In today’s highly competitive landscape, organizations strive to maintain exceptional product quality, minimize risks, and meet regulatory requirements. Corrective and preventive actions, or “CAPAs,” are a powerful way to identify, investigate, and address deviations, nonconformances, and potential issues within processes, products, and services.

Below, we’ll define a CAPA and explain how it can be implemented into your day-to-day operations.  We’ll share how CAPAs can improve your hardware products, benefit your teams, and address issues with newfound confidence.

What is corrective and preventive action (CAPA)?

A CAPA is a systematic process to identify, investigate, and resolve issues that arise during product development, manufacturing, or service delivery: Take corrective actions to address existing problems and implement preventive measures to avoid future occurrences. The primary goal of a CAPA is to improve processes, maintain product quality, and minimize defects.

Corrective action vs. preventive action

There are distinct differences between corrective and preventive actions.

Corrective action is more of a reactive approach. It aims to address existing problems by eliminating root causes or putting out fires that are currently affecting your organization. 

As you may have guessed, preventive action is a proactive and anticipatory protocol. It helps you anticipate potential issues before they arise or become more severe. An internal audit, for example, can be used as a preventative tool during a management review to mitigate or eliminate developing topics.

Why is it important to have a CAPA process?

Defining the issue is half the battle. You also need to collaborate with your team to determine a solution and move forward. Here’s why a defined CAPA process is a crucial business strategy:

Provides a uniform method for problem-solving

Consistency and efficiency across your organization is the most prominent advantage of the CAPA system. Without a defined, standardized procedure, your team may be unable to effectively identify, analyze, and resolve existing and potential issues.

Ensures compliance

Some industries have extremely stringent regulations that can limit your options when dealing with an issue. Securing compliance with all relevant regulatory bodies helps you avoid costly penalties.

For example, regulatory bodies such as the Food and Drug Administration (FDA) require you to have a robust CAPA process in place for things such as medical devices, biological products, and pharmaceuticals. A description of what the FDA requires is described below.These 

Maintains product quality and minimizes defects

Organizations can address current issues, eliminate root causes, and prevent future problems. By systematically managing product-related issues, CAPAs enhances product quality, reduces defects, improves customer satisfaction, and ensures adherence to regulatory standards.

Increases customer satisfaction

An effective CAPA process will ensure the timely resolution of customer complaints and give your organization a mechanism for gathering and acting on customer feedback. You can then use this feedback to improve future iterations of your product. 

When customers see their feedback is valued, it builds trust and brand loyalty. As a result of this customer-first approach, your brand perception will improve, and you’ll be better positioned to cultivate long-term customer relationships.

Who should set up a CAPA process?

Organizations 

Various types of companies and industries would benefit from a CAPA system. However, there are a number of complex product-oriented industries where an effective process is required. Here are some industries where CAPAs are essential:

  • Medical device: Medical devices have many restrictions. CAPA helps ensure that any issues or nonconformities in medical device design, manufacturing, or distribution are promptly addressed.
  • Pharmaceutical: A CAPA process is required to address quality deviations, adverse events, product recalls, and other issues which improve both the safety and impact of your pharmaceuticals.
  • Aerospace: A CAPA process enables you to identify, plan, and resolve any issues that may compromise airworthiness and quality.
  • Automotive: Automotive companies use CAPA to address defects, quality issues, recalls, and noncompliance with regulatory standards.
  • Electronics: The electronics industry, encompassing manufacturers of electronic components, devices, and equipment, relies on CAPA for quality, reliability, and compliance with regulations.
  • Food and beverage: The food and beverage industry requires a robust CAPA process to address food safety hazards, product contamination, quality deviations, and regulatory noncompliance.
  • Biotechnology: Biotechnology companies involved in developing biological products, diagnostics, and therapeutics, need a CAPA process to ensure the quality, safety, and efficacy of their products.

Job roles

  • Quality managers: Quality managers oversee the implementation and maintenance of the CAPA process within an organization. They’ll ensure compliance with quality standards, lead investigations, and monitor the effectiveness of corrective and preventive actions.
  • Design engineers: Design engineers collaborate with their teams and play a crucial role in the CAPA process. They’re particularly valuable in addressing design-related issues that may impact product quality or performance with cross-functional teams to implement corrective actions and design changes.
  • Regulatory affairs professionals: Regulatory affairs professionals monitor regulatory changes, provide guidance on compliance, and ensure that CAPA activities address any regulatory noncompliance effectively.
  • Production managers: As a production manager, you will work closely with quality teams to identify process-related issues and implement improvements to enhance product quality and consistency.

Understanding CAPA in the context of ISO 13485 and 21 CFR 820

Two primary quality management standards require a corrective and preventive action plan: 21 CFR 820 and ISO 13485.

Understanding the CAPA processes and quality processes outlined in both standards is essential for organizations seeking to meet regulatory requirements and maintain high-quality standards.

21 CFR 820

21 CFR 820, also known as the Quality System Regulation (QSR) for medical devices, sets forth the requirements for designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices intended for commercial distribution in the United States.

Under 21 CFR 820, the CAPA process requires medical device manufacturers to establish procedures for investigating and addressing nonconformities and implementing corrective and preventive actions.

