api audit checklist 9thedition.docx

8/21/2019 api audit checklist 9thedition.docx

1/36

Audit ReportDoc ID: FM-198

Revision: 2.1

Efective Date: TBD

Table of Contents

Audit Information.......................................................................................................................................2

Verification of Scope of Registration / Monogram License(s and !"clusions....................................#

Audit Report............................................................................................................................................... #

Management S$stem Re%uirements.................................................................................................... #

4.1.1 Quality Management System......................................................................................................34.4.1 Quality Manual............................................................................................................................3

4.1.2 Quality Policy.............................................................................................................................. 3

4.1.3 Quality Objectives.......................................................................................................................4

4.1.5 Communication........................................................................................................................... 4

4.2 Management Responsibility........................................................................................................... 4

4.3 Ogani!ational Capability...............................................................................................................5

4.3.1 Povision o" Resouces...............................................................................................................5

4.3.2.2 Pesonnel Competence........................................................................................................... 5

4.3.2.3 #aining an$ %&aeness...........................................................................................................'

4.3.3 (o) *nvionment...................................................................................................................... '

4.4 +ocumentation Re,uiements...................................................................................................... .-

4.4.3 Contol o" +ocuments................................................................................................................. -

4.5 Contol o" Reco$s......................................................................................................................... -

&MS Monitoring' Measurement' Anal$sis Impro)ement.................................................................*'.2.1 Custome Satis"action.................................................................................................................

'.2.2 /ntenal %u$its.............................................................................................................................

'.2.3 Pocess *valuation.....................................................................................................................0

'.3 %nalysis o" +ata............................................................................................................................. 0

'.4.2 Coective %ction.........................................................................................................................0

'.4.3 Peventive %ction...................................................................................................................... 1

'.5 Management Revie&................................................................................................................... 1

Ris+ Assessment Management....................................................................................................... ,,Contingenc$ -lanning.........................................................................................................................,2Management of Cange...................................................................................................................... ,2

-roduct Realiation................................................................................................................................. ,0

Audit Conditions......................................................................................................................................,0

-roduct Realiation 1 Contract Re)ie............................................................................................. ,3-roduct Realiation 4 5esign 5e)elopment................................................................................... ,6-roduct Realiation 4 -urcasing.......................................................................................................,7-roduct Realiation 1 -roduction and Ser)icing.............................................................................. 228se of A-I Monogram' A-I&R and A9A: Mar+s...............................................................................26

Audit Time Summar$............................................................................................................................... 2*

Audit Summar$........................................................................................................................................ 2*

Conclusion / Recommendation.............................................................................................................. 27

Supplemental Audit Information................................................................................................... ......... #;


2/36


Revision: 2.1

Efective Date: TBD

Top of the Docume

Audit Information

Audit I5>

Lead Auditor>

Audit Team Members>

Audit Start 5ate> Audit !nd 5ate>

Sifts> Start Time !nd Time 9o. of!mplo$ees Audited? (@/9

Sift ,

Sift 2

Sift #

!"planation(required for

shifts not audited):

Additional Comments>

Audit Criteria>

/SO 01 %P/ Spec Q1 %P/ Spec Q2

/SO#S 201 /SO 141 OS%S 11

%P/ Specs (list all applicable specifications6

Ot7e citeia6

&MS and Applicable

Standards/Specifications(verify current versions)>

Audit Scope/=becti)e:

Re%uired Audit 5a$s>Actual Audit

5a$s>

Justification required if different from required aud

days

Bustification

(Notify !I of changes)6

Additional Comments>

9umber of Maor

("ystemic)>

Minor

(Isolated)>Concerns>

Comments>

Page 2 o" 3'


3/36


Revision: 2.1

Efective Date: TBD

Top of the Docume

Verification of Scope of Registration / Monogram License(s and !"clusions

Verif$ eac of te folloing> Select =ne>

Additional comments>

Audit Report

Management S$stem Re%uirements

In the space provided belo%, detail the ob'ective evidence (documentation revie%ed, records revie%ed and personnel intervie%ed) to

ensure conformance %ith #" requirements Detail any discrepancies * nonconformance identified

Re%uirement> =becti)e !)idence/Comments>

0.,., &ualit$ Management S$stem

>ei"y t7at t7e ogani!ation 7as establis7e$=$ocumente$= implemente$ an$ maintaine$ aQMS "o all sevicing an$ po$ucts povi$e$ "ouse in t7e petoleum an$ natual gas in$usty.

0.0., &ualit$ Manual

>ei"y t7at t7e QM a$$esses t7e "ollo&ing

e,uiements6

•Scope o" t7e QMS= inclu$ing eei"y t7at t7e Quality Policy 7as been $e"ine$=

$ocumente$ an$ appove$ as e,uie$ an$ meets

all e,uiements i$enti"ie$ in t7e applicable

stan$a$.

Page 3 o" 3'


4/36


Revision: 2.1

Efective Date: TBD

0.,.# &ualit$ =becti)es

>ei"y t7at Quality Objectives ae appove$=

$ocumente$= an$ establis7e$ at elevant

"unctions an$ levels an$ ae measuable an$

consistent &it7 t7e Quality Policy.

>ei"y @P/s ae i$enti"ie$ "o use in +ata %nalysis.

0.,.0 -lanning

>ei"y t7at management 7as ensue$ t7at6

• citeia an$ met7o$s nee$e$ "o t7e opeation an$

contol o" t7e QMS ae $etemine$= manage$

an$ ae e""ective

• planning o" t7e QMS is caie$ out to meet spec

e,uiements


0.,.3 Communication

0.,.3., Internal Communication

>ei"y t7at t7e ogani!ation 7as establis7e$

appopiate communication pocesses an$ t7e

e""ectiveness o" t7e MS is communicate$.

