Aerospace Quality Management Systems Eugene M. Barker – The Boeing Company Using material initially developed by Dale Gordon – MPC Products Abstract Since being established in December 1998 the International Aerospace Quality Group (IAQG) has developed a comprehensive suite of standards and guides and a supporting infrastructure that is resulting in improved quality while reducing costs across the aviation, space and defense supply chain. This paper provides an overview of this comprehensive system, the interaction and relationship between the various documents and a description of the Industry Controlled Other Party (ICOP) process that provides oversight. Aerospace Supply Chain The aerospace supply chain can be depicted as a pyramid with a few major Vehicle, Airframe and Propulsion Manufacturers (Tier 1) at the top supported by Integrators, Major Assemblers, Component Designers, Specialty Electronics and Software Designers at the 2nd and 3rd Tiers, and Make-to-print Machine Shops and Fabricators at Tier 4. Lower in the pyramid are Distributors and Detail Hardware providers and Raw Material manufacturers. Across all six tiers are organizations that provide Special Processes (an operation that cannot be verified afterward by non-destructive examination.) The International Aerospace Quality Group (IAQG) has developed a suite of industry consensus standards that define the appropriate quality management system requirements for the suppliers at all Tiers within the supply chain. These standards comprise an Aerospace Quality System Model. They translate company requirements into specific expectations and international requirements using a hierarchy of standards supported by an internationally agreed implementation process. Aerospace Quality Standards Numbering System The IAQG has established a consistent method of numbering the standards using prefixes that represent the standards development organization (SDO) issuing the standard and a common numeric suffix. Standards that are released internationally are identified with a four digit suffix beginning with 91xx. These standards are word-to-word equivalent, published by the national SDO in the local language. Standards published exclusively within the Americas have a suffix of 90xx and an AS prefix. These standards may be adopted internationally and when this happens the number is changed to a 91xx-series standard. All AS standards are published by the SAE. European standards are published by the AeroSpace and Defense (ASD) organization and carry an EN suffix. The Society of Japanese Aerospace Companies publishes the standards in Japan using either a JIS Q or a SJAC prefix. SDOs in Brazil, China, Korea, Russia and other nations publish some of the IAQG standards, using the same numeric suffix identification or other cross reference to the base standards. Aerospace Quality System Standards A partial listing of the IAQG standards includes the following documents: 9100 – Quality Management System for Aerospace Manufacturers 9102 – First Article Inspection 9103 – Management of Key Characteristics 9104 – Requirements for Registration of Aerospace Quality Management systems 9100 – Quality Management System for Aerospace Repair Stations 9120 – Quality Management System for “Pass-Through” Distributors Additional guides are also published and individual IAQG sectors have published their own standards. Why an Aerospace Sector Standard? The aerospace industry recognized in the mid-90s that minimal compliance with ISO 9001 was inadequate to address the products used within the industry. Most of the Tier 1 companies were adding additional requirements to ISO 9001 when they communicated their expectations for a quality management system to their suppliers. This resulted in a supplier receiving multiple expectations from their customers. The 9100 standard was developed to standardize these expectations on a global level. This reduced the variation at suppliers, improving quality while reducing costs throughout the value stream. ISO 9001 is the Base ISO 9001 was selected as the base for these industry expectations. This allowed the industry to build upon a proven quality management system and the supporting certification structure. The industry expectations added regulatory, safety, reliability and maintainability requirements. The industry strongly supports the year 2000 additions to ISO 9001. A process based quality management system accommodates the complexity of the industry products and products. Customer satisfaction has long been the objective of the industry and establishing an expectation for continual improvement assures that the industry continues to meet the ever increasing expectations of our customers. When the ISO 9001 standard was revised in 2000 the requirement for achieving continual improvement was added. This was a significant addition. However the very nature of the standard mandates that it be suitable for everything from anvils to airplanes and that it address the needs of the service industries such as hotels and hospitals as well as products. The aerospace industry, recognizing that the ISO 9001 standard, while providing an excellent base was not adequate for the specific needs of the industry added a series of additional expectations. These included the requirement for including variability reduction as a portion of the organization’s continual improvement process. All processes benefit when operated near nominal, allowing a more robust interaction with other processes and reducing the probability that the process will drift outside of its boundary conditions. Additional added requirements include: Interfaces with regulatory organizations Configuration management A number of additional expectations during