AS 9100C ChecklistContractor:Date:AS9100C Audit ChecklistProgram
PLAS Code:NumberQuestionProcess/Procedure ReferenceComments4.
Quality Management System4.1 General Requirements:Has the
contractor established, documented, implemented, and maintained a
Quality Management System, in accordance with the requirements of
AS 9100?1Is an effective "Continuous Improvement" program, an
active part of the contractor's Quality Management System?23Has 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?4Does the contractor manage these processes, in
accordance with AS 9100 requirements?Do adequate controls exist,
and are they identified within the contractor's Quality Management
System, for process requirements that are outsourced, and affect
product conformity?5Contractor:Date:AS9100C Audit ChecklistProgram
PLAS Code:NumberQuestionProcess/Procedure ReferenceComments4.2
Documentation Requirements:4.2.1 General:6Does 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 to ensure that personnel have
access to, and are aware of, relevant Quality Management System
documentation and changes?74.2.2 Quality Manual:8Has 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
Management System adequately controlled?910Has a documented
procedure been established, identifying the following
controls:a)Approval of documents for adequacy "prior" to
issue?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsb)Review and
update as necessary, including re-approval of documents?10c)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 provide evidence of conformity to
requirements, and of the effective operation of the Quality
Management system?1112Has 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 the
method for controlling records that are created by, and/or retained
by, suppliers?13Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments5. Management
Responsibility5.1 Management Commitment:Has top management provided
evidence of its commitment to the development and implementation of
the Quality Management System, and for continuous improvement of
its effectiveness, by:1a)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
requirements are determined and met, with the aim of enhancing
customer satisfaction?2Has top management established and
implemented a process, to ensure that product conformity and
on-time delivery are measured, and that appropriate action is taken
if planned results are not, or will not, be achieved?35.3 Quality
Policy:4Has 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?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments4e)Is reviewed for continual appropriateness?5.4
Planning:5.4.1 Quality Objectives:Has top management ensured that
Quality objectives are established for relevant functions, and at
appropriate levels within the organization?56Have Quality
objectives, needed to meet the requirements of the product, been
established?7Are 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
needed to achieve the Quality objectives are planned for, and
identified?8Is the output of the contractor's planning documented?
(ie; quality manual, procedures, work instructions, quality plans,
etc.)9When changes to the Quality Management System are planned and
implemented, does top management ensure that the integrity of the
Quality System is maintained?105.5 Responsibility, Authority, and
Communication:5.5.1 Responsibility and Authority:Has top management
ensured that responsibilities and authorities for the Quality
Management System are defined, and communicated throughout the
contractor's organization?115.5.2 Management Representative:Has top
management designated and appointed member(s) of management, who
have reponsibility and authority that includes:12a)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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Promoting
awareness of customer requirements throughout the contractor's
organization?12d)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 communication processes have been established
throughout the organization?1314Does 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 Quality Management System at planned intervals, to
ensure it's continuing suitability, adequacy, and
effectiveness?15Are opportunities for improvement, and the need for
changes to the Quality Management System, including the
contractor's Quality Policy and Quality Objectives, evaluated
during "Management Reviews"?1617Are records of "Management Reviews"
documented and maintained as Quality records?5.6.2 Review
Input:18Do 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure
ReferenceComments18g)Recommendations for improvement?5.6.3 Review
Output:19Do 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 Management6.1 Provision of Resources:1Have
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 quality, is competency based on appropriate education,
training, skills, and experience?26.2.2 Competency, Awareness, and
Training:3Has 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsd)Ensured
that employees are aware of the significance and importance of
their activities, and how they contribute to the achievement of the
Quality objectives?3e)Maintained appropriate personnel records of
education, training, skills, and experience?6.3 Infrastructure:To
achieve conformity of the product, does the contractor's
organization identify, provide, and maintain appropriate
facilities, including:4a)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 product requirements,
been determined and managed adequately (noise, temperature,
lighting, humidity, etc)?57. Product Realization7.1 Planning of
Realization Process:Is planning of the contractor's product
realization, consistent with the requirements of the other
processes of the Quality Management System?12When 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure
ReferenceComments(a-Con't.)Quality objectives, and requirements for
the product, including:5) Selection and development of embedded
software?26) 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?3Is 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 manner, to meet customer requirements at an
acceptable risk, within resource and schedule constraints?47.1.2
Risk Management:Has the contractor established, implemented, and
maintained processes, to manage "risk" and achieve applicable
