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WEATHERFORD AEROSPACE, INC. 1020 E. Columbia Street 610 W.

Third Street Weatherford, TX 76086

DOCUMENT NO.

QP 8.2.2

Number of Pages

11

Quality Procedure

INTERNAL AUDIT
(Supersedi ! "# 8.2.2 $e%. &'

SAE AS9100C 8.2.2 QMS-001 8.2.2

REVISION LEVEL: EFFECTIVITY DATE:


REVIEW N!

E
8 NOVEMBER 2013

REVISED BY
!"#$ D. S%&'&$(, C#)&* A+,)%"-, AS9100C C#./0)"$1

PPROV L REVIEWED AND APPROVED BY


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Signature on File
REVIEWED AND APPROVED BY
B)33)& C"-$&3)+(, P-",+2%)"$ Q+.3)%4 M.$.5&-1

Signature on File
REVIEWED AND APPROVED BY
T",, W&6(%&-, D)-&2%"- "* Q+.3)%4 A((+-.$2&1

Signature on File

Signature on File

IDENTIFY COPY STATUS IF CONTRO77ED. THE DOCUMENT CONTRO7 OFFICE HO7DS THE ORI8INA7, SI8NED HARD COPY OF THIS DOCUMENT AT 1020 CO7UMBIA ST., WEATHERFORD, T9 :;08;. CONTACT THE DOCUMENT CONTRO7 COORDINATOR AT E9TENSION <1; FOR A CURRENT =CONTRO77ED COPY> OF THIS DOCUMENT.

CONTRO77ED COPY (C(EC) *+X'(#,-CE C+.T$+, ST-/# -.& .0/*E$


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PRINTED COPIES OF THIS DOCUMENT NOT BEARIN8 A =CONTRO77ED COPY> STAMP SHA77 BE =FOR REFERENCE ON7Y>. REFERENCE COPIES MAY BE PRINTED FROM THE E7ECTRONIC 7IBRARY FOUND AT R:?QUA7ITY?Q+.3)%4 P-"2&,+-&(.
(2o a Tull, &o3ume t Co trol Coordi ator'

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Signature on File

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

REVISION HISTORY R&'. NC A B D&%.)3( "# 177100 8 2 itial $elease 8 This re%isio supersedes all li9e or Similar do3ume ts i the W-2 "/S. "# 8.2.2 8 Supersedes "# 177100 to meet -S:100C re;uireme ts. Complete $e%isio . -dded5 4i!ure 7.2 -udit -3ti%it< #ro3ess 4lo= -dded5 To 8.1.2 8 >Whe the audit is ot feasible, a alter ati%e should be proposed to meet audit fre;ue 3< re;uireme ts. $e7s3heduled audit a3ti%it< should o33ur =ithi thirt< da<s of ori!i al audit date.? -dded5 To 8.2.1 8 >6erif< the feasibilit< of the audit (Whe the audit is ot feasible, a alter ati%e should be proposed to the auditee to meet audit fre;ue 3< re;uireme ts. $e7s3heduled audit a3ti%it< should o33ur =ithi thirt< da<s of ori!i al audit date.'.? -dded5 #ara!raph 10.0 &o3ume t 2mpro%eme t C"/03&%& R&')()"$ -dded5 To se3tio 1@.0 8 -S:101& shall be emplo<ed as the +E$. -dded5 To sub7se3tio 1A.2 8 4orm 2-7008 2 ter al -udit $eport shall be 0sed to report audit status to &ire3tor of "ualit<. -dded5 To se3tio 8.0 8 -udit s3hedule 3ha !es re;uire appro%al from the &ire3tor of "ualit<. D.%& /ar3h 6, 2007 /ar3h 16, 2012

-pril 6, 2012

C &

< !+$& 201@ 20 -u!ust 201@

A,,)%)"$ M.,& 8 N"' 201@ -dded5 To Se3tio 1@.2 >.o 3o forma 3es ha%i ! a dire3t impa3t o produ3t ;ualit< or a stro ! pote tial for produ3t impa3t shall re;uire 3ustomer otifi3atio =ithi 2A hours of dis3o%er<.? Rationale: Customer (GE) driven requirement per ISO 9001: 00!" Se#tion $%&% -dditio pri ted i bold a d hi!hli!hted i ori!i al a d 3o trolled pri t 3op< (lo39ed Word do3ume t'.