the design and development activity, including added verification and validation activities Enhanced control of changes during the production processes Additional control of production equipment, tools used to produce and control the product and computer aided production and test equipment Specific controls for those supplying products, processes and services Attention to the verification of the initial products to assure that they conform and that the processes producing them are significantly robust to assure continuing compliance Additional records requirements including inspection documentation. The above assure a standardized approach to the flow down of requirements to suppliers. This allows them to develop a common quality management system meeting the needs of all of their customers. Clause 4 of the standard specifies that the requirements of the regulatory authorities are included within the organization’s documented quality system. This includes specific provisions that allow the authorities access to facilities and a review of the records. The standard requires that a “trace” be maintained between the standard, the organizations Quality Manual and the implementing procedures. This is to facilitate the review of the quality system by those charged with its verification. A process used for Configuration Management must be documented. This should include the use of control techniques across the entire product life cycle. Clause 7 contains a significant amount of supplementation. This is to be expected since this section discusses the requirements during the product realization processes. Design and Development contains requirements to conduct variability management whenever a Key Characteristic is identified by a customer. The organization may also determine Keys and when they do these also must be managed. The intent is to identify those processes that influence the generation of the Key Characteristic and then by the application of variation management methodology assure that the process operates as close to nominal as practical. Additional Design and Development activities include: The assurance that the design process provides all of the data necessary to produce the product The use of formal Design Reviews at appropriate steps in the design process Documentation of the Design verification and validation process including the supporting reports and calculations The provision for the review of design changes by customers and regulatory authorities when required The management of the entire supply chain is an essential responsibility for every organization. Organizations are increasingly depending upon suppliers for providing a substantial amount of the work content. The organization is responsible to assure that every supplier and their sub-tier suppliers are in compliance with all product, process, contractual and regulatory requirements. The process for managing suppliers must include: Maintenance of a list of approved suppliers, including the processor approving and disapproving these sources Periodic review of the performance of the suppliers Control of special processes and their sources The process to be used for suppliers for notifying the organization of nonconformances and the extent of permission for dispositioning nonconforming product The right of access for customers and regulators Specific requirements regarding the stringent flow down of requirements to subtier suppliers and the process used to validate that this occurs must be documented. When an organization plans for the production or service of the product a significant opportunity exists to assure that the methods chosen afford a repeatable and reliable process. This planning should take into account the development of control plans and process controls, driven from a consideration of the associated risks. The methods used for product and process verification should be defined with specific attention paid to assuring that verification occurs prior to the attribute being hidden by a subsequent operation. When tooling is designed for use in verifying conformance consideration should be given to providing the ability to take variable measurements, allowing the implementation of variation management techniques, as appropriate. During the production process adequate means must be provided to assure the accountability of product. This should include evidence that all operations have been satisfactorily completed. Consideration should be given to the elimination of the generation of foreign objects and if this is not possible then adequate means must be provided to remove these items prior to subsequent operations. The processes should take into account the potential for environmental influences and make adequate provisions for the protection of employees, those using the product and the facilities where the product is produced. Frequently a number of quality characteristics are related to the execution of skill-related operations. The criteria associated with these operations should be specified. The extent of the information contained within the work instructions should be consistent with the knowledge level of those performing the work. The 9100 standard contains two important concepts. The first is the performance of verification activities associated with assuring that the initial production items conform to the engineering requirements and intent. Typically referred to as First Article Inspection (FAI), this process id always required when making an initial production run or when a change is made to the process that is significant enough to warrant a new review for conformity. Unless specified by contract 9102, FAI, is not mandatory, however it does provide excellent guidance for