AS9100C Checklists

AS 9100C: 2009 Quality Management System Audit Checklist
Contractor: AS9100C Audit Checklist

!um"er #uestion Process$Procedure %e&erence
Date: Program P AS Code:

Comments
4. Quality Management System

4.1 General Re uirements:
)as the contractor esta"lished- documentedimplemented- and maintained a #uality .anagement System- in accordance with the re/uirements o& AS 91000
'
1s an e&&ective 2Continuous 1mprovement2 program- an active part o& the contractor3s #uality .anagement System0
)as the contractor:
a*
1denti&ied the processes needed &or the #uality .anagement System- including their applications throughout the contractor3s organi4ation0
"*
Determined the se/uence and interaction o& these processes0
c*
Determined the criteria and methods neededto ensure that "oth the operation and control o& these processes are e&&ective0
d*
5nsured the availa"ility o& resources and in&ormation necessary- to support the operation and monitoring o& these processes0
e*
.easured- monitored- and analy4ed these processes0
&*
1mplemented the actions necessary to achieve their planned results- including continuous improvement o& the processes0
Does the contractor manage these processes- in accordance with AS 9100 re/uirements0
Do ade/uate controls e6ist- and are they identi&ied within the contractor3s #uality .anagement System- &or process re/uirements that are outsourced- and a&&ect product con&ormity0
Developed By: Art Baldwin
Page 1 of 79


Comments
4.2 !"cumentati"n Re uirements:

4.2.1 General: 7
Does the #uality .anagement System documentation include:
a*
Documented statements o& a #uality policyand #uality o":ectives0
"*
A #uality manual0
c*
Documented procedures re/uired "y AS 91000
d*
Procedures needed "y the contractor to ensure e&&ective planning- operation- and control o& the processes0
e*
%ecords re/uired "y AS 91000
Does an ade/uate communication process e6ist to ensure that personnel have access to- and are aware o&- relevant #uality .anagement System documentation and changes0
4.2.2 Quality Manual: 9

)as a #uality manual "een esta"lished and maintainedthat includes:
a*
;he scope o& the #uality .anagement System- including details o&- and :usti&ication &or any e6clusions or e6ceptions0
"*
Documented procedures esta"lished &or the #uality .anagement System- or re&erence to them0
c*
A description o& the interaction "etween the processes o& the #uality .anagement System0
4.2.# C"ntr"l "$ !"cuments:

Are the documents that are re/uired &or the #uality .anagement System ade/uately controlled0
10
)as a documented procedure "een esta"lishedidenti&ying the &ollowing controls:
a*
Approval o& documents &or ade/uacy 2prior2 to issue0
Page 2 of 79

!um"er "* 10 c*
5nsures that changes- and the current revision status o& documents are identi&ied0

Process$Procedure %e&erence Comments
#uestion
%eview and update as necessary- including re<approval o& documents0
d*
5nsure that latest revisions- or relevant versions o& applica"le documents- are availa"le at points o& use0
e*
5nsures that documents remain legi"le- and are readily identi&ia"le0
&*
5nsure that documents o& e6ternal origin are identi&ied- and their distri"ution is controlled0
g*
Preventing the unintended use o& o"solete documents- and to apply suita"le identi&ication to them i& they are retained0
4.2.4 C"ntr"l "$ Rec"rds:

)ave records "een esta"lished and maintained to provide evidence o& con&ormity to re/uirements- and o& the e&&ective operation o& the #uality .anagement system0
11
1'
)as a documented procedure "een esta"lished to de&ine the &ollowing re/uired controls0
a*
1denti&ication0
"*
Storage0
c*
%etrieval0
d*
Protection0
e*
%etention ;ime0
&*
Disposition0
1(
Does a documented procedure e6ist- de&ining the method &or controlling records that are created "yand$or retained "y- suppliers0
Page 3 of 79


Comments
5. Management Responsibility
%.1 Management C"mmitment:
)as top management provided evidence o& its commitment to the development and implementation o& the #uality .anagement System- and &or continuous improvement o& its e&&ectiveness, "y:
a*
Communicating to the organi4ation the importance o& meeting customer- as well as regulatory and legal re/uirements0
"*
5sta"lishing the #uality policy0
c*
5nsuring that #uality o":ectives are esta"lished0
d*
Conducting .anagement %eviews0
e*
5nsuring the availa"ility o& ade/uate resources0
%.2 Cust"mer &"cus:

)as top management ensured that customer re/uirements are determined and met- with the aim o& enhancing customer satis&action0
'
)as top management esta"lished and implemented a process- to ensure that product con&ormity and on<time delivery are measured- and that appropriate action is taken i& planned results are not- or will not- "e achieved0
%.# Quality '"licy:

+
)as top management ensured that the #uality Policy:
a*
1s appropriate &or the purpose o& the contractor3s organi4ation0
"*
1ncludes a commitment to comply with re/uirements- and to continually improve the e&&ectivness o& the #uality .anagement System0
c*
Provides a &ramework &or esta"lishing and reviewing #uality o":ectives0
d*
1s communicated and understood within the contractor3s organi4ation0
Page 4 of 79

!um"er + e* #uestion
1s reviewed &or continual appropriateness0

%.4 'lanning:
%.4.1 Quality ()*ecti+es:
)as top management ensured that #uality o":ectives are esta"lished &or relevant &unctions- and at appropriate levels within the organi4ation0
)ave #uality o":ectives- needed to meet the re/uirements o& the product- "een esta"lished0
Are #uality o":ectives measura"le- and consistant with the contractor3s documented #uality Policy0
%.4.2 Quality Management System 'lanning:

)as top management ensured that the resources needed to achieve the #uality o":ectives are planned &or- and identi&ied0
1s the output o& the contractor3s planning documented0 =ie> /uality manual- procedures- work instructions- /uality plans- etc?*
10
@hen changes to the #uality .anagement System are planned and implemented- does top management ensure that the integrity o& the #uality System is maintained0
%.% Res,"nsi)ility- Auth"rity- and C"mmunicati"n:

%.%.1 Res,"nsi)ility and Auth"rity:
)as top management ensured that responsi"ilities and authorities &or the #uality .anagement System are de&ined- and communicated throughout the contractor3s organi4ation0
11
%.%.2 Management Re,resentati+e:

)as top management designated and appointed mem"er=s* o& management- who have reponsi"ility and authority that includes:
1'
a*
5nsuring that #uality processes are esta"lished- implemented- and maintained0
"*
%eporting to top management on the per&ormance o& the #uality .anagement System- including any needs &or improvement0
Page 5 of 79

!um"er c* 1' #uestion
Promoting awareness o& customer re/uirements throughout the contractor3s organi4ation0

d*
;he organi4ational &reedom- and unrestricted access to top management- to resolve #uality .anagement issues0
%.%.# .nternal C"mmunicati"ns:

)as top management ensured that appropriate communication processes have "een esta"lished throughout the organi4ation0
1(
1+
Does communication- regarding the e&&ectiveness o& the #uality .anagement System- take place0
%./ Management Re+ie0:

%./.1 General:
Does top management accomplish 2%eviews2 o& the #uality .anagement System at planned intervals- to ensure it3s continuing suita"ility- ade/uacy- and e&&ectiveness0
1,
17
Are opportunities &or improvement- and the need &or changes to the #uality .anagement System- including the contractor3s #uality Policy and #uality B":ectivesevaluated during 2.anagement %eviews20
18
Are records o& 2.anagement %eviews2 documented and maintained as #uality records0
%./.2 Re+ie0 .n,ut: 19

Do the inputs to 2.anagement %eviews2 include in&ormation on:
a*
%esults o& audits0
"*
Customer Aeed"ack0
c*
Process per&ormance and product con&ormity0
d*
Status o& preventive and corrective actions0
e*
Aollow<up actions &rom previous .anagement %eviews0
&*
Planned changes that could a&&ect the #uality .anagement System0
Page 6 of 79

!um"er 19 g* #uestion
%ecommendations &or improvement0

%./.# Re+ie0 (ut,ut: 19

Do the outputs &rom the 2.anagement %eviews2 include the decisions and actions related to:
a*
1mprovement o& the e&&ectiveness o& the #uality .anagement System- and its processes0
"*
1mprovement o& the product- related to customer re/uirements0
c*
%esources that are re/uired0
6. Resource Management
/.1 'r"+isi"n "$ Res"urces:
1
)ave the resources "een determined and made availa"le &or:
a*
1mplementing and maintaining a #uality .anagement System- including continuous improvement o& it3s e&&ectiveness0
"*
5nhancing customer satis&action- "y meeting customer re/uirements0
/.2 1uman Res"urces:

/.2.1 General:
Aor personnel who per&orm work a&&ecting product /uality- is competency "ased on appropriate educationtraining- skills- and e6perience0
'
/.2.2 C"m,etency- A0areness- and 2raining:
)as the contractor3s organi4ation:
a*
Determined the appropriate skills and competencies- &or personnel per&orming work a&&ecting /uality0
"*
Provided training- or taken other actions to satis&y competency needs0
c*
5valuated the e&&ectiveness o& any actions taken0
Page 7 of 79

!um"er d* #uestion
5nsured that employees are aware o& the signi&icance and importance o& their activities- and how they contri"ute to the achievement o& the #uality o":ectives0

e*
.aintained appropriate personnel records o& educationtraining- skills- and e6perience0
/.# .n$rastructure:
;o achieve con&ormity o& the product- does the contractor3s organi4ation identi&y- provide- and maintain appropriate &acilities- including:
a*
Buildings- workspace- and associated utilities0
"*
Process e/uipment- including hardware- and so&tware0
c*
Supporting Services0
/.4 3"rk 4n+ir"nment:

)as the environment- needed to attain con&ormity o& product re/uirements- "een determined and managed ade/uately =noise- temperature- lighting- humidity- etc*0
7. Product Realization
5.1 'lanning "$ Reali6ati"n 'r"cess:
1s planning o& the contractor3s product reali4ationconsistent with the re/uirements o& the other processes o& the #uality .anagement System0
'
@hen planning product reali4ation processes- are the &ollowing "eing considered and determined:
a*
#uality o":ectives- and re/uirements &or the product- including: 1* Product and personnel sa&ety0
'* %elia"ility- maintaina"ility- and availa"ility0
(* Produci"ility and inspecta"ility0
+* Suita"ility o& parts and materials used in the product0
Page 8 of 79

!um"er #uestion

Process$Procedure %e&erence

Comments
=a<Con3t?* #uality o":ectives- and re/uirements &or the product- including: ,* Selection and development o& em"edded so&tware0
'
7* %ecycling or &inal disposal o& the product at the end o& it3s li&e0
"*
;he need to esta"lish processes- documentsand provide resources 2speci&ic2 to the product re/uirements0
c*
%e/uired veri&ication- validation- monitoringinspection- and test activities- 2speci&ic to the product2- and criteria &or product acceptance0
d*
%ecords that are needed- to provide evidence that the reali4ation processes and resulting product- satis&y customer re/uirements0
e*
Con&iguration management appropriate to the product0
&*
%esources to support the use and maintenance o& the product0
1s the planning output in a &orm- appropriate &or the contractor3s methods o& operation0
5.1.1 'r"*ect Management:

)as the contractor esta"lished an ade/uate system- with associated processes- to plan and manage product reali4ation in a structured and controlled manner- to meet customer re/uirements at an accepta"le risk- within resource and schedule constraints0
5.1.2 Risk Management:

)as the contractor esta"lished- implemented- and maintained processes- to manage 2risk2 and achieve applica"le customer re/uirements- including:
a*
Assignment o& responsi"ilities &or risk management0
"*
De&initions o& risk criteria =e?g? likelihoodconse/uences- risk acceptance*0
c*
1denti&ication- assessment- and communication o& risks throughout product reali4ation0
Page 9 of 79

!um"er d* , #uestion


Comments
1denti&ication- implementation- and management o& actions- to mitigate risks that e6ceed the de&ined risk acceptance criteria0
e*
Acceptance o& risks remaining- a&ter implementation o& mitigating actions0
5.1.# C"n$igurati"n Management:

)as the contractor esta"lished- implemented- and maintained a con&iguration management process that includes:
a*
Con&iguration management planning0
"*
Con&iguration identi&ication0
c*
Change control processes0
d*
.aintaining records o& con&iguration status0
e*
Con&iguration audits0
5.1.4 C"ntr"l "$ 3"rk 2rans$ers:

)as the contractor esta"lished- implemented- and maintained a process- to plan and control the temporary or permanent trans&er o& work =e?g? &rom one contractor &acility to another- &rom the contractor to a supplier- or &rom one supplier to another supplier*- and to veri&y con&ormity o& the work to the contract$customer re/uirements0
5.2 Cust"mer Related 'r"cesses:

5.2.1 !eterminati"n "$ Re uirements Related t" the 'r"duct: 9
)as the contractor3s organi4ation determined:
a*
%e/uirements speci&ied "y the customerincluding the re/uirements &or delivery and post<delivery activities0
"*
%e/uirements not stated "y the customer- "ut necessary &or speci&ied or intended use- when known0
c*
Statutory and regulatory re/uirements related to the product0
d*
Any additional product re/uirementsmandated "y the contractor3s Policies and$or Procedures0
Page 10 of 79

!um"er #uestion 5.2.2 Re+ie0 "$ Re uirements Related t" the 'r"duct:
Prior to commitment to the customer =eg> su"mission o& Proposals- acceptance o& Contracts or Brders- or acceptance o& Change Brders or Contract .odi&ications*are re/uirements reviewed to ensure that:

a*
Product re/uirements are de&ined0
"*
Contract or Brder re/uirements- di&&erent &rom those previously e6pressed- are resolved0
c*
;he contractor has the a"ility to comply with the de&ined re/uirements0
d*
Any special re/uirements o& the product are determined0
e*
Areas o& risk have "een identi&ied =e?g? new technology- short delivery time &rame- etc*0
10
Are the results o& %eviews- and actions arising &rom these %eviews- recorded and maintained as records0
11
@here the customer has not provided a documented statement o& re/uirements- are customer re/uirements con&irmed "y the contractor- prior to acceptance0
1'
@here product re/uirements are changed- does the contractor3s organi4ation ensure that applica"le documentation is amended- and relevant personnel are made aware o& the changed re/uirements0
5.2.# Cust"mer C"mmunicati"n:

)as the contractor3s organi4ation determined and implemented- an e&&ective process &or communicating with customers- relating to:
1(
a*
Product in&ormation and re/uirements0
"*
1n/uiries- Contracts- Amendments- or Brder handling0
c*
Customer &eed"ack- including customer complaints0
Page 11 of 79

!um"er #uestion


Comments
5.# !esign and !e+el",ment:

5.#.1 !esign and !e+el",ment 'lanning: 1+
Are product design and development activities planned and controlled0
1,
During design and development planning- has the contractor determined and documented:
a*
;he various stages o& design and development0
"*
%eview- veri&ication- and validation stepsappropriate to each design and development stage0
c*
%esponsi"ilities and authorities &or design and development0
17
)as the contractor esta"lished the necessary processes to allow &or the division o& the design and development e&&orts into distinct activities- and &or each activityde&ined the tasks- necessary resources- responsi"ilitiesdesign content- input and output data- and planning constraints0
18
Are the di&&erent design and development tasks to "e accomplished- "ased on the sa&ety and &unctional o":ectives o& the product- in accordance with the customer3s re/uirements- statutory- and regulatory re/uirements0
19
Does the contractor3s process &or design and development planning- take into consideration the capa"ility to produce- inspect- test- and maintain the product0
19
Are inter&aces managed- "etween the di&&erent groups that are involved in the design and development processes- to ensure e&&ective communication- and clear assignment o& responsi"ilities0
'0
1s planning output updated- as design and development progresses0
5.#.2 !esign and !e+el",ment .n,uts: '1

Are inputs- related to product re/uirements- de&ineddocumented- and maintained0
''
Does design and development include:
a*
Aunctional and per&ormance re/uirements0
"*
Applica"le statutory and regulatory re/uirements0
Page 12 of 79

!um"er "* '' c* #uestion


Comments
Applica"le in&ormation derived &rom previous similar designs0
d*
Bther re/uirements that are essential &or designs and development0
'(
Are design and development inputs reviewed &or ade/uacy0
'+
Are incomplete- am"iguous- con&using- or con&licting re/uirements resolved0
5.#.# !esign and !e+el",ment (ut,uts:

Are outputs o& the design and development- provided in a &orm that ena"les veri&ication against the design and development inputs0
',
'7
Are design outputs approved- prior to release0
'8
Does the design and development output:
a*
.eet the design and development input re/uirements0
"*
Provide appropriate in&ormation &or purchasing- production- and &or a repair$service provision0
c*
Contain or re&erence product acceptance critieria0
d*
Speci&y the product characteristics that are essential to it3s sa&e and proper use0
e*
Speci&y any critical items- i& applica"leincluding any key characteristics- and speci&ic actions to "e accomplished &or these items0
'9
Does the contractor have esta"lished processes to de&ine the data re/uired to allow the product to "e identi&iedmanu&actured- inspected- tested- used- and maintainedincluding:
a*
Drawings- parts lists- and speci&ications necessary to de&ine the con&iguration and the design &eatures o& the product0
"*
.aterial- process- manu&acturing- and assem"ly data- re/uired to ensure con&ormity o& the product0
Page 13 of 79

!um"er #uestion 5.#.4 !esign and !e+el",ment Re+ie0:
Are systematic 2%eviews2 =audits* per&ormed in accordance with planned arrangements- at applica"le stages in the design and development process0

'9
(0
Do design and development 2%eviews2 =audits*:
a*
5valuate the capa"ility o& the design and development e&&orts- to comply with customer re/uirements0
"*
1denti&y pro"lems- and propose necessary corrective actions0
c*
Authori4e progression to the ne6t stage0
(1
Do 2%eview2 participants include representatives o& &unctions- involved with the design and development stage=s* "eing reviewed0
('
Are results o& %eviews- and any corrective actions necessary- maintained as records0
5.#.% !esign and !e+el",ment 7eri$icati"n:

1s design and development veri&ication per&ormed in accordance with the contractor3s plan- to ensure that the design outputs- con&orm to the design and development input re/uirements0
((
(+
Are the results o& veri&ications and corrective actions documented- and maintained as records0
5.#./ !esign and !e+el",ment 7alidati"n: (,

1s design and development validation per&ormed in accordance with planned arrangements0
(7
1s design and development validation per&ormed- to con&irm that the product is capa"le o& meeting the re/uirements o& the speci&ied application- and it3s intended purpose0
(8
1s validation completed prior to delivery- or implementation o& the product- wherever applica"le0
(9
Are the results o& validation- and associated actionsmaintained as records0
Page 14 of 79

!um"er #uestion
5.#./.1 !esign and !e+el",ment 7eri$icati"n and 7alidati"n 2esting: @hen testing is necessary &or veri&ication and validationare these tests planned- reviewed- controlled- and documented- to ensure and prove the &ollowing:

(9
a*
Do the test plans or speci&ications identi&y the product "eing tested and the resources that are to "e used0 1* Do they de&ine the test o":ectives and conditions0
'* Do they identi&y the test parameters that are to "e recorded0
(* Do they speci&y the relevant acceptance criteria0
"*
Do the test procedures descri"e the methods o& operation- the per&ormance o& the test- and the recording o& the test results0
c*
Are re/uirements speci&ied to veri&y that the correct con&iguration o& the product is "eing su"mitted &or the test0
d*
Are there provisions speci&ied to ensure that the re/uirements o& the test plan and the test procedures are complied with0
e*
Are there provisions speci&ied to ensure that acceptance criteria are met0
5.#./.2 !esign and !e+el",ment 7eri$icati"n and 7alidati"n !"cumentati"n: At the completion o& design and$or development- does the contractor3s documentation and records ensure that reports- calculations- test data- inspection results- etcdemonstrate that the product meets the speci&ication re/uirements &or all operational conditions0
+0
5.#.5 C"ntr"l "$ !esign and !e+el",ment Changes:
+1
Are design and$or development changes identi&ieddocumented- and maintained as records0
+'
Do reviews o& design and development changes includeevaluation o& the e&&ect o& the changes on associated parts- and product already delivered0
Page 15 of 79

!um"er #uestion
Are design and development changes reviewed- veri&iedand validated- as appropriate- and are the changes approved- prior to implementation0

+(
++
Are results o& the review o& changes and re/uired corrective actionsmaintained as records0
5.4 'urchasing:
5.4.1 'urchasing C"ntr"l:
Do the Su"contracting$Purchasing processes have ade/uate controls in<place- to ensure that purchased products and$or services con&orm to the Purchase Brder re/uirements0
+,
+7
Are the types o& controls- and to what e6tent they applied to the suppliers and purchased products- evaluated and dependent upon the e&&ect o& the purchased product on su"se/uent product processing- or the &inal product0
+8
Does the contractor have ade/uate controls =e?g? policiesprocedures- processes- etc* in<place- to accept responsi"ility &or the con&ormity o& all products purchased &rom suppliers- including product &rom suppliers mandated "y the customer0
+9
Are su"contractors$suppliers evaluated and selected"ased on their a"ility to supply product- in accordance with the contractor3s re/uirements0
+9
)as the contractor3s organi4ation esta"lished procedures and criteria &or selection- evaluation- and re<evaluation o& suppliers0
,0
Are results o& the evaluations- and any necessary actions taken- maintained as records0
,1
)as the contractor esta"lished a process in the #uality .anagement System to:
a*
.aintain a register o& it3s suppliers that includes approval status =e?g? approvedconditional- disapproved*- and the scope o& the approval =e?g? product type- process &amily- etc*0
"*
Periodically review supplier per&ormanceutili4ing the results o& the reviews as a "asis &or esta"lishing the level o& controls to "e implemented0
c*
De&ine the necessary actions to take- when dealing with suppliers that do not meet re/uirements0
Page 16 of 79

!um"er d* #uestion
5nsure that when re/uired- "oth the contractor and all suppliers use customer< approved special process sources0

,1
e*
De&ine the process- responsi"ilities- and authority &or the approval status decisionchanges o& the approval status- and conditions &or a controlled use o& suppliersdepending on the suppliers approval status0
&*
Determine and manage the risk- when selecting and using suppliers0
5.4.2 'urchasing .n$"rmati"n: ,'

Does the purchasing in&ormation descri"e the product to "e purchased0
,(
Do the Purchase Brders =purchasing in&ormation* to su"contractors and suppliers include:
a*
%e/uirements &or approval o& productprocedures- processes- and$or e/uipment0
"*
%e/uirements &or /uali&ication o& personnel0
c*
#uality .anagement System re/uirements0
d*
;he identi&ication and revision status o& speci&ications- drawings- process re/uirements- inspection$veri&ication instructions- and other technical data0
e*
%e/uirements &or design- test- inspectionveri&ication =including production process veri&ication*- use o& statistical techni/ues &or product acceptance and related instructions &or acceptance "y the contractor- and i& applica"le- critical items- including key characteristics0
,(
&*
%e/uirements &or test specimens =e?g? production method- num"er- storage conditions- etc* &or design approvalinspection$veri&ication- investigation- or auditing0
g*
%e/uirements regarding the need &or the supplier$su"contractor to: 1* !oti&y the prime contractor o& noncon&orming product0
Page 17 of 79

!um"er g* ,(
=Con3t*


Comments
#uestion
%e/uirements regarding the need &or the supplier$su"contractor to: '* B"tain prime contractor approval &or noncon&orming product disposition0
(* !oti&y the contractor o& changes to the product and$or process- changes o& supplierschanges o& manu&acturing &acility locationand when re/uired- o"tain prime contractor approval0
+* Alow<down in the supply chain- applica"le re/uirements- including customer re/uirements0
h*
%etention o& records0
i*
2%ight o& access2 "y the contractor- the customer- and regulatory authorities- to applica"le areas o& 2all &acilities2- at any level in the supply chain involved with the order- and access to 2all applica"le records20
,+
Are speci&ied purchasing re/uirements evaluated &or ade/uacy- prior to "eing issued to suppliers0
5.4.# 7eri$icati"n "$ 'urchased 'r"duct:

)as an inspection process- or other activities- "een esta"lished and implemented- which are necessary &or ensuring that purchased product complies with speci&ied purchase re/uirements0
,,
,7
)as the contractor implemented an ade/uate process- to ensure that when purchased product is released &or production use- pending completion o& all re/uired veri&ication activities- that it is identi&ied and recorded- to allow &or recall and replacement- i& it is su"se/uently &ound that the product does not meet re/uirements0
,8
Does the contractor have procedures which de&ine re/uirements &or delegations- and re/uire maintaining a register o& delegations- &or instances when the contractor chooses to delegate veri&ication activities to the supplier0
,9
Are veri&ication arrangements- and$or methods o& product release- speci&ied in the purchasing in&ormation- where the contractor3s organi4ation- or it3s customer- intends to per&orm veri&ication at the supplier3s premises0
5.% 'r"ducti"n and Ser+ice 'r"+isi"n:

5.%.1 C"ntr"l "$ 'r"ducti"n and Ser+ice 'r"+isi"n:
Page 18 of 79

!um"er #uestion


Comments
,9
Are the production and service provisions planned and carried out under controlled conditions- including:
a*
Availa"ility o& in&ormation that descri"es the product characteristics0
"*
Availa"ility o& work instructions =e?g? travelers- routers- manu&acturing plansinspection documents- etc*0
c*
Cse o& suita"le e/uipment =e?g? :igs- &i6turesmolds- etc*0
d*
Availa"ility and use o& measuring and monitoring devices0
e*
1mplementation o& monitoring and measurement0
&*
1mplementation o& release- delivery- and post<delivery activities0
g*
Accounta"ility &or all product during production =e?g? parts lists- parts /uantitiessplit orders- noncon&orming product- etc*0
h*
5vidence that all production and inspection$veri&ication operations have "een completed as planned- or as otherwise documented and authori4ed0
i*
Provisions &or the prevention- detection- and removal o& &oreign o":ects0
:*
.onitoring and control o& utilities and supplies =e?g? water- compressed airelectricity- chemical products- etc*0
k*
Cnderstanda"le- clear criteria &or workmanship =e?g? written standardsrepresentative samples- illustrations- etc*0
70
@hen planning controls &or production- has the contractor considered- esta"lished- implemented- and maintained processes &or:
a*
.anaging critical items- including process controls when key characteristics have "een identi&ied0
"*
Designing- manu&acturing- and using tooling to measure varia"le data0
Page 19 of 79
Page 20 of 79

!um"er c* 70 #uestion
1denti&ying in<process inspection and veri&ication points- when ade/uate veri&ication o& con&ormance cannot "e per&ormed at later stages o& production$reali4ation0


Comments
d*
Special processes0
5.%.1.1 'r"ducti"n 'r"cess 7eri$icati"n:
71
)as the contractor esta"lished and implemented a mandatory 2Airst Article 1nspection2 process:
a*
Csing a representative item &rom the &irst production run o& a new part or assem"ly- to veri&y that the production processesproduction documentation- and tooling- are capa"le o& producing parts and assem"lies that meet re/uirements0
"*
1ncorporating provisions that the process shall "e repeated- when changes occur that invalidate the original 2Airst Article 1nspection2 results =e?g? engineering changesmanu&acturing process changes- tooling changes- etc*0
5.%.1.2 C"ntr"l "$ 'r"ducti"n 'r"cess Changes:
7'
)as the contractor esta"lished a method- process- and$or procedure &or identi&ication o& personnel- authori4ed to approve changes to production processes0
7(
)as the contractor implemented a process- to control and document changes a&&ecting processesproduction e/uipment- tools- or so&tware programs0
7+
)as the contractor developed and implemented a processto evaluate the results o& changes to production processes- assessing them to con&irm that the desired e&&ect has "een accomplished- without adversely a&&ecting product con&ormity0
5.%.1.# C"ntr"l "$ 'r"ducti"n 4 ui,ment- 2""ls- and S"$t0are 'r"grams: )as the contractor implemented a process to ensure that production e/uipment- tools- and so&tware programsused to automate and control- or monitor product reali4ation processes- are validated prior to release &or production- and are maintained0
7,
77
)as the contractor initiated a process- de&ining storage re/uirements- including periodic preservation and condition checks- &or production e/uipment and$or tooling in storage0
Page 21 of 79
Page 22 of 79

!um"er #uestion
5.%.1.4 '"st8!eli+ery Su,,"rt:


Comments
78
)as the contractor esta"lished a post<delivery support process- which provides &or the:
a*
Collection and analysis o& in<service data0
"*
Actions to "e taken- including investigation and reporting- when pro"lems are detected a&ter delivery0
c*
Control and updating o& technical data0
d*
Approval- control- and use o& repair methods0
e*
Controls re/uired &or o&&<site work =e?g? contractor3s work accomplished at customer3s &acilities*0
5.%.2 7alidati"n "$ 'r"cesses $"r 'r"ducti"n and Ser+ice 'r"+isi"n:

)ave processes- where de&iciencies may "ecome apparent only a&ter the product is in use- or the service has "een delivered- "een validated0
79
79
Do the results o& validation- demonstrate the a"ility o& the processes to achieve the contractor3s planned results0
80
)as the contractor esta"lished a system and processes &or:
a*
De&ining the criteria- &or the review and approval o& the processes0
"*
Approval o& e/uipment- and /uali&ication o& personnel0
c*
Cse o& speci&ic methods- and$or procedures0
d*
%e/uirements &or records0
e*
%e<validation- i& re/uired0
5.%.# .denti$icati"n and 2racea)ility: 81

1s the product ade/uately identi&ia"le- throughout the product reali4ation processes0
8'
Does the contractor have a process- to maintain con&iguration identi&ication o& the product- in order to identi&y any di&&erences "etween the actual con&igurationand the agreed<to con&iguration0
Page 23 of 79
Page 24 of 79

!um"er 8( #uestion
1s the product status identi&ia"le- with respect to monitoring and measurement re/uirements0

8+
)as the contractor esta"lished a process- &or control o& 2Acceptance Authority2 media =e?g? stamps- electronic signatures- passwords- etc*0
8,
@hen tracea"ility is a re/uirement- is the product uni/uely identi&ied and controlled- and:
a*
1s there a process to ensure that identi&ication is maintained throughout the product li&e0
"*
Does the contractor have a process esta"lished- providing the a"ility to trace all products- manu&actured &rom the same "atch o& raw material- or &rom the same manu&acturing "atch- to the destination =e?g? delivery- scrap- etc*0
c*
Aor an assem"ly- does the contractor have a process esta"lished- providing the a"ility to trace components to an assem"ly- and then to the ne6t higher level assem"ly0
d*
Aor a product- does the contractor have a process esta"lished- providing the a"ility to retrieve a se/uential record o& its production =manu&acture- assem"ly- inspection- testetc*0
87
1s the product3s uni/ue identi&ication maintained as a record0
5.%.4 Cust"mer 'r",erty:

Does the contractor e6ercise ade/uate care with customer property- while it is under the organi4ation3s control- or is "eing used "y the contractor0
88
89
1s customer property identi&ied- veri&ied- protected- and sa&eguarded0
89
1& lost- damaged- or otherwise &ound to "e unsuita"le &or use- is the condition documented- reported to the customer- and maintained as a record0
5.%.% 'reser+ati"n "$ 'r"duct:

1s con&ormity o& product preserved during internal processing- and delivery to the intended destination0
90
Page 25 of 79

!um"er 91 #uestion
Do the contractor3s preservation activities include:


Comments
a*
1denti&ication0
"*
)andling0
c*
Packaging0
d*
Storage0
e*
Protection0
9'
Are preservation activities applied to associated component parts o& a product0
9(
1n accordance with product speci&ications- and applica"le statutory and regulatory re/uirements- does the contractor3s preservation processes include provisions &or:
a*
Cleaning0
"*
Prevention- detection- and removal o& &oreign o":ects0
c*
Special handling &or sensitive products0
d*
.arking and la"eling- including sa&ety warnings0
e*
Shel& li&e control and stock rotation0
&*
Special handling &or ha4ardous materials0
5./ C"ntr"l "$ Measuring and M"nit"ring !e+ices:

)as the contractor3s organi4ation determined the monitoring and measurement to take place-and the types o& monitoring and measurement devices that are re/uiredto provide evidence o& con&ormity to re/uirements0
9+
9,
)as the contractor esta"lished and maintained a register$record o& monitoring and measurement e/uipment that is utili4ed0
97
)as the contractor esta"lished and de&ined the processemployed &or the cali"ration and veri&ication o& monitoring and measurement e/uipment- including details o&:
a*
5/uipment type0
Page 26 of 79

!um"er "* 97 c*
ocation0


Comments
#uestion
Cni/ue identi&ication0
d*
Are/uency o& checks0
e*
Deri&ication$check method0
&*
Acceptance criteria0
98
)as the contractor identi&ied monitoring and measurement e/uipment- which is used to produce inspection data to provide evidence o& product con&ormity- as including- "ut not limited to:
a*
;est hardware0
"*
;est so&tware0
c*
Automated ;est 5/uipment =A;5*0
d*
Plotters0
e*
Personally owned e/uipment0
&*
Customer supplied e/uipment0
99
)ave processes "een esta"lished- to ensure that monitoring and measurement can "e carried out- in a manner consistent with the monitoring and measurement re/uirements0
99
)as the contractor arranged &or- and ensured that e6isting environmental conditions are suita"le &or:
a*
Cali"ration0
"*
1nspection0
c*
.easurement0
d*
;esting0
90
@hen necessary to ensure valid results- are measuring e/uipment:
a*
Cali"rated or veri&ied at speci&ic intervals- or prior to use- against measurement standards that are tracea"le to international or national measurement standards> where no standard e6ists- is the &oundation used &or cali"ration or veri&ication recorded0
Page 27 of 79

!um"er "* #uestion
Ad:usted- or re<ad:usted as necessary0


Comments
c*
1denti&ied to ena"le the cali"ration status to "e determined0
d*
Sa&eguarded &rom ad:ustments that would invalidate the measurement results0
e*
Protected &rom damage and deterioration during handling- maintenance- and storage0
91
)as the contractor esta"lished- implemented- and maintained a process- &or the recall o& monitoring and measurement e/uipment re/uiring cali"ration or veri&ication0
9'
)as the contractor evaluated and recorded the validity o& previous measuring results- when the e/uipment is &ound not to con&orm to the re/uirements- and have they taken the appropriate corrective action on the e/uipment- and any a&&ected product0
9(
Are records o& cali"ration and veri&ication results maintained0
9+
@hen computer so&tware is used in the monitoring and measurement o& speci&ied re/uirements- is the a"ility o& the computer so&tware to satis&y the intended purpose con&irmed- prior to use0
9,
Does the contractor3s process- &or con&irmation o& computer so&tware to satis&y it3s intended purposeinclude veri&ication and con&iguration management to maintain it3s suita"ility &or use0
97
1s the a"ility o& computer so&tware- to satis&y the intended application- reconfirmed as needed0
8. Measurement, nalysis, and !mpro"ement

9.1 General:
)ave the monitoring- measurement- analysis- and improvement processes "een planned- documented- and implemented to:
a*
Demonstrate con&ormity o& the product0
"*
5nsure con&ormity o& the #uality .anagement System0
Page 28 of 79

!um"er 1 c* #uestion
Continually improve the e&&ectiveness o& the #uality .anagement System0

'
)ave applica"le process methods- including statistical techni/ues- and their e6tent o& use- "een determined0
Does the contractor use statistical techni/ues to support:
a*
Design veri&ication =e?g? relia"ilitymantaina"ility- sa&ety- etc*0
"*
Process controls- including: 1* Selection and inspection o& key characteristics0
'*
Process capa"ility measurements0
(*
Statistical process control0
+*
Design o& e6periments0
c*
1nspection0
d*
Aailure mode- e&&ect- and criticality analysis0
9.2 M"nit"ring and Measurement:

9.2.1 Cust"mer Satis$acti"n:
1s in&ormation and data- relating to customer perceptionmonitored "y the contractor- as to whether customer re/uirements have "een met0
)ave the methodologies &or o"taining and using in&ormation and data- related to customer perception"een determined0
1s the in&ormation that the contractor monitors and uses &or evaluation o& customer satis&action include- "ut not limited to:
a*
Product con&ormity0
"*
Bn<time delivery per&ormance0
c*
Customer complaints0
d*
Corrective action re/uests0
Page 29 of 79

