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AS9100 Element Questions


Note: Not all requirements are documented here. When the requirement is identical to ISO 9001, then
the requirements will not be listed.

Cov AS9100 Requirement Assessment Evidence Issue

 4.1 General Requirements AS9100 is identical to ISO 9001 for this


clause. See notes made in ISO 9001
section above.
 4.2.1 Documentation Requirements:  Adequate
General
 Implemented
4.2.1.f quality system requirements
imposed by the applicable regulatory  Effective
authorities.

 4.2.1 Documentation Requirements:  Adequate


General
 Implemented
The organization shall ensure that
personnel have access to QMS  Effective
documentation and are aware of
relevant procedures. Customer and/or
regulatory authorities’ representatives
shall have access to QMS
documentation.

 4.2.2 Quality Manual  Adequate


4.2.2.b when referencing the  Implemented
documented procedures, the
relationship between the requirements  Effective
of this International Standard and the
documented procedures shall be clearly
shown.

 4.2.3 Control of Documents  Adequate


The organization shall coordinate  Implemented
document changes with customers
and/or regulatory authorities in  Effective
accordance with contract or regulatory
requirements.

 4.2.4 Control of Records  Adequate


The documented procedure shall define  Implemented
the method for controlling records that
are created by and/or retained by  Effective
suppliers.

 4.2.4 Control of Records  Adequate


Records shall be available for review by  Implemented
customers and regulatory authorities in
accordance with contract or regulatory  Effective
requirements.

 4.2.3 Configuration Management  Adequate


The organization shall establish,  Implemented
document and maintain a configuration
management process appropriate to  Effective
the product.

 5.1 Management Commitment AS9100 is identical to ISO 9001 for this


clause. See notes made in ISO 9001
section above.

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 5.2 Customer Focus AS9100 is identical to ISO 9001 for this


clause. See notes made in ISO 9001
section above.
 5.3 Quality Policy AS9100 is identical to ISO 9001 for this
clause. See notes made in ISO 9001
section above.
 5.4 Planning AS9100 is identical to ISO 9001 for this
clause. See notes made in ISO 9001
section above.
 5.5.1 Responsibility & Authority AS9100 is identical to ISO 9001 for this
clause. See notes made in ISO 9001
section above.
 5.5.2.d the organizational freedom to  Adequate
resolve matters pertaining to quality.
 Implemented
 Effective

 5.5.3 Internal Communication AS9100 is identical to ISO 9001 for this


clause. See notes made in ISO 9001
section above.
 5.6 Management Responsibility AS9100 is identical to ISO 9001 for this
clause. See notes made in ISO 9001
section above.
 6.1 Provision of Resources AS9100 is identical to ISO 9001 for this
clause. See notes made in ISO 9001
section above.
 6.2 Human Resources AS9100 is identical to ISO 9001 for this
clause. See notes made in ISO 9001
section above.
 6.3 Infrastructure AS9100 is identical to ISO 9001 for this
clause. See notes made in ISO 9001
section above.
 6.4 Work Environment  Adequate
Note: Factors that may affect the  Implemented
conformity of the product include
temperature, humidity, lighting,  Effective
cleanliness, protection from
electrostatic discharge, etc.

 7.1.e the identification of resources to  Adequate


support operation and maintenance of
 Implemented
the product.
 Effective

 7.2.1 Determination of requirements AS9100 is identical to ISO 9001 for this


related to the product clause. See notes made in ISO 9001
section above.
 7.2.2.d risks (e.g. new technology,  Adequate
short delivery time scale) have been
 Implemented
evaluated.
 Effective

 7.2.3 Customer communication AS9100 is identical to ISO 9001 for this


clause. See notes made in ISO 9001
section above.
 7.3 Design and Development Exclusion

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 7.4.1 Purchasing Process  Adequate


The organization shall be responsible  Implemented
for the quality of all products purchased
from suppliers, including customer-  Effective
designated sources.

