Posts Tagged ‘Root cause analysis’
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.
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 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.
AS9100 Root Cause And Corrective Action
Root cause corrective action for nonconformance’s has long been a requirement in theaerospace industry as stated in the AS9100 standard. It is a process of determining the causes that led to a nonconformance or event, and implementing corrective actions to prevent a recurrence of the event. The requirements for corrective action have been imposed on the aerospace industry for decades and while not new, may not have been aggressively enforced.
Corrective action begins with clearly defining the actual problem. While this may seem simple,many recurring nonconformance’s result because the wrong problem was solved, only the result was fixed, or only one problem was corrected when there were really two or more problems. In order to fix a problem, it must be clearly and suitably defined. Frequently, the nonconformance identified is not really the problem, but the symptom of the problem.
The best ways to arrive at the true root cause of a nonconformance is collect and analyze data that will support your conclusions. There are many tools and methods to collect data that can aid in problem identification. Among these tools are software solutions which can collect and graph information for ease of analysis. AS9100 software applications can help your organization clearly and accurately identify the root cause of a problem, so that you can implement corrective action that will resolve and prevent the problem from reoccurring in the future.
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.
.
NONCONFORMANCES ARE GOOD THINGS!
You want everyone to generate them and you want lots of them! Yes you will have to sort through some outlandish stuff, but underneath will be a treasure chest full of continual improvement opportunities that make the organization work more efficiently and cut costs.
Senior Management listen up – you need to get comfortable with the fact that your workers probably know about a lot of the things going wrong in your organization, and that they know about some you don’t. You need to create an environment where they will tell you about them.
And here’s an even more outlandish suggestion Senior Management – they probably know how to fix many of them as well. You need to listen to them by providing an opportunity and method for them to tell you.
This does not mean that your employees know what’s best for your company and you should do everything they say, but it is a greatly underutilized source of information which is often found to be right on target.
A great way to capture this information so you can sort through and find the meat, is through the application of software. Your CIS consultant can assist you in simplifying your data gathering. Whether you are looking for a tool to help you better organize a quality management system such as iso 9001 or as9100 this is a great low cost high performing tool.
Preventive Action “What If”?
Many organizations struggle with how to determine what constitutes a preventive action. To determine what should trigger a Preventive Action investigation, ask the question “What If”.
- What if weI only have one piece of equipment?
- What If we only have one set of tools for a critical process?
- What if we only have one person with the skills to do a certain process?
- What if one of our key suppliers goes out of business or is destroyed by a natural disaster?
Any of these criteria may point you to a potential opportunity for a preventive action. When investigating a preventive action it is important to identify all the risks and costs of having the problem and weigh it against the likelihood of it happening. The benefit to the process and or company if you were to implement the improvement and the legal and ethical reasons for implementing the action regardless of the cost or potential benefit should always be considered prior to implementation. ISO 9001 software and as9100 software packages can aid you in collecting and evalateing this information you gateher from this prcess.
Common Misconceptions of Preventive Action
Corrective Action Preventive Action (CAPA) is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or prevent from occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall quality management system (QMS).
A common misconception is that preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy.
Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk aversion). Corrective and Preventive Actions both include investigation, action, review, and further action if so required. It can be seen that both fit into the Plan Do Check Act philosophy as determined by the Deming – Shewhart cycle.
Increasingly these days, the aerospace industry is driving it’s suppliers to perform better and better. By continuously focusing on prevention and jumping on correction, some companies are rising to the top and securing larger portions of the business. Your CIS software consultant can help you achieve your goals and satisfy your as9100 auditing requirements. This as9100 software will blow your competition out of the sky.
Preventive Action When and How
A preventive action is a change implemented to address a weakness in a business management system that is not yet responsible for causing nonconforming product or service.
Preventive Actions cannot be determined until the direct, causative, and root causes have been identified. When determining a solution, remember that there is no single right answer. The solution should be chosen on its effectiveness, feasibility, suitability 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. Good tool for exploring and determining the best alternative is called “The Five Whys”. Five Whys is the Japanese philosophy of repeatedly asking why to find not only the direct sources of your problems, but also the root of those sources. It’s about thinking long-term and looking both ahead and behind, not just in the present. It is also important to correct the process from a long term perspective 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.
Candidates for preventive action generally result from suggestions from customers or participants in the process but preventive action is a proactive process to identify opportunities for improvement rather than a simple reaction to identified problems or complaints. Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results.
The focus for preventive actions is to avoid creating nonconformances, but also commonly includes improvements in efficiency. Preventive actions can address technical requirements related to the product or service supplied or to the internal management system.