727

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

INDE9 ITEM $E62S2+. (2ST+$1 1.0 SC+#E 2.0 -0T(+$2T1 @.0 $ES#+.S2*2,2T1 A.0 $E4E$E.CE &+C0/E.TS B.0 TE$/S -.& &E42.2T2+.S 6.0 CE.E$-, $E"02$E/E.TS 7.0 #$+CESS 4,+W 8.0 SC(E&0,2.C :.0 #,-..2.C 10.0 11.0 12.0 1@.0 1A.0 1B.0 16.0 17.0 -0&2T .+T242C-T2+. &ES)T+# -0&2T +.7S2TE -0&2T 2&E.T2412.C -.& $EC+$&2.C -0&2T 42.&2.CS -0&2T $E#+$T2.C .+.C+.4+$/2T1 /-.-CE/E.T -0&2T $EC+$&S 2/#$+6E/E.T PA8E 2 A A A A A B 6 6 7 7 7 7 8 : 10 10 11

7@7

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

1.0

SCOPE P+-0"(&: To defi e 2 ter al -udit re;uireme ts. I$%&$%: To meet -S:100C, Sub73lause 8.2.2 re;uireme ts. A003)2.%)"$: The re;uireme ts of this do3ume t shall appl< to all W-2 &epartme ts.

2.0

AUTHORITY M.$.5&/&$% R&0-&(&$%.%)'&: The &ire3tor of "ualit< -ssura 3e has authorit< o%er the i terpretatio of this do3ume t a d the ri!ht to resol%e disputes related to its use. A+,)% P-"5-./ M.$.5&-: The Chief -uditor shall ha%e authorit< o%er the i ter al audit pro!ram.

@.0

RESPONSIBI7ITY D&0.-%/&$% M.$.5&-(: The /a a!er(s' respo sible for the area(s' bei ! audited shall e sure that a < e3essar< 3orre3tio s a d 3orre3ti%e a3tio s are ta9e =ithout u due dela< to elimi ate the dete3ted o 3o formities a d their 3auses. A+,)% P-"5-./ M.$.5&-: The Chief -uditor is respo sible for pla establishi ! re3ords a d reporti ! audit results. i ! a d 3o du3ti ! audits,

<.0

P-"2&(( OA$&-: The Chief -uditor is the respo sible pro3ess o= er for this do3ume t.

REFERENCE DOCUMENTS ISO 9000 ISO 9001 ISO 19011 SAE AS9100 SAE AS9101 QMS-001 QP <.2.< QP 8.B.1 QP 8.B.2 QP 8.B.@ "/S 8 4u dame tals a d 6o3abular< "/S 8 $e;uireme ts Cuideli es for -uditi ! /a a!eme t S<stems "/S 8 $e;uireme ts for -%iatio , Spa3e a d &efe se +r!a iDatio s "/S 8 -udit $e;uireme ts for -%iatio , Spa3e a d &efe se +r!a iDatio s "ualit< /a ual for S<stems /a a!eme t (W-2' Co trol of $e3ords (W-2' Co ti ual 2mpro%eme t (W-2' Corre3ti%e -3tio (W-2' #re%e ti%e -3tio (W-2'

