Defining the Problem

The understanding of the problem is the critical first step in the CAPA process. If you don’t understand the issue, you can’t determine the proper or all root causes and you may not make effective changes–and even if you do make effective changes, they may not be as comprehensive as required.

The first step in understanding is defining the problem. A good practice here is to write down the problem statement. A documented declaration of the problem helps ensure you understand the starting point.

Consider the Source

The next step is to consider the possible sources of the problem. A good tool for helping understand this is the Fishbone diagram – force yourself to determine if people, process, equipment, materials, environment, or management could contribute to the problem. Remember that you’re not solving the problem here; your goal is to understand.

Consider the Scope

Next, consider the scope. Maybe you use the same equipment to make multiple parts but are only seeing problems on one part. You should still consider the possibility that the equipment COULD contribute to problems on other parts made with that equipment. Maybe you have some documentation failures in one area. You should look at the other areas to see if they could be occurring there also. Assessing scope is also critical to being able to ensure all root causes are identified AND that changes will be effective.

Consider Why the Problem Happened

Consider why the problem escaped detection (if it did). Maybe there could have been upstream checks (or maybe the upstream checks were ineffective). This is especially key for software where defects are so much more costly to fix in the latter stages of the process.

For example, if a design review of an interface specification could have prevented a failure found in verification testing, it would have been much cheaper to fix. Think about the earliest stage the problem COULD have been found when trying to understand the issue.
As always, document your findings. This not only helps in compliance but also helps downstream folks working on the CAPA.