Posts Tagged ‘aerospace’
If AS9100:2009 is published, why can’t I get certified to AS9100C now?
Before any company can be certified to the AS9100C standard, the aerospace industry must complete these milestones:
- The AS9104-1 standard must be published (expected spring 2010)
- The AS9101D standard (checklist) must be published (expected Spring 2010)
- The AS9100C/AS9101D course for certification body auditors (NQA auditors) must be developed, vetted and made available for use by certification bodies (expected by 30 April 2010)
- Certification body auditors must attend this course, pass it, submit their applications to RABQSA and get approved (we expect that to happen over the summer and fall of 2010)
- The registrars must submit an application to ANAB and then be audited before we can be accredited to perform audits to AS9100C (we expect that to happen early summer of 2010)
Once all of the above tasks are completed, registrars will be able to conduct audits to the quality management system requirements of AS9100 revision C.
As to when your company must transition to this new standard, all AS9100 audits after July 1st, 2011 must be to AS9100C and that by July 1st, 2012, AS9100B will cease to exist and all registrations for AS9100 must be to revision C of the standard.
AS 9100C What Is New?
The focus of the AS9100C requirements added to ISO 9001 is on Aerospace & Defense Industry needs. An important point is that a company currently registered to ISO 9001 that also has automotive requirements such as APQP, FMEA & PPAP built into their system or with staff that is familiar with these requirements will have an easier time upgrading their current system.
Production Process Verification (Basically the “First Article Inspection” FAI) and Work Transfer processes are AS9100 Specific, but companies experienced in PPAP will find that they are quite prepared to meet these requirements.
The chief new requirements in AS9100C focus on: Project Management, Risk Management, and changes to Configuration Management. A company with a strong, documented design and product launch process will find that they meet most of these requirements and will have suitable process to which they can add any additional items required. Companies that do not have proper processes for the above items will find a will get the most benefit in establishing and implementing these processes (Increasing efficiency & quality and reducing risk).
If the organization does not have the internal resources to implement the changes needed to comply with these new requirements, it would be a good idea to get help from a competent business management consulting firm.
The Goal Of The AS9101 Rewrite
The AS9101 rewrite goal is to provide requirements on process auditing and development of the AS9100 audit approaches and tools that focus not only on conformity, but also on effectiveness of a quality management system (QMS). The AS9101 proposal is to develop an enhanced audit process for evaluating process-based management systems that aligns with ISO 17021 and consists of:
- Process-based information gathering.
- Assessment or analysis and audit planning.
- Development of performance-based and process-oriented audit methods and techniques.
- The ability to capture objective evidence of process conformity and effectiveness.
The AS9101 Rev D has aligned itself with the process approach for quality management systems as indicated in the 9100-series of standards. There are four basic questions asked when evaluating quality management systems which is linked to each process which is being audited:
- is the process identified and appropriately defined?
- are the responsibilities assigned?
- are the procedures implemented and maintained?
- is the process effective in achieving the desired results?
The Goal Of The AS9101 Rewrite
The AS9101 rewrite goal is to provide requirements on process auditing and development of AS9100 series audit approaches and tools that focus not only on conformity, but also on effectiveness of a AS9100 quality management system (QMS). The AS9101 proposal is to develop an enhanced audit process for evaluating process-based management systems that aligns with ISO 17021 and consists of:
• Process-based information gathering.
• Assessment or analysis and audit planning.
• Development of performance-based and process-oriented audit methods and techniques.
• The ability to capture objective evidence of process conformity and effectiveness.
The major proposed changes in the rewrite of AS9101 include:
• Creation of one document covering AS9100, AS9110 and AS9120.
• Elimination of scoring and key requirements designations.
• Use of data and customer feedback concerning organizational QMS performance as an input for process-oriented audits (for example, Online Aerospace Supplier Information System (OASIS) customer satisfaction or performance scores).
• Inclusion of determination of effectiveness, in addition to conformity.
• More emphasis on performance measuring.
• Introduction of the objective evidence record.
A major theme of the AS9101 rewrite is examining process effectiveness. ISO 9000:2005 defines effectiveness as the extent to which planned activities are realized and planned results achieved. The ultimate measure of QMS effectiveness is customer satisfaction.
What has not changed in AS9101 includes determining conformity to the standards, documenting discovered nonconformities and drawing conclusions on conformity of the organization’s QMS based on information collected during the audit.
Essential Changes To The Continual Improvement Of AS9100
The scope was changed from aerospace to aviation, space and defense to recognize that complex systems can include multiple sectors.
The requirement to include quality system requirements imposed by regulatory authorities when developing QMS documentation
Special requirements are those identified by the customer or determined by the organization that has high risks to being achieved
Critical items (for example, functions, parts, software, characteristics and processes) are those having significant effect on product realization and use of the product.