B.0

TERMS AND DEFINITIONS

7A7

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

4or the purposes of this do3ume t, the terms a d defi itio s pro%ided i the $efere 3e &o3ume ts a d the follo=i ! appl<. M.C"- N"$2"$*"-/)%4: - o 7fulfillme t of a re;uireme t =hi3h is li9el< to result i the failure of the "/S or redu3e its abilit< to assure 3o trolled pro3esses or 3omplia t produ3tsEser%i3esF it 3a be o e or more of the follo=i ! 3o ditio s5 o o o o - o 3o formit< =here the effe3t is Gud!ed to be detrime tal to the i te!rit< of the produ3t or ser%i3eF The abse 3e of or total brea9do= of a s<stem to meet a -S:100 sta dard re;uireme t, a W-2 pro3edure, or 3ustomer "/S re;uireme tF - < o 3o formit< that =ould result i the probable shipme t of o 3o formi ! produ3tF a dEor - 3o ditio that 3ould result i the failure or redu3e the usabilit< of the produ3t or ser%i3e a d its i te ded purpose.

M)$"- N"$2"$*"-/)%4: - o 7fulfillme t of a re;uireme t =hi3h is ot li9el< to result i the failure of the "/S or redu3e its abilit< to assure 3o trolled pro3esses or 3omplia t produ3tsEser%i3esF it 3a be either o e of the follo=i ! situatio s5 o o - si !le s<stem failure or lapse i 3o forma 3e =ith a -S:100 sta dard re;uireme t or 3ustomer "/S re;uireme tF or - si !le s<stem failure or lapse i 3o forma 3e =ith a pro3edure asso3iated =ith the W-2 "/S. N"%&: - umber of mi or o 3o forma 3es a!ai st o e re;uireme t (e.!., similar o 3o formities asso3iated =ith differe t sites or differe t departme tsEpro3esses =ithi a si !le site' 3a represe t a total brea9do= of the s<stem a d thus be 3o sidered a maGor o 3o formit<.

;.0

QMS: "ualit< /a a!eme t S<stem WAI: Weatherford -erospa3e, 2 3.

8ENERA7 REQUIREMENTS W-2 shall 3o du3t i ter al audits at pla o o ed i ter%als to determi e =hether the "/S5

Co forms to 3ustomer H re!ulator< authorit< re;uireme ts a d to -S:100 re;uireme tsF a d 2s effe3ti%el< impleme ted a d mai tai ed.

The 2 ter al -udit S3hedule shall ide tif< the i ter%als a d shall ta9e i to 3o sideratio the status a d importa 3e of the pro3esses a d areas to be audited a d shall be updated i respo se to the results of pre%ious audit a3ti%it<. -udit #la s shall defi e the 3riteria, s3ope, a d methods for ea3h i ter al audit. The sele3tio of auditors a d 3o du3t of audits shall e sure obGe3ti%it< a d impartialit< of the audit pro3ess. -uditors shall ot audit their o= =or9. $e3ords of the audits a d their results shall be mai tai ed.

7B7

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

The /a a!eme t respo sible for the area bei ! audited shall e sure that a < e3essar< 3orre3tio s a d 3orre3ti%e a3tio s are ta9e =ithout u due dela< to elimi ate dete3ted o 3o formities a d their 3auses. 4ollo=7up a3ti%ities (to 3orre3tio s a d 3orre3ti%e a3tio ' shall i 3lude the %erifi3atio of the a3tio s ta9e a d the reporti ! of %erifi3atio results.

:.0

PROCESS F7OW F)5+-& 1. I$%&-$.3 A+,)% P-"2&(( F3"A

0pdate S3hedule #ro3ess -udit I .+ #$+CESS &2-C$-/

2 ter al -udit S3hedule -udit #la -udit -3ti%it< -udit $eport

0pdate S3hedule

1ES

&etermi e 4ollo=70p

#E-$(s'

1ES

#ro3ess -udit I .+

Effe3ti% e ,e%el J @ I 1ES


YES

.+

"/S #$+CESS /-T$2X $E#+$T

.o 3o forma 3e

.C$(s' 2de tifie d I .+

1ES -ssi! C-$(s'

767

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE 8.0 SCHEDU7IN8 9.0 F"-/ IA-001 I$%&-$.3 A+,)% S2#&,+3& IAS1

