Posts Tagged ‘ISO 9001 software’
ISO 9001 Business Management System; Corrective vs. Preventive Action
Corrective and Preventive Action Processes are two different processes within ISO 9001 requirements.
There is a great deal of confusion between the 3 areas covered under the ISO 9001 standard, corrective action, preventive action and preventive maintenance.
Corrective action treats a nonconformity or problem that has already occurred. The problem exists. The nonconformity lives and needs to be addressed.
Preventive maintenance focuses on the care of machines. It is a system that protects machines from breaking down. ISO 9001 auditors do not look at preventive maintenance as preventive action. Preventive maintenance is important for the infrastructure (resource management) section of the ISO 9001 standard.
Preventive action determines and eliminates potential causes of non conformities. This means the non conformity has not yet happen. If you act to prevent a problem from occurring then this is a preventive action. The ISO 9001 standard requires you to take preventive action to eliminate potential nonconformities.
There are ISO 9001 software applications that can help guide an organization through this murky area within the ISO standard. A certified CIS consultant can show an organization just how simple it is to report, track and follow-up on corrective and preventive actions. If that’s not enough, there are also ISO 9001 templates available to help clarify the standard requirements for these and other areas of your business management system. So if you are looking to start a new quality management system, or just take your old system and reengineer your process to promote continual improvement, help is not far away.
What Is The Role Of ISO 9001?
The objective of any standard, whether it relates to the manufacture of cars, airplanes, machinery, or the delivery of a service – transportation, hospitals, etc. – is the same. Standards are designed to promote, facilitate and enable consistency in a process or product; to provide assurance that the process or product output will meet requirements; to provide a uniform and predictable output every time a set of procedures are executed. Because standards assist buyers and consumers in establishing confidence levels in the products and services they procure, standards facilitate fair trade practices.
Without satisfied customers, an organization’s future is at risk! To keep customers satisfied, the organization needs to meet and/or exceed their requirements. The ISO 9001 standard provides a universally recognized, tried and tested framework for taking a systematic approach to managing the organization’s processes, so that they consistently turn out product that satisfies customers’ expectation.
So, who shall survive the resent economic down turn, and who will succumb to it? Small businesses are in a unique situation to position themselves for the future. Obtaining certification need not be a costly time consuming process. There are many business consulting firms available today that are uniquely equipped to provide the newest and lest expense tools and guidance to help an organization of any size obtain certification. So if you believe that ISO 9001 is something that can help your company meet the changes of today’s world, you don’t need to spend hundreds of thousands of dollars to get there, and don’t let anyone tell you that you do.
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.
True Value-Quality Management Software
There are many business management software packages out there today. Many of these packages promise a lot but deliver little. Once you’re in, the cost to operate and maintain the system grows exponentially. This is fine for large companies who almost expect something to cost a lot of money for it to be worth using, but let’s face it, how many small business owners can really afford this. If perceived worth is judged by how much or little someone pays for a product, it would seem that the only companies that get great value are the ones with deep pockets.
I suggest that the true value of anything we purchase, is the overall cost, actual benefit and ease of use over the long haul that makes a product truly valuable. For example we have two companies, both have approximately fifty employees. They have selected two software products as possible solutions for their management system needs.
Software product No.1 offers the following:
- Upfront Cost: $ 5,000.00 (ALL MODULES)
- Monthly Support: $ 385.00, OR
- Yearly Support: $ 4,620.00 (for comparison purposes)
- Unlimited Users and Storage and support including revisions and new features.
- Upfront Cost = $ 5,000.00
- Cost over 5-Years: $ 28,100.00
Software product No.2 offers the following:
Core Tool Kit includes: Non-Conformances | Corrective/Preventative Actions | Document Control | Tooling & Equipment Maintenance | Customer Service | MOPS (Trend Analysis) | Key Indicators Dashboard
- Cost for Core Tool Kit: $ 5,000.00 for First User
- Each Additional User: $ 1,500.00/User (49 required)
- Cost for Additional Modules:
- Auditing: $1,500.00
- Education & Safety: $1,500.00
- Health & Safety: $1,500.00
- Web-Based Surveys: $1,500.00
- Inspection: $2,500.00
- Annual Maintenance Fee: 18% of Total Cost including users fees
- Yearly Maintenance( 18% of Total): $ 15,660.00
- Upfront Cost = $ 87,000.00
- Cost over 5-Years: $ 165,300.00 (training not included)
Both software applications offer similar capabilities, but the up front and ongoing costs are light years apart. Both companies have proven track records for achieving certification to international standards such as AS9100 and ISO 9001. Now, you tell me where is the true value?
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.
What Has To Be Calibrated: ISO 9001
Measuring and test equipment that has an effect on the product/service you supply to your customer must be objectively verified and calibrated (where possible) so that the degree of measurement uncertainty is known. Devices used to “demonstrate conformance to requirements” must be “controlled and calibrated.
The further away a measurement device is, in the process, from the product/service, the less critical this is. If a measurement is worth doing, it’s worth doing with a device that you can have confidence in because it’s been objectively verified.
It is not necessarily required that this be done by a third party. If you have internal capability and certified / traceable measurement equipment to calibrate with, you can do it yourself. All such calibrations need to be traceable to national / international standards. For example, if you have hand held measurement tools (calipers, micrometers), you can calibrate them with a set of certified gauge blocks. This reduces the need for external calibration.
Calibration / verification of test equipment is a huge and target rich environment for ISO 9001 audits. Make sure your system is up to snuff and covers all of the equipment (and all the requirements in 7.6). Make sure there are work instructions covering calibration of equipment that you verify in-house.
Improving Your Business
Business owners know that it’s important to make continual efforts to improve the quality and efficiency of business. For this reason, the ISO 9000 quality management system was created to ensure that a business runs at maximum potential. Businesses that can claim they are ISO 9001 certified receive a certain degree of respect from other business owners, indicating the business is formalized and operating efficiently. There are several requirements in an ISO 9001 certification, including:
~ maintaining adequate records
~ regular reviews of process and the effectiveness of the quality system
~ monitoring processes to ensure effectiveness
~ checking for defects with appropriate corrective action
~ fostering continual improvement
Businesses must adhere to stringent standards in order to meet the requirements of ISO 9001 certification. The standards for ISO 9001 were originally used to monitor manufacturing, but now are applied to several other fields. You can purchase ISO 9001 software to work towards meeting ISO 9001 requirements and a more efficient business.