customer requirements, including:5a)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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure
ReferenceCommentsd)Identification, implementation, and management
of actions, to mitigate risks that exceed the defined risk
acceptance criteria?5e)Acceptance of risks remaining, after
implementation of mitigating actions?7.1.3 Configuration
Management:Has the contractor established, implemented, and
maintained a configuration management process that
includes:6a)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 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?77.2 Customer Related
Processes:7.2.1 Determination of Requirements Related to the
Product:8Has 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments7.2.2 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 Modifications),
are requirements reviewed to ensure that:9a)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 these Reviews,
recorded and maintained as records?10Where the customer has not
provided a documented statement of requirements, are customer
requirements confirmed by the contractor, prior to
acceptance?11Where product requirements are changed, does the
contractor's organization ensure that applicable documentation is
amended, and relevant personnel are made aware of the changed
requirements?127.2.3 Customer Communication:Has the contractor's
organization determined and implemented, an effective process for
communicating with customers, relating to:13a)Product information
and requirements?b)Inquiries, Contracts, Amendments, or Order
handling?c)Customer feedback, including customer
complaints?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments7.3 Design
and Development:7.3.1 Design and Development Planning:14Are product
design and development activities planned and controlled?15During
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 each activity, defined the tasks,
necessary resources, responsibilities, design content, input and
output data, and planning constraints?16Are the different design
and development tasks to be accomplished, based on the safety and
functional objectives of the product, in accordance with the
customer's requirements, statutory, and regulatory
requirements?17Does the contractor's process for design and
development planning, take into consideration the capability to
produce, inspect, test, and maintain the product?18Are interfaces
managed, between the different groups that are involved in the
design and development processes, to ensure effective
communication, and clear assignment of responsibilities?1920Is
planning output updated, as design and development progresses?7.3.2
Design and Development Inputs:21Are inputs, related to product
requirements, defined, documented, and maintained?22Does design and
development include:a)Functional and performance
requirements?b)Applicable statutory and regulatory
requirements?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsb)Applicable
statutory and regulatory requirements?22c)Applicable information
derived from previous similar designs?d)Other requirements that are
essential for designs and development?23Are design and development
inputs reviewed for adequacy?24Are incomplete, ambiguous,
confusing, or conflicting requirements resolved?7.3.3 Design and
Development Outputs:Are outputs of the design and development,
provided in a form that enables verification against the design and
development inputs?2526Are design outputs approved, prior to
release?27Does 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 define the data required to allow the
product to be identified, manufactured, inspected, tested, used,
and maintained, including:28a)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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments7.3.4 Design
and Development Review:Are systematic "Reviews" (audits) performed
in accordance with planned arrangements, at applicable stages in
the design and development process?2930Do 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 functions, involved with
the design and development stage(s) being reviewed?3132Are results
of Reviews, and any corrective actions necessary, maintained as
records?7.3.5 Design and Development Verification:Is design and
development verification performed in accordance with the
contractor's plan, to ensure that the design outputs, conform to
the design and development input requirements?3334Are the results
of verifications and corrective actions documented, and maintained
as records?7.3.6 Design and Development Validation:35Is design and
development validation performed in accordance with planned
arrangements?Is design and development validation performed, to
confirm that the product is capable of meeting the requirements of
the specified application, and it's intended purpose?36Is
validation completed prior to delivery, or implementation of the
product, wherever applicable?3738Are the results of validation, and
associated actions, maintained as records?Contractor:Date:AS9100C
Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments7.3.6.1 Design and Development Verification and
Validation Testing:When testing is necessary for verification and
validation, are these tests planned, reviewed, controlled, and
documented, to ensure and prove the following:39a)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, inspection results, etc,
demonstrate that the product meets the specification requirements
for all operational conditions?407.3.7 Control of Design and
Development Changes:Are design and/or development changes
identified, documented, and maintained as records?41Do reviews of
design and development changes include, evaluation of the effect of
the changes on associated parts, and product already
delivered?42Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsAre design
and development changes reviewed, verified, and validated, as
appropriate, and are the changes approved, prior to
implementation?4344Are 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 adequate controls
in-place, to ensure that purchased products and/or services conform
to the Purchase Order requirements?45Are the types of controls, and
to what extent they applied to the suppliers and purchased
products, evaluated and dependent upon the effect of the purchased
product on subsequent product processing, or the final
product?46Does the contractor have adequate controls (e.g.
