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AS9100C: An Update

It's been 10 years since the aerospace's guiding standard has been updated, and there are some major changes to prepare for.

arlier this year, the International Aerospace Quality Group (IAQG) released revision C to AS9100, the aerospace quality management system (QMS) standard. The revision marks the first major change to the standard since its initial release in 1999. AS9100C is based on ISO 9001:2008 and includes all of its

by Roger Ritterbeck Jr.

E

Check Points

As9100 is based on iso 9001:2008 and is maintained and administered by the international Aerospace Quality group (iAQg), which started its revision in 2005. As9100c was released early this year. As9100c includes definitions for three important new terms: risk, special requirements, and critical items. other critical changes to the standard involve quality manual relationships, customer satisfaction, project management, recognition of supplier quality data, and approval status of suppliers. it might be next year before anyone is allowed to officially be certified to As9100c, as a revision to As9101 must be published before this can happen. the iAQg has already established a 30-month transition period for As9100c, but it won't begin until As9101d has been released.

requirements. Aerospace-unique requirements are identified by bold italic text within the standard. The requirements are considered to be complementary to customer and/or regulatory requirements. The IAQG is responsible for maintaining AS9100 and began the rewrite process in 2005. A key aspect was to gather stakeholder input. Stakeholders included civil aviation authorities, defense and space authorities, certification bodies, trade associations, aerospace suppliers, and IAQG member companies. The input came in the form of comments and each comment had to be addressed as part of the process. There were 350 comments to be addressed. Based on stakeholder input and the IAQG charter, the rewrite team had some key objectives: · Incorporate ISO 9001:2008's requirements. · Expand the scope from an aerospace standard to an aviation, space, and defense standard. · Incorporate new requirements based on stakeholder input. · Ensure alignment with IAQG strategies. · Clarify existing requirements. Revisions to the standard include the addition of new definitions, new requirements, moving existing clauses to other sections, modifying existing requirements, and, in some cases, even deleting requirements. There are many changes throughout the standard, but there are some key ones to focus on initially to become familiar with the new standard.

Definitions

There are three new terms in the updated standard that are important to understand during the implementation phase: · Risk. An undesirable situation or circumstance that has the likelihood of occurring and a potentially negative outcome. Understanding risk is important in developing a proactive aerospace QMS. · Special requirements. Those requirements that have a high risk of being achieved, thus requiring their inclusion into the riskmanagement process. Factors used to determine special requirements are product or process complexity, past experience, and/or product or process maturity. It will be important to understand the potential flow from special requirements to critical items and/or key characteristics. · Critical items. Those items having significant effect on product realization and the use of products that require specific management. Organizations will need to understand critical items coming from special requirements and ensure they are systematically addressed and linked to risk management.

Key changes

· Quality manual relationships (4.2.2). This change deleted the previous requirement to create a document showing the relationship between AS9100's requirements and the organization's documented procedures. The stakeholder input was that this requirement had no

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effect on product quality and was viewed as prescriptive. Customer focus/satisfaction (5.2/8.2.1). A new requirement that requires on-time delivery, that product quality be measured, and that appropriate actions taken when customer objectives are not met. The evaluation of customer satisfaction shall include monitoring of product conformity, delivery performance, complaints, and corrective action requests. This requirement will establish a clear relationship between the QMS and organizational performance. Project management (7.1.1). A new requirement for planning and managing product realization in a structured and controlled way. Most aerospace products are complex and involve multitier partners and suppliers. Organizations will have to have a process to manage product realization to ensure quality and that schedules are not compromised. Risk management (7.1.2). The new requirement under clause 7.1 requires an organization to implement a risk management process. This clause will require organizations to identify and classify risk, determine levels of acceptable risk, and have effective risk mitigation plans for unacceptable risk. This requirement puts a focus on product risk during product realization. This is vital as new technologies in aircraft, space vehicles, defense systems, and materials are introduced. Organizations will need to ensure that a risk-management process is in place, that risks are appropriately applied in the process, and that they are successfully managed. Configuration management (7.1.3). The existing configuration management clause was simply moved to section 7. This puts the focus on product instead of documentation. Some level of configuration management is expected for all products at all levels of the supply chain. · Recognition of supplier quality data (7.4.1). This change is in the form of a guidance note that encourages the use of data from external sources in the supplier selection and evaluation process. The industry trend is to use externally provided supplier performance data. · Approval status of suppliers (7.4.1). This will require organizations to define the various supplier status levels they use, along with the scope of approval for each. They will also have to define the process for supplier approval status decisions and changes. This requirement stems from the increased emphasis on supply chain management throughout the aerospace industry. Conditions for using a supplier must depend on the approval status and an organization must be able to demonstrate the logic used in making those decisions. Process, responsibilities, and authorities must be defined. · Validation of test reports (7.4.3). The previous revision required organizations to periodically validate test reports for raw material. This was often a misunderstood concept, frequently misapplied, viewed as prescriptive, and subject to varying interpretations. The rationale going forward will be if an organization is making critical items in which the material chemical and physical requirements are important, it should be verifying test reports as part of its risk-management process. · Production process validation (7.5.1.1). This change moves the first-article inspection requirement from clause 8.2.4. It will require organizations to verify that their production processes, documentation, and tooling are capable of producing parts and assemblies that meet requirements. AS9102 will still be referenced as guidance and is often flowed down from major aerospace companies. · Detailed tools and techniques (8.2.2). This change removed the requirement for organizations to use detailed tool and techniques such as checksheets and flowcharts, etc., to support the internal audit process. Industry considered this to be too prescriptive and decided it was best to leave the identification of tools up to the supplier. · Sampling inspection (8.2.4). AS9100C requires that when the organization uses sampling inspection for product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for use. The rationale was that numerous requests were received to improve the sampling clause and that the way it was previously written confined organizations under other plans that could still be proven statistically valid. This is just a sampling of key changes in AS9100C. For a complete comparison matrix between AS9100B and AS9100C go to www .qmi-saiglobal.com/registration/ aerospace/ and click on "AS9100 Revision C Update."

