This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective and preventive action (CAPA) process as a continuous improvement process for driving higher product quality and improved patient safety.
Introduction
Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a structured CAPA process and which can be resolved in alternative ways. The concept of a risk-based approach is not in itself new ‒ it is explicit in the International Organization for Standardization’s (ISO’s) 13485:2016 standard1 and is included in the preamble to US Quality System Regulation (comment 159).2 Nevertheless, many medical device companies still take a conservative approach and apply a one-size-fits-all method, subjecting most issues to a rigid and heavily documented CAPA process.
In conducting quality system maturity appraisals as part of the case-for-quality (CFQ) voluntary improvement program (VIP), it became clear that organizations place a strong emphasis on manufacturing and assembling products to address functionality and quality characteristics. However, it was found that organizations spend less time identifying opportunities to make improvements. As a result, they fail to ensure habitual and persistent improvement for important processes – an original intent of the CAPA process.
Clearly, change is needed in implementing a successful CAPA process. To explore ways to shift the emphasis from compliance to problem solving, organizations voluntarily joined a global team led by the MDIC under the CFQ program. The 25-member team included MDIC members from 14 medical device organizations, as well as representatives from consulting firms and the US Food and Drug Administration (FDA). The team sought to identify cultural and procedural best practices across various industries to determine how the medical device industry could apply these best practices to redefine the CAPA process. The objective was to make today’s CAPA process more effective, efficient, and user friendly, while meeting the intent of the regulations.
The joint team summarized its findings and recommendations in a whitepaper and included a proposed framework for risk-based improvement. The full MDIC CFQ CAPA Process Improvement whitepaper is available online.3
The group recommended that industry participants test the proposed framework through a live pilot. This summary article and the MDIC whitepaper do not constitute advocacy or lobbying or present recommendations on policy or political matters. In addition, although FDA representatives on the program team supported the framework developed by the group, the white paper does not represent conclusions or policy changes made by the agency.
How the framework was developed
As part of the framework development process, the team sought to understand best practices used by similar industries. Team members interviewed 10 quality experts from automotive, aerospace, high-tech, software, and financial services companies to identify their common themes. Through this process, the team gained key insights that shaped its thinking as it developed the proposed framework. Common best-practices themes among the companies included:
A similar survey of the CAPA process at six medical device companies resulted in responses from more than 30 users. In all, more than 300 pain point responses were collected, with the top three industry pain points identified as:
Multiple in-person workshops also helped to develop and refine the proposed framework. The first workshop leveraged principles from design thinking, bringing together process subject matter experts, regulators, and design-thinking experts. The goal of the workshop was to develop a highly innovative, outside-the-box prototype solution, based on user needs, and before considering regulatory constraints.
After the framework had been developed and refined across a series of additional workshops, the team conducted retrospective reviews of recently closed CAPAs. The findings demonstrated that by following a risk-based approach 70% of the roughly 200 CAPAs reviewed could have followed a less burdensome path and could have been managed through existing quality systems. This approach was similar to that observed in the benchmarking interviews of companies outside of the medical device industry.
Proposed risk-based improvement framework
The working team developed a framework consisting of two main “flows,” external events and internal events, acknowledging that not all issues are created equal. The framework allows organizations to triage issues and improvement opportunities based on the risk to users and patients:
The framework proposes that external issues be managed through the traditional CAPA process because they would be considered issues warranting increased attention, whereas internal issues could be managed through existing subsystems within the quality management system (QMS; e.g., nonconformance, complaints, etc.).
The external flow is the CAPA process most familiar to the med-tech industry today—with fully documented cause analysis. It aims to apply more rigor in critical thinking to identify the root cause (or underlying cause) of the nonconformity, implement investigation decisions, and verify or validate effectiveness. Furthermore, organizations are encouraged to apply the good practices outlined in Appendix 2 of the whitepaper3 to strengthen their internal processes for CAPA.
The internal flow includes medium- and low-risk trends that can be addressed through existing subsystems embedded within the quality system by using a fast-track, or streamlined, CAPA process. Events falling under this flow would require organizations to confirm whether the product remains within its control and perform a risk assessment when preset, trend thresholds have been exceeded. Within these quality subsystems, in-depth documentation is not warranted for the cause of the issue, and simplified effectiveness checks can be leveraged. Although documentation and compliance requirements of the fast-track CAPA process are less rigorous, the intent is to enable more problems to be solved over time, not to encourage less problem-solving rigor. Rather, the emphasis is on correcting or preventing issues while still meeting the fundamental requirements of CAPA, with the overall goal of preventing the issue from occurring or recurring and/or becoming a patient-impacting event.
Both flows require mature risk management, monitoring, and trending capabilities, which are central to an effective quality system. Furthermore, an organization should bear the burden of developing a strong problem-solving system to support cause identification. By enabling organizations to apply a least burdensome method for documentation, the framework promotes a problem-solving culture being rolled-out to all levels of the organization. However, there are instances, such as when issues have escaped from the organizations control, that increased documentation, cross-functional-team oversight, and regulatory scrutiny are needed and add value. In the absence of a strong problem-solving system, the framework provides for escalation to the external CAPA process.
The framework acknowledges that not all issues are created equal. As a result, in-depth, standalone records are not warranted for every issue, and some corrective actions can appropriately be handled, quickly and compliantly, through other quality system processes with identified governance controls. By separating issues into flows of internal and external events, the proposed framework gives greater emphasis to identifying and resolving issues that could affect the user or patient and is intended to enable a greater number of improvements over time, favorably affecting product quality in the field. In short, the paradigm shift calls for industry and regulators to acknowledge that there is a benefit in promoting a problem-solving culture and by understanding that not all issues must be documented with the same level of detail.
Highlights of the regulatory context
Regulations, both in the US and internationally, allow organizations to address issues using an approach commensurate with risk. The framework prioritizes those issues with a greater risk of patient impact and proposes that not all issues must be solved within an external CAPA process flow. Furthermore, the framework proposes that the fast-track CAPA process can be further optimized by integrating it within other applicable QMS processes, such as the nonconforming product, internal audit process, or change management process. The team completed a rigorous comparison of the framework and the relevant regulatory requirements (see MDIC CAPA Improvement whitepaper for a detailed regulatory discussion3). The team found that the regulations support the use of the approach set out in the framework. The table below provides a high-level summary of the comparison.
Conclusion and next steps
The FDA’s guidance defines “least burdensome” as being the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. 5 This concept applies to all products meeting the statutory definition of a device throughout the product lifecycle. The framework gives greater emphasis to identifying and resolving issues that could have an impact on the patient or user. It is intended to enable organizations make a greater number of improvements more quickly, and over time, which will have a favorable impact on product quality in the field. It is not a proposal for new regulations but, rather, a new paradigm for how to meet the current regulations. In short, the paradigm shift calls for regulators to acknowledge the benefit in promoting a problem-solving culture and understanding that lower-risk issues may not be investigated in as much detail as higher-risk issues.
Given that this article presented a summary of initial findings developed by the joint team, readers should review the full MDIC CFQ CAPA Process Improvement whitepaper,3 for a more detailed view of the framework. To test this framework and the principles outlined in this article, the working team is currently conducting pilots across seven sites and is accepting invitations for additional sites to participate. Organizations interested in joining the pilot or wishing to provide feedback on the framework should contact the program chair, Kathryn Merrill (Kathryn.merrill@medtronic.com) or the MDIC CFQ program director, Alan Baumel (abaumel@mdic.org).
Abbreviations
CAPA, corrective and preventive action; CFR, Code of Federal Regulations; CFQ, case for quality; FDA, [US] Food and Drug Administration; ISO, International Organization for Standardization; MDIC, Medical Device Innovation Consortium; ORA, Office of Regulatory Affairs; RMAT, regenerative medicine advanced therapies; VIP, voluntary improvement program; QMS, quality management system.
References
Introduction
Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a structured CAPA process and which can be resolved in alternative ways. The concept of a risk-based approach is not in itself new ‒ it is explicit in the International Organization for Standardization’s (ISO’s) 13485:2016 standard1 and is included in the preamble to US Quality System Regulation (comment 159).2 Nevertheless, many medical device companies still take a conservative approach and apply a one-size-fits-all method, subjecting most issues to a rigid and heavily documented CAPA process.
In conducting quality system maturity appraisals as part of the case-for-quality (CFQ) voluntary improvement program (VIP), it became clear that organizations place a strong emphasis on manufacturing and assembling products to address functionality and quality characteristics. However, it was found that organizations spend less time identifying opportunities to make improvements. As a result, they fail to ensure habitual and persistent improvement for important processes – an original intent of the CAPA process.
Clearly, change is needed in implementing a successful CAPA process. To explore ways to shift the emphasis from compliance to problem solving, organizations voluntarily joined a global team led by the MDIC under the CFQ program. The 25-member team included MDIC members from 14 medical device organizations, as well as representatives from consulting firms and the US Food and Drug Administration (FDA). The team sought to identify cultural and procedural best practices across various industries to determine how the medical device industry could apply these best practices to redefine the CAPA process. The objective was to make today’s CAPA process more effective, efficient, and user friendly, while meeting the intent of the regulations.
