Posts Tagged ‘AS 9100 Software’
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 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.
Business Management software and Document Control
Document management systems can range from a shoebox all the way to a software management system that controls and manages all of the documentation for an organization. There are several common issues that are involved in managing documents, whether the system is an informal, makeshift, paper-based method for one person or if it is a formal, structured, computer enhanced business management software system for many people across multiple offices. Most methods for managing documents address the following areas:
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Business Process Management-New Ways To Improve
Business Process Management is a field of management focused on aligning organizations with the wants and needs of clients. It is a holistic management approach that promotes business effectiveness and efficiency while striving for originality, flexibility, and incorporation with technology. Business process management attempts to improve processes continuously. It could therefore be described as a “process optimization process.”
Process optimization is the discipline of adjusting a process so as to optimize some specified set of parameters without violating some constraint. The most common goals are minimizing cost, maximizing throughput, and/or efficiency. This is one of the major quantitative tools in industrial decision making.
Your business management system can be automated to enhance your organizations ability to optimize your processes, faster and more efficiently, by making the information available real time. Many business management consulting firms now have quality management software that is capable of managing your system with a low cost, high performance output. These systems manage themselves, as long as the organization uses them correctly. Data is collected and graphed automatically and reminders are sent to those who have corrective and preventive actions to address. But the best feature yet, is the ability to connect your business management system to your customers and supplier allowing improved service throughout the supply chain.
The 5 Why’s of Corrective Action
 The 5 Why method asks why an event happened and place the resulting answer in the cause chain. Each question should be simple, short, focused on a single question and starting with “Why…?” After each cause has been identified, the next question to ask is “Why did this event happen?” |
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| Example of 5 WhysProblem Statement: Caliper was found in use on shop floor beyond its calibration date.
Why was a caliper in use beyond its calibration date? |
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| Why was the caliper not recalled? Because the caliper was not on the recall list. Why was the caliper not on the recall list? Why are new caliper not added to recall list? |
Why did the operator not check the label? Because the operator was recently hired and had not been trained to check calibration labels. Why wasn’t the operator trained to check labels? Why doesn’t OJT address calibration labels? |
Once the 5 why’s have been used successfully your business management system will see marked improvements.
Through you internal auditing process you will find many opportunities for improvement, and there are software solutions that can aid you as you progress in your problem resolution understanding. ISO 9001 software and as9100 software packages will help you collect and analyze your problem solving information to help make better decisions and improve your bottom line.
Common Misconceptions of Preventive Action
Corrective Action Preventive Action (CAPA) is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or prevent from occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall quality management system (QMS).
A common misconception is that preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy.
Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk aversion). Corrective and Preventive Actions both include investigation, action, review, and further action if so required. It can be seen that both fit into the Plan Do Check Act philosophy as determined by the Deming – Shewhart cycle.
Increasingly these days, the aerospace industry is driving it’s suppliers to perform better and better. By continuously focusing on prevention and jumping on correction, some companies are rising to the top and securing larger portions of the business. Your CIS software consultant can help you achieve your goals and satisfy your as9100 auditing requirements. This as9100 software will blow your competition out of the sky.
AS9100C and Risk Management
This new AS9100 certification standard, AS 9100C, involves implementation of a risk management process throughout product realization (product life-cycle).
The stated requirement for risk management within the current version of AS9100B is to understand risk during review of requirements related to the product during contracting activities. Risk management, to some extent, has always been at least inferred by QMSs through planning and preventive action processes. The new risk management clause requires organizations to establish a process for managing risks to achieving customer,statutory and regulatory requirements.
The process should consider: assignment of responsibilities for risk management;criteria for risk acceptance; identification, assessment and communication of risk; and identification, implementation and management of actions to mitigate risk.
There are many business consulting firms that can assist you with how to determine your risks and then prioritize them to better safeguard your companies interests and the community at large.
AS9100 Managing Suppliers
Managing suppliers throughout the aerospace supply chain is a major challenge for the industry. The chain is long, and within the supply base, there are sources that serve many industries. Because the industry is so dependent upon this supply chain, AS9100 includes a number of additional expectations for identifying and maintaining suppliers. Supplier approval is just one step in the process of managing suppliers.
Effectively communicating requirements is very important. The standard lists seven specific areas for consideration. They range from defining engineering requirements to managing test samples and right of access to suppliers’ facilities.
The industry typically relies upon one of three methods for product acceptance. An organization might conduct a receiving inspection, perform the inspection at the supplier’s facility or formally assign product acceptance to the supplier. Procedures for determining the method of supplier control are required, as are the processes used when using these methods.
But no element of supplier control is more important than understanding that a supplier is responsible for managing its suppliers and subtier suppliers. This includes performing special processes that are frequently subcontracted to business consutling firms. The supplier must use customer-approved sources; however, ensuring that the processing is properly performed is the supplier’s responsibility.
A new avenue has opened up in supplier surveillance auditing, which has had the effect of lowering cost and delivering real time results to customers. AS9100 software applications have made it possible to manage the quality requirements for as9100 from your desk top, while lowering the cost of visiting suppliers less frequently. This system is so effective that some registrars are now considering using it for such requirements as document review, corrective and preventive action effectiveness, quality objective review, internal audit effectiveness etc. All of this is done remotely thus lowering travel costs and disruptions to the customer business. Some requirements will always require on site visits, but the amount of time needed to complete a surveillance audit will reduce dramatically.
What Are the Benifits of AS9100, and Why Now?
Under the circumstances of today’s economy, one might ask “why should my company spend the time and money to become certified to AS9100?” Companies are downsizing ant an alarming rate, cutting costs and basically operating in survival mode. So you may ask, why now? The best answer is to look at the benefits of AS9100 certification going forward into the future. Those companies that have successfully implemented AS9100 now, will realize these benefits then:
· AS9100 Provides access to the best practices of the aerospace industry
· Demonstrates your commitment to deliver quality products and services to your customers
· Brings your quality management system to level with the global standard adopted by the aerospace industry
· Improves your new market / new customer prospects on a worldwide basis
· Reduces multiple expectations and number of 2nd and 3rd party audits
· Creates independent feedback to foster continual improvement
· Improved customer satisfaction
· Reduces organizational waste, inefficiencies, and defects
· Facilitates continual improvement in business processes and customer satisfaction
· Improves process consistency and stability