The Importance of Root Cause Investigation and Effectiveness Checks in Corrective Action

ISO standards and industry regulations require medical device organizations to have a corrective action process. But it’s not enough to just have one—it must be efficient and effective enough to handle issues in a fast-paced and high-impact industry.

Here, we’ll examine two major components of corrective action systems—root cause investigation and effectiveness check—and how to strengthen them to optimize processes.

Corrective Action vs. CAPA: What’s the Difference?
Despite precautions and trainings, issues can (and probably will) still happen. When there is a deviation, nonconformance, or other problem, what is done next makes the difference between a quick resolution and a full-blown recall or injured patients. This is where organizations need to implement either corrective action or Corrective and Preventive Action (CAPA). Some people think these are interchangeable, but they are in fact slightly different.

Corrective action aims to immediately correct the issue and identify how to prevent a recurrence. This may include addressing the issue identified, determining the scope of the issue, containing the affected product, and correcting the immediate problem.

Preventive action aims to eliminate the occurrence of an event in future products by evaluating product and process designs and controls. More simply, it is an evaluation and complete elimination of all risks during product development phases. This definition better aligns with new standards, as “preventive action” has been moved to a risk management function. Therefore, CAPA has shifted to corrective action under ISO 9001:2015 and will be referred to as such in most cases.

Recurring Issues: What Causes Repeat Problems?
The same or similar issues repeatedly coming up is usually an indication of a problem in the corrective action process. A weak corrective action system is often due to a fault in one of the two main components: the root cause investigation and effectiveness check.

Without those two functions, corrective action merely addresses surface problems, but doesn’t go any deeper to find the systemic cause. Think of the adverse event as an injured person—bandaging a wound will stop the bleeding, but will not heal the cut. Strong root cause investigations and effectiveness checks are essential in building the proper corrective action system and ensuring that action plans truly solve the problem.

A common mistake in corrective action is confusing a symptom with a root cause. Hasty investigations do not assess the issue thoroughly enough and only uncover the results of an issue. For example, if a part breaks on a machine and leads to nonconforming products, the first reaction would be to remove the affected products and fix the machine parts. But a true root cause investigation would go further and ask why the machine broke. Perhaps an employee was not properly maintaining that machine and needs to be retrained, or conditions on the floor lead to additional wear and tear and must be adjusted.

Just as an improper medical diagnosis leads to improper treatment, an improper root cause investigation provokes the wrong corrective action plan.

Effectiveness checks are supposed to confirm a corrective action plan was successful and preventive controls will be effective moving forward. But they often fail when either the metric used to determine the effectiveness did not yield an acceptable result, or the verification was delayed or missed altogether.

Without a good effectiveness check, there is no way to know if the root cause issue was actually corrected. The good news is there are a few simple steps to improve root cause investigation and effectiveness check processes.

1. Identify the Proper Corrective Actions
One simple way to streamline the factors in corrective action is to change the way corrective actions are used altogether. This is a twofold process. The first part involves determining what actually needs a formal corrective action launched. Sometimes, surface level issues arise that do not warrant full investigations. The second part deals with prioritizing issues that need corrective actions. Use risk-based filtering tools to prioritize corrective actions that pose the biggest threats, rather than handling them only chronologically. This works best for two reasons:

• When impacts are greater (as is the case with high-risk events), there are more residual symptoms. Therefore, it is more difficult to determine the root cause. What is left is a guessing game where one can only hope that the right issue is addressed.
• Similarly, it is more difficult to determine the effectiveness of a corrective action plan when high-impact issues get out of hand and lead to further issues.

Knowing when to issue corrective actions and how to prioritize them will permit better root cause analyses and effectiveness checks.

2. Dig Deeper into the Process
“What caused the problem?” is not a deep enough question for a root cause analysis. Following are some steps to take to dive deeper and discover the true root cause.

• Look into related investigations to identify larger patterns.
• Route the investigation to other team members to get more eyes on the issue. They may catch a pattern or detail that was initially missed.
• Understand the issues in their context, rather than in isolation, to see how other factors contribute.
• Integrate root cause with employee training to see if there is a training gap that could lead to repeat issues.
• Integrate root cause with supplier management to see if the issues are supplier related and give them a secure channel for resolution.

Going beyond surface level evaluations provides insight into what exactly caused the issue and what foundational changes can be made to prevent similar problems.

3. Verify Effectiveness Thoroughly
Most people think the work is done once the corrective action is planned and executed. But verifying the effectiveness afterwards is a crucial step—without it, there would be no way to know whether the issue was fully or properly addressed. These two tips can help to drastically improve the way a corrective action’s efficacy is verified.

• Check results against the criteria outlined in the action plan. When planning the corrective action steps, define a clear metric to use as a measure of success. Going back to ensure this metric is met is crucial. If the necessary metrics were found not to be met, review the action plan to see where it can be improved and repeat as soon as possible.
• Calculate the new risk associated with the current state. Risk is an excellent measure of how effective corrective action is because it quantifies the measure of severity and frequency. Measuring the change in risk from before and after the corrective action gives a reliable, quantifiable measure of effectiveness. The corrective action can be considered effective if the risk is an As Low as Reasonably Practicable (ALARP) level or As Low as Possible (ALAP) level depending on the organization’s standards and process requirements.

Without thorough verification, there is no way to truly tell if a corrective action addressed the right issue to the proper extent.

4. Use Problem-Solving Techniques
Corrective actions are necessary because a problem has occurred. Therefore, using problem-solving techniques can help get to the bottom of the issue and make a solid plan moving forward. The downfall here is people often use an insufficient problem-solving technique, so the plan they develop is weak.

Many people employ the “firefighting” technique for problem solving. This technique treats symptoms with the short-term focus on getting the product back out. This would mirror the bandage in the previous example—masking the symptoms, but not actually healing the wound. Using this approach leaves processes susceptible to repeat incidents.

A more successful and thorough approach would encompass problem and loss awareness. A common method is the “plan-do-check-act” method, which can be further broken down into seven steps.

1. Define the problem and determine the objective of the corrective action. Ask “What is the issue?” and “What would be the ideal outcome?”
2. Analyze the problem and find out why it happened. Keep digging deeper until the ultimate root cause is reached.
3. Generate potential solutions, each with the goal of addressing the root cause and the corresponding symptoms.
4. Select the most efficient solution for the company’s resources and best addresses its issues. Plan the fix, alerting all involved personnel.
5. Implement the solutions and carry out the action plan.
6. Evaluate the result—did the plan address the root cause? This is a good place to use risk assessment to determine the effectiveness. If risk was not lowered to an acceptable level, implement one of the other solutions considered, repeating until the issue is completely addressed.
7. Once a successful plan is found, standardize it and maintain the control. Make the corrective action part of the everyday process so the incident does not repeat itself.

A complete and systematic problem-solving technique ensures corrective action and effectiveness checks are well thought out, complete, and effective.
Some organizations only have a corrective action system because ISO standards mandate them for medical device companies. But having a subpar system can come back to haunt companies when issues arise.

Taking the necessary steps to improve root cause analysis and effectiveness check procedures will pay off in the long run. In the fast-paced world of the medical device industry, it’s important to handle issues as quickly as possible—and eventually, prevent them altogether. A strong corrective action process comprised of a root cause analysis and an effectiveness check can help to do just that. 

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Alexa Sussman is a marketing content writer for EtQ. She is responsible for developing and writing content for EtQ, a leading enterprise quality and compliance management software provider.