The joint team summarized its findings and recommendations in a whitepaper and included a proposed framework for risk-based improvement. The full MDIC CFQ CAPA Process Improvement whitepaper is available online.3
The group recommended that industry participants test the proposed framework through a live pilot. This summary article and the MDIC whitepaper do not constitute advocacy or lobbying or present recommendations on policy or political matters. In addition, although FDA representatives on the program team supported the framework developed by the group, the white paper does not represent conclusions or policy changes made by the agency.
How the framework was developed
As part of the framework development process, the team sought to understand best practices used by similar industries. Team members interviewed 10 quality experts from automotive, aerospace, high-tech, software, and financial services companies to identify their common themes. Through this process, the team gained key insights that shaped its thinking as it developed the proposed framework. Common best-practices themes among the companies included:
- Focusing quality practices on protecting patients and customers.
- Not assigning equal importance to all issues – when everything is important, nothing is.
- Applying a risk-based approach to problem solving because not all issues warrant equal treatment.
- Promoting alignment among key stakeholders and senior leaders on what is important to facilitate the assignment and prioritization of resources.
- Addressing internal issues at the lowest possible level at which they can be resolved in the shortest time and without unnecessary burden, and then escalate as needed commensurate with risk. Problem solving should be executed as close as possible to the related work.
A similar survey of the CAPA process at six medical device companies resulted in responses from more than 30 users. In all, more than 300 pain point responses were collected, with the top three industry pain points identified as:
- Lack of clarity on when to open a CAPA.
- Lack of clarity on the relationship with other systems (nonconformance process, continuous improvement process), resulting in overlaps and duplication.
- Lack of advanced planning for allocating resources to CAPA.
Multiple in-person workshops also helped to develop and refine the proposed framework. The first workshop leveraged principles from design thinking, bringing together process subject matter experts, regulators, and design-thinking experts. The goal of the workshop was to develop a highly innovative, outside-the-box prototype solution, based on user needs, and before considering regulatory constraints.
After the framework had been developed and refined across a series of additional workshops, the team conducted retrospective reviews of recently closed CAPAs. The findings demonstrated that by following a risk-based approach 70% of the roughly 200 CAPAs reviewed could have followed a less burdensome path and could have been managed through existing quality systems. This approach was similar to that observed in the benchmarking interviews of companies outside of the medical device industry.
Proposed risk-based improvement framework
The working team developed a framework consisting of two main “flows,” external events and internal events, acknowledging that not all issues are created equal. The framework allows organizations to triage issues and improvement opportunities based on the risk to users and patients:
- External events, those outside an organization’s control, and high-risk trends, that have the potential to impact a patient or user, would be addressed in what the team called an “External CAPA.” This process is like the more traditional CAPA process requiring a focused, cross-functional effort that includes a fully documented root-cause analysis and statistically valid effectiveness checks.
- Internal events, those within an organization’s control (that is, that have been effectively identified and prevented from escaping), and low-risk trends would be addressed in what the team called a “Fast-Track CAPA.” This CAPA can be completed by resources closest to the work, within the affected quality management system, such as the nonconformance or the internal audit process versus in a standalone CAPA record. In addition, these CAPAs would be completed with reduced-cause documentation and simplified effectiveness checks, such as routine monitors used to identify a recurrence.
The framework proposes that external issues be managed through the traditional CAPA process because they would be considered issues warranting increased attention, whereas internal issues could be managed through existing subsystems within the quality management system (QMS; e.g., nonconformance, complaints, etc.).
The external flow is the CAPA process most familiar to the med-tech industry today—with fully documented cause analysis. It aims to apply more rigor in critical thinking to identify the root cause (or underlying cause) of the nonconformity, implement investigation decisions, and verify or validate effectiveness. Furthermore, organizations are encouraged to apply the good practices outlined in Appendix 2 of the whitepaper3 to strengthen their internal processes for CAPA.
The internal flow includes medium- and low-risk trends that can be addressed through existing subsystems embedded within the quality system by using a fast-track, or streamlined, CAPA process. Events falling under this flow would require organizations to confirm whether the product remains within its control and perform a risk assessment when preset, trend thresholds have been exceeded. Within these quality subsystems, in-depth documentation is not warranted for the cause of the issue, and simplified effectiveness checks can be leveraged. Although documentation and compliance requirements of the fast-track CAPA process are less rigorous, the intent is to enable more problems to be solved over time, not to encourage less problem-solving rigor. Rather, the emphasis is on correcting or preventing issues while still meeting the fundamental requirements of CAPA, with the overall goal of preventing the issue from occurring or recurring and/or becoming a patient-impacting event.
