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8/20/2019 ASQ Meeting Slides Whittington

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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1

Requirements and Guidance

for

Internal AuditsLearning from

Industry Sources

Whittington & Associates, LLC636 Gun! "oad, #a$ietta, GA 3006%

'WhittingtonAssociates'co(

)00*+0+*%5)5 o$ %%0*55*%5)5


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Audit References

REQUIREMENTS(No additional audit requirements in TL 9000:2001 or ISO 13485:2003)

-S. 001/2000 Qualit! #anage(ent S!ste(s Q#S * "eui$e(ents

AS100/200+ Qualit! S!ste(s * Ae$os4ace * "eui$e(ents

-S.S 16+/ 2002 Q#S * Auto(oti7e Su44lie$s * "eui$e(ents 8o$ the A44lication o8 -S. 001/2000

-S. 1+001/ 200+ 9n7i$on(ental #anage(ent S!ste(s 9#S * "eui$e(ents ith Guidance 8o$ :se

GUIDANCE (No additional audit uidan!e in "S910#:2003)

-S. 00+/2000 Qualit! #anage(ent S!ste(s * Guidelines 8o$ ;e$8o$(ance -(4$o7e(ent

-S.S 16+/2002 -(4le(entation Guide

-S. 1+00+/ 200+ 9#S * Gene$al Guidelines on ;$inci4les, S!ste(s, and Su44o$ting echniues

-S. 0003/200+ Guidelines 8o$ the A44lication o8 -S. 001/2000 to Co(4ute$ So8ta$e

-S. 1011/ 2002 Guidelines 8o$ Qualit! ando$ 9n7i$on(ental #anage(ent S!ste(s Auditing

Q91011S/ 200+ Guidelines 8o$ Q#S ando$ 9#S Auditing/ :S e$ ?andout Audit Wo$>sheet u$tle Diag$a( 8$o( Whittington & Associates

S4ea>e$ ?andout Audit Quic> "e8e$ence 8$o( Whittington & Associates, LLC


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Audit Definition

S$stemati!% inde&endent% and do!umented &ro!ess 'or otainin audit eiden!e and

ealuatin it o*e!tiel$ to determine t+e

e,tent to -+i!+ areed !riteria are 'ul'illed.

-S. 000/2000 * Clause 3''1

@unda(entals and


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QAD 2006 © 2005 Whittington & Associates, LLC Slide +

Requirements - ISO !!"#$!!!

Clause )'2'2 Docu(ented 4$ocedu$e 8o$ inte$nal audits


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Audit Guidance - ISO !!%#$!!!

Clause )'2'1'3/9stalish e88ecti7e and e88icient inte$nal audits

Assess st$engths and ea>nesses o8 the Q#S

:se as (anage(ent tool 8o$ inde4endent 7ie.tain oBecti7e e7idence that $eui$e(ents (et

udge e88ecti7eness and e88icienc! o8

o$ganiation


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Audit Guidance - ISO !!%#$!!!

Clause )'2'1'3/9nsu$e i(4$o7e(ent actions a$e ta>en on $esults

9stalish 8leEile audit 4lans 8o$ inte$nal audits

;e$(it changes in e(4hasis ased on e7idenceDe7elo4 4lans ith in4ut 8$o( a$eas to e audited

Conside$ 4lanning in4ut 8$o( inte$ested 4a$ties


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QAD 2006 © 2005 Whittington & Associates, LLC Slide %

Audit Su&'ects - ISO !!%#$!!!

Clause )'2'1'3/988ecti7e and e88icient 4$ocess i(4le(entation.44o$tunities 8o$ continual i(4$o7e(ent

Ca4ailit! o8 4$ocesses988ecti7e and e88icient use o8 statistical techniues:se o8 in8o$(ation technolog!

Anal!sis o8 ualit! cost data988ecti7e and e88icient use o8 $esou$ces;$ocess and 4$oduct 4e$8o$(ance $esults


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QAD 2006 © 2005 Whittington & Associates, LLC Slide )

Audit Su&'ects - ISO !!%#$!!!

