Posts Tagged ‘preventive action’
ISO 9001 Follow-up For Effectiveness
The ISO 9001:2008 stand requires follow-up for effectiveness when corrective or preventive actions have taken place. Many companies do a great job of identifying corrective and preventive actions, some even excel at following through and completing these actions. But where most organizations fall short, is following up to see if what they have enacted, actually had the desired affect and corrected or prevented something from happening again or in the future.
Some organizations do follow-up for effectiveness, but never take the time to record the results of this activity. There are several areas in the ISO 9001:2008 which actually require follow-up actives take place:
1. Section 8.2.2 Internal Audit states 
follow-up actives shall include the verification of actions and the reporting of verification results.
2. Section 8.5.2 Corrective Action states that a documented procedure shall be established to define requirements for reviewing the effectiveness of the corrective actions taken, and records of the results of actions taken.
3. Section 8.5.3 Preventive Action states that a documented procedure shall be established to define the requirements for reviewing the effectiveness of the preventive actions taken, and records of the results of actions taken.
If you are certified to ISO 9001 or some other quality management system, my question to you is this; Why wouldn’t you want to know if the time and energy you put into implementing a corrective or preventive action actual paid off? If you are going to invest the time and money to have a quality management system which is certified to a standard, shouldn’t you get something out of it? Without the data to support your decisions, aren’t you just spinning your wheels?
ISO 9001 and Training: What Do I Need to Know?
ISO 9001 is not just satisfying the documentation requirements and your of and running. Training everyone to the standard and their part in the process is key to your success. If everyone in your organization has a working knowledge of the requirements and process of becoming certified, you can begin to develop the roles and responsibilities and the documentation. Once you have identified the roles and responsibilities and have developed the necessary documentation, you need to begin the training to each of the defined processes.
Here is the best part, by developing a robust training program you can reduce the amount of work instructions required to manage your processes. . The amount and extent of an organizations documentation, above and beyond the required documentation called out in the standard, is directly related to the amount and extent of the training an organization provides to its work force. This is not to say that you will not need some work instructions. Some training that you will need to consider while implementing your quality management system:
- ISO 9001 Introduction
- Corrective/Preventive Action
- Root Cause Analysis
- Introduction To Process Mapping
- Documentation Training
- Internal Auditing
- Quality Policy Training
- Job Specific Training
- Management Review Training
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?
Root Cause Analysis and Continual Improvement
Root cause analysis is a class of problem solving methods aimed at identifying the root causes of problems or events. The practice of root cause analysis is based on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is hoped that the likelihood of problem recurrence will be minimized. However, it is recognized that complete prevention of recurrence by a single action is not always possible. Thus, root cause analysis is often considered to be a repetitive process, and is frequently viewed as a tool of continuous improvement.
Root cause analysis, initially is a reactive method of problem detection and solving. This means that the analysis is done after an event has occurred. By gaining expertise in root cause analysis it becomes a pro-active method. This means that root cause analysis is able to forecast the possibility of an event even before it could occur.
A well implemented quality management system will include training and understanding of how root cause analysis tools and techniques can be used to promote continuous improvement.
ISO 9004 Satisfying Customer Needs
The upcoming revision of ISO 9004 is based on the principle that satisfying customers may bring success, but to sustain success organizations need to delve much more deeply and satisfy the needs and expectations of all interested parties. This attempt suggests applying quality management principles to the quest of sustained success in an organization, but nothing new is added by way of quality management principles. It is implying that sustained success can be accomplished by intelligent use of the eight quality management principles through a system of hands-on managed processes that:
- Continually monitor and analyze the organization’s environment
- Define the needs and expectations of interested parties
- Establish and maintain a mission, a vision and values consistent with the needs and expectations of interested parties
- Deliberately set out, implement and communicate a strategy and policies for fulfilling the mission and vision which supports the values
- Identify, provide and manage the internal and external resources needed for the accomplishment of the objectives in the short and long term
- Provide products that will continue to meet the needs and expectations of customers and other interested parties, continuously.
- Regularly monitor, measure, analyze and review the continual success of the organization
ISO 9004:2009 Self Assessment
ISO 9004:2009 allows organizations to enhance the quality of product and service delivery to their customers by promoting self-assessment as an important tool to enable organizations to:
- Benchmark their level of maturity, covering leadership, strategy, management system, resources, and processes
- Identify their strengths and weaknesses
- Identify opportunities for either improvements or innovation, or both.
