When managing CAPAs, customers have asked us for recommendations on how to handle the final Verification of Effectiveness (VoE) within their eQMS in terms of what records to create or steps to include on their event templates. We have two recommendations that are detailed below along with the pros and cons of each to help you determine the best option for your organization and existing processes.
Importance of VoE
The VoE check is essential for ensuring that implemented corrective or preventive actions have effectively resolved the issue identified and reduced, or eliminated, the risk of recurrence. Performing a VoE supports data-driven decision making, which in turn drives continuous improvement within an organization’s QMS. The reasons why conducting a VoE is important include:
Assessing the Solution: the VoE ensures that the proposed solution mitigates the issue effectively and evaluates whether the root cause has been properly addressed and its recurrence prevented.
Preventing Recurrence: the key goal of a CAPA is to prevent recurrence of an identified issue. The VoE validates whether the implemented action has effectively eliminated the root cause and reduced the risk of the problem occurring again.
Compliance with Standards and Regulations: ISO 13485:2016 states that an organization shall document a procedure to define requirements for reviewing the effectiveness of corrective actions taken and preventive action taken, as appropriate. Similarly, the FDA Code of Federal Regulations (21 CFR Part 820) requires each manufacturer to establish and maintain procedures for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.
The same goes for therapeutic products manufactured to the ISO 9001:2015 standard which says the organization must review the effectiveness of any corrective action taken or with regulations such as the Eudralex Vol.4 stating that the effectiveness of CAPAs should be monitored and assessed.
Documentation and Auditing: The VoE check provides documented evidence that a CAPA was implemented and evaluated for effectiveness. This documentation is essential for regulatory compliance and serves as a reference during internal and external audits.
Data-Driven Decision Making: The VoE relies on objective evidence to determine the effectiveness of the implemented action. It aids in making informed decisions centered around measurable outcomes rather than assumptions or subjective opinions.
Continuous Improvement: Evaluating the outcomes and lessons learned from previous CAPAs allows organizations to refine their processes, identify systemic issues and enhance their overall performance, all of which play a key role in the continuous improvement process.
Recommendations for VoE in your QMS
Option 1: Include VoE as the last event step
Pro: All steps of the event are logged and tracked on one record.
Con: The event remains open for the length required for VoE check which may be a long time depending on criteria.
Option 2: Create a separate VoE event and link it to original event
Pro: Different VoE may have different timelines- this allows you to close out original CAPA and keep VoE check open. If VoE fails, you can reopen the original CAPA. This provides better data (in my opinion) of how long it is really taking an organization to perform the “doing” steps of a CAPA (investigation/RCA/implement actions).
Con: Two separate events in the QMS. Similar to an extension request, a VoE can be linked to an event to provide traceability.
Note: If you use a separate VoE record, you would change the last step of the CAPA process and put in instructions to link the VoE event and close the CAPA event.
What Auditors are Looking For
Timeline: Auditors like to see that sufficient time has been taken to determine the correct duration of a VoE check. Many companies default to a 3 month VoE duration, however this may not always be the correct length of time needed to ensure that a corrective or preventive action has been effective in mitigating the issue. For example, if a corrective action is implemented for the manufacturing process which only occurs once a quarter due to demand or supply of materials, extending the VoE to 9 months will provide more data-driven evidence about the corrective actions effectiveness, rather than making an assumption based on one manufacturing run performed in the default 3 month VoE timeframe.
CAPA Closure: CAPAs are considered fully closed once a VoE check has been completed. Premature closure without an effectiveness check may result in the issue occurring again, resulting in an ineffective CAPA and most certainly, an audit finding.
Data Evaluation: Auditors evaluate the data collected during the verification process to confirm if it was accurate, complete and aligned with the objectives of the verification. In addition, they’ll assess the adequacy of the data analysis techniques employed to reach conclusions about the effectiveness of the CAPA.
Objectivity and Independence: Auditors check if the VoE was conducted by individuals or teams independent of those responsible for implementing the CAPA. This independence helps ensure unbiased evaluations and minimizes the risk of conflicts of interest.
5 Tips for VoE
Five Tips for VoE