Archive for September, 2009
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 C, What’s The Hold UP?
The AS9100 revision C standard was released in January 2009 but as of now, no companies have been registered to it. This holdup is an result to a delay in the release of the accompanying AS9101D standard (checklist). This new checklist will take the place of the AS9101C checklist your auditor currently uses which simply breaks down the current revision of the AS9100 standard into question form.
Since the AS9100C standard is tied to the AS9101 D checklist, the general consensus within the aerospace industry is that it will not be before the 1st quarter of 2010, at the earliest, before any company can be registered to the requirements of the AS9100 C standard.
While we wait, is your AS9100 quality management system ready to meet this new standard? Your documentation may need a tune up, but it doesn’t need to be painful. There are AS9100 Templates that are available now that will help you move effortlessly to this new system. Now is the time to make ready, don’t make the mistake of waiting too long to upgrade your QMS.
AS9100 Fast Becoming A Supplier Requirement
The aerospace industry has recognized AS9100 as a means for continually improving quality and on-time delivery within their supply chain. Most of the major aircraft engine manufacturers, such as General Electric’s Aircraft Engine division (GEAE), Boeing, Rolls-Royce Allison and Pratt & Whitney, are requiring their suppliers to be certified to AS9100.
AS9100 certification can be used throughout the entire aerospace supply chain including the design and manufacture of airport and airline operations, replacement parts, supply and maintenance, cargo handling, overhaul and repair depots and flight operations.
The industry is moving towards requiring their suppliers to be AS9100 compliant / certified. By becoming AS9100 compliant / certified, suppliers can gain a competitive advantage and benefit from the process approach and continual improvement that are the foundation of ISO 9001:200* certified QMS.
Currently, the Boeing Company requires all Boeing suppliers to be BQMS (Boeing’s Quality Management System) approved or have a waiver. AS9100 Rev B is a significant part of Boeing’s BQMS requirements.
General Electric Aircraft Engines (GEAE) was one of the first manufacturers to require AS9000 compliance by all of their direct material suppliers. Currently, GEAE is requiring AS9100 certification for all new suppliers, and existing suppliers have a gap audit and a certification audit performed to coincide with their existing surveillance audit schedule.
Transitioning From ISO 9001 to AS9100
A company with a rock-hard ISO 9001 quality management system will have a reasonably easy transition to AS9100. With the additional focus on configuration management, supplier management, product and process traceability, product planning and customers/regulatory requirement compliance; AS9100 is not far from the base ISO 9001 standard. The main difference between the systems is not as much the additions to the standard itself but how the registrars enforce the standard. With the revision of the AS9100 standard form “B” to Revision “C”, registrars will now be placing greater importance on whether the system implementation actually adds benefit to the company and if the company is really working toward continuous improvement.
As an AS9100 Auditor for third party registrars, it is very easy to discern whether or not a company is using their quality management system effectively or just running through the motions to retain their certification. A company that is living their system will realize actual sustainable improvements that will result in cost savings and increased business.
Know Your AS9100 Aerospace Terms
The aerospace industry is very different from other industries. Filled with terms, acronyms and processes that catch many new suppliers, fighting to get into the industry, off guard while leaving potential customers wondering if it is worth taking a chance on them. It is worth the time to get to know some of the more common terms to ease this customer doubt. Here is a short list of terms to get familiar with:
AS9100 – standard created the SAE international to standardize the quality requirements between the main players in the aerospace industry, military and regulatory agencies. Built upon ISO 9001 with 80 additional clauses specific to the aerospace and military industries.
FAI (First Article Inspection) - This is the stated documentation procedure required in order to submit product in the aerospace industry. Defined in the AS9102 standard by SAE international this procedure is used to show compliance to product and process requirements.
FAIR (First Article Inspection Report) – The actual paperwork created by following the FAI procedure. A sample, compliant, form is supplied at the end of the AS9102 created by SAE international.
CAR or SCAR (Corrective Action Report or Supplier Corrective Action Report) – basic corrective action report given by or submitted to the customer or supplier.
MRB (Material Review Board) – Assigned board of members, usually based on experience and knowledge, that can disposition product that does not meet predefined quality requirements.
NC (Non-Conformance)- Product of processes that do not meet quality requirements.
NCR (Non-Conformance Report) – The documentation that records an NC.
