api audit checklist 9thedition.docx

Audit Report

Doc ID: FM-198 Revision: 2.1 Efective Date: TBD

Table of Contents

Audit Information........... Information......................... ........................... ........................... ............................ ........................... ........................... ............................ ........................... ............................ ............... 2 Verification Verification of Scope of Registration / Monogram Monogram License(s and !"clusions....................................# !"clusions....................................# Audit Report.................. Report................................ ........................... ........................... ........................... ........................... ............................ ........................... ........................... .............................. ................ # Management S$stem Re%uirements............ Re%uirements......................... ........................... ........................... ........................... ................................................ .................................. # 4.1.1 Quality Management System...................... System................................... ........................... ............................ ........................... ........................... .......................... ............ 3 4.4.1 Quality Manual....................... Manual.................................... ........................... ........................... ........................... ............................ ........................... ................................. .................... 3 4.1.2 Quality Policy.................... Policy.................................. ............................ ........................... ........................... ............................ ........................... ..................................... ........................ 3 4.1.3 Quality Objectives................... Objectives................................. ........................... ........................... ............................ ........................... ........................... ................................ .................. 4 4.1.5 Communication................. Communication............................... ........................... ........................... ............................ ........................... ........................... ............................ ........................ .......... 4 4.2 Management Responsibility................ Responsibility.............................. ............................ ........................... ........................... ............................ ........................... ...................... ......... 4 4.3 Ogani!ational Capability.................. Capability................................ ........................... ........................... ............................ ........................... ...................................... ......................... 5 4.3.1 Povision o" Resouces....................... Resouces.................................... ........................... ............................ ........................... ........................... .................................. .................... 5 4.3.2.2 Pesonnel Competence.................... Competence................................. ........................... ............................ ........................... .............................................. ................................. 5 4.3.2.3 #aining #aining an$ %&aeness.............. %&aeness............................ ........................... ........................... ........................... ........................... ............................ .........................' ...........' 4.3.3 (o) *nvionment................... *nvionment................................. ........................... ........................... ............................ ........................... ............................................ ............................... ' 4.4 +ocumentation Re,uiements..................... Re,uiements.................................. ........................... ............................ ........................... ........................................ ........................... . 4.4.3 Contol o" +ocuments....................... +ocuments.................................... ........................... ............................ ........................... ........................... .................................... ...................... 4.5 Contol o" Reco$s....................... Reco$s..................................... ........................... ........................... ........................... ........................... ............................ .............................. ................ &MS Monitoring' Monitoring' Measurement' Anal$sis  Impro)ement................. Impro)ement............................... ........................... ........................... .....................* .......* '.2.1 Custome Satis"action................ Satis"action.............................. ........................... ........................... ............................ ........................... ........................... ............................. ...............  '.2.2 /ntenal %u$its................. %u$its............................... ............................ ........................... ........................... ........................... ........................... ........................................ ..........................  '.2.3 Pocess *valuation..................... *valuation................................... ........................... ........................... ........................... ........................... .......................................... ............................ 0 '.3 %nalysis o" +ata...................... +ata................................... ........................... ............................ ........................... ........................... ............................ ................................... ..................... 0 '.4.2 Coective %ction................. %ction............................... ........................... ........................... ............................ ........................... ........................... ............................ ...................... ........ 0 '.4.3 Peventive %ction.................. %ction................................ ............................ ........................... ........................... ........................... ........................... ................................ .................. 1 '.5 Management Revie&..................... Revie&................................... ........................... ........................... ........................... ........................... ........................................ .......................... 1 Ris+ Assessment  Management................ Management.............................. ............................ ........................... ........................... ............................ ................................ .................. ,, Contingenc$ Contingenc$ -lanning............. -lanning.......................... ........................... ............................ ........................... ........................... ............................ ........................................ .......................... ,2 Management of Cange................. Cange............................... ............................ ........................... ........................... ............................ .............................................. ................................ ,2 -roduct Realiation............... Realiation............................. ........................... ........................... ............................ ........................... ........................... .............................................. ................................ ,0 Audit Conditions.......... Conditions....................... ........................... ............................ ........................... ........................... ............................ ........................... ........................... ............................. ............... ,0 -roduct Realiation 1 Contract Re)ie............................... Re)ie............................................ ........................... ................................................. ................................... ,3 -roduct Realiation 4 5esign  5e)elopment................ 5e)elopment.............................. ........................... ........................... ........................................ .......................... ,6 -roduct Realiation 4 -urcasing.............. -urcasing............................ ........................... ........................... ............................ ........................... ........................... ..................... ....... ,7 -roduct Realiation 1 -roduction -roduction and Ser)icing.................. Ser)icing................................ ........................... ........................... ................................. ................... 22 8se of A-I Monogram' A-I&R and A9A: Mar+s.......................... Mar+s........................................ ........................... ........................... ..........................26 ............26 Audit Time Summar$................... Summar$................................. ............................ ........................... ........................... ........................... ........................... ............................ .......................... ............ 2* Audit Summar$.................... Summar$................................. ........................... ............................ ........................... ........................... ........................... ........................... ................................... ..................... 2* Conclusion Conclusion / Recommendation........ Recommendation..................... ........................... ............................ ........................... ........................... ............................ .................................. .................... 27 Supplemental Supplemental Audit Information.......... Information....................... ........................... ............................ ........................... ........................... ................................... ..................... ......... #;
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Audit Report

Top of the Document

Audit Information

Audit I5>

Lead Auditor>

Audit Team Members>

Audit Start 5ate> Sifts>

Audit !nd 5ate> Start Time

!nd Time

9o. of!mplo$ees

Audited? (@ (@/9

Sift , Sift 2 Sift # !"planation(required !"planation (required for shifts not audited): Additional Comments>

Audit Criteria>

/SO 01 %P/ Spec Q1 /SO#S 201 /SO 141 %P/ Specs (list all applicable specifications6 specifications 6

%P/ Spec Q2 OS%S 11

Ot7e citeia6 &MS and Applicable Standards/Specifications (verify current versions)> versions)> Audit Scope/=becti)e: Scope/=becti)e :
9o