>ei"y t7at pocesses 7ave been establis7e$ to

ensue t7at t7e impotance o" meeting

e,uiements an$ analysis o" $ata is

communicate$ at elevant "unctions.

0.,.3.2 !"ternal Communication

>ei"y t7at t7e ogani!ation 7as establis7e$

appopiate communication &it7 eei"y t7at communications pocesses meet

applicable e,uiements o" t7e stan$a$.


0.2 Management Responsibilit$

0.2., Resources

+escibe 7o& top management ensues

availability o" esouces essential to t7e QMS.

0.2.2 Responsibilit$ and Autorit$

+escibe 7o& esponsibilities= aut7oities= an$

accountabilities ae $e"ine$= $ocumente$ an$

Page 4 o" 3'


5/36


Revision: 2.1

Efective Date: TBD

communicate$ t7oug7out t7e ogani!ation.

0.2.# Management Representati)e

/$enti"y t7e name o" t7e appointe$ Management

Repesentative.

>ei"y Competence= #aining ? %&aeness "o

appointment.

>ei"y applicable esponsibility an$ aut7oity 7as

been gante$.

+escibe 7o& t7e Management Repesentative

epots to management on t7e pe"omance o" t7e

MS.


0.# =rganiational Capabilit$0.#., -ro)ision of Resources

+escibe 7o& t7e ogani!ation $etemines an$

allocates esouces nee$e$ to implement=

maintain an$ impove t7e e""ectiveness o" t7e

e,uiements o" t7e MS.


0.#.2.2 -ersonnel Competence -rocedure>

>ei"y t7at t7e poce$ue meets all e,uiements

o" t7e applicable stan$a$ an$ is contolle$=

implemente$= an$ maintaine$.

o& $oes t7e ogani!ation $etemine t7e

necessay competence "o pesonnel pe"oming

&o) a""ecting po$uct ,ualityA

(7at actions $oes t7e ogani!ation ta)e to a$$ess

position competency e,uiementsA

>ei"y is) assessment associate$ &it7 po$uct

,uality inclu$es t7e availability o" competent

pesonnel. *nsue is)s ae i$enti"ie$ an$

contolle$ 5.3c.

Page 5 o" 3'


6/36


Revision: 2.1

Efective Date: TBD

0.#.2.# Training and Aareness -rocedure>




>ei"y t7at t7e ogani!ation6

• povi$es "o QMS taining an$ job tainingB

• inclu$es custome9speci"ie$ an$o custome9

povi$e$ tainingB

• i$enti"ies t7e "e,uency an$ content o" tainingB

• ensue pesonnel ae a&ae o" t7e elevance an$

impotance o" t7ei activities an$ 7o& t7ey

contibute to t7e ac7ievements o" t7e ,uality

objectivesB an$

• maintains appopiate eco$s.

o& $oes t7e "acility i$enti"y taining nee$s an$

ensue t7at pesonnel eceive a$e,uate taining

to a$$ess competency nee$s. (7at ot7e

met7o$s 7as t7e "acility use$ to a$$ess

competency nee$s outsoucing= pocess

c7anges= etc.A

+escibe 7o& t7e e""ectiveness o" t7e actions

evaluate$ an$ maintaine$ i.e.= competence

evaluation to ensue competence e,uiements

ae met.


0.#.# Dor+ !n)ironment

+escibe t7e &o) envionment= inclu$ing

buil$ings= &o)space an$ utilitiesB pocess

e,uipmentB suppoting sevicesB con$itions un$e

&7ic7 &o) is pe"ome$.

>ei"y t7at t7e ogani!ation 7as $etemine$=

povi$e$= manages= an$ maintains t7e &o)

envionment nee$e$ to ac7ieve con"omity

applicable to t7e manu"actue o" t7e po$ucts.

>ei"y is) assessment associate$ &it7 po$uct

$elivey inclu$es "acilitye,uipment availability an$

maintenance. *nsue is)s ae i$enti"ie$ an$

contolle$ 5.3a.

Page ' o" 3'


7/36


Revision: 2.1

Efective Date: TBD


0.0 5ocumentation Re%uirements

0.0.2 -rocedures

>ei"y t7at poce$ue e,uie$ by t7e stan$a$ aeestablis7e$= $ocumente$= implemente$= an$maintaine$ "o continual suitability.

0.0.# Control of 5ocuments -rocedure>




+escibe 7o& t7e "acility contols $ocuments

e,uie$ by t7e QMS to ensue t7at elevant

vesions ae use$ an$ maintaine$.

+escibe 7o& e




o& $oes t7e "acility ensue integation o"

eei"y t7at po$uct an$ ot7e speci"ic

e,uiements ae integate$ as e,uie$.

