AS 9100C: 2009

Quality Management System

Audit Checklist

Contractor: Date:
AS9100C Audit Checklist Program PLAS Code:
Number Question Process/Procedure Reference Comments
4. Quality Management System

4.1 General Requirements:

Has the contractor established, documented,

1 implemented, and maintained a Quality
Management System, in accordance with the
requirements of AS 9100?

Is an effective "Continuous Improvement" program,

2 an active part of the contractor's Quality
Management System?

3 Has the contractor:

a) Identified the processes needed for the

Quality Management System, including
their applications throughout the
contractor's organization?

b) Determined the sequence and interaction

of these processes?

c) Determined the criteria and methods

needed, to ensure that both the operation
and control of these processes are
effective?

d) Ensured the availability of resources and

information necessary, to support the
operation and monitoring of these
processes?

e) Measured, monitored, and analyzed these

processes?

f) Implemented the actions necessary to

achieve their planned results, including
continuous improvement of the
processes?

4 Does the contractor manage these processes, in

accordance with AS 9100 requirements?

Do adequate controls exist, and are they identified

5 within the contractor's Quality Management
System, for process requirements that are
outsourced, and affect product conformity?

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4.2 Documentation Requirements:

4.2.1 General:

6 Does the Quality Management System

documentation include:

a) Documented statements of a Quality

policy, and Quality objectives?

b) A Quality manual?

c) Documented procedures required by AS

9100?

d) Procedures needed by the contractor to

ensure effective planning, operation, and
control of the processes?

e) Records required by AS 9100?

Does an adequate communication process exist

7 to ensure that personnel have access to, and are
aware of, relevant Quality Management System
documentation and changes?

4.2.2 Quality Manual:

8 Has a Quality manual been established and

maintained, that includes:

a) The scope of the Quality Management

System, including details of, and
justification for any exclusions or
exceptions?

b) Documented procedures established for

the Quality Management System, or
reference to them?

c) A description of the interaction between

the processes of the Quality Management
System?

4.2.3 Control of Documents:

Are the documents that are required for the Quality

9 Management System adequately controlled?

10 Has a documented procedure been established,

identifying the following controls:

a) Approval of documents for adequacy

"prior" to issue?

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b) Review and update as necessary,

including re-approval of documents?
10

c) Ensures that changes, and the current

revision status of documents are
identified?

d) Ensure that latest revisions, or relevant

versions of applicable documents, are
available at points of use?

e) Ensures that documents remain legible,

and are readily identifiable?

f) Ensure that documents of external origin

are identified, and their distribution is
controlled?

g) Preventing the unintended use of

obsolete documents, and to apply
suitable identification to them if they are
retained?

4.2.4 Control of Records:

Have records been established and maintained to

11 provide evidence of conformity to requirements,
and of the effective operation of the Quality
Management system?

12 Has a documented procedure been established to

define the following required controls?

a) Identification?

b) Storage?

c) Retrieval?

d) Protection?

e) Retention Time?

f) Disposition?

Does a documented procedure exist, defining

13 the method for controlling records that are
created by, and/or retained by, suppliers?

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5. Management Responsibility

5.1 Management Commitment:

Has top management provided evidence of its

commitment to the development and
1 implementation of the Quality Management
System, and for continuous improvement of its
effectiveness, by:

a) Communicating to the organization the

importance of meeting customer, as well
as regulatory and legal requirements?

b) Establishing the Quality policy?

c) Ensuring that Quality objectives are

established?

d) Conducting Management Reviews?

e) Ensuring the availability of adequate

resources?

5.2 Customer Focus:

Has top management ensured that customer

2 requirements are determined and met, with the aim
of enhancing customer satisfaction?

Has top management established and implemented

a process, to ensure that product conformity and on-
time delivery are measured, and that appropriate
3 action is taken if planned results are not, or will not,
be achieved?

5.3 Quality Policy:

4 Has top management ensured that the Quality

Policy:

a) Is appropriate for the purpose of the

contractor's organization?

b) Includes a commitment to comply with

requirements, and to continually improve
the effectivness of the Quality
Management System?

c) Provides a framework for establishing

and reviewing Quality objectives?

d) Is communicated and understood within

the contractor's organization?

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4 e) Is reviewed for continual

appropriateness?

5.4 Planning:

5.4.1 Quality Objectives:

Has top management ensured that Quality

5 objectives are established for relevant functions,
and at appropriate levels within the organization?

6 Have Quality objectives, needed to meet the

requirements of the product, been established?

7 Are Quality objectives measurable, and consistant

with the contractor's documented Quality Policy?

5.4.2 Quality Management System Planning:

Has top management ensured that the resources

8 needed to achieve the Quality objectives are
planned for, and identified?

Is the output of the contractor's planning

9 documented? (ie; quality manual, procedures, work
instructions, quality plans, etc.)

When changes to the Quality Management System

10 are planned and implemented, does top
management ensure that the integrity of the Quality
System is maintained?

5.5 Responsibility, Authority, and

Communication:

5.5.1 Responsibility and Authority:

Has top management ensured that responsibilities

11 and authorities for the Quality Management System
are defined, and communicated throughout the
contractor's organization?

5.5.2 Management Representative:

Has top management designated and appointed

12 member(s) of management, who have reponsibility
and authority that includes:

a) Ensuring that Quality processes are

established, implemented, and
maintained?

b) Reporting to top management on the

performance of the Quality Management
System, including any needs for
improvement?

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c) Promoting awareness of customer

requirements throughout the contractor's
organization?
12

d) The organizational freedom, and

unrestricted access to top management,
to resolve Quality Management issues?

5.5.3 Internal Communications:

Has top management ensured that appropriate

13 communication processes have been established
throughout the organization?

14 Does communication, regarding the effectiveness of

the Quality Management System, take place?

5.6 Management Review:

5.6.1 General:

Does top management accomplish "Reviews" of the

15 Quality Management System at planned intervals,
to ensure it's continuing suitability, adequacy, and
effectiveness?

Are opportunities for improvement, and the need

for changes to the Quality Management System,
including the contractor's Quality Policy and
16 Quality Objectives, evaluated during "Management
Reviews"?

17 Are records of "Management Reviews" documented

and maintained as Quality records?

5.6.2 Review Input:

18 Do the inputs to "Management Reviews" include

information on:

a) Results of audits?

b) Customer Feedback?

c) Process performance and product

conformity?

d) Status of preventive and corrective

actions?

e) Follow-up actions from previous

Management Reviews?

f) Planned changes that could affect the

Quality Management System?

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18 g) Recommendations for improvement?

5.6.3 Review Output:

19 Do the outputs from the "Management Reviews"

include the decisions and actions related to:

a) Improvement of the effectiveness of the

Quality Management System, and its
processes?

b) Improvement of the product, related to

customer requirements?

c) Resources that are required?

6. Resource Management

6.1 Provision of Resources:

1 Have the resources been determined and made

available for:

a) Implementing and maintaining a Quality

Management System, including
continuous improvement of it's
effectiveness?

b) Enhancing customer satisfaction, by

meeting customer requirements?

6.2 Human Resources:

6.2.1 General:

For personnel who perform work affecting product

2 quality, is competency based on appropriate
education, training, skills, and experience?

6.2.2 Competency, Awareness, and Training:

3 Has the contractor's organization:

a) Determined the appropriate skills and

competencies, for personnel performing
work affecting quality?

b) Provided training, or taken other actions

to satisfy competency needs?

c) Evaluated the effectiveness of any

actions taken?

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d) Ensured that employees are aware of the

significance and importance of their
activities, and how they contribute to the
achievement of the Quality objectives?
3

e) Maintained appropriate personnel

records of education, training, skills, and
experience?

6.3 Infrastructure:

To achieve conformity of the product, does the

4 contractor's organization identify, provide, and
maintain appropriate facilities, including:

a) Buildings, workspace, and associated

utilities?

b) Process equipment, including hardware,

and software?

c) Supporting Services?

6.4 Work Environment:

Has the environment, needed to attain conformity of

5 product requirements, been determined and
managed adequately (noise, temperature, lighting,
humidity, etc)?

7. Product Realization

7.1 Planning of Realization Process:

Is planning of the contractor's product realization,

1 consistent with the requirements of the other
processes of the Quality Management System?

2 When planning product realization processes, are

the following being considered and determined:

a) Quality objectives, and requirements for

the product, including:

1) Product and personnel safety?

2) Reliability, maintainability, and

availability?

3) Producibility and inspectability?

4) Suitability of parts and materials used

in the product?

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(a-Con't.) Quality objectives, and requirements for

the product, including:

5) Selection and development of

2 embedded software?

6) Recycling or final disposal of the

product at the end of it's life?

b) The need to establish processes,

documents, and provide resources
"specific" to the product requirements?

c) Required verification, validation,

monitoring, inspection, and test
activities, "specific to the product", and
criteria for product acceptance?

d) Records that are needed, to provide

evidence that the realization processes
and resulting product, satisfy customer
requirements?

e) Configuration management appropriate

to the product?

f) Resources to support the use and

maintenance of the product?

3 Is the planning output in a form, appropriate for the

contractor's methods of operation?

7.1.1 Project Management:

Has the contractor established an adequate system,

with associated processes, to plan and manage
product realization in a structured and controlled
4 manner, to meet customer requirements at an
acceptable risk, within resource and schedule
constraints?

7.1.2 Risk Management:

Has the contractor established, implemented, and

5 maintained processes, to manage "risk" and achieve
applicable customer requirements, including:

a) Assignment of responsibilities for risk

management?

b) Definitions of risk criteria (e.g.

likelihood, consequences, risk
acceptance)?

c) Identification, assessment, and

communication of risks throughout
product realization?

