CAPA Process: 7 Essential Steps for Medical Device Manufacturers

Medical device manufacturers are required to integrate a corrective and preventive action (CAPA) into their quality management systems (QMS). Investigations and violations of CAPA systems frequently top the list of concerns during regulatory inspections or audits.

That leads to the necessity for medical device companies to establish an effective and comprehensive CAPA process. We have already discussed what CAPA is and the difference between preventive action, corrective action, and correction.

Now, let's look at our recommended comprehensive step-by-step approach to optimize CAPA outcomes for medical device manufacturers.

Advantages of implementing a CAPA system for businesses

By implementing an effective CAPA system, businesses can proactively manage risk, improve processes, and improve overall quality.

The following points can be considered as benefits for any business when implementing effective CAPA processes:

• increased quality of products or services;

• identifying and mitigating potential risks before they become more serious problems;

• regulatory compliance;

• promoting a culture of continuous improvement by encouraging feedback and learning from past mistakes;

• customer satisfaction and loyalty can be increased by minimizing errors and defects;

• addressing issues proactively can result in cost savings by avoiding potential recalls, rework, or legal penalties.

The investigation and CAPA system serve a threefold purpose:

• gathering and analyzing product/process/system data to identify current and potential quality system issues;

• investigate the root cause(s) of significant product and quality issues, which are assessed based on their risk level;

• implementing appropriate, effective, and comprehensive actions in response.

7 Steps to a Comprehensive CAPA

In our article Top 10 Reading List for Quality & Compliance Managers within Medical Devices, we suggested the Handbook of Investigation and Effective CAPA Systems. 

According to the handbook, an effective CAPA process must be a closed-loop system. This means that sufficient controls are in place to ensure that investigations and CAPA processes progress through all necessary steps to completion. Very often, employees focus on completing the individual tasks of a particular corrective action while losing track of the original purpose of the CAPA. A bright example could be when a particular issue may be resolved, but no evaluation is ever performed to ensure the solution was effective. In this case, the loop was never closed.

Let's look at all the steps of the effective CAPA process using an imaginary case where Company A manufactures cardiac pacemakers. The Company received complaints from healthcare providers and patients about a potential safety concern related to a batch of cardiac pacemakers. Some devices from this batch are experiencing intermittent failures, leading to temporary disruptions in pacing therapy delivery.

CAPA process steps

Identifying the issue

The first step is identifying and documenting an actual or potential issue or non-conformance through various internal and external channels, such as customer complaints, internal audits, or process deviations.

Step 1 of Company A. Since the issue had already occurred, the Company's quality assurance team decided to take corrective actions (CAs) to eliminate the cause of nonconformities and prevent recurrence. The issue record includes a detailed description and supporting evidence. Company A initiated an investigation into the reported failures.

Assessing potential impact and risk level

The next step is evaluating the severity and (potential) impact of the issue on product quality, safety, regulatory compliance, and customer satisfaction. Determination of the risk level should be taken to prioritize actions accordingly.

Step 2 of Company A. Recognizing the critical nature of pacemaker therapy in managing cardiac conditions, Company A categorizes the issue as high-risk due to the impact on patient health and safety.

Develop an investigation procedure.

Evaluating the (potential) impact and risk of the issue is followed by establishing a systematic procedure for investigating its root cause.

Step 3 of Company A. Company A forms a specialized investigation team comprising the RAQA team, biomedical engineers, and cardiologists. This Team determines a procedure for thoroughly investigating the problem. It includes an objective for the actions to be taken, the investigative steps, a timeline to be followed, responsible parties, and required resources.

Analyzing the problem and identifying its cause

At this step, all data must be documented and organized. Thoroughly analyze the gathered data to identify the issue's underlying cause(s), considering factors such as human error, equipment malfunction, or process deficiencies. Tools such as 5 Why analysis, Fishbone diagram (a.k.a. Ishikawa diagram), Failure Mode and Effects Analysis (FMEA), Fault tree analysis (FTA), or Pareto charts can be used to investigate the root cause of the issue.

Step 4 of Company A. After brainstorming, analyzing the gathered data, and extensive analysis, the Team identified a manufacturing defect in the pacemaker's electronic circuitry, which led to sporadic disruptions in therapy delivery.

Formulating an Efficient Action Plan

Based on the root cause analysis, a comprehensive action plan that includes corrective actions to address the immediate issue (corrections) and/or preventive actions to prevent recurrence should be developed.

Corrective actions should at least include the following:

• corrections (actions to eliminate the detected nonconformity itself);

• corrective activities;

• planned action date;

• personnel responsible for each task and specific link tasks (if any);

• measures of effectiveness check;

• planned check date;

• evidence to prove the effectiveness of the CA.

Preventive actions should at least include the following:

• preventive activities;

• planned action date;

• personnel responsible for each task and specific link tasks (if any).

• measures of effectiveness check;

• planned check date;

• evidence to prove the effectiveness of the PA.

Step 5 of Company A. The Team formulates a comprehensive action plan to address the issue:

Correction action:

1) Send a safety notice to notify healthcare providers of the reported failures and advise on interim patient management strategies.

Corrective actions:

1) Implement a recall of the affected pacemaker batch.

2) Offer device replacements to affected patients.

3) Conduct comprehensive testing and validation of all pacemaker components.

Implement corrective/preventive measures

Once the action plan is established, it should be executed strictly according to its steps. This step needs to be thoroughly documented and recorded. Involved people should have real-time access to track and follow the CAPA.

Step 6 of Company A. Company A swiftly implements the action plan mentioned in Step 5.

Validate effectiveness

The final step is validation of the effectiveness of the implemented actions through follow-up assessments, testing or monitoring to ensure that the issue has been adequately addressed and recurrence prevented.

Step 7 of Company A. Following implementation, Company A monitors the performance of the updated pacemaker models and conducts post-market surveillance to ensure that the corrective actions have effectively addressed the issue. Feedback from healthcare providers and patients is collected and analyzed to identify any further concerns or improvements needed.

In this case, the issue of temporary disruptions of cardiac pacemakers was resolved, evaluation was performed to ensure the solution was effective, and the CAPA "loop" was closed.

Utilize Matrix Requirements solution designed to assist in managing the CAPA

Given the ongoing pursuit of improvement within quality systems for processes, products and services, it's crucial to implement an intuitive and fully customizable quality management system (eQMS). MatrixQMS helps companies ensure compliance and product quality, manage CAPAs, manage suppliers, conduct internal audits, and more.

Our CAPA system enables you to go through all the steps for managing issues in a company's processes, products, or services. The complicated process can be and should turned out in a clear and effective workflow of handling CAPA.

Do not hesitate to contact us for more information about our products and solutions for your company.