Posts Tagged ‘ISO 9001 software’
What Are The Inputs and Outputs and Key Measurables Of A Process?
With ever business process that you put in place there are inherent inputs, outputs and key measurable that will help you determine whether or not you are meeting the objectives of the process. You will first need to determine the inputs of your processes, “What are the key aspects of the process that you would like to achieve?” For instance, in your supplier management process what will be your objective? Your objective should be to have approved suppliers. Now, what will you put in place to achieve your objective: Supplier approval criteria, Supplier Evaluation (inspection discrepancies) and Supplier Reevaluation. These will become the inputs to your supplier management process.
Once you have determined the inputs of your process you will next need to determine the outputs of the process. In the example noted above some possible outputs to the supplier management process would be an Approved Supplier Register, and Receiving Discrepancies. These will become the evidence of your approval process objectives.
Once you have determined the inputs and outputs of your process, you must now measure the process to see if it is accomplishing its intended purpose (Approved Suppliers based on the inputs and outputs you have set in place). Key measurable for a supplier management process may include Supplier Performance data reviewed in Management Review (Receiving Inspections), Evidence of the organizations certification to an international standard (A copy of a current ISO 9001 or AS9100 certificate), results from a supplier audit or survey , etc. You must determine how you will measure a supplier’s performance towards your requirements and then keep records to verify their effectiveness at meeting these requirements.
Quality Management Systems Software Advantage
With all of the software packages out there today, it is hard to believe that there are any companies who still design their quality systems on paper. I grew up on the manual paper version of a quality management system, back when there was a whole department dedicated to document control and everyone had a three ring binder full of documented procedures on their desk. So here we are today with ISO 9001:2008, AS 9100 C and various other international standards which do not require reams of paper to be compliant. When a company decides to implement a new quality management system, I don’t believe anyone sets out to create the quality system from hell, but all too often that is exactly what happens.
Why put yourself through all of that pain and unnecessary cost? There are so many software solutions available today that make getting and maintaining your certification effortless. As a management representative for a small company in Arizona, I was able to manage the quality system and carry out the responsibilities of a supply chain manager without adding one more person to the company for the sake of our quality system. How you may ask is this possible? The answer is a fully customizable software application that put all of our processes and documentation in one place. This software is SaaS based and therefore it is accessible from anywhere internet access is provided. All of our employees, key customers and suppliers were able to view and make entries as need and management decisions where determined through the analysis of the data collected by the system. What was most impressive about the implementation process was how easy it was to train everyone to use the system.
As I said before there are literally thousands of software applications for quality management system implementation. The range of products goes from supper high upfront and maintenance costs, to low upfront and maintenance costs. Complicated canned systems with little customization possibilities to easy fully customizable systems are also available. If your company is use to complicated and costly to believe you are getting a good product, then that’s the road for you. If on the other hand you are a small to midsize company with limited resources, (People and Finances), you may be interested in the latter. Do your research well and you can find a system that will work for you and actually deliver a cost savings benefit. Some items to consider:
Costs
- Upfront Cost
- Monthly Support Costs: or
- Yearly Support Costs:
- Does your system include Unlimited Users and Storage and support and revisions and new features.
- Education & Safety Costs
- Cost for Additional Modules
Applications
- Communication System
- Document Management
- Reports and Graphs
- Master Calendar
- Work Orders
- User Preferences
- Nonconformance
- Corrective Action
- Customer Feedback
- Preventive Action
- Near Miss
- Customer Supplied Product
- Inspection
- Management Review
- Internal Audits
- Calibration Control
- Quality Objectives
- Supplier Approval and Evaluation
- Competency, Training and Awareness
- Purchasing
- Job Management
- Special requirements
The Internal Audit and Follow-up for Effectiveness
O.K. now that you have defined your internal auditing process, and have a few audits under your belt, what have you learned that will actually help you improve your organization? Corrective and preventive actions have been assigned, responses have been logged, and actions have taken placed. Did the actions taken, improve the process? This is probably the biggest stumbling block I have seen as a third party auditor, follow-up for effectiveness. Did anyone review the effectiveness of the corrective or preventive action; did it accomplish what you intended? If you do not go back and review the results of the actions taken, you have missed the boat on continual improvement. To merely find areas for improvement without making sure that they have been addressed and actual improvements have been made, is never going to move your company closer to sustained success.
Your business management system can be the best possible way to propel your organization to a new level of profitability and success, use it effectively! Make your quality management processes work for you and you will realize actual benefits that will lower costs, improve cycle times, reduce scrap, and improve customer satisfaction. You can skate by with your paper certificate, but wouldn’t you rather get something for your money?
Time Saving, Money Saving ISO 9001, AS 9100 Alternatives
There are now products and services available that make it possible to work together with one or more of your staff online to create and write or revise the necessary procedures that are required by an ISO 9001 or AS 9100 system. Your staff can be at different locations or even at their own desks within your company. There is no need to meet in a conference room, since the conference room is virtual (on the Internet). This approach reduces costs dramatically and results in a better and more efficient working relationship.
First, this technology makes it possible to work at your pace and at your schedule to meet the project’s deadline;
Second, there are no flight, hotel or meal costs! Huge cost reduction;
Third, you can work with your ISO consultant and multiple managers at your facility or at your facilities across the nation in one meeting;
Training is the most important feature of any management system. The better trained the better performance you can expect from your staff. This technology can also make it possible for your ISO 9001 consultant to provide training online to one or many of your employees at the same time. This training can be at your schedule and because the training is performed online, there is no travel, hotel or other expenses.