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d) Identification, implementation, and

management of actions, to mitigate risks
that exceed the defined risk acceptance
5 criteria?

e) Acceptance of risks remaining, after

implementation of mitigating actions?

7.1.3 Configuration Management:

Has the contractor established, implemented, and

6 maintained a configuration management process
that includes:

a) Configuration management planning?

b) Configuration identification?

c) Change control processes?

d) Maintaining records of configuration

status?

e) Configuration audits?

7.1.4 Control of Work Transfers:

Has the contractor established, implemented, and

maintained a process, to plan and control the
temporary or permanent transfer of work (e.g. from
7 one contractor facility to another, from the
contractor to a supplier, or from one supplier to
another supplier), and to verify conformity of the
work to the contract/customer requirements?

7.2 Customer Related Processes:

7.2.1 Determination of Requirements Related

to the Product:

8 Has the contractor's organization determined:

a) Requirements specified by the customer,

including the requirements for delivery
and post-delivery activities?

b) Requirements not stated by the customer,

but necessary for specified or intended
use, when known?

c) Statutory and regulatory requirements

related to the product?

d) Any additional product requirements,

mandated by the contractor's Policies
and/or Procedures?

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7.2.2 Review of Requirements Related to the

Product:

Prior to commitment to the customer (eg;

submission of Proposals, acceptance of Contracts or
Orders, or acceptance of Change Orders or Contract
9 Modifications), are requirements reviewed to ensure
that:

a) Product requirements are defined?

b) Contract or Order requirements, different

from those previously expressed, are
resolved?

c) The contractor has the ability to comply

with the defined requirements?

d) Any special requirements of the product

are determined?

e) Areas of risk have been identified (e.g.

new technology, short delivery time
frame, etc)?

Are the results of Reviews, and actions arising from

10 these Reviews, recorded and maintained as records?

Where the customer has not provided a documented

11 statement of requirements, are customer
requirements confirmed by the contractor, prior to
acceptance?

Where product requirements are changed, does the

contractor's organization ensure that applicable
documentation is amended, and relevant personnel
12 are made aware of the changed requirements?

7.2.3 Customer Communication:

Has the contractor's organization determined and

13 implemented, an effective process for
communicating with customers, relating to:

a) Product information and requirements?

b) Inquiries, Contracts, Amendments, or

Order handling?

c) Customer feedback, including customer

complaints?

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7.3 Design and Development:

7.3.1 Design and Development Planning:

14 Are product design and development activities

planned and controlled?

15 During design and development planning, has the

contractor determined and documented:

a) The various stages of design and

development?

b) Review, verification, and validation

steps, appropriate to each design and
development stage?

c) Responsibilities and authorities for

design and development?

Has the contractor established the necessary

processes to allow for the division of the design and
development efforts into distinct activities, and for
16 each activity, defined the tasks, necessary
resources, responsibilities, design content, input and
output data, and planning constraints?

Are the different design and development tasks to

be accomplished, based on the safety and functional
objectives of the product, in accordance with the
17 customer's requirements, statutory, and regulatory
requirements?

Does the contractor's process for design and

18 development planning, take into consideration the
capability to produce, inspect, test, and maintain the
product?

Are interfaces managed, between the different

groups that are involved in the design and
development processes, to ensure effective
19 communication, and clear assignment of
responsibilities?

20 Is planning output updated, as design and

development progresses?

7.3.2 Design and Development Inputs:

21 Are inputs, related to product requirements,

defined, documented, and maintained?

22 Does design and development include:

a) Functional and performance

requirements?

b) Applicable statutory and regulatory

requirements?

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b) Applicable statutory and regulatory

22 requirements?

c) Applicable information derived from

previous similar designs?

d) Other requirements that are essential for

designs and development?

23 Are design and development inputs reviewed for

adequacy?

24 Are incomplete, ambiguous, confusing, or

conflicting requirements resolved?

7.3.3 Design and Development Outputs:

Are outputs of the design and development,

25 provided in a form that enables verification against
the design and development inputs?

26 Are design outputs approved, prior to release?

27 Does the design and development output:

a) Meet the design and development input

requirements?

b) Provide appropriate information for

purchasing, production, and for a
repair/service provision?

c) Contain or reference product acceptance

critieria?

d) Specify the product characteristics that

are essential to it's safe and proper use?

e) Specify any critical items, if applicable,

including any key characteristics, and
specific actions to be accomplished for
these items?

Does the contractor have established processes to

28 define the data required to allow the product to be
identified, manufactured, inspected, tested, used,
and maintained, including:

a) Drawings, parts lists, and specifications

necessary to define the configuration and
the design features of the product?

b) Material, process, manufacturing, and

assembly data, required to ensure
conformity of the product?

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7.3.4 Design and Development Review:

Are systematic "Reviews" (audits) performed in

29 accordance with planned arrangements, at
applicable stages in the design and development
process?

30 Do design and development "Reviews" (audits):

a) Evaluate the capability of the design and

development efforts, to comply with
customer requirements?

b) Identify problems, and propose

necessary corrective actions?

c) Authorize progression to the next stage?

Do "Review" participants include representatives of

31 functions, involved with the design and
development stage(s) being reviewed?

32 Are results of Reviews, and any corrective actions

necessary, maintained as records?

7.3.5 Design and Development Verification:

Is design and development verification performed

33 in accordance with the contractor's plan, to ensure
that the design outputs, conform to the design and
development input requirements?

34 Are the results of verifications and corrective

actions documented, and maintained as records?

7.3.6 Design and Development Validation:

35 Is design and development validation performed in

accordance with planned arrangements?

Is design and development validation performed, to

36 confirm that the product is capable of meeting the
requirements of the specified application, and it's
intended purpose?

Is validation completed prior to delivery, or

37 implementation of the product, wherever
applicable?

38 Are the results of validation, and associated actions,

maintained as records?

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7.3.6.1 Design and Development Verification and

Validation Testing:

When testing is necessary for verification and

39 validation, are these tests planned, reviewed,
controlled, and documented, to ensure and prove the
following:

a) Do the test plans or specifications

identify the product being tested and the
resources that are to be used?

1) Do they define the test objectives and

conditions?

2) Do they identify the test parameters

that are to be recorded?

3) Do they specify the relevant

acceptance criteria?

b) Do the test procedures describe the

methods of operation, the performance
of the test, and the recording of the test
results?

c) Are requirements specified to verify that

the correct configuration of the product
is being submitted for the test?

d) Are there provisions specified to ensure

that the requirements of the test plan and
the test procedures are complied with?

e) Are there provisions specified to ensure

that acceptance criteria are met?

7.3.6.2 Design and Development Verification and

Validation Documentation:

At the completion of design and/or development,

does the contractor's documentation and records
ensure that reports, calculations, test data,
40 inspection results, etc, demonstrate that the product
meets the specification requirements for all
operational conditions?

7.3.7 Control of Design and Development

Changes:

Are design and/or development changes identified,

41 documented, and maintained as records?

Do reviews of design and development changes

42 include, evaluation of the effect of the changes on
associated parts, and product already delivered?

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Are design and development changes reviewed,

43 verified, and validated, as appropriate, and are the
changes approved, prior to implementation?

44 Are results of the review of changes and required

corrective actions, maintained as records?

7.4 Purchasing:

7.4.1 Purchasing Control:

Do the Subcontracting/Purchasing processes have

45 adequate controls in-place, to ensure that purchased
products and/or services conform to the Purchase
Order requirements?

Are the types of controls, and to what extent they

applied to the suppliers and purchased products,
evaluated and dependent upon the effect of the
46 purchased product on subsequent product
processing, or the final product?

Does the contractor have adequate controls (e.g.

policies, procedures, processes, etc) in-place, to
accept responsibility for the conformity of all
47 products purchased from suppliers, including
product from suppliers mandated by the customer?

Are subcontractors/suppliers evaluated and selected,

48 based on their ability to supply product, in
accordance with the contractor's requirements?

Has the contractor's organization established

49 procedures and criteria for selection, evaluation,
and re-evaluation of suppliers?

50 Are results of the evaluations, and any necessary

actions taken, maintained as records?

51 Has the contractor established a process in the

Quality Management System to:

a) Maintain a register of it's suppliers that

includes approval status (e.g. approved,
conditional, disapproved), and the scope
of the approval (e.g. product type,
process family, etc)?

b) Periodically review supplier

performance, utilizing the results of the
reviews as a basis for establishing the
level of controls to be implemented?

c) Define the necessary actions to take,

when dealing with suppliers that do not
meet requirements?

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d) Ensure that when required, both the

contractor and all suppliers use
customer-approved special process
sources?
51

e) Define the process, responsibilities, and

authority for the approval status
decision, changes of the approval status,
and conditions for a controlled use of
suppliers, depending on the suppliers
approval status?

f) Determine and manage the risk, when

selecting and using suppliers?

7.4.2 Purchasing Information:

52 Does the purchasing information describe the

product to be purchased?

53 Do the Purchase Orders (purchasing information) to

subcontractors and suppliers include:

a) Requirements for approval of product,

procedures, processes, and/or
equipment?

b) Requirements for qualification of

personnel?

c) Quality Management System

requirements?

d) The identification and revision status of

specifications, drawings, process
requirements, inspection/verification
instructions, and other technical data?

e) Requirements for design, test, inspection,

verification (including production
process verification), use of statistical
techniques for product acceptance and
related instructions for acceptance by the
contractor, and if applicable, critical
items, including key characteristics?

53

f) Requirements for test specimens (e.g.

production method, number, storage
conditions, etc) for design approval,
inspection/verification, investigation, or
auditing?

g) Requirements regarding the need for the

supplier/subcontractor to:

1) Notify the prime contractor of

nonconforming product?

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g) Requirements regarding the need for the

53 (Con't) supplier/subcontractor to:

2) Obtain prime contractor approval for

nonconforming product disposition?