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

The 2 ter al -udit S3hedule shall 3o%er all -S:100 Clauses a d Sub7Clauses a d .ad3ap -udit -3ti%it<. The -udit #ro!ram /a a!er is respo sible for s3heduli ! all 2 ter al -udit -3ti%it<, ta9i ! i to 3o sideratio the status a d importa 3e of the pro3esses a d areas to be audited. The 2-$ shall be updated a d re%ised i respo se to the results of pre%ious audit a3ti%it<. $e%isio s to the 2 ter al -udit S3hedule re;uire the appro%al of the &ire3tor of "ualit< -ssura 3e. The 2-$ shall be i 3luded i audit re3ords.

P7ANNIN8 9.1 9.2 AUDIT P7ANNIN8 F"-/ IA-002 I$%&-$.3 A+,)% P3.$ IAP1

The 2 ter al -udit #la shall defi e the area(s' to be audited, audit obGe3ti%e(s', audit s3ope, audit 3riteria, audit methods, a d audit date(s' a d time(s'. The 3ompleted 2-# shall be i 3luded i the audit re3ords. DIA8RAMMIN8 PROCESSES F"-/ IA-00@ P-"2&(( T+-%3&1 D).5-./

#ro3ess &ia!ram form(s' shall be de%eloped for those pro3ess a3ti%ities ide tified =ith Clause 7 of -S:100 a d its sub73lauses to aid audit a3ti%it<. The 3ompleted #ro3ess &ia!ram(s' shall be i 3luded i the audit re3ords.

10.0

AUDIT NOTIFICATION O0%)"$.31 Where pra3ti3able, otif< the auditee prior to the starti ! o 7site audit a3ti%it<. Co ta3t ma< be i formal (e.!., dire3t 3o %ersatio , telepho e, or e7mail' or formal ( otifi3atio letter' a d should be made b< the -udit #ro!ram /a a!er or ,ead -uditor.

11.0 12.0

DESDTOP AUDIT Ea3h audit shall re;uire the des9top re%ie= of rele%a t do3ume ts a d re3ords. The des9top audit ma< be 3o du3ted prior to, duri !, a dEor after the o 7site audit a3ti%it<. The fi di !s ide tified =ith the des9top audit shall be re3orded as obGe3ti%e e%ide 3e. ON-SITE AUDIT 12.1 8ENERA7 Ea3h o 7site audit, eK3ept for o 3o formit< follo=7up a d spe3ial audits, shall i 3lude the follo=i !5

777

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE o o o o o - audit of the "/S performa 3e a d effe3ti%e essF

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

- audit of W-2 pro3esses (their performa 3e a d effe3ti%e ess', =here appli3ableF - audit of the 3o ti ual impro%eme t of the "/SF - audit of spe3ial pro3esses, =here ide tified i the audit pla F a d, - audit of follo=7up a3tio s from pre%ious audits, as appli3able.

&uri ! the audit, the use of rele%a t audit methods shall be 3o sidered.

12.2

OPENIN8 MEETIN8 O0%)"$.31 The ope i ! meeti ! shall be 3o du3ted b< the -udit Team ,eader. -tte da 3e to the ope i ! meeti ! shall be re3orded. &uri ! the ope i ! meeti !, the auditor should5 o o o o o o Co firm audit obGe3ti%es, s3ope a d 3riteriaF 2 form the auditee that 3o formit< a d o 3o formit< fi di !s =ill be re3ordedF 2 form the auditee that a < o 3o formities ide tified shall be !raded based o their se%erit< a d pote tial impa3tF #ro%ide i formatio about the 3losi ! meeti !F #ro%ide i formatio about ho= to deal =ith possible fi di !s duri ! the auditF a d, 2 form the auditee that feedba39 3o 3er i ! the audit, i 3ludi ! a < 3o 3er s, 3omplai ts or appeals to audit fi di !s should be addressed i =riti ! to the &ire3tor of "ualit< -ssura 3e.

