inspection module

8/12/2019 Inspection Module

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Project co-financed by

European Union Project co- financed

by Asean

EUROPEAN COMMITTEE FORSTANDARDISATION - Implementing Agency

HOW TO CONDUCT ANHOW TO CONDUCT AN

INSPECTIONINSPECTION


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by Asean

EUROPEAN COMMITTEE FOR

STANDARDISATION - Implementing Agency

CONTENTS

1.1. ObjectivesObjectives

2.2. ScopeScope

3.3. Qualifications of an InspectorQualifications of an Inspector

4.4. QualitiesQualities

5.5. ommunication S!illsommunication S!ills

".". Inspection #rocessInspection #rocess

$.$. %ypes of Inspection%ypes of Inspection&.&. 'eport (riting'eport (riting


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OBJECTIVES

To promote harmoniation!To promote harmoniation!

To a""i"t #o$ernmentTo a""i"t #o$ernment

in"pe%tor" in a""e""in# &MPin"pe%tor" in a""e""in# &MP%omp'ian%e (or %o"meti%"!%omp'ian%e (or %o"meti%"!

To a""i"t the in)*"trie" inTo a""i"t the in)*"trie" in

preparation (or re#*'ator+preparation (or re#*'ator+a*)it!a*)it!


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SCOPE

App'ie" to a'' nationa'App'ie" to a'' nationa'

re#*'ator+ a*thoritie" ,NRAre#*'ator+ a*thoritie" ,NRA

o( %o*ntrie" .ho areo( %o*ntrie" .ho are

mem/er" o( the A""o%iationmem/er" o( the A""o%iation

o( So*th Ea"t A"ian Nation!o( So*th Ea"t A"ian Nation!

)'*+,I

-I,%+A

#/I0I##I+,S

A)OIA I+O+,SIA

%/AI0A+

A0ASIA

A+A'

0AO

#'

SI+A#O',
http://www.myanmar.com/http://www.cpv.org.vn/


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THE INSPECTOR


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0UA1IFICATIONS0UA1IFICATIONS

M*"t ha$e *n)er#oneM*"t ha$e *n)er#oneappropriate trainin# in theappropriate trainin# in the%*rrent pro%e)*re" an)%*rrent pro%e)*re" an)te%hni2*e" o( &MPte%hni2*e" o( &MPin"pe%tion"!in"pe%tion"!

M*"t ha$e %omp'eteM*"t ha$e %omp'ete.or3in# 3no.'e)#e o( the.or3in# 3no.'e)#e o( theASEAN &MP #*i)e'ine" (orASEAN &MP #*i)e'ine" (orCo"meti%"Co"meti%"an) (ami'iar .ithan) (ami'iar .iththe trainin# mo)*'e"the trainin# mo)*'e"

en)or"e) /+ the ACCen)or"e) /+ the ACC

M*"t ha$e per"ona' 2*a'itie"M*"t ha$e per"ona' 2*a'itie"o( inte#rit+4 ta%t an)o( inte#rit+4 ta%t an)%hara%ter!%hara%ter!


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An in"pe%tor m*"t5!An in"pe%tor m*"t5!

1.1. )e able to present factual)e able to present factualreport.report.

2.2.

)e able to communicate)e able to communicateellell.

3.3. /ave a goo or!ing/ave a goo or!ing!nolege of t6e national!nolege of t6e national

legislation an t6e #legislation an t6e #guielines t6atguielines t6atmanufacturers are e7pectemanufacturers are e7pecteto comply it6.to comply it6.


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An in"pe%tor m*"t5!An in"pe%tor m*"t5!4.4. )e able to offer assistance8 in 6is or)e able to offer assistance8 in 6is or

6er opinion8 to serve t6e public6er opinion8 to serve t6e public

interest.interest.

5.5. )e able to motivate a manufacturer)e able to motivate a manufacturer

to comply it6 # or correctto comply it6 # or correct

specific eficiencies.specific eficiencies.