3) Notify the contractor of changes to the

product and/or process, changes of
suppliers, changes of manufacturing
facility location, and when required,
obtain prime contractor approval?

4) Flow-down in the supply chain,

applicable requirements, including
customer requirements?

h) Retention of records?

i) "Right of access" by the contractor, the

customer, and regulatory authorities, to
applicable areas of "all facilities", at any
level in the supply chain involved with
the order, and access to "all applicable
records"?

54 Are specified purchasing requirements evaluated for

adequacy, prior to being issued to suppliers?

7.4.3 Verification of Purchased Product:

Has an inspection process, or other activities, been

55 established and implemented, which are necessary
for ensuring that purchased product complies with
specified purchase requirements?

Has the contractor implemented an adequate

process, to ensure that when purchased product is
released for production use, pending completion of
all required verification activities, that it is
56 identified and recorded, to allow for recall and
replacement, if it is subsequently found that the
product does not meet requirements?

Does the contractor have procedures which define

requirements for delegations, and require
maintaining a register of delegations, for instances
57 when the contractor chooses to delegate verification
activities to the supplier?

Are verification arrangements, and/or methods of

product release, specified in the purchasing
information, where the contractor's organization, or
58 it's customer, intends to perform verification at the
supplier's premises?

7.5 Production and Service Provision:

7.5.1 Control of Production and Service

Provision:

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7.5.1 Control of Production and Service

Provision:

Are the production and service provisions planned

59 and carried out under controlled conditions,
including:

a) Availability of information that describes

the product characteristics?

b) Availability of work instructions (e.g.

travelers, routers, manufacturing plans,
inspection documents, etc)?

c) Use of suitable equipment (e.g. jigs,

fixtures, molds, etc)?

d) Availability and use of measuring and

monitoring devices?

e) Implementation of monitoring and

measurement?

f) Implementation of release, delivery, and

post-delivery activities?

g) Accountability for all product during

production (e.g. parts lists, parts
quantities, split orders, nonconforming
product, etc)?

h) Evidence that all production and

inspection/verification operations have
been completed as planned, or as
otherwise documented and authorized?

i) Provisions for the prevention, detection,

and removal of foreign objects?

j) Monitoring and control of utilities and

supplies (e.g. water, compressed air,
electricity, chemical products, etc)?

k) Understandable, clear criteria for

workmanship (e.g. written standards,
representative samples, illustrations,
etc)?

When planning controls for production, has the

60 contractor considered, established, implemented,
and maintained processes for:

a) Managing critical items, including

process controls when key characteristics
have been identified?

b) Designing, manufacturing, and using

tooling to measure variable data?

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c) Identifying in-process inspection and

verification points, when adequate
verification of conformance cannot be
60 performed at later stages of
production/realization?

d) Special processes?

7.5.1.1 Production Process Verification:

61 Has the contractor established and implemented a

mandatory "First Article Inspection" process:

a) Using a representative item from the first

production run of a new part or
assembly, to verify that the production
processes, production documentation,
and tooling, are capable of producing
parts and assemblies that meet
requirements?

b) Incorporating provisions that the process

shall be repeated, when changes occur
that invalidate the original "First Article
Inspection" results (e.g. engineering
changes, manufacturing process changes,
tooling changes, etc)?

7.5.1.2 Control of Production Process Changes:

Has the contractor established a method, process,

62 and/or procedure for identification of personnel,
authorized to approve changes to production
processes?

Has the contractor implemented a process, to

63 control and document changes affecting processes,
production equipment, tools, or software programs?

Has the contractor developed and implemented a

process, to evaluate the results of changes to
production processes, assessing them to confirm
64 that the desired effect has been accomplished,
without adversely affecting product conformity?

7.5.1.3 Control of Production Equipment, Tools,

and Software Programs:

Has the contractor implemented a process to ensure

that production equipment, tools, and software
programs, used to automate and control, or monitor
65 product realization processes, are validated prior to
release for production, and are maintained?

Has the contractor initiated a process, defining

66 storage requirements, including periodic
preservation and condition checks, for production
equipment and/or tooling in storage?

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7.5.1.4 Post-Delivery Support:

67 Has the contractor established a post-delivery

support process, which provides for the:

a) Collection and analysis of in-service

data?

b) Actions to be taken, including

investigation and reporting, when
problems are detected after delivery?

c) Control and updating of technical data?

d) Approval, control, and use of repair

methods?

e) Controls required for off-site work (e.g.

contractor's work accomplished at
customer's facilities)?

7.5.2 Validation of Processes for Production

and Service Provision:

Have processes, where deficiencies may become

68 apparent only after the product is in use, or the
service has been delivered, been validated?

Do the results of validation, demonstrate the ability

69 of the processes to achieve the contractor's planned
results?

70 Has the contractor established a system and

processes for:

a) Defining the criteria, for the review and

approval of the processes?

b) Approval of equipment, and qualification

of personnel?

c) Use of specific methods, and/or

procedures?

d) Requirements for records?

e) Re-validation, if required?

7.5.3 Identification and Traceability:

71 Is the product adequately identifiable, throughout

the product realization processes?

Does the contractor have a process, to maintain

72 configuration identification of the product, in order
to identify any differences between the actual
configuration, and the agreed-to configuration?

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73 Is the product status identifiable, with respect to

monitoring and measurement requirements?

Has the contractor established a process, for control

74 of "Acceptance Authority" media (e.g. stamps,
electronic signatures, passwords, etc)?

75 When traceability is a requirement, is the product

uniquely identified and controlled, and:

a) Is there a process to ensure that

identification is maintained throughout
the product life?

b) Does the contractor have a process

established, providing the ability to trace
all products, manufactured from the
same batch of raw material, or from the
same manufacturing batch, to the
destination (e.g. delivery, scrap, etc)?

c) For an assembly, does the contractor

have a process established, providing the
ability to trace components to an
assembly, and then to the next higher
level assembly?

d) For a product, does the contractor have a

process established, providing the ability
to retrieve a sequential record of its
production (manufacture, assembly,
inspection, test, etc)?

76 Is the product's unique identification maintained as

a record?

7.5.4 Customer Property:

Does the contractor exercise adequate care with

77 customer property, while it is under the
organization's control, or is being used by the
contractor?

78 Is customer property identified, verified, protected,

and safeguarded?

If lost, damaged, or otherwise found to be

79 unsuitable for use, is the condition documented,
reported to the customer, and maintained as a
record?

7.5.5 Preservation of Product:

Is conformity of product preserved during internal

80 processing, and delivery to the intended
destination?

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81 Do the contractor's preservation activities include:

a) Identification?

b) Handling?

c) Packaging?

d) Storage?

e) Protection?

82 Are preservation activities applied to associated

component parts of a product?

In accordance with product specifications, and

83 applicable statutory and regulatory requirements,
does the contractor's preservation processes include
provisions for:

a) Cleaning?

b) Prevention, detection, and removal of

foreign objects?

c) Special handling for sensitive products?

d) Marking and labeling, including safety

warnings?

e) Shelf life control and stock rotation?

f) Special handling for hazardous

materials?

7.6 Control of Measuring and Monitoring

Devices:

Has the contractor's organization determined the

monitoring and measurement to take place,and the
types of monitoring and measurement devices that
84 are required, to provide evidence of conformity to
requirements?

Has the contractor established and maintained a

85 register/record of monitoring and measurement
equipment that is utilized?

Has the contractor established and defined the

86 process, employed for the calibration and
verification of monitoring and measurement
equipment, including details of:

a) Equipment type?

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b) Unique identification?
86

c) Location?

d) Frequency of checks?

e) Verification/check method?

f) Acceptance criteria?

Has the contractor identified monitoring and

measurement equipment, which is used to produce
inspection data to provide evidence of product
87 conformity, as including, but not limited to:

a) Test hardware?

b) Test software?

c) Automated Test Equipment (ATE)?

d) Plotters?

e) Personally owned equipment?

f) Customer supplied equipment?

Have processes been established, to ensure that

88 monitoring and measurement can be carried out, in
a manner consistent with the monitoring and
measurement requirements?

89 Has the contractor arranged for, and ensured that

existing environmental conditions are suitable for:

a) Calibration?

b) Inspection?

c) Measurement?

d) Testing?

90 When necessary to ensure valid results, are

measuring equipment:

a) Calibrated or verified at specific

intervals, or prior to use, against
measurement standards that are traceable
to international or national measurement
standards; where no standard exists, is
the foundation used for calibration or
verification recorded?

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b) Adjusted, or re-adjusted as necessary?

c) Identified to enable the calibration status

to be determined?

d) Safeguarded from adjustments that

would invalidate the measurement
results?

e) Protected from damage and deterioration

during handling, maintenance, and
storage?

Has the contractor established, implemented, and

91 maintained a process, for the recall of monitoring
and measurement equipment requiring calibration
or verification?

Has the contractor evaluated and recorded the

validity of previous measuring results, when the
equipment is found not to conform to the
92 requirements, and have they taken the appropriate
corrective action on the equipment, and any
affected product?

93 Are records of calibration and verification results

maintained?

When computer software is used in the monitoring

and measurement of specified requirements, is the
ability of the computer software to satisfy the
94 intended purpose confirmed, prior to use?

Does the contractor's process, for confirmation of

95 computer software to satisfy it's intended purpose,
include verification and configuration management
to maintain it's suitability for use?

96 Is the ability of computer software, to satisfy the

intended application, reconfirmed as needed?

8. Measurement, Analysis, and

Improvement

8.1 General:

Have the monitoring, measurement, analysis, and

1 improvement processes been planned, documented,
and implemented to:

a) Demonstrate conformity of the product?

b) Ensure conformity of the Quality

Management System?

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1 c) Continually improve the effectiveness of

the Quality Management System?

