How many times have you done something and immediately wished you could undo it? Or how many times have you wished you could know the outcome of something before it happens? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA). In principle, following best practices in CAPA leads to effective remediation and the avoidance of future problems. In practice, this looks a little different.
CAPA more often resembles a sci-fi movie about time travel. The hero goes back in time to prevent something awful … and makes things worse. So, he or she goes back in time again to fix it … and makes things worse. Everything the hero does has unintended consequences. Often the ramifications are huge and change the course of history. If your CAPA process resembles this dizzying process, you need better effectiveness checks.
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What are effectiveness checks? An effectiveness check is the measure and determination that the corrective action has (or has not) eliminated the problem. They’re ways to ensure your corrective or preventive action does, in fact, correct or prevent. Verification and validation are examples of effectiveness checks. Verification consists of actions taken beforehand to make sure remediation plays out as expected and validation is done after implementation to ensure the solution worked.
By the time you’ve reached this part of the CAPA process, you’ve already completed your investigation, determined what you believe to be the root cause of the problem, and settled on an action that you believe will solve it. This is where that time traveler mindset usually sets in. If you’ve settled on a course of action, why not just do it and see what happens? Because you might be wrong. Save yourself a bunch of trips through time by looking ahead at what’s likely to happen and determine how you’ll measure success.
Verification is where time travel would really be beneficial. You could just go forward a few weeks and see the results of your actions. Next to a flux capacitor, the best way to predict the future is with proper planning and data. For example, you can conduct a non-invasive test or experiment and see if the result is what you expected. You can look at the specifications, design and requirements to build confidence that the solution will work. If you have the right kind of data, you can use predictive analytics to see the likely outcome. All this is done before you make major changes. Doing this beforehand lets you see any potential problems that need addressing.
Validation takes place after you’ve implemented the action. This is the point at which the time traveler has a “What have I done?” moment and races back to fix things. When you properly verify, you don’t have this moment. You should’ve already determined what will constitute success. You need a measurable goal to see if your action worked and you should specify a time period for how long you’ll monitor it. After seeing how the solution performs, you can determine if there are any other problems that you didn’t anticipate and if you need to make additional changes to the process.
The number one best practice for effectiveness checks is to do them. Especially verification. This step is frequently skipped over because of the aforementioned time traveler mindset. To help overcome this mindset, here are some other CAPA best practices as applied to effectiveness checks.
Best practices for effectiveness checks also indicate that they’re not just for CAPAs. Instead of quickly trying to solve a major problem, verification and validation can be used to constructively make continuous improvement. As part of general change control, effectiveness checks are essential.