Posts Tagged ‘small business’
ISO 9001/AS9100, Why Do I Have To Conduct A Management Review?
Just as a person should have periodic physical exams, your QMS must be reviewed periodically to stay “healthy.” Management reviews are critical to continual improvement and ensure that the quality management system will continue to meet your facility’s needs over time.
The ISO 9001 standard states, the purpose of a management review is to review the Quality Management System to ensure its continuing adequacy, suitability and effectiveness. This should include an evaluation of the performance of the system based on existing data (review inputs), and should also address any decisions or actions necessary to improve the management system and its related processes (review outputs).
To make your reviews meaningful, such reviews should be performed at least annually, although they may be performed on a more frequent basis, including quarterly or even monthly. The frequency of these reviews is your choice, but I personally recommend that organizations with “newer” systems perform this function on a more frequent basis, at least for the first 18-24 months.
Records of these reviews should be maintained in accordance with your documented control of record procedures. These records should include, the date of the review, participants in the review, criteria by which the system is measured, (Inputs), strengths and weaknesses of the system, and any decisions or actions that are required (Outputs). Such inputs should include, but are not limited to the following:
- Results of Internal Audits
- Customer feedback, both positive and negative
- Process performance and product conformity
- Status of corrective and preventive actions (Are they closed and are the actions taken effective)
- Follow-up of actions from previous management reviews (Are actions being completed?)
- Any changes that could affect the quality system (Personnel, facility, regulations, business direction etc.)
- Recommendations for improvement
Outputs from this review should include and decisions or actions related to the following:
- Improvement of the effectiveness of the QMS and its processes
- Improvement related to customer requirements
- Resource needs to support the QMS.
My Customer Wants Us Certified to AS9100, HELP!
You are a small business owner who has just been told you must become certified to AS9100 in order to continue to receive business from your largest customer. You have been putting this off for some time, hoping you would be able to wait until the economy gets better. Now what, you have a deadline and you haven’t got a clue how to get there from here? The best advice, find a competent consultant and get some training to the standard.
Those organizations who recruit good consultants get the job done roughly twice as fast. By helping you avoid mistakes, a good consultant can help you get the job done faster. But only a good consultant can do this. Not all consultants are created equally, and it is important to select a consultant that is right for you. A reputable consultant works hard to ensure that you fully own your quality management system at the time of registration. Key services you will require, if you have no idea what you are doing or how you will do it are as follows:
1. Required documentation development and implementation
2. Training: Quality policy and objectives, Management review, Corrective and Preventive action, Internal auditing, AS9100 Overview, Risk analysis, Overview of the Complete QMS, Collecting and analyzing data.
3. If software is being used to facilitate and run your quality system, you will also need training and implementation services for this.
4. Implementation of a competency, awareness and training program, internal audit, corrective and preventive action programs, management review and overall continual improvement programs.
5. Conduct internal audits for entire system (all processes), one high level internal audit to the AS9101C checklist in preparation for registration audit.
This is just a short list of services that you may need to accomplish your goal of certification to AS9100. Depending on the size and complexity of your organization and processes more may be needed. A good consultant can help you determine your individual needs.
Quality Management Software
With the size and complexity of some supply chains, it is no wonder that organizations struggle with how to implement and control this process. Many small business owners have been asked to provide proof of this control by their customers. The question is, how?
If you are struggling with how to manage your supplier management program there are now software applications that can assist you with this task. For example, CIS Software can eliminate the time and money of issuing Supplier Report cards or Performance Reviews. Watch this YouTube video for some great information on how to better manage this process. CIS Software
ISO 9001: Verification of Effectiveness?
What exactly is verification of effectiveness? Many organizations struggle with this quality management requirement. When you are verifying the effectiveness of a corrective action you are seeking evidence that the causes of the problem have been removed or reduced. In a perfect world, each problem cause would be removed. This however is not always possible. Sometimes the best you can hope for is a reduction of the causes. The cause is still there, but it manifests itself less frequently or less severely. So the best option is to remove the cause, but the next best option is to at least reduce the cause.
The key to verification of effectiveness is evidence. You are seeking objective, factual evidence that your problem causes have been reduced or removed. This evidence usually takes the form of data or records. Another powerful form of evidence is your own first-hand observations. That’s not to say that you can’t accept verbal evidence, but records, data, and first-hand observations are certainly better and more easily audited. To improve your current corrective action process make sure that each time you act to correct a non-conformance, you go back and verify that what you did actually accomplished what you set out to do, “ remove or reduce the problem”. Some software applications available today can greatly aid an organization that is struggling with this requirement by prompting the responsible individual to review the corrective action taken so that a decision can be made as to the effectiveness of that action. Let’s face it, today small business owners are concerned about where each dollar is being spent and what the pay back will be. Software is one of the best ways to add value when organizations are continuing to down size.
ISO 9001 A Marketing Advantage
With competition in the marketplace today, customers are looking for better suppliers, and certification can make a difference. ISO certification gives you a recognized, readily accepted business credential. It provides a means for delineation in the market. Talk with your sales and marketing teams, customers, and trade groups to determine what certification means to them.