Have applicable process methods, including

2 statistical techniques, and their extent of use, been
determined?

3 Does the contractor use statistical techniques to

support:

a) Design verification (e.g. reliability,

mantainability, safety, etc)?

b) Process controls, including:

1) Selection and inspection of

key characteristics?

2) Process capability
measurements?

3) Statistical process control?

4) Design of experiments?

c) Inspection?

d) Failure mode, effect, and criticality

analysis?

8.2 Monitoring and Measurement:

8.2.1 Customer Satisfaction:

Is information and data, relating to customer

4 perception, monitored by the contractor, as to
whether customer requirements have been met?

Have the methodologies for obtaining and using

5 information and data, related to customer
perception, been determined?

Is the information that the contractor monitors and

6 uses for evaluation of customer satisfaction include,
but not limited to:

a) Product conformity?

b) On-time delivery performance?

c) Customer complaints?

d) Corrective action requests?

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Has the contractor developed and implemented

plans for customer satisfaction improvement,
addressing deficiencies identified by these
7 evaluations, and assessing the effectiveness of the
results?

8.2.2 Internal Audits:

Are internal audits conducted at planned intervals,

8 to determine whether the Quality Management
System:

a) Conforms to planned arrangements,

requirements of ISO 9001, customer
contractual requirements, and the Quality
Management System?

b) Is effectively implemented and

maintained?

When planning audits, does the contractor take into

9 consideration the status and importance of the
processes and areas to be audited, as well as the
results of previous audits?

10 Are audit criteria, scope, frequency, and methods

defined?

Is auditor selection considered by the contractor, to

11 ensure objectivity and impartiality of the audit
process?

12 Do controls exist to ensure that auditors do not

audit their own work?

Has a documented procedure been established to

13 define the responsibilities, requirements for
planning and conducting audits, reporting results,
and maintaining records?

Has management, which is responsible for the

area(s) being audited, ensured that corrective
actions have been initiated without delay, to
14 eliminate detected nonconformities, and their root
causes?

Do follow-up activities include verification of the

15 corrective actions taken, and the reporting of the
verification results?

8.2.3 Monitoring and Measurement of

Processes:

Are appropriate methods applied for monitoring,

16 and where applicable, measurement of the Quality
Management System processes, that are required to
meet customer requirements?

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17 Do these methods demonstrate the ability of the

processes to achieve the planned results?

18 Are corrective actions implemented, when planned

results are not achieved?

In the event of process nonconformity, has the

19 contractor established and implemented a process
and controls to:

a) Take appropriate action to correct the

nonconforming process?

b) Evaluate whether the process

nonconformity has resulted in product
nonconformities?

c) Determine if the process nonconformity

is limited to a specific case, or whether it
could have affected other processes or
products?

d) Identify and control any nonconforming

product?

8.2.4 Monitoring and Measurement of

Product:

Are product characteristics monitored and

20 measured, to verify that product requirements are
met?

Is monitoring and measurement of product

21 characteristics, implemented at appropriate stages
of the product realization process, in accordance
with the contractor's plans?

22 Is evidence of conformity with the acceptance

criteria, documented and maintained?

Has the contractor established the process, and

23 documented measurement requirements for product
acceptance, including:

a) Criteria for acceptance and/or rejection?

b) Where in the manufacturing sequence,

measurement and testing are to be
performed?

c) Required records of the measurement

results (e.g. at a minimum, indication of
acceptance or rejection)?

d) Any unique or specific measurement

instruments required, and any specific
instructions associated with their use?

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When critical items, including any key

characteristics have been identified, does the
contractor ensure they are controlled and monitored,
24 in accordance with established processes?

When the contractor has decided to use "Sampling

Inspection" as a means of product acceptance, has
the sampling plan been justified on the basis of
recognized statistical principles, and is it
25 appropriate for use (e.g. matching the sampling plan
to the criticality of the product, and to process
capability)?

Does the contractor have a documented process

established, so that when product is released for
further processing and production use, pending
completion of all required measurement, inspection,
26 testing, and monitoring activities, is it adequately
identified and recorded to allow for recall and
replacement, if it is subsequently found that the
product does not meet requirements?

27 Are records maintained that indicate the person(s)

authorizing release of product?

When required to demonstrate product

qualification, does the contractor have an
established process, to ensure that records provide
28 evidence that the product meets the defined
requirements?

Unless otherwise approved by a relevant authority,

29 or where applicable, the customer, are all planned
processes satisfactorily completed, prior to
proceeding with release of the product?

Does the contractor have an established process, to

30 ensure that all documents that are required to
accompany the product, are present at delivery?

8.3 Control of Nonconforming Product:

31 Is nonconforming product identified and controlled,

to prevent unintended use or delivery?

Has a documented procedure been established to

32 define process controls, identify authorities and
their related responsibilities, for dealing with
nonconforming product?

Do the contractor's procedures define

33 nonconforming product, as including
nonconforming product returned by the customer?

Does the contractor's documented procedure(s)

define the responsibility, and authority, for the
review and disposition of nonconforming product,
34 and explain the process for approving personnel
making these decisions?

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35 Is the process for dealing with nonconforming

product, one or more of the following ways:

a) Is action taken to eliminate the detected

nonconformity?

b) Nonconforming product is authorized for

use, release, or acceptance, by approval
of a relevant authority, and when
applicable, by the customer?

c) Is adequate action taken, to prevent using

the nonconforming product for it's
original intended use or application?

d) When nonconforming product is detected

after delivery, or use has started, is
appropriate evaluation and corrective
action taken by the contractor, to analyze
the effect, or potential effect, the
nonconformity may have on other
component parts, and/or Systems?

e) Does the contractor take the necessary

actions, to contain and/or limit the
potential effects of the nonconformity,
on other processes or products?

Does the contractor's process for control of

36 nonconforming product, provide for timely
reporting of delivered nonconforming product?

Does the contractor have a process established, for

notification of parties concerning nonconforming
product, including notification to applicable
37 suppliers, internal organizations, customers,
distributors, and regulatory authorities?

Does the contractor's process procedures for control

of nonconforming material, specify that dispositions
of "use-as-is" or "repair", shall only be used, after
approval by an authorized representative, or
38 personnel having delegated authority, from the
organization responsible for design?

If the nonconformity results in a departure from the

contract requirements, does the contractor have
provisions in their control of nonconforming
39 material process, to prevent the use of "use-as-is"
and "repair" dispositions, unless specifically
authorized by the customer?

Does the contractor's control of nonconforming

material process procedure(s), specify that product
dispositioned for "scrap", shall be conspicuously
40 and permanently marked, or positively controlled,
until physically rendered unusable?

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Are adequate records maintained, identifying the

41 nature of nonconformities, and any subsequent
corrective actions taken, including any waivers,
deviations, or authorized concessions?

When nonconforming product is corrected, is it

42 subject to re-verification, to demonstrate conformity
to the requirements?

8.4 Analysis of Data:

Is appropriate data determined, collected, and

analyzed, to demonstrate the suitability and
effectiveness of the Quality Management System,
43 and to evaluate where continuous improvement of
the effectiveness of the Quality Management
System can be made?

Does this data include data generated from

44 monitoring , measurement, and other relevant
sources?

45 Does the contractor's analysis of data, provide

information related to:

a) Customer satisfaction?

b) Conformance to product requirements?

c) Characteristics and trends, of products

and processes, including opportunities
for preventive action?

d) Adequacy of suppliers/subcontractors?

8.5 Process Improvement:

8.5.1 Continual Improvement:

Does the contractor have procedure(s) and a process

46 established, to promote continual improvement of
the effectiveness of the Quality Management
System?

Are the results of audits, analysis of data, corrective

47 and preventive actions, Management Reviews,
Quality Policy, and Quality Objectives, used for
continual improvement?

Does the contractor have a process established, to

monitor the implementation of improvement
activities, resulting from activities such as "lessons
48 learned", "problem resolutions", and the
"benchmarking of best practices", and evaluate the
effectiveness of the results?

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8.5.2 Corrective Action:

Are corrective actions taken to eliminate the root

49 cause(s) of nonconformities, and to prevent
recurrence?

50 Are corrective actions appropriate to eliminate the

effects of the nonconformities encountered?

51 Has a documented procedure been established, to

define the requirements for:

a) Reviewing nonconformities, including

customer complaints?

b) Determining the root cause(s) of

nonconformities?

c) Evaluating the need for corrective

action(s), to ensure that nonconformities
do not recur?

d) Determining and implementing adequate

corrective action(s)?

e) Recording and maintaining the results of

corrective actions taken?

f) Reviewing corrective actions?

g) Flowing down corrective action

requirements to a supplier, when it is
determined that the supplier is
responsible for the nonconformity?

h) Specific actions, when timely and/or

effective corrective actions are not
achieved?

i) Determining if additional nonconforming

product exists, based on the causes of the
nonconformities, and taking further
action, when required?

8.5.3 Preventive Action:

Has the contractor's organization initiated adequate

52 corrective actions, to eliminate the root causes of
potential nonconformities, in order to prevent
reoccurrence?

Are preventive action opportunities, such as "risk

management", "error proofing", " failure mode and
effect analysis (FMEA)", and "information on
53 product problems reported by external sources",
utilized appropriately to control and/or eliminate
effects of potential problems?

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54 Has a documented procedure been established, to

define the requirements for:

a) Determining potential nonconformities

and their root causes?

b) Evaluating the need for preventive

action, to preclude reoccurrence of
nonconformities?

c) Determining and implementing

corrective and preventive actions that are
needed?

d) Recording and maintaining the results of

preventive actions taken?

e) Review of preventive actions taken?

Notes & Comments

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4. Quality Management System

4.1 General Requirements:

Has the contractor established, documented,

1 implemented, and maintained a Quality
Management System, in accordance with the
requirements of AS 9100?

