Make CAPA ‘cool’: FDA gives thumbs-up to framework that retools CAPA process for device makers

A new framework that rethinks the corrective and preventive action (CAPA) process by using a risk-based approach has been given the thumbs-up by the US Food and Drug Administration (FDA), with one agency official explaining that medical device manufacturers can use the tool to solve their most pressing of problems first.

The framework is an output of a collaborative “#makeCAPAcool” initiative from the Medical Device Innovation Consortium (MDIC) Case for Quality Collaborative Community (CfQcc), in which FDA participates. Under the framework, CAPA is recast as a continuous improvement tool rather than a place where problems often go to linger, be ignored and never die. It begets a process that filters through a firm’s problems so it can put its resources where they will have most impact.

Bleta Vuniqi, an FDA biomedical engineer who works on the CfQcc team, said results from a recent CAPA Process Improvement Pilot—wherein participating manufacturers tested the #makeCAPAcool framework—showed a reduction of up to 80% in the amount of time it took for firms to put corrections in place. Some of industry’s largest companies, including Medtronic, Boston Scientific, Stryker, BD and Edwards Lifesciences, took part in the pilot.

An “up to 80% reduction in time required to implement improvements … is huge and of high benefit to industry,” Vuniqi said at a 2 May MDIC Live session, during which a 57-page white paper on the #makeCAPAcool program was released. Further, “this all leads to improved product quality for patients and providers, which directly ties to the mission of CDRH,” which is FDA’s Center for Devices and Radiological Health.

The #makeCAPAcool framework pushes device makers to focus on the most important events that could impact product quality and patient experience, rather than dumping every event, regardless of risk or significance, into their CAPA system.

“The risk-based CAPA process and the framework that was defined by the [CfQcc] working group is in alignment with 21 CFR [Part] 820 requirements. It is in alignment with ISO 13485. In addition, it is in alignment with ISO 14971, which requires that risk management be fully integrated into the established QMS,” Vuniqi said.

21 CFR Part 820 is FDA’s Quality System Regulation (QSR), while ISO 13485:2016 is the standard for device quality systems, from the International Organization for Standardization (ISO). Meanwhile, ISO 14971:2019 instructs device manufacturers on how to best put together a risk management program; FDA currently does not require companies to implement ISO 14971, although the agency strongly endorses the standard’s risk management guidelines.

FDA “has always expected that the extent of effort to resolve an issue be commensurate or proportionate to risk, which is what the [#makeCAPAcool] framework has really leveraged and incorporated,” Vuniqi said.

As described in the MDIC white paper, corrective and preventive actions are essentially split into two buckets under the framework:

External CAPAs: These CAPAs are more traditional, and address high-risk trends and outside events; and
Fast-Track CAPAs: Low-risk trends and internal issues are addressed with these CAPAs, which allow for simplified effectiveness checks and reduced root-cause documentation.

“The framework … does highlight how to really interconnect workflows and QMS [quality management system] elements such as risk management, as well as the trending process that can be leveraged by the organization to triage issues and implement opportunities based on the potential risk to users,” Vuniqi said. “So, the framework does give greater emphasis to the identified issues that are higher risk or more complex that could potentially impact patients or users or providers, while it also enables a less burdensome approach for lower-risk issues, which … has allowed organizations to make a greater number of improvements over time.”

The white paper points out that it is important for companies to have a mature and robust risk management process in place, and to track and trend issues to ensure an effective risk-based CAPA process.

While the white paper “walks you through one way of establishing a risk-based approach,” Vuniqi said, she noted that there are “other ways that an organization can establish a risk-based CAPA process, and we do encourage you to identify what is the best way for your organization.”

She went on: “We do highly encourage organizations to evaluate the maturity of the systems that they have established, but also identify a risk-based framework that works for them. [#makeCAPAcool] is one approach. But there are others. Some may have already established a risk-based approach and the CAPA white paper may allow them to continue to improve that approach. For others, this may be new, and it’s an opportunity to continue evaluating and seeing how to best address it within their own organizations.”

Will the #makeCAPAcool framework be adjusted for FDA’s forthcoming final QMSR?

When asked by Focus during the MDIC Live session whether the new framework will have to be modified after FDA implements its final Quality Management System Regulation (QMSR), Vuniqi said “further evaluation” will be made at that time.

“But from what we know now, [the framework] is in full alignment with 21 CFR, [Part] 820, as well as ISO 13485,” she said.

The QMSR, when finalized, will replace the decades-old Quality System Regulation; the agency issued its draft QMSR in February 2022 and has indicated that it may release a final QMSR rule this December. (RELATED: MedCon: FDA ramps up for transition to QMSR, Regulatory Focus 27 April 2023)

Make CAPA ‘cool’: FDA gives thumbs-up to framework that retools CAPA process for device makers

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