 7.4.1 Purchasing Process


The organization shall:

 7.4.1.a maintain a register of approved  Adequate


suppliers that includes the scope of
 Implemented
approval;
 Effective

 7.4.1.b periodically review supplier  Adequate


performance; records of these reviews
 Implemented
shall be used as a basis for establishing
the level of controls to be implemented;  Effective

 7.4.1.c define the necessary actions to  Adequate


take when dealing with suppliers that
 Implemented
do not meet requirements;
 Effective

 7.4.1.d ensure where required that  Adequate


both the organization and all suppliers
 Implemented
use customer approved special process
sources;  Effective

 7.4.1.e ensure that the function having  Adequate


responsibility for approving supplier
 Implemented
quality systems has the authority to
disapprove the use of sources.  Effective

 7.4.2.d the name or other positive  Adequate


identification, and applicable issues of
 Implemented
specifications, drawings, process
requirements, inspection instructions  Effective
and other relevant technical data,

 7.4.2.e requirements for design, test,  Adequate


examination, inspection and related
 Implemented
instructions for acceptance by the
organization,  Effective

 7.4.2.f requirements for test  Adequate


specimens (e.g., production method,
 Implemented
number, storage conditions) for design
approval, inspection, investigation or  Effective
auditing,

 7.4.2.g requirements relative to  Adequate


- supplier notification to organization of  Implemented
nonconforming product and
 Effective
- arrangements for organization
approval of supplier nonconforming
material

 7.4.2.h requirements for the supplier  Adequate


to notify the organization of changes in
 Implemented
product and/or process definition and,
where required, obtain organization  Effective
approval,

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 7.4.2.i right of access by the  Adequate


organization, their customer, and
 Implemented
regulatory authorities to all facilities
involved in the order and to all  Effective
applicable records, and,

 7.4.2.j requirements for the supplier to  Adequate


flow down to sub-tier suppliers the
 Implemented
applicable requirements in the
purchasing documents, including key  Effective
characteristics where required.

 7.4.3.
Verification activities may include

 7.4.3.a obtaining objective evidence of  Adequate


the quality of the product from
 Implemented
suppliers (e.g., accompanying
documentation, certificate of  Effective
conformity, test reports, statistical
records, process control),

 7.4.3.b inspection and audit at  Adequate


supplier’s premises,
 Implemented
 Effective

 7.4.3.c review of the required  Adequate


documentation,
 Implemented
 Effective

 7.4.3.d inspection of products upon  Adequate


receipt, and
 Implemented
 Effective

 7.4.3.e delegation of verification to  Adequate


the supplier, or supplier certification.
 Implemented
 Effective

 7.4.3 Verification of Purchased Product  Adequate


Purchased product shall not be used or  Implemented
processed until it has been verified as
conforming to specified requirements  Effective
unless it is released under positive
recall procedure.

 7.4.3 Verification of Purchased Product  Adequate


Where the organization utilizes test  Implemented
reports to verify purchased product, the
data in those reports shall be  Effective
acceptable per applicable
specifications. The organization shall
periodically validate test reports for raw
material.

 7.4.3 Verification of Purchased Product  Adequate


Where the organization delegates  Implemented
verification activities to the supplier,
the requirements for the delegation  Effective
shall be defined and a register of
delegations maintained.

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 7.4.3 Verification of Purchased Product  Adequate


Where specified in the contract, the  Implemented
customer or the customer’s
representative shall be afforded the  Effective
right to verify at the supplier’s
premises and the organization’s
premises that subcontracted product
conforms to specifications.

 7.4.3 Verification of Purchased Product  Adequate


Verification by the customer shall not  Implemented
be used by the organization as
evidence of effective control of quality  Effective
by the supplier and shall not absolve
the organization of the responsibility to
provide acceptable product, nor shall it
preclude subsequent rejection by the
supplier.