ISO 9001 Is Steeped With Myths and Misconceptions
Why do so many companies shy away from becoming certified to ISO 9001? For one thing, ISO 9001 is steeped with myths and misconceptions. Let’s examine some of these.
- Perception: My Quality Manual has to plagiarize the ISO 9001 standard: False, if you have referenced the standard in your manual, why would you need to recreate it again? What would be the purpose? The only requirements stated in the new ISO 9001:2008 standard are: a scope which includes any exclusions you may have, the procedures or reference to the procedures for your management system and complete description of the interaction between the various processes that are required to operate your business.
- Perception: I must have a document (work instruction, flow chart, procedure, etc.) for every process in my company: False, The extent of the documentation that your organization will require depends on the size and complexity of your organization and how well your employees are trained to do their jobs. The only time a procedure is required is when someone cannot do their job without it. If your procedures are collecting dust, get rid of them, they will come back to bite you.
- Perception: Implementing and maintaining ISO 9001 is expensive: False, a quality system done right is both a money saver and time saver. The use of ISO 9001 software and other tools have made the job of implanting and maintaining a well run quality management system an effortless task.
- 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 quality management system belongs to everyone in the organization and can be assigned to any individual within the organization. Many companies assign the plant manager or supply chain manager as their management representative. Keep in mind this system belongs to everyone and everyone must participate to make it successful.
A Better Way to Manage Internal Audits and Management Reviews
Many organizations struggle with how to manage and maintain their internal audit and management review processes. While no one sets out to deliberately miss manage these processes, they can take on a life of their own. So, how do you better manage these processes? The ISO 9001 standard does not expressly tell you how, but it does tell you what is expected. Does the standard say you have to actually meet to satisfy this clause of the standard or does it tell you that you have to review the necessary criteria at set interval? If it were possible for top management to review all of the in-puts and out-puts of a management review and assign actions with follow-up, without actually sitting in a meeting, how much more time could be spent on actually improving your systems?
Meeting/audit module in CIS Software is a powerful management action item tool and may be used for many other functions other than just meetings and audits. Because of its design and ability to assign action items to a manager or group of managers and to follow-up on these action items until completion, this module is truly invaluable.
By using the meeting/audit module, there is no need to hold follow-up meetings to review and ensure that previous action items from a meeting or internal audit were completed. Since holding these follow-up meetings is the normal management approach in most organizations, this module alone will cut your valuable meeting time by more than 30 %.
Furthermore, the meeting/audit module includes special tools for Process Auditing. Since the management meetings are all shown on the master calendar and audits may be scheduled monthly, quarterly or yearly, the internal audit plan is always at the click of a mouse. Furthermore, the auditor and auditee is always informed of these audits on their personal calendar and on the master calendar
Business Management Software For Sustained Success
Business management software has become a great way to improve an organizations business processes and communications while reducing the amount of time and effort it take to manage the system. Years ago everything was done via telephone, in person or by way of formal letter. In the past few years things have become more immediate with the advent of the internet, e-mail and other software applications such as cis software. We are now able to communicate instantly from anywhere in the world, how great is that!
But what are the real tangibles that come with this new technology? Lower costs from reduced travel needs? Faster resolution of critical business issues? Improved communications with customers and suppliers to make the act of doing business more responsive? Or, is it just the knowledge that your overall business management systems are working 24/7 whether you are there or not? My vote would be, all of it. There is no need to struggle with how to implement and maintain a quality management system that not only meets the requirements of iso 9001, or any standard for that matter, but actually reduces costs and improves productivity.
ISO 9001 Software Solutions For Obsolete Documentation
A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration. Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed. CIS software can reduce the need for a system based on the production of hard copy documentation, therefore reducing the possibilities for nonconformance’s due to obsolete documentation use. A CIS consultant can open up whole new possibilities for an organization struggling with document control, and much more.
If the only documentation available for use is always current and all obsolete documents are stored in a history tab (Unavailable for use), then the auditor will never be able to write another corrective action based on the use of obsolete documents. Wouldn’t that be great! And just think, how much time will that save when you no longer have to hunt down all the obsolete documents in your facility before the auditor arrives. Bliss
Preventive Action Is Alot Cheaper Than Corrective Action
While corrective action is the result of something going wrong (an incident), preventive action seeks to identify possible issues before they become failures or incidents. Preventative action is a lot cheaper and is often easier to implement than corrective action – which only happens after the event.
When a possible non-conformity is raised by whatever means, the owner of the area in which it is raised must:
- Determine a solution to reduce the risk identified by completing the preventive action to determine how to reduce the risk to an acceptable level
- Submit the preventive action to management for consideration and if approved it will be implemented.
- If the preventive action is not accepted then the owner of the area must determine another solution to address the issues raised.
CIS software is an incredible tool for implementing and following up for effectiveness of preventive actions. This tool can effectively automate the continuous improvement process of any organization that seeks to stay ahead of the competition and deliver the best possible services and products to its customers.
ISO 9001 vs. Six Sigma
Six Sigma is a statistically-based process that strengthens organizational ability for ongoing business process improvement. “Six Sigma” or “six standards of deviation” endeavors to reduce defects to a rate of 3.4 defects per million defect opportunities by identifying and eliminating causes of variation in business processes. In defining defects or errors, Six Sigma focuses on developing a clear understanding of customer requirements and is therefore very customer focused.
ISO 9001 and Six Sigma serve two different purposes. ISO 9001 is a quality management system, while Six Sigma is a strategy and methodology for business performance improvement. ISO 9001, with guidelines for problem solving and decision making, requires a continual improvement process in place but does not indicate what the process should look like. Six Sigma can provide the needed improvement process. However, it does not provide a template for evaluating an organization’s overall quality management efforts whereas ISO 9001 does.