@esIf @es If yes, include changes on facility info sheet

Actual 9umber of !mplo$ees> Actual Audit 5a$s>

Re%uired Audit 5a$s>

Justification required if different from required audit days

Bustification (Notify !I of changes)6

Additional Comments> 9umber of

Maor ("ystemic)> ("ystemic)>

Minor (Isolated)> (Isolated)>

Concerns>

Comments>

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Audit Report

Top of the Document

Audit Information

Audit I5>

Lead Auditor>

Audit Team Members>

Audit Start 5ate> Sifts>

Audit !nd 5ate> Start Time

!nd Time

9o. of!mplo$ees

Audited? (@ (@/9

Sift , Sift 2 Sift # !"planation(required !"planation (required for shifts not audited): Additional Comments>

Audit Criteria>

/SO 01 %P/ Spec Q1 /SO#S 201 /SO 141 %P/ Specs (list all applicable specifications6 specifications 6

%P/ Spec Q2 OS%S 11

Ot7e citeia6 &MS and Applicable Standards/Specifications (verify current versions)> versions)> Audit Scope/=becti)e: Scope/=becti)e :
9o

@esIf @es If yes, include changes on facility info sheet

Actual 9umber of !mplo$ees> Actual Audit 5a$s>

Re%uired Audit 5a$s>

Justification required if different from required audit days

Bustification (Notify !I of changes)6

Additional Comments> 9umber of

Maor ("ystemic)> ("ystemic)>

Minor (Isolated)> (Isolated)>

Concerns>

Comments>

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Audit Report


Top of the Document

Verification of Scope of Registration / Monogram License(s and !"clusions Select =ne>

Verif$ eac of te folloing> Scope o" egistation is accuate "o t7e activities an$ pocesses pe"ome$ by t7e "acility. "acility. Monogam Only 9 Only 9 Po$uct scope o" Monogam :icense is accuate "o t7e activities an$ pocesses pe"ome$ by t7e "acility an$ "acility 7as t7e manu"actuing capability "o eac7 po$uct &it7in t7e scope o" t7e licenses.

@es 9o 8 Note all changes on the applicable #$, as %ell 9o 8 as an e&planation for the changes @es 9o 8 Note all changes on the applicable #$, as %ell 9o 8 as an e&planation for the changes 9/A 1 ;o Monogam :icenses !"clusions are Accurate and Appropriate

*
9o !"clusions !"clusions sould be updated as follos>

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>

=becti)e !)idence/Comments> !)idence/Comments>

0.,., &ualit$ Management S$stem >ei"y t7at t7e ogani!ation 7as establis7e$= >ei"y $ocumente$= implemente$ an$ maintaine$ a QMS "o all sevicing an$ po$ucts p ovi$e$ "o use in t7e petoleum p etoleum an$ natual gas in$usty. 0.0., &ualit$ Manual >ei"y >ei"y t7at t7e QM a$$esses t7e "ollo&ing e,uiements6 Scope o" t7e QMS= inclu$ing e
• • •

QMS

0.,.2 &ualit$ -olic$ >ei"y >ei"y t7at t7e Quality Policy 7as been $e"ine$= $ocumente$ an$ appove$ as e,uie$ an$ meets all e,uiements i$enti"ie$ in t7e applicable stan$a$.

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0.,.# &ualit$ =becti)es >ei"y t7at Quality Objectives a e appove$= $ocumente$= an$ establis7e$ at elevant "unctions an$ levels an$ ae measuable an$ consistent &it7 t7e Quality Policy. >ei"y @P/s ae i$enti"ie$ "o use in +ata %nalysis. 0.,.0 -lanning >ei"y t7at management 7as ensue$ t7at6 •

•

citeia an$ met7o$s nee$e$ "o t7e opeation an$ contol o" t7e QMS ae $etemine$= manage$ an$ ae e""ective planning o" t7e QMS is caie$ out to meet spec e,uiements Re%uirement>

=becti)e !)idence/Comments>


0.,.3 Communication 0.,.3., Internal Communication >ei"y t7at t7e ogani!ation 7as establis7e$ appopiate communication pocesses an$ t7e e""ectiveness o" t7e MS is communicate$. >ei"y t7at pocesses 7ave been establis7e$ to ensue t7at t7e impotance o" meeting e,uiements an$ analysis o" $ata is communicate$ at elevant "unctions. 0.,.3.2 !"ternal Communication >ei"y t7at t7e ogani!ation 7as establis7e$ appopiate communication &it7 eei"y t7at communications pocesses meet applicable e,uiements o" t7e stan$a$. Re%uirement> 0.2 Management Responsibilit$ 0.2., Resources

+escibe 7o& top management ensues availability o" esouces essential to t7e QMS.

0.2.2 Responsibilit$ and Autorit$ +escibe 7o& esponsibilities= aut7oities= an$ accountabilities ae $e"ine$= $ocumente$ an$ Page 4 o" 3'

Audit Report


communicate$ t7oug7out t7e ogani!ation. 0.2.# Management Representati)e /$enti"y t7e name o" t7e appointe$ Management Repesentative. >ei"y Competence= #aining ? %&aeness "o appointment. >ei"y applicable esponsibility an$ aut7oity 7as been gante$. +escibe 7o& t7e Management Repesentative epots to management on t7e pe"omance o" t7e MS. =becti)e !)idence/Comments>

Re%uirement>


0.#.2.2 -ersonnel Competence

-rocedure>

Re%uirement> 0.# =rganiational Capabilit$ 0.#., -ro)ision of Resources +escibe 7o& t7e ogani!ation $etemines an$ allocates esouces nee$e$ to implement= maintain an$ impove t7e e""ectiveness o" t7e e,uiements o" t7e MS.

>ei"y t7at t7e poce$ue meets all e,uiements o" t7e applicable stan$a$ an$ is contolle$= implemente$= an$ maintaine$.

o& $oes t7e ogani!ation $etemine t7e necessay competence "o pesonnel pe"oming &o) a""ecting po$uct ,ualityA

(7at actions $oes t7e ogani!ation ta)e to a$$ess position competency e,uiementsA

>ei"y is) assessment associate$ &it7 po$uct ,uality inclu$es t7e availability o" competent pesonnel. *nsue is)s ae i$enti"ie$ an$ contolle$ 5.3c.