0.3 Control of Records -rocedure>




o& $oes t7e "acility i$enti"y= stoe= potect=etain= etieve an$ $ispose o" eco$sA

as t7e "acility i$enti"ie$ contols an$

esponsibilities nee$e$ to i$enti"y= collect= stoe=

potect= etain= etieve an$ $ispose o" eco$sA

as t7e "acility maintaine$ eco$s base$ on t7ee,uie$ etention times as speci"ie$ in t7eapplicable stan$a$= po$uct spec= an$ o t7ecustome QMS e,uiementsA

Page - o" 3'


8/36


Revision: 2.1

Efective Date: TBD

&MS Monitoring' Measurement' Anal$sis Impro)ement

Re%uirements> =becti)e !)idence / Comments>

E.2., Customer Satisfaction -rocedure>

>ei"y t7at t7e poce$ue meets all e,uiementso" t7e applicable stan$a$ an$ is contolle$=


(7at met7o$s 7ave t7e ogani!ation implemente$"o obtaining an$ using in"omation elating tocustome peception as to &7et7e e,uiements7ave been metA

o& 7as t7e ogani!ation e""ectively measue$

custome satis"action an$ analy!e$ t7e esultsA

E.2.2 Internal Audits -rocedure>




/$enti"y t7e $ate t7e last intenal au$it &as

complete$.

>ei"y t7at t7e au$it &as pe"ome$ &it7in 12

mont7s "om t7e pevious intenal au$it i"

applicable.

Note: !I interprets +ast Internal udit- to mean the lastcomplete audit of the .NTI$. ", %hether performed at one

time or over the period of /0 months

+i$ intenal au$it planning ta)e into account

esults o" pevious au$its an$ citicality o" t7e

pocess being au$ite$A

>ei"y t7at t7e intenal au$it pe"ome$6

• con"oms to planne$ aangements inclu$ing t7e

e,uiements o" t7e applicable stan$a$ speci"icationB

• 7as been e""ectively implemente$ an$ maintaine$=

inclu$ing eco$sB

• &as pe"ome$ by in$epen$ent objective=

competent pesonnelB

• inclu$e outsouce$ activities t7at impact t7e ,uality

o" t7e po$uct an$ t7at ae pe"ome$ at t7e

"acilityBan$

• inclu$es all pocesses e,uie$ by t7e MS e,uie$

Page o" 3'


9/36


Revision: 2.1

Efective Date: TBD

to meet t7e applicable stan$a$ speci"ication.

+escibe 7o& t7e ogani!ation a$$essesnoncon"omances i$enti"ie$ $uing t7e intenal au$ite.g.= esponse times= esponsibilities= epoting=

an$ eco$s.

E.2.# -rocess !)aluation

(7at met7o$s ae applie$ "o monitoing an$

measuing QMS pocessesA #7ese met7o$s

s7all $emonstate t7e ability o" t7e pocesses to

ac7ieve planne$ esults.

(7en planne$ esults ae not ac7ieve$= &7at

actions ae ta)en to ensue con"omity o" t7epo$uctA /$enti"y e =becti)e !)idence / Comments>

E.# Anal$sis of 5ata -rocedure>




(7at $ata 7ave been $etemine$= collecte$ an$ analy!e$ to $emonstate t7e suitability an$ e""ectiveness o" t7e QMSA[ "uch data analysis may be related to quality ob'ectives and result in modifications to these ob'ectives, number of nonconforming product, etc ]

5ata T$pes Anal$sis MetodReported

Fo


10/36


Revision: 2.1

Efective Date: TBD

(7at actions ae ta)en by t7e ogani!ation to

eliminate t7e cause o" noncon"omitiesA %ctions

s7oul$ inclu$e6

• evie&ing noncon"omities

•

$etemining cause o" noncon"omities• evaluating action to pevent ecuence

• $eteminingimplementing action nee$e$

• eco$ing o" esults

• evie&ing coective action ta)en

+escibe 7o& coective actions vei"ie$ "o

e""ectiveness.

o& ae coective actions initiate$A o& ae

esponse times "o a$$essing coective actions

tac)e$A

E.0.# -re)enti)e Action -rocedure>

(7at actions ae ta)en by t7e ogani!ation to

minimi!e t7e li)eli7oo$ o" potential

noncon"omitiesA %ctions s7oul$ inclu$e6

• $etemining potential noncon"omities an$ t7ei

cause

• evaluating action to pevent occuence

• $eteminingimplementing action nee$e$

• eco$ing o" esults

• evie&ing peventive action ta)en.


E.3 Management Re)ie -rocedure>




/$enti"y $ates o" management evie&s &it7in t7elast 129mont7 peio$. >ei"y t7at managementevie&s ae con$ucte$ at least evey 12 mont7s.

>ei"y t7at t7e management evie& 7as been

$ocumente$ &it7 su""icient evi$ence to

Page 1 o" 3'


11/36


Revision: 2.1

Efective Date: TBD

$emonstate con"omity &it7 applicable

e,uiements. /" no= note $e"iciencies.

E.3.2 Re)ie Input 9 >ei"y t7at t7e management

evie& inclu$es all inputs e,uie$ by t7e

applicable stan$a$= inclu$ing6

•Result o" au$its

•Custome ee$bac)

•Results o" Ris) %ssessment

•Status o" C% P%

•Supplie Pe"omance %nalysis

•Pocess Pe"omance an$ Po$uct Con"omity

•C7anges t7at coul$ a""ect t7e MS

•Recommen$ations "o /mpovement

E.3.# Re)ie =utput 4 >ei"y t7at t7e

management evie& output inclu$es a summay

assessment o" t7e e""ectiveness o" t7e MS$etailing any6

•Re,uie$ c7anges to t7e pocesses

•+ecisions an$ actions

•Re,uie$ esouces

•/mpovement "o po$ucts

Ris+ Assessment Management


3.# Ris+ Management Assessment -rocedure>

>ei"y t7e poce$ue meets all e,uiements o" t7estan$a$ an$ is contolle$= implemente$= an$

maintaine$.