policies, procedures, processes, etc) in-place, to accept
responsibility for the conformity of all products purchased from
suppliers, including product from suppliers mandated by the
customer?47Are subcontractors/suppliers evaluated and selected,
based on their ability to supply product, in accordance with the
contractor's requirements?48Has the contractor's organization
established procedures and criteria for selection, evaluation, and
re-evaluation of suppliers?4950Are results of the evaluations, and
any necessary actions taken, maintained as records?51Has 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsd)Ensure that
when required, both the contractor and all suppliers use
customer-approved special process sources?51e)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:52Does the purchasing
information describe the product to be purchased?53Do 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?53f)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?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsg)Requirements regarding the need for the
supplier/subcontractor to:53(Con't)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"?54Are 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 established and implemented, which are necessary for ensuring
that purchased product complies with specified purchase
requirements?55Has 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 identified and recorded, to allow for recall and
replacement, if it is subsequently found that the product does not
meet requirements?56Does the contractor have procedures which
define requirements for delegations, and require maintaining a
register of delegations, for instances when the contractor chooses
to delegate verification activities to the supplier?57Are
verification arrangements, and/or methods of product release,
specified in the purchasing information, where the contractor's
organization, or it's customer, intends to perform verification at
the supplier's premises?587.5 Production and Service
Provision:7.5.1 Control of Production and Service
Provision:Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments7.5.1 Control
of Production and Service Provision:Are the production and service
provisions planned and carried out under controlled conditions,
including:59a)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 contractor considered, established, implemented, and
maintained processes for:60a)Managing critical items, including
process controls when key characteristics have been
identified?b)Designing, manufacturing, and using tooling to measure
variable data?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Identifying
in-process inspection and verification points, when adequate
verification of conformance cannot be performed at later stages of
production/realization?60d)Special processes?7.5.1.1 Production
Process Verification:61Has 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, and/or procedure for
identification of personnel, authorized to approve changes to
production processes?62Has the contractor implemented a process, to
control and document changes affecting processes, production
equipment, tools, or software programs?63Has the contractor
developed and implemented a process, to evaluate the results of
changes to production processes, assessing them to confirm that the
desired effect has been accomplished, without adversely affecting
product conformity?647.5.1.3 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 product
realization processes, are validated prior to release for
production, and are maintained?65Has the contractor initiated a
process, defining storage requirements, including periodic
preservation and condition checks, for production equipment and/or
tooling in storage?66Contractor:Date:AS9100C Audit ChecklistProgram
PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.5.1.4
Post-Delivery Support:67Has 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
apparent only after the product is in use, or the service has been
delivered, been validated?68Do the results of validation,
demonstrate the ability of the processes to achieve the
contractor's planned results?6970Has 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:71Is the product
adequately identifiable, throughout the product realization
processes?Does the contractor have a process, to maintain
configuration identification of the product, in order to identify
any differences between the actual configuration, and the agreed-to
configuration?72Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments73Is the
product status identifiable, with respect to monitoring and
measurement requirements?Has the contractor established a process,
for control of "Acceptance Authority" media (e.g. stamps,
electronic signatures, passwords, etc)?7475When 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)?76Is the product's
unique identification maintained as a record?7.5.4 Customer
Property:Does the contractor exercise adequate care with customer
property, while it is under the organization's control, or is being
used by the contractor?7778Is customer property identified,
verified, protected, and safeguarded?If lost, damaged, or otherwise
found to be unsuitable for use, is the condition documented,
reported to the customer, and maintained as a record?797.5.5
Preservation of Product:Is conformity of product preserved during
internal processing, and delivery to the intended
destination?80Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments81Do the
contractor's preservation activities
include:a)Identification?b)Handling?c)Packaging?d)Storage?e)Protection?82Are
preservation activities applied to associated component parts of a
product?In accordance with product specifications, and applicable
statutory and regulatory requirements, does the contractor's
preservation processes include provisions
for:83a)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 are required, to
provide evidence of conformity to requirements?84Has the contractor
established and maintained a register/record of monitoring and
measurement equipment that is utilized?85Has the contractor
established and defined the process, employed for the calibration
and verification of monitoring and measurement equipment, including
details of:86a)Equipment type?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsb)Unique identification?86c)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
conformity, as including, but not limited to:87a)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
monitoring and measurement can be carried out, in a manner
consistent with the monitoring and measurement requirements?8889Has
the contractor arranged for, and ensured that existing
environmental conditions are suitable
for:a)Calibration?b)Inspection?c)Measurement?d)Testing?90When
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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsb)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 maintained a process, for
the recall of monitoring and measurement equipment requiring
calibration or verification?91Has the contractor evaluated and
recorded the validity of previous measuring results, when the
equipment is found not to conform to the requirements, and have
they taken the appropriate corrective action on the equipment, and
any affected product?9293Are 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 intended purpose
confirmed, prior to use?94Does the contractor's process, for
confirmation of computer software to satisfy it's intended purpose,
include verification and configuration management to maintain it's
suitability for use?9596Is the ability of computer software, to
satisfy the intended application, reconfirmed as needed?8.
