For many years, we’ve been conducting remediation projects for organizations of different sizes from around the world. From our experience, one of the most common causes of regulatory issues is one that can be addressed in house with proper training – effective root cause analysis of CAPA’s.
We’ve seen widespread poor use of this technique – usually because bad advice is passed down the quality hierarchy and the problem is not properly or effectively analyzed. This almost always leads to the same mistakes being made over and over again. Successful organizations are those who provide effective RCA training and adopt a forward thinking approach to prevent quality failures in the future.
In the majority of cases, the “5 Why’s” tool is mostly used; however Ishikawa charts, Cause and Effect Diagrams and Statistical Data Analysis are quite common – it’s always a good idea to use a combination of these simultaneously for top results. Also, depending on the complexity of the issues requiring attention, sometimes it may take more or less than 5 Why’s to fully explain a problem.
When using the 5 Why’s, two different problems must be confronted at the same time:
- Why was the problem made
- Why wasn’t it detected?
It is imperative that the issue must be clearly stated in order for it to be correctly resolved – this is your first why. The second why should provide a clearer statement to back up your first.
You reach a very critical point on your third why, and the temptation here is to make a decision on a course of action based on issues that are suddenly being discovered. It’s important to keep an open mind.
When you reach the fourth and fifth why’s, it becomes likely that you have found your root cause, but it is still possible to be dealing with process causes – keep going if so. You will know that you’ve successfully identified the root cause of your problem if you can use all the information in one sentence and be able to clearly understand it.
So, the message here is simple - clearly define your issue, keep an open mind and remember that it’s an exercise in identifying the root cause; it doesn’t solve the actual problem itself.