One of the most common and important types of quality management measures in clinical research is the Corrective and Preventive Action (CAPA) plan. Learning the CAPA process will provide insight into how corrective and preventive actions are handled, along with creating an effective game plan for your use of CAPAs.
The CAPA template can be used by manufacturers or providers of products, services, or goods who have identified a potential issue that may lead to compliance failures. CAPAs protect clinical research participants, taking into account their rights and welfare during a trial while also ensuring the accuracy and credibility of the data collected from their study experiences. Meanwhile, pharmaceutical firms rely on quality as the core of their operations, and one should not lose sight of this fact when implementing CAPAs because, with proper application, high standards will always be upheld.
What is CAPA in Clinical Research?
CAPA plans are essential for conducting clinical trials in terms of minimizing risks to participants and ensuring that their rights, as well as welfare, are protected. Moreover, these plans safeguard the study data by preventing any sort of breach affecting safety and efficacy, which is essential for upholding high-value research. Incorporating CAPAs in an organization allows for identifying the root cause of problems that arise, thereby preventing recurrence and providing effective project management.
Several basic steps constitute the CAPA process:
- Detection: The first step is to detect a potential concern. It all starts with a dissection of the issue in terms of its history and its consequence.
- Root Cause Analysis: Identify and perform a deep dive investigation of the root cause of issues. To do this, one must ask how the problem came to be.
- Prevention: As always, the next step after identifying the root cause is to determine how you will prevent this issue from surfacing again. This means enacting steps for improvement.
- Documentation: Finally, we need to document the whole process in a structured, sequential way. This provides an evidence trail that secures an implemented CAPA plan.
Corrective Actions
These are immediate responses taken to correct a problem/quality issue which has already occurred. One vital method involved is the utilization of tools such as the 5 WHYs to investigate whether a particular problem that arose was incidental, or if it might lead to some serious impacts in the future (more about this below). Important considerations when establishing corrective actions include distinguishing between real and perceived problems and understanding how big the problem is. Situation-specific details regarding a CAPA plan’s use must be recorded once any corrective action has been made. This documentation serves as a future reference while ensuring that corrective actions can be validated as working as intended and that duplicate issues do not occur.
The 5 WHYs Method
The 5 WHYs method is a problem-solving tool where you ask “Why?” five times to find the root cause of an event. In this example, the cause of a site coordinator’s failure to ship a blood sample is being investigated by a sponsor:
- Sponsor’s Q: Why did the site coordinator fail to ship out a routine blood sample? Site’s A: She forgot.
- Q: Why did she forget? A: She was doing something else.
- Q: Why was she so occupied with other activities? A: She had two trials to manage.
- Q: Why was she tasked with two trials? A: The site was understaffed at the time.
- Q: Why is there a staffing shortage at the site? A: Your budget for hiring is too low.
In this process, we found the root cause: Due to the limited staff recruitment budget, the site coordinator was overburdened and ultimately forgot about shipping the blood sample. Identifying the root cause allows for a proper corrective action that helps avoid a resurgence of the same issue later.
Preventive Actions
Preventive actions are performed to get rid of the root causes of real or potential defects and keep them from leading to first-time or repeat problems. This involves preparing a full-blown contingency plan—your risk profile for what could happen or potentially go awry. Everyone who has a task or role in reaching a resolution for a defect through preventive action should approve this CAPA plan (principal investigators, research coordinators, quality assurance managers, other site staff, etc.). That way the CAPA has a high chance of preventing a variety of future quality problems and not just any single problem.
The U.S. Food and Drug Administration (FDA) offers information about the design and use of CAPA plans for medical devices, which are also addressed in Subpart J of 21 CFR Part 820 in the Code of Federal Regulations. Details on CAPA within the Pharmaceutical Quality System are also available from the FDA.
Conclusion
To sum it up, CAPA plans represent a critical quality management system implemented in clinical research to close compliance issues and prevent their recurrence. With the central CAPA process, clinical research sites can maintain quality control and mitigate risk for participants by identifying areas of protocol non-compliance. Using corrective and preventive actions, in addition to proper documentation and validation, ensures that quality problems are fixed in a time-efficient and cost-effective manner. Develop and adopt your own CAPAs if you haven’t already to achieve better quality in your clinical research organization and greater success in your clinical trials.
Contributed by Viswakanth Makutam, PharmD, MS, ACRP-CP, a Clinical Research Quality Associate and volunteer peer reviewer for ACRP’s Clinical Researcher journal