!um"er #uestion
)as the contractor developed and implemented plans &or customer satis&action improvement- addressing de&iciencies identi&ied "y these evaluations- and assessing the e&&ectiveness o& the results0

9.2.2 .nternal Audits:

Are internal audits conducted at planned intervals- to determine whether the #uality .anagement System:
a*
Con&orms to planned arrangementsre/uirements o& 1SB 9001- customer contractual re/uirements- and the #uality .anagement System0
"*
1s e&&ectively implemented and maintained0
@hen planning audits- does the contractor take into consideration the status and importance o& the processes and areas to "e audited- as well as the results o& previous audits0
10
Are audit criteria- scope- &re/uency- and methods de&ined0
11
1s auditor selection considered "y the contractor- to ensure o":ectivity and impartiality o& the audit process0
1'
Do controls e6ist to ensure that auditors do not audit their own work0
1(
)as a documented procedure "een esta"lished to de&ine the responsi"ilities- re/uirements &or planning and conducting audits- reporting results- and maintaining records0
1+
)as management- which is responsi"le &or the area=s* "eing audited- ensured that corrective actions have "een initiated without delay- to eliminate detected noncon&ormities- and their root causes0
1,
Do &ollow<up activities include veri&ication o& the corrective actions taken- and the reporting o& the veri&ication results0
9.2.# M"nit"ring and Measurement "$ 'r"cesses:
17
Are appropriate methods applied &or monitoring- and where applica"le- measurement o& the #uality .anagement System processes- that are re/uired to meet customer re/uirements0
Page 30 of 79

!um"er 18 #uestion
Do these methods demonstrate the a"ility o& the processes to achieve the planned results0


Comments
19
Are corrective actions implemented- when planned results are not achieved0
19
1n the event o& process noncon&ormity- has the contractor esta"lished and implemented a process and controls to:
a*
;ake appropriate action to correct the noncon&orming process0
"*
5valuate whether the process noncon&ormity has resulted in product noncon&ormities0
c*
Determine i& the process noncon&ormity is limited to a speci&ic case- or whether it could have a&&ected other processes or products0
d*
1denti&y and control any noncon&orming product0
9.2.4 M"nit"ring and Measurement "$ 'r"duct:
'0
Are product characteristics monitored and measured- to veri&y that product re/uirements are met0
'1
1s monitoring and measurement o& product characteristics- implemented at appropriate stages o& the product reali4ation process- in accordance with the contractor3s plans0
''
1s evidence o& con&ormity with the acceptance criteriadocumented and maintained0
'(
)as the contractor esta"lished the process- and documented measurement re/uirements &or product acceptance- including:
a*
Criteria &or acceptance and$or re:ection0
"*
@here in the manu&acturing se/uencemeasurement and testing are to "e per&ormed0
c*
%e/uired records o& the measurement results =e?g? at a minimum- indication o& acceptance or re:ection*0
d*
Any uni/ue or speci&ic measurement instruments re/uired- and any speci&ic instructions associated with their use0
Page 31 of 79
Page 32 of 79

!um"er #uestion


Comments
'+
@hen critical items- including any key characteristics have "een identi&ied- does the contractor ensure they are controlled and monitored- in accordance with esta"lished processes0
',
@hen the contractor has decided to use 2Sampling 1nspection2 as a means o& product acceptance- has the sampling plan "een :usti&ied on the "asis o& recogni4ed statistical principles- and is it appropriate &or use =e?g? matching the sampling plan to the criticality o& the product- and to process capa"ility*0
'7
Does the contractor have a documented process esta"lished- so that when product is released &or &urther processing and production use- pending completion o& all re/uired measurement- inspection- testing- and monitoring activities- is it ade/uately identi&ied and recorded to allow &or recall and replacement- i& it is su"se/uently &ound that the product does not meet re/uirements0
'8
Are records maintained that indicate the person=s* authori4ing release o& product0
'9
@hen re/uired to demonstrate product qualificationdoes the contractor have an esta"lished process- to ensure that records provide evidence that the product meets the de&ined re/uirements0
'9
Cnless otherwise approved "y a relevant authority- or where applica"le- the customer- are all planned processes satis&actorily completed- prior to proceeding with release o& the product0
(0
Does the contractor have an esta"lished process- to ensure that all documents that are re/uired to accompany the product- are present at delivery0
9.# C"ntr"l "$ :"nc"n$"rming 'r"duct:

(1
1s noncon&orming product identi&ied and controlled- to prevent unintended use or delivery0
('
)as a documented procedure "een esta"lished to de&ine process controls- identi&y authorities and their related responsi"ilities- &or dealing with noncon&orming product0
((
Do the contractor3s procedures de&ine noncon&orming product- as including noncon&orming product returned "y the customer0
(+
Does the contractor3s documented procedure=s* de&ine the responsi"ility- and authority- &or the review and disposition o& noncon&orming product- and e6plain the process &or approving personnel making these decisions0
Page 33 of 79
Page 34 of 79

!um"er (, #uestion


Comments
1s the process &or dealing with noncon&orming productone or more o& the &ollowing ways:
a*
1s action taken to eliminate the detected noncon&ormity0
"*
!oncon&orming product is authori4ed &or userelease- or acceptance- "y approval o& a relevant authority- and when applica"le- "y the customer0
c*
1s ade/uate action taken- to prevent using the noncon&orming product &or it3s original intended use or application0
d*
@hen noncon&orming product is detected a&ter delivery- or use has started- is appropriate evaluation and corrective action taken "y the contractor- to analy4e the e&&ector potential e&&ect- the noncon&ormity may have on other component parts- and$or Systems0
e*
Does the contractor take the necessary actions- to contain and$or limit the potential e&&ects o& the noncon&ormity- on other processes or products0
(7
Does the contractor3s process &or control o& noncon&orming product- provide &or timely reporting o& delivered noncon&orming product0
(8
Does the contractor have a process esta"lished- &or noti&ication o& parties concerning noncon&orming product- including noti&ication to applica"le suppliersinternal organi4ations- customers- distri"utors- and regulatory authorities0
(9
Does the contractor3s process procedures &or control o& noncon&orming material- speci&y that dispositions o& 2use<as<is2 or 2repair2- shall only "e used- after approval "y an authori4ed representative- or personnel having delegated authority- &rom the organi4ation responsi"le &or design0
(9
1& the noncon&ormity results in a departure &rom the contract re/uirements- does the contractor have provisions in their control o& noncon&orming material process- to prevent the use o& 2use<as<is2 and 2repair2 dispositions- unless speci&ically authori4ed "y the customer0
+0
Does the contractor3s control o& noncon&orming material process procedure=s*- speci&y that product dispositioned &or 2scrap"- shall "e conspicuously and permanently marked- or positively controlled- until physically rendered unusa"le0
Page 35 of 79

!um"er #uestion
Are ade/uate records maintained- identi&ying the nature o& noncon&ormities- and any su"se/uent corrective actions taken- including any waivers- deviations- or authori4ed concessions0

+1
+'
@hen noncon&orming product is corrected- is it su":ect to re<veri&ication- to demonstrate con&ormity to the re/uirements0
9.4 Analysis "$ !ata:

1s appropriate data determined- collected- and analy4edto demonstrate the suita"ility and e&&ectiveness o& the #uality .anagement System- and to evaluate where continuous improvement o& the e&&ectiveness o& the #uality .anagement System can "e made0
+(
++
Does this data include data generated &rom monitoring measurement- and other relevant sources0
+,
Does the contractor3s analysis o& data- provide in&ormation related to:
a*
Customer satis&action0
"*
Con&ormance to product re/uirements0
c*
Characteristics and trends- o& products and processes- including opportunities &or preventive action0
d*
Ade/uacy o& suppliers$su"contractors0
9.% 'r"cess .m,r"+ement:

9.%.1 C"ntinual .m,r"+ement:
Does the contractor have procedure=s* and a process esta"lished- to promote continual improvement o& the e&&ectiveness o& the #uality .anagement System0
+7
+8
Are the results o& audits- analysis o& data- corrective and preventive actions- .anagement %eviews- #uality Policy- and #uality B":ectives- used &or continual improvement0
+9
Does the contractor have a process esta"lished- to monitor the implementation o& improvement activitiesresulting &rom activities such as 2lessons learned22pro"lem resolutions2- and the 2"enchmarking o& "est practices2- and evaluate the e&&ectiveness o& the results0
Page 36 of 79

!um"er #uestion 9.%.2 C"rrecti+e Acti"n:


Comments
+9
Are corrective actions taken to eliminate the root cause=s* o& noncon&ormities- and to prevent recurrence0
,0
Are corrective actions appropriate to eliminate the e&&ects o& the noncon&ormities encountered0
,1
)as a documented procedure "een esta"lished- to de&ine the re/uirements &or:
a*
%eviewing noncon&ormities- including customer complaints0
"*
Determining the root cause=s* o& noncon&ormities0
c*
5valuating the need &or corrective action=s*to ensure that noncon&ormities do not recur0
d*
Determining and implementing ade/uate corrective action=s*0
e*
%ecording and maintaining the results o& corrective actions taken0
&*
%eviewing corrective actions0
g*
Alowing down corrective action re/uirements to a supplier- when it is determined that the supplier is responsi"le &or the noncon&ormity0
h*
Speci&ic actions- when timely and$or e&&ective corrective actions are not achieved0
i*
Determining i& additional noncon&orming product e6ists- "ased on the causes o& the noncon&ormities- and taking &urther actionwhen re/uired0
9.%.# 're+enti+e Acti"n:

)as the contractor3s organi4ation initiated ade/uate corrective actions- to eliminate the root causes o& potential noncon&ormities- in order to prevent reoccurrence0
,'
,(
Are preventive action opportunities- such as 2risk management2- 2error proo&ing2- 2 &ailure mode and e&&ect analysis =A.5A*2- and 2in&ormation on product pro"lems reported "y e6ternal sources2- utili4ed appropriately to control and$or eliminate e&&ects o& potential pro"lems0
Page 37 of 79

!um"er ,+ #uestion

a*
Determining potential noncon&ormities and their root causes0
"*
5valuating the need &or preventive action- to preclude reoccurrence o& noncon&ormities0
c*
Determining and implementing corrective and preventive actions that are needed0
d*
%ecording and maintaining the results o& preventive actions taken0
e*
%eview o& preventive actions taken0
#otes $ %omments
Page 38 of 79

Contractor: AS9100C Audit Checklist Date: Program P AS Code:
#otes $ %omments
Page 39 of 79

!um"er #uestion
AS 9100C: '009 Audit Checklist < #uality .anagement System Chapter + < Eeneral %e/uirements

Comments
4. Quality Management System

4.1 General Re uirements:
)as the contractor esta"lished- documentedimplemented- and maintained a #uality .anagement System- in accordance with the re/uirements o& AS 91000
'
1s an e&&ective 2Continuous 1mprovement2 program- an active part o& the contractor3s #uality .anagement System0
)as the contractor:
a*
1denti&ied the processes needed &or the #uality .anagement System- including their applications throughout the contractor3s organi4ation0
"*
Determined the se/uence and interaction o& these processes0
c*
Determined the criteria and methods neededto ensure that "oth the operation and control o& these processes are e&&ective0
d*
5nsured the availa"ility o& resources and in&ormation necessary- to support the operation and monitoring o& these processes0
e*
.easured- monitored- and analy4ed these processes0
&*
1mplemented the actions necessary to achieve their planned results- including continuous improvement o& the processes0
Does the contractor manage these processes- in accordance with AS 9100 re/uirements0
Do ade/uate controls e6ist- and are they identi&ied within the contractor3s #uality .anagement System- &or process re/uirements that are outsourced and a&&ect product con&ormity0
4.2 !"cumentati"n Re uirements:

4.2.1 General: 7
Does the #uality .anagement System documentation include:
a*
Documented statements o& a #uality policyand #uality o":ectives0
"*
A #uality manual0
Page 40 of 79