Clause )'2'1'3/;e$8o$(ance (easu$e(ents/

F Adeuac! F Accu$ac!

-(4$o7e(ent acti7ities"elationshi4s ith inte$ested 4a$ties

-nte$nal Audit "e4o$ting/Sha$e e7idence o8 eEcellent 4e$8o$(ance;$o7ide o44o$tunities 8o$ $ecognition#oti7ate 4eo4le


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QAD 2006 © 2005 Whittington & Associates, LLC Slide

Requirements - AS"!!(#$!!%

De7elo4 detailed audit tools and techniues, e'g',Chec>sheets, ;$ocess 8locha$ts, o$

Si(ila$ (ethodsto su44o$t audits o8 the Q#S $eui$e(ents'

#easu$e acce4tailit! o8 audit tools against/

988ecti7eness o8 inte$nal audit 4$ocess ;e$8o$(ance o8 o7e$all o$ganiation

Assess cont$act ando$ $egulato$! $eui$e(ents'


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Requirements - ISO)TS "*%

+,$,$," Qualit Mana.ement Sstem Audit Audit the Q#S to 7e$i8! co(4liance ith -S.S 16+ and

an! additional ualit! (anage(ent s!ste( $eui$e(ents'

+,$,$,$ Manufacturin. /rocess Audit Audit the e88ecti7eness o8 each (anu8actu$ing 4$ocess'

+,$,$,0 /roduct Audit Audit 4$oducts at a44$o4$iate stages o8 4$oduction and

deli7e$! to 7e$i8! con8o$(ance to all s4eci8ied $eui$e(ents,

such as 4$oduct dimensions, 'un!tionalit$ , &a!/ain , and

laelin at a de8ined 8$euenc!'


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Requirements - ISO)TS "*%

+,$,$,% Internal Audit /lans Co7e$ all ualit! (anage(ent $elated 4$ocesses,

acti7ities, and shi8ts Schedule acco$ding to an annual 4lan' -nc$ease audit 8$euenc! hen inte$nal o$ eEte$nal

noncon8o$(ities o$ custo(e$ co(4laints occu$

ote/ S4eci8ic chec>lists should e used 8o$ each audit

+,$,$,1 Internal Auditor Qualification :se inte$nal audito$s ho a$e uali8ied to audit the

$eui$e(ents o8 -S.S 16+


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Guidance - ISO)TS "*%#$!!$

-S.S 16+ -(4le(entation Guide

Qualit! #anage(ent S$stem AuditH :se the 4$ocess a44$oach to (onito$ natu$al o$> 8lo

#anu8actu$ing ro!ess AuditH @ocus on a 4$ocess ithin ualit! (anage(ent s!ste(

rodu!t AuditH @ocus on the 4$oduct cha$acte$istics

H


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Turtle Dia.ram - ISO)TS "*%

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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1+

Requirements - ISO "%!!"#$!!%

Clause +'5'5 is si(ila$ to -S. 001/2000, eEce4t/

ISO !!"#$!!!.$ganiation (ust conduct inte$nal audits'

ISO "%!!"#$!!%.$ganiation (ust ensu$e the! a$e conducted'

ISO !!"#$!!!Dete$(ine i8 S has een e88ecti7el! i(4le(ented'

ISO "%!!"#$!!%Dete$(ine i8 S has een 4$o4e$l! i(4le(ented'


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Requirements - ISO "%!!"#$!!%

#issing di$ect co7e$age o8 these -S. 001/2000 $eui$e(ents/

ISO !!"#$!!! * #anage(ent $es4onsile 8o$ a$ea eing

audited (ust ensure a!tions are ta/en ithout undue dela!

to eli(inate detected noncon8o$(ities and thei$ causes'

ISO "%!!"#$!!% * ot included'

ISO !!"#$!!! * @ollo*u4 acti7ities (ust include eri'i!ation

o' a!tions ta/en and the re&ortin o' eri'i!ation results'

ISO "%!!"#$!!% * ot included'

Add$essed indi$ectl! ! -S. 1+001/200+, clause +'5'3, on

oncon8o$(it!, Co$$ecti7e Action, and ;$e7enti7e Action'


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Audit Guidance - ISO "%!!"#$!!%

Guidance on :se 8$o( AnneE A'5'5 ;e$8o$( inte$nal audits ! 4e$sonnel 8$o( ithin

the o$ganiation o$ ! eEte$nal 4e$sons selected

! the o$ganiation, o$>ing on its ehal8 9nsu$e 4e$sons conducting audit a$e co(4etent

and in 4osition to do so i(4a$tiall! and oBecti7el!

