Posts Tagged ‘business process improvement’
ISO 9001 Horror Stories

Some of the horror stories about ISO 9001 implementations include companies who have binders of procedures, work instruction, and forms (generally with a layer of dust on top) and have been trying to implement ISO 9001 anywhere from one to five years unsuccessfully. Some have spent fifty-thousand dollars and others more than two hundred-thousand dollars on internal resources and/or consultants. Some have had a prior quality manager that wrote a management system for them and then left the company and no other employee knew how to continue the quality management system requirements. Some have gone through three quality managers each of them defining, adding to the last management system, or changing requirements that result in confusion.
In many instances, we find that companies who have invested considerable time and money in the process of certification that they have a hard time letting go of it even when it has proven not to be effective or useful for them. A company must decide if they want to chase bad money with good money when faced with this problem. If you are one of these companies, consider letting the existing management system go and documenting a new and effective management system from scratch.
How many of you have an ISO 9001 implementation horror story to tell. The fact is there are far too many of you. This is your opportunity to share your story with other organizations that are just starting out. Sharing your story may help someone else avoid the pit falls of your experience and reap the rewards of your eventual success. Lets not act like capital hill, now is the prefect time to show solidarity and help our economy move forward. With each success there is a certain amount of blood sweat and tears that goes along with it. If it is possible for us to help just one organization become stronger by our lessions learned, this is the time and form to share.
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?
Your Internal Auditing Process, Does It Hurt Or Help Continuous Improvement?
A Quality audit is the process of organized inspection of a quality management system carried out by an internal or external quality auditor or an audit team. It is an important part of organization’s quality management system and is a key element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly-defined internal quality monitoring procedures linked to effective corrective and preventive actions. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards a process approach of the actual effectiveness of the Quality Management System and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined objectives, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.
Internal audits should always be performed with the intension of improving the overall systems being audited, never as a fault finding or witch hunt practice designed to punish. If internal audits are properly executed with a spirit of open communication and real process improvement, this process can be the single most important driver for continual improvement. Done wrong, the internal quality audit processes can create a culture of fear which will hinder continual improvement. It is important that everyone within the organization clearly understands the objectives of quality auditing and their role in them.
Does Your Corrective Action Process Really Work?
When a deficiency in your quality management system is discovered, is it documented and thought of as a good thing? One of the most common problems I have encountered as a third party auditor and consultant is the fear of Nonconformance’s. During initial presentations to a company, particularly if I have senior management in the room, I will ask about their corrective action process, how it’s working for them and how many nonconformance’s they document in an average month. A typical answer is a very proud indication that they have a great corrective action system and they generate very few nonconformances. That is a self-contradicting statement.
Chances are very good that nonconformances are seen as a bad thing in these companies and the person responsible for this horrible offense is hunted down and profusely reprimanded for such callous offenses. Does this sound familiar?
Let me set those who still feel that nonconformance’s are bad, THEIR NOT! If you find 3 things going wrong within your organization this week, and resolve them so they never happen again, do you think you have improved your company’s performance? Hello McFly, guess what the bonus is – there’s a pretty good chance you will improve your bottom line as well! So get out there and find as many nonconformances as you can. You have nothing to lose and everything to gain. Remember, the whole idea is to continually improve your products and processes so that you can compete and grow.
ISO 9001 Don’t Survive, Thrive!

Why is it that when times get tuff most companies invest most of their time and money in short term short sited goals? The ultimate goal of any company should be more than just survival; it should be forward thinking total sustained success. How can a company reach for and attain sustained success with the economy in such distress? The best way is to invest in continuous process improvements that result in cost reductions and increased market share.
Becoming certified to the industry standards that your industry leaders are requiring is the surest way to stand out and get noticed. If your competition is already certified to ISO 9001, AS 9100, RC 1400, ISO 1400 or some other industry standard, they have a decided advantage over you and how much more business they will receive as a result of this certification. If you are certified, how well you manage your business processes can help or hurt your progress toward sustained success.
Many companies go after certification to satisfy a customer request or simply because they believe it the right thing to do. However, the majority of the organizations that embark on the road to certification, go into the process ill equip and ill informed. The result of such endeavors usually produces a business management system which may ultimately result in certification, but offers no advantages and becomes just another expense to absorb.
My advice, get educated, hire a competent business management consultant if you fell you need one, and make your business management system your own. Every business is different and so each business management system should be unique as well. Don’t waste hundreds of thousands of dollars and years of consulting fees to reach you goals. Take ownership of your system and make it a transparent part of your everyday work experience. When a well designed business management system is implemented, it is effortless and provides real tangible benefits that result in sustained success. Don’t survive, thrive.
Software applications To Better Manage Your Environmental Processes
Lets talk about the “G” word, Green technoloy. Software applications will be one of the top ways that companies will better manage their green management processes. You not only save a tree, but you also improve your entire business management system at the same time.Elements of your environmental program such as the environmental aspects and impacts are all managed using our preventive action module, special requirements and objectives for improvement.
In fact, this software provides excellent template procedures with CIS that meet and exceed the requirements of ISO 14001 and RC 14001 for Environmental, health, safety and security to help you fast-track your system! These template procedures are easy to modify to suit your specific needs and they all work with the CIS Continuous Improvement Software.
What better way to start an environmental program than to eliminate those blue boxes by eliminating paper completely?
ISO 9001 and 8D Problem Solving