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Audit Report 0.#.2.# Training and Aareness


-rocedure>

>ei"y t7at t7e poce$ue meets all e,uiements o" t7e applicable stan$a$ an$ is contolle$= implemente$= an$ maintaine$. >ei"y t7at t7e ogani!ation6 • •

• •

•

povi$es "o QMS taining an$ job tainingB inclu$es custome9speci"ie$ an$o custome9 povi$e$ tainingB i$enti"ies t7e "e,uency an$ content o" tainingB ensue pesonnel ae a&ae o" t7e elevance an$ impotance o" t7ei activities an$ 7o& t7ey contibute to t7e ac7ievements o" t7e ,uality objectivesB an$ maintains appopiate eco$s. o& $oes t7e "acility i$enti"y taining nee$s an$ ensue t7at pesonnel eceive a$e,uate taining to a$$ess competency nee$s. (7at ot7e met7o$s 7as t7e "acility use$ to a$$ess competency nee$s outsoucing= pocess c7anges= etc.A +escibe 7o& t7e e""ectiveness o" t7e actions evaluate$ an$ maintaine$ i.e.= competence evaluation to ensue competence e,uiements ae met. Re%uirement>


0.#.# Dor+ !n)ironment +escibe t7e &o) envionment= inclu$ing buil$ings= &o)space an$ utilitiesB pocess e,uipmentB suppoting sevicesB con$itions un$e &7ic7 &o) is pe"ome$.

>ei"y t7at t7e ogani!ation 7as $etemine$= povi$e$= manages= an$ maintains t7e &o) envionment nee$e$ to ac7ieve con"omity applicable to t7e manu"actue o" t7e po$ucts. >ei"y is) assessment associate$ &it7 po$uct $elivey inclu$es "acilitye,uipment availability an$ maintenance. *nsue is)s ae i$enti"ie$ an$ contolle$ 5.3a. Page ' o" 3'

Audit Report

Re%uirement>



0.0 5ocumentation Re%uirements 0.0.2 -rocedures >ei"y t7at poce$ue e,uie$ by t7e stan$a$ ae establis7e$= $ocumente$= implemente$= an$ maintaine$ "o continual suitability. 0.0.# Control of 5ocuments

-rocedure>

>ei"y t7at t7e poce$ue meets all e,uiements o" t7e applicable stan$a$ an$ is contolle$= implemente$= an$ maintaine$. +escibe 7o& t7e "acility contols $ocuments e,uie$ by t7e QMS to ensue t7at elevant vesions ae use$ an$ maintaine$. +escibe 7o& e
-rocedure>

>ei"y t7at t7e poce$ue meets all e,uiements o" t7e applicable stan$a$ an$ is contolle$= implemente$= an$ maintaine$. o& $oes t7e "acility ensue integation o" eei"y t7at po$uct an$ ot7e speci"ic e,uiements ae integate$ as e,uie$. 0.3 Control of Records

-rocedure>

>ei"y t7at t7e poce$ue meets all e,uiements o" t7e applicable stan$a$ an$ is contolle$= implemente$= an$ maintaine$. o& $oes t7e "acility i$enti"y= stoe= potect= etain= etieve an$ $ispose o" eco$sA as t7e "acility i$enti"ie$ contols an$ esponsibilities nee$e$ to i$enti"y= collect= stoe= potect= etain= etieve an$ $ispose o" eco$sA as t7e "acility maintaine$ eco$s base$ on t7e e,uie$ etention times as speci"ie$ in t7e applicable stan$a$= po$uct spec= an$  o t7e custome  QMS e,uiementsA

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&MS Monitoring' Measurement' Anal$sis  Impro)ement Re%uirements>

=becti)e !)idence / Comments>

E.2., Customer Satisfaction

-rocedure>


(7at met7o$s 7ave t7e ogani!ation implemente$ "o obtaining an$ using in"omation elating to custome peception as to &7et7e e,uiements 7ave been metA

o& 7as t7e ogani!ation e""ectively measue$ custome satis"action an$ analy!e$ t7e esultsA E.2.2 Internal Audits

-rocedure>

>ei"y t7at t7e poce$ue meets all e,uiements o" t7e applicable stan$a$ an$ is contolle$= implemente$= an$ maintaine$. /$enti"y t7e $ate t7e last intenal au$it &as complete$. >ei"y t7at t7e au$it &as pe"ome$ &it7in 12 mont7s "om t7e pevious intenal au$it i" applicable. Note: !I interprets +ast Internal udit- to mean the last complete audit of the .NTI$. ", %hether performed at one time or over the period of /0 months

+i$ intenal au$it planning ta)e into account esults o" pevious au$its an$ citicality o" t7e pocess being au$ite$A

>ei"y t7at t7e intenal au$it pe"ome$6 •

•

•

•

•

con"oms to planne$ aangements inclu$ing t7e e,uiements o" t7e applicable stan$a$  speci"icationB 7as been e""ectively implemente$ an$ maintaine$= inclu$ing eco$sB &as pe"ome$ by in$epen$ent  objective= competent pesonnelB inclu$e outsouce$ activities t7at impact t7e ,uality o" t7e po$uct an$ t7at ae pe"ome$ at t7e "acilityBan$ inclu$es all pocesses e,uie$ by t7e MS e,uie$

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Audit Report to meet t7e applicable stan$a$  speci"ication.

+escibe 7o& t7e ogani!ation a$$esses noncon"omances i$enti"ie$ $uing t7e intenal au$it e.g.= esponse times= esponsibilities= epoting= an$ eco$s.

E.2.# -rocess !)aluation (7at met7o$s ae applie$ "o monitoing an$ measuing QMS pocessesA #7ese met7o$s s7all $emonstate t7e ability o" t7e p ocesses to ac7ieve planne$ esults.

