Avoiding a Time Traveler’s Mindset With Effectiveness Checks


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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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Effectiveness Checks in the CAPA Process

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

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

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.

Best Practices for Effectiveness Checks

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.

  • Adaptable: The process for your effectiveness checks should be consistent, but also adaptable to any situation.
  • Risk-based: What you choose to do for verification and validation needs to be based on risk. A high-risk change warrants more effectiveness checks and more expense.
  • Effective: This doesn’t just apply to verification and validation themselves; it also means that your process leads you to the right answer.
  • Efficient: While you certainly need enough time and data to fix the problem, effectiveness checks shouldn’t run on for so long that they hinder your company or become a drain on resources.

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.

Conclusion

Time machines might not exist, but effective ways to foresee the future do. Using effectiveness checks — both verification and validation — can indicate if your CAPA will perform as expected. Verification serves as an important point where you can ensure the benefits of the solution outweigh the potential problems and validation is when you see the fruits of your labors. By adapting these best practices you can turn a frantic CAPA process into one that lets your company continually improve.
2019-bl-author-sarah-bealeSarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, website landing pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Her areas of expertise include the nutraceuticals, cannabis, and food industries. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.