De(onst$ate audito$ inde4endence in s(alle$o$ganiations ! the audito$ eing 8$ee 8$o(

$es4onsiilit! 8o$ the acti7it! eing audited


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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1%

Audit Guidance - ISO "%!!%#$!!%

;e$8o$( inte$nal audits to identi8! o44o$tunities 8o$i(4$o7e(ent in en7i$on(ental s!ste(

9stalish an audit 4$og$a( to di$ect the 4lanning

and conduct o8 audits and identi8! the auditsneeded to (eet the 4$og$a(s oBecti7es

ase 4$og$a( on the natu$e o8 o4e$ations, in te$(s

o8 its en7i$on(ental as4ects and 4otential i(4acts,

the $esults o8 4ast audits, and othe$ $ele7ant 8acto$s


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QAD 2006 © 2005 Whittington & Associates, LLC Slide 1)


9ach inte$nal audit need not co7e$ enti$e s!ste(,so long as audit 4$og$a( ensu$es all o$ganiational

units and 8unctions, s!ste( ele(ents, and 8ull

sco4e o8 the 9#S a$e audited 4e$iodicall!

;lan and conduct audits ! oBecti7e and i(4a$tial

audito$s, aided ! technical eE4e$ts, as

a44$o4$iate, selected 8$o( ithin o$ganiation o$

8$o( eEte$nal sou$ces


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Collecti7e co(4etence o8 audito$s should esu88icient to (eet oBecti7es and sco4e o8 the

4a$ticula$ audit and 4$o7ide con8idence as to the

deg$ee o8 $eliailit! that can e 4laced on $esults

"esults o8 an inte$nal 9#S audit can e 4$o7ided

in the 8o$( o8 a $e4o$t and used to/

F Co$$ect o$ 4$e7ent s4eci8ic noncon8o$(ities

F @ul8ill one o$ (o$e oBecti7es o8 the audit 4$og$a(

F ;$o7ide in4ut to the (anage(ent $e7ie


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Audit Guidance - ISO !!!0#$!!%

When so8ta$e o$ganiations se4a$ate thei$ o$>into 4$oBects, inte$nal audit 4lanning should/

De8ine a selection o8 4$oBects

Co7e$ all stages and all 4$ocesses Assess co(4liance o8 4$oBect ualit! 4lan to

Q#S

Assess 4$oBect co(4liance to 4$oBect ualit! 4lan


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Audit Guidance - ISO !!!0#$!!%

Audit 7a$ious 4$oBects at di88e$ent stages o84$oduct de7elo4(ent li8e c!cle, o$

Audit a single 4$oBect as it 4$og$esses

th$ough 7a$ious stages'

-8 intended 4$oBect changes its ti(escale,

$e7ie inte$nal audit schedule to/

1' Change ti(ing o8 the audit, o$

2' Conside$ a di88e$ent 4$oBect'


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Audit Guidance - ISO "!""#$!!$

Guidelines 8o$ S and S AuditingH :nde$standing 4$inci4les o8 auditing

H -denti8!ing needed audito$ co(4etence

H Selecting audit tea(s

H Conducting inte$nal and eEte$nal audits

H#anaging audit 4$og$a(s

H 97aluating audito$ 4e$8o$(ance


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Audit Acti3ities - ISO "!""#$!!$

1' Initiation De8ine audit oBecti7es'2' Re3ie4 9Ea(ine the docu(ents'

3' /re5aration;lan 8o$ onsite acti7ities'

+' E6ecution Audit the ualit! s!ste('

5' Re5ortin. "e4o$t the audit $esults'

6' Com5letion Co(4lete the audit 4lan'

. Follow-Up ondu!t 'ollo-6u& audit.

