Corrective Action and Preventive Action (CAPA). Posted by Rob Packard on July 1. The author describes five tools (Five Why Analysis, Is/Is Not Analysis, Fishbone Diagram, Affinity Diagrams and Pareto Analysis) and how each one can help conduct effective root cause analysis. Quality problems are like weeds.
Because the people responsible for the corrective actions, (CAPA), were not adequately trained on root cause analysis. Adequate training on root cause analysis requires three things: Courage to admit that your process is broken. Learning more than one tool for analyzing problems. Practicing the use of root cause analysis tools.
If your auditor identifies a nonconformity and you disagree with the finding, then you should not accept the finding and state your case. If an inspector rejects a part and you believe the part is acceptable, then you should allow the part to be used .
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Sometimes the problem is that . I recommend pausing a moment and reflecting on what your auditors and inspectors are saying and doing. You may realize that you caused the problem. Once you have accepted that there is a problem, you need to learn how to analyze the problem.
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There are five root cause analysis tools that I recommend: Five Why Analysis. A . I have read about this, used this tool, and taught this concept to students; but I learned of a critical instruction that I was missing when I read Toyota Under Fire (http: //bit.
Toyota. Under. Fire). In that book, Jeff Liker makes the following statement, . One of the instructors was from Pathwise, and he explained the . A few years later, I learned that this tool is actually called the . This method involves asking where the problem is occurring as a potential clue to the reason for the problem. For example, if the problem only occurs on one machine, you can rule out a lot of possible factors and focus on the few that are machine- specific.
The reverse approach is also used to help identify the cause. You can ask where the problem is not occurring. This approach may also lead you to possible solutions for your problem. For example, if the problem never occurs on first or second shift, you should focus on the processes and the people that work on the third shift to locate the cause. Other names for this diagram are. If a problem is occurring in low frequency and has always existed, this might not be your first tool.
However, I typically start with this tool when I am doing an investigation of nonconforming product. However, I like to organize and categorize the ideas from a brainstorming session into the . This was also the subject of a book called The 8. Principle: The Secret to Achieving More with Less (http: //bit. Pareto. Chart). When you have a large number of nonconformities, you should categorize those problems and organize them into a Pareto Chart. Then you should open one CAPA for the #1 problem, and one CAPA for the #2 problem.
If you get to #3, consider yourself lucky to have the time and resources for it. If you are interested in learning more about root cause analysis and actually practicing these techniques (i. Click here to register for the event: http: //bit. MDAWorkshops. To view a related blog.