!um"er c* 7 #uestion

Comments
Documented procedures re/uired "y AS 91000
d*
Procedures needed "y the contractor to ensure the e&&ective planning- operation- and control o& the processes0
e*
%ecords re/uired "y AS 91000
Does an ade/uate communication process e6ist to ensure that personnel have access to- and are aware o&- relevant #uality .anagement System documentation and changes0
4.2.2 Quality Manual: 9

)as a #uality manual "een esta"lished and maintainedthat includes:
a*
;he scope o& the #uality .anagement System- including details o&- and :usti&ication &or any e6clusions or e6ceptions0
"*
Documented procedures esta"lished &or the #uality .anagement System- or re&erence to them0
c*
A description o& the interaction "etween the processes o& the #uality .anagement System0
4.2.# C"ntr"l "$ !"cuments:

Are the documents that are re/uired &or the #uality .anagement System ade/uately controlled0
10
)as a documented procedure "een esta"lishedidenti&ying the &ollowing controls:
a*
Approval o& documents &or ade/uacy 2prior2 to issue0
"*
%eview and update as necessary- including re<approval o& documents0
c*
5nsures that changes- and the current revision status o& documents are identi&ied0
d*
5nsure that latest revisions- or relevant versions o& applica"le documents- are availa"le at points o& use0
e*
5nsures that documents remain legi"le- and are readily identi&ia"le0
Page 41 of 79

!um"er &* 10 #uestion

Comments
5nsure that documents o& e6ternal origin are identi&ied- and their distri"ution is controlled0
g*
Preventing the unintended use o& o"solete documents- and to apply suita"le identi&ication to them i& they are retained0
4.2.4 C"ntr"l "$ Rec"rds:

)ave records "een esta"lished and maintained to provide evidence o& con&ormity to re/uirements- and o& the e&&ective operation o& the #uality .anagement system0
11
1'
)as a documented procedure "een esta"lished to de&ine the &ollowing re/uired controls0
a*
1denti&ication0
"*
Storage0
c*
%etrieval0
d*
Protection0
e*
%etention ;ime0
&*
Disposition0
1(
Does a documented procedure e6ist- de&ining the method &or controlling records that are created "yand$or retained "y- suppliers0
#otes $ %omments
Page 42 of 79
#otes $ %omments
Page 43 of 79
AS 9100C: '009 Audit Checklist < #uality .anagement System Chapter , < .anagement Systems

Comments
5. Management Responsibility
%.1 Management C"mmitment:
)as top management provided evidence o& its commitment to the development and implementation o& the #uality .anagement System- and &or continuous improvement o& its e&&ectiveness, "y:
a*
Communicating to the organi4ation the importance o& meeting customer- as well as regulatory and legal re/uirements0
"*
5sta"lishing the #uality policy0
c*
5nsuring that #uality o":ectives are esta"lished0
d*
Conducting .anagement %eviews0
e*
5nsuring the availa"ility o& ade/uate resources0
%.2 Cust"mer &"cus:

)as top management ensured that customer re/uirements are determined and met- with the aim o& enhancing customer satis&action0
'
)as top management esta"lished and implemented a process- to ensure that product con&ormity and on<time delivery are measured- and that appropriate action is taken i& planned results are not- or will not- "e achieved0
%.# Quality '"licy:

+
)as top management ensured that the #uality Policy:
a*
1s appropriate &or the purpose o& the contractor3s organi4ation0
"*
1ncludes a commitment to comply with re/uirements- and to continually improve the e&&ectivness o& the #uality .anagement System0
c*
Provides a &ramework &or esta"lishing and reviewing #uality o":ectives0
d*
1s communicated and understood within the contractor3s organi4ation0
Page 44 of 79
!um"er + e* #uestion
1s reviewed &or continual appropriateness0

%.4 'lanning:
%.4.1 Quality ()*ecti+es:
)as top management ensured that #uality o":ectives are esta"lished &or relevant &unctions- and at appropriate levels within the organi4ation0
)ave #uality o":ectives- needed to meet the re/uirements o& the product- "een esta"lished0
Are #uality o":ectives measura"le- and consistant with the contractor3s documented #uality Policy0
%.4.2 Quality Management System 'lanning:

)as top management ensured that the resources needed to achieve the #uality o":ectives are planned &or- and identi&ied0
1s the output o& the contractor3s planning documented0 =ie> /uality manual- procedures- work instructions- /uality plans- etc?*
10
@hen changes to the #uality .anagement System are planned and implemented- does top management ensure that the integrity o& the #uality System is maintained0
%.% Res,"nsi)ility- Auth"rity- and C"mmunicati"n:

%.%.1 Res,"nsi)ility and Auth"rity:
)as top management ensured that responsi"ilities and authorities &or the #uality .anagement System are de&ined- and communicated throughout the contractor3s organi4ation0
11
%.%.2 Management Re,resentati+e:

)as top management designated and appointed mem"er=s* o& management- who have reponsi"ility and authority that includes:
1'
a*
5nsuring that #uality processes are esta"lished- implemented- and maintained0
"*
%eporting to top management on the per&ormance o& the #uality .anagement System- including any needs &or improvement0
Page 45 of 79
!um"er c* 1' #uestion
Promoting awareness o& customer re/uirements throughout the contractor3s organi4ation0

d*
;he organi4ational &reedom- and unrestricted access to top management- to resolve #uality .anagement issues0
%.%.# .nternal C"mmunicati"ns:

)as top management ensured that appropriate communication processes have "een esta"lished throughout the organi4ation0
1(
1+
Does communication- regarding the e&&ectiveness o& the #uality .anagement System- take place0
%./ Management Re+ie0:

%./.1 General:
Does top management accomplish 2%eviews2 o& the #uality .anagement System at planned intervals- to ensure it3s continuing suita"ility- ade/uacy- and e&&ectiveness0
1,
17
Are opportunities &or improvement- and the need &or changes to the #uality .anagement System- including the contractor3s #uality Policy and #uality B":ectivesevaluated during 2.anagement %eviews20
18
Are records o& 2.anagement %eviews2 documented and maintained as #uality records0
%./.2 Re+ie0 .n,ut: 19

Do the inputs to 2.anagement %eviews2 include in&ormation on:
a*
%esults o& audits0
"*
Customer Aeed"ack0
c*
Process per&ormance and product con&ormity0
d*
Status o& preventive and corrective actions0
e*
Aollow<up actions &rom previous .anagement %eviews0
&*
Planned changes that could a&&ect the #uality .anagement System0
Page 46 of 79
!um"er 19 g* #uestion
%ecommendations &or improvement0

%./.# Re+ie0 (ut,ut: 19

Do the outputs &rom the 2.anagement %eviews2 include the decisions and actions related to:
a*
1mprovement o& the e&&ectiveness o& the #uality .anagement System- and its processes0
"*
1mprovement o& the product- related to customer re/uirements0
c*
%esources that are re/uired0
#otes $ %omments
Page 47 of 79
#otes $ %omments
Page 48 of 79
AS 9100C: '009 Audit Checklist < #uality .anagement System Chapter 7 < %esource .anagement


Comments
6. Resource Management
/.1 'r"+isi"n "$ Res"urces:
1
)ave the resources "een determined and made availa"le &or:
a*
1mplementing and maintaining a #uality .anagement System- including continuous improvement o& it3s e&&ectiveness0
"*
5nhancing customer satis&action- "y meeting customer re/uirements0
/.2 1uman Res"urces:

/.2.1 General:
Aor personnel who per&orm work a&&ecting product /uality- is competency "ased on appropriate educationtraining- skills- and e6perience0
'
/.2.2 C"m,etency- A0areness- and 2raining:
)as the contractor3s organi4ation:
a*
Determined the appropriate skills and competencies- &or personnel per&orming work a&&ecting /uality0
"*
Provided training- or taken other actions to satis&y competency needs0
c*
5valuated the e&&ectiveness o& any actions taken0
d*
5nsured that employees are aware o& the signi&icance and importance o& their activities- and how they contri"ute to the achievement o& the #uality o":ectives0
e*
.aintained appropriate personnel records o& educationtraining- skills- and e6perience0
D eveloped By : A rt B aldw in
Page 49 of 79

Comments
/.# .n$rastructure:
;o achieve con&ormity o& the product- does the contractor3s organi4ation identi&y- provide- and maintain appropriate &acilities- including:
a*
Buildings- workspace- and associated utilities0
"*
Process e/uipment- including hardware- and so&tware0
c*
Supporting Services0
/.4 3"rk 4n+ir"nment:

)as the environment- needed to attain con&ormity o& product re/uirements- "een determined and managed ade/uately =noise- temperature- lighting- humidity- etc*0
#otes $ %omments
Page 50 of 79
#otes $ %omments
Page 51 of 79
AS 9100C: '009 Audit Checklist < #uality .anagement System Chapter 8 < %isk- Design- Production- and Supplier Processes


Comments
7. Product Realization
5.1 'lanning "$ Reali6ati"n 'r"cess:
1s planning o& the contractor3s product reali4ationconsistent with the re/uirements o& the other processes o& the #uality .anagement System0
'
@hen planning product reali4ation processes- are the &ollowing "eing considered and determined:
a*
#uality o":ectives- and re/uirements &or the product- including: 1* Product and personnel sa&ety0
'* %elia"ility- maintaina"ility- and availa"ility0
(* Produci"ility and inspecta"ility0
+* Suita"ility o& parts and materials used in the product0
,* Selection and development o& em"edded so&tware0
7* %ecycling or &inal disposal o& the product at the end o& it3s li&e0
"*
;he need to esta"lish processes- documentsand provide resources 2speci&ic2 to the product re/uirements0
c*
%e/uired veri&ication- validation- monitoringinspection- and test activities- 2speci&ic to the product2- and criteria &or product acceptance0
d*
%ecords that are needed- to provide evidence that the reali4ation processes and resulting product- satis&y customer re/uirements0
e*
Con&iguration management appropriate to the product0
&*
%esources to support the use and maintenance o& the product0
1s the planning output in a &orm- appropriate &or the contractor3s methods o& operation0
Page 52 of 79

!um"er #uestion 5.1.1 'r"*ect Management:
)as the contractor esta"lished an ade/uate system- with associated processes- to plan and manage product reali4ation in a structured and controlled manner- to meet customer re/uirements at an accepta"le risk- within resource and schedule constraints0

5.1.2 Risk Management:

)as the contractor esta"lished- implemented- and maintained processes- to manage 2risk2 and achieve applica"le customer re/uirements- including:
a*
Assignment o& responsi"ilities &or risk management0
"*
De&initions o& risk criteria =e?g? likelihoodconse/uences- risk acceptance*0
c*
1denti&ication- assessment- and communication o& risks throughout product reali4ation0
d*
1denti&ication- implementation- and management o& actions- to mitigate risks that e6ceed the de&ined risk acceptance criteria0
e*
Acceptance o& risks remaining- a&ter implementation o& mitigating actions0
5.1.# C"n$igurati"n Management:

)as the contractor esta"lished- implemented- and maintained a con&iguration management process that includes:
a*
Con&iguration management planning0
"*
Con&iguration identi&ication0
c*
Change control processes0
d*
.aintaining records o& con&iguration status0
e*
Con&iguration audits0
Page 53 of 79
!um"er #uestion 5.1.4 C"ntr"l "$ 3"rk 2rans$ers:
)as the contractor esta"lished- implemented- and maintained a process- to plan and control the temporary or permanent trans&er o& work =e?g? &rom one contractor &acility to another- &rom the contractor to a supplier- or &rom one supplier to another supplier*- and to veri&y con&ormity o& the work to the contract$customer re/uirements0

5.2 Cust"mer Related 'r"cesses:

5.2.1 !eterminati"n "$ Re uirements Related t" the 'r"duct: 9
)as the contractor3s organi4ation determined:
a*
%e/uirements speci&ied "y the customerincluding the re/uirements &or delivery and post<delivery activities0
"*
%e/uirements not stated "y the customer- "ut necessary &or speci&ied or intended use- when known0
c*
Statutory and regulatory re/uirements related to the product0
d*
Any additional product re/uirementsmandated "y the contractor3s Policies and$or Procedures0
5.2.2 Re+ie0 "$ Re uirements Related t" the 'r"duct:

Prior to commitment to the customer =eg> su"mission o& Proposals- acceptance o& Contracts or Brders- or acceptance o& Change Brders or Contract .odi&ications*are re/uirements reviewed to ensure that:
a*
Product re/uirements are de&ined0
"*
Contract or Brder re/uirements- di&&erent &rom those previously e6pressed- are resolved0
c*
;he contractor has the a"ility to comply with the de&ined re/uirements0
d*
Any special re/uirements o& the product are determined0
e*
Areas o& risk have "een identi&ied =e?g? new technology- short delivery time &rame- etc*0
Page 54 of 79
!um"er #uestion
Are the results o& %eviews- and actions arising &rom these %eviews- recorded and maintained as records0

10
11
@here the customer has not provided a documented statement o& re/uirements- are customer re/uirements con&irmed "y the contractor- prior to acceptance0
1'
@here product re/uirements are changed- does the contractor3s organi4ation ensure that appropriate documentation is amended- and relevant personnel are made aware o& the changed re/uirements0
5.2.# Cust"mer C"mmunicati"n:

)as the contractor3s organi4ation determined and implemented- an e&&ective process &or communicating with customers- relating to:
1(
a*
Product in&ormation and re/uirements0
"*
1n/uiries- Contracts- Amendments- or Brder handling0
c*
Customer &eed"ack- including customer complaints0
5.# !esign and !e+el",ment:

5.#.1 !esign and !e+el",ment 'lanning: 1+
Are product design and development activities planned and controlled0
1,
During design and development planning- has the contractor determined and documented:
a*
;he various stages o& design and development0
"*
%eview- veri&ication- and validation stepsappropriate to each design and development stage0
c*
%esponsi"ilities and authorities &or design and development0
17
)as the contractor esta"lished the necessary processes to allow &or the division o& the design and development e&&orts into distinct activities- and &or each activityde&ined the tasks- necessary resources- responsi"ilitiesdesign content- input and output data- and planning constraints0
Page 55 of 79

!um"er #uestion
Are the di&&erent design and development tasks to "e accomplished- "ased on the sa&ety and &unctional o":ectives o& the product- in accordance with the customer3s re/uirements- statutory- and regulatory re/uirements0

18
19
Does the contractor3s process &or design and development planning- take into consideration the capa"ility to produce- inspect- test- and maintain the product0
19
Are inter&aces managed- "etween the di&&erent groups that are involved in the design and development processes- to ensure e&&ective communication- and clear assignment o& responsi"ilities0
'0
1s planning output updated- as design and development progresses0
5.#.2 !esign and !e+el",ment .n,uts: '1

Are inputs- related to product re/uirements- de&ineddocumented- and maintained0
''
Does design and development include:
a*
Aunctional and per&ormance re/uirements0
"*
c*
Applica"le in&ormation derived &rom previous similar designs0
d*
Bther re/uirements that are essential &or designs and development0
'(
Are design and development inputs reviewed &or ade/uacy0
'+
Are incomplete- am"iguous- con&using- or con&licting re/uirements resolved0
5.#.# !esign and !e+el",ment (ut,uts:

Are outputs o& the design and development- provided in a &orm that ena"les veri&ication against the design and development inputs0
',
'7
Are design outputs approved- prior to release0
Page 56 of 79
!um"er '8 #uestion
Does the design and development output:

a*
.eet the design and development input re/uirements0
"*
Provide appropriate in&ormation &or purchasing- production- and &or a repair$service provision0
c*
Contain or re&erence product acceptance critieria0
d*
Speci&y the product characteristics that are essential to it3s sa&e and proper use0
e*
Speci&y any critical items- i& applica"leincluding any key characteristics- and speci&ic actions to "e accomplished &or these items0
'9
Does the contractor have esta"lished processes to de&ine the data re/uired to allow the product to "e identi&iedmanu&actured- inspected- tested- used- and maintainedincluding:
a*
Drawings- parts lists- and speci&ications necessary to de&ine the con&iguration and the design &eatures o& the product0
"*
.aterial- process- manu&acturing- and assem"ly data- re/uired to ensure con&ormity o& the product0
5.#.4 !esign and !e+el",ment Re+ie0:

Are systematic 2%eviews2 =audits* per&ormed in accordance with planned arrangements- at applica"le stages in the design and development process0
'9
(0
Do design and development 2%eviews2 =audits*:
a*
5valuate the capa"ility o& the design and development e&&orts- to comply with customer re/uirements0
"*
1denti&y pro"lems- and propose necessary corrective actions0
c*
Authori4e progression to the ne6t stage0
(1
Do 2%eview2 participants include representatives o& &unctions- involved with the design and development stage=s* "eing reviewed0
Page 57 of 79
!um"er (' #uestion
Are results o& 2%eviews2- and any corrective actions necessary- maintained as records0

5.#.% !esign and !e+el",ment 7eri$icati"n:

1s design and development veri&ication per&ormed in accordance with the contractor3s plan- to ensure that the design outputs- con&orm to the design and development input re/uirements0
((
(+
Are the results o& veri&ications and corrective actions documented- and maintained as records0
5.#./ !esign and !e+el",ment 7alidati"n: (,

1s design and development validation per&ormed in accordance with planned arrangements0
(7
1s design and development validation per&ormed- to con&irm that the product is capa"le o& meeting the re/uirements o& the speci&ied application- and it3s intended purpose0
(8
1s validation completed prior to delivery- or implementation o& the product- wherever applica"le0
(9
Are the results o& validation- and associated actionsmaintained as records0
5.#./.1 !esign and !e+el",ment 7eri$icati"n and 7alidati"n 2esting: @hen testing is necessary &or veri&ication and validationare these tests planned- reviewed- controlled- and documented- to ensure and prove the &ollowing:
(9
a*
Do the test plans or speci&ications identi&y the product "eing tested and the resources that are to "e used0 1* Do they de&ine the test o":ectives and conditions0
'* Do they identi&y the test parameters that are to "e recorded0
(* Do they speci&y the relevant acceptance criteria0
"*
Do the test procedures descri"e the methods o& operation- the per&ormance o& the test- and the recording o& the test results0
Page 58 of 79
!um"er c* (9 #uestion
Are re/uirements speci&ied to veri&y that the correct con&iguration o& the product is "eing su"mitted &or the test0

d*
Are there provisions speci&ied to ensure that the re/uirements o& the test plan and the test procedures are complied with0
e*
Are there provisions speci&ied to ensure that acceptance criteria are met0
5.#./.2 !esign and !e+el",ment 7eri$icati"n and 7alidati"n !"cumentati"n: At the completion o& design and$or development- does the contractor3s documentation and records ensure that reports- calculations- test data- inspection results- etcdemonstrate that the product meets the speci&ication re/uirements &or all operational conditions0
+0
5.#.5 C"ntr"l "$ !esign and !e+el",ment Changes:
+1
Are design and$or development changes identi&ieddocumented- and maintained as records0
+'
Do reviews o& design and development changes includeevaluation o& the e&&ect o& the changes on associated parts- and product already delivered0
+(
Are design and development changes reviewed- veri&iedand validated- as appropriate- and are the changes approved- prior to implementation0
++
Are results o& the review o& changes- and any re/uired corrective actionsmaintained as records0
5.4 'urchasing:
5.4.1 'urchasing C"ntr"l:
Do the Su"contracting$Purchasing processes have ade/uate controls in<place- to ensure that purchased products- and$or services- con&orm to the Purchase Brder re/uirements0
+,
+7
Are the types o& controls- and to what e6tent they applied to the suppliers and purchased products- evaluated and dependent upon the e&&ect o& the purchased product on su"se/uent product processing- or the &inal product0
Page 59 of 79
!um"er #uestion
Does the contractor have ade/uate controls =e?g? policiesprocedures- processes- etc* in<place- to accept responsi"ility &or the con&ormity o& all products purchased &rom suppliers- including product &rom suppliers mandated "y the customer0

+8
+9
Are su"contractors$suppliers selected and evaluated"ased on their a"ility to supply product- in accordance with the contractor3s re/uirements0
+9
)as the contractor3s organi4ation esta"lished procedures and criteria &or selection- evaluation- and re<evaluation o& suppliers0
,0
Are results o& the evaluations- and any necessary actions taken- maintained as records0
,1
)as the contractor esta"lished a process in the #uality .anagement System to:
a*
.aintain a register o& it3s suppliers that includes approval status =e?g? approvedconditional- disapproved*- and the scope o& the approval =e?g? product type- process &amily- etc*0
"*
Periodically review supplier per&ormanceutili4ing the results o& the reviews as a "asis &or esta"lishing the level o& controls to "e implemented0
c*
De&ine the necessary actions to take- when dealing with suppliers that do not meet re/uirements0
d*
5nsure that when re/uired- "oth the contractor and all suppliers use customer< approved special process sources0
e*
De&ine the process- responsi"ilities- and authority &or the approval status decisionchanges o& the approval status- and conditions &or a controlled use o& suppliersdepending on the suppliers approval status0
&*
Determine and manage the risk- when selecting and using suppliers0
5.4.2 'urchasing .n$"rmati"n: ,'

Does the purchasing in&ormation descri"e the product to "e purchased0
Page 60 of 79

!um"er ,( #uestion
Do the Purchase Brders =purchasing in&ormation* to su"contractors and suppliers include:

a*
%e/uirements &or approval o& productprocedures- processes- and$or e/uipment0
"*
%e/uirements &or /uali&ication o& personnel0
c*
#uality .anagement System re/uirements0
d*
;he identi&ication and revision status o& speci&ications- drawings- process re/uirements- inspection$veri&ication instructions- and other technical data0
e*
%e/uirements &or design- test- inspectionveri&ication =including production process veri&ication*- use o& statistical techni/ues &or product acceptance and related instructions &or acceptance "y the contractor- and i& applica"le- critical items- including key characteristics0
&*
%e/uirements &or test specimens =e?g? production method- num"er- storage conditions- etc* &or design approvalinspection$veri&ication- investigation- or auditing0
g* ,(
%e/uirements regarding the need &or the supplier$su"contractor to: 1* !oti&y the prime contractor o& noncon&orming product0
'* B"tain prime contractor approval &or noncon&orming product disposition0
(* !oti&y the contractor o& changes to the product and$or process- changes o& supplierschanges o& manu&acturing &acility locationand when re/uired- o"tain prime contractor approval0
+* Alow<down in the supply chain- applica"le re/uirements- including customer re/uirements0
h*
%etention o& records0
Page 61 of 79
!um"er i* ,( #uestion
2%ight o& access2 "y the contractor- the customer- and regulatory authorities- to applica"le areas o& 2all &acilities2- at any level in the supply chain involved with the order- and access to 2all applica"le records20

,+
Are speci&ied purchasing re/uirements evaluated &or ade/uacy- prior to "eing issued to suppliers0
5.4.# 7eri$icati"n "$ 'urchased 'r"duct:

)as an inspection process- or other activities- "een esta"lished and implemented- which are necessary &or ensuring that purchased product complies with speci&ied purchase re/uirements0
,,
,7
)as the contractor implemented an ade/uate process- to ensure that when purchased product is released &or production use- pending completion o& all re/uired veri&ication activities- that it is identi&ied and recorded- to allow &or recall and replacement- i& it is su"se/uently &ound that the product does not meet re/uirements0
,8
Does the contractor have procedures which de&ine re/uirements &or delegations- and re/uire maintaining a register o& delegations- &or instances when the contractor chooses to delegate veri&ication activities to the supplier0
,9
Are veri&ication arrangements- and$or methods o& product release- speci&ied in the purchasing in&ormation- where the contractor3s organi4ation- or it3s customer- intends to per&orm veri&ication at the supplier3s premises0
5.% 'r"ducti"n and Ser+ice 'r"+isi"n:

,9
Are the production and service provisions planned and carried out under controlled conditions- including:
a*
Availa"ility o& in&ormation that descri"es the product characteristics0
"*
Availa"ility o& work instructions =e?g? travelers- routers- manu&acturing plansinspection documents- etc*0
c*
Cse o& suita"le e/uipment =e?g? :igs- &i6turesmolds- etc*0
d*
Availa"ility and use o& measuring and monitoring devices0
Page 62 of 79
!um"er e* ,9 &* #uestion
1mplementation o& monitoring and measurement0