(7en planne$ esults ae not ac7ieve$= &7at actions ae ta)en to ensue con"omity o" t7e po$uctA /$enti"y e


E.# Anal$sis of 5ata

-rocedure>

>ei"y t7at t7e poce$ue meets all e,uiements o" t7e applicable stan$a$ an$ is contolle$= implemente$= an$ maintaine$. (7at $ata 7ave been $etemine$= collecte$ an$ analy!e$ to $emonstate t7e suitability an$ 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 ]

Reported 5ata T$pes

Anal$sis Metod

Fo

=becti)e / G-I

Custome Satis"action Supplie /n"omation Po$uct Con"omity /ntenal %u$it

Re%uirements>


E.0.2 Correcti)e Action

-rocedure>


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(7at actions ae ta)en by t7e ogani!ation to eliminate t7e cause o" noncon"omitiesA %ctions s7oul$ inclu$e6 •

evie&ing noncon"omities

•

$etemining cause o" noncon"omities

•

evaluating action to pevent ecuence

•

$eteminingimplementing action nee$e$

•

eco$ing o" esults

•

evie&ing coective action ta)en

+escibe 7o& coective actions vei"ie$ "o e""ectiveness.

o& ae coective actions initiate$A o& ae esponse times "o a$$essing coective actions tac)e$A E.0.# -re)enti)e Action

-rocedure>

(7at actions ae ta)en by t7e ogani!ation to minimi!e t7e li)eli7oo$ o" potential noncon"omitiesA %ctions s7oul$ inclu$e6

•

$etemining potential noncon"omities an$ t7ei cause evaluating action to pevent occuence

•

$eteminingimplementing action nee$e$

•

eco$ing o" esults

•

evie&ing peventive action ta)en.

•

Re%uirements>


E.3 Management Re)ie

-rocedure>


/$enti"y $ates o" management evie&s &it7in t7e last 129mont7 peio$. >ei"y t7at management evie&s ae con$ucte$ at least evey 12 mont7s. >ei"y t7at t7e management evie& 7as been $ocumente$ &it7 su""icient evi$ence to

Page 1 o" 3'

Audit Report $emonstate con"omity &it7 e,uiements. /" no= note $e"iciencies.


applicable

E.3.2 Re)ie Input 9 >ei"y t7at t7e management evie& inclu$es all inputs e,uie$ by t7e applicable stan$a$= inclu$ing6

•

Result o" au$its Custome ee$bac) Results o" Ris) %ssessment Status o" C%  P% Supplie Pe"omance %nalysis Pocess Pe"omance an$ Po$uct Con"omity C7anges t7at coul$ a""ect t7e MS

•

Recommen$ations "o /mpovement

• • • • • •

E.3.# Re)ie =utput 4 >ei"y t7at t7e management evie& output inclu$es a summay assessment o" t7e e""ectiveness o" t7e MS $etailing any6 • • • •

Re,uie$ c7anges to t7e pocesses +ecisions an$ actions Re,uie$ esouces /mpovement "o po$ucts Ris+ Assessment  Management Re%uirements>


3.# Ris+ Management  Assessment

-rocedure>

>ei"y t7e poce$ue meets a ll e,uiements o" t7e stan$a$ an$ is contolle$= implemente$= an$ maintaine$. >ei"y t7e RM pocess 7as been establis7e$ to i$enti"y an$ contol is)s associate$ &it76 •

impact on $elivey= inclu$ing "acilitye,uipment availability= maintenance an$ supplie pe"omance an$ mateial availabilitysupplyB ,uality o" po$uct= inclu$ing $elivey o" noncon"oming po$uct ?availability o" competent pesonnel. +escibe t7e tools= tec7ni,ues an$ t7ei application "o is) i$enti"ication= assessment an$ mitigation utili!e$ by t7e ogani!ation. Identif$process interaction / e"amples of Ris+ Assessment  Management implementation and tools / tecni%ues used>

Cec+ eac re%uirement upon )erification(e&planation must be given for any blan1 bo&es)> Ris)s i$enti"ie$ Ris)s assesse$

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Ris)s mitigate$ Reco$s maintaine$

Contingenc$ -lanning Re%uirements>


3.3 Contingenc$ -lanning

-rocedure>

>ei"y t7e poce$ue meets a ll e,uiements o" t7e stan$a$ an$ is contolle$= implemente$= an$ maintaine$. >ei"y t7at contingency planning is base$ on assesse$ is)s 5.3. >ei"y t7at t7e output o" contingency planning is $ocumente$= up$ate$ an$ communicate$ as e,uie$. Identif$process interaction / e"amples of Contingenc$ -lanning implementation>

Cec+ eac re%uirement upon )erification(e&planation must be given for any blan1 bo&es)> Dase$ on assesse$ is)s Output $ocumente$  up$ate$ as e,uie$ Output communicate$ Reco$s maintaine$

Management of Cange Re%uirements>


3.,, M=C -rocess +escibe t7e MOC pocess establis7e$ by t7e "acility. >ei"y t7at t7e MOC pocess 7as been establis7e$ to ensue t7at integity o" t7e MS &7en c7anges ae planne$ an$ implemente$.

o& $oes t7e "acility i$enti"y potential is)s associate$ &it7 c7anges pio to ma)ing t7e c7angeA >ei"y t7at c7anges ae appove$ as e,uie$ pio to ma)ing c7anges.