It includes steps such as identifying and documenting nonconformities, determining root causes, implementing corrective actions, verifying their effectiveness, and maintaining records of CAPA activities.

ISO 13485

ISO 13485 is an international standard for quality management systems in the medical device industry. This standard is essential for companies looking to deliver products globally and remain compliant.

This provides a framework for organizations to establish and maintain a comprehensive quality management system that meets regulatory requirements and ensures the safety and effectiveness of medical devices.

The CAPA process in ISO 13485 requires organizations to have procedures for identifying, investigating, and correcting nonconformities and causes of nonconformities.

The ISO 13485 CAPA process involves problem identification, investigation, determining root causes, implementing corrective and preventive actions, and verifying their effectiveness.

The CAPA process

Now that we have explored the importance and significance of the CAPA process, let’s look at the process itself.

1. Problem identification

Problem identification is the recognition and documentation of quality issues, nonconformities, or deviations from established standards or requirements. It serves as the foundation for the subsequent steps of the CAPA process, as it sets the stage for investigation and resolution.

You can initiate this step through various means, such as customer complaints, internal audits, quality control checks, or regulatory inspections.

2. Investigation and root cause analysis

Root cause analysis helps identify the immediate causes of a problem and the underlying systemic or process-related issues. This step involves gathering relevant data, examining processes, procedures, and systems, conducting analyses, and identifying the primary factors contributing to the problem.

3. Corrective action implementation

Corrective actions should be carefully planned, documented, and executed to ensure their effectiveness and alignment with regulatory requirements and quality objectives.

Take decisive steps during this stage. Include process adjustments, system modifications, employee training, rework or repairs, or other necessary actions to resolve the matter and mitigate its impact.

4. Documentation and verification

Validation activities, such as testing and analysis, are part of this crucial step. Documentation and verification play a vital role in ensuring the effectiveness and traceability of the CAPA process.

Documentation records the entire process, demonstrating compliance with regulatory requirements and serving as a reference for future audits or inspections. Verification involves evaluating the results of corrective actions. Then, confirming their effectiveness in resolving the problem and preventing it from happening again.

5. Review and follow-up

The review and follow-up step involves assessing the overall effectiveness of the CAPA process and monitoring the implemented corrective actions over time.

Follow-up activities may involve occasional audits, performance monitoring, and ongoing surveillance to confirm sustained compliance and continuous improvement.

What the FDA looks for in your CAPA process

The FDA is one of the strictest regulating bodies in the United States. They’ll review your CAPA process to ensure it includes root cause analysis, verification and validation, in addition to the following:

Procedures and documentation

Your company must establish and maintain documented procedures for various quality processes, including CAPA management. These procedures outline the step-by-step approach for identifying, investigating, and resolving quality problems.

You are also required to define the roles and responsibilities of stakeholders involved in the CAPA process.

Documentation includes CAPA forms, templates, reports, and other relevant documents that capture the details of the quality issue, investigation findings, root cause analysis, and corrective/preventive actions implemented.

Risk-based approach

Companies are required to perform a risk analysis, which typically includes methods such as failure mode and effects analysis (FMEA) or fishbone diagrams. This analysis helps identify the root cause of the problem by examining potential failure modes and their potential impacts.

Implementing a risk-based approach lets you focus on critical issues impacting patient safety, product quality, and regulatory compliance. 

Timeliness and efficiency

It’s crucial to promptly identify and address quality problems to mitigate their impact on patient safety and product quality; timely CAPA actions help prevent potential harm and minimize the scope of issues.

It would be best to establish appropriate timeframes and escalation procedures to confirm that CAPA activities are conducted promptly. Timeliness and efficiency in CAPA execution demonstrate a commitment to effective quality management and regulatory compliance.

Training and competency

Personnel involved in the CAPA process should receive appropriate training to understand their roles and responsibilities and the procedures and requirements associated with CAPA management.

Training programs should cover problem identification, investigation techniques, root cause analysis methods, corrective action planning, and documentation requirements.

You can conduct competency assessments to evaluate the proficiency of personnel involved in CAPA activities. That way, you’ll identify any training needs or opportunities for improvement.

Continuous improvement

Emphasizing the ongoing enhancement of processes, products, and systems increases efficiency, effectiveness, and customer satisfaction.

Within the CAPA process, continuous improvement involves evaluating the effectiveness of implemented actions, monitoring outcomes, and seeking opportunities for further enhancements.

This may include analyzing data and trends, conducting periodic reviews and audits, and implementing additional preventive measures or process controls.

Optimize your CAPA process with Duro

A well-implemented CAPA process is critical for organizations operating in regulated industries such as medical devices, pharmaceuticals, aerospace, automotive, electronics, and food and beverage.

This process involves critical steps such as problem identification, investigation and root cause analysis, corrective action implementation, documentation and verification, and review and follow-up.

When it comes to establishing sound CAPA processes, your organization needs to lean on the right tools to maintain compliance. Duro, a leading PLM solution provider, gives businesses a centralized way for teams to collaborate and share information. Tie CAPA information back to your original designs with Duro. That way, you’ll ensure that everyone is on the same page and can easily manage revisions. 

See how Carecubes leverages Duro for compliance, collaboration, and quality control. Alternatively, request a demo to see what we can do for your teams.