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Per"ona' 0*a'itie"Per"ona' 0*a'itie"

Con(orm to %o)e" o( ethi%" an)Con(orm to %o)e" o( ethi%" an)%on)*%t%on)*%t

In)epen)ent6no %on('i%t o( intere"tIn)epen)ent6no %on('i%t o( intere"t

No )o*/'e ro'e a" in"pe%tor an)No )o*/'e ro'e a" in"pe%tor an)%on"*'tant%on"*'tant

Re"i"t attempt" to in('*en%eRe"i"t attempt" to in('*en%e

)e%i"ion")e%i"ion"

Di"%reteDi"%rete


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Comm*ni%ation S3i''"Comm*ni%ation S3i''"0anguage0anguage

*se suitable language to*se suitable language to

t6e levels of t6e personst6e levels of t6e personsbeing aresse.being aresse.

)e able to convey ; elicit)e able to convey ; elicit

information on allinformation on all

occasions.occasions.


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Comm*ni%ation S3i''"Comm*ni%ation S3i''")oy 0anguage)oy 0anguage

Same gesture can meanSame gesture can mean

ifferent t6ings to ifferentifferent t6ings to ifferentpeople from ifferentpeople from ifferentcountries.countries.

S6o interest byS6o interest byencouraging it6 a smileencouraging it6 a smilean a no of t6e 6ea.an a no of t6e 6ea.


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Comm*ni%ation S3i''"Comm*ni%ation S3i''"


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INSPECTION PROCESSINSPECTION PROCESS


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PRE- INSPECTIONPRE- INSPECTION

7!7! Or#anie the team .ith aOr#anie the team .ith a'ea)er .ho i" re"pon"i/'e'ea)er .ho i" re"pon"i/'e(or8(or8

P'annin# the in"pe%tionP'annin# the in"pe%tion

1ea)in# the openin# an)1ea)in# the openin# an)e9it meetin#" .ith thee9it meetin#" .ith the%ompan+%ompan+

Preparin# the )e(i%ien%+Preparin# the )e(i%ien%+an) (ina' )ra(t reportan) (ina' )ra(t report


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PRE- INSPECTIONPRE- INSPECTION:!:! 1ea) in"pe%tor noti(ie" the1ea) in"pe%tor noti(ie" the

%ompan+ at 'ea"t a .ee3%ompan+ at 'ea"t a .ee3

/e(ore!/e(ore!An unscheduled audit mayAn unscheduled audit may

be considered when thebe considered when the

true extent of GMPtrue extent of GMP

compliance cannot becompliance cannot be

assessed otherwiseassessed otherwise..


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PRE- INSPECTIONPRE- INSPECTION

3.3. Inspection team reviesInspection team reviest6e folloing=t6e folloing=

anufacturinganufacturinglicenselicense

Site information fileSite information file#revious inspection#revious inspectionreportsreports

#rouct ossiers#rouct ossiers

4.4. #repares an auit plan#repares an auit planAie>memoirAie>memoir

6ec!list6ec!list


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INSPECTION PROPER

1.1. eeting it6 t6e company?seeting it6 t6e company?srepresentatives.representatives.

%6e leaer introuces t6e members of%6e leaer introuces t6e members of

t6e team an ac@uaints 6imself an t6et6e team an ac@uaints 6imself an t6e

team it6 t6e company?s !eyteam it6 t6e company?s !ey

personnel.personnel.

)rief iscussion on t6e purpose of t6e)rief iscussion on t6e purpose of t6e

visit an gat6er upates from t6evisit an gat6er upates from t6e

company pertaining to plant operationscompany pertaining to plant operations

#resents t6e auit plan.#resents t6e auit plan.


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INSPECTION PROPER

2.2. #erusal of t6e folloing ocuments=#erusal of t6e folloing ocuments=

0ayout of site an iagrams of utilities0ayout of site an iagrams of utilities

Self inspectioninternal auit reportsSelf inspectioninternal auit reports

omplaints fileomplaints file

Stanar Operating #roceuresStanar Operating #roceures


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INSPECTION PROPER3.3. (al! t6roug6 visual(al! t6roug6 visual

inspectioninspection

SiBe of t6e facilitySiBe of t6e facility

+umber of employees+umber of employees

,mployee practices,mployee practices

,nvironmental,nvironmentalconitions in an outconitions in an out

of t6e plantof t6e plant


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INSPECTION PROPER

anual an automateanual an automate

practicespractices

anufacturing floanufacturing flo

et6o of ata collectionet6o of ata collection

aintenance of builingaintenance of builing

eneral 6ouse!eepingeneral 6ouse!eeping

Sources ofSources of

contaminationcontamination


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INSPECTION PROPER

4.4. %eam meets to%eam meets to

iscuss ;iscuss ;prepareprepare

eficiencyeficiency

report.report.