 7.5.1 Control of Production & Service


Provision
Planning shall consider, as applicable,
- the establishment of process controls
and development of control plans
where key characteristics have been
defined,
- the identification of in-process
verification points where adequate
verification of conformance cannot be
performed at a later stage of
realization,
- the design, manufacture, and use of
tooling so that variable measurements
can be taken, particularly for key
characteristics, and
- special processes (see 7.5.2).

 7.5.1.g accountability for all product  Adequate


during manufacture (e.g., parts
 Implemented
quantities, split orders, nonconforming
product),  Effective

 7.5.1.h evidence that all  Adequate


manufacturing and inspection
 Implemented
operations have been completed as
planned, or as otherwise documented  Effective
and authorized,

 7.5.1.i provision for the prevention,  Adequate


detection, and removal of foreign
 Implemented
objects,
 Effective

 7.5.1.j monitoring and control of  Adequate


utilities and supplies such as water,
 Implemented
compressed air, electricity and
chemical products to the extent they  Effective
affect product quality, and

 7.5.1.k criteria for workmanship, which  Adequate


shall be stipulated in the clearest
 Implemented
practical manner (e.g., written
standards, representative samples or  Effective
illustrations).

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 7.5.1.1 Production Documentation  Adequate


Production operations shall be carried  Implemented
out in accordance with approved data.
The data shall contain as necessary:  Effective

 7.5.1.1.a drawings, parts lists, process  Adequate


flow charts including inspection
 Implemented
operations, production documents (e.g.,
manufacturing plans, traveler, router,  Effective
work order, process cards); and
inspection documents (see 8.2.4.1)

 7.5.1.1.b a list of specific or  Adequate


nonspecific tools and numerical control
 Implemented
(NC) machine programs required and
any specific instructions associated  Effective
with their use.

 7.5.1.2 Control of Production Process  Adequate


Changes
 Implemented
Persons authorized to approve changes
to production processes shall be  Effective
identified.
The organization shall identify and
obtain acceptance of changes that
require customer and/or regulatory
authority approval in accordance with
contract or regulatory requirements.

 7.5.1.2 Control of Production Process  Adequate


Changes
 Implemented
Changes affecting processes,
production equipment, tools and  Effective
programs shall be documented.
Procedures shall be available to control
their implementation.
The results of changes to production
processes shall be assessed to confirm
that the desired effect has been
achieved without adverse effects to
product quality.

 7.5.1.3 Control of Production  Adequate


Equipment, Tools and Numerical
 Implemented
Control (NC) Machine programs:
Production equipment, tools and  Effective
programs shall be validated prior to use
and maintained and inspected
periodically according to documented
procedures. Validation prior to
production use shall include verification
of the first article produced to the
design data/specification.
Storage requirements, including
periodic preservation/condition checks,
shall be established for production
equipment or tooling in storage.

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 7.5.1.4 Control of Work Transferred, on  Adequate


a Temporary basis, outside the
 Implemented
organization’s facilities: When planning
to temporarily transfer work to a  Effective
location outside the organization’s
facilities, the organization shall define
the process to control and validate the
quality of the work.

 7.5.1.5 Control of Service Operations:


Where servicing is a specified
requirement, service operation
processes shall provide for

 7.5.1.5.a a method of collecting &  Adequate


analyzing in-service data
 Implemented
 Effective

 7.5.1.5.b actions to be taken where  Adequate


problems are identified after delivery,
 Implemented
including investigation, reporting
activities, and actions on service  Effective
information consistent with contractual
and/or regulatory requirements.

 7.5.1.5.c the control and handling of  Adequate


technical documentation
 Implemented
 Effective

 7.5.1.5.d the approval, control, and  Adequate


use of repair schemes, and
 Implemented
 Effective

 7.5.1.5.e the controls required for off-  Adequate


site work (e.g., organization’s work
 Implemented
undertaken at the customer’s facilities).
 Effective

 7.5.2 Validation of Processes for  Adequate


Production and Service Provision:
 Implemented
Note: these processes are frequently
referred to as special processes  Effective

 7.5.2.a – qualification & approval of  Adequate


special processes prior to use
 Implemented
 Effective

 7.5.2.c – control of the significant  Adequate


operations and parameters of special
 Implemented
processes in accordance with
documented process specifications and  Effective
changes thereto,

 7.5.3 Identification & Traceability  Adequate


The organization shall maintain the  Implemented
identification of the configuration of the
product in order to identify any  Effective
differences between the actual
configuration and the agreed
configuration.