Is an effective "Continuous Improvement" program,

2 an active part of the contractor's Quality
Management System?

3 Has the contractor:

a) Identified the processes needed for the

Quality Management System, including
their applications throughout the
contractor's organization?

b) Determined the sequence and interaction

of these processes?

c) Determined the criteria and methods

needed, to ensure that both the operation
and control of these processes are
effective?

d) Ensured the availability of resources and

information necessary, to support the
operation and monitoring of these
processes?

e) Measured, monitored, and analyzed these

processes?

f) Implemented the actions necessary to

achieve their planned results, including
continuous improvement of the
processes?

4 Does the contractor manage these processes, in

accordance with AS 9100 requirements?

Do adequate controls exist, and are they identified

5 within the contractor's Quality Management
System, for process requirements that are
outsourced and affect product conformity?

4.2 Documentation Requirements:

4.2.1 General:

6 Does the Quality Management System

documentation include:

a) Documented statements of a Quality

policy, and Quality objectives?

b) A Quality manual?

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c) Documented procedures required by AS

6 9100?

d) Procedures needed by the contractor to

ensure the effective planning, operation,
and control of the processes?

e) Records required by AS 9100?

Does an adequate communication process exist

7 to ensure that personnel have access to, and are
aware of, relevant Quality Management System
documentation and changes?

4.2.2 Quality Manual:

8 Has a Quality manual been established and

maintained, that includes:

a) The scope of the Quality Management

System, including details of, and
justification for any exclusions or
exceptions?

b) Documented procedures established for

the Quality Management System, or
reference to them?

c) A description of the interaction between

the processes of the Quality Management
System?

4.2.3 Control of Documents:

Are the documents that are required for the Quality

9 Management System adequately controlled?

10 Has a documented procedure been established,

identifying the following controls:

a) Approval of documents for adequacy

"prior" to issue?

b) Review and update as necessary,

including re-approval of documents?

c) Ensures that changes, and the current

revision status of documents are
identified?

d) Ensure that latest revisions, or relevant

versions of applicable documents, are
available at points of use?

e) Ensures that documents remain legible,

and are readily identifiable?

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f) Ensure that documents of external origin

10 are identified, and their distribution is
controlled?

g) Preventing the unintended use of

obsolete documents, and to apply
suitable identification to them if they are
retained?

4.2.4 Control of Records:

Have records been established and maintained to

11 provide evidence of conformity to requirements,
and of the effective operation of the Quality
Management system?

12 Has a documented procedure been established to

define the following required controls?

a) Identification?

b) Storage?

c) Retrieval?

d) Protection?

e) Retention Time?

f) Disposition?

Does a documented procedure exist, defining

13 the method for controlling records that are
created by, and/or retained by, suppliers?

Notes & Comments

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Notes & Comments

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Chapter 5 - Management Systems

Contractor: Date:
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5. Management Responsibility

5.1 Management Commitment:

Has top management provided evidence of its

commitment to the development and
1 implementation of the Quality Management
System, and for continuous improvement of its
effectiveness, by:

a) Communicating to the organization the

importance of meeting customer, as well
as regulatory and legal requirements?

b) Establishing the Quality policy?

c) Ensuring that Quality objectives are

established?

d) Conducting Management Reviews?

e) Ensuring the availability of adequate

resources?

5.2 Customer Focus:

Has top management ensured that customer

2 requirements are determined and met, with the aim
of enhancing customer satisfaction?

Has top management established and implemented

a process, to ensure that product conformity and on-
time delivery are measured, and that appropriate
3 action is taken if planned results are not, or will not,
be achieved?

5.3 Quality Policy:

4 Has top management ensured that the Quality

Policy:

a) Is appropriate for the purpose of the

contractor's organization?

b) Includes a commitment to comply with

requirements, and to continually improve
the effectivness of the Quality
Management System?

c) Provides a framework for establishing

and reviewing Quality objectives?

d) Is communicated and understood within

the contractor's organization?

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4 e) Is reviewed for continual

appropriateness?

5.4 Planning:

5.4.1 Quality Objectives:

Has top management ensured that Quality

5 objectives are established for relevant functions,
and at appropriate levels within the organization?

6 Have Quality objectives, needed to meet the

requirements of the product, been established?

7 Are Quality objectives measurable, and consistant

with the contractor's documented Quality Policy?

5.4.2 Quality Management System Planning:

Has top management ensured that the resources

8 needed to achieve the Quality objectives are
planned for, and identified?

Is the output of the contractor's planning

9 documented? (ie; quality manual, procedures, work
instructions, quality plans, etc.)

When changes to the Quality Management System

10 are planned and implemented, does top
management ensure that the integrity of the Quality
System is maintained?

5.5 Responsibility, Authority, and

Communication:

5.5.1 Responsibility and Authority:

Has top management ensured that responsibilities

11 and authorities for the Quality Management System
are defined, and communicated throughout the
contractor's organization?

5.5.2 Management Representative:

Has top management designated and appointed

12 member(s) of management, who have reponsibility
and authority that includes:

a) Ensuring that Quality processes are

established, implemented, and
maintained?

b) Reporting to top management on the

performance of the Quality Management
System, including any needs for
improvement?

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c) Promoting awareness of customer

requirements throughout the contractor's
organization?
12

d) The organizational freedom, and

unrestricted access to top management,
to resolve Quality Management issues?

5.5.3 Internal Communications:

Has top management ensured that appropriate

13 communication processes have been established
throughout the organization?

14 Does communication, regarding the effectiveness of

the Quality Management System, take place?

5.6 Management Review:

5.6.1 General:

Does top management accomplish "Reviews" of the

15 Quality Management System at planned intervals,
to ensure it's continuing suitability, adequacy, and
effectiveness?

Are opportunities for improvement, and the need

for changes to the Quality Management System,
including the contractor's Quality Policy and
16 Quality Objectives, evaluated during "Management
Reviews"?

17 Are records of "Management Reviews" documented

and maintained as Quality records?

5.6.2 Review Input:

18 Do the inputs to "Management Reviews" include

information on:

a) Results of audits?

b) Customer Feedback?

c) Process performance and product

conformity?

d) Status of preventive and corrective

actions?

e) Follow-up actions from previous

Management Reviews?

f) Planned changes that could affect the

Quality Management System?

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18 g) Recommendations for improvement?

5.6.3 Review Output:

19 Do the outputs from the "Management Reviews"

include the decisions and actions related to:

a) Improvement of the effectiveness of the

Quality Management System, and its
processes?

b) Improvement of the product, related to

customer requirements?

c) Resources that are required?

Notes & Comments

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6. Resource Management

6.1 Provision of Resources:

1 Have the resources been determined and made

available for:

a) Implementing and maintaining a Quality

Management System, including
continuous improvement of it's
effectiveness?

b) Enhancing customer satisfaction, by

meeting customer requirements?

6.2 Human Resources:

6.2.1 General:

For personnel who perform work affecting product

2 quality, is competency based on appropriate
education, training, skills, and experience?

6.2.2 Competency, Awareness, and Training:

3 Has the contractor's organization:

a) Determined the appropriate skills and

competencies, for personnel performing
work affecting quality?

b) Provided training, or taken other actions

to satisfy competency needs?

c) Evaluated the effectiveness of any

actions taken?

d) Ensured that employees are aware of the

significance and importance of their
activities, and how they contribute to the
achievement of the Quality objectives?

e) Maintained appropriate personnel

records of education, training, skills, and
experience?

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6.3 Infrastructure:

To achieve conformity of the product, does the

4 contractor's organization identify, provide, and
maintain appropriate facilities, including:

a) Buildings, workspace, and associated

utilities?

b) Process equipment, including hardware,

and software?

c) Supporting Services?

6.4 Work Environment:

Has the environment, needed to attain conformity of

5 product requirements, been determined and
managed adequately (noise, temperature, lighting,
humidity, etc)?

Notes & Comments

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7. Product Realization

7.1 Planning of Realization Process:

Is planning of the contractor's product realization,

1 consistent with the requirements of the other
processes of the Quality Management System?

2 When planning product realization processes, are

the following being considered and determined:

a) Quality objectives, and requirements for

the product, including:

1) Product and personnel safety?

2) Reliability, maintainability, and

availability?

3) Producibility and inspectability?

4) Suitability of parts and materials used

in the product?

5) Selection and development of

embedded software?

6) Recycling or final disposal of the

product at the end of it's life?

b) The need to establish processes,

documents, and provide resources
"specific" to the product requirements?

c) Required verification, validation,

monitoring, inspection, and test
activities, "specific to the product", and
criteria for product acceptance?

d) Records that are needed, to provide

evidence that the realization processes
and resulting product, satisfy customer
requirements?

e) Configuration management appropriate

to the product?

f) Resources to support the use and

maintenance of the product?

3 Is the planning output in a form, appropriate for the

contractor's methods of operation?

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7.1.1 Project Management:

Has the contractor established an adequate system,

with associated processes, to plan and manage
product realization in a structured and controlled
4 manner, to meet customer requirements at an
acceptable risk, within resource and schedule
constraints?

7.1.2 Risk Management:

Has the contractor established, implemented, and

5 maintained processes, to manage "risk" and achieve
applicable customer requirements, including:

a) Assignment of responsibilities for risk

management?

b) Definitions of risk criteria (e.g.

likelihood, consequences, risk
acceptance)?

c) Identification, assessment, and

communication of risks throughout
product realization?

d) Identification, implementation, and

management of actions, to mitigate risks
that exceed the defined risk acceptance
criteria?

e) Acceptance of risks remaining, after

implementation of mitigating actions?

7.1.3 Configuration Management:

Has the contractor established, implemented, and

6 maintained a configuration management process
that includes:

a) Configuration management planning?

b) Configuration identification?

c) Change control processes?

d) Maintaining records of configuration

status?

e) Configuration audits?

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7.1.4 Control of Work Transfers:

Has the contractor established, implemented, and

maintained a process, to plan and control the
temporary or permanent transfer of work (e.g. from
7 one contractor facility to another, from the
contractor to a supplier, or from one supplier to
another supplier), and to verify conformity of the
work to the contract/customer requirements?

7.2 Customer Related Processes:

7.2.1 Determination of Requirements Related

to the Product:

8 Has the contractor's organization determined:

a) Requirements specified by the customer,

including the requirements for delivery
and post-delivery activities?

b) Requirements not stated by the customer,

but necessary for specified or intended
use, when known?

c) Statutory and regulatory requirements

related to the product?

d) Any additional product requirements,

mandated by the contractor's Policies
and/or Procedures?

7.2.2 Review of Requirements Related to the

Product:

Prior to commitment to the customer (eg;

submission of Proposals, acceptance of Contracts or
Orders, or acceptance of Change Orders or Contract
9 Modifications), are requirements reviewed to ensure
that:

a) Product requirements are defined?

b) Contract or Order requirements, different

from those previously expressed, are
resolved?

c) The contractor has the ability to comply

with the defined requirements?

d) Any special requirements of the product

are determined?

e) Areas of risk have been identified (e.g.

new technology, short delivery time
frame, etc)?

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Are the results of Reviews, and actions arising from

10 these Reviews, recorded and maintained as records?

Where the customer has not provided a documented

11 statement of requirements, are customer
requirements confirmed by the contractor, prior to
acceptance?

Where product requirements are changed, does the

contractor's organization ensure that appropriate
documentation is amended, and relevant personnel
12 are made aware of the changed requirements?

7.2.3 Customer Communication:

Has the contractor's organization determined and

13 implemented, an effective process for
communicating with customers, relating to:

a) Product information and requirements?

b) Inquiries, Contracts, Amendments, or

Order handling?

c) Customer feedback, including customer

complaints?

7.3 Design and Development:

7.3.1 Design and Development Planning:

14 Are product design and development activities

planned and controlled?

15 During design and development planning, has the

contractor determined and documented:

a) The various stages of design and

development?

b) Review, verification, and validation

steps, appropriate to each design and
development stage?

c) Responsibilities and authorities for

design and development?

Has the contractor established the necessary

processes to allow for the division of the design and
development efforts into distinct activities, and for
16 each activity, defined the tasks, necessary
resources, responsibilities, design content, input and
output data, and planning constraints?

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Are the different design and development tasks to

be accomplished, based on the safety and functional
objectives of the product, in accordance with the
17 customer's requirements, statutory, and regulatory
requirements?

Does the contractor's process for design and

18 development planning, take into consideration the
capability to produce, inspect, test, and maintain the
product?

Are interfaces managed, between the different

groups that are involved in the design and
development processes, to ensure effective
19 communication, and clear assignment of
responsibilities?

20 Is planning output updated, as design and

development progresses?

7.3.2 Design and Development Inputs:

21 Are inputs, related to product requirements,

defined, documented, and maintained?

22 Does design and development include:

a) Functional and performance

requirements?

b) Applicable statutory and regulatory

requirements?

c) Applicable information derived from

previous similar designs?

d) Other requirements that are essential for

designs and development?

23 Are design and development inputs reviewed for

adequacy?

24 Are incomplete, ambiguous, confusing, or

conflicting requirements resolved?

7.3.3 Design and Development Outputs:

Are outputs of the design and development,

25 provided in a form that enables verification against
the design and development inputs?

26 Are design outputs approved, prior to release?

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27 Does the design and development output:

a) Meet the design and development input

requirements?

b) Provide appropriate information for

purchasing, production, and for a
repair/service provision?

c) Contain or reference product acceptance

critieria?

d) Specify the product characteristics that

are essential to it's safe and proper use?

e) Specify any critical items, if applicable,

including any key characteristics, and
specific actions to be accomplished for
these items?

Does the contractor have established processes to

28 define the data required to allow the product to be
identified, manufactured, inspected, tested, used,
and maintained, including:

a) Drawings, parts lists, and specifications

necessary to define the configuration and
the design features of the product?

b) Material, process, manufacturing, and

assembly data, required to ensure
conformity of the product?

7.3.4 Design and Development Review:

Are systematic "Reviews" (audits) performed in

29 accordance with planned arrangements, at
applicable stages in the design and development
process?

30 Do design and development "Reviews" (audits):

a) Evaluate the capability of the design and

development efforts, to comply with
customer requirements?

b) Identify problems, and propose

necessary corrective actions?

c) Authorize progression to the next stage?

Do "Review" participants include representatives of

31 functions, involved with the design and
development stage(s) being reviewed?

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32 Are results of "Reviews", and any corrective actions

necessary, maintained as records?

7.3.5 Design and Development Verification:

Is design and development verification performed

33 in accordance with the contractor's plan, to ensure
that the design outputs, conform to the design and
development input requirements?

34 Are the results of verifications and corrective

actions documented, and maintained as records?

7.3.6 Design and Development Validation:

35 Is design and development validation performed in

accordance with planned arrangements?

Is design and development validation performed, to

36 confirm that the product is capable of meeting the
requirements of the specified application, and it's
intended purpose?

Is validation completed prior to delivery, or

37 implementation of the product, wherever
applicable?

38 Are the results of validation, and associated actions,

maintained as records?

7.3.6.1 Design and Development Verification and

Validation Testing:

When testing is necessary for verification and

39 validation, are these tests planned, reviewed,
controlled, and documented, to ensure and prove the
following:

a) Do the test plans or specifications

identify the product being tested and the
resources that are to be used?

1) Do they define the test objectives and

conditions?

2) Do they identify the test parameters

that are to be recorded?

3) Do they specify the relevant

acceptance criteria?

b) Do the test procedures describe the

methods of operation, the performance
of the test, and the recording of the test
results?

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c) Are requirements specified to verify that

the correct configuration of the product
is being submitted for the test?
39

d) Are there provisions specified to ensure

that the requirements of the test plan and
the test procedures are complied with?

e) Are there provisions specified to ensure

that acceptance criteria are met?

7.3.6.2 Design and Development Verification and

Validation Documentation:

At the completion of design and/or development,

does the contractor's documentation and records
ensure that reports, calculations, test data,
40 inspection results, etc, demonstrate that the product
meets the specification requirements for all
operational conditions?

7.3.7 Control of Design and Development

Changes:

Are design and/or development changes identified,

41 documented, and maintained as records?

Do reviews of design and development changes

42 include, evaluation of the effect of the changes on
associated parts, and product already delivered?

Are design and development changes reviewed,

43 verified, and validated, as appropriate, and are the
changes approved, prior to implementation?

Are results of the review of changes, and any

44 required corrective actions, maintained as records?

7.4 Purchasing:

7.4.1 Purchasing Control:

Do the Subcontracting/Purchasing processes have

45 adequate controls in-place, to ensure that purchased
products, and/or services, conform to the Purchase
Order requirements?

Are the types of controls, and to what extent they

applied to the suppliers and purchased products,
evaluated and dependent upon the effect of the
46 purchased product on subsequent product
processing, or the final product?

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Does the contractor have adequate controls (e.g.

policies, procedures, processes, etc) in-place, to
accept responsibility for the conformity of all
47 products purchased from suppliers, including
product from suppliers mandated by the customer?

Are subcontractors/suppliers selected and evaluated,

48 based on their ability to supply product, in
accordance with the contractor's requirements?

Has the contractor's organization established

49 procedures and criteria for selection, evaluation,
and re-evaluation of suppliers?

50 Are results of the evaluations, and any necessary

actions taken, maintained as records?

51 Has the contractor established a process in the

Quality Management System to:

a) Maintain a register of it's suppliers that

includes approval status (e.g. approved,
conditional, disapproved), and the scope
of the approval (e.g. product type,
process family, etc)?

b) Periodically review supplier

performance, utilizing the results of the
reviews as a basis for establishing the
level of controls to be implemented?

c) Define the necessary actions to take,

when dealing with suppliers that do not
meet requirements?

d) Ensure that when required, both the

contractor and all suppliers use
customer-approved special process
sources?

e) Define the process, responsibilities, and

authority for the approval status
decision, changes of the approval status,
and conditions for a controlled use of
suppliers, depending on the suppliers
approval status?

f) Determine and manage the risk, when

selecting and using suppliers?

7.4.2 Purchasing Information:

52 Does the purchasing information describe the

product to be purchased?

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53 Do the Purchase Orders (purchasing information) to

subcontractors and suppliers include:

a) Requirements for approval of product,

procedures, processes, and/or
equipment?

b) Requirements for qualification of

personnel?

c) Quality Management System

requirements?

d) The identification and revision status of

specifications, drawings, process
requirements, inspection/verification
instructions, and other technical data?

e) Requirements for design, test, inspection,

verification (including production
process verification), use of statistical
techniques for product acceptance and
related instructions for acceptance by the
contractor, and if applicable, critical
items, including key characteristics?

f) Requirements for test specimens (e.g.

production method, number, storage
conditions, etc) for design approval,
inspection/verification, investigation, or
auditing?

g) Requirements regarding the need for the

53 supplier/subcontractor to:

1) Notify the prime contractor of

nonconforming product?

2) Obtain prime contractor approval for

nonconforming product disposition?

3) Notify the contractor of changes to the

product and/or process, changes of
suppliers, changes of manufacturing
facility location, and when required,
obtain prime contractor approval?

4) Flow-down in the supply chain,

applicable requirements, including
customer requirements?

h) Retention of records?