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5.5. ,7it meeting it6 t6e,7it meeting it6 t6ecompanycompany

0eaer gives overvie0eaer gives overvieof t6e auit an itsof t6e auit an itsoutcome.outcome.

0eaer may provie t6e0eaer may provie t6ecompany it6 t6ecompany it6 t6eeficiency report aneficiency report anencourages iscussion.encourages iscussion.

0eaer re@uests ritten0eaer re@uests rittenresponse to t6e finalresponse to t6e finaleficiency report it6ineficiency report it6in4 ee!s from t6e ate4 ee!s from t6e ateof receipt.of receipt.

INSPECTION PROPERINSPECTION PROPERProject co-financed by

European Union


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0*e"tion" to a"30*e"tion" to a"3

Open @uestions starting it6=Open @uestions starting it6=

(6at(6at (6y(6y

(6en(6en /o/o (6ere(6ere (6o(6o

Si'en%e %an /e $er+ po.er(*'Si'en%e %an /e $er+ po.er(*'


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It pa+" to 'i"ten!!It pa+" to 'i"ten!!

Stop tal!ingCStop tal!ingC

/elp t6e spea!er to feel free to tal!/elp t6e spea!er to feel free to tal!

)e approac6able)e approac6able

S6o t6e spea!er t6at you areS6o t6e spea!er t6at you are

interesteintereste

'emove istractions'emove istractions

%ry to unerstan t6e spea!er?s%ry to unerstan t6e spea!er?s

point of viepoint of vie


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It pa+" to 'i"ten!!It pa+" to 'i"ten!!

)e patient)e patient

/ol your temper/ol your temper

%ry not to criticiBe%ry not to criticiBe

As! @uestionsAs! @uestions

Stop8 loo! anStop8 loo! an

listenlisten


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T;PES OF INSPECTIONT;PES OF INSPECTIONRo*tine6 Re#*'ar


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Ro*tine In"pe%tionRo*tine In"pe%tion

Done .hen the man*(a%t*rer8Done .hen the man*(a%t*rer8Is nely establis6eIs nely establis6e

'e@uests reneal of license to operate'e@uests reneal of license to operate

+e prouct line or ne prouct+e prouct line or ne prouct

/as mae !ey c6anges in e@uipment8/as mae !ey c6anges in e@uipment8

personnel8 premisespersonnel8 premises

/as a 6istory of non>compliance/as a 6istory of non>compliance

/as not been inspecte for t6e past years/as not been inspecte for t6e past years


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Fo''o.-*p In"pe%tionFo''o.-*p In"pe%tion

ae to monitor t6e results ofae to monitor t6e results of

corrective actions.corrective actions.

one it6in " ee!s to "one it6in " ee!s to "

mont6s after initial inspection.mont6s after initial inspection.

0imite to specific #0imite to specific #

re@uirements t6at 6ave notre@uirements t6at 6ave not

been observe or inae@uatelybeen observe or inae@uately

implementeimplemente!!


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Spe%ia' In"pe%tionSpe%ia' In"pe%tion

ae to carry out spotae to carry out spotc6ec!s folloingc6ec!s folloingcomplaints incluingcomplaints incluing

allergic reactions or recallsallergic reactions or recallsrelate to @uality efects inrelate to @uality efects inproucts.proucts.

,stablis6 6o a prouct is,stablis6 6o a prouct is

manufacture as a pre>manufacture as a pre>re@uisite for mar!etingre@uisite for mar!etingapproval.approval.


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Spe%ia' In"pe%tionSpe%ia' In"pe%tion

Investigate specificInvestigate specific

operation.operation.

Avise manufacturer onAvise manufacturer on

regulatory [email protected] re@uirements.


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0*a'it+ S+"tem" Re$ie.0*a'it+ S+"tem" Re$ie.

