Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
We often hear that the CAPA process is the “heartbeat” of the quality system. The changes that emerge from the CAPA process are critical to correcting defects, improving business processes, and meeting customer expectations. When you think more about CAPA, you realize that an effective CAPA process hinges on your team’s ability to understand the true cause of each problem you encounter. With that in mind, here are some tips to help refine your root cause analysis process and keep risky problems from reoccurring.
Do: Keep your end goal in mind
In the end, the goal of root cause analysis in not only to fix the problem at hand. It is to understand why the problem occurred so the right actions can be taken to prevent that problem from reoccurring. A root cause needs to be specific, and it needs to be something that can be changed with action. This is the reason why causes such as “operator error” are typically not viewed as true root causes. Operator error alone can’t be fixed — there is an underlying process behind the operator error that contributed to the error. Identifying that process is the key to finding the true root cause, and for recommending the most effective preventive action.
Keeping the end goal in mind can also mean acknowledging that more than one factor may have contributed to a problem. Each of these factors will need to be thoroughly analyzed to create a solid set of recommendations for preventing the problem’s reoccurrence.
Do: Understand the benefits and limitations of your analysis method
The root cause analysis technique you choose is critical to a successful investigation. 5 Why Analysis, Fishbone (Cause & Effect) Diagrams, FMEA, and statistical methods are all considered valid root cause analysis techniques. But have you considered the benefits and limitations of these methods within your investigation process?
5 Why Analysis, for example, is a commonly used technique because it puts cause analysis in the hands of anyone in the organization. This is a great benefit in terms of your quality culture because everyone in your organization is empowered to analyze problems and improve processes. However, the 5 Why approach has limitations that may make it more suitable for low-risk CAPA investigations. These limitations include variations in approach by each person performing the analysis, the lack of data required to reach the root cause, and the method’s focus on finding a single cause for each problem.
Fishbone diagrams and other analysis methods each have their own sets of benefits and limitations. So it’s important to understand which method is appropriate for the problem at hand, and to ensure that your team is prepared to carry it out.
Don’t: Go it alone
There are times when root cause analysis can be a creative process — the cause of a problem may come from an unexpected source. That’s why a team approach to root cause analysis is valuable. Although most root cause analysis methods can be carried out by a single person, there is value in receiving input from team members throughout your organization.
Your organization is likely already using a team approach, at least for major investigations. So take a moment to analyze the makeup of your typical team. Is it cross-functional? Does it contain both people who are affected by the problem and people from outside of the process who can bring a “fresh set of eyes” to the problem? Does your team have the technical expertise needed to analyze the problem? Understanding each of these factors can help you bring in the people who will help you meet your end goal of getting to the correct cause.
Do: Take time to look at the larger picture
Root cause investigations occur over time as defects are found and CAPAs are opened. One important aspect of your investigation is to understand whether the problem has happened before, and which causes have been attributed to the problem in the past. This understanding can help make your investigation more efficient — if the problem is still happening, then the previous preventive actions were not effective. Your internal quality management software is an excellent resource for beginning your analysis of recurring root cause.
Even if you don’t have an open CAPA, quality system data is your go-to resource for analysis of recurring root causes for continuous improvement purposes. You may find that a certain business area, plant area, or process has many root causes attributed to it over time. This view of root cause data gives you a starting point for process improvement efforts.
As you are looking at your data, don’t forget to monitor CAPA effectiveness. A trend toward ineffective CAPAs can be a sign of a weak root cause analysis process. If you’re not getting to the true cause of a problem, you can’t prevent it from reoccurring.
Don’t: Lose sight of the positive
Here’s an interesting take on root cause analysis. Why not use it to analyze the good things that are happening in your organization? You can use the same techniques that you use to find the source of a problem to dig into the reason why certain processes perform exceptionally well. This gives you another opportunity for continuous improvement, which is, after all, a quality professional’s goal.
Do you have any root cause analysis do’s or don’ts? Please share them in the comments below
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- Root Cause Analysis: Addressing Some Limitations of the 5 Whys
- Fishbone (Cause and Effect or Ishikawa) Diagram
- Root Cause Analysis For Beginners (PDF)