Change is the inevitable result of CAPA processes—continuous improvement is the entire purpose of the CAPA regulation. A carefully planned CAPA process ensures compliance, but more important, it provides a platform for continuously improving processes and products. By tying changes or actions back to a specific root cause, organizations can ensure that action plans are focused on identifying and implementing the most effective solution for each nonconformance, deviation, complaint, or other quality event.
CAPA processes aren’t compliant or effective without continuous management support. To lower the risk of receiving an FDA 483, managers need to comprehend and implement all CAPA procedures, and conduct management reviews of appropriate records and data. By maintaining involvement in the CAPA process, managers can leverage these systems to improve patient outcomes, increase customer satisfaction, boost productivity, and safeguard the company brand.
FDA Compliance
Five Necessary Steps to Maintain a Reliable CAPA Process
CAPA systems require continuous management, effectiveness checks, and support
A robust CAPA system, in conjunction with quality assurance programs, can record a problem, verify and assess any associated risks, investigate at the appropriate level, implement corrective and preventive actions, and review their effectiveness. These systems then use this information to take appropriate actions to prevent the reoccurrence of such instances. To have a truly successful and dependable CAPA program, there is a set of comprehensive steps companies need to follow.
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1. Document the CAPA process
4. Maintain involvement
Not every deviation, complaint, audit finding, or supplier failure should require a CAPA, despite heavy regulatory pressure. The time-consuming and expensive mentality that every process must require a CAPA plan can be avoided by using trend analysis and risk management. By monitoring trends and patterns revealed by analysis, it’s possible to tell if a deviation is an anomaly or a component of a bigger problem that might justify a CAPA procedure. Trending can also help prioritize nonconformance for further investigation and highlight small issues before they grow into larger, high-risk ones.
Regardless of source, these nonconformities need to be both corrected and prevented for the future, which is where CAPA is used. Corrective action does as its name implies: It corrects once the root cause is identified. Additionally, eliminating a quality issue’s root cause is a priority of preventive action, which focuses on eliminating possible nonconformities to prevent occurrence.
Corrective actions are a long-term solution to an issue, rather than just an immediate, one-time correction. These actions look to shift the root cause of an issue toward a resolution. Any action must be monitored after implementation to ensure that there are no continuous problems. On the other hand, preventive action looks at what might cause future issues, and that includes procedures that can be improved. While corrective action is reactive, preventive action is proactive.
Regulations and common roadblocks when implementing CAPA processes
A successful CAPA process hinges on the internal team’s ability to properly identify all failure modes for an issue and comprehend the root cause of each. The root cause must be specific, and it must be something that can be improved even if that requires new controls to reduce the risk of occurrence or severity. The efficacy of the CAPA system relies on a clear root cause analysis process; corrective and preventive actions aren’t effective if the root cause isn’t correctly understood.
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An effective CAPA program must be well-planned and organized. It may seem straightforward, but FDA 483 citations for a lack of CAPA process documentation are frequently issued, and they can harm a brand’s reputation and possibly lead to a closure. Prior to adopting a CAPA workflow, several elements must be recorded. These include the processes to be monitored, trends and analytics to monitor, the people to include in the process, overall risk and severity levels and the procedures for investigations, processes for identifying failures and root causes action plans, and effectiveness checks.
Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S. Food and Drug Administration (FDA) inspections, particularly for the medical device industry. Issues can occur while manufacturing medical devices or pharmaceuticals, and when they do, companies must ensure they take all necessary steps to identify and resolve the issue and, importantly, work to prevent it from reoccurring.
One of the challenges in implementing CAPA processes is an ineffective action plan. Each part of the CAPA process relies on the previous step, and an inadequate and underdeveloped plan can cause significant issues. Another barrier is a lack of documentation. Investigations into root cause can be improved with sufficient documentation practices; inaccurate or incomplete records can hinder the entire process and may result in citations. Appropriate documentation will be critical to the successful application of AI and machine learning in your organization’s quality management processes as well. CAPA systems require continuous management and effectiveness checks and support, which can be a burden for quality teams.
Five steps for a reliable CAPA process
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2. Pinpoint risks by leveraging trends
5. Act
Published: Thursday, July 27, 2023 – 12:03