those developing the process. The management of Key Characteristics is a valuable tool and the methodology is defined within the 9103 standard. This is a guidance document unless specifically called out by the customer. Organizations are strongly encouraged to consider the use of variation management when developing their suite of continual improvement tools. First Article Inspection The 9102 standard provides the requirements for the performance of First Article Inspection (FAI). These are performed to verify that the initial production meets all of the design requirements. This process should verify that the manufacturing planning is correct, contains the right sequence of activities and appropriate verification activities. This process applies to all levels of parts from castings and forgings, to machined items and full assemblies. The verification is performed by the supplier and includes the collection of appropriate quantitative data. Where special processes are required specific attention must be paid to assure compliance. The FAI includes the verification of all design characteristics. This is typically accomplished by marking up (or ballooning) the engineering drawing and then recording the results of each of these measurements. When material and special processes are involved the certification status of those performing the work should be verified. A review of the manufacturing planning should include verification that all processes are specified and properly sequenced. Information regarding tooling and gaging should be recorded. And all tests and certifications verified. Nonconformances should be documented and dispositioned, including a decision on the need to conduct additional verifications from the next production run. The methods used to perform the FAI and the extent is the responsibility of the organization making the part unless specific contractual requirements exist. A change of the design requirements or the manufacturing process may require a partial or complete FAI to be performed. Key Characteristics Management The process for the management of Key Characteristics is specified in the 9103 standard. A Key Characteristic is defined as “the feature of a material or part whose variation has a significant influence on the fit, performance, service life or manufacturability” of the product. These features can include dimensional features such as thickness, diameter, length, hole location, etc., chemical concentrations or time, pressure, speed, voltage output, etc. The intent is to drive improvement of the process or processes that influence the generation of the Key Characteristic. Ideally the process should be operated to cause the characteristic to be produced as close to nominal as possible with a minimum of variation. The typical methodology includes understanding the process, using appropriate tools to monitor the process, identification of the factor(s) that influence variation and bringing these parameters into statistical control, then reducing this variation. Records Retention During the design of the quality management system attention must be given to the retention of records. The 9130 standard provides direction on this topic. In addition, a guidance document (ARP9034) is being developed to address the considerations associated with the long term retention and retrieval of digital data. The products that we produce last for over 50 years and it’s essential that during the product life the design data can be readily accessed. Supply Chain – Risk Management A number of IAQG and AAQG standards and guides address processes associated with the procurement of parts and management of suppliers. With the increased dependence upon purchased items and their increased complexity this continues to be an area of opportunity for improvement. The use of Risk Management techniques to establish the extent of supplier control is becoming increasingly important. ARP9113 provides a methodology that accesses the complexity of the product against the maturity of the supplier in establishing the methodology for supplier management. Software Quality AS9006 has been developed to translate the requirements of the AS9100 standard when used in the development and procurement of deliverable software. ARP9005 provides guidance for the control of software used in the design, manufacture and verification of products. Standard Contract Clauses A recently released resource is ARP9009 that provides a series of standard contract clauses that can be used by customers to communicate specific expectations to their suppliers. Special processes Sources performing special processing such as heat treating, nondestructive evaluation and chemical processing provide unique challenges. These activities cannot be verified after the fact without destructive testing. It is essential that the processes used to perform these operations be strictly controlled and evaluated. To assist the industry an industry-controlled and managed process called Nadcap has been developed administered by the Performance Review Institute (PRI) of SAE International. This process uses highly skilled technical experts to conduct detailed process audits using industry-developed checklists. Sampling Inspection / Statistical technicques Product verification, whether performed by the function performing the work or an independent organization, requires adequate controls to insure the integrity of the process. We have already discussed the conducting of First Article Inspections and the management of key characteristics. ARP9008 provides a series of sampling plans and their associated implementation requirements to facilitate the appropriate use of statistical techniques during product acceptance and inprocess