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by Eugene M. Barker
Representing
the first international effort to formulate a quality management system
standard for the aerospace industry, the two-year-old AS9100 is beginning
to show its long-term value. The standard supplements ISO 9001 by
addressing the additional expectations of the aerospace industry. Already,
reports along this complicated manufacturing chain attest to—among other
benefits—AS9100's contribution to more consistent verification methods and
fewer verification audits.
Initially released in October 1999 by the Society of Automotive
Engineers in the Americas and the European Association of Aerospace
Industries in Europe, and shortly thereafter by standards organizations in
Japan and Asia, AS9100 was a cooperative effort of the International
Aerospace Quality Group. As such, it combines and harmonizes requirements
outlined in the SAE's AS9000 and Europe's prEN9000-1 standards. Recently,
AS9100 was revised to align with ISO 9001:2000.
Separating "whats"
from "how tos"
AS9100 defines additional areas within an aerospace quality
management system that must be addressed when implementing an ISO
9001:2000-based quality system. Typically, these requirements are included
within robust aerospace quality systems. The industry experts who wrote the
standard and the representatives who approved it all agree that these
additions are essential to ensure product, process and service safety and
quality.
Although the standard outlines industry "whats" for a
quality management system, the "how tos" were deliberately left
out and remain the system designers' responsibility. This reflects the
AS9100 writing team's, and my, belief that how-to information stifles
continuous improvement.
All quality systems must be designed to meet the specific needs of
the users. And although AS9100 identifies areas to address within the
aerospace industry, system designers are encouraged to first establish a
robust quality system that's both effective and efficient. This system should
be a holistic entity with practices spanning multiple functions and
processes within the business.
For example, regulatory requirements are critical functions within
the industry. The requirements within AS9100 are complementary to
contractual and applicable law and regulations. Those implementing a
quality system compliant with AS9100 must ensure that the additional
requirements of their customers, regulatory agencies (such as the FAA and
the JAA) and local, state and national laws are also referenced within the
system's documentation.
Aerospace
requirements and ISO 9001
Within AS9100, additions and clarifications have been made to most
areas of ISO 9001:2000. Although the specific requirements of that standard
don't fall within this article's scope, a discussion of the primary areas
where ISO 9001 overlaps with AS9100 will benefit those implementing the
aerospace standard. Some additional expectations relevant to the aerospace
industry follow. Most are based upon existing best practices, which are
collected and formatted in AS9100 to ensure that manufacturers meet the
industry's expectations.
The AS9100 standard provides guidance for managing variation when
a "key characteristic" is identified. Keys are features of a
material, process or part in which the variation has a significant
influence on product fit, performance, service life or manufacturability.
AS9100 requires that an organization establish and document a configuration
management process.
Planning product realization is essential for effective and
efficient processes. The standard emphasizes planning for in-process
verification when a product can't be verified at a later point. Tooling
design must also be considered when process control methodology is used to
ensure that process data will be captured.
The AS9100 standard includes extensive supplementation in
design-and-development functions. This isn't surprising given the
complexity of aerospace products and customers' expectations for reliable
performance during a protracted period of time. The European prEN9000-1
standard provided many of these additions. Both standards cover planning
for design-and-development activities and ensuring interim control points
during the design process. Design outputs are supplemented to provide
identification of key characteristics, and the data essential for the
product that will be identified, manufactured, inspected, used and
maintained is detailed.
Notes are included for both design-and-development verification
and validation highlighting traditional areas of emphasis. Additionally,
AS9100 provides information on areas of verification documentation and
validating testing and results.
Managing suppliers throughout the aerospace supply chain remains a
major challenge for the industry. The chain is very long, and within the
supply base, there are sources that serve multiple industries. Because the
industry is so dependent upon this supply chain, it isn't surprising that
AS9100 includes a number of additional expectations for identifying and
maintaining suppliers. Supplier approval is just one step in the process of
managing suppliers.
Effectively communicating requirements is essential. The standard
lists seven specific areas for consideration. They range from clarifying
engineering requirements to managing test specimens and right of access to
suppliers' facilities.
The industry typically relies upon one of three methods for
product acceptance. An organization might conduct a receiving inspection,
perform the inspection at the supplier's facility or formally delegate
product acceptance to the supplier. Procedures for determining the method
of supplier control are required, as are the processes used when employing
these methods.
But no element of supplier control is more important than
understanding that a supplier is responsible for managing its suppliers and
subtier suppliers. This includes performing special processes that are
frequently subcontracted to processing houses. The supplier must use
customer-approved sources; however, ensuring that the processing is
properly performed is the supplier's responsibility.
Product
safety and quality control
Manufacturing a product as sophisticated as an airplane or space
vehicle requires special attention during the production processes. It's
important, for example, to ensure that the correct revision of the
engineering documentation is being used and documented within the work
instructions, and that work performance is recorded. This frequently
requires a specific reference to the person performing the work.