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 7.5.3 Identification & Traceability  Adequate


When acceptance authority media are  Implemented
used (e.g., stamps, electronic
signatures, passwords), the  Effective
organization shall establish and
document controls for the media.

 7.5.3 Identification & Traceability


According to the level of traceability
required by contract, regulatory, or
other established requirement, the
organization system shall provide for:

 7.5.3.a identification to be maintained  Adequate


throughout product life
 Implemented
 Effective

 7.5.3.b all the products manufactured  Adequate


from the same batch of raw material or
 Implemented
from the same manufacturing batch to
be traced, as well as the destination  Effective
(delivery, scrap) of all products of the
same batch.

 7.5.3.c for an assembly, the identity of  Adequate


its components and those of the next
 Implemented
higher assembly to be traced;
 Effective

 7.5.3.d for a given product, a  Adequate


sequential record of its production
 Implemented
(manufacture, assembly, inspection) to
be retrieved.  Effective

 7.5.4 Customer property AS9100 is identical to ISO 9001 for this


Note: Customer property can include clause. See notes made in ISO 9001
intellectual property, including section above.
customer furnished data used for
design, production and/or inspection.

 7.5.5 Preservation of Product


Preservation of product shall also
include, where applicable in accordance
with product specifications and/or
applicable regulations, provisions for:

 7.5.5.a cleaning;  Adequate


 Implemented
 Effective

 7.5.5.b prevention, detection and  Adequate


removal of foreign objects;
 Implemented
 Effective

 7.5.5.c special handling for sensitive  Adequate


products;
 Implemented
 Effective

 7.5.5.d marking and labeling including  Adequate


safety warnings;
 Implemented
 Effective

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 7.5.5.e shelf life control and stock  Adequate


rotation;
 Implemented
 Effective

 7.5.5.f special handling for hazardous  Adequate


materials.
 Implemented
 Effective

 7.5.5 The organization shall ensure  Adequate


that documents required by the
 Implemented
contract/order to accompany the
product are present at delivery and are  Effective
protected against loss and
deterioration.

 7.6 Control of Monitoring and  Adequate


Measuring Devices:
 Implemented
The organization shall maintain a
register of these monitoring and  Effective
measuring devices, and define the
process employed for their calibration
including details of equipment type,
unique identification, location,
frequency of checks, check method and
acceptance criteria.
NOTE: Monitoring and measuring
devices include, but are not limited to:
test hardware, test software,
automated test equipment (ATE) and
plotters used to produce inspection
data. It also includes personally owned
and customer supplied equipment used
to provide evidence of product
conformity.
The organization shall ensure that
environmental conditions are suitable
for the calibrations, inspections,
measurements and tests being carried
out.

 7.6.f be recalled to a defined method  Adequate


when requiring calibration.
 Implemented
 Effective

 8.1 Measurement, Analysis and


Improvement

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 8.1 General  Adequate


Note: According to the nature of the  Implemented
product and depending on the specified
requirements, statistical techniques  Effective
may be used to support:
- design verification (e.g., reliability,
maintainability, safety)
- process control
- selection and inspection of key
characteristics
- process capability measurements;
- statistical process control
- design of experiment
- inspection – matching sampling rate
to the criticality of the product and to
the process capability;
- failure mode and effect analysis

 8.2.1 Customer satisfaction AS9100 is identical to ISO 9001 for this


clause. See notes made in ISO 9001
section above.
 8.2.2 Internal Audit  Adequate
Detailed tools and techniques shall be  Implemented
developed such as check sheets,
process flowcharts, or any similar  Effective
method to support audit of the QMS
requirements. The acceptability of the
selected tools will be measured against
the effectiveness of the internal audit
process and overall organization
performance.
Internal audits shall also meet contract
and/or regulatory requirements.

