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Sal Lucido

FDA Compliance

Savvy Compliance Strategy, Part IV

Closing the circle of compliance loop

Published: Monday, October 4, 2010 - 08:03

Figure 1: Closed-loop process for managing regulatory compliance

In Part I, Part II, and Part III of this compliance series, I have described the benefits of using a closed-loop process for managing regulatory compliance (illustrated in figure 1).

Readers of this series have learned that setting up key performance indicators (KPIs) that monitor performance to goals is a good way to check that processes are working properly, thus reducing the need to perform manual audits of a given operation. We also looked at how to collect and process problem information, thus ensuring that the right information is collected, the problem is contained, and that the root cause is identified. This sets us up for the next step, which is to fix the problem by executing a corrective and preventive action (CAPA) project.

The primary goal of this step is to implement changes that correct (corrective action) the problems and prevent recurrence (preventive action). This is where we get our payoff; this is where we “close” the loop. Remember, the overall goal is to systematically and continuously improve regulatory compliance. The inputs that we will need to execute the CAPA project are show in figure 2.

Figure 2: Corrective action inputs

Problem scope: Determine the boundaries of the problem we are trying to solve. Trending helps determine the scope. If the scope is too narrow, the project will not address all of the future potential issues. If the scope is too broad, the project may be too time-consuming and expensive.

Root cause(s): In the previous step we determine the root cause or causes. Check that the corrective actions taken in the project address all of the causes.

Project schedule: Determine how long this project is expected to take or how long you want to allow it to take. Time is money. This will guide your resource loading decisions.

Project costs: Determine the overall project budget. Include all labor and material costs.

Determining the root cause or causes is a crucial part of the process. Here are two effective methods for making this determination. The eight-discipline workflow shown in figure 3 is optimized for larger, multimember team projects.

Figure 3: Eight-discipline workflow

The 5 Whys methodology shown in figure 4 is an effective technique for separating symptoms from causes. The example in the diagram illustrates this process.

Figure 4: The 5 Whys. Five or more iterations of asking “why” are generally sufficient to get to a root cause.

Once you have all of this information you can execute the CAPA project. The CAPA project outputs are shown in figure 5.

Figure 5: Corrective action outputs

Action items: Define and assign each task that needs to be completed. Unassigned tasks never get done.

Due dates: Refer to your project schedule and consider the order in which to execute the action items to set target due dates for each task. With team projects, each member reports on progress toward the due dates. Missing a due date is a symptom of problems with the project (i.e., not enough resources, unclear tasks). Address these to keep the project on schedule and budget.

Document changes: If you don’t change the process or product—which are documented in your procedures or specifications—then you are not improving your operations. Remember what Einstein said, “Insanity is defined as doing the same thing over and over again and expecting different results.”

Notification and training: If a tree falls in the forest and no one is around to hear it, does it make a sound? The same can be asked of CAPA projects. If processes and products are changed and no one is notified or trained on these changes, did we make an improvement? I know the answer to the second question… no.

Verification: Check to make sure the project goal was achieved—solving the problem. This step usually takes place some time after the project is completed. Coordinate and schedule the verification criteria before closing the project.

And there you have it—we have closed the loop. We have described how a closed-loop process—defined by what I call the “circle of compliance”—is used to automate a process that continuously “pulls” the operations toward meeting regulations. By replacing a manual audit and check routine with this process, your company saves time and money while improving its ability to comply with industry regulations. This is the definition of a win-win situation.


About The Author

Sal Lucido’s picture

Sal Lucido

Sal Lucido is vice president of enterprise solutions at AssurX Inc. headquartered in Morgan Hill, California. Twitter him at  http://twitter.com/ComplianceTips