Controlling production processes is essential to demonstrate that
operations have been correctly performed. This is especially important when
conducting special processes that don't lend themselves to after-the-fact
inspection techniques.
The industry frequently relies upon tooling and other production
equipment, including computer-controlled machines, to fabricate and
assemble products. This equipment often forms the basis for product
acceptance. In these cases, it's essential to demonstrate the integrity of
these tools and machines and to develop a process that will ensure adequate
oversight of the entire process.
Aircraft are designed to perform for 50 years or more, and
properly maintaining the aircraft is essential for continued safe
operation. Thus, servicing requirements are an important part of the total
quality system. These include maintenance and repair manuals as well as the
actual servicing work. Again, record-keeping is important in documenting the
work performed, the equipment used and the people doing the work.
Some products require traceability of part or all of their
components. This requirement may be imposed by contract, regulatory agency
or internal need. In any case, AS9100 provides the essentials of an
effective traceability program.
Using measuring devices of known accuracy—and this may include
computer-assisted measuring and test equipment—is essential in the
verification process. Maintaining a calibration history of this equipment
and documented proof that it's reviewed and verified periodically underlies
the entire metrology system.
Diagnosing the quality management system's health and using this
information to guide improvement activity is important for efficiency and
effectiveness. Internal audits performed by competent personnel are a vital
input into this health measurement system. AS9100 provides some additional
expectations regarding internal quality audits.
Detailed first-article inspections are frequently performed to
demonstrate product conformance to engineering requirements. Documenting
the actual inspection and test results is an established method of
demonstrating initial item acceptance. The standard provides general
direction in this regard and suggests that AS/EN/JISQ9102 be consulted for
further guidance. Another international aerospace standard, called AS9102
and developed by the IAQG, outlines a methodology for performing and
documenting first-article inspections.
When things don't go as planned, AS9100 gives directions for
controlling and disposing nonconforming material. This includes specific
requirements for contacting the customer for authorization when using or
repairing a product that doesn't conform to engineering requirements.
Verifying
compliance to AS9100
More than 60 percent of IAQG members have implemented the AS9100
standard internally and are flowing it down to their suppliers. Most
members will require suppliers to comply to the updated version of AS9100
(which is aligned to ISO 9001:2000 and supercedes older ISO 9000 standards)
beginning in December 2003. This is consistent with the transition from the
old ISO 9001 standard to the new version.
Organizations within the industry differ in their compliance to
AS9100 verification requirements. Some use their own external auditors to
verify suppliers' quality management systems. Others share the results of
their quality system audits with suppliers in the industry. Most provide
suppliers with copies of external audits. Most permit suppliers to share
the audit results with other customers, too.
Increasingly, the industry is using the results of third-party
registrars as a means of demonstrating a quality management system's
compliance to AS9100. The Americas Aerospace Quality Group, working with
the Registrar Accreditation Board, has established a process and
requirements for auditors performing audits to AS9100 and registrars
granting supplemental registrations. The process includes additional
training and practical experience and ensures that auditors are competent
and that registrars are experienced in the industry. The AAQG has created a
Registrar Management Committee to oversee this important function. Its
methodology is defined in SAE AIR5359. Europe and Asia are developing
equivalent methods.
The Federal Aviation Administration has determined that AS9100 is
"a comprehensive quality standard containing the basic quality
control/assurance elements required by the current Code of Federal
Regulations (CFR), Title 14, Part 21." Both the U.S. Department of
Defense and NASA have reviewed the standard and have published guidance
material on using the standard for contractual requirements.
As AS9100 becomes established within the industry, the standard's
benefits become apparent. Two obvious ones are a reduction in multiple
expectations and a consistency in verification methodology. Both prime
manufacturers and their suppliers are pleased with the results. Suppliers
report a reduction in verification audits and an increased consistency in
expectations. As a direct result, suppliers' customers are seeing a
reduction in oversight costs and an improvement in supplier performance.
Additional information on the philosophy behind the specific
additions within AS9100 are available in the AS9100 technical requirements
chapter found in The ISO 9000:2000 Handbook published by ASQ Quality Press
in 2002.
About the author
Eugene M. Barker is a technical fellow at The Boeing Co.
responsible for quality industry association interfaces. He led the
industry writing team that drafted SAE AS9000 and chaired both Working
Group 11 of ISO TC20 and the International Aerospace Quality Group that
developed AS/EN9100. Barker is also a fellow of the American Society for
Quality, a member of the Registrar Accreditation Board board of directors
and a founding member of the IAQG.
E-mail Barker at ebarker@qualitydigest.com
. Letters to the editor regarding this article can be e-mailed to letters@qualitydigest.com .
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