See ?andout/ IAudit Quic> "e8e$enceJ


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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2+

Audit Guidance - QE"!""S#$!!%

-S. 1011 4$o7ides guidance and eEa(4les:S decided additional guidance as needed

;ulished AS--S.ASQ Q91011S/200+

Q91011S includes -S. 1011 guidance

Q91011S adds guidance and eEa(4les 8o$/

F @i$st*4a$t! inte$nal audits F Second*4a$t! eEte$nal audits F S(all o$ganiations


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Audit Guidance - QE"!""S#$!!%

*,1,7 Conductin. a Closin. Meetin.


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ISO !!"#$!!! Inter5retations

Go to/ htt4/'tc1%6'o$ginte$4$e'as4Request# "@-*036 8o$ Clause )'2'2

Clause )'2'2/ IAn audit 4$og$a( shall e 4lanned, ta>ing into conside$ation the

status and i(4o$tance o8 the 4$ocesses and a$eas to e audited, '''J'

-s it a $eui$e(ent o8 this clause that the c$ite$ia to dete$(ine the status and thei(4o$tance o8 the 4$ocesses and a$eas to e audited ha7e to e docu(entedK

(ac:.round#he$e is di7e$gence ith the audito$ $ega$ding a $eui$e(ent 8o$ docu(entation

o8 Istatus and i(4o$tance c$ite$iaJ des4ite the 8act that e7idence as 4$o7idedthat the 4lanning o8 the audit 4$og$a( has ta>en the status and i(4o$tance o8

the 4$ocesses and a$eas to e audited into conside$ation'

Inter5retation# o'


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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2%

ISO !!"#$!!! Auditin. ;it

http://www.iso.org/tc17/IS!"##1$uditing%ractices&roup he need 8o$ a 2*stage a44$oach to auditing

#easu$ing Q#S e88ecti7eness and i(4$o7e(ents

-denti8ication o8 4$ocesses

:nde$standing the 4$ocess a44$oach Dete$(ination o8 the Ihe$e a44$o4$iateJ 4$ocesses

Auditing the Ihe$e a44$o4$iateJ $eui$e(ents

De(onst$ating con8o$(it! to the standa$d

Lin>ing audit o8 a tas>, acti7it! o$ 4$ocess to o7e$all s!ste(

Auditing continual i(4$o7e(ent

Auditing a Q#S hich has (ini(u( docu(entation


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QAD 2006 © 2005 Whittington & Associates, LLC Slide 2)


?o to audit to4 (anage(ent 4$ocesses he $ole and 7alue o8 the audit chec>list

Sco4e o8 -S. 001, Q#S, and ce$ti8ication

?o to add 7alue du$ing the audit 4$ocess

Auditing co(4etence and e88ecti7eness o8 actions ta>en

Auditing statuto$! and $egulato$! $eui$e(ents

Auditing the ualit! 4olic! and ualit! oBecti7es

Auditing %'6 ontrol o' monitorin and measurin dei!es #a>ing e88ecti7e use o8 -S. 1011

Auditing custo(e$ 8eedac> 4$ocesses


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Docu(enting a noncon8o$(it! Guidance 8o$ $e7ieing and closing noncon8o$(ities

Auditing inte$nal co((unications

Auditing 4$e7enti7e action

Auditing se$7ice o$ganiations

hi$d 4a$t! audito$ i(4a$tialit! and con8lict o8 inte$est

Auditing the e88ecti7eness o8 the inte$nal audit

Auditing elect$onic*ased (anage(ent s!ste(s Auditing the (anage(ent o8 $esou$ces

Auditing custo(e$ co((unications


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Remainin. Questions<

Audit Requirements< Audit Guidance<-S. 001/2000 -S. 00+/2000

AS100/200+ -S.S 16+ Guide

-S.S 16+/2002 -S. 1+00+/200+-S. 1+001/200+ -S. 0003/200+

=andouts< -S. 1011/2002

Audit Wo$>sheet Q91011S/200+

Audit Quic> "e8e$ence 'iso'o$g

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