AS9100 QMS Standards in Southern California
Where quality control is essential, this industry has reached a consensus.
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 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.
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