1mplementation o& release- delivery- and post<delivery activities0
g*
Accounta"ility &or all product during production =e?g? parts lists- parts /uantitiessplit orders- noncon&orming product- etc*0
h*
5vidence that all production and inspection$veri&ication operations have "een completed as planned- or as otherwise documented and authori4ed0
i*
Provisions &or the prevention- detection- and removal o& &oreign o":ects0
:*
.onitoring and control o& utilities and supplies =e?g? water- compressed airelectricity- chemical products- etc*0
k*
Cnderstanda"le- clear criteria &or workmanship =e?g? written standardsrepresentative samples- illustrations- etc*0
70
@hen planning controls &or production- has the contractor considered- esta"lished- implemented- and maintain processes &or:
a*
.anaging critical items- including process controls when key characteristics have "een identi&ied0
"*
Designing- manu&acturing- and using tooling to measure varia"le data0
c*
1denti&ying in<process inspection and veri&ication points- when ade/uate veri&ication o& con&ormance cannot "e per&ormed at later stages o& production$reali4ation0
d*
Special processes0
5.%.1.1 'r"ducti"n 'r"cess 7eri$icati"n:
71
)as the contractor esta"lished and implemented a mandatory 2Airst Article 1nspection2 process:
a*
Csing a representative item &rom the &irst production run o& a new part or assem"ly- to veri&y that the production processesproduction documentation- and tooling- are capa"le o& producing parts and assem"lies that meet re/uirements0
Page 63 of 79
!um"er "* 71 #uestion
1ncorporating provisions that the process shall "e repeated- when changes occur that invalidate the original 2Airst Article 1nspection2 results =e?g? engineering changesmanu&acturing process changes- tooling changes- etc*0

5.%.1.2 C"ntr"l "$ 'r"ducti"n 'r"cess Changes:
7'
)as the contractor esta"lished a method- process- and$or procedure &or identi&ication o& personnel- authori4ed to approve changes to production processes0
7(
)as the contractor implemented a process- to control and document changes a&&ecting processesproduction e/uipment- tools- or so&tware programs0
7+
)as the contractor developed and implemented a processto evaluate the results o& changes to production processes- assessing them to con&irm that the desired e&&ect has "een accomplished- without adversely a&&ecting product con&ormity0
5.%.1.# C"ntr"l "$ 'r"ducti"n 4 ui,ment- 2""ls- and S"$t0are 'r"grams: )as the contractor implemented a process to ensure that production e/uipment- tools- and so&tware programsused to automate and control- or monitor product reali4ation processes- are validated prior to release &or production- and are maintained0
7,
77
)as the contractor initiated a process- de&ining storage re/uirements- including periodic preservation and condition checks- &or production e/uipment and$or tooling in storage0
5.%.1.4 '"st8!eli+ery Su,,"rt:
78
)as the contractor esta"lished a post<delivery support process- which provides &or the:
a*
Collection and analysis o& in<service data0
"*
Actions to "e taken- including investigation and reporting- when pro"lems are detected a&ter delivery0
c*
Control and updating o& technical data0
d*
Approval- control- and use o& repair methods0
Page 64 of 79
!um"er 78 e* #uestion
Controls re/uired &or o&&<site work =e?g? contractor3s work accomplished at customer3s &acilities*0

5.%.2 7alidati"n "$ 'r"cesses $"r 'r"ducti"n and Ser+ice 'r"+isi"n:

)ave processes- where de&iciencies may "ecome apparent only a&ter the product is in use- or the service has "een delivered- "een validated0
79
79
Do the results o& validation- demonstrate the a"ility o& the processes to achieve the contractor3s planned results0
80
)as the contractor esta"lished a system and processes &or:
a*
De&ining the criteria- &or the review and approval o& the processes0
"*
Approval o& e/uipment- and /uali&ication o& personnel0
c*
Cse o& speci&ic methods- and$or procedures0
d*
%e/uirements &or records0
e*
%e<validation- i& re/uired0
5.%.# .denti$icati"n and 2racea)ility: 81

1s the product ade/uately identi&ia"le- throughout the product reali4ation processes0
8'
Does the contractor have a process- to maintain con&iguration identi&ication o& the product- in order to identi&y any di&&erences "etween the actual con&igurationand the agreed<to con&iguration0
8(
1s the product status identi&ia"le- with respect to monitoring and measurement re/uirements0
8+
)as the contractor esta"lished a process- &or control o& 2Acceptance Authority2 media =e?g? stamps- electronic signatures- passwords- etc*0
8,
@hen tracea"ility is a re/uirement- is the product uni/uely identi&ied and controlled0
a*
1s there a process to ensure that identi&ication is maintained throughout the product li&e0
Page 65 of 79
!um"er "* #uestion
Does the contractor have a process esta"lished- providing the a"ility to trace all products- manu&actured &rom the same "atch o& raw material- or &rom the same manu&acturing "atch- to the destination =e?g? delivery- scrap- etc*0

8,
c*
Aor an assem"ly- does the contractor have a process esta"lished- providing the a"ility to trace components to an assem"ly- and then to the ne6t higher level assem"ly0
d*
Aor a product- does the contractor have a process esta"lished- providing the a"ility to retrieve a se/uential record o& its production =manu&acture- assem"ly- inspection- testetc*0
87
1s the product3s uni/ue identi&ication maintained as a record0
5.%.4 Cust"mer 'r",erty:

Does the contractor e6ercise ade/uate care with customer property- while it is under the organi4ation3s control- or is "eing used "y the contractor0
88
89
1s customer property identi&ied- veri&ied- protected- and sa&eguarded0
89
1& lost- damaged- or otherwise &ound to "e unsuita"le &or use- is the condition documented- reported to the customer- and maintained as a record0
5.%.% 'reser+ati"n "$ 'r"duct:

1s con&ormity o& the product preserved during internal processing- and delivery to the intended destination0
90
91
Do the contractor3s preservation activities include:
a*
1denti&ication0
"*
)andling0
c*
Packaging0
d*
Storage0
e*
Protection0
Page 66 of 79
!um"er 9' #uestion
Are preservation activities applied to associated component parts o& a product0

9(
1n accordance with product speci&ications- and applica"le statutory and regulatory re/uirements- does the contractor3s preservation processes include provisions &or:
a*
Cleaning0
"*
Prevention- detection- and removal o& &oreign o":ects0
c*
Special handling &or sensitive products0
d*
.arking and la"eling- including sa&ety warnings0
e*
Shel& li&e control and stock rotation0
&*
Special handling &or ha4ardous materials0
5./ C"ntr"l "$ Measuring and M"nit"ring !e+ices:

)as the contractor3s organi4ation determined the monitoring and measurement to take place-and the types o& monitoring and measurement devices that are re/uiredto provide evidence o& con&ormity to re/uirements0
9+
9,
)as the contractor esta"lished and maintained a register$record o& monitoring and measurement e/uipment that is utili4ed0
97
)as the contractor esta"lished and de&ined the processemployed &or the cali"ration and veri&ication o& monitoring and measurement e/uipment- including details o&:
a*
5/uipment type0
"*
Cni/ue identi&ication0
c*
ocation0
d*
Are/uency o& checks0
e*
Deri&ication$check method0
&*
Acceptance criteria0
Page 67 of 79
!um"er #uestion
)as the contractor identi&ied monitoring and measurement e/uipment- which is used to produce inspection data to provide evidence o& product con&ormity- as including- "ut not limited to:

98
a*
;est hardware0
"*
;est so&tware0
c*
Automated ;est 5/uipment =A;5*0
d*
Plotters0
e*
Personally owned e/uipment0
&*
Customer supplied e/uipment0
99
)ave processes "een esta"lished- to ensure that monitoring and measurement can "e carried out- in a manner consistent with the monitoring and measurement re/uirements0
99
)as the contractor arranged &or- and ensured that e6isting environmental conditions are suita"le &or:
a*
Cali"ration0
"*
1nspection0
c*
.easurement0
d*
;esting0
90
@hen necessary to ensure valid results- are measuring e/uipment:
a*
Cali"rated or veri&ied at speci&ic intervals- or prior to use- against measurement standards that are tracea"le to international or national measurement standards> where no standard e6ists- is the &oundation used &or cali"ration or veri&ication recorded0
"*
Ad:usted- or re<ad:usted as necessary0
c*
1denti&ied to ena"le the cali"ration status to "e determined0
d*
Sa&eguarded &rom ad:ustments that would invalidate the measurement results0
Page 68 of 79
!um"er e* 90 #uestion
Protected &rom damage and deterioration during handling- maintenance- and storage0

91
)as the contractor esta"lished- implemented- and maintained a process- &or the recall o& monitoring and measurement e/uipment re/uiring cali"ration or veri&ication0
9'
)as the contractor evaluated and recorded the validity o& previous measuring results- when the e/uipment is &ound not to con&orm to the re/uirements- and have they taken the appropriate corrective action on the e/uipment- and any a&&ected product0
9(
Are records o& cali"ration and veri&ication results maintained0
9+
@hen computer so&tware is used in the monitoring and measurement o& speci&ied re/uirements- is the a"ility o& the computer so&tware to satis&y the intended purpose con&irmed- prior to use0
9,
Does the contractor3s process- &or con&irmation o& computer so&tware to satis&y it3s intended purposeinclude veri&ication and con&iguration management to maintain it3s suita"ility &or use0
97
1s the a"ility o& computer so&tware- to satis&y the intended application- reconfirmed as needed0
#otes $ %omments
Page 69 of 79
#otes $ %omments
Page 70 of 79
AS 9100C: '009 Audit Checklist < #uality .anagement System Chapter 9 < .easurement $ 1nternal Audits $ Corrective Action

Comments
8. Measurement, nalysis, and !mpro"ement

9.1 General:
)ave the monitoring- measurement- analysis- and improvement processes "een planned- documented- and implemented to:
a*
Demonstrate con&ormity o& the product0
"*
5nsure con&ormity o& the #uality .anagement System0
c*
Continually improve the e&&ectiveness o& the #uality .anagement System0
'
)ave applica"le process methods- including statistical techni/ues- and their e6tent o& use- "een determined0
Does the contractor use statistical techni/ues to support:
a*
Design veri&ication =e?g? relia"ilitymantaina"ility- sa&ety- etc*0
"*
Process controls- including: 1* Selection and inspection o& key characteristics0
'*
Process capa"ility measurements0
(*
Statistical process control0
+*
Design o& e6periments0
c*
1nspection0
d*
Aailure mode- e&&ect- and criticality analysis0
9.2 M"nit"ring and Measurement:

9.2.1 Cust"mer Satis$acti"n:
1s in&ormation and data- relating to customer perceptionmonitored "y the contractor- as to whether customer re/uirements have "een met0
)ave the methodologies &or o"taining and using in&ormation and data- related to customer perception"een determined0
Page 71 of 79

!um"er #uestion
1s the in&ormation that the contractor monitors and uses &or evaluation o& customer satis&action include- "ut not limited to:

a*
Product con&ormity0
"*
Bn<time delivery per&ormance0
c*
Customer complaints0
d*
Corrective action re/uests0
)as the contractor developed and implemented plans &or customer satis&action improvement- addressing de&iciencies identi&ied "y these evaluations- and assessing the e&&ectiveness o& the results0
9.2.2 .nternal Audits:

Are internal audits conducted at planned intervals- to determine whether the #uality .anagement System:
a*
Con&orms to planned arrangementsre/uirements o& 1SB 9001- customer contractual re/uirements- and the #uality .anagement System0
"*
1s e&&ectively implemented and maintained0
@hen planning audits- does the contractor take into consideration the status and importance o& the processesand areas to "e audited- as well as the results o& previous audits0
10
Are audit criteria- scope- methods- and &re/uency de&ined0
11
1s auditor selection considered "y the contractor- to ensure o":ectivity and impartiality o& the audit process0
1'
Do controls e6ist to ensure that auditors do not audit their own work0
1(
)as a documented procedure "een esta"lished to de&ine the responsi"ilities- re/uirements &or planning and conducting audits- reporting results- and maintaining records0
Page 72 of 79