Measurement, Analysis, and Improvement8.1 General:Have the
monitoring, measurement, analysis, and improvement processes been
planned, documented, and implemented to:1a)Demonstrate conformity
of the product?b)Ensure conformity of the Quality Management
System?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure
ReferenceComments1c)Continually improve the effectiveness of the
Quality Management System?Have applicable process methods,
including statistical techniques, and their extent of use, been
determined?23Does 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
perception, monitored by the contractor, as to whether customer
requirements have been met?4Have the methodologies for obtaining
and using information and data, related to customer perception,
been determined?5Is the information that the contractor monitors
and uses for evaluation of customer satisfaction include, but not
limited to:6a)Product conformity?b)On-time delivery
performance?c)Customer complaints?d)Corrective action
requests?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsHas the
contractor developed and implemented plans for customer
satisfaction improvement, addressing deficiencies identified by
these evaluations, and assessing the effectiveness of the
results?78.2.2 Internal Audits:Are internal audits conducted at
planned intervals, to determine whether the Quality Management
System:8a)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 consideration the status and
importance of the processes and areas to be audited, as well as the
results of previous audits?910Are audit criteria, scope, frequency,
and methods defined?Is auditor selection considered by the
contractor, to ensure objectivity and impartiality of the audit
process?1112Do controls exist to ensure that auditors do not audit
their own work?Has a documented procedure been established to
define the responsibilities, requirements for planning and
conducting audits, reporting results, and maintaining records?13Has
management, which is responsible for the area(s) being audited,
ensured that corrective actions have been initiated without delay,
to eliminate detected nonconformities, and their root causes?14Do
follow-up activities include verification of the corrective actions
taken, and the reporting of the verification results?158.2.3
Monitoring and Measurement of Processes:Are appropriate methods
applied for monitoring, and where applicable, measurement of the
Quality Management System processes, that are required to meet
customer requirements?16Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments17Do these methods demonstrate the ability of the
processes to achieve the planned results?18Are corrective actions
implemented, when planned results are not achieved?In the event of
process nonconformity, has the contractor established and
implemented a process and controls to:19a)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 measured, to verify that product requirements are
met?20Is monitoring and measurement of product characteristics,
implemented at appropriate stages of the product realization
process, in accordance with the contractor's plans?2122Is evidence
of conformity with the acceptance criteria, documented and
maintained?Has the contractor established the process, and
documented measurement requirements for product acceptance,
including:23a)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?Contractor:Date:AS9100C
Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsWhen critical items, including any key
characteristics have been identified, does the contractor ensure
they are controlled and monitored, in accordance with established
processes?24When 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 appropriate for use (e.g. matching the sampling plan to
the criticality of the product, and to process capability)?25Does
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,
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?2627Are 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 evidence that the product meets the defined
requirements?28Unless otherwise approved by a relevant authority,
or where applicable, the customer, are all planned processes
satisfactorily completed, prior to proceeding with release of the
product?29Does the contractor have an established process, to
ensure that all documents that are required to accompany the
product, are present at delivery?308.3 Control of Nonconforming
Product:31Is nonconforming product identified and controlled, to
prevent unintended use or delivery?Has a documented procedure been
established to define process controls, identify authorities and
their related responsibilities, for dealing with nonconforming
product?32Do the contractor's procedures define nonconforming
product, as including nonconforming product returned by the
customer?33Does the contractor's documented procedure(s) define the
responsibility, and authority, for the review and disposition of
nonconforming product, and explain the process for approving
personnel making these decisions?34Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments35Is 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 nonconforming product, provide for timely reporting of
delivered nonconforming product?36Does the contractor have a
process established, for notification of parties concerning
nonconforming product, including notification to applicable
suppliers, internal organizations, customers, distributors, and
regulatory authorities?37Does 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 personnel having delegated authority,
from the organization responsible for design?38If the nonconformity
results in a departure from the contract requirements, does the
contractor have provisions in their control of nonconforming
material process, to prevent the use of "use-as-is" and "repair"
dispositions, unless specifically authorized by the customer?39Does
the contractor's control of nonconforming material process
procedure(s), specify that product dispositioned for "scrap", shall