To a""e"" aTo a""e"" a

2*a'it+ a""*ran%e2*a'it+ a""*ran%e"+"tem that ha""+"tem that ha"

/een "ho.n to/een "ho.n to

operateoperate

"ati"(a%tori'+!"ati"(a%tori'+!


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ANNOUNCED = UNANNOUNCEDANNOUNCED = UNANNOUNCED

INSPECTIONSINSPECTIONSepens on type of inspectionepens on type of inspection

Announce=Announce=

compre6ensive inspectioncompre6ensive inspection*nannounce=*nannounce=

routine inspectionroutine inspection DD

follo>up inspectionfollo>up inspection DD

special inspectionspecial inspection DD@uality systems revie@uality systems revie

< Termino'o#+ a/o$e are inter%han#ea/'e .ithin the NRA in"pe%torate

"+"tem to a'i#n .ith the pre"ent 2*a'it+ "+"tem in p'a%e


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FRE0UENC; OF INSPECTIONFRE0UENC; OF INSPECTION

Ba"e) on the )e#ree o( ri"3" to %on"*mer"

"*%h a"8

%ype of proucts manufacture%ype of proucts manufacture'esult of previous # inspectioncompany?s'esult of previous # inspectioncompany?s

compliance 6istorycompliance 6istory

#rouct complaint or recalls since last inspection#rouct complaint or recalls since last inspection

'esults of prouct testing by +'A laboratories or'esults of prouct testing by +'A laboratories orot6er agencies.ot6er agencies.


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FRE0UENC; OF INSPECTIONFRE0UENC; OF INSPECTION

+'A surveillance+'A surveillance

Significant c6anges it6in t6eSignificant c6anges it6in t6e

company8 ie8 !ey personnel8company8 ie8 !ey personnel8

builings8 !ey e@uipment anbuilings8 !ey e@uipment an

prouctsproucts


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DURATION OF INSPECTIONDURATION OF INSPECTION

An inspection may ta!e a ay or up toAn inspection may ta!e a ay or up toseveral ays an involves a etaileseveral ays an involves a etaile

e7amination of t6e operations ane7amination of t6e operations anproceures of t6e factory.proceures of t6e factory.

%6e initial inspection of a ne manufacturer%6e initial inspection of a ne manufacturermust be t6oroug6 an compre6ensiveE amust be t6oroug6 an compre6ensiveE a

minimum of to full ays is t6ereforeminimum of to full ays is t6ereforeusually allocate to a full manufacturerusually allocate to a full manufacturerinspection.inspection.


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DURATION OF INSPECTIONDURATION OF INSPECTION epens on type of inspectionepens on type of inspection

Inspectorate resources Fe.g.Inspectorate resources Fe.g.

or!loa8 number of inspectorsGor!loa8 number of inspectorsG SiBe of t6e companySiBe of t6e company

#urpose of t6e visit#urpose of t6e visit

+umber of inspectors+umber of inspectors


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EUROPEAN COMMITTEE FORSTANDARDISATION - Implementing Agency

REPORT WRITIN&REPORT WRITIN&


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CONTENTSCONTENTS

I.I. ,+,'A0 I+HO'A%IO+ OH,+,'A0 I+HO'A%IO+ OH

%/, O#A+HAI0I%%/, O#A+HAI0I%

II.II. )'I,H ,S'I#%IO+ O+)'I,H ,S'I#%IO+ O+AO' AS#,%S OH #AO' AS#,%S OH #

III.III. HI+I+SHI+I+S

I-.I-. O+0*SIO+O+0*SIO+


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I!I! &ENERA1 INFORMATION OF&ENERA1 INFORMATION OFTHE COMPAN;6FACI1IT;THE COMPAN;6FACI1IT;

+ame of ompany+ame of ompany

AressAress0icense to operate incluing valiity0icense to operate incluing valiity

#roucts manufacture#roucts manufacture

#ersons Intervieemet uring#ersons Intervieemet uring

inspectioninspection#urpose of Inspection#urpose of Inspection

ate of 0ast Inspectionate of 0ast Inspection


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II!II! BRIEF DESCRIPTION ONBRIEF DESCRIPTION ONMAJOR ASPECTS OF &MPMAJOR ASPECTS OF &MP

