Ask any quality leader at a medical device company what consumes the most unplanned time in the quality system, and CAPA – corrective and preventive action – is likely to rank near the top. Investigations stack up, timelines slip, and teams can spend weeks analyzing issues that, on closer examination, pose little risk to patients or users.
That’s the problem the Medical Device Innovation Consortium (MDIC) sought to address a few years ago with its “Make CAPA Cool” model. Given an official thumbs-up by the US Food and Drug Administration (FDA) in 2023, the Make CAPA Cool initiative and MDIC’s 57-page white paper on the topic reframed the CAPA process as a risk-based approach.
Under the Make CAPA Cool model, CAPA is a continuous improvement tool rather than a place where problems go to linger, be ignored, and never die. The framework produces a process that filters through a company’s problems so it can put its resources where they’ll have most impact, using risk-based triage to identify issues that warrant a traditional CAPA from lower-risk ones that may be addressed through a faster, less burdensome pathway.
The model also pushes device makers to focus on the most important events that could impact product quality and patient experience, rather than dumping every event, regardless of risk or significance, into their CAPA system. (Related Story: “When FDA Smells Blood: Why Risk-Based CAPA Matters Under QMSR,” QualityHub, July 14, 2026.)
But putting the Make CAPA Cool approach into practice is more complicated than changing a decision tree.
QualityHub Senior Consultant Aryssa Wernle, who’s also Owner & Lead Consultant at AFW Consulting, is a quality leader who helped guide a multiyear, network-wide implementation of the framework – from the initial proposal through a pilot program, global rollout, and years of subsequent monitoring – for a large, multi-site maker of devices.
Wernle’s firsthand work applying the model offers practical insights into the opportunities, considerations, and lessons that can help companies successfully implement the risk-based model for themselves.
Wernle’s overarching message is straightforward: Make CAPA Cool is not a shortcut, and it won’t compensate for weak root-cause analysis, inconsistent documentation, or an immature CAPA system. But when used properly, a risk-based approach can reduce the time and cost devoted to lower-risk issues while allowing manufacturers to focus more attention on problems with meaningful potential impact.
Below are six of Wernle’s lessons to help your firm Make CAPA Cool.
1. Test It Before You Trust It
Before rolling out the model, Wernle’s team ran existing CAPA records through the proposed Make CAPA Cool risk-assessment logic to see how the company’s issues would be classified. The results didn’t line up with what the team expected, and that exercise caught problems in the classification logic before it ever touched any of the firm’s live CAPAs.
Once the logic was refined, the team piloted the approach at several sites before expanding it network-wide. Following the global launch of fast-track procedures and the CAPA workflow software adjustments, the rollout was backed by an interim control and a defined hypercare period.
“Don’t jump into something only to find that it’s not going to work out, because you might end up finding yourself with a mess that might need to be remediated or re-investigated,” Wernle said. “Piloting a large process change like Make CAPA Cool before you use it just makes sense.”
Wernle noted, however, that her advice comes from her work in implementing Make CAPA Cool at a large company with more than 30 manufacturing/design sites around the world. She said smaller firms might be able to implement the CAPA framework without first running a potentially costly pilot.
Regardless, running historical data through new logic first, then piloting before full rollout, gives companies a chance to catch unexpected results, refine the approach, and build confidence before it becomes business as usual. The hypercare period of heightened support matters too – closer monitoring after go-live lets quality leaders spot patterns and correct problems before they become embedded in the process.
2. Align KPIs With Risk
Make CAPA Cool points to a high proportion of CAPAs potentially qualifying for the fast-track pathway based on its pilot experience. In practice, Wernle noted that device makers may see different levels of fast-track usage depending on their processes, culture, and performance metrics.
One implementation consideration she urges companies to consider is the relationship between fast-track classification and closure expectations. Because fast-track CAPAs can be generally expected to have shorter closure timelines, manufacturers should consider whether their performance metrics could inadvertently make teams reluctant to use the pathway in scenarios that allow for its use and benefits.
For example, if the company’s metrics place significant emphasis on closure speed, specifically by holding fast-track CAPAs to a quicker closure target/KPI (Key Performance Indicator), teams could perceive fast-track designation as creating additional performance pressure. This is worth evaluating before implementation.
“Just because a problem falls into fast track doesn’t necessarily mean it’s not complex and it doesn’t require lengthy remediation.” – Aryssa Wernle
That concern points to an important distinction: Fast-track classification is about patient/user risk, not necessarily complexity.
“Just because a problem falls into fast track doesn’t necessarily mean it’s not complex and it doesn’t require lengthy remediation,” Wernle said.
A low-risk issue can still require substantial time to investigate and/or remediate. Conversely, a relatively straightforward issue may warrant a traditional CAPA pathway if its potential impact demands it.
Manufacturers should examine whether any KPI changes specific to fast-track CAPAs reinforce the behavior the MDIC’s model is intended to produce.
3. Adapt the Model Deliberately
The Make CAPA Cool framework encourages companies to embed CAPA activities within other QMS processes so problems and corrective actions are addressed where they can be most effectively managed. That can include processes such as change control and other existing quality system mechanisms.
Wernle’s organization ultimately chose not to adopt every element of the MDIC’s framework.