>ei"y t7e RM pocess 7as been establis7e$ to

i$enti"y an$ contol is)s associate$ &it76

• impact on $elivey= inclu$ing "acilitye,uipment

availability= maintenance an$ supplie

pe"omance an$ mateial availabilitysupplyB

,uality o" po$uct= inclu$ing $elivey o"

noncon"oming po$uct ?availability o"

competent pesonnel.

+escibe t7e tools= tec7ni,ues an$ t7ei

application "o is) i$enti"ication= assessment an$

mitigation utili!e$ by t7e ogani!ation.

Identif$process interaction / e"amples of Ris+ Assessment Management

implementation and tools / tecni%ues used>

Cec+ eac re%uirement upon

)erification(e&planation must be

given for any blan1 bo&es)>

Ris)s i$enti"ie$

Ris)s assesse$

Page 11 o" 3'


12/36


Revision: 2.1

Efective Date: TBD

Ris)s mitigate$

Reco$s maintaine$

Contingenc$ -lanning


3.3 Contingenc$ -lanning -rocedure>

>ei"y t7e poce$ue meets all e,uiements o" t7e

stan$a$ an$ is contolle$= implemente$= an$

maintaine$.

>ei"y t7at contingency planning is base$ on

assesse$ is)s 5.3.

>ei"y t7at t7e output o" contingency planning is

$ocumente$= up$ate$ an$ communicate$ ase,uie$.

Identif$process interaction / e"amples of Contingenc$ -lanning implementation>




Dase$ on assesse$ is)s

Output $ocumente$ up$ate

as e,uie$

Output communicate$

Reco$s maintaine$

Management of Cange


3.,, M=C -rocess

+escibe t7e MOC pocess establis7e$ by t7e

"acility.

>ei"y t7at t7e MOC pocess 7as been establis7e$

to ensue t7at integity o" t7e MS &7en c7anges

ae planne$ an$ implemente$.

o& $oes t7e "acility i$enti"y potential is)s

associate$ &it7 c7anges pio to ma)ing t7e

c7angeA

>ei"y t7at c7anges ae appove$ as e,uie$ pio

to ma)ing c7anges.

Page 12 o" 3'


13/36


Revision: 2.1

Efective Date: TBD

+escibe 7o& t7e "acility ensues t7at t7e MOC

pocess is use$ "o c7anges t7at may a""ect t7e

QMS negatively= inclu$ing c7anges6

•to t7e ogani!ational stuctueB

•in )ey o essential pesonnelB

•in citical suppliesB an$

•to MS pocesses= inclu$ing c7anges esulting

"om C% P%

+escibe t7e ogani!ationEs pocess "o

noti"ication o" c7anges. (7en is noti"ication

e,uie$A #o &7o is noti"ication e,uie$A

Identif$ process interaction / e"amples of Management of Cange

implementation>



given for any blan1 bo&es)>;egative a""ects on QMS

i$enti"ie$

Ris)s i$enti"ie$ pio to c7an

%ppove$ pio to c7ange

;oti"ication o" c7ange

Reco$s maintaine$

Page 13 o" 3'


14/36


Revision: 2.1

Efective Date: TBD

-roduct Realiation

Audit Conditions

The audit must determine the degree to %hich products are being manufactured under the scope of the applicable !I

onogram icense(s) and * or $egistered #"Determine the availability of the products for revie% and revie% processes in con'unction %ith these products

s a reminder, product and service are to be considered the same

Priority should be established at the start of the audit to verify manufacturing according to the following

conditions:

Categor$ Categor$ 5efinition

, Monogam po$uct cuently being manu"actue$ an$ available "o evie&

2Monogammable po$uct meeting all e,uiements but not ma)e$ po$uct cuently being

manu"actue$ an$ available "o evie&

# ;on9monogammable po$uct cuently being manu"actue$ an$ available "o evie&

0 Monogam po$uct manu"actue$ since t7e last %P/ au$it but not available "o evie& records re)ie

3Monogammable po$uct manu"actue$ since t7e last %P/ au$it but not available "o evie& records

re)ie

E ;on9monogammable po$uct manu"actue$ since t7e last %P/ au$it

6o $ual ? egistation clients 8 Po$uct cuently being manu"actue$ o sevices cuently being

povi$e$ t7at "all un$e t7e scope o" t7e egistee$ ,uality management system.9=T! ,> Please see %P/ Ceti"ication Pogams ad)isor$ * ega$ing implementation o" QMS e,uiements by a :icensee at

7ttp6&&&.api.ogceti"icationsmonogam$ocumentsa$visoies.c"m

9=T! 2> Please i$enti"y any po$ucts sevices t7at ae being a$$e$ to t7e scope o" :icensing an$ o Registation= inclu$ing po$ucts

sevices t7at ae Fne&G an$ 7ave been a$$e$ since t7e last au$it. #7ese po$ucts sevices must be consi$ee$ &7en sampling

objective evi$ence $uing t7e au$it. o e

Categor$ -roduct/Ser)ice Identification Specification (as applicabl

Page 14 o" 3'