This new requirement requires product conformity and on-time delivery be measured and appropriate actions be taken if planned results are not achieved.
This revision has added a requirement to monitor customer satisfaction data and develop improvement plans that address deficiencies.
Using various business management systems tools can help an organization achieve organizational excellence and satisfy necessary requirements set forth in this new revision of AS9100. AS9100 software as well as AS9100 templates have been developed, that can guide an organization to succeed with meeting this new challenge. Let’s face it, most small business today do not have the resources and cash that the big guy do. These tools are being used as an alternative to high cost consulting services.
AS9100 C What’s New
AS9100 is based on ISO9001:2008 and is maintained and administered by the International Aerospace Quality Group (IAQG), which started its revision in 2005. AS9100Cwas 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.
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 quality management system.
• Special requirements. Those requirements that have a high risk of being achieved, thus requiring their inclusion into the risk-management 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. CIS Software has a special requirments module which helps to orgainize and track key supplier special requirments.
• 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.
AS9100 The Key to Success
The key to success in the aerospace or any industry for that matter lies in its ability to learn on a continuous basis, new and more efficient ways to achieve cost and quality objectives. Only the most advance quality management tools along with the AS9100 standard can get aerospace organizations ready to compete in global marketplace. Our generation must concern itself with bench marking best practices in order to continuously move forward and compete in this market. There are many new software and educational tools available today that can aid in this objective. These tools range in cost from hundreds of thousands which many large companies employ, to products that cost only a few thousand dollars to satisfy the small business entity.
What is most important to the small business organization is time, overall cost and resources to implement and maintain their AS9100 quality management system. If the organization chooses the right AS9100 software package all of these concerns can be met and resolved. CIS Software for instance is easy to implement, requiring only a few days to fully install and begin using.
There are also many AS9100 consultants who offer fully documented AS9100 templates to help kick start your quality management system implementation or streamline that system, if the system you have is way too complicated to maintain.
AS9100 Calibration Requirements
Using measuring devices of known accuracy, and this may include computer-assisted measuring and test equipment is essential in the verification process for any quality management system. Maintaining a calibration history of this equipment and documented proof that it’s reviewed and verified periodically underlies the entire metrology system.
Clause 7.6 states: The organization shall ensure that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.
Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage;
f) be recalled to a defined method when requiring calibration.
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
What Are The Main Drivers Behind The Aerospace Standard AS 9100?
Because safety and reliability are critical issues in the aerospace industry, the requirements for quality management are second to none. Manufacturers, suppliers and service organizations succeeding in this highly competitive global market are those who regard quality management as a key business driver. Independent AS 9100 registration is a presentation of their commitment to quality, safety and reliability. Through the AAQG and IAQG, the Aerospace Industry is clearly signifying that the whole aerospace supply chain will be expected to comply with the AS 9100 standard and it’s related standards such as AS 9110 for Repair and Overhaul facilities and AS 9120 for Pass-through Aerospace Distributors. Many large Aerospace OEMs have indicated that certification to the AS 9100 document though the Industry Controlled Other Party (ICOP) process will result in less oversight of the suppliers. The Boeing Company has already indicated that they expect new suppliers to be certified to AS 9100 and existing suppliers are being “strongly urged” to do so, as well.
So if your in the business, or just thinking about entering the aerospace business, it is time to climb aboard the AS 9100 band wagan. With the present business outlook, now is the best time to be certified to AS 9100 if your thinking about growing your aerospace business.
AS9100 consultant companies offer as9100 templates to help small businesses begin the documentation of their quality management systems. These templates can be altered to meet the individual needs of your processes.
Supplier Quality Management
Due to recent economic, safety and security issues, supplier quality management has emerged as one of the leading business practices in recent years. Today it is imperative for manufacturers to make significant investments in systems and processes to improve supplier quality. For instance, companies in the aerospace, food, and industrial products arena, need to preserve their preferred supplier status to continue to be considered for future business. As a result, they are under pressure to ensure that their products continue to meet or exceed acceptable quality levels and Corrective Action thresholds set by their customers. Therefore, managing their supplier’s quality is mandatory for these companies.
Supplier Auditing is an excellent tool to ensure that suppliers are following the processes and procedures that you agreed to during the selection processes. The supplier audit identifies non-conformances in manufacturing process, shipment process, engineering change process, invoicing process and quality process at the supplier. Once the audit is completed, the supplier and customer jointly identify corrective actions which must be implemented by the supplier within an agreed-upon timeframe. Continued surveillance audits ensure that these corrective actions have been successfully implemented.