Friday, December 24, 2010

" AEROSPACE’S AS9100 QMS STANDARD " 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 (IAQG).

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 sub-tier 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.


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