Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483 observations and warning letters cite Corrective Action / Preventive Action (CAPA) incident management deficiencies.
Every Life Sciences company needs to have an effective CAPA system in place to minimize risk and ensure compliance with regulations, but maintaining an effective CAPA process can be challenging. Challenges can occur at every step of the CAPA process and it requires vigilance to ensure that they don’t derail the process and expose the company to unnecessary or excessive risk.
Here are the top eight challenges of CAPA systems and processes:
- CAPA Silos: The biggest challenge Life Sciences companies find themselves caught with is a siloed CAPA system (or multiple CAPA systems) in which the data in the CAPA system(s) cannot be effectively shared across the company or cross-referenced with other data. This makes it hard for companies to link related problems and even harder to generate metrics and perform trend analysis on elements like products, problem types, root causes, costs, and more. These companies need to break down their CAPA silos to achieve a single, managed, integrated and complete view of the process – and enable a common way for them to do trending and put preventive action in place across the company.
- Complex Processes: The first step of effective CAPA systems is to create and document the process. However, companies often make the mistake of trying to build every potential exception condition or possible incident into the CAPA system which makes it too complex for people to understand and follow. Complex systems lead to slow resolution and aging CAPAs because people are unsure of the next steps. Instead, CAPA systems and processes need to be simple, yet comprehensive and they need to include a process for escalations and exceptions that provides guidelines but doesn’t necessarily dictate specific steps that may not be appropriate in every case.
- Lack of Documentation at Every Step of the CAPA Process: When people are in a hurry to resolve an issue before it escalates, they naturally tend to focus on taking the action rather than documenting the reasoning behind the action. Part of an effective CAPA process should be full documentation at every step; your people don’t need to write a novel before every action, but they do need to record what they are doing and why. Be careful not to let documentation lag the CAPA process because you can lose valuable information; however, employees need to answer the who, what, when, where, how and why questions for every step.
- Confusion between a Corrective Action and a Preventive Action: A Corrective Action generates a solution to issues that have already occurred. A Preventive Action looks for solutions to problems that might occur. Don’t fall into the trap of thinking that every problem and every process change needs to have a CAPA to justify it. That will bog down your system and critical actions may not get resolved as quickly because of it. Instead, ensure that people understand the distinctions between corrective actions and preventive actions, and that they reserve them for actual or potential incidents.
- Imprecise Language: If people can’t state the problem succinctly, the team will be unlikely to resolve the issue or even to measure results of their actions. People often try to jump ahead to possible solutions when defining the CAPA or they get emotional in their description. Neither choice is conducive to rapid resolution, so don’t tolerate sloppy problem definitions. Make sure team members are trained in writing simple, concise problem statements that highlight the difference between the current state and the future state. When people know the starting and ending points, plotting the route and measuring progress are much simpler. It also makes it simpler to determine relative priorities and risk associated with each incident of non-conformance.
- Jumping to Solutions: This is often a direct result of imprecise problem statements. When people jump to conclusions about the solution to the problem before fully defining and investigating the issue, they may make “corrections” that don’t correct anything. Instead, companies need to insist that every problem statement answers the “who, what, when, where, how and why,” as well as the frequency and severity of the effects of the problem. Don’t let panic about compliance cause people to rush through the steps, because you may end up addressing the symptoms rather than the causes of the problem.
- Insufficient Process Training: After CAPA processes have been sufficiently defined, companies need to make sure to train employees in the proper steps and procedures. Many companies train people to follow the rote steps, but they don’t provide training in precisely defining the problem or how to determine the severity of an issue. As a result, the CAPA system bogs down with aging or unnecessary corrective actions and preventive actions that remain open due to either insufficient resources or sheer bafflement about the actual issue. CAPA systems and processes require in-depth employee training, and frequent re-training, in order to remain effective and compliant.
- Inconsistency in Applying the Process: Many companies today have multiple sites, often in multiple countries or regions. This requires extra diligence to ensure that all sites react the same way and apply procedures the same way. One of the worst situations you can have is having each site following different processes or treating equivalent incidents differently. Companies can prevent this problem with extra training (as mentioned above), and by implementing a centralized CAPA system that connects departments and locations. Don’t believe any statements that “we’re different” unless you investigate and agree that one site should be an exception. If there is a reason for a different process at a facility, document it and make it part of the corporate process.
It requires vigilance to ensure regulatory compliance, but effective CAPA systems and processes should be an important part of your compliance arsenal. When used correctly, your CAPA systems will help you resolve non-conformances quickly and minimize risk.
Our solution’s Corrective Action Preventive Action (CAPA) Incident Management ERP software capabilities enable you to increase control and assuredness for how your organization operates. With Merit for Life Science, you can generate a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. This CAPA tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of problems. It also enables companies to improve brand loyalty and customer satisfaction by continuously improving quality and responding quickly to potential incidents.