control. Quality System Audits An adequate audit program is required to provide management with visibility regarding the effectiveness and efficiency of the quality management system. ISO Technical Committee (TC) 176 has developed a set of audit requirements and published them as ISO 19011. These should be reviewed when establishing the organization’s internal audit process. Management of Nonconforming Material Unfortunately mistakes happen resulting in generating nonconforming material. The quality management system must provide a robust process to assure the identification, control and disposition of this material. An acceptable process, including reporting, is defined in AS9131. Industry-Controlled Other-party process A number of approaches exist to demonstrate the compliance of he quality management system to the appropriate standard. These are most typically referred to as: 1st party – an organization conducts their own evaluation and declares compliance 2nd party – a customer reviews their suppliers quality management system and determines compliance 3rd party – an independent organization, typically an accredited registrar, audits the organizations quality management system and certifies compliance The aerospace industry has developed a process for the oversight of the 3 rd party process when performing audits to the 9100, 9110 and 9120 standards. This is typically referred to as the Industry-Controlled Other-Party (ICOP) process. Under this process the industry conducts independent reviews of those accrediting the registrars and conduct witness audits of these registrars as they perform quality management system audits. The result is a list of Registrars authorized to perform aerospace QMS audits. The details regarding this methodology are contained in the IAQG procedure 9104. Other Quality Management Systems In addition to the 9100 quality management system, the IAQG has developed two other QMS’ one for use with Maintenance, Repair and Overhaul systems (9110) and the other for Distributors (9120). The Distributor system is used by those “pass through” stockiest and distributors that handle parts and supplies used in aerospace products. The standard is built upon ISO 9001 and 9100, but only applies necessary system requirements. It does include expectations for their management of their suppliers. An ICOP registration process has just begun. The 9110 standard for Repair Stations is developed for use by manufacturers and airlines for flow down to those providing maintenance, repair and overhaul services. They expect suppliers that have defined quality management systems with reputable verification. This standard is developing interest from airlines and the military. The standard is based upon ISO 9001 and the 9100 standard plus includes the expectations of the civil aviation authorities (FAA/JAA 145). Like the 9100 and the 9120 standards, an ICOP process for registration is also available. Global Recognition of Compliance The aerospace industry has spent considerable time and expended substantial energy in developing an International Aerospace Sector Certification Scheme. The intent is for the IAQG to have an agreed and compatible system acceptable to all, which allows sharing of audit results and approvals resulting in the elimination of multiple assessments and process improvement. The goal is for suppliers to receive one aerospace quality system approval that is acceptable to all aerospace OEMs (and their suppliers) throughout the world. The key to this is confidence. Over two years ago the aerospace industry identified eleven requirements of a global QMS evaluation system. Single global standard Harmonized system of application Inter-National accreditation control Approved certified bodies and registrars Approved aerospace auditors Global acceptance by supplier base Data easily available to all participants Active industry participation One audit accepted by primes Oversight /control by IAQG and Sectors Inter-National Aviation Authority endorsement All but the last item have been achieved. A tremendous accomplishment when the global nature of our business is understood. The remaining action, an endorsement by the regulators, must await demonstrated performance by the industry of the process. The ICOP process includes requirements for the Accreditation Boards and CRBs, the auditors and the associated training. The system includes requirements for the minimum audit time and reporting the results of the audits. The industry is responsible to provide oversight for the process, to report problems with the registrars and their auditors and to track the performance of the suppliers and their associated registrars. An On-line Aerospace Supplier Information System (OASIS) went operational in July 2003. Since then over 2000 registration have been reported. All assessments are entered by the registrars and consist of two sets of data. The first is the public information contained on the Certificate of Registration. The private information includes the detailed audit findings. Access to this private data is controlled by the certified organization. This data is also summarized periodically to allow visibility to the industry’s performance to the standard. The OASIS database is an essential element of this robust system. This paper has provided a comprehensive overview of the basic standards and guides available to the aerospace supply chain. And the supporting ICOP process. The industry leaders are listening. They have aggressively supported a common system of standards and support structure and they are implementing this system. The result is the elimination of redundant quality management system assessments and a clearer communication of industry expectations.