12.@

AUDIT CONDUCT The audit shall be 3o du3ted thou!h the auditi ! methods defi ed b< the audit pla . $ele%a t audit trails =ill be pursued to assist i the determi atio of "/S 3o formit< a d effe3ti%e ess.

1@.0

IDENTIFYIN8 AND RECORDIN8 AUDIT FINDIN8S 1@.1 OB!ECTIVE EVIDENCE RECORD F"-/ IA-00B O6C&2%)'& E'),&$2& R&2"-, OER1

The +bGe3ti%e E%ide 3e $e3ord shall be -S:101& -ppe diK -. +bGe3ti%e E%ide 3e $e3ord. &etailed obGe3ti%e e%ide 3e Laudit e%ide 3e (i.e., re%ie=ed pro3edures, shop orders, trai i ! re3ords, produ3ts, a d %erifi3atio re3ords'M shall be re3orded o the +bGe3ti%e E%ide 3e $e3ord. 4or pro3ess a3ti%ities ide tified =ith Clause 7 of -S:100 a d its sub73lauses, the obGe3ti%e e%ide 3e shall be do3ume ted o the #E-$ form. 2f Clause 7 of -S:100 a d its sub73lauses are asso3iated =ith pro3esses that are addressed b< #E-$s, the obGe3ti%e e%ide 3e is o l< re;uired to be do3ume ted o the #E-$.

787

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE The 3ompleted +E$ shall be i 3luded i the audit re3ords.

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

$e3urre 3e of the same or similar o 3o formit< fou di ! duri ! 3o se3uti%e audits at a parti3ular siteElo3atio shall be 3o sidered as a failure of the 3orre3ti%e a3tio pro3ess a d shall result i a maGor o 3o formit< bei ! issued. REPORTIN8 NONCONFORMANCE F"-/ QA 1020 C"--&2%)'& A2%)"$ R&0"-% CAR1 The Corre3ti%e -3tio $eport shall be used to re3ord o 3o formities. Ea3h C-$ shall 3o tai o l< o e o 3o formit<. Whe o 3o formities are ide tified, the o 3o formit< shall be 3lassified as NmaGorO or Nmi orO, a33ordi ! to the defi itio s pro%ided i this do3ume t. $e3urre 3e of the same or similar o 3o formit< fou d duri ! 3o se3uti%e audits at a parti3ular lo3atio shall be 3o sidered as a failure of the 3orre3ti%e a3tio pro3ess a d shall result i a NmaGorO o 3o formit< (C-$' bei ! issued. P-"2&(( $"$2"$*"-/.$2& #.')$5 . ,)-&2% )/0.2% "$ 0-",+2% E+.3)%4 "- . (%-"$5 0"%&$%).3 *"0-",+2% )/0.2% (#.33 -&E+)-& 2+(%"/&- $"%)*)2.%)"$ A)%#)$ 2< #"+-( "* ,)(2"'&-4. PROCESS EFFECTIVENESS F"-/ IA-00; P-"2&(( E**&2%)'&$&(( A((&((/&$% R&0"-% PEAR1

1@.2

1@.@ 1<.0

The results of effe3ti%e ess shall be re3orded o the #E-$ form for ea3h audited produ3t realiDatio pro3ess (-S:100, Clause 7'. The le%el of effe3ti%e ess for ea3h re3orded pro3ess shall be re3orded o the #E-$ (stateme t of effe3ti%e ess le%el'. 2f the le%el of effe3ti%e ess has bee 3lassified as a N2O or a N1O, this shall result i a o 3o formit< bei ! issued a!ai st -S:100, Clauses A.1 3 a d f. -t the dis3retio of the -udit #ro!ram /a a!er, other pro3esses 3a be re3orded o a #E-$ form. The 3ompleted #E-$ form shall be3ome part of the audit re3ord.