 8.2.3 Monitoring and Measurement of


Processes:
In the event of process nonconformity,
the organization shall

 8.2.3.a take appropriate action to  Adequate


correct the nonconforming process,
 Implemented
 Effective

 8.2.3.b evaluate whether the process  Adequate


nonconformity has resulted in product
 Implemented
nonconformity, and
 Effective

 8.2.3.c identify and control the  Adequate


nonconforming product in accordance
 Implemented
with clause 8.3.
 Effective

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 8.2.4 When key characteristics have  Adequate


been identified, they shall be monitored
 Implemented
and controlled.
When the organization uses sampling  Effective
inspection as a means of product
acceptance, the plan shall be
statistically valid and appropriate for
use. The plan shall preclude the
acceptance of lots whose samples have
known nonconformities. When required,
the plan shall be submitted for
customer approval.
Product shall not be used until it has
been inspected or otherwise verified as
conforming to specified requirements,
except when product is released under
positive-recall procedures pending
completion of all required
measurements and monitoring
activities.

 8.2.4.1 Inspection Documentation:


Measurement requirements for product
or service acceptance shall be
documented. This documentation may
be part of the production
documentation, but shall include

 8.2.4.1.a criteria for acceptance  Adequate


and/or rejection,
 Implemented
 Effective

 8.2.4.1.b where in the sequence  Adequate


measurement and testing operations
 Implemented
are performed,
 Effective

 8.2.4.1.c a record of the measurement  Adequate


results,
 Implemented
 Effective

 8.2.4.1.d type of measurement  Adequate


instruments required and any specific
 Implemented
instructions associated with their use.
 Effective

 8.2.4.1. Test records shall show actual


test results data when required by
specification or acceptance test plan.
Where required to demonstrate product
qualification the organization shall
ensure that records provide evidence
that the products meets the defined
requirements.

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 8.2.4.2. First Article Inspection: The


organization’s system shall provide a
process for the inspection, verification,
and documentation of a representative
item form the first production run of a
new part, or following any subsequent
change that invalidates the previous
first article inspection result.
NOTE: See (AS) (EN) (SJAC) 9102 for
guidance.

 8.3 NOTE: The term “nonconforming


product” includes nonconforming
product returned from a customer.
The organization’s documented
procedure shall define the
responsibility for review and authority
for the disposition of nonconforming
product and the process for approving
personnel making these decisions.

 8.3 The organization shall not use


dispositions of use-as-is or repair,
unless specifically authorized by the
customer, if
- the product is produced to customer
design, or
- the nonconformity results in a
departure from the contract
requirements.
Unless otherwise restricted in the
contract, organization-designed product
which controlled via customer
specification may be dispositioned by
the organization as use-as-is repair,
provided the nonconformity does not
result in a departure from customer –
specified requirements.
Products dispositioned for scrap shall
be conspicuously and permanently
marked, or positively controlled, until
physically rendered unusable.

 8.3 In addition to any contract or


regulatory authority reporting
requirements, the organization’s
system shall provide for timely
reporting of delivered nonconforming
product that may affect reliability or
safety. Notification shall include a clear
description of the nonconformity, which
includes as necessary parts affected,
customer and/or organization part
numbers, quantity, and date(s)
delivered.

NOTE: Parties requiring notification of


nonconforming product may include
suppliers, internal organizations,
customers, distributors, and regulatory
authorities.

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 8.5.2.g flow down of the corrective  Adequate


action requirement to a supplier, when
 Implemented
it is determined that the supplier is
responsible for the root cause, and  Effective

 8.5.2.h specific actions where timely  Adequate


and/or effective corrective actions are
 Implemented
not achieved.
 Effective

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