15/36


Revision: 2.1

Efective Date: TBD

Top of the Docume

-roduct Realiation 1Contract Re)ie

Re%uired -rocedure>

2erify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained

3.,., Contract Re)ie -rocedure>

Contract

Re)ie

(3.,.,

List all Contracts re)ieed / sampled>

5eterminationof -roduct

Re%uirements

(3.,.2

5etail e)idence obser)ed(including records and documents revie%ed,

personnel intervie%ed, and processes observed)>


)erification( e&planation must be


5etermination of re%uirements> Custome Re,uiements

:egal ot7e applicablee,uiements

Re,uiements not state$ by

custome

%lso vei"y6

Re,uiements con"ime$ an$ eco$s

maintaine$ &7ee no e,uiements ae

state$$ocumente$ by custome

Re)ie of

-roduct

Re%uirements(3.,.#

Re)ie of re%uirements> Revie&e$ pio to

commitment

Re,uiements i$enti"ie$ an$

$ocumente$

Capability con"ime$

Reco$s maintaine$

Canges to

Re%uirements

(3.,.#

Canges to contract re%uirements> +ocuments amen$e$

C7anges communicate$

AuditorHs Assessment of -rocess(es>


16/36


Revision: 2.1

Efective Date: TBD

Top of the Document

-roduct Realiation 1 -lanning

-lanning(3.2






-lanning of product realiation> Consistent &it7 QMS poces

Re,uie$ esouces &o)

envionment 4.3

Po$uct custome

e,uiement 5.1

:egal ot7e applicable

e,uiements

Contingencies base$ on is)

assessment 5.3= 5.5

+esign an$ $evelopment

e,uiements 5.4

Re,uie$ vei"ication=

vali$ation= monitoing=

measuing= inspection= test

activities

MOC 5.11

Reco$s maintaine$

=utput of product realiation planning> Output $ocumente$

Plans up$ate$ as c7anges

occu

Plans maintaine$ suitably



17/36


Revision: 2.1

Efective Date: TBD

Top of the Docume

-roduct Realiation 4 5esign 5e)elopment

Re%uired -rocedure>


3.0 5esign 5e)elopment -lanning Control -rocedure>

5esign

5e)elopment

Acti)ities

Select all tat appl$>

Pe"ome$ in97ouse

Pe"ome$ at a $i""eent location &it7in t7e same ogani!ation

Outsouce$

*


18/36


Revision: 2.1

Efective Date: TBD

5esign 5e)elopment =utputs> Output as pe 5.4.3

Reco$s Maintaine$

%lso vei"y6

9 +%C i$enti"ie$ e"eence$

9 Citical po$uctscomponents i$enti"ie$

e"eence$

5esign 5e)elopment Re)ie> Revie& as pe 5.4.4

Reco$s Maintaine$

5esign 5e)elopment >ei"ication an$ inal Revie

as pe 5.4.5

Con$ucte$ $ocumente$ pe

planne$ aangement 5.4.1

Reco$s Maintaine$

5esign 5e)elopment Validation Appro)al> >ali$ation an$ %ppoval aspe 5.4.'

Reco$s Maintaine$

5esign 5e)elopment Canges> C7anges as pe 5.4.-

Reco$s Maintaine$

5esign

5e)elopment

Controls 1

=utsourced

(3.0.,

SupplierHs Competenc$ and Control of =utsourced Acti)ities> Pesonnel Competence

Reco$s Maintaine$

%lso vei"y6

9Resouces= esponsibilities= aut7oitiesan$ t7ei inte"aces

9 Supplies contol= &7en $esign activiti

ae outsouce$

Training

Competence(

Design 4

Development)

(0.#.2.2' 0.#.2.#

&ualification/competenc$ of personnel> CompetentQuali"ie$

#aining *valuation

Reco$s Maintaine$


Page 1 o" 3'


19/36


Revision: 2.1

Efective Date: TBD


20/36


Revision: 2.1

Efective Date: TBD

Top of the Docume

-roduct Realiation 4-urcasing

Re%uired -rocedure(s>


3.E.,., -urcasing Poce$ue63.E.# Verification of -urcased -roducts and

Acti)itiesPoce$ue6

3.6.# Identification and Traceabilit$ Poce$ue6

3.6.0 -roduct Inspection/Test Status Poce$ue6

3.6.3 Customer4supplied -ropert$ Poce$ue6

3.6.E.,-reser)ation of -roduct Poce$ue6

-urcasing

Controls

(3.E.,






Control of -urcasing> Citicality o"activitiespo$ucts

$etemine$

#ype an$ e


21/36


Revision: 2.1

Efective Date: TBD

=utsourced

Acti)ities

(3.E.,.E

List all outsourced acti)ities and processes (if applicable>Ogani!ationEs applicable

QMS e,uiements satis"ie$

Reco$s Maintaine$

%lso vei"y6

Ogani!ation maintains esponsibility "o

po$uct con"omance to speci"ie$

e,uiements inclu$ing %P/ Spec

Control of outsourced acti)ities>

-urcasing

Information

(3.E.2

-urcasing Information (include contracts*!3s sampled 5minimum of

6)> %cceptance citeia

$ocumente$

Reco$s Maintaine$

%lso vei"y6

+ocumente$ e,uiements pe 5.'.2a

c$= &7ee applicable

Verification

of -urcased

-roduct /

Acti)ities

(3.E.#

Verification of conformance to purcase re%uirements (include

records revie%ed as evidence of conformance )>

Reco$s Maintaine$

%lso vei"y6

9 Contols "o vei"ication at supplieEs

pemises= &7ee applicable

Identification

and

Traceabilit$(3.6.#

Verification of identification / traceabilit$ (as applicable> Reco$s Maintaine$

+elivey an$ post9$elivey

activities

Maintenance an$

eplacement o" i$enti"ication

ma)s

%lso vei"y6

/$enti"ication an$ taceability o"

custome9supplie$ po$ucts

-roduct

Inspection /

Test Status

(3.6.0

Identification of inspection and/or test status (as applicable> /n$icates con"omity non9

con"omity o po$uct

Reco$s Maintaine$

%lso vei"y6

Release o" po$uct t7at meets

e,uiementso aut7oi!e$ un$e

Page 21 o" 3'