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+escibe 7o& t7e "acility ensues t7at t7e MOC pocess is use$ "o c7anges t7at may a""ect t7e QMS negatively= inclu$ing c7anges6 to t7e ogani!ational stuctueB in )ey o essential pesonnelB in citical suppliesB an$ to MS pocesses= inclu$ing c7anges esulting "om C%  P%

• • • •

+escibe t7e ogani!ationEs pocess "o noti"ication o" c7anges. (7en is noti"ication e,uie$A #o &7o is noti"ication e,uie$A Identif$ process interaction / e"amples of Management of Cange implementation>

Cec+ eac re%uirement upon )erification(e&planation must be given for any blan1 bo&es)> ;egative a""ects on QMS i$enti"ie$ Ris)s i$enti"ie$ pio to c7ange %ppove$ pio to c7ange ;oti"ication o" c7ange Reco$s maintaine$

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-roduct Realiation 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 Monogam po$uct cuently being manu"actue$ an$ available "o evie&

#

Monogammable po$uct meeting all e,uiements but not ma)e$ po$uct cuently being manu"actue$ an$ available "o evie& ;on9monogammable po$uct cuently being manu"actue$ an$ available "o evie&

0

Monogam po$uct manu"actue$ since t7e last %P/ au$it but not available "o e vie& records re)ie

2

3 E 6

Monogammable po$uct manu"actue$ since t7e last %P/ au$it but not available "o evie&  records re)ie ;on9monogammable po$uct manu"actue$ since t7e last %P/ au$it o $ual ? egistation clients 8 Po$uct cuently being manu"actue$ o sevices cuently being povi$e$ t7at "all un$e t7e scope o" t7e egistee$ ,uality management system.

9=T! ,> Please see %P/ Ceti"ication Pogams ad)isor$ * ega$ing implementation o" QMS e,uiements by a :icensee at 7ttp6&&&.api.ogceti"icationsmonogam$ocumentsa$visoies.c"m 9=T! 2> Please i$enti"y any po$ucts  sevices t7at ae being a$$e$ to t7e scope o" :icensing an$  o Registation= inclu$ing po$ucts  sevices t7at ae Fne&G an$ 7ave been a$$e$ since t7e last au$it. #7ese po$ucts  sevices must be consi$ee$ &7en sampling objective evi$ence $uing t7e au$it. o e
Complete te table belo based on te abo)e classifications> Categor$

-roduct/Ser)ice Identification

Specification (as applicable

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Top of the Document

-roduct Realiation 1Contract Re)ie Re%uired -rocedure> 2erify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained

-rocedure>

3.,., Contract Re)ie

List all Contracts re)ieed / sampled> Contract Re)ie (3.,.,

5etail e)idence obser)ed(including records and documents revie%ed, personnel intervie%ed, and processes observed)> 5etermination of re%uirements>

Cec+ eac re%uirement upon )erification( e&planation must be given for any blan1 bo&es)> Custome Re,uiements

5etermination of -roduct Re%uirements (3.,.2

:egal  ot7e applicable e,uiements Re,uiements not state$ by custome %lso vei"y6 Re,uiements con"ime$ an$ eco$s maintaine$ &7ee no e,uiements ae state$$ocumente$ by custome

Revie&e$ pio to commitment

Re)ie of re%uirements> Re)ie of -roduct Re%uirements (3.,.#

Canges to Re%uirements

Re,uiements i$enti"ie$ an$ $ocumente$ Capability con"ime$ Reco$s maintaine$

Canges to contract re%uirements>

+ocuments amen$e$ C7anges communicate$

(3.,.#

AuditorHs Assessment of -rocess(es>

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-roduct Realiation 1 -lanning 5etail e)idence obser)ed(including records and documents revie%ed, personnel intervie%ed, and processes observed)>

Cec+ eac re%uirement upon )erification(e&planation must be given for any blan1 bo&es)> Consistent &it7 QMS pocess

-lanning of product realiation>

Re,uie$ esouces  &o) envionment 4.3 Po$uct  custome e,uiement 5.1 :egal  ot7e applicable e,uiements Contingencies base$ on is) assessment 5.3= 5.5 +esign an$ $evelopment e,uiements 5.4

-lanning (3.2

Re,uie$ vei"ication= vali$ation= monitoing= measuing= inspection= test activities MOC 5.11 Reco$s maintaine$

=utput of product realiation planning>

Output $ocumente$ Plans up$ate$ as c7anges occu Plans maintaine$ suitably


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-roduct Realiation 4 5esign  5e)elopment Re%uired -rocedure> 2erify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained

3.0 5esign  5e)elopment -lanning  Control

-rocedure>

Select all tat appl$> Pe"ome$ in97ouse Pe"ome$ at a $i""eent location &it7in t7e same ogani!ation Outsouce$ * ("elect a representative sampling (minimum of three) of the applicable products (per !I "pecifications or $egistration "cope)

5esign  5e)elopment Acti)ities

5esign -ac+age Re%uirements (onogram 3nly) (Anne" A.E

5esign  5e)elopment Controls 1 In4ouse / different location itin same organiation (3.0.,' 3.0.2' 3.0.#' 3.0.0' 3.0.3' 3.0.E' 3.0.6

Note: Any license in “application” status requires verification of all product designs within that specification Any product additions to e!isting licenses must have evidence of e!isting designs

Verif$ tat te licensee/applicant as a design pac+age for eac product under te scope of eac Monogram License if design is re%uired.

5etail e)idence obser)ed(including records and documents revie%ed, personnel intervie%ed, and processes observed)> 5esign  5e)elopment -lanning>

Cec+ eac re%uirement upon )erification(e&planation must be given for any blan1 bo&es)> Planning as pe 5.4.1 +esign plan up$ate$ *""ective communication +esign acceptance citeia

5esign  5e)elopment Inputs>

%P/ Spec e,uiements inclu$e$ &7en applicable /nputs pe 5.4.2 Reco$s Maintaine$ %lso vei"y6 9 Custome e,uiements 5.1 9 Results "om is) assessment 5.3 9 Re,uiements "om e
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5esign  5e)elopment =utputs>


Output as pe 5.4.3 Reco$s Maintaine$ %lso vei"y6 9 +%C i$enti"ie$  e"eence$ 9 Citical po$uctscomponents i$enti"ie$  e"eence$

5esign  5e)elopment Re)ie>

Revie& as pe 5.4.4 Reco$s Maintaine$

5esign  5e)elopment

>ei"ication an$ inal Revie& as pe 5.4.5 Con$ucte$  $ocumente$ pe planne$ aangement 5.4.1 Reco$s Maintaine$

