords are revie'ed and dis"ussed along 'it( all "orre"tive a"tion and follo'-up re"ords. #(e internal auditor0 5is"uss audit results 'it( all appropriate plant personnel at t(e "on"lusion of t(e audit. ;rites an audit report 'it(in a 'ee1 after t(e "o)pletion of t(e audit. ./e audit essentia!!* consists of t/e fo!!o$ing steps: &.3.1 Pre+#udit Preparation 2.3.1.1 %rogra) sele"tion 2.3.1.1 Audit $"(eduling 2.3.1.3 <at(er 8a"1ground Infor)ation 2.3.1.4 5eveloping Audit $trateg! &.'.(.& )p"ating Protocols 2.3.1.6 $ele"ting #ea) -e) ers &.3.2 On+Site activities ,ollo'ing point is "overed in on-site a"tivities &.3.2.1 #ssess Progra% 0asis: 2.3.2.1.1 Intervie's* 2.3.2.1.2 $ite inspe"tion=revie' for in(erent ris1s 2.3.2.2 Assess progra) 5esign .Content0 2.3.2.2.1 Internal Controls* 2.3.2.2.2 7erifi"ation #esting &.3.2.3 #ssess progra% i%p!e%entation : 2.3.2.3.1 O servation* 2.3.2.3.2 5o"u)ent Revie' 2.3.2.3.3 Intervie'ing 2.3.2.3.4$a)pling $trategies 2.3.2.4 Asses progra) -aintenan"e 2.3.2.2 Co))uni"ate Audit findings &.3.3 Post audit activities ,ollo'ing points are ta1en as post audit a"tivities 2.3.3.1 %repare 5raft Report 2.3.3.2 Revie' of 5raft Report 2.3.3.3 %repare ,inal Report 2.3.3.4 Corre"tive A"tion planning 2.3.3.2 ,ollo' -9p of Corre"tive A"tion %lan &.3." #uditor1s #ssess%ent 2.3.4.1 -anage)ent )onitor auditor>s "apa ilit! )et(ods 8! assessing t(e audit report Prepare" #y Document Controller Approve" #y Management e!re"entat#$e
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Department: Quality Assurance Issue Date: 01.12.06 Su !ect 8! 8! 8! 8! Internal Au"it tra"1ing t(e audit s"(edule Corre"tive a"tion tra"1ing assessing intervie'ing s1ills assessing interpersonal s1ills

DOC. No. : AV/IA/SOP/001 Page No. : Page . of 8 Revision No. & Date : (02)01.12.06

&.3.& #uditor1s criteria <ood "o))uni"ation Audit s1ill Integrit! ?on- t(reatening <ood listener %atient &.3.2 ,!assification of Non ,onfor%ance ?on "onfor)an"es t(at are raised during t(e audit 'ill e evaluated and pla"ed into one of t(ree "ategories0 ,ritica! Ris3 An! finding or stru"tural s(ort"o)ing in t(e +ualit! s!ste) t(at "ould0 Create a )a:or (ealt( and=or safet! "on"ern* re+uiring produ"tion to e stopped i))ediatel! and )ar1et pla"e a"tions initiated. and=or Result in a )a:or pu li" relations e) arrass)ent* t(ere ! severel! putting #(e Co)pan!>s integrit! or reputation at ris1. and=or Result in signifi"ant legal or regulator! a"tion or lia ilit!* t(ere ! severel! putting #(e Co)pan!>s integrit! or reputation or legal rig(t to operate at ris1. and=or $ignifi"antl! redu"e or eli)inate "urrent or future sales and=or $ignifi"antl! redu"e or eli)inate t(e finan"ial results of t(e operation #(e usiness ris1 to t(e Co)pan! or t(e operation is "riti"al.