AUDIT REPORTIN8 1<.1 QMS PROCESS MATRI9 REPORT F"-/ IA-00: QMS P-"2&(( M.%-)F R&0"-% PMR1

The "/S #ro3ess /atriK $eport shall be 3ompleted for ea3h audit to demo strate =hi3h pro3esses a d "/S 3lauses ha%e bee audited. The #/$ form is used to assist i %isibl< prese ti ! the 3ross7refere 3es bet=ee -S:100 re;uireme ts a d W-2 pro3esses. The #/$ form 3a be pre7populated prior to o 7site audit a3ti%it< a d easil< modifiedEre%ised, as appropriate, duri ! ea3h %isit. The 3ompleted #/$ form shall be3ome part of the audit re3ord.

7:7

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE 1<.2 INTERNA7 AUDIT REPORT F"-/ IA-008 I$%&-$.3 A+,)% R&0"-% IAR1

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

The 2 ter al -udit $eport shall be 3ompiled at the 3o 3lusio of ea3h audit. The 3o te t of the 2-$, i 3ludi ! fi di !s, shall !i%e a true a d i depe de t %ie= of the 3o formit< status a d determi atio of "/S i order to !i%e 3o fide 3e to 3ustomers, pote tial 3ustomers, a d W-2 Top /a a!eme tF e abli ! them to dra= appropriate 3o 3lusio s re!ardi ! the effe3ti%e ess of the "/S. The audit summar< shall refle3t the serious ess of a < o 3o formities (i.e., umber, 3riti3alit<, impa3t'. The 2-$ shall be issued to the &ire3tor of "ualit< -ssura 3e (audit 3ustomer' for re%ie= =ithi fi%e (B' =or9i ! da<s of o 7site audit a3ti%it<. 4ollo=i ! si! ature re%ie= b< the audit 3ustomer, 3opies of the 2-$ shall be issued =ithi three (@' =or9i ! da<s to the affe3ted &epartme t /a a!ers (auditees'. INTERNA7 AUDIT SUMMARY F"-/ IA-009 A+,)% S+//.-4 R&0"-% ASR1

1<.@ 1B.0

The -udit Summar< $eport shall be used to summariDe the 3urre t status of i ter al audits. The -S$ shall be 3ompleted b< the -udit #ro!ram /a a!er a d for=arded to the &ire3tor of "ualit< -ssura 3e o a ;uarterl< basis. The 3ompleted -S$ shall be3ome part of the audit re3ords.

NONCONFORMITY MANA8EMENT F"-/ QA 1020 C"--&2%)'& A2%)"$ R&0"-% CAR1 With issua 3e of a C-$, the auditee shall5 o o Ta9e immediate a3tio to affe3t 3o tai me t of the o 3o forma 3e ide tified a d affe3t 3orre3tio of the 3o ditio F &etermi e a d report the 3orre3ti%e a3tio pla to the -udit #ro!ram /a a!er =ithi te (10' 3ale dar da<s after the audit a d rea3h a!reeme t (a33epta 3e of pla ' =ith the -udit #ro!ram /a a!er =ithi the eKt fourtee (1A' 3ale dar da<s. N"%&: EKte sio s to the assi! ed 3orre3ti%e a3tio due date re;uire submissio of a letter to the &ire3tor of "ualit< -ssura 3e =ithi fi%e (B' 3ale dar da<s of re3ei%i ! the C-$. -ppro%al of eKte sio is ot !uara teed.

Complete the 3orre3ti%e a3tio pla =ithi a maKimum of thirt< (@0' da<s from the date the C-$ =as issued. N"%&: Corre3tio pla s that re;uire more tha thirt< (@0' da<s shall re;uire the submissio of a re;uest letter to the &ire3tor of "ualit< -ssura 3e =ithi te (10' 3ale dar da<s of re3ei%i ! the C-$. -ppro%al for a eKte sio to the time allo=ed to affe3t 3orre3ti%e a3tio a3ti%it< is ot !uara teed.

The C-$ shall be used to do3ume t %erifi3atio a d o 3o formit< 3losure.