1.1. )uiling#remises)uiling#remises

SitelocationSitelocation

onstruction materialsfinis6es useonstruction materialsfinis6es use

#rocess (ater#rocess (ater

*tilities*tilities


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2.2. #ersonnel#ersonnel

QualificationsQualifications

Ae@uacy in numberAe@uacy in number

%raining%raining


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3.3. ,@uipment,@uipment

ajor e@uipment incluingajor e@uipment incluing

capacitycapacity

aterials use for constructionaterials use for construction

leaning proceures FI#Gleaning proceures FI#G


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II!II! BRIEF DESCRIPTION ONBRIEF DESCRIPTION ON

MAJOR ASPECTS OF &MPMAJOR ASPECTS OF &MP

4.4. Quality ontrolQuality ontrol

Ae@uacy of apparatus use for testingAe@uacy of apparatus use for testingaintaining ra8 pac!aging ; finis6eaintaining ra8 pac!aging ; finis6e

prouct specificationsprouct specifications

esign of t6e laboratory facility to suitesign of t6e laboratory facility to suit

relevant operationsrelevant operations


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II!II! BRIEF DESCRIPTION ON MAJORBRIEF DESCRIPTION ON MAJOR

ASPECTS OF &MPASPECTS OF &MP

5.5. ocumentationocumentation

Stanar Operating #roceuresStanar Operating #roceures

)atc6 #rouction 'ecors)atc6 #rouction 'ecors

aster batc6 prouction recorsaster batc6 prouction recors

#ac!aging 'ecors#ac!aging 'ecors

'ecors of omplaints ; 'ecalls'ecors of omplaints ; 'ecalls

Self>inspection 'eportsSelf>inspection 'eports


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Ot6er ocumentsOt6er ocuments

alibration recorsalibration recors

#est ontrol#est ontrol

%raining sc6eule%raining sc6eule

#reventive maintenance plan ; recors#reventive maintenance plan ; recors


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III!III! FINDIN&SFINDIN&S

#ositive finings J morale boosters#ositive finings J morale boosters

+egative finings J eficiencies+egative finings J eficienciesnotenote


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C1ASSIFICATION OFC1ASSIFICATION OF

FINDIN&SFINDIN&SCriti%a'8

%6ere is a ris! t6at prouct may not meet%6ere is a ris! t6at prouct may not meet

performance re@uirements or specifications.performance re@uirements or specifications.ritical observations may result from inae@uateritical observations may result from inae@uate@uality systems8 or consist of numerous major@uality systems8 or consist of numerous majorobservations in t6e same auit area or repeateobservations in t6e same auit area or repeate

major observations.major observations.


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FINDIN&SFINDIN&S

Ma>or8Ma>or8

inimum ris! t6at finis6e prouctsinimum ris! t6at finis6e prouctsmay not meet performancemay not meet performance

re@uirements or specifications.re@uirements or specifications.

# eviations are not a result on# eviations are not a result on

t6e lac! of @uality systems.t6e lac! of @uality systems.


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FINDIN&SFINDIN&S

Minor8Minor8

+o ris! t6at prouct ill not meet+o ris! t6at prouct ill not meet

performance re@uirements orperformance re@uirements or

specifications.specifications.


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FINDIN&SFINDIN&S

Observations are Opportunity forObservations are Opportunity forImprovement FOHIGImprovement FOHIG


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IV!IV! CONC1USIONCONC1USION

a!e compliance ratinga!e compliance rating oooo SatisfactorySatisfactory #oor#oor

an isclaimeran isclaimere.g Hinings cite uring t6e inspection aree.g Hinings cite uring t6e inspection arebase on ranom sampling an it is notbase on ranom sampling an it is notan e76austive list for corrective action.an e76austive list for corrective action.%6ere may be ot6er non compliance in t6e%6ere may be ot6er non compliance in t6earea inspecte not inspecte. It is t6earea inspecte not inspecte. It is t6e

manufacturer?s responsibility to !eepmanufacturer?s responsibility to !eepabreast it6 t6e c6anges in # an toabreast it6 t6e c6anges in # an tobe in compliance at all time.be in compliance at all time.


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inspection module

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