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Sal Lucido

FDA Compliance

Savvy Compliance Strategy, Part III

Tracking problems

Published: Thursday, July 22, 2010 - 09:01

In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also showed how 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.

Figure 1: The circle of compliance

Let’s now take a closer look at the “track problems” step. The primary goal of this step is to collect and analyze data related to operational problems. This is a vital prerequisite for the next step in the process: improve. Remember our overall goal is to systematically and continuously improve regulatory compliance. So let’s first take a look at collecting data.

Collecting data about operational problems sounds like an easy task, but it turns out to be anything but. First, there is a cultural stigma associated with anything labeled as a problem. This is because where there is a problem, there is blame. And where there is blame, there are consequences. Given the fact that we are talking about consequences associated with someone’s livelihood, this is not something to take lightly. Therefore it is important to set a “tone from the top” that lets employees know the data will be used to improve operational processes and not punish employees. It is also helpful to ask employees to suggest improvement ideas. I’ve even seen some companies acknowledge and reward employees for suggestions that result in positive actions. These are all good ways to encourage problem reporting. You want to tip the scale in favor of logging problems as shown in figure 2.

Figure 2: Logging problems

The next question is, “What data should we be collecting?” Some data are better than no data. Waiting to create the perfect system will result in the loss of valuable information that could have alerted you to looming problems. So at the very least, start collecting data any way you can.

I have seen hundreds of problem-tracking forms spanning many processes and industries. I’ve created product-issue forms, process-problem forms, out-of-spec forms, suggestions forms for industries regulated by the Food and Drug Administration, North American Electric Reliability Corp., and the U.S. Securities and Exchange Commission. I’ve summarized four design tips in the figure 3.

Figure 3: Problem-tracking form design tips

Now that you are collecting problem data, what should you do with it? The high-level steps for processing issues are: identification, investigation, immediate actions, analysis, and planning for further action as seen in the flowchart in figure 4.

Figure 4: Problem-processing flowchart

Identify. Collect problem data from all sources. Route these to someone who can determine immediate actions and investigate the problem.
Investigate. Look into the problem beyond the initial problem report. Look for trends from other sources (e.g., employees, vendors, customers) and from similar products and problems.
Immediate actions. This step may be performed in parallel with or before the investigate step. Determine if there are any immediate actions that need to be taken to contain the problem. While you are looking for root causes, you don’t want the problem to grow or continue to do damage.
Root cause analysis. This is different from the initial investigate step in that you now are trying to determine what actually caused the problem. During the investigation, you may determine that the problem was a result of operator error. But the root cause analysis may reveal that the operating procedure is unclear and is, in fact, the root cause of the problem.
Plans for further action. Once you have established the root cause, you can take actions to improve operations. In this step, you would plan out what those improvement actions will entail, who will implement them, and how long they will take to enact. Typically this corrective action project requires management approval to allocate the required resources.

One benefit of this process is that a single corrective action project can provide a solution that addresses multiple problems as illustrated in figure 5. The next step is to improve operations through implementing the corrective action project. We will take look at that step in the next article.

Figure 5: Investigation funnel




About The Author

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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