Corrective Action Preventive Action (CAPA) Support

What is CAPA Plan?

The FDA defines CAPA (Corrective and Preventive Action) in its regulation 21 CFR Part 820.100. This regulation mandates that manufacturers implement and maintain procedures to address both corrective and preventive actions. The key components include analyzing various sources of quality data to identify existing or potential quality problems, investigating the root causes of these issues, and determining the necessary actions to correct and prevent them. The procedures also involve verifying the effectiveness of these actions, ensuring they do not negatively impact the product, and disseminating relevant information to those responsible for quality assurance. Additionally, management must review the identified problems and the actions taken. All these activities and their outcomes must be thoroughly documented.

Similarly, ISO 13485:2016 addresses CAPA under two specific clauses. Clause 8.5.2 focuses on corrective actions, requiring organizations to eliminate the causes of nonconformities to prevent their recurrence. This includes reviewing and analyzing nonconformities, determining their causes, and planning and implementing appropriate actions. The effectiveness of these actions must be verified, and any adverse effects on regulatory compliance or product safety must be avoided. Clause 8.5.3 deals with preventive actions, emphasizing the need to identify and eliminate potential causes of nonconformities before they occur. This involves assessing potential problems, planning preventive measures, and ensuring these actions do not compromise regulatory compliance or product safety. The effectiveness of preventive actions should also be reviewed and documented. In essence, a CAPA plan is a structured approach to identifying, addressing, and preventing quality issues, requiring a thorough analysis and collaborative effort from the team.

Who needs CAPA plan?

Anyone who has experienced a workplace incident should be familiar with creating a CAPA plan. When addressing significant issues such as harassment, fraud, or breaches of company ethics, having a CAPA plan is crucial.

• Industries Requiring CAPA Plans: Legally, certain industries are mandated to have robust CAPA procedures. Specifically, companies involved in medical device manufacturing and pharmaceuticals must maintain “adequate” CAPA systems. The FDA rigorously examines these systems during inspections, premarket approval applications, and recalls to ensure compliance and effectiveness.
• Benefits for All Organizations: Beyond legal requirements, implementing a CAPA plan is beneficial for all organizations, regardless of industry. A structured CAPA plan helps in identifying root causes and resolving issues efficiently. Experts and guidelines across various countries recommend adopting CAPA systems to maintain and enhance organizational operations and compliance.

Why is CAPA plan important?

The CAPA plan is recognized by the FDA as one of the most essential components of quality systems. It serves an important role in both corrective and preventive actions, which can be employed individually or in combination. The main objective is to enhance manufacturing and production processes, ensuring that the final products are devoid of defects and nonconformities. Additionally, CAPA is vital for reducing safety hazards in the workplace, contributing to a safer and more efficient work environment.

For example, in manufacturing, when a defect is detected in a product, the CAPA process involves documenting the issue, identifying the root cause, and implementing actions to correct and prevent the problem from happening again. This approach focuses on altering the production processes rather than merely fixing the defective product, thereby ensuring long-term improvements in quality. In high-risk sectors like construction, CAPA is crucial for ensuring worker safety. Safety officers regularly conduct briefings and assess potential hazards, using the information gathered to proactively enhance safety protocols. In the maritime industry, adhering to CAPA and ISPS code standards helps prevent security threats, ensuring safe and secure operations. Thus, CAPA is indispensable for maintaining high standards of quality, safety, and regulatory compliance across various industries.

What should be included in a CAPA plan?

A CAPA (Corrective and Preventive Action) plan is a critical component for organizations aiming to systematically resolve issues and foster continuous improvement. To be effective, a CAPA plan should be comprehensive, addressing various key elements to ensure thorough problem resolution and enhanced performance. Here are the essential components to include in a CAPA plan:

Issue Identification:

• Clearly articulate and define the problem or non-conformance.
• Ensure a deep understanding of the issue to address it effectively.

Criticality Assessment:

• Evaluate the severity and significance of the problem.
• Prioritize issues based on their impact on quality, compliance, or performance to allocate resources accordingly.

Root Cause Analysis:

• Perform an in-depth investigation to discover the fundamental causes and contributing factors.
• Employ appropriate techniques and tools to pinpoint the root cause(s) for a thorough understanding.

Action Plan Development:

• Create detailed plans that specify the actions, responsibilities, and timelines required to resolve the problem.
• Ensure the plans are practical, measurable, and aligned with the desired outcomes.

Plan Implementation:

• Carry out the action plans and implement the necessary corrective or preventive measures.
• Encourage effective teamwork, communication, and coordination among all parties involved in the process.

Effectiveness Measurement:

• Establish relevant metrics or key performance indicators (KPIs) to assess the success of the implemented plans.
• Continuously monitor and evaluate progress against these metrics to determine the plan’s impact and effectiveness.

Documentation and Procedural Updates:

• Record any necessary procedural changes or updates to prevent similar issues from occurring in the future.
• Maintain detailed records of the entire CAPA process, including issue identification, root cause analysis, action plans, implementation, and verification results.

Communication:

• Develop effective communication channels to disseminate CAPA-related information to relevant stakeholders.
• Ensure timely and clear communication regarding the CAPA plan, its progress, and any necessary updates throughout the process.

By incorporating these components, organizations can effectively address issues, enhance compliance, and improve overall performance through systematic problem resolution and continuous improvement.

About Accel

Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.