be conspicuously and permanently marked, or positively controlled,
until physically rendered unusable?40Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsAre adequate records maintained, identifying the
nature of nonconformities, and any subsequent corrective actions
taken, including any waivers, deviations, or authorized
concessions?41When nonconforming product is corrected, is it
subject to re-verification, to demonstrate conformity to the
requirements?428.4 Analysis of Data:Is appropriate data determined,
collected, and analyzed, to demonstrate the suitability and
effectiveness of the Quality Management System, and to evaluate
where continuous improvement of the effectiveness of the Quality
Management System can be made?43Does this data include data
generated from monitoring , measurement, and other relevant
sources?4445Does 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
established, to promote continual improvement of the effectiveness
of the Quality Management System?46Are the results of audits,
analysis of data, corrective and preventive actions, Management
Reviews, Quality Policy, and Quality Objectives, used for continual
improvement?47Does the contractor have a process established, to
monitor the implementation of improvement activities, resulting
from activities such as "lessons learned", "problem resolutions",
and the "benchmarking of best practices", and evaluate the
effectiveness of the results?48Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments8.5.2 Corrective Action:Are corrective actions
taken to eliminate the root cause(s) of nonconformities, and to
prevent recurrence?4950Are corrective actions appropriate to
eliminate the effects of the nonconformities encountered?51Has 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 corrective actions, to eliminate the root causes of
potential nonconformities, in order to prevent reoccurrence?52Are
preventive action opportunities, such as "risk management", "error
proofing", " failure mode and effect analysis (FMEA)", and
"information on product problems reported by external sources",
utilized appropriately to control and/or eliminate effects of
potential problems?53Contractor:Date:AS9100C Audit ChecklistProgram
PLAS Code:NumberQuestionProcess/Procedure ReferenceComments54Has 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 &
CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:Notes & Comments
&C&"Times New Roman,Bold Italic"&18AS 9100C:
2009Quality Management SystemAudit Checklist&L&"Times New
Roman,Regular"&1Developed By:Art Baldwin &CPage &P of
&N
AS9100 Ch. 4 General Reqmn'tsContractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments4. Quality Management System4.1 General
Requirements:Has the contractor established, documented,
implemented, and maintained a Quality Management System, in
accordance with the requirements of AS 9100?1Is an effective
"Continuous Improvement" program, an active part of the
contractor's Quality Management System?23Has 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?4Does the contractor manage these processes, in
accordance with AS 9100 requirements?Do adequate controls exist,
and are they identified within the contractor's Quality Management
System, for process requirements that are outsourced and affect
product conformity?54.2 Documentation Requirements:4.2.1
General:6Does the Quality Management System documentation
include:a)Documented statements of a Quality policy, and Quality
objectives?b)A Quality manual?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsc)Documented procedures required by AS
9100?6d)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 to
ensure that personnel have access to, and are aware of, relevant
Quality Management System documentation and changes?74.2.2 Quality
Manual:8Has 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 Management System adequately
controlled?910Has 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?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsf)Ensure that documents of external origin are
identified, and their distribution is controlled?10g)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 provide
evidence of conformity to requirements, and of the effective
operation of the Quality Management system?1112Has 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 the
method for controlling records that are created by, and/or retained
by, suppliers?13Notes & CommentsContractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:Notes & Comments
&C&"Times New Roman,Regular"&18AS 9100C: 2009Audit
Checklist - Quality Management System Chapter 4 - General
Requirements&L&"Times New Roman,Regular"&1Developed By:
Art Baldwin &CPage &P of &N
AS9100 Ch. 5 Mgm't SystemsContractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments5. Management Responsibility5.1 Management
Commitment:Has top management provided evidence of its commitment
to the development and implementation of the Quality Management
System, and for continuous improvement of its effectiveness,
by:1a)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
requirements are determined and met, with the aim of enhancing
customer satisfaction?2Has top management established and
implemented a process, to ensure that product conformity and
on-time delivery are measured, and that appropriate action is taken
if planned results are not, or will not, be achieved?35.3 Quality
Policy:4Has 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?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments4e)Is reviewed for continual appropriateness?5.4
Planning:5.4.1 Quality Objectives:Has top management ensured that
Quality objectives are established for relevant functions, and at
appropriate levels within the organization?56Have Quality
objectives, needed to meet the requirements of the product, been
established?7Are 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
needed to achieve the Quality objectives are planned for, and
identified?8Is the output of the contractor's planning documented?
