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Kari Miller

FDA Compliance

Five Necessary Steps to Maintain a Reliable CAPA Process

CAPA systems require continuous management, effectiveness checks, and support

Published: Thursday, July 27, 2023 - 11:03

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.

These problems can be solved with CAPA systems. CAPA processes are necessary to maintain and improve the quality of products as well as to remain compliant with regulations. They provide structure for finding and solving the root cause of an issue. The intent of the CAPA process is to assist medical device or pharmaceutical companies in eliminating nonconformities, deviations, or complaints. Noncompliance can also present itself in the form of quality management system (QMS) or process failures.

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

The FDA requires CAPA systems, and they are a critical focus during quality audits or inspections. FDA 21 CFR 820 Subpart J is the quality system regulation that requires CAPA processes to be documented in medical devices, and ICH Q10 is the respective regulation for pharmaceutical manufacturing. They require established and maintained procedures for implementing CAPA processes. Similarly, ISO 9001:2015, while not specifically calling out preventive action, does detail the fundamental principles and concepts of quality management, and includes actively identifying, documenting, removing, and mitigating any risks.

These systems are more than just requirements; they are tools that allow manufacturers to improve quality and avoid future risk. They provide a wealth of product quality information, but few companies truly leverage these procedures and guidelines to the full extent. Efficient and reliable CAPA processes can shorten cycle times and improve patient outcomes while preventing and resolving issues quickly to maintain compliance with all regulatory requirements.

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

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.

1. Document the CAPA process

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.

2. Pinpoint risks by leveraging trends

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.

3. Strengthen failure mode and root cause analysis

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.

The goal of the analysis is to correct and prevent in the long term, rather than just fixing the immediate issue. Preventing the reoccurrence of the problem is the purpose of CAPA systems.

4. Maintain involvement

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.

Other involvement should include stakeholders, customers, employees, and suppliers. These stakeholders will have different points of view, providing new information and insight.

5. Act

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.

In the life sciences field, patient safety is a top priority; any quality-related risks that may arise for medical devices or pharmaceutical products must be addressed quickly and accurately.

CAPA processes can provide long-term solutions to quality issues, improving product quality while shortening cycle times, maintaining compliance, and fostering a culture of continuous improvement. However, without a reliable CAPA system with the ability to measure effectiveness, organizations may find themselves facing repeated, otherwise preventable quality issues that ultimately lead not only to compliance issues but also patient concerns and negative effects to brand reputation.


About The Author

Kari Miller’s picture

Kari Miller

As regulatory and product management leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction and delivering industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated life sciences market. She also is responsible for the quality compliance product road map, product partner relationships, and overall product direction. Miller earned bachelor’s degrees in business administration and psychology from Marian College, Fond du Lac, Wisconsin.