Root cause analysis help needed!

Since I have no view into what has actually happened in your implementation it is not really possible for me to do a 5 Why analysis, even as an example. For instance, apart from identifying that the starting problem is that you “did not have a process for making minor changes to controlled procedures”, I do not know the cause of this. Is it because you didn’t think it was needed? Is it because you didn’t think this process needed to be controlled? Did you think uncontrolled work instruction was acceptable?

As you can see, without knowing your full details I cannot really give you a 5Why analysis. I can only point out that the process you need to go through from your initial statement is identifying why this problem happened. Then you ask why that cause happened and proceed until you get to the root cause of the problem; the purpose of which is to do something about that root cause to prevent the issue from happening again.

You can learn more about how corrective action works in the aerospace QMS in the article:

• Complete guide to corrective action vs. preventive action https://advisera.com/blog/2021/07/19/complete-guide-to-corrective-action-vs-preventive-action/