(ie; quality manual, procedures, work instructions, quality plans,
etc.)9When changes to the Quality Management System are planned and
implemented, does top management ensure that the integrity of the
Quality System is maintained?105.5 Responsibility, Authority, and
Communication:5.5.1 Responsibility and Authority:Has top management
ensured that responsibilities and authorities for the Quality
Management System are defined, and communicated throughout the
contractor's organization?115.5.2 Management Representative:Has top
management designated and appointed member(s) of management, who
have reponsibility and authority that includes:12a)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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Promoting
awareness of customer requirements throughout the contractor's
organization?12d)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 communication processes have been established
throughout the organization?1314Does 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 Quality Management System at planned intervals, to
ensure it's continuing suitability, adequacy, and
effectiveness?15Are opportunities for improvement, and the need for
changes to the Quality Management System, including the
contractor's Quality Policy and Quality Objectives, evaluated
during "Management Reviews"?1617Are records of "Management Reviews"
documented and maintained as Quality records?5.6.2 Review
Input:18Do 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure
ReferenceComments18g)Recommendations for improvement?5.6.3 Review
Output:19Do 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 & CommentsContractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:Notes & Comments
&C&"Times New Roman,Regular"&18AS 9100C: 2009Audit
Checklist - Quality Management System Chapter 5 - Management
Systems&L&"Times New Roman,Regular"&1Developed By: Art
Baldwin &CPage &P of &N
AS9100 Ch. 6 Resource Mgm't Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments6. Resource Management6.1 Provision of
Resources:1Have 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 quality, is competency based on appropriate education,
training, skills, and experience?26.2.2 Competency, Awareness, and
Training:3Has 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?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments6.3 Infrastructure:To achieve conformity of the
product, does the contractor's organization identify, provide, and
maintain appropriate facilities, including:4a)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 product requirements,
been determined and managed adequately (noise, temperature,
lighting, humidity, etc)?5Notes &
CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:Notes & Comments
&C&"Times New Roman,Regular"&18AS 9100C: 2009Audit
Checklist - Quality Management System Chapter 6 - Resource
Management&L&"Times New Roman,Regular"&1Developed By:
Art Baldwin &CPage &P of &N
AS9100 Ch.7 Product & SuppliersContractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments7. Product Realization7.1 Planning of Realization
Process:Is planning of the contractor's product realization,
consistent with the requirements of the other processes of the
Quality Management System?12When 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?3Is the planning output in a form, appropriate for the
contractor's methods of operation?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments7.1.1 Project Management:Has the contractor
established an adequate system, with associated processes, to plan
and manage product realization in a structured and controlled
manner, to meet customer requirements at an acceptable risk, within
resource and schedule constraints?47.1.2 Risk Management:Has the
contractor established, implemented, and maintained processes, to
manage "risk" and achieve applicable customer requirements,
including:5a)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 maintained a configuration
management process that includes:6a)Configuration management
planning?b)Configuration identification?c)Change control
processes?d)Maintaining records of configuration
status?e)Configuration audits?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments7.1.4 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 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?77.2 Customer
Related Processes:7.2.1 Determination of Requirements Related to
the Product:8Has 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 Modifications), are requirements reviewed
to ensure that:9a)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)?Contractor:Date:AS9100C
Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsAre the results of Reviews, and actions arising
from these Reviews, recorded and maintained as records?10Where the
customer has not provided a documented statement of requirements,
are customer requirements confirmed by the contractor, prior to
acceptance?11Where product requirements are changed, does the
contractor's organization ensure that appropriate documentation is
amended, and relevant personnel are made aware of the changed
requirements?127.2.3 Customer Communication:Has the contractor's
organization determined and implemented, an effective process for
communicating with customers, relating to:13a)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:14Are
product design and development activities planned and
controlled?15During 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 each activity, defined the tasks, necessary resources,
responsibilities, design content, input and output data, and
planning constraints?16Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsAre the different design and development tasks to
be accomplished, based on the safety and functional objectives of
the product, in accordance with the customer's requirements,
statutory, and regulatory requirements?17Does the contractor's
process for design and development planning, take into
