Posts Tagged ‘corrective action’
Steps to Effective Corrective Action
Most organizations do not take the time to really determine effective corrective action. The knee jerk reaction to a non-conformance is to fix the symptom. When we take the short cut to correct a significant non-conformance we ultimately doom ourselves to repeat the same mistakes over and over again, until we actually correct the root cause. How do you go about getting to the real cause (root cause) of a non-conformance? There are several steps that can help determine “why” something went wrong. Using these steps will simply the corrective action resolution process and add real value to your quality management system.
- Identify the non-conformance and document it (Describe what went wrong).
- Take immediate action to contain the problem (This is containment not the ultimate corrective action).
- Determine the root cause for the discrepancy (Why did this happen). Don’t jump to conclusions at this step. Take the time to ask pointed “Why” questions, and answer them until you get to the ultimate cause. Most organizations never get to the real cause because they are in a hurry to close the action out and move on. Take your time, think it through; the answer you should almost never come to should be human error. If someone makes a mistake the next question should be “why” did they make this mistake? Don’t put a Band-Aid on the problem; fix it or I grantee it will come back.
- Now that you have determined the real cause you will need to but a corrective action in place to resolve, (prevent), the problem from reoccurring in the future. Implement the action and close the corrective action out.
- Last, and very important, you need to go back at a later date after you have implemented the corrective action and verify that the action actually had the effect you intended. If the action was effective you have successfully completed the corrective action process and have implemented a meaningful resolution to a problem. If the action did not resolve the issue you will need to go back and start the process all over again until you come up with an action that does effectively eliminate the issue.
Corrective and preventive actions are the backbone of your continuous improvement process, done right you can make significant improvements to your organization.
ISO 9001 Internal Auditing What, When, How?
Most companies understand the idea of auditing but not the concept of “Process Auditing” as expected to be compliant within both ISO 9001 and their own quality management system. Even companies that are currently registered to the standard may not have a thorough means for evaluating its processes through their internal audit program. Which processes are expected to be audited under ISO 9001?
The ISO 9001:2008 standard is quite vague as to what should to be audited or even how often these processes should be reviewed. The standard indicates that audits be carried out at planned intervals to determine whether the quality management system conforms to the planned arrangements, to the requirements of the standard and the organizations own quality management system requirements. So what is an appropriate interval for your company? Ask yourself,” What is the worst that can happen and where could it happen”? Where are we having the most problems now? Look at your interrelationship of processes and pinpoint the likely areas that have the most chance of resulting in non-conformance. Conduct a risk assessment to determine where the highest risks are, and which risks may produce the most significant impact on your product performance (Status and importance of the processes). Now audit these processes, interview staff, observe activities and view relevant records then determine if there are weaknesses and assign corrective actions. Go back to these areas after the corrective actions are put in place and determine if the actions have accomplished the desired effect. If the actions are effective, close out the audit and move on to the next process.
Don’t audit a process for the sake of having an audit record to show an auditor. If a process is functioning properly it does not need to be audited once a year. Nowhere in the ISO 9001 standard does it say you have to audit all of your processes once a year. You are in the driver seat, and you will determine what, when, and how you will audit your system.
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?
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.
WHAT IF WE DON’T PASS THE ISO 9001 REGISTRATION AUDIT?
There are basically three things that can happen in a registration audit:
- Your company may “pass ”the iso audit, (in official language, your company will be “recommended for registration”), in which case the company will receive its official registration in about a month.
- Your company may be told that a follow-up visit must be scheduled and that if corrective action on all nonconformities found during the audit is successfully completed by that visit, registration will be issued.
- Your registrar may find that your company has quite a bit of work to do before it will be ready for registration, and another registration audit will have to be scheduled.
In all cases, the registration auditor will report all findings to your management before he or she leaves, so that your company knows where it stands.
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?” |
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| 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? |
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| 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.
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Supplier Quality Management
Due to recent economic, safety and security issues, supplier quality management has emerged as one of the leading business practices in recent years. Today it is imperative for manufacturers to make significant investments in systems and processes to improve supplier quality. For instance, companies in the aerospace, food, and industrial products arena, need to preserve their preferred supplier status to continue to be considered for future business. As a result, they are under pressure to ensure that their products continue to meet or exceed acceptable quality levels and Corrective Action thresholds set by their customers. Therefore, managing their supplier’s quality is mandatory for these companies.
Supplier Auditing is an excellent tool to ensure that suppliers are following the processes and procedures that you agreed to during the selection processes. The supplier audit identifies non-conformances in manufacturing process, shipment process, engineering change process, invoicing process and quality process at the supplier. Once the audit is completed, the supplier and customer jointly identify corrective actions which must be implemented by the supplier within an agreed-upon timeframe. Continued surveillance audits ensure that these corrective actions have been successfully implemented.
Managing Changing Expectations: Part 2
It was clear to me when at the height of the fuel prices I drove by two automotive dealers in my small town. The GM dealer’s lot was full of large SUVs, Pick-up Trucks and Cadillacs while the Toyota Dealer’s lot was full of the Yaris, Corolla, Prius, Matrix and very few Pick-up Trucks and SUVs.
While consumer’s expectations had changed, Toyota had the products available that met their expectations. In fact, I myself only buy American and called the GM dealer asking about the new Malibu Hybrid that was advertised and the sales person told me that they have not even seen one and do not know when they will receive one.
I believe that it is the attitude of management and the lack of visioning that resulted in this type of crisis. This scenario is not limited to only larger corporations and in fact, it is more critical in small business management systems that do not receive financial assistance when they fail.
Attitude is something that starts at the top of an organization and flows down to the very bottom. The following are two examples of how attitude can make such a huge difference:
- 1. Every quality/management system includes an element for corrective action. How often do managers resent or even become aggravated and angry when a corrective action is issued to them? Their attitude often suggests that receiving a corrective action reflects negatively on their performance within the organization. However, this is not the case! In fact, it is quite the opposite. When a problem occurs, management establishes key personnel who they feel have the skill sets, experience and management focus to address the problem, determine the root cause and implement an effective long-term solution. This speaks to itself. Therefore, rather than having a negative attitude when receiving a corrective action, managers should understand that the reason they were selected to receive a corrective action is that the executive management has the confidence that they can resolve the issue. That is a compliment and not a negative benchmark on their performance.