QPR(s) (Quality Purchasing Requirements) – The quality requirements, usually placed on a purchase order, that describe the quality requirements of the product and the quality management system used to produce the product as well as record retention requirement.
FOD (Foreign object damage/debris) – Refers to any object that can compromise the proper function of a aerospace product or damage caused by such objects.
DPD (Digital Product Definition) – The procedure used to handle customer supplied data, including prints, cad data and numerical programs. Many international standard address DPD, the must commonly referred to is the Boeing DPD standard which can be found on Boeing’s website.
ITAR (International traffic in arms regulations) – US government regulation concerning arms or products and information pertaining to the production of arms (items on the US munitions list) and their transfer outside on the US or to persons within the US that are not citizens or permanent residents.
HOW DO I ANSWER AN AS9100 AUDITOR’S QUESTIONS?
I am a third party AS9100 auditor, (your registrar’s auditor). In my experience, I have seen a lot of apprehension while auditing. The whole purpose for auditing a quality management system is to improve the overall organization so that it can compete more successfully. The auditor is not looking for faults in a system; they are looking for compliance to the standard. If a non-conformance is found, it should be viewed as and opportunity to improve, not as a reason to reprimand. The best advice for answering an auditor’s questions is … just be polite and honest. In general, the auditor is not out to trick or deceive you, so you should return the favor. Here are a few more tips you should know when talking to auditors:
• When talking to an internal auditor, you should feel free to offer any information on the subject being tackled that you feel is important, even if it’s not specifically asked for. Your internal auditors are there to help improve the system for everyone. Don’t be afraid to ask the internal auditor a question or ask for advice.
• When talking to a third-party auditor, you should still be honest, but only answer their question. There is no need to volunteer information with third-party auditors.
• Never lie to an auditor… They often know the right answer before they ask the question.
• Answer the auditor’s question directly and with confidence when you know the answer. If you don’t feel very confident about answering a question, you can:
• Tell the auditor you don’t understand the question, and ask him or her to restate it.
• Take the time to find the answer in your area’s quality procedures or work instructions. (Remember, that’s what they’re there for!)
• Ask someone else, such as your manager, for help in answering the question (especially if you feel the question falls outside your
job responsibilities). Remember that the auditors want you to succeed. They are not “out to get you.”
AS9100 Root Cause And Corrective Action
Root cause corrective action for nonconformance’s has long been a requirement in theaerospace industry as stated in the AS9100 standard. It is a process of determining the causes that led to a nonconformance or event, and implementing corrective actions to prevent a recurrence of the event. The requirements for corrective action have been imposed on the aerospace industry for decades and while not new, may not have been aggressively enforced.
Corrective action begins with clearly defining the actual problem. While this may seem simple,many recurring nonconformance’s result because the wrong problem was solved, only the result was fixed, or only one problem was corrected when there were really two or more problems. In order to fix a problem, it must be clearly and suitably defined. Frequently, the nonconformance identified is not really the problem, but the symptom of the problem.
The best ways to arrive at the true root cause of a nonconformance is collect and analyze data that will support your conclusions. There are many tools and methods to collect data that can aid in problem identification. Among these tools are software solutions which can collect and graph information for ease of analysis. AS9100 software applications can help your organization clearly and accurately identify the root cause of a problem, so that you can implement corrective action that will resolve and prevent the problem from reoccurring in the future.
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.
ISO 9001 And Risk Management
Under the ISO 9001:2008 standard risk management falls under strategic, operational, and legal/regulatory categories. Management performs risk assessment activities as part of the ordinary course of business in each of these categories. Examples include: strategic planning, and marketing planning.
Risk management is basically very simple with the level of complexity prescribed by the nature of the situation that it applies to – usually a process, and the parties involved. In its basically speaking risk management involves:
1. Identifying risk – Looking for anything that threatens the successful operation of the process against the original requirement. Risks can be environmental, organizational, technical, legal, economic or commercial.
2. Neutralizing risk – Taking action to remove or reduce the probability of a risk being brought to fruition. The response depends on the nature or seriousness of the risk.
3. Acting when the risk incident occurs – Putting in place whatever contingency measures were planned for the risk that has occurred.
Risk management can be greatly simplified by using such tools as quality management software, and ISO 9001 templates that are designed to classify and indentify significant risks so that strategic plans can be put in place to neutralize them.