consideration the capability to produce, inspect, test, and
maintain the product?18Are interfaces managed, between the
different groups that are involved in the design and development
processes, to ensure effective communication, and clear assignment
of responsibilities?1920Is planning output updated, as design and
development progresses?7.3.2 Design and Development Inputs:21Are
inputs, related to product requirements, defined, documented, and
maintained?22Does 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?23Are design and development inputs reviewed for
adequacy?24Are incomplete, ambiguous, confusing, or conflicting
requirements resolved?7.3.3 Design and Development Outputs:Are
outputs of the design and development, provided in a form that
enables verification against the design and development
inputs?2526Are design outputs approved, prior to
release?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments27Does 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 define the data required to allow the
product to be identified, manufactured, inspected, tested, used,
and maintained, including:28a)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 accordance with planned arrangements, at applicable
stages in the design and development process?2930Do 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 functions, involved with
the design and development stage(s) being
reviewed?31Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments32Are results
of "Reviews", and any corrective actions necessary, maintained as
records?7.3.5 Design and Development Verification:Is design and
development verification performed in accordance with the
contractor's plan, to ensure that the design outputs, conform to
the design and development input requirements?3334Are the results
of verifications and corrective actions documented, and maintained
as records?7.3.6 Design and Development Validation:35Is design and
development validation performed in accordance with planned
arrangements?Is design and development validation performed, to
confirm that the product is capable of meeting the requirements of
the specified application, and it's intended purpose?36Is
validation completed prior to delivery, or implementation of the
product, wherever applicable?3738Are 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 validation, are these tests planned,
reviewed, controlled, and documented, to ensure and prove the
following:39a)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?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsc)Are requirements specified to verify that the
correct configuration of the product is being submitted for the
test?39d)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, inspection results, etc,
demonstrate that the product meets the specification requirements
for all operational conditions?407.3.7 Control of Design and
Development Changes:Are design and/or development changes
identified, documented, and maintained as records?41Do reviews of
design and development changes include, evaluation of the effect of
the changes on associated parts, and product already
delivered?42Are design and development changes reviewed, verified,
and validated, as appropriate, and are the changes approved, prior
to implementation?43Are results of the review of changes, and any
required corrective actions, maintained as records?447.4
Purchasing:7.4.1 Purchasing Control:Do the
Subcontracting/Purchasing processes have adequate controls
in-place, to ensure that purchased products, and/or services,
conform to the Purchase Order requirements?45Are the types of
controls, and to what extent they applied to the suppliers and
purchased products, evaluated and dependent upon the effect of the
purchased product on subsequent product processing, or the final
product?46Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsDoes the
contractor have adequate controls (e.g. policies, procedures,
processes, etc) in-place, to accept responsibility for the
conformity of all products purchased from suppliers, including
product from suppliers mandated by the customer?47Are
subcontractors/suppliers selected and evaluated, based on their
ability to supply product, in accordance with the contractor's
requirements?48Has the contractor's organization established
procedures and criteria for selection, evaluation, and
re-evaluation of suppliers?4950Are results of the evaluations, and
any necessary actions taken, maintained as records?51Has 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:52Does the purchasing
information describe the product to be
purchased?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments53Do 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
supplier/subcontractor to:531) 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?Contractor:Date:AS9100C Audit
ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsi)"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"?5354Are 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 established and
implemented, which are necessary for ensuring that purchased
product complies with specified purchase requirements?55Has 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
identified and recorded, to allow for recall and replacement, if it
is subsequently found that the product does not meet
requirements?56Does the contractor have procedures which define
requirements for delegations, and require maintaining a register of
delegations, for instances when the contractor chooses to delegate
verification activities to the supplier?57Are verification
arrangements, and/or methods of product release, specified in the
purchasing information, where the contractor's organization, or
it's customer, intends to perform verification at the supplier's
premises?587.5 Production and Service Provision:7.5.1 Control of
Production and Service Provision:Are the production and service
provisions planned and carried out under controlled conditions,
