Changing Paradigm of CAPA

As industry-wide advancement of Corrective and Preventive Action (CAPA) management is required to master its implementation and navigate through regulatory compliance, contemporary CAPA approaches are entering the limelight. A suitable example would be the #makeCAPAcool initiative .

#makeCAPAcool Program: Background

The game-changing #makeCAPAcool initiative formed in 2018 by the Medical Device Innovation Consortium (MDIC) emerged as a response to the prevailing sentiment within the medical device industry, where engineers expressed their readiness for problem-solving and propelling product improvements but voiced dissatisfaction with the current CAPA process.

Conventionally, the CAPA process had become overly compliance-focused, with many manufacturers taking a “one-size-fits-all” approach and employing a standardized strategy that failed to consider varying product and process risk levels. Moreover, the fear of regulatory scrutiny often led to excessive paperwork, impeding the timely enactment of necessary operational changes.

In response to this situation, the MDIC Case for Quality Collaborative Community (CfQcc) took action by launching the CAPA Process Improvement program. This initiative promptly attracted voluntary participation from organizations across the globe, including more than 20 medical device organizations associated with MDIC, along with representatives from consulting firms and the FDA.

#makeCAPAcool Program: Overview

The #makeCAPAcool endeavor sought to augment CAPA effectiveness by enhancing the maturity of established systems and promoting a risk-based CAPA framework tailored to each organization’s specific needs while simultaneously fulfilling regulatory requirements. In order to achieve this goal, the suggested framework brings about a shift in focus from mere compliance-driven documentation towards the core purpose of CAPA, which is problem-solving and improvement. The importance of aligning documentation with risk levels and ensuring that it adds value to the organization by promoting a robust problem-solving process was acknowledged. The program’s objective was to expedite and sustain improvement by boosting the current CAPA process’s efficiency and user-friendliness, thus making it a “cool” routine for managing non-compliances in the industry.

1. Identification of the need for action(s)
2. Investigation
3. Root Cause Identification
4. Implementation of Improvements
5. Effectiveness Evaluation

Conventionally, this activity has been captured within a single QMS, and therefore, a CAPA often came to mean this single “CAPA record” versus referring to the steps separately. The new framework explores to include each element of the CAPA process by combining the CAPA record with those elements captured within the broader QMS.

The proposed framework is examined first by viewing it through the initial tier of risk assessment. This means that, in simple terms, the framework suggests that external events (events beyond an organization’s control) and high-risk trends that could potentially affect users or consumers should be addressed through the external CAPA path involving a stand-alone CAPA record. In contrast, internal events (events within an organization’s control) and low-risk trends should be handled through a fast-track CAPA path involving reduced documentation and simplified effectiveness checks embedded in the QMS. It is summarized as follows:

Risk Based CAPA Framework

External Events and High-Risk Trends – External CAPA

Internal Events and Lower Risk Trends – External CAPA

For further understanding, the framework comprises three interconnected flows. The first flow addresses external events needing detailed documentation of the investigation of the issue, analysis of the cause(s), underlying root cause(s), and proposed actions and the determination of their potential impact on the product and the QMS, selection of which corrective action to implement, implementation of the corrective action and the verification or validation of its effectiveness. The second and third flows address internal events where the organizations may leverage and utilize existing QMS processes to manage and address issues identified internally, i.e., the CAPA could be contained within the nonconformance process. Specifically, the second flow addresses internal items that have become a trend, while the third flow addresses non-trend events. Both paths must meet the regulatory requirements, but to an extent proportionate with the risks.

New CAPA Framework: Three Flows

1. External Events and High-Risk Trends – External CAPA
2. Internal Issues that have become Trend Events – QMS process
3. Internal Issues that are Non-Trend Events – QMS process

The clear differentiation between external and internal flows aims to help organizations consistently make use of the current regulatory expectations for risk-based problem-solving. External CAPA aims at identifying the underlying “root cause” of the problem through systematic methods and the recording of the thought process, whereas the fast-track CAPA aims at identifying and recording the likely cause(s) of the problem through more intuitive methods by pivoting the emphasis from compliance to continuous improvement at all levels of the organization by using practical/offline problem-solving. This clear decision point also makes it easier for employees with different experience levels and roles to comprehend and follow the process daily.

It is important to note that the framework is only one among many ways to define a risk-based QMS. When designing a risk-based process, the procedures undertaken may be based on any methodologies, such as a case-by-case approach in which the process workflow is the same for all situations, a tiered approach in which the process has parallel workflows whose applicability is determined by the situation, and the combination approach which is selected for the framework. The two main CAPA workflows are primarily determined by the type of data source (a tiered approach), and the final decision on which workflow is followed based on a case-by-case determination of risk (e.g., a high-risk trend will move from a lower-tier to an upper-tier workflow).

As an opening, a two-year pilot program partnered with participating organizations to implement the framework was undertaken. The CAPA framework decision process pilot was conducted over an extended period of real-world production, which yielded significant and positive changes in the CAPA process. Not only did the framework facilitate the implementation of improvements in a matter of months instead of years (with up to an 80% reduction in implementation time), but organizations also encountered improvements in the connected QMS processes, such as risk management. Employees in pilot organizations felt empowered to initiate more improvements proactively. Ultimately, this helped to reinforce the understanding of an organization’s capacity to appoint meaningful trend thresholds for action, adequately distinguish risk levels, and identify and evaluate trends that indicate process quality, making the whole QMS more powerful.

#makeCAPAcool Program: What Should Be Expected?

The new framework, established under the “#makeCAPAcool” initiative, was approved by the FDA and intended to recast CAPA as a risk-based, continuous improvement tool. Within the framework, CAPA shifts its role from being a stagnant space where problems linger, get ignored, and never get resolved to a powerful tool to bring a process that filters through an organization’s issues, allowing resources to be allocated where they have the most impact.

The framework recognizes that not all issues carry the same level of importance, and hence by adopting a risk-based strategy, enterprises could eliminate insufficient corrective and preventive action procedures and execute CAPA with minimal burden. Consequently, only some deviations would require an extensive improvement process to ensure compliance, thus bringing forth a proportional and customized CAPA system based on the nature and criticality of each issue.

The framework will likely offer a means to effectively connect workflows and elements of the QMS to prioritize and address higher-risk or more complex issues by concentrating resources and attention on these critical areas so that the most pressing concerns receive appropriate consideration. By redirecting the CAPA principle towards effectual risk management and tracking and trending issues, companies could set up revitalized CAPA management to deliver optimal results.