7 10 7

WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

E%aluatio a d 3losi ! of the 3orre3ti%e a3tio pla a d asso3iated 3orre3ti%e a3tio s relati ! to a o 3o formit< shall ot be performed duri ! the audit i =hi3h the o 3o formit< =as issued. N"%&: - < 3o tai me t a3tio a d 3orre3tio 3a be re%ie=ed duri ! the audit.

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6erifi3atio a3ti%ities (follo=7up' shall be 3arried out as determi ed b< the -udit #ro!ram /a a!er. 6erifi3atio shall be 3arried out o 7site, if the %erifi3atio of the 3orre3ti%e a3tio 3a ot be 3arried out based o a re%ie= of the do3ume tatio a d supporti ! obGe3ti%e e%ide 3e pro%ided b< the auditee. Corre3ti%e a3tio follo=7up ma< i 3lude audit a3ti%it< a d re;uire re%isio s to the audit s3hedule.

AUDIT RECORDS 2 formatio pertai i ! to the audit (e.!., 3he39lists, ;uestio e%ide 3e' shall be3ome part of the audit re3ords. aires, auditor otes, re3ords of obGe3ti%e

-udit re3ords pro%idi ! e%ide 3e of 3omplia 3e =ith do3ume t re;uireme ts i 3lude the follo=i !5 o o o o o o o o o F"-/ IA-001 F"-/ IA-002 F"-/ IA-00@ F"-/ IA-00B F"-/ IA-00; F"-/ IA-00: F"-/ IA-008 F"-/ IA-009 I$%&-$.3 A+,)% S2#&,+3& IAS1 I$%&-$.3 A+,)% P3.$ IAP1 P-"2&(( T+-%3&1 D).5-./ O6C&2%)'& E'),&$2& R&2"-, OER1 P-"2&(( E**&2%)'&$&(( A((&((/&$% R&0"-% PEAR1 QMS P-"2&(( M.%-)F R&0"-% PMR1 I$%&-$.3 A+,)% R&0"-% IAR1 A+,)% S+//.-4 R&0"-% ASR1

F"-/ QA 1020 C"--&2%)'& A2%)"$ R&0"-% CAR1

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-udit re3ords shall be mai tai ed per pro3edure "# A.2.A Co trol of $e3ords. -udit re3ords shall remai le!ible, readil< ide tifiable, a d retrie%able throu!hout the rete tio period.

IMPROVEMENT 1:.1 DOCUMENT IMPROVEMENT F"-/ QA 1001 D"2+/&$% C#.$5& R&E+&(% F"-/ The &o3ume t Cha !e $e;uest 4orm ma< be used to re3omme d 3ha !es to this do3ume t per pro3edure "# A.2.@ Co trol of &o3ume ts. PROCESS IMPROVEMENT 1:.2.1 CONTINUA7 IMPROVEMENT F"-/ QA 10@@ A2%)"$ P3.$ The -3tio #la ma< be used to impro%e the i ter al audit pro3ess per pro3edure "# 8.B.1 Co ti ual 2mpro%eme t #ro3edure.

1:.2

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WE-T(E$4+$& -E$+S#-CE, 2.C. INTERNA7 AUDIT PROCEDURE 1:.2.2 CORRECTIVE ACTION F"-/ QA 1020 C"--&2%)'& A2%)"$ R&0"-% CAR1

&+C0/E.T .+.5 QP 8.2.2 $E62S2+. ,E6E,5 E E44ECT262T1 &-TE5 8 N"'&/6&- 201@

.o 3o formit< i i ter al audit pra3ti3e re;uires 3orre3ti%e a3tio . The C-$ ma< be used to impro%e the i ter al audit pro3ess per pro3edure "# 8.B.2 Corre3ti%e -3tio .

1:.2.@ PREVENTIVE ACTION F"-/ QA 1011 P-&'&$%)'& A2%)"$ F"-/ The #re%e ti%e -3tio 4orm ma< be used to impro%e the i ter al audit pro3ess =ith the ide tifi3atio of pre%e ti%e a3tio (s' per pro3edure "# 8.B.@ #re%e ti%e -3tio #ro3edure.

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