Changes are coming
ISO/TC 176, the technical committee that’s concerned with quality management and assurance, is now working on an amendment to ISO 9001:2000. Because 9100 is based on ISO 9001, a revision to the aerospace standard will also be required to reflect the changes made to ISO 9001. Additionally, user experience with 9100 has revealed improvement opportunities for the standard. The IAQG 9100 Team launched its revision initiative to update 9100 in October 2005, and works in parallel with the schedule established by ISO/TC 176 for amending ISO 9001.
In November 2005, the 9100 Team met for three days to develop processes and a design specification for the revision project. It also identified stakeholders, and created a comments template and an online survey to obtain stakeholder feedback.
The 9100 design specification established a disciplined process for considering proposed changes to the standard. The specification requires that changes or additions to the standard:
• Constitute QMS requirements that are contractual in nature or that contain product-specific requirements
• Enhance the clarity of requirements or address stakeholder needs
• Are compatible for use by all stakeholder segments and by organizations of all types and sizes
• Offer benefits that outweigh the effect of implementation
The team developed a decision tree based on these factors and a benefits-vs.-impact matrix to use as tools while reviewing proposed changes. Two additional considerations were that the proposed changes mustn’t be prescriptive (i.e., establish “what,” not “how”), and that they were auditable. The design specification also directed that the 9100 standard would continue to overlay aerospace requirements onto ISO 9001; thus, the ISO 9001 text is sacrosanct. Any requested changes to ISO 9001 requirements are out of scope and won’t be addressed by the 9100 Team.
Due to the global deployment and wide adoption of 9100, its stakeholder base is now considerably larger than when the standard was first published. Current 9100 stakeholders include not only IAQG member companies but also the global aerospace supply chain, the space and defense sectors, civil aviation authorities, national and regional defense authorities, certification/registration bodies, and other IAQG teams. Existing relationships between IAQG strategy and relationship growth teams and the stakeholder groups were leveraged, and stakeholders were invited to provide comments about 9100. An e-mail was sent to 9100-registered companies listed in the IAQG Online Aerospace Supplier Information System database (
www.iaqg.org/oasis), inviting these companies to participate in the survey.
Data mining results
The data mining period, which extended from January 2006 until August 2006, garnered about 340 comments and change recommendations to 9100. The large number of comments received is a testament to the success of the data mining outreach and shouldn’t set off alarms in the user community: There won’t be 340 new requirements in the revised 9100 standard. Many of the comments were duplicative, and many won’t meet the design specification criteria; others are asking only for clarification of existing requirements. Although it’s too soon to forecast the number of new requirements that will appear in the revised standard, the number is expected to be relatively low.
The 9100 Team met for three days in October 2006 to begin reviewing the data mining results, using the 9100 design specification criteria to guide the review. The team will continue this effort during its next meeting in Melbourne, Australia, in April. As a result of the initial reviews at the October meeting, subteams were formed to address areas that had numerous comments or that represented significant potential new requirements. These subteams will provide their recommendations to the full 9100 Team at the Melbourne meeting.
Topics under review
The proposed changes to 9100 are varied. Many comments requested editorial clarifications. Other comments challenged the validity or benefit of some requirements and requested that a requirement be deleted or reduced in scope. Yet other comments requested the addition of new requirements, recognizing that continual improvement requires regularly raising the bar.
Some of the items that were challenged were the aerospace requirements in subclauses 4.2.2 and 8.2.2. In subclause 4.2.2, “Quality manual,” users were having a difficult time understanding the intent behind the requirement to show the relationship between the standard’s requirements and documented procedures; in some cases this caused unnecessary, nonvalue-added work. In subclause 8.2.2, “Internal audit,” the aerospace requirement to measure the effectiveness of selected audit tools generally wasn’t understood, and even when it was, the cost often exceeded the benefit. In either case, auditability of this requirement is an issue. Both of these topics, as well as the other valid challenges to existing requirements, will be reviewed to determine if the requirements can be clarified, revised in scope or deleted.
Multiple requests for clarification were received for the requirements related to “positive recall” in subclauses 7.4.3 and 8.2.4. These requirements, which can be traced back to a similar requirement in ISO 9001:1994, involve the release--under controlled conditions--of product prior to completing verification. The term “positive recall” often wasn’t understood, and these requirements will be revised to more closely align with the original ISO 9001:1994 text.
The test report validation requirement in subclause 7.4.3 was another topic that received comments. Why did this requirement apply only to raw material? What constitutes raw material? What validation methods are acceptable? How often should validation be performed? There were many questions related to this requirement, and all are under review by the 9100 Team.
Other items to be clarified include statistical sampling in subclause 8.2.4 (What’s statistically valid? What’s the statistical validity of this requirement as written?), and first-article inspection (FAI) in subclause 8.2.4.2. (Is it necessary to perform FAI or only have a process for it? What’s a “part,” and does it include assemblies?) Clarifications were also requested in other sections of the standard--in particular, subclauses 7.3, “Design and development”; 7.4, “Purchasing”; and 7.5, “Production and service provision.” These requests are understandable, given the high number of aerospace requirements in these subclauses.
9100’s existing coverage for key characteristics was the subject of a number of comments, and this topic is also under review, particularly how to link 9100 with the IAQG-prepared 9103 standard (known in the U.S. as SAE AS9103, “Variation Management of Key Characteristics”). The current (lean) requirement for configuration management in subclause 4.3 is also under review, and additional coverage of this topic should be expected in the revision.
There were also requests for new requirements related to risk management. These varied in the depth and breadth of the risk coverage. Some favored a packaged risk management clause; others that various elements of risk be embedded in appropriate clauses throughout the standard. A subteam has been formed to review all requests and develop a recommendation.
Due to the complex nature of most aerospace products, and global sourcing and partnering at multiple levels of the supply chain, a requirement for project management is under discussion. Some emphasis on this topic can be expected in the revised 9100 standard. One subteam is reviewing requests for the addition of requirements for key performance indicators; another subteam is determining whether there’s an opportunity to codify any continual improvement methodologies to supplement the existing requirements outlined in subclause 8.5.1.
Of interest was a small groundswell of opinion from users requesting that the term “quality” be dropped from the title of the standard. This was based on the recognition that, with the wide use of business excellence models and other management models and tools, we’re closing in on the time when the QMS may have to expand to be an overall “enterprise” or “integrated” management system. Because 9100 is an ISO 9001-based standard, these requests are obviously out of scope and beyond the control of the 9100 Team. However, the issue will undoubtedly be the subject of ISO technical committee work in the future.
In addition to expected editorial and technical changes, the industry scope of the 9100 standard will be expanding in the next revision. Recognizing that many of the major aerospace companies have defense divisions, and that there’s great similarity between land- and sea-based defense systems and aerospace systems, the charter of the IAQG was recently revised to include organizations that provide land- and sea-based systems for defense applications. As a result, 9100’s title and foreword will be revised to indicate applicability of the standard to the aviation, space and defense industries.
The preceding is a brief description of some of the noteworthy subjects identified by the data mining process. The 340 comments received covered many of the clauses of the standard and, given such comprehensive criticism, the entire standard is under review. The desired end state is to learn from the past seven years of stakeholder experience, to clarify and improve existing aerospace requirements where necessary, and to add new requirements only when they provide value to the QMS. This effort is likely to enhance product conformity and demonstrate that the benefits of implementation will outweigh implementation costs.