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i) "Right of access" by the contractor, the

53 customer, and regulatory authorities, to
applicable areas of "all facilities", at any
level in the supply chain involved with
the order, and access to "all applicable
records"?

54 Are specified purchasing requirements evaluated for

adequacy, prior to being issued to suppliers?

7.4.3 Verification of Purchased Product:

Has an inspection process, or other activities, been

55 established and implemented, which are necessary
for ensuring that purchased product complies with
specified purchase requirements?

Has the contractor implemented an adequate

process, to ensure that when purchased product is
released for production use, pending completion of
all required verification activities, that it is
56 identified and recorded, to allow for recall and
replacement, if it is subsequently found that the
product does not meet requirements?

Does the contractor have procedures which define

requirements for delegations, and require
maintaining a register of delegations, for instances
57 when the contractor chooses to delegate verification
activities to the supplier?

Are verification arrangements, and/or methods of

product release, specified in the purchasing
information, where the contractor's organization, or
58 it's customer, intends to perform verification at the
supplier's premises?

7.5 Production and Service Provision:

7.5.1 Control of Production and Service

Provision:

Are the production and service provisions planned

59 and carried out under controlled conditions,
including:

a) Availability of information that describes

the product characteristics?

b) Availability of work instructions (e.g.

travelers, routers, manufacturing plans,
inspection documents, etc)?

c) Use of suitable equipment (e.g. jigs,

fixtures, molds, etc)?

d) Availability and use of measuring and

monitoring devices?

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e) Implementation of monitoring and

59 measurement?

f) Implementation of release, delivery, and

post-delivery activities?

g) Accountability for all product during

production (e.g. parts lists, parts
quantities, split orders, nonconforming
product, etc)?

h) Evidence that all production and

inspection/verification operations have
been completed as planned, or as
otherwise documented and authorized?

i) Provisions for the prevention, detection,

and removal of foreign objects?

j) Monitoring and control of utilities and

supplies (e.g. water, compressed air,
electricity, chemical products, etc)?

k) Understandable, clear criteria for

workmanship (e.g. written standards,
representative samples, illustrations,
etc)?

When planning controls for production, has the

60 contractor considered, established, implemented,
and maintain processes for:

a) Managing critical items, including

process controls when key characteristics
have been identified?

b) Designing, manufacturing, and using

tooling to measure variable data?

c) Identifying in-process inspection and

verification points, when adequate
verification of conformance cannot be
performed at later stages of
production/realization?

d) Special processes?

7.5.1.1 Production Process Verification:

61 Has the contractor established and implemented a

mandatory "First Article Inspection" process:

a) Using a representative item from the first

production run of a new part or
assembly, to verify that the production
processes, production documentation,
and tooling, are capable of producing
parts and assemblies that meet
requirements?

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b) Incorporating provisions that the process

shall be repeated, when changes occur
that invalidate the original "First Article
61 Inspection" results (e.g. engineering
changes, manufacturing process changes,
tooling changes, etc)?

7.5.1.2 Control of Production Process Changes:

Has the contractor established a method, process,

62 and/or procedure for identification of personnel,
authorized to approve changes to production
processes?

Has the contractor implemented a process, to

63 control and document changes affecting processes,
production equipment, tools, or software programs?

Has the contractor developed and implemented a

process, to evaluate the results of changes to
production processes, assessing them to confirm
64 that the desired effect has been accomplished,
without adversely affecting product conformity?

7.5.1.3 Control of Production Equipment, Tools,

and Software Programs:

Has the contractor implemented a process to ensure

that production equipment, tools, and software
programs, used to automate and control, or monitor
65 product realization processes, are validated prior to
release for production, and are maintained?

Has the contractor initiated a process, defining

66 storage requirements, including periodic
preservation and condition checks, for production
equipment and/or tooling in storage?

7.5.1.4 Post-Delivery Support:

67 Has the contractor established a post-delivery

support process, which provides for the:

a) Collection and analysis of in-service

data?

b) Actions to be taken, including

investigation and reporting, when
problems are detected after delivery?

c) Control and updating of technical data?

d) Approval, control, and use of repair

methods?

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67 e) Controls required for off-site work (e.g.

contractor's work accomplished at
customer's facilities)?

7.5.2 Validation of Processes for Production

and Service Provision:

Have processes, where deficiencies may become

68 apparent only after the product is in use, or the
service has been delivered, been validated?

Do the results of validation, demonstrate the ability

69 of the processes to achieve the contractor's planned
results?

70 Has the contractor established a system and

processes for:

a) Defining the criteria, for the review and

approval of the processes?

b) Approval of equipment, and qualification

of personnel?

c) Use of specific methods, and/or

procedures?

d) Requirements for records?

e) Re-validation, if required?

7.5.3 Identification and Traceability:

71 Is the product adequately identifiable, throughout

the product realization processes?

Does the contractor have a process, to maintain

72 configuration identification of the product, in order
to identify any differences between the actual
configuration, and the agreed-to configuration?

73 Is the product status identifiable, with respect to

monitoring and measurement requirements?

Has the contractor established a process, for control

74 of "Acceptance Authority" media (e.g. stamps,
electronic signatures, passwords, etc)?

75 When traceability is a requirement, is the product

uniquely identified and controlled?

a) Is there a process to ensure that

identification is maintained throughout
the product life?

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b) Does the contractor have a process

established, providing the ability to trace
all products, manufactured from the
same batch of raw material, or from the
same manufacturing batch, to the
75 destination (e.g. delivery, scrap, etc)?

c) For an assembly, does the contractor

have a process established, providing the
ability to trace components to an
assembly, and then to the next higher
level assembly?

d) For a product, does the contractor have a

process established, providing the ability
to retrieve a sequential record of its
production (manufacture, assembly,
inspection, test, etc)?

76 Is the product's unique identification maintained as

a record?

7.5.4 Customer Property:

Does the contractor exercise adequate care with

77 customer property, while it is under the
organization's control, or is being used by the
contractor?

78 Is customer property identified, verified, protected,

and safeguarded?

If lost, damaged, or otherwise found to be

79 unsuitable for use, is the condition documented,
reported to the customer, and maintained as a
record?

7.5.5 Preservation of Product:

Is conformity of the product preserved during

80 internal processing, and delivery to the intended
destination?

81 Do the contractor's preservation activities include:

a) Identification?

b) Handling?

c) Packaging?

d) Storage?

e) Protection?

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82 Are preservation activities applied to associated

component parts of a product?

In accordance with product specifications, and

83 applicable statutory and regulatory requirements,
does the contractor's preservation processes include
provisions for:

a) Cleaning?

b) Prevention, detection, and removal of

foreign objects?

c) Special handling for sensitive products?

d) Marking and labeling, including safety

warnings?

e) Shelf life control and stock rotation?

f) Special handling for hazardous

materials?

7.6 Control of Measuring and Monitoring

Devices:

Has the contractor's organization determined the

monitoring and measurement to take place,and the
types of monitoring and measurement devices that
84 are required, to provide evidence of conformity to
requirements?

Has the contractor established and maintained a

85 register/record of monitoring and measurement
equipment that is utilized?

Has the contractor established and defined the

86 process, employed for the calibration and
verification of monitoring and measurement
equipment, including details of:

a) Equipment type?

b) Unique identification?

c) Location?

d) Frequency of checks?

e) Verification/check method?

f) Acceptance criteria?

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Number Question Process/Procedure Reference Comments

Has the contractor identified monitoring and

measurement equipment, which is used to produce
inspection data to provide evidence of product
87 conformity, as including, but not limited to:

a) Test hardware?

b) Test software?

c) Automated Test Equipment (ATE)?

d) Plotters?

e) Personally owned equipment?

f) Customer supplied equipment?

Have processes been established, to ensure that

88 monitoring and measurement can be carried out, in
a manner consistent with the monitoring and
measurement requirements?

89 Has the contractor arranged for, and ensured that

existing environmental conditions are suitable for:

a) Calibration?

b) Inspection?

c) Measurement?

d) Testing?

90 When necessary to ensure valid results, are

measuring equipment:

a) Calibrated or verified at specific

intervals, or prior to use, against
measurement standards that are traceable
to international or national measurement
standards; where no standard exists, is
the foundation used for calibration or
verification recorded?

b) Adjusted, or re-adjusted as necessary?

c) Identified to enable the calibration status

to be determined?

d) Safeguarded from adjustments that

would invalidate the measurement
results?

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e) Protected from damage and deterioration

90 during handling, maintenance, and
storage?

Has the contractor established, implemented, and

91 maintained a process, for the recall of monitoring
and measurement equipment requiring calibration
or verification?

Has the contractor evaluated and recorded the

validity of previous measuring results, when the
equipment is found not to conform to the
92 requirements, and have they taken the appropriate
corrective action on the equipment, and any
affected product?

93 Are records of calibration and verification results

maintained?

When computer software is used in the monitoring

and measurement of specified requirements, is the
ability of the computer software to satisfy the
94 intended purpose confirmed, prior to use?

Does the contractor's process, for confirmation of

95 computer software to satisfy it's intended purpose,
include verification and configuration management
to maintain it's suitability for use?

96 Is the ability of computer software, to satisfy the

intended application, reconfirmed as needed?

Notes & Comments

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Notes & Comments

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Contractor: Date:
AS9100C Audit Checklist Program PLAS Code:
Number Question Process/Procedure Reference Comments
8. Measurement, Analysis, and
Improvement

8.1 General:

Have the monitoring, measurement, analysis, and

1 improvement processes been planned, documented,
and implemented to:

a) Demonstrate conformity of the product?

b) Ensure conformity of the Quality

Management System?

c) Continually improve the effectiveness of

the Quality Management System?

Have applicable process methods, including

2 statistical techniques, and their extent of use, been
determined?