5esign  5e)elopment Validation  Appro)al>

>ali$ation an$ %ppoval as pe 5.4.' Reco$s Maintaine$

5esign  5e)elopment Canges>

C7anges as pe 5.4.Reco$s Maintaine$

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

Pesonnel Competence Reco$s Maintaine$

5esign  5e)elopment Controls 1 =utsourced (3.0.,

%lso vei"y6

9Resouces= esponsibilities= aut7oities an$ t7ei inte"aces 9 Supplies contol= &7en $esign activities ae outsouce$

&ualification/competenc$ of personnel> Training  Competence ( Design 4 Development) (0.#.2.2' 0.#.2.#

CompetentQuali"ie$ #aining *valuation Reco$s Maintaine$


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-roduct Realiation 4-urcasing Re%uired -rocedure(s> 2erify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained

3.E.,., -urcasing

Poce$ue6

3.E.# Verification of -urcased -roducts and Acti)ities

Poce$ue6

3.6.# Identification and Traceabilit$

Poce$ue6

3.6.0 -roduct Inspection/Test Status

Poce$ue6

3.6.3 Customer4supplied -ropert$

Poce$ue6

3.6.E.,-reser)ation of -roduct

Poce$ue6

5etail e)idence obser)ed(including records and documents revie%ed, personnel intervie%ed, and processes observed)> Control of -urcasing> -urcasing Controls (3.E.,

Cec+ eac re%uirement upon )erification(e&planation must be given for any blan1 bo&es)> Citicality o" activitiespo$ucts $etemine$ #ype an$ e
Suppliers sampled and product/component/acti)it$ performed> Critical Suppliers 1 !)aluation and Ree)aluation (3.E.,.2' 3.E.,.0

9on4Critical Suppliers 1 !)aluation and Ree)aluation (3.E.,.#' 3.E.,.0

/nitial capability assessment pe 5.'.1.2 a=b Site speci"ic citeia Reevaluation pe 5.'.1.3 Reco$s Maintaine$ 5.'.1.5 %lso vei"y6 Ris) assessment associate$ &it7 po$uct $elivey inclu$es supplie pe"omance. *nsue is)s ae i$enti"ie$ an$ contolle$ 5.3b.

Suppliers sampled and product/component/acti)it$ performed>

/nitial an$ on9going capability assessment pe 5.'.1.3 Reco$s Maintaine$ 5.'.1.5 %lso vei"y6 Ris) assessment associate$ &it7 po$uct $elivey inclu$es supplie pe"omance. *nsue is)s ae i$enti"ie$ an$ contolle$ 5.3b.

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List all outsourced acti)ities and processes (if applicable>


Ogani!ationEs applicable QMS e,uiements satis"ie$ Reco$s Maintaine$

%lso vei"y6

=utsourced Acti)ities (3.E.,.E

-urcasing Information (3.E.2

Ogani!ation maintains esponsibility "o po$uct con"omance to speci"ie$ e,uiements inclu$ing %P/ Spec

Control of outsourced acti)ities>

-urcasing Information (include contracts*!3s sampled 5minimum of 6)>

%cceptance citeia $ocumente$ Reco$s Maintaine$ %lso vei"y6 +ocumente$ e,uiements pe 5.'.2ab c$= &7ee applicable

Verification of -urcased -roduct / Acti)ities (3.E.#

Verification of conformance to purcase re%uirements (include records revie%ed as evidence of conformance )>

Reco$s Maintaine$ %lso vei"y6 9 Contols "o vei"ication at supplieEs pemises= &7ee applicable

Verification of identification / traceabilit$ (as applicable>

Reco$s Maintaine$ +elivey an$ post9$elivey activities

Identification and Traceabilit$

Maintenance an$ eplacement o" i$enti"ication  ma)s

(3.6.#

%lso vei"y6 /$enti"ication an$ taceability o" custome9supplie$ po$ucts

-roduct Inspection / Test Status (3.6.0

Identification of inspection and/or test status (as applicable>

/n$icates con"omity  non9 con"omity o po$uct Reco$s Maintaine$ %lso vei"y6 Release o" po$uct t7at meets e,uiementso aut7oi!e$ un$e

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concession

Poce$ue pe 5.-.5

Control of customer4supplied propert$ (if applicable> Customer4 supplied -ropert$

Reco$s maintaine$ %lso vei"y6 Re,uiements "o epoting to custome

(3.6.3 -reser)ation of products and constituent parts (include evidence of verification of stoc1 assessment) >

Poce$ue pe 5.-.'.1 Re,uiements "o stoage an$ assessment i$enti"ie$

-reser)ation of -roduct Storage and Assessment

+esignate$ stoage aeas Reco$s maintaine$ %lso vei"y6

(3.6.E' 3.6.E.2

9 /$enti"icationtaceability ma)s= 9

Inspection and testing

Inspection and testing of purcased product / ser)ices 6

tanspotation= 7an$ling= pac)aging an$ potection /nteval appopiate to t7e po$uctpat being assesse$

Poce$ue pe 5.-.-.1 *vi$ence o" con"omity &it7 acceptance citeia maintaine$

(3.6.6

&ualification/competenc$ of personnel> Training  Aareness -ersonnel Competence (in5house and outsourced) (0.#.2.2' 0.#.2.#

#aining "e,uency an$ contents i$enti"ie$ Competent,uali"ie$ #aining evaluation Reco$s maintaine$ %lso vei"y6 9 Custome9speci"ie$povi$e$ taining 9%&aeness o" pesonnel &it7 espect to t7ei activitiescontibution to QMS


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-roduct Realiation 1 -roduction and Ser)icing =ter processes included>

Po$uction ? Sevice Povision

Pesonnel Competence

#aining ? %&aeness

Contol o" #esting= Measuing ? Monitoing *,uipment

Po$uct Release

MOC

Contol o" ;oncon"oming Po$uct

Ris) %ssessment ? Management

Manu"actuing Capability Re%uired -rocedure> 2erify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained

3.6.,., -roduction

Poce$ue6

3.6.,.2 Ser)icing (if applicable)