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Transitioning to AS9100C

Although AS9100C has been out since early this year, no certification (Continued on page 19)

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output was communicated to the audit function across all sites. · A global audit report was issued as one of the key outputs to the management review process. At the conclusion of each global audit report, feedback was initially provided to the audit teams at each site during biweekly audit conference meetings and to the owners of each of the subsystems identified in the audit schedule. At the first communication meeting the feedback included recommended changes to the audit process. Examples included: · Consider standardizing the audit reports for ease of review and analysis. · Establish ground rules for audits. What are the boundaries to which issues are reported or not included in the report? For example: For issues found in audits that are being addressed by a plan (such as a quality plan), should they state them in the report as observations/nonconformity or exclude them from the report? At the end of the pilot program, the data were submitted to management and subsystem owners. The recommendation for the team was to benchmark external audit nonconformities and assess the regulatory impact to the audit program and what changes would be proposed to improve the program in the next audit cycle.

About the author

Sandra Storli is an audit program manager. A

AS9100C: An Update

audits are taking place yet and may not for quite a while. To conduct audits to the AS9100C, the new revision to AS9101 must be published. Unfortunately, that document has hit some snags at the IAQG approval level. It could be third quarter of this year before it is released. To maintain existing certification to revision B and allow for a smooth transition to revision C, the IAQG has established a 30-month transition period. The transition period does not begin until AS9101D is published, so it's important for certified organizations to be aware of that progress. The first six months of the transition period is dedicated to the development and deployment of IAQG-sanctioned training. All aerospace auditors must undergo this training to conduct certification audits. Taking into consideration that AS9101D hasn't yet been published and sanctioned training material must be developed, it's quite likely that it could be mid-2010 before any certification audits take place

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definitions. · More than ever, understand and deploy customer requirements. · Focus on on-time delivery and quality performance. · Stay abreast of the progress for on the release of AS9101D and the pending transition timeline. Visit the following Web sites periodically for updates on the transition to AS9100C: www.qmi-saiblobal .com/registration/aerospace, www .iaqg.org, and www.sae.org/aaqg.

to AS9100C. During the transition period, both revision B and C certificates will be acceptable. Certification bodies can continue to issue revision B certificates during the first 18 months of the transition cycle. This will accommodate organizations that may be coming up on a recertification audit early in the process. All suppliers holding revision B certificates will have to upgrade during the last 12 months of the transition or they will lose their certification.

Summary

The revision to AS9100 brings significant changes, not only to the standard but also to how audits will be conducted. It will be an audit tool and auditors will be measuring organizational effectiveness. There are many key points to consider, but a few to take are: · Study the comparison matrix and understand the depth of the changes. · Understand the new terms and

About the author

Roger Ritterbeck Jr. is the aerospace product manager at QMI, where he has worked since 1998. Prior to joining QMI, he worked for a major aerospace manufacturer in various quality management roles. Ritterbeck is an ASQ Certified Quality Manager and is qualified to perform audits for ISO 9001 and AS9100. Contact him at (800) 247-0802, or via e-mail at [email protected] A

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