Angel Domingo

Ask most medical device companies where the U.S. Food and Drug Administration (FDA) and international regulators have continued to deeply scrutinize industry compliance and most will give you the same answer: corrective and preventive action processes, usually simply referred to as CAPA. In the past several years, CAPA consistently has ranked as one of the top quality system issues cited in FDA 483s for medical device companies.

The purpose of CAPA is to identify and investigate product and quality concerns and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

The corrective and preventive elements of CAPA frequently get blurred. To clarify, a corrective action is intended to correct a problem that already has occurred and prevent it from happening again; it’s about trying to eliminate the root cause of the non-conformance, whereas the preventive action is about identifying a potential problem that hasn’t yet occurred and put actions in place to prevent it from ever happening.

For example, consider a product that is in the design control phase. In this phase, there is a section where a “risk assessment” needs to be done. This part of the process attempts to foresee potential risks or problems that could develop if specific instructions are not followed. Therefore, a preventive action would be to put explicit notes in the assembly instructions about what not to do and why, in order to try and mitigate those unacceptable risks.

Having (and adhering to) a formalized, written CAPA process is mandatory, as it is a subsystem embedded into the FDA’s Quality Systems Inspectional Technique (QSIT) model (CAPA + 1—with the “+1” being another quality systems element). The QSIT model is used by the FDA to initially gauge a medical device company’s overall system integrity and compliance.

A medical device company that establishes and maintains a strong CAPA process that continually brings quality data into that system strengthens its ability to be a dependable industry partner. Conversely, if a company’s CAPA model is unsatisfactory and reveals non-conformities, the FDA, customers and the industry as a whole will have less confidence in the company’s ability to handle and address problems.

A high-quality, effective CAPA process doesn’t have to be as daunting and complex as it’s often made out to be. The following tips can guide you not only in correcting problematic issues that arise, but also in preventing non-conformities from occurring in the first place.

1. Secure Senior Leadership Support
Senior leadership reinforces and promotes a productive CAPA system. If the leadership within your medical device organization has been lackluster in their support of CAPA, then it’s important to communicate the consequences that can have on the company’s financial health and stability, including:

• At-risk safety and patient safety;
• Negative customer experience, because needs and concerns aren’t being responded to quickly and sufficiently, which ultimately can damage a company’s image; and
• FDA penalties including fines, delayed product reviews and approvals, and even refusal by the agency to allow your company to market a specific product.

The only way to successfully address a CAPA in a timely manner is to have adequate resources available. This requires the dedication and support of senior leadership. Without it, it’s likely that costly, time-consuming non-conformances will continue, and resolution of them will be stalled or neglected.

2. Establish Cross-Functional Ownership
In some organizations, CAPA is viewed as the domain of the quality assurance department. However, truly productive organizations don’t work in silos. If a problem emerges (product or process), it is essential to acquire the perspectives of other divisions (i.e., engineering, production, etc.). Cross-functional ownership of a problem is invaluable because different divisions will have different points of view for solving it. And different viewpoints can lead to better solutions.

Acquiring multiple perspectives on how to address a problem also helps you obtain broad consensus across the organization. This does not mean that different divisions need to approve every little action step taken to address the issue. The main purpose is to gain consensus that there is indeed a problem and gather diverse suggestions for how to address it. Once the problem has been sufficiently defined, confined and documented, broad-based consensus makes the process of implementing the solution much more unified, simplified and effective.

3. Document Appropriately
If a CAPA record doesn’t have enough detail and objective evidence, then a medical device company will struggle to demonstrate compliance. Some companies are very general with their documentation because they don’t want to implicate themselves or the company in any way. Unfortunately, the documentation ends up being so vague that one has to rely on tribal knowledge to understand it. Sufficient record keeping needs to include enough information and storytelling so that anyone within the organization knowledgeably can discuss the issue with an FDA auditor at any given time.

Conversely, you don’t want to be overly detailed either. CAPA needs to be commensurate to the problem. Some companies want to document every little thing—even things that don’t really need a CAPA. When the risk of the problem is minimal, over-meticulous documentation actually can complicate the process and waste time and money. You can have different levels of CAPA, but they need to be appropriate to the risk of the problem.

4. Follow-Up for Certainty
In some cases, companies conclude their CAPA process after they’ve verified that a CAPA plan has been implemented. However, verification of the actions isn’t enough. To prevent the problem from reoccurring, it’s essential to ascertain whether or not the corrective change is effective.

For example, if the issue is product-related, it’s important to go back and watch service and repair trends; investigate production quality data (i.e., receiving inspection, non-conforming material reports, final test yields, etc.); conduct audits (internal and external); and perform additional risk assessments down the road.

Failure to follow-up is akin to building a medical device and then not running it after an autoclave cycle to evaluate its functionality.

5. Close the Loop
Even if an original equipment manufacturer (OEM) outsources the development and manufacture of its device to a contract supplier, in the eyes of the FDA, any issue that materializes is ultimately the responsibility of the OEM. Therefore, if the OEM receives a 483 or warning letter and notifies its contract supplier of the problem, it’s imperative that the supplier provide the OEM customer with a detailed, written summary of the whole CAPA.

This report should convey that the contract supplier acknowledged the problem; investigated the root cause; established an action plan; and followed-up on specific dates to ensure that the actions taken to resolve the problem and prevent it from reoccurring were effective.

Providing thorough documentation for the OEM’s files closes the loop on the non-conformity. It also demonstrates that the contract supplier is dedicated to supporting its OEM customer’s system and ability to comply with FDA guidelines.