Poce$ue6

3.6.* -re)enti)e Maintenance

Poce$ue6

3.* Control of Testing' Monitoring and Measurement !%uipment

Poce$ue6

3.7 -roduct Release

Poce$ue6

-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 (ie, are they capable of manufacturing, %hat are they capable of manufacturing)9 >

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Audit Report List production / ser)icing processes re)ieed / sampled> -roduction / Ser)icing Acti)ities

Cec+ eac re%uirement upon )erification(e&planation must be given for any blan1 bo&es)> Poce$ue as pe 5.-.1.1

5etail e)idence obser)ed(including records and documents revie%ed, personnel intervie%ed, and processes observed)> Controls establised and implemented for production>

+esign e,uiementsc7anges Suitable e,uipment

Control of -roduction (3.6.,.,

Pocess contol $ocuments %lso vei"y6 9 9 9 9

Controls establised and implemented for ser)icing>

/mplementation o" Quality Plan= i" e,uie$ (o) instuctions= &7en applicable Monitoing ? measuing activities Po$uct elease activities

Poce$ue as pe 5.-.1.2 Revie& o" e,uiements Suitable e,uipment

Control of Ser)icing (if applicable) (3.6.,.2

/$enti"icationtaceability Pocess contol $ocuments %lso vei"y6 9 (o) instuctions= &7en applicable 9 Monitoing ? measuing activities 9 Re,uiements "o elease o" sevice$ po$uct

5ocumentation of process controls> -rocess Control 5ocuments (3.6.,.#

/nclu$es e,uiements "o vei"ying con"omance &it7 ,uality plans= po$uct specs= custome e,uiements Re"eence instuctions %cceptance citeia %lso vei"y6 /nspection 7ol$s an$ &itness points

-roduct realiation documentation sampled>

-roduct Realiation Capabilit$ 5ocuments (3.6.,.0

Po$uct eali!ation plan 5.2 Reco$s o" evie&vei"ication= vali$ation= monitoing= measuement= inspection= tests %cceptance citeia $emonstating capability to manu"actue po$ucts"amily o" po$ucts

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Validation of -rocesses for -roduction and Ser)icing (3.6.,.3

Validation of processes for production and ser)ices (including outsourced)>

+emonstates ability to ac7ieve planne$ esults >ei"ication o" supplie con"omance to stan$a$ e,uiements 5.'.1.' Reco$s maintaine$

-roduct %ualit$ plan re%uired b$ te contract>

%$$esses eac7 e,uiement o" 5.-.2 a t7oug7 e Revisions $ocumente$  appove$

-roduct &ualit$ -lans (if required) (3.6.2

Identification and Traceabilit$ -roduct Inspection / Test Status -reser)ation of -roduct (3.6.#' 3.6.0' 3.6.3' 3.6.E


Communicate$

Identification / traceabilit$ trougout product realiation process>

Reco$s maintaine$ %lso vei"y 6 9 +elivey an$ post9$elivey 9 Maintenance  eplacement o" i$enti"ication  ma)s

Identification of inspection / test status trougout product realiation process>

Reco$s maintaine$ in$icating con"omity  noncon"omity o" po$uct

Customer4supplied propert$ trougout product realiation (if applicable)>

Poce$ue pe 5.-.5 Reco$s maintaine$ %lso vei"y6 Re,uiements "o epoting to custome

-reser)ation of product trougout product realiation and deli)er$>

/$enti"ication  taceability ma)s #anspotation= 7an$ling= pac)aging an$ potection Reco$s maintaine$

Storage and assessment trougout product realiation and deli)er$>

+esignate$ stoage aea  stoc) ooms Reco$s o" assessment maintaine$

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In4process inspection and testing>


Poce$ue as pe 5.-.-.1 /nspection  testing at planne$ stages pe plan  poce$ue *vi$ence o" con"omity &it7 acceptance citeia maintaine$

Inspection and Testing (3.6.6

Poce$ue as pe 5.-.-.2 inal inspection  testing pe plan  poce$ues *vi$ence o" con"omity to e,uiements maintaine$

-re)enti)e maintenance for e%uipment used in product realiation>

-re)enti)e Maintenance (3.6.*

Control of Testing' Monitoring and Measuring !%uipment (3.*

Poce$ue as pe 5.-. #ype o" e,uipment= "e,uency= esponsible pesonnel i$enti"ie$ Reco$s maintaine$

Control and maintenance of testing' monitoring and measuring e%uipment>

Poce$ue as pe 5. /$enti"ication= status= taceability= "e,uency= calibationvei"ication met7o$s= acceptance citeia %lso vei"y6 Contol o" out9o" 8toleance e,uipment an$ assessment o" pevious measuements

Testing' monitoring and measurement e%uipment sampled>

Ini,uely i$enti"ie$ Calibation status i$enti"ie$ #aceable to natElintEl stan$a$ /nclu$e$ on egisty Reco$s maintaine$ %lso vei"y6 9Compute so"t&ae con"imation

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9 *
Release of product>

Poce$ue as pe 5.0 Release upon satis"actoy completion o" planne$ aangements

-roduct Release (3.7

%lso vei"y6 %ppoval o" elease by aut7oitycustome &7en planne$ aangements ae not met

Poce$ue as pe 5.1.1

Control of nonconforming product>

Met7o$ o" a$$essing non9 con"oming po$uct i$enti"ie$ pe 5.1.2 Concession appove$ by elevant aut7oity an$o custome Custome noti"ication pe 5.1.4

Control of 9onconforming -roduct

Reco$s maintaine$ 5.1.5 %lso vei"y6

(3.,;

9 Pope i$enti"ication to pevent uninten$e$ use 9 %$$essing t7e noncon"omity 9 /$enti"ication= $ocumentation= analysis an$ actions ta)en "o noncon"oming po$uct i$enti"ie$ a"te $elivey 9 Ris) assessment associate$ &it7 po$uct ,uality inclu$es supplie pe"omance. *nsue is)s ae i$enti"ie$ an$ contolle$ 5.3b.