22/36


Revision: 2.1

Efective Date: TBD

concession

Customer4

supplied

-ropert$

(3.6.3

Control of customer4supplied propert$ (if applicable> Poce$ue pe 5.-.5

Reco$s maintaine$

%lso vei"y6

Re,uiements "o epoting to custome

-reser)ation

of -roduct

Storage and

Assessment

(3.6.E' 3.6.E.2

-reser)ation of products and constituent parts (include evidence of

verification of stoc1 assessment)>Poce$ue pe 5.-.'.1

Re,uiements "o stoage

an$ assessment i$enti"ie$

+esignate$ stoage aeas

Reco$s maintaine$

%lso vei"y6

9 /$enti"icationtaceability ma)s=tanspotation= 7an$ling= pac)aging a

potection

9 /nteval appopiate to t7e po$uctpatbeing assesse$

Inspection

and testing

(3.6.6

Inspection and testing of purcased product / ser)ices6 Poce$ue pe 5.-.-.1

*vi$ence o" con"omity

&it7 acceptance citeia

maintaine$

Training

Aareness

-ersonnel

Competence

(in5house and

outsourced)

(0.#.2.2'

0.#.2.#

&ualification/competenc$ of personnel> #aining "e,uency an$

contents i$enti"ie$

Competent,uali"ie$

#aining evaluation

Reco$s maintaine$

%lso vei"y6

9 Custome9speci"ie$povi$e$ taining

9%&aeness o" pesonnel &it7 espect t

t7ei activitiescontibution to QMS



23/36


Revision: 2.1

Efective Date: TBD

Top of the Document

-roduct Realiation 1 -roduction and Ser)icing

=ter

processes

included>

Po$uction ? Sevice Povision Pesonnel Competence

#aining ? %&aeness Contol o" #esting= Measuing ? Monitoing *,uipment

Po$uct Release MOCContol o" ;oncon"oming Po$uct Ris) %ssessment ? Management

Manu"actuing Capability

Re%uired -rocedure>


3.6.,., -roduction Poce$ue6

3.6.,.2 Ser)icing (if applicable) Poce$ue6

3.6.* -re)enti)e Maintenance Poce$ue6

3.* Control of Testing' Monitoring and

Measurement !%uipmentPoce$ue6

3.7 -roduct Release Poce$ue6

-roduction and/or Ser)icing

!rovide a detailed overvie% of the production * servicing activities and capabilities observed at the facility

Include all monogrammable and non5monogrammable products

5escription of -roduction and/or Ser)icing processes (describe %hat manufacturing processes actually ta1e place at

the facility and interactions)>

5escription of -roduction / Ser)icing capabilities 78hat capabilities does the facility have (ie, are they capable of

manufacturing, %hat are they capable of manufacturing)9 >

Page 23 o" 3'


24/36


Revision: 2.1

Efective Date: TBD

-roduction /

Ser)icing

Acti)ities

List production / ser)icing processes re)ieed / sampled>

Control of

-roduction

(3.6.,.,






Controls establised and implemented for production> Poce$ue as pe 5.-.1.1

+esign e,uiementsc7anges

Suitable e,uipment

Pocess contol $ocuments

%lso vei"y6

9 /mplementation o" Quality Plan= i" e,uie$9 (o) instuctions= &7en applicable

9 Monitoing ? measuing activities9 Po$uct elease activities

Control of

Ser)icing (if

applicable)

(3.6.,.2

Controls establised and implemented for ser)icing> Poce$ue as pe 5.-.1.2

Revie& o" e,uiements

Suitable e,uipment

/$enti"icationtaceability

Pocess contol $ocuments

%lso vei"y6

9 (o) instuctions= &7en applicable

9 Monitoing ? measuing activities9 Re,uiements "o elease o" sevice$

po$uct

-rocess

Control

5ocuments

(3.6.,.#

5ocumentation of process controls> /nclu$es e,uiements "o

vei"ying con"omance &it7

,uality plans= po$uct specs=

custome e,uiements

Re"eence instuctions

%cceptance citeia

%lso vei"y6

/nspection 7ol$s an$ &itness points

-roduct

Realiation

Capabilit$

5ocuments

(3.6.,.0

-roduct realiation documentation sampled> Po$uct eali!ation plan 5.2

Reco$s o" evie&vei"ication=

vali$ation= monitoing=measuement= inspection=

tests

%cceptance citeia

$emonstating capability to

manu"actue po$ucts"amily

o" po$ucts

Page 24 o" 3'


25/36


Revision: 2.1

Efective Date: TBD

Validation of

-rocesses for

-roduction

and Ser)icing

(3.6.,.3

Validation of processes for production and ser)ices (including

outsourced)>

+emonstates ability to

ac7ieve planne$ esults

>ei"ication o" supplie

con"omance to stan$a$

e,uiements 5.'.1.'

