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First, consider a different approach. The first question to ask when implementing a corrective action system is why? Most answers will be to comply with ISO 9001 or to improve processes. Well, the best answer is to avoid having to discuss and deal with the same failures repeatedly so that we can discuss and deal with our successes and fortunes!
Second, decide if implementing a corrective action system should be a race against time or if it should be treated with patience and understanding so that it results in an effective system for all concerned - customers and suppliers included.
Finally, an approach and a plan must be created and this is where we differ. What would happen if every single person in the company were trained on corrective action and root cause analysis? I mean fully trained! Not a thirty-minute seminar but real training that will be the foundation for your improvement system. I will now refer to the quality management system as “the improvement system” because that is what it should be. It should never be stagnant and should always be changing and improving. When we use the term quality system, it tends to give us the impression that we have it and that it is something in place. The real problem is the term itself seems to indicate that the goal is to acquire the quality system itself and once acquired that we have accomplished our goal. That does not seem to fit our real goal of avoiding those meetings to discuss failures and problems on a continual basis.
So from now on, we should have a new goal to achieve our objective. That goal should be to create and implement an improvement system. With this goal in mind, we now have something to sink our teeth in to and we have something small yet powerful. We now have something that just might eliminate those corrective and preventive action meetings we dread. Now we have one focus: improvement.
It is funny how one word can change the game. However, I firmly believe that it does. If we were to implement an improvement system, then we would be required to train everyone in the company on the tools necessary to accomplish improvement in all processes. These tools would be:
1. Reporting Problems;
2. Performing a root cause analysis using one of many tools such as a why-tree analysis;
3. Containing the problem at hand;
4. Implementing an effective corrective action, and
5. Follow-up on the corrective action periodically to ensure continued effectiveness;
When we implement an improvement system, we would be addressing actual problems within the organization and not perceived problems following the guidelines of the ISO 9001:2000 model for quality assurance. In fact, after the implementing an improvement system, I believe that in a short time, all elements of ISO 9001:2000 will be addressed. Again, this is just common sense. Below are a few examples that demonstrate this approach:
Problem: Manufacturing worked with an obsolete specification that resulted in product rejection from the client.
Root Cause Results: The organization does not have a system for document and data control.
Corrective Action: Create a system to control documents and specifications that ensure that all documents are current and that obsolete documents cannot be used.
Comment: This would be the beginning of addressing ISO 9001:2000 Element 4.2.3 – Control of Documents.
Problem: Customer rejected product for dimensional failure.
Root Cause Results: A Vernier Calliper used by inspection was worn and its accuracy was +/- 0.003 inch when it should be +/- 0.001 inch. This was because there was no system in place that would periodically inspect the accuracy of the instruments.
Corrective Action: Create a system to periodically inspect measurement instruments to ensure that they are always meeting their standards for accuracy and that we have these results to show the client when measurement accuracy is questioned in the future.
Comment: This would be the beginning of ISO 9001:2000 Element 7.6 – Control of Monitoring and Measurement Devices.
As you can see from the above example, the longer we work with an Improvement System, the closer we get to achieving our objective and achieving a system that would eventually conform with the ISO 9001:2000 Standard. The real difference is that:
1. The solutions were created by existing personnel in a collaborated effort (home grown);
2. The solutions were to address real problems that they can put their hands around;
3. Motivated personnel implemented the solutions since they were solving their own problems;
4. The solutions will have a better chance to succeed;
5. The system is based on improvement; therefore, there is no ending point!
By implementing an improvement system, we ensure that the system continues and that it never is stagnant. We ensure that problems are always addressed, solved and that their solutions are effective and that proper follow-up is performed on a continual bases. In fact, this follow-up in itself forms the foundation for ISO 9001:2000 Element 8.2.2 – Internal Audit.
A colleague of mine, Bretta Kelly has written an excellent article titled “ISO is not Rocket Science” that should be read before starting any new ISO 9001 project. A copy of her article may be requested by e-mail at email@example.com.