&ualification/Competenc$ of personnel>

Training / Competence (production and servicing personnel) (0.#.2.2' 0.#.2.#

#aining "e,uency an$ contents i$enti"ie$ Competent,uali"ie$ #aining evaluation Reco$s maintaine$ %lso vei"y6

9 Custome9speci"ie$  povi$e$ 9 Outsouce$ pesonnel ,uali"icationcompetence


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8se of A-I Monogram' A-I&R and A9A: Mar+s A.3 Control of te Application of te A-I Monogram

-rocedure>

Re%uirements>


>ei"y t7e poce$ue $ocuments all ma)ingmonogamming e,uiements inclu$es all e,uiements o" %nne< %. +escibe t7e licenseeEs %P/ Monogam ma)ing emoval poce$ue "o non9con"oming po$uct. /$enti"y evi$ence o" implementation= i" applicable. AMA 4 i" t7e "acility 7as an %M%= i$enti"y t7e ma)ing "acility an$ $etail contols establis7e$. Po$uct con"oms to %P/9spec e,uiements

List all A-I MonogramMar+s sampled(on products, letterhead, business cards or any other medium)>

%pplie$ by licensee only /nclu$es ma) an$ license numbe %pplie$ at license$ "acility location

Verif$ conformance of te folloing re%uirements for use of te Monogram and A9A:/A-I&R mar+. An$ 9oselected is considered a nonconformance.

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%P/QR Ma)s ae onl$ on coespon$ence= a$vetising= an$ pomotional mateials t7at ae elate$ to t7e goo$s an$ sevices e"eence$ in t7e scope o" t7e Ogani!ationEs egistation. #7e%P/QR  %;%D Ma) as not been use$ on a po$uct o in suc7 a &ay as to suggest t7at %P/QR  %;%D 7ave ceti"ie$ o appove$ any po$uct= pocess o sevice o" t7e egistee$ ogani!ation. #7e %P/QR an$ %;%D Ma)s ae use$ in conunction it t7e ogani!ationEs name= location an$ egistation ceti"icate numbes. #7e %;%D Ma) is use$ in conunction it t7e %P/QR Ma). #7e %P/QR an$ %;%D Ma)s are epo$uce$6 5. in blac)= its oiginal colos o t7e pe$ominant colo o" t7e lette7ea$ o pinting= '. on a clealy contasting bac)goun$= an$ -. in a si!e &7ic7 ma)es t7e ma)Es "eatues clealy $istinguis7able= t7e lengt7 o" a si$e being in no case less t7an 12mm %P/QR Ma) an$ 1mm %;%D Ma). Ipon &itten noti"ication= t7e ogani!ation immediatel$ ceased and desisted in t7e use o" t7e %P/QR%;%D Ma)s an$o %P/ Monogam 1 upon suspension o cancellation o 2 use in any manne= &7ic7 %P/%P/QR intepets as mislea$ing. Applicant organiation 1 %P/QR= %;%D Ma)s an$o %P/ Monogam a)e not been i$enti"ie$ in pomotional mateials o ot7e company $ocumentation.

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Audit Time Summar$ 5ate

Start Time

!nd Time

5a$ , 5a$ 2 5a$ # 5a$ 0 5a$ 3 5a$ E 5a$ 6 If audit duration is longer than ; days, please add additional daily start*stop time Time spent auditing offsite or at othe locations, such as subcontractors, must be identified and noted in the audit report Audit Summar$ Strengts>

=pportunities for Impro)ement (=

-ro)ide a summar$ of te closure and )erification of correcti)e actions for pre)ious findings' if an$>

-ro)ide an o)erall assessment of te capabilit$ of te facilit$ to manufacture product(s (Monogram>

-ro)ide an o)erall assessment of te effecti)eness of te management s$stem and te facilit$Hs abilit$ to perfor acti)ities itin te scope of te registration>

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Conclusion / Recommendation Registation an$  o :icensing ae gante$  continue$  einstate$ base$ on satis"actoy implementation o" a Management System an$  o $emonstate$ capability to meet applicable speci"ication e,uiements &it7 no noncon"omities i$enti"ie$. Registation an$  o :icensing be gante$  continue$  einstate$ subject to t7e evie& o" t7e noncon"omance i$enti"ie$ an$ acceptance o" appopiate coective actions by t7e %P/ Registation ? :icensing Committee. Registation an$  o :icensing subject to t7e evie& o" t7e noncon"omances i$enti"ie$ an$ acceptance o" appopiate coective actions by t7e %P/ Registation ? :icensing Committee. #7is $ecision may inclu$e a e9 au$it to vei"y t7e e,uie$ coective actions. 9ote6%u$its may esult in suspension o cancellation o" t7e ogani!ationEs licenses an$o egistations o &it7$a&al o application "o licensingegistation.%P/ ma)es t7e "inal $etemination o" ceti"ication status an$ s7all be t7e sole ju$ge o" &7et7e licensue o egistation &ill be gante$maintaine$.Jou &ill be noti"ie$ by %P/ i" you licenseegistation is a$vesely a""ecte$ by t7e esults o" t7is au$it. Comments / 9otes>

=rganiationHs Representati)e Comments>

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

ist suveillance au$it a"te stage 2 initial au$it 8 MIS# be sc7e$ule$ 0 mont7s a"te t7e last $ay o" t7e stage 2 au$it

•

Secon$  subse,uent suveillance au$its 8 aoun$ au$it annivesay $ate o" initial  "ist suveillance au$it

•

Receti"ication au$its 8 at least ' mont7s pio to t7e e

9e"t Audit 5ate>

"y signing below# $ %we& attest that the information above is accurate and has been collected by the audit t eam during the 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 the audi team (he signature only confirms that the audit was performed) that a copy of this document %*+,-./& was left) and# the au recommendations and audit conclusions were communicated by the auditor AP$ reserves the right to have final determinati of the level of nonconformity identified by in the audit AA0s and final audit report

=rganiation Representati)e>

5ate>

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Supplemental Audit Information .nter additional information relevant to the audit, if necessary
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9/C or Concern

-roduct Impact

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Audito Initials

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=pening / Closing Meeting Attendance Seet 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/cec+ te 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

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api audit checklist 9thedition.docx

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