Many customers require certification. As a minimum, they require ISO 9001, but many are moving to the industry sector standards that have increased requirements, like AS9100, and RC14001. To become a preferred supplier, or even bid on contracts, you may be required to be certified to 9001 or other standards. In this case, certification has a clear and quantifiable value. Use the information you gather to put a solid plan in place based on your business, requirements, resources, and timing. If you wait until you have to do it to save business or get that one new, big customer, you endanger the effective implementation and real benefits to your business operations.
If you are not sure how to go about implementing an effective quality management system, there are plenty of competent business management consulting firms that can help. In today’s world, a small business does not have the resources to invest like larger businesses, so they wait. This puts the small business at a distinct disadvantage for growth. But the good word is, you don’t need to spend an arm and a leg or invest huge amounts of time and resources to reach your certification goal. So don’t let what you have heard stop you from moving forward.
Why Use Templates To Document Your Business Mnagement System
So why would anyone want to a documentation derived from ISO 9001 templates or AS9100 templates that a business consulting organization has developed? I can think of at least three good reasons to start with a templated system if you are a small to midsized organization:
1. Money
2. Time
3. Resources (People)
Let’s face it; a small business today has less of all three of these assets. A documented system based on set of proven tempated procedures that meet all of the documentation requirements for ISO 9001 or AS9100 would absolutely save an organization in all three of these areas. Using these templates an organization can adapt them to meet their business process needs and catapult them to the next stage which is training and understanding.
ISO 9001 Some False Interpretations
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There are many different interpretations of the ISO 9001 standard (and some are absurd). In an effort to highlight some common misunderstandings we will highlight some of these myths, urban legends or perceptions of different requirements that may still exist.
Perception: Implementing and maintaining ISO 9001 is expensive.
False: it does not have to be expensive at all! Simply document your management system based on what you already do and put in place the programs required to improve upon them and you are pretty much done. The sooner you set up your management system and use it, the more cost savings you will enjoy. The ROI will be very quick!
Perception: The ISO 9001 system is a Quality System (belongs in the quality department or is the responsibility of the quality manager), or many organizations feel they need to hire somebody full time to manage the ISO 9001 system (internal audit coordinator, corrective action coordinator, ISO coordinator, etc.).
False: the ISO 9001 system covers your entire business starting with customer requirements, review and acceptance of those requirements, executing those requirements, measuring and monitoring your processes to ensure you are meeting those requirements and then, ultimately delivery of a product or service that meets those requirements to ensure customer satisfaction. If only the quality department is responsible for ensuring the above, then I suppose everyone in the company should work for the quality department.
CIS: Continuous Improvement Software
CIS is a program that helps businesses of all sizes with managing the elements of their organization, and ensuring the business complies with ISO 9001, NADCAP, and FAA requirements. It’s a good idea for all businesses to have a CIS consultant, whether an appointed employee, or an outside auditor. CIS training is available from several sources online, and with this training, an individual can become CIS certified and able to approve businesses under CIS standards. Having a CIS consultant at the company with certifications is an invaluable resource. With CIS in place, it’s much easier to achieve full market potential, and ensure the business runs smooth at all times and isn’t diverting funds to costs that don’t make a whole lot of sense. CIS makes sense because it’s paperless, and doesn’t require a whole lot of resources or time with an experienced CIS technician at the helm.
Sending an employee, or spending money on a CIS training seminar is a great idea that will come back to the employer tenfold. There’s no end to what businesses can accomplish when they’re running at max efficiency due to well implemented CIS.
Supplier Management Software Solutions
Controlling Your Supplier Base Using CIS – Large corporations may not have a need for CIS Software for their own applications because they generally have an integrated information system that has been in use for many years that meets their requirements for management and quality assurance. However, their system does not integrate with their supplier base and does not provide for a complete control over their suppliers other than simple reporting of nonconformities, engineering approvals and purchasing.
Most larger corporations have a supplier control department that will audit and approve suppliers to ensure that the suppliers are capable of meeting their stringent requirements. Additionally, the supplier control department will monitor and perform periodic audits of the suppliers to ensure continued conformance to their specifications.
This approach, although effective in controlling the quality, is very expensive when the travelling expenses and time to audit is factored into the overall cost.
CIS Software offers the larger corporation as well as small business a solution that is more effective and far less costly. If the suppliers to a large corporation are using the CIS Software, then the supplier control department can perform electronic audits of their systems far more often without the huge travelling expense. CIS will also offer immediate reporting of supplier issues and their resolutions.
Improving Business Processes
Both small and large businesses can continue to benefit from improving even the most mundane business processes. When a business is built from the ground up, there are often dozens or even hundreds of expenses that are taken for granted. This is even more apparent in governments, which are like massive businesses with thousands of different arms and subsidies through which funds are funneled. But even the smallest businesses will have a few processes that can be improved upon. To identify these processes, it’s best to implement quality improvement software, and task an individual (inside or outside the company) with finding business process improvement opportunities. Often finding processes which can be improved upon involves auditing to find costs that could be irrelevant or put towards better use in other areas of the country.
It’s important to note that marketing and research and development are the two forces that drive a company to succeed; these are the two forces within all companies that provide an increase in revenue rather than serve as an expense. Quality improvement can find more funds to dedicate to these two sources, and even help run the business smoother.