including:59a)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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure
ReferenceCommentse)Implementation of monitoring and
measurement?59f)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 contractor considered, established, implemented, and
maintain processes for:60a)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:61Has 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure
ReferenceCommentsb)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)?617.5.1.2
Control of Production Process Changes:Has the contractor
established a method, process, and/or procedure for identification
of personnel, authorized to approve changes to production
processes?62Has the contractor implemented a process, to control
and document changes affecting processes, production equipment,
tools, or software programs?63Has the contractor developed and
implemented a process, to evaluate the results of changes to
production processes, assessing them to confirm that the desired
effect has been accomplished, without adversely affecting product
conformity?647.5.1.3 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 product realization
processes, are validated prior to release for production, and are
maintained?65Has the contractor initiated a process, defining
storage requirements, including periodic preservation and condition
checks, for production equipment and/or tooling in
storage?667.5.1.4 Post-Delivery Support:67Has 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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceComments67e)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
apparent only after the product is in use, or the service has been
delivered, been validated?68Do the results of validation,
demonstrate the ability of the processes to achieve the
contractor's planned results?6970Has 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:71Is the product
adequately identifiable, throughout the product realization
processes?Does the contractor have a process, to maintain
configuration identification of the product, in order to identify
any differences between the actual configuration, and the agreed-to
configuration?7273Is the product status identifiable, with respect
to monitoring and measurement requirements?Has the contractor
established a process, for control of "Acceptance Authority" media
(e.g. stamps, electronic signatures, passwords, etc)?7475When
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?Contractor:Date:AS9100C
Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceCommentsb)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)?75c)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)?76Is the product's unique identification maintained as a
record?7.5.4 Customer Property:Does the contractor exercise
adequate care with customer property, while it is under the
organization's control, or is being used by the contractor?7778Is
customer property identified, verified, protected, and
safeguarded?If lost, damaged, or otherwise found to be unsuitable
for use, is the condition documented, reported to the customer, and
maintained as a record?797.5.5 Preservation of Product:Is
conformity of the product preserved during internal processing, and
delivery to the intended destination?8081Do the contractor's
preservation activities
include:a)Identification?b)Handling?c)Packaging?d)Storage?e)Protection?Contractor:Date:AS9100C
Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure
ReferenceComments82Are preservation activities applied to
associated component parts of a product?In accordance with product
specifications, and applicable statutory and regulatory
requirements, does the contractor's preservation processes include
provisions for:83a)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 are
required, to provide evidence of conformity to requirements?84Has
the contractor established and maintained a register/record of
monitoring and measurement equipment that is utilized?85Has the
contractor established and defined the process, employed for the
calibration and verification of monitoring and measurement
equipment, including details of:86a)Equipment type?b)Unique
identification?c)Location?d)Frequency of
checks?e)Verification/check method?f)Acceptance
criteria?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentsHas the
contractor identified monitoring and measurement equipment, which
is used to produce inspection data to provide evidence of product
conformity, as including, but not limited to:87a)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
monitoring and measurement can be carried out, in a manner
consistent with the monitoring and measurement requirements?8889Has
the contractor arranged for, and ensured that existing
environmental conditions are suitable
for:a)Calibration?b)Inspection?c)Measurement?d)Testing?90When
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?Contractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:NumberQuestionProcess/Procedure ReferenceCommentse)Protected
from damage and deterioration during handling, maintenance, and
storage?90Has the contractor established, implemented, and
maintained a process, for the recall of monitoring and measurement
equipment requiring calibration or verification?91Has the
contractor evaluated and recorded the validity of previous
measuring results, when the equipment is found not to conform to
the requirements, and have they taken the appropriate corrective
action on the equipment, and any affected product?9293Are 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 intended purpose confirmed, prior to use?94Does the
contractor's process, for confirmation of computer software to
satisfy it's intended purpose, include verification and
configuration management to maintain it's suitability for
use?9596Is the ability of computer software, to satisfy the
intended application, reconfirmed as needed?Notes &
CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS
Code:Notes & Comments
&C&"Times New Roman,Regular"&18AS 9100C: