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FDA approves a framework similar to Orcanos that simplifies the CAPA process for medical device manufacturers, making it easier to implement.

FDA approves risk-based CAPA approach, 80% faster implementation. Orcanos eQMS aids efficiency.


The FDA has approved a new risk-based approach for the CAPA process. According to an FDA official, this tool can assist medical device manufacturers in addressing their most crucial issues first.

The MDIC Case for Quality Collaborative Community (CfQcc) and the FDA collaborated to develop a framework that aims to transform the CAPA process into a continuous improvement mechanism, rather than allowing issues to remain unresolved. This process allows companies to identify and prioritize their problems, so they can allocate their resources effectively.

Bleta Vuniqi, a biomedical engineer at the FDA who works with the CfQcc team, conducted a pilot program to improve the CAPA process. As part of this program, manufacturers who participated were able to test out the framework. The results showed that these firms were able to implement corrections up to 80% faster than before. The pilot included major companies such as Medtronic, Boston Scientific, Stryker, BD, and Edwards Lifesciences.

A 57-page white paper was released on the #makeCAPAcool program during the MDIC Live session on May 2nd. The industry could benefit greatly from an 80% reduction in improvement implementation time. This improvement would improve product quality for patients and providers, aligning with the FDA’s CDRH mission.

The framework encourages device makers to prioritize important events that can affect product quality and patient experience. It discourages the inclusion of every event in their CAPA system, regardless of its level of risk or significance.

“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. It aligns with ISO 14971, which integrates risk management into the established QMS.

According to an FDA representative, the risk-based CAPA process and framework established by the CfQcc working group align with the requirements of 21 CFR [Part] 820 and ISO 13485. Additionally, it complies with ISO 14971, which mandates the integration of risk management into the established QMS.

Both FDA’s Quality System Regulation (QSR), Part 820, and ISO 13485:2016 by the International Organization for Standardization (ISO) serve as quality system standards for devices. Additionally, ISO 14971:2019 guides manufacturers on risk management programs, which FDA encourages but currently does not require companies to implement.

The FDA places priority on taking action according to the level of risk involved. The existing framework has incorporated this principle.

According to the MDIC white paper, corrective and preventive actions are categorized into two types:

  • External CAPAs – These are the traditional type that deals with high-risk trends and outside events.
  • Fast-Track CAPAs – These address low-risk trends and internal issues, and involve simplified effectiveness checks and reduced root-cause documentation.

According to the representative from the FDA, the framework incorporates workflows, quality management, and risk management. Organizations can prioritize and resolve problems by evaluating potential risks to patients, users, or providers. The framework places greater emphasis on higher-risk or more complex issues, while still allowing for a less burdensome approach to lower-risk issues. This has resulted in organizations being able to make more improvements over time.

Effective risk management is essential for companies. Orcanos’ eQMS platform with AI capabilities facilitates efficient risk-based CAPA processes.

Although the white paper provides guidance on establishing a risk-based approach, the FDA representative acknowledges that there are alternative methods for setting up a risk-based CAPA process. Hence, it is advisable that you decide on the most appropriate course of action for your company.

The framework representative recommends that organizations assess the maturity level of their current systems and select a risk-based framework that meets their needs. While the Orcanos CAPA system is one option, there are others available. For those who have already implemented a risk-based approach, the CAPA white paper can help with further improvement. For those who are new to this, it presents an opportunity to evaluate and determine the best way to address it within their organization.

Will you modify the framework to align with the FDA’s upcoming final QMSR?

MDIC Live attendees asked FDA about modifying the new framework after QMSR implementation. The FDA announced they will conduct a “further evaluation” in response. “But from what we know now, the framework is in full alignment with 21 CFR, [Part] 820, as well as ISO 13485,” they said.

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

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