Both flows require mature risk management, monitoring, and trending capabilities, which are central to an effective quality system. Furthermore, an organization should bear the burden of developing a strong problem-solving system to support cause identification. By enabling organizations to apply a least burdensome method for documentation, the framework promotes a problem-solving culture being rolled-out to all levels of the organization. However, there are instances, such as when issues have escaped from the organizations control, that increased documentation, cross-functional-team oversight, and regulatory scrutiny are needed and add value. In the absence of a strong problem-solving system, the framework provides for escalation to the external CAPA process.
The framework acknowledges that not all issues are created equal. As a result, in-depth, standalone records are not warranted for every issue, and some corrective actions can appropriately be handled, quickly and compliantly, through other quality system processes with identified governance controls. By separating issues into flows of internal and external events, the proposed framework gives greater emphasis to identifying and resolving issues that could affect the user or patient and is intended to enable a greater number of improvements over time, favorably affecting product quality in the field. In short, the paradigm shift calls for industry and regulators to acknowledge that there is a benefit in promoting a problem-solving culture and by understanding that not all issues must be documented with the same level of detail.
Highlights of the regulatory context
Regulations, both in the US and internationally, allow organizations to address issues using an approach commensurate with risk. The framework prioritizes those issues with a greater risk of patient impact and proposes that not all issues must be solved within an external CAPA process flow. Furthermore, the framework proposes that the fast-track CAPA process can be further optimized by integrating it within other applicable QMS processes, such as the nonconforming product, internal audit process, or change management process. The team completed a rigorous comparison of the framework and the relevant regulatory requirements (see MDIC CAPA Improvement whitepaper for a detailed regulatory discussion3). The team found that the regulations support the use of the approach set out in the framework. The table below provides a high-level summary of the comparison.
Conclusion and next steps
The FDA’s guidance defines “least burdensome” as being the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. 5 This concept applies to all products meeting the statutory definition of a device throughout the product lifecycle. The framework gives greater emphasis to identifying and resolving issues that could have an impact on the patient or user. It is intended to enable organizations make a greater number of improvements more quickly, and over time, which will have a favorable impact on product quality in the field. It is not a proposal for new regulations but, rather, a new paradigm for how to meet the current regulations. In short, the paradigm shift calls for regulators to acknowledge the benefit in promoting a problem-solving culture and understanding that lower-risk issues may not be investigated in as much detail as higher-risk issues.
Given that this article presented a summary of initial findings developed by the joint team, readers should review the full MDIC CFQ CAPA Process Improvement whitepaper,3 for a more detailed view of the framework. To test this framework and the principles outlined in this article, the working team is currently conducting pilots across seven sites and is accepting invitations for additional sites to participate. Organizations interested in joining the pilot or wishing to provide feedback on the framework should contact the program chair, Kathryn Merrill (Kathryn.merrill@medtronic.com) or the MDIC CFQ program director, Alan Baumel (abaumel@mdic.org).
Abbreviations
CAPA, corrective and preventive action; CFR, Code of Federal Regulations; CFQ, case for quality; FDA, [US] Food and Drug Administration; ISO, International Organization for Standardization; MDIC, Medical Device Innovation Consortium; ORA, Office of Regulatory Affairs; RMAT, regenerative medicine advanced therapies; VIP, voluntary improvement program; QMS, quality management system.
References
- International Organization for Standardization. ISO 13485: 2016 Medical devices — Quality management systems — Requirements for regulatory purposes. https://www.iso.org/standard/59752.html. Last reviewed and confirmed 2020. Accessed 13 July 2020.
- US Food and Drug Administration. Medical devices; Current good manufacturing practice (CGMP) final rule; Quality system regulation. https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation. Current as of 23 March 2018. Accessed 13 July 2020.
- Medical Device Innovation Consortium. MDIC case for quality: CAPA process improvement. A report of the case for quality CAPA workstream of the Medical Device Innovation Consortium (MDIC). https://mdic.org/wp-content/uploads/2019/12/MDIC-CfQ-CAPA-Whitepaper.pdf. Dated 3 December 2019. Accessed 13 July 2010.
- US Food and Drug Administration. CFR - Code of Federal Regulations. Title 21 – Food and drugs. Chapter I, Food and Drug Administration, Department of Health and Human Services. Subchapter H – Medical devices. Part 820, Quality system regulation. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820. Current as of 1 April 2019. Accessed 13 July 2020.
- US Food and Drug Administration. The least burdensome provisions: Concept and principles. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles. Issued February 2019. Accessed 13 July 2020.
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