!um"er #uestion
)as management- which is responsi"le &or the area=s* "eing audited- ensured that corrective actions have "een initiated without delay- to eliminate detected noncon&ormities- and their root causes0

1+
1,
Do &ollow<up activities include veri&ication o& the corrective actions taken- and the reporting o& the veri&ication results0
9.2.# M"nit"ring and Measurement "$ 'r"cesses:
17
Are appropriate methods applied &or monitoring- and where applica"le- measurement o& the #uality .anagement System processes- that are re/uired to meet customer re/uirements0
18
Do these methods demonstrate the a"ility o& the processes to achieve the planned results0
19
Are corrective actions implemented- when planned results are not achieved0
19
1n the event o& process noncon&ormity- has the contractor esta"lished and implemented a process and controls to:
a*
;ake appropriate action to correct the noncon&orming process0
"*
5valuate whether the process noncon&ormity has resulted in product noncon&ormities0
c*
Determine i& the process noncon&ormity is limited to a speci&ic case- or whether it could have a&&ected other processes or products0
d*
1denti&y and control any noncon&orming product0
9.2.4 M"nit"ring and Measurement "$ 'r"duct:
'0
Are product characteristics monitored and measured- to veri&y that product re/uirements are met0
'1
1s monitoring and measurement o& product characteristics- implemented at appropriate stages o& the product reali4ation process- in accordance with the contractor3s plans0
Page 73 of 79
!um"er '' #uestion
1s evidence o& con&ormity with the acceptance criteriadocumented and maintained0

'(
)as the contractor esta"lished the process- and documented measurement re/uirements &or product acceptance- including:
a*
Criteria &or acceptance and$or re:ection0
"*
@here in the manu&acturing se/uencemeasurement and testing are to "e per&ormed0
c*
%e/uired records o& the measurement results =e?g? at a minimum- indication o& acceptance or re:ection*0
d*
Any uni/ue or speci&ic measurement instruments re/uired- and any speci&ic instructions associated with their use0
'+
@hen critical items- including any key characteristics have "een identi&ied- does the contractor ensure they are controlled and monitored- in accordance with esta"lished processes0
',
@hen the contractor has decided to use 2Sampling 1nspection2 as a means o& product acceptance- has the sampling plan "een :usti&ied on the "asis o& recogni4ed statistical principles- and is it appropriate &or use =e?g? matching the sampling plan to the criticality o& the product- and to process capa"ility*0
'7
Does the contractor have a documented process esta"lished- so that when product is released &or &urther processing and production use- pending completion o& all re/uired measurement- inspection- testing- and monitoring activities- is it ade/uately identi&ied and recorded to allow &or recall and replacement- i& it is su"se/uently &ound that the product does not meet re/uirements0
'8
Are records maintained that indicate the person=s* authori4ing release o& product0
'9
@hen re/uired to demonstrate product qualificationdoes the contractor have an esta"lished process- to ensure that records provide evidence that the product meets the de&ined re/uirements0
'9
Cnless otherwise approved "y a relevant authority- or where applica"le- the customer- are all planned processes satis&actorily completed- prior to proceeding with release o& the product0
Page 74 of 79
!um"er #uestion
Does the contractor have an esta"lished process- to ensure that all documents that are re/uired to accompany the product- are present at delivery0

(0
9.# C"ntr"l "$ :"nc"n$"rming 'r"duct:

(1
1s noncon&orming product identi&ied and controlled- to prevent unintended use or delivery0
('
)as a documented procedure "een esta"lished to de&ine process controls- identi&y authorities- and their related responsi"ilities- &or dealing with noncon&orming product0
((
Do the contractor3s procedures de&ine noncon&orming product- as including noncon&orming product returned "y the customer0
(+
Does the contractor3s documented procedure=s* de&ine the responsi"ility- and authority- &or the review and disposition o& noncon&orming product- and e6plain the process &or approving personnel making these decisions0
(,
1s the process &or dealing with noncon&orming productone or more o& the &ollowing ways:
a*
1s action taken to eliminate the detected noncon&ormity0
"*
!oncon&orming product is authori4ed &or userelease- or acceptance- "y approval o& a relevant authority- and when applica"le- "y the customer0
c*
1s ade/uate action taken- to prevent using the noncon&orming product &or it3s original intended use or application0
d*
@hen noncon&orming product is detected a&ter delivery- or use has started- is appropriate evaluation and corrective action taken "y the contractor- to analy4e the e&&ector potential e&&ect- the noncon&ormity may have on other component parts- and$or Systems0
e*
Does the contractor take the necessary actions- to contain and$or limit the potential e&&ects o& the noncon&ormity- on other processes or products0
(7
Does the contractor3s process &or control o& noncon&orming product- provide &or timely reporting o& delivered noncon&orming product0
Page 75 of 79

!um"er #uestion
Does the contractor have a process esta"lished- &or noti&ication o& parties concerning noncon&orming product- including noti&ication to applica"le suppliersinternal organi4ations- customers- distri"utors- and regulatory authorities0

(8
(9
Does the contractor3s process procedures &or control o& noncon&orming material- speci&y that dispositions o& 2use<as<is2 or 2repair2- shall only "e used- after approval "y an authori4ed representative- or personnel having delegated authority- &rom the organi4ation responsi"le &or design0
(9
1& the noncon&ormity results in a departure &rom the contract re/uirements- does the contractor have provisions in their control o& noncon&orming material process- to prevent the use o& 2use<as<is2 and 2repair2 dispositions- unless speci&ically authori4ed "y the customer0
+0
Does the contractor3s control o& noncon&orming material process procedure=s*- speci&y that product dispositioned &or 2scrap"- shall "e conspicuously and permanently marked- or positively controlled- until physically rendered unusa"le0
+1
Are ade/uate records maintained- identi&ying the nature o& noncon&ormities- and any su"se/uent corrective actions taken- including any waivers- deviations- or authori4ed concessions0
+'
@hen noncon&orming product is corrected- is it su":ect to re<veri&ication- to demonstrate con&ormity to the re/uirements0
9.4 Analysis "$ !ata:

1s appropriate data determined- collected- and analy4edto demonstrate the suita"ility and e&&ectiveness o& the #uality .anagement System- and to evaluate where continuous improvement o& the e&&ectiveness o& the #uality .anagement System can "e made0
+(
++
Does this data include data generated &rom monitoring measurement- and other relevant sources0
+,
Does the contractor3s analysis o& data- provide in&ormation related to:
a* "*
Customer satis&action0
Con&ormance to product re/uirements0
Page 76 of 79
!um"er c* +, #uestion
Characteristics and trends- o& products and processes- including opportunities &or preventive action0

d*
Ade/uacy o& suppliers$su"contractors0
9.% 'r"cess .m,r"+ement:

9.%.1 C"ntinual .m,r"+ement:
Does the contractor have procedure=s* and a process esta"lished- to promote continual improvement o& the e&&ectiveness o& the #uality .anagement System0
+7
+8
Are the results o& audits- analysis o& data- corrective and preventive actions- .anagement %eviews- #uality Policy- and #uality B":ectives- used &or continual improvement0
+9
Does the contractor have a process esta"lished- to monitor the implementation o& improvement activitiesresulting &rom activities such as 2lessons learned22pro"lem resolutions2- and the 2"enchmarking o& "est practices2- and evaluate the e&&ectiveness o& the results0
9.%.2 C"rrecti+e Acti"n:

Are corrective actions taken to eliminate the root cause=s* o& noncon&ormities- and to prevent recurrence0
+9
,0
Are corrective actions appropriate to eliminate the e&&ects o& the noncon&ormities encountered0
,1
a*
%eviewing noncon&ormities- including customer complaints0
"*
Determining the root cause=s* o& noncon&ormities0
c*
5valuating the need &or corrective action=s*to ensure that noncon&ormities do not recur0
d*
Determining and implementing ade/uate corrective action=s*0
e*
%ecording and maintaining the results o& corrective actions taken0
&*
%eviewing corrective actions0
Page 77 of 79
!um"er g* ,1 #uestion
Alowing down corrective action re/uirements to a supplier- when it is determined that the supplier is responsi"le &or the noncon&ormity0

h*
Speci&ic actions- when timely and$or e&&ective corrective actions are not achieved0
i*
Determining i& additional noncon&orming product e6ists- "ased on the causes o& the noncon&ormities- and taking &urther actionwhen re/uired0
9.%.# 're+enti+e Acti"n:

)as the contractor3s organi4ation initiated ade/uate corrective actions- to eliminate the root causes o& potential noncon&ormities- in order to prevent reoccurrence0
,'
,(
Are preventive action opportunities- such as 2risk management2- 2error proo&ing2- 2 &ailure mode and e&&ect analysis =A.5A*2- and 2in&ormation on product pro"lems reported "y e6ternal sources2- utili4ed appropriately to control and$or eliminate e&&ects o& potential pro"lems0
,+
a*
Determining potential noncon&ormities and their root causes0
"*
5valuating the need &or preventive action- to preclude reoccurrence o& noncon&ormities0
c*
Determining and implementing corrective and preventive actions that are needed0
d*
%ecording and maintaining the results o& preventive actions taken0
e*
%eview o& preventive actions taken0
#otes $ %omments
Page 78 of 79
#otes $ %omments
Page 79 of 79

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AS 9100C: 2009 Quality Management System Audit Checklist

Contractor: AS9100C Audit Checklist

Date: Program P AS Code:

4. Quality Management System

)as the contractor:

Determined the se/uence and interaction o& these processes0

.easured- monitored- and analy4ed these processes0

Developed By: Art Baldwin

AS 9100C: 2009 Quality Management System Audit Checklist

Date: Program P AS Code:

4.2 !"cumentati"n Re uirements:

Documented statements o& a #uality policyand #uality o":ectives0

Documented procedures re/uired "y AS 91000

%ecords re/uired "y AS 91000

4.2.2 Quality Manual: 9

4.2.# C"ntr"l "$ !"cuments:

)as a documented procedure "een esta"lishedidenti&ying the &ollowing controls:

Approval o& documents &or ade/uacy 2prior2 to issue0

Developed By: Art Baldwin

AS 9100C: 2009 Quality Management System Audit Checklist

Date: Program P AS Code:

5nsures that documents remain legi"le- and are readily identi&ia"le0

4.2.4 C"ntr"l "$ Rec"rds:

Developed By: Art Baldwin

AS 9100C: 2009 Quality Management System Audit Checklist

Date: Program P AS Code:

5sta"lishing the #uality policy0

5nsuring that #uality o":ectives are esta"lished0

Conducting .anagement %eviews0

5nsuring the availa"ility o& ade/uate resources0

%.2 Cust"mer &"cus:

%.# Quality '"licy:

1s appropriate &or the purpose o& the contractor3s organi4ation0

Provides a &ramework &or esta"lishing and reviewing #uality o":ectives0

1s communicated and understood within the contractor3s organi4ation0

Developed By: Art Baldwin

AS 9100C: 2009 Quality Management System Audit Checklist

Date: Program P AS Code:

%.4.2 Quality Management System 'lanning:

%.% Res,"nsi)ility- Auth"rity- and C"mmunicati"n:

%.%.2 Management Re,resentati+e:

5nsuring that #uality processes are esta"lished- implemented- and maintained0

Developed By: Art Baldwin

AS 9100C: 2009 Quality Management System Audit Checklist

Date: Program P AS Code:

%.%.# .nternal C"mmunicati"ns:

%./ Management Re+ie0:

%./.2 Re+ie0 .n,ut: 19

%esults o& audits0

Process per&ormance and product con&ormity0

Status o& preventive and corrective actions0

Aollow<up actions &rom previous .anagement %eviews0

Planned changes that could a&&ect the #uality .anagement System0

Developed By: Art Baldwin

AS 9100C: 2009 Quality Management System Audit Checklist

Date: Program P AS Code:

%./.# Re+ie0 (ut,ut: 19

1mprovement o& the product- related to customer re/uirements0

%esources that are re/uired0

5nhancing customer satis&action- "y meeting customer re/uirements0

/.2 1uman Res"urces:

/.2.2 C"m,etency- A0areness- and 2raining:

)as the contractor3s organi4ation:

Provided training- or taken other actions to satis&y competency needs0