The self-assessment tool may become a key element during the strategic planning processes in any organization.
“The objectives of customer satisfaction and product quality are extended in ISO 9004:2009 to include the satisfaction of interested parties and the performance of the organization. The combination of ISO 9001 and ISO 9004 will allow you to get the most of your quality management system.
ISO 9001 Return On Investment
The ISO 9001standard is not designed to tell you how to run your business, but instead give you a basis to comply with the requirements in a way that best meets your specific business goals, requirements, needs, and environment, etc. On the range from “no quality system” to “world-class quality system,” an ISO 9001 quality management system is a starting point roughly in the middle. It is not in itself going to radically change someone’s business. It is however a place to begin and many industries have used it as such. Aerospace, automotive, and chemicals are a few examples of industries that began with ISO 9001 and added additional requirements for their suppliers and partners. Many companies do the same. They begin with ISO 9001, learn, improve, and continually build on their management system.
Should you implement an ISO 9001 quality management system? And, should you certify your ISO 9001 system? As companies undertake the initiative, they look for the benefit and return on investment. A quality management system that is ISO 9001 certified provides discipline, improves processes and increases the productivity and effectiveness of the companies’ operations. Consistent, reliable, well documented quality management systems result in reduced scrap and waste, less human errors, and therefore increased profitability and customer satisfaction.
What Must An Organization Do To Have An EMS That Meets The ISO 14001 standard?
The ISO 14001 standard requires that an organization put in place and implement a series of practices and procedures that, when taken together, result in an environmental management system. ISO 14001 is not a technical standard and as such does not in any way replace technical requirements embodied in statutes or regulations. It also does not set prescribed standards of performance for organizations. The major requirements of an EMS under ISO 14001 include:
A policy statement which includes commitments to prevention of pollution, continual improvement of the EMS leading to improvements in overall environmental performance, and compliance with all applicable statutory and regulatory requirements.
- Identification of all aspects of the organization’s activities, products, and services that could have a significant impact on the environment, including those that are not regulated
- Setting performance objectives and targets for the quality management system which link back to the three commitments established in the organization’s policy (i.e. prevention of pollution, continual improvement, and compliance)
- Implementing the EMS to meet these objectives. This includes activities like training of employees, establishing work instructions and practices, and establishing the actual metrics by which the objectives and targets will be measured.
- Establishing a program to periodically audit the operation of the EMS
- Checking and taking corrective and preventive actions when deviations from the EMS occur, including periodically evaluating the organization’s compliance with applicable regulatory requirements.
- Undertaking periodic reviews of the EMS by top management to ensure its continuing performance and making adjustments to it, as necessary.
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?” |
|
| 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? |
|
| 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.
Steps To Corrective Action
Immediate corrective action is really a misnomer. It is really a description of what was done after the problem or event was discovered. What actions were taken to contain the problem and stop it from continuing? If you were making bad parts, what did you do to stop making bad parts and what did you do about the bad parts you made? Immediate Corrective Action is where you describe the extent of the problem and the action taken to assure no other hardware is affected and that all affected hardware is identified.
After the problem/event is contained, the causes must be identified to prevent recurrence. The direct cause is the source that directly results in the nonconformance. Contributing causes are those that left unchecked, bring about the direct cause but on their own, may not have sufficient power to result in the incident taking place. Root Cause is simply the last reasonable cause in the chain and the essential logical change necessary to prevent a recurrence.
The impact of the incident is where you describe what impact the nonconformance actually had. recommend if hardware was impacted or not and tell us how you determined this. Failure to comply with contractual requirements constitutes an impact on hardware. If the product was (or may have been) impacted, be certain to include information and objective evidence on customer notification.
Preventive Actions cannot be determined until the direct, contributing, and root causes have been identified. When formulating a solution, remember that there is no single right answer. The solution should be chosen on its effectiveness, viability, appropriateness to the company, and the company’s budget. Solutions should not be rushed into. Rushing can cause additional problems. It is best to think about alternatives before choosing a solution. It is also important to correct the process from a long term viewpoint instead of focusing on the short term. If the solution is only focused on the short term, there is no point in performing a corrective action.
Objective Evidence needs to be provided to verify that Preventive Corrective Actions were put into place and that they are effective in preventing recurrence. Your CIS Consultant can help you develop the tools to capture this information and analyze it to continuously improve your business management system.
.