Reco$s maintaine$

-roduct

&ualit$ -lans

(if required)

(3.6.2

-roduct %ualit$ plan re%uired b$ te contract> %$$esses eac7 e,uiement

o" 5.-.2 a t7oug7 e

Revisions $ocumente$

appove$

Communicate$

Identification

and

Traceabilit$

-roduct

Inspection /

Test Status

-reser)ation

of -roduct

(3.6.#' 3.6.0'

3.6.3' 3.6.E

Identification / traceabilit$ trougout product realiation

process>

Reco$s maintaine$

%lso vei"y 6

9 +elivey an$ post9$elivey

9 Maintenance eplacement o"

i$enti"ication ma)s

Identification of inspection / test status trougout product

realiation process>

Reco$s maintaine$

in$icating con"omity

noncon"omity o" po$uct

Customer4supplied propert$ trougout product realiation (if

applicable)>

Poce$ue pe 5.-.5

Reco$s maintaine$

%lso vei"y6

Re,uiements "o epoting to custome

-reser)ation of product trougout product realiation and

deli)er$>

/$enti"ication taceability

ma)s

#anspotation= 7an$ling=pac)aging an$ potection

Reco$s maintaine$

Storage and assessment trougout product realiation and

deli)er$>

+esignate$ stoage aea

stoc) ooms

Reco$s o" assessment

maintaine$

Page 25 o" 3'


26/36


Revision: 2.1

Efective Date: TBD

Inspection

and Testing

(3.6.6

In4process inspection and testing> Poce$ue as pe 5.-.-.1

/nspection testing at planne$

stages pe plan poce$ue

*vi$ence o" con"omity &it7acceptance citeia maintaine$

Poce$ue as pe 5.-.-.2

inal inspection testing pe

plan poce$ues

*vi$ence o" con"omity to

e,uiements maintaine$

-re)enti)e

Maintenance

(3.6.*

-re)enti)e maintenance for e%uipment used in product

realiation>

Poce$ue as pe 5.-.

#ype o" e,uipment= "e,uency=

esponsible pesonnel

i$enti"ie$

Reco$s maintaine$

Control of

Testing'

Monitoring

and

Measuring

!%uipment

(3.*

Control and maintenance of testing' monitoring and measuring

e%uipment>

Poce$ue as pe 5.

/$enti"ication= status=

taceability= "e,uency=

calibationvei"ication

met7o$s= acceptance citeia

%lso vei"y6

Contol o" out9o" 8toleance e,uipment

an$ assessment o" pevious

measuements

Testing' monitoring and measurement e%uipment sampled> Ini,uely i$enti"ie$

Calibation status i$enti"ie$

#aceable to natElintEl stan$a$

/nclu$e$ on egisty

Reco$s maintaine$

%lso vei"y6

9Compute so"t&ae con"imation

Page 2' o" 3'


27/36


Revision: 2.1

Efective Date: TBD

9 * Poce$ue as pe 5.0

Release upon satis"actoy

completion o" planne$

aangements

%lso vei"y6

%ppoval o" elease by aut7oitycustome

&7en planne$ aangements ae not met

Control of

9onconforming

-roduct

(3.,;

Control of nonconforming product> Poce$ue as pe 5.1.1

Met7o$ o" a$$essing non9

con"oming po$uct i$enti"ie$

pe 5.1.2

Concession appove$ by

elevant aut7oity an$o

custome

Custome noti"ication pe

5.1.4

Reco$s maintaine$ 5.1.5

%lso vei"y6

9 Pope i$enti"ication to pevent uninten$e$

use

9 %$$essing t7e noncon"omity

9 /$enti"ication= $ocumentation= analysisan$ actions ta)en "o noncon"oming

po$uct i$enti"ie$ a"te $elivey

9 Ris) assessment associate$ &it7

po$uct ,uality inclu$es supplie

pe"omance. *nsue is)s ae i$enti"ie$

an$ contolle$ 5.3b.

Training /

Competence

(production

and servicing

personnel)(0.#.2.2'

0.#.2.#

&ualification/Competenc$ of personnel> #aining "e,uency an$

contents i$enti"ie$

Competent,uali"ie$

#aining evaluation

Reco$s maintaine$

%lso vei"y6

9 Custome9speci"ie$ povi$e$9 Outsouce$ pesonnel

,uali"icationcompetence



28/36


Revision: 2.1

Efective Date: TBD

Page 2 o" 3'


29/36


Revision: 2.1

Efective Date: TBD

Top of the Document

8se of A-I Monogram' A-I&R and A9A: Mar+s

A.3 Control of te Application of te A-I

Monogram-rocedure>

Re%uirements> =becti)e !)idence / Comments> ei"y t7e poce$ue $ocuments all

ma)ingmonogamming e,uiements inclu$es all

e,uiements o" %nne< %.

+escibe t7e licenseeEs %P/ Monogam ma)ing

emoval poce$ue "o non9con"oming po$uct.

/$enti"y evi$ence o" implementation= i" applicable.

AMA 4 i" t7e "acility 7as an %M%= i$enti"y t7e

ma)ing "acility an$ $etail contols establis7e$.

List all A-I MonogramMar+s sampled(on products, letterhead, business cards or

any other medium)>

Po$uct con"oms to %P/9spec

e,uiements

%pplie$ by licensee only

/nclu$es ma) an$ license

numbe

%pplie$ at license$ "acility

location

Verif$ conformance of te folloing re%uirements for use of te Monogram and A9A:/A-I&R

mar+. An$ 9oselected is considered a nonconformance. @es 9o 9/A

%P/QR Ma)s ae onl$ on coespon$ence= a$vetising= an$ pomotional mateials t7at ae elate$

to t7e goo$s an$ sevices e"eence$ in t7e scope o" t7e Ogani!ationEs egistation.

#7e%P/QR %;%D Ma) as not been use$ on a po$uct o in suc7 a &ay as to suggest t7at

%P/QR %;%D 7ave ceti"ie$ o appove$ any po$uct= pocess o sevice o" t7e egistee$ogani!ation.

#7e %P/QR an$ %;%D Ma)s ae use$ in conunction it t7e ogani!ationEs name= location an$

egistation ceti"icate numbes.