One concern was that spreading CAPA-related activities across multiple systems could make it more difficult to compile a complete list of CAPAs – particularly during an audit or FDA inspection – and trend/query that CAPA data. Wernle described her organization’s decision as an attempt to avoid creating “islands of automation.”
Her team instead sought to preserve a central repository of its CAPA activity while incorporating selected elements of the MDIC approach. The team also added an existing “issue evaluation” workflow to the model, which allowed for issues to be evaluated for their risk and systemic nature, determine whether a CAPA was required, and if so, decide whether the fast-track pathway could be used.
The broader lesson is that adopting a risk-based framework doesn’t require copying it word for word. “It’s OK to explore deviating from the MDIC’s model,” Wernle said.
Manufacturers should understand the intent behind each element of the MDIC’s framework, determine what fits their existing QMS, and document the rationale for significant adaptations. The goal is not conformity to someone else’s implementation; rather, it’s a controlled process that achieves the intended quality and risk management outcomes.
4. Assess CAPA Maturity First
The appeal of Make CAPA Cool’s fast track is obvious, because lower-risk issues can require less documentation and a more streamlined investigation. But that flexibility can become a liability when the underlying CAPA process is weak.
Wernle raised a fundamental consideration for less mature organizations: A company that already struggles with inconsistent investigations and documentation may not be able to reliably distinguish between a traditional CAPA and one that should be fast-tracked.
Making CAPA “cool” isn’t about doing less. Rather, it’s about doing the right amount of work for the level of risk.
“You need to have a solid CAPA foundation before you try to implement the MDIC framework,” she said.
That’s an important qualification for manufacturers considering the model as a response to CAPA fatigue.
Before implementing risk-based pathways, firms should have confidence that personnel understand root-cause analysis, documentation expectations, risk assessment, escalation criteria, and effectiveness checks. They should also be able to demonstrate that those fundamentals are applied consistently across sites and functions.
Otherwise, lowering documentation or investigation requirements may cloud visibility without reducing risk.
5. Guard Against Misuse of Fast-Track CAPAs
Monitoring for potential misuse of fast-track CAPAs is another important component of a successful Make CAPA Cool implementation, Wernle said.
A cost-of-CAPA analysis that translates investigation time into fully loaded labor costs will typically show that traditional CAPAs are substantially more resource-intensive than fast-track ones. That kind of comparison helps demonstrate that CAPA optimization isn’t simply a quality system exercise. It has a measurable operational and financial impact.
But the cost difference also creates a potential weakness. If fast-track CAPAs are significantly less resource-intensive, manufacturers need to guard against classifying issues as fast track simply because doing so is cheaper and faster.
Manufacturers should address that risk by monitoring decision-tree outputs and using system controls to verify that CAPAs requiring the traditional pathway are in fact using it. In Wernle’s experience, skirting traditional CAPAs wasn’t observed, but it was something her organization monitored for several years after rollout to be sure.
The principle is important. A system that gives people greater flexibility also needs controls that ensure the flexibility is being used for the right reasons, Wernle said.
Firms should establish monitoring criteria before implementation, including how classification decisions will be reviewed, how trends will be identified, and how the company will respond if fast-track usage begins to drift from the intended risk-based approach.
6. Make Continuous Monitoring Part of the Model
One of the features that most distinguishes the fast-track approach from a traditional CAPA is the use of continuous effectiveness monitoring when appropriate.
Rather than treating effectiveness as a single, time-bound event that must be completed before CAPA record closure, the MDIC model allows ongoing monitoring to serve as the effectiveness check when suitable measurement systems are already in place. If monitoring identifies recurrence or a worsening trend, the issue can be reassessed and escalated as necessary.
For Wernle, that capability represents an important part of the model’s long-term value.
“Ultimately, the whole model drives you to enhance and conduct that all-important quality data monitoring,” she said.
That approach can also help companies identify problems before they become larger quality issues.
“Manufacturers that continuously monitor as needed are going to get better at getting ahead of issues before they become noncompliances,” Wernle said. “That was also a point of the fast-track methodology – that it will slowly improve your QMS over time.”
The objective isn’t simply to close CAPAs faster; instead, it’s to create a quality system that continuously watches for recurrence, identifies emerging problems, and uses that information to improve processes before issues become larger problems.
For companies considering a risk-based CAPA model, that should be a design objective from the beginning. Build the monitoring and trending capabilities that allow the organization to detect problems after the record is closed, not just document what happened before closure.
The Bigger Lesson
Wernle’s experience of implementing Make CAPA Cool suggests that CAPA optimization is less about creating a faster process than creating a smarter one.
The most successful implementation is unlikely to be the one that simply produces the highest percentage of fast-track CAPAs. It’s the one that reliably directs organizational attention according to patient/user risk, preserves appropriate documentation and oversight, and gives quality teams the flexibility to address lower-risk issues without weakening the system.
That requires more than a new CAPA decision tree.
Manufacturers need reliable classification logic, appropriate KPIs, a mature CAPA foundation, deliberate process adaptations, controls against inappropriate use, and monitoring that continues after individual issues are closed.
In other words, making CAPA “cool” isn’t about doing less. Rather, it’s about doing the right amount of work for the level of risk – and getting that right takes just as much discipline as the traditional CAPA process it’s designed to improve.
