The new article further elaborates on the most crucial aspects related to corrective and preventative actions to be taken by the parties responsible for medical devices in order to ensure continued safety and proper performance.
Table of content
The Medical Device Coordination Group (MDCG) has published a guidance document dedicated to corrective and prevention action (CAPA) plan assessment, addressed to conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams. The document describes in detail the relevant regulatory requirements based on the existing legal framework and also provides additional clarifications and recommendations to be taken into consideration by all the parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. In particular, the document outlines the detailed guidance for notified bodies (NBs) on implementing corrective and preventive actions (CAPAs) to address non-conformities (NCs) and verify their effectiveness.
Definition and Purpose
According to the guidance, corrective actions are defined as actions to eliminate the cause of a potential or actual NC, while preventive actions aim to prevent potential NCs from occurring. CAPAs are essential for addressing root causes of NCs and ensuring they do not recur.
For major NCs, NBs must provide evidence of both corrective and preventive actions.
Characteristics of Effective CAPAs
CAPAs must:
- Be appropriate to the classification and severity of the NC.
- Clearly link to the root causes identified in the root cause analysis.
- Address systemic issues, not just symptoms of the problem.
- Include comprehensive preventive measures, even for potential NCs not yet identified.
For example, if a lack of expertise contributed to an NC, the NB should review all related processes handled by the same personnel to identify and address potential gaps.
Steps for Corrective and Preventive Actions
In order to assist the parties involved, the guidance provides a step-by-step description of an action plan to be developed and implemented.
- Identify Corrective Actions:
- Ensure they are directly linked to root causes.
- Address all identified causes.
- Verify their feasibility and effectiveness.
- Plan and Implement Actions: Detail the implementation plan in the CAPA template, including:
- Description of regulatory requirements.
- Assignment of roles and responsibilities.
- Required resources and timelines.
- Verification and validation protocols.
- Focus on Measurability: Avoid vague actions; define measurable outcomes for effectiveness. For example, instead of a generic statement like “improve procedures,” specify how the procedure will be revised, implemented, and monitored.
- Iterate When Necessary: If initial corrective actions are deemed infeasible or ineffective, re-evaluate and develop alternative solutions.
Distinguishing Between Corrections, Corrective Actions, and Preventive Actions
As explained by the MDCG, determining whether an action is a correction, corrective action, or preventive action can be challenging. The focus should remain on the effectiveness of the action in enhancing the system.
Actions should be documented in the most relevant section of the CAPA template based on their primary purpose. For example, revising a checklist for sterilization validation can be categorized as corrective or preventive action, depending on whether it addresses an existing NC or a potential issue.
Verification of Effectiveness
In accordance with the applicable regulatory requirements, it is also important to take the necessary step to verify the actual effectiveness of the steps taken.
NBs should outline specific actions to verify the effectiveness of implemented CAPAs.
Verification plans should:
- Use SMART criteria:
- Specific: Target the identified root causes.
- Measurable: Define clear success metrics.
- Achievable: Ensure feasibility within available resources.
- Realistic: Align with operational capabilities.
- Time-bound: Set clear deadlines for completion.
Specify responsibilities and timelines for effectiveness checks, considering the following:
- The classification of the NC.
- The complexity of the corrective and preventive actions.
NBs then should confirm that:
- The root cause has been addressed.
- The NC has not recurred.
- Similar NCs have not occurred.
- Corrective actions remain effective and consistently implemented.
Progress can be monitored through scheduled internal audits or similar mechanisms. The results of verification should be clearly documented for review by the designating authority (DA).
Role of the Designating Authority (DA)
While the CAPA plan includes verification actions, the actual verification of effectiveness falls outside the scope of joint assessments and is monitored by the DA as part of ongoing oversight.
Key Practices for NBs include:
- Comprehensive Review: Ensure CAPAs address not only the identified NC but also potential systemic weaknesses.
- Detailed Documentation: Maintain clear records of CAPA actions, verification protocols, and results for DA review.
- Proactive Prevention: Consider preventive actions to mitigate risks even in areas not flagged during assessments.
- Measurable Outcomes: Focus on achieving demonstrable improvements through clearly defined and implemented actions.
Conclusion
Thus, by following these practices, NBs can ensure robust management of NCs and strengthen their quality management systems under MDR and IVDR. The document highlights the key aspects to be taken into consideration in order to ensure compliance thereto, and also provides additional clarifications regarding specific matters associated with the CAPA plan development and implementation.
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