#7e %;%D Ma) is use$ in conunction it t7e %P/QR Ma).

#7e %P/QR an$ %;%D Ma)s are epo$uce$6

5. in blac)= its oiginal colos o t7e pe$ominant colo o" t7e lette7ea$ o pinting='. on a clealy contasting bac)goun$= an$-. in a si!e &7ic7 ma)es t7e ma)Es "eatues clealy $istinguis7able= t7e lengt7 o" a si$e being in no

case less t7an 12mm %P/QR Ma) an$ 1mm %;%D Ma).

Ipon &itten noti"ication= t7e ogani!ation immediatel$ ceased and desisted in t7e use o" t7e %P/QR%;%D Ma)s an$o %P/ Monogam 1 upon suspension o cancellation o 2 use in any

manne= &7ic7 %P/%P/QR intepets as mislea$ing.

Applicant organiation 1 %P/QR= %;%D Ma)s an$o %P/ Monogam a)e not been i$enti"ie$ in

pomotional mateials o ot7e company $ocumentation.

Page 20 o" 3'


30/36


Revision: 2.1

Efective Date: TBD

Top of

Audit Time Summar$

5ate Start Time !nd Time

=pportunities for Impro)ement (=

-ro)ide a summar$ of te closure and )erification of correcti)e actions for pre)ious findings' if an$>

-ro)ide an o)erall assessment of te capabilit$ of te facilit$ to manufacture product(s (Monogram>

-ro)ide an o)erall assessment of te effecti)eness of te management s$stem and te facilit$Hs abilit$ to

acti)ities itin te scope of te registration>

Page 3 o" 3'


31/36


Revision: 2.1

Efective Date: TBD

Conclusion / Recommendation

Registation an$ o :icensing ae gante$ continue$ einstate$ base$ on satis"actoy implementatio

Management System an$ o $emonstate$ capability to meet applicable speci"ication e,uiements &it

noncon"omities i$enti"ie$.

Registation an$ o :icensing be gante$ continue$ einstate$ subject to t7e evie& o" t7e noncon"o

i$enti"ie$ an$ acceptance o" appopiate coective actions by t7e %P/ Registation ? :icensing CommRegistation an$ o :icensing subject to t7e evie& o" t7e noncon"omances i$enti"ie$ an$ acceptanc

appopiate coective actions by t7e %P/ Registation ? :icensing Committee. #7is $ecision may inclu

au$it to vei"y t7e e,uie$ coective actions.

9ote6%u$its may esult in suspension o cancellation o" t7e ogani!ationEs licenses an$o egistations o &it7

application "o licensingegistation.%P/ ma)es t7e "inal $etemination o" ceti"ication status an$ s7all be t7e sole

&7et7e licensue o egistation &ill be gante$maintaine$.Jou &ill be noti"ie$ by %P/ i" you licenseegistation

a$vesely a""ecte$ by t7e esults o" t7is au$it.

Comments / 9otes>

=rganiationHs Representati)e Comments>

!nter te ne"t audit date for 5ual/Registration Audits belo (Does not apply to onogram only audits)>

•ist suveillance au$it a"te stage 2 initial au$it 8 MIS# be sc7e$ule$ 0 mont7s a"te t7e last $ay o" t7e stage 2 au$

•Secon$ subse,uent suveillance au$its 8 aoun$ au$it annivesay $ate o" initial "ist suveillance au$it

•Receti"ication au$its 8 at least ' mont7s pio to t7e e

"y signing below# $ %we& attest that the information above is accurate and has been collected by the audit team durin

performance of the audit that was assigned to me %us& by AP$:

Audit Team Leader> 5ate>

Audit Team Member> 5ate>Audit Team Member> 5ate>

"y signing this document# it is not an admission of the acceptance of any nonconformities'concerns identified by

team (he signature only confirms that the audit was performed) that a copy of this document %*+,-./& was left) and

recommendations and audit conclusions were communicated by the auditor AP$ reserves the right to have final det

of the level of nonconformity identified by in the audit AA0s and final audit report

=rganiation Representati)e> 5ate>

Page 31 o" 3'


32/36


Revision: 2.1

Efective Date: TBD

(op of the 1ocument

Supplemental Audit Information

.nter additional information relevant to the audit, if necessary


33/36


Revision: 2.1

Efective Date: TBD


34/36


Revision: 2.1

Efective Date: TBD

(op of th


35/36


Revision: 2.1

Efective Date: TBD

(op of the 1ocument

=pening / Closing Meeting Attendance Seet

8hen performing the opening and closing meeting, please refer to the 3pening and =losing meeting guidelines

Audit I5>

Audit Team Leader>

Audit Team Members>

Audit =bser)er(s>

=pening Meeting (5a$

Time>

Closing Meeting

(5a$ Time>

-articipants (9ame Title 4 Initial/cec+ te meetings attended =pening Closing

The information contained in this report is confidential and sub'ect to the confidentiality agreement bet%een the udit

Team*uditor(s) and !I Details of the assessment results are found in the succeeding pages of this report

Page 35 o" 3'


36/36


Revision: 2.1

Efective Date: TBD

(op of the 1oc

Audit -ac+age Cec+list

acility /n"omation S7eetKK Po$uct QuestionsK Stage 1 %u$it RepotK

Q%RsKKQ1= 0t7 *$ition Lap

%nalysis in$ings %%RsK

> If required

>>!lease update as necessary

api audit checklist 9thedition.docx

Documents

Transcript of api audit checklist 9thedition.docx