8D is a problem-solving methodology for product and business process improvement. It is structured into eight disciplines, emphasizing team synergy. The team as whole is better and smarter than the quality sum of the individuals. Each discipline is supported by a checklist of assessment questions, such as “what is wrong with what”, “what, when, where, how much”.
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The Eight Disciplines |
| 1. Use Team Approach
Establish a small group of people with the knowledge, time, authority and skill to solve the problem and implement corrective actions. The group must select a team leader. 2. Describe the Problem Describe the problem in measurable terms. Specify the internal or external customer problem by describing it in specific terms. 3. Implement and Verify Short-Term Corrective Actions Define and implement those intermediate actions that will protect the customer from the problem until permanent corrective action is implemented. Verify with data the effectiveness of these actions. 4. Define and Verify Root Causes Identify all potential causes which could explain why the problem occurred. Test each potential cause against the problem description and data. Identify alternative corrective actions to eliminate root cause. 5. Verify Corrective Actions Confirm that the selected corrective actions will resolve the problem for the customer and will not cause undesirable side effects. Define other actions, if necessary, based on potential severity of problem. 6. Implement Permanent Corrective Actions Define and implement the permanent corrective actions needed. Choose on-going controls to insure the root cause is eliminated. Once in production, monitor the long-term effects and implement additional controls as necessary. 7. Prevent Recurrence Modify specifications, update training, review work flow, improve practices and procedures to prevent recurrence of this and all similar problems. 8. Congratulate Your Team Recognize the collective efforts of your team. Publicize your achievement. Share your knowledge and learning. |
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.
ISO 9001 The Process Approach
How often have you heard that ISO 9001 promotes the process approach to managing an organization, and requires the QMS to consider the organization as a series of interlinked processes? What does this really mean in laymen’s terms?
Processes can be characterized as consisting of one or more linked activities that require resources and must be managed to achieve predetermined output. The output of one process may directly form the input to the next process and the final product is often the result of a network or system of processes. Every organization is made up of a series of interacting processes.
The process approach considers the interaction between these processes, and the inputs and outputs that tie these processes together. The output of one process becomes the input of another.
The ISO 9001 Standard is designed to manage and improve those processes.
1. First, you identify your key processes.
2. Second, you define quality standards for those processes.
3. Third, you decide how process quality will be measured.
4. Fourth, you document your approach to achieving the desired quality, as determined by your measurements.
5. Fifth, you evaluate your quality and continuously improve.
Once these are identified, an organization can ensure its processes are effective (they produce the desired output), and efficient (they promote continual improvement and lower cost by effective use of resources). The organizations ability to master the techniques of business process improvement, can help the organization gain a distinct advantage over the competition.
Quality Perspective
Quality is a perceptual, conditional and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly.
There are many definitions and method that have been created to assist in managing the quality-that can have an effect on business operations. Many different methods and concepts have developed to improve product or service quality. There are two common quality-related functions within a business, quality assurance and quality control. Quality assurance is the prevention of defects, such as by the deployment of a quality management system. Quality control is the detection of defects, most commonly associated with testing which takes place within a quality management system typically referred to as verification and validation.
It can be said that validation can be expressed by the question “Are you building the right thing?” and verification by “Are you building the thing right?” “Building the right thing” refers back to the user’s needs, while “building it right” confirms that the specifications are correctly implemented by the system. In some situations, it is required to have written requirements for both as well as formal procedures or Practices for determining compliance.
Preventive actions are happening all the time in the business world, but are probably the least documented aspect of the business management process. Just think, how much more an organization could improve if they actually tracked and reviewed these actions. How many more improvements could an organization realize if they only knew how to use this information?