3 Does the contractor use statistical techniques to

support:

a) Design verification (e.g. reliability,

mantainability, safety, etc)?

b) Process controls, including:

1) Selection and inspection of

key characteristics?

2) Process capability
measurements?

3) Statistical process control?

4) Design of experiments?

c) Inspection?

d) Failure mode, effect, and criticality

analysis?

8.2 Monitoring and Measurement:

8.2.1 Customer Satisfaction:

Is information and data, relating to customer

4 perception, monitored by the contractor, as to
whether customer requirements have been met?

Have the methodologies for obtaining and using

5 information and data, related to customer
perception, been determined?

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Is the information that the contractor monitors and

6 uses for evaluation of customer satisfaction include,
but not limited to:

a) Product conformity?

b) On-time delivery performance?

c) Customer complaints?

d) Corrective action requests?

Has the contractor developed and implemented

plans for customer satisfaction improvement,
addressing deficiencies identified by these
7 evaluations, and assessing the effectiveness of the
results?

8.2.2 Internal Audits:

Are internal audits conducted at planned intervals,

8 to determine whether the Quality Management
System:

a) Conforms to planned arrangements,

requirements of ISO 9001, customer
contractual requirements, and the Quality
Management System?

b) Is effectively implemented and

maintained?

When planning audits, does the contractor take into

9 consideration the status and importance of the
processes, and areas to be audited, as well as the
results of previous audits?

10 Are audit criteria, scope, methods, and frequency

defined?

Is auditor selection considered by the contractor, to

11 ensure objectivity and impartiality of the audit
process?

12 Do controls exist to ensure that auditors do not

audit their own work?

Has a documented procedure been established to

13 define the responsibilities, requirements for
planning and conducting audits, reporting results,
and maintaining records?

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Has management, which is responsible for the

area(s) being audited, ensured that corrective
actions have been initiated without delay, to
14 eliminate detected nonconformities, and their root
causes?

Do follow-up activities include verification of the

15 corrective actions taken, and the reporting of the
verification results?

8.2.3 Monitoring and Measurement of

Processes:

Are appropriate methods applied for monitoring,

16 and where applicable, measurement of the Quality
Management System processes, that are required to
meet customer requirements?

17 Do these methods demonstrate the ability of the

processes to achieve the planned results?

18 Are corrective actions implemented, when planned

results are not achieved?

In the event of process nonconformity, has the

19 contractor established and implemented a process
and controls to:

a) Take appropriate action to correct the

nonconforming process?

b) Evaluate whether the process

nonconformity has resulted in product
nonconformities?

c) Determine if the process nonconformity

is limited to a specific case, or whether it
could have affected other processes or
products?

d) Identify and control any nonconforming

product?

8.2.4 Monitoring and Measurement of

Product:

Are product characteristics monitored and

20 measured, to verify that product requirements are
met?

Is monitoring and measurement of product

21 characteristics, implemented at appropriate stages
of the product realization process, in accordance
with the contractor's plans?

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22 Is evidence of conformity with the acceptance

criteria, documented and maintained?

Has the contractor established the process, and

23 documented measurement requirements for product
acceptance, including:

a) Criteria for acceptance and/or rejection?

b) Where in the manufacturing sequence,

measurement and testing are to be
performed?

c) Required records of the measurement

results (e.g. at a minimum, indication of
acceptance or rejection)?

d) Any unique or specific measurement

instruments required, and any specific
instructions associated with their use?

When critical items, including any key

characteristics have been identified, does the
contractor ensure they are controlled and monitored,
24 in accordance with established processes?

When the contractor has decided to use "Sampling

Inspection" as a means of product acceptance, has
the sampling plan been justified on the basis of
recognized statistical principles, and is it
25 appropriate for use (e.g. matching the sampling plan
to the criticality of the product, and to process
capability)?

Does the contractor have a documented process

established, so that when product is released for
further processing and production use, pending
completion of all required measurement, inspection,
26 testing, and monitoring activities, is it adequately
identified and recorded to allow for recall and
replacement, if it is subsequently found that the
product does not meet requirements?

27 Are records maintained that indicate the person(s)

authorizing release of product?

When required to demonstrate product

qualification, does the contractor have an
established process, to ensure that records provide
28 evidence that the product meets the defined
requirements?

Unless otherwise approved by a relevant authority,

29 or where applicable, the customer, are all planned
processes satisfactorily completed, prior to
proceeding with release of the product?

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Does the contractor have an established process, to

30 ensure that all documents that are required to
accompany the product, are present at delivery?

8.3 Control of Nonconforming Product:

31 Is nonconforming product identified and controlled,

to prevent unintended use or delivery?

Has a documented procedure been established to

32 define process controls, identify authorities, and
their related responsibilities, for dealing with
nonconforming product?

Do the contractor's procedures define

33 nonconforming product, as including
nonconforming product returned by the customer?

Does the contractor's documented procedure(s)

define the responsibility, and authority, for the
review and disposition of nonconforming product,
34 and explain the process for approving personnel
making these decisions?

35 Is the process for dealing with nonconforming

product, one or more of the following ways:

a) Is action taken to eliminate the detected

nonconformity?

b) Nonconforming product is authorized for

use, release, or acceptance, by approval
of a relevant authority, and when
applicable, by the customer?

c) Is adequate action taken, to prevent using

the nonconforming product for it's
original intended use or application?

d) When nonconforming product is detected

after delivery, or use has started, is
appropriate evaluation and corrective
action taken by the contractor, to analyze
the effect, or potential effect, the
nonconformity may have on other
component parts, and/or Systems?

e) Does the contractor take the necessary

actions, to contain and/or limit the
potential effects of the nonconformity,
on other processes or products?

Does the contractor's process for control of

36 nonconforming product, provide for timely
reporting of delivered nonconforming product?

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Number Question Process/Procedure Reference Comments

Does the contractor have a process established, for

notification of parties concerning nonconforming
product, including notification to applicable
37 suppliers, internal organizations, customers,
distributors, and regulatory authorities?

Does the contractor's process procedures for control

of nonconforming material, specify that dispositions
of "use-as-is" or "repair", shall only be used, after
approval by an authorized representative, or
38 personnel having delegated authority, from the
organization responsible for design?

If the nonconformity results in a departure from the

contract requirements, does the contractor have
provisions in their control of nonconforming
39 material process, to prevent the use of "use-as-is"
and "repair" dispositions, unless specifically
authorized by the customer?

Does the contractor's control of nonconforming

material process procedure(s), specify that product
dispositioned for "scrap", shall be conspicuously
40 and permanently marked, or positively controlled,
until physically rendered unusable?

Are adequate records maintained, identifying the

41 nature of nonconformities, and any subsequent
corrective actions taken, including any waivers,
deviations, or authorized concessions?

When nonconforming product is corrected, is it

42 subject to re-verification, to demonstrate conformity
to the requirements?

8.4 Analysis of Data:

Is appropriate data determined, collected, and

analyzed, to demonstrate the suitability and
effectiveness of the Quality Management System,
43 and to evaluate where continuous improvement of
the effectiveness of the Quality Management
System can be made?

Does this data include data generated from

44 monitoring , measurement, and other relevant
sources?

45 Does the contractor's analysis of data, provide

information related to:

a) Customer satisfaction?

b) Conformance to product requirements?

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c) Characteristics and trends, of products

45 and processes, including opportunities
for preventive action?

d) Adequacy of suppliers/subcontractors?

8.5 Process Improvement:

8.5.1 Continual Improvement:

Does the contractor have procedure(s) and a process

46 established, to promote continual improvement of
the effectiveness of the Quality Management
System?

Are the results of audits, analysis of data, corrective

47 and preventive actions, Management Reviews,
Quality Policy, and Quality Objectives, used for
continual improvement?

Does the contractor have a process established, to

monitor the implementation of improvement
activities, resulting from activities such as "lessons
48 learned", "problem resolutions", and the
"benchmarking of best practices", and evaluate the
effectiveness of the results?

8.5.2 Corrective Action:

Are corrective actions taken to eliminate the root

49 cause(s) of nonconformities, and to prevent
recurrence?

50 Are corrective actions appropriate to eliminate the

effects of the nonconformities encountered?

51 Has a documented procedure been established, to

define the requirements for:

a) Reviewing nonconformities, including

customer complaints?

b) Determining the root cause(s) of

nonconformities?

c) Evaluating the need for corrective

action(s), to ensure that nonconformities
do not recur?

d) Determining and implementing adequate

corrective action(s)?

e) Recording and maintaining the results of

corrective actions taken?

f) Reviewing corrective actions?

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g) Flowing down corrective action

requirements to a supplier, when it is
determined that the supplier is
51 responsible for the nonconformity?

h) Specific actions, when timely and/or

effective corrective actions are not
achieved?

i) Determining if additional nonconforming

product exists, based on the causes of the
nonconformities, and taking further
action, when required?

8.5.3 Preventive Action:

Has the contractor's organization initiated adequate

52 corrective actions, to eliminate the root causes of
potential nonconformities, in order to prevent
reoccurrence?

Are preventive action opportunities, such as "risk

management", "error proofing", " failure mode and
effect analysis (FMEA)", and "information on
53 product problems reported by external sources",
utilized appropriately to control and/or eliminate
effects of potential problems?

54 Has a documented procedure been established, to

define the requirements for:

a) Determining potential nonconformities

and their root causes?

b) Evaluating the need for preventive

action, to preclude reoccurrence of
nonconformities?

c) Determining and implementing

corrective and preventive actions that are
needed?

d) Recording and maintaining the results of

preventive actions taken?

e) Review of preventive actions taken?

Notes & Comments

Developed By:
Art Baldwin
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Chapter 8 - Measurement / Internal Audits / Corrective Action

Contractor: Date:
AS9100C Audit Checklist Program PLAS Code:
Notes & Comments

Developed By:
Art Baldwin
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