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Department: Quality Assurance Issue Date: 01.12.06 Su !ect Internal Au"it

DOC. No. : AV/IA/SOP/001 Page No. : Page 6 of 8 Revision No. & Date : (02)01.12.06

Ite)s are ran1ed as "riti"al ris1 if* on furt(er investigation* it is found t(at ot( t(e preventative and dete"tive "ontrols are inade+uate. Corre"tive a"tion needs to e initiated i))ediatel! and "o)pleted efore operational a"tivities )a! e restarted. 4ig/ Ris3 An! finding or stru"tural s(ort"o)ing in t(e +ualit! s!ste) t(at "ould 0 Create a (ealt( and=or safet! "on"ern re+uiring produ"tion to e stopped. and=or Result in pu li" relations e) arrass)ent t(ere ! putting #(e Co)pan!>s integrit! or reputation at ris1. and=or Result in legal or regulator! a"tion or lia ilit!* t(ere ! putting #(e Co)pan!>s integrit! or reputation at ris1 or e&posing #(e Co)pan! to legal fines or ot(er san"tions. and=or Redu"e "urrent or future sales and=or Redu"e t(e finan"ial results of t(e operation #(e usiness ris1 to t(e Co)pan! or t(e operation is (ig(. Ite)s are ran1ed as (ig( ris1 if* on furt(er investigation* it is found t(at eit(er t(e preventative or dete"tive "ontrols are inade+uate. A nu) er of (ig( ris1 findings* '(en revie'ed "olle"tivel!* )a! present a "riti"al ris1 to t(e operation. In t(ese instan"es* t(e audit tea) )a! dee) it appropriate to present t(ese "olle"tive (ig( ris1s as a "riti"al ris1 finding. Corre"tive a"tion needs to e initiated i))ediatel! and "o)pleted efore resu)ing nor)al a"tivities. Potentia! Ris3 An! finding t(at (as a "urrent or potential (ig( i)pa"t on +ualit! @t(e finding "an e isolated or s!ste)ati"A. An! stru"tural s(ort"o)ing in a +ualit! s!ste) ele)ent.

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Department: Quality Assurance Issue Date: 01.12.06 Su !ect Internal Au"it

DOC. No. : AV/IA/SOP/001 Page No. : Page / of 8 Revision No. & Date : (02)01.12.06

#(e usiness ris1 to t(e Co)pan! or t(e operation is "urrentl! not signifi"ant. A nu) er of potential ris1 findings* '(en revie'ed "olle"tivel!* )a! present a (ig( ris1 to t(e operation. In t(ese instan"es* t(e audit tea) )a! dee) it appropriate to present t(ese "olle"tive potential ris1s as a (ig( ris1 finding. Corre"tive a"tion s(ould e in"luded as a priorit! 'it(in t(e operation>s on-going a"tivities. I%prove%ent Opportunit* - An! lo' i)pa"t finding @isolated or s!ste)ati"A* '(i"( is not a stru"tural s(ort"o)ing to a +ualit! s!ste) ele)ent. - An! issue '(ere t(ere is no eviden"e of ad results* ut '(ere t(e s!ste) does not provide enoug( guarantee for "onsistent effe"tive perfor)an"e. - An! situation '(ere t(e "urrent s!ste) )eets t(e re+uire)ents of /ualit! s!ste) ut t(ere is an i)portant opportunit! for effi"ien"! i)prove)ent A nu) er of i)prove)ent opportunities* '(en revie'ed "olle"tivel!* )a! present a potential ris1 to t(e operation. In t(ese instan"es* t(e audit tea) )a! dee) it appropriate to present t(ese "olle"tive i)prove)ent opportunities as a potential ris1 finding. #(e finding s(ould e in"luded in t(e "orre"tive a"tion progra) of t(e operation.

Strengt/ A su""essful pra"ti"e t(at needs to e s(ared 'it( ot(er operations @an! progra)* pro"edure* a"tivit! or te"(ni"al solution t(at t(e auditors (ave found to produ"e "onsistent satisfa"tor! results 'ell a ove t(e level re+uired in /ualit! $!ste)A. 2.0 Docu%entation

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Department: Quality Assurance Issue Date: 01.12.06 Su !ect Internal Au"it

DOC. No. : AV/IA/SOP/001 Page No. : Page 8 of 8 Revision No. & Date : (02)01.12.06

01e follo2#ng Document" "u!!ort t1e #m!lementat#on of t1e SOP 3 1. A7-IA-ACB-01 Internal audit $"(edule 2. A7-IA-ACB-02 Internal Audit #ea) 3. A7-IA-,R--01 Internal Audit Report 5.0 Reference:

Prepare" #y Document Controller

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