SAE has published the latest version of the aerospace industry’s Quality Management System standard, AS9100 revision C. In the document’s forward, it states the new version “has been revised to incorporate the requirements of ISO 9001:2008” and “industry requirements, definitions and notes have been revised and additional requirements have been included”. These objectives have been achieved by the writing committee of the International Aerospace Quality Group (IAQG).
Changes to incorporate the requirements of ISO 9001:2008 were a small effort in the sense that ISO 9001 did not contain substantive changes in the new 2008 version. The new version better aligned itself with ISO 14001 and added some clarity to existing requirements.
Significant New Requirements
Many of the new requirements of AS9100C are foreshadowed in Section 3, Terms and Definitions. Terms that have been added are Risk, Special Requirements, and Critical Items. These terms are defined in Section 3 and they appear in several subsequent sections of the document, with specific requirements.
This introduction of requirements for risk is considerable. In Section 7.1 Planning of Product Realization, Risk Management has its own subsection, 7.1.2, with no less than six new requirements. Also in Section 7, risk next appears in 7.2.2. as a new requirement for Review of Requirements Related to the Product. Another new requirement is in Section 7.4.1.f, which states risk must be determined and managed when selecting and using suppliers. And despite the fact that the term “risk” is not used in Section 8.5.2.j, this new requirement to determine if additional nonconforming product exists clearly is borne from the new standard’s emphasis on risk.
These new requirements for risk analysis, evaluation, and control may not be common practices across the community of AS9100 registered organizations. This may require changes in processes for several organizations and will require for many organizations the development or improvement of records to provide objective evidence of meeting these new requirements.
There are also substantial changes with new requirements for Configuration Management. This has been a long-standing expectation of the aerospace industry and, hopefully, should not require major changes to most organizations. But it is noteworthy that the industry feels compelled to spell out new requirements relating to Configuration Management in AS9100C.
Configuration Management first appears in Section 7.1.e as a new requirement for Planning of Product Realization. Section 7.1 goes on to devote a whole subsection, 7.1.3 to Configuration Management and requires an established process to plan, identify, control, status and audit this process. In Section 7.3.7, a new requirement is for design and development changes to be controlled in accordance with the Configuration Management process referenced in 7.3.1.
While there are other additional new requirements in the standard, they are isolated as individual items and should not provide much difficulty for most organizations that are currently registered to AS9100B.
Increasing Industry Expectations
The Aerospace industry has made their expectations of all certification bodies and aerospace auditors very clear in the Registrar Management Committee meetings, in AAQG meetings, and by the conduct of audit activities of registrars and auditors: there must be increased emphasis on the effectiveness of the Corrective Action process and specifically root cause analysis.
Aerospace auditors and registrars must clearly communicate the expectation that true root cause analysis is a requirement of AS9100 (8.5.2.b). Auditors must evaluate documented corrective actions to determine their ability to effectively meet this requirement. The most common tools utilized to determine the root cause(s) of nonconformances are the “Five Why” approach or the use of the Ishikawa (“Fishbone”) diagram. But whatever methods are utilized, there must be auditable evidence that root cause(s) has been determined and corrective actions plan address the root cause(s) to eliminate the recurrence of the nonconformance.
Performing a “Gap Analysis”
To better prepare you for your registration to AS9100C, a matrix has been provided that lists the new requirements. This can allow you to evaluate your Management System’s ability to meet these new requirements, and identify where “gaps” exist. Keep in mind that not only your documented Management System must meet these new requirements, but you must have the ability to provide evidence that your organization’s practices meet these requirements.
Envisioned Timetable for Implementation to AS9100C
The most frequently asked question seems to be “When can (or will) I be audited to AS9100C?” At this point in time, there is no definitive answer. While the standard has been published, no registrar is permitted to conduct an audit to AS9100C. Two other events must occur before that is possible.
AS9100B audits are conducted utilizing a checklist that was developed by the IAQG, that checklist being known as AS9101C. A new checklist is being developed, but has not yet been finalized. Audits to the requirements of AS9100C will require the use of this yet-developed checklist AS9101D.
After release of AS9101D, another achievement must be reached. Aerospace auditors (AAs, AEAs, and AIEAs) must be trained to both the new standard and trained to the new checklist. In order to assure the community of auditors is trained uniformly and the understanding and interpretation of the documents is consistent, a single set of training materials will be developed and utilized. Naturally, the training cannot be developed until the checklist is released. In addition, the developed training must go through an approval process to assure it addresses all requirements and fully meets expectations.
It is unlikely all these events will be accomplished before the fourth quarter of 2009, or early in 2010. As with most new standards, there will be a defined implementation period. Historically, this has been a twelve to fifteen month period.
In these challenging economic times, planning for additional resources to assure compliance to the new standard can be difficult. At this time, it seems most organizations will not have to address these issues until 2010.
As more information becomes available, SQA will provide updates on our webpage and inform our aerospace auditors, Feel free to contact your auditor for further information.
Choose SQA for your AS9100 Registrar
The decision to pursue AS9100 certification involves a substantial commitment of time and resources. Smithers Quality Assessments recognizes that this is a very personal decision requiring a solution tailored to your needs. To arrange for a SQA representative to review your certification needs, contact us at 330-762-4231 today.