The Importance of Management Reviews for CAPAs

The corrective and preventive action (CAPA) process is a cornerstone to a healthy QMS, and provides oversights, insights, and checks and balances for nonconforming products and procedures.

However, without a properly functioning CAPA plan in place, the actions taken may not have much impact. Findings from our 2022 State of Medical Device Report show that only 17% of medical device organizations rated their CAPA competency as being, “excellent.” This trend has left many medical device organizations wondering where to start improving their CAPA plan.

One potential blindspot plaguing your CAPA quality may have to do with management—specifically in their role to ensure the effectiveness of the CAPA process with management reviews.

BONUS RESOURCE: Click here to download your free copy of our Sample Management Review Template.

What is a management review?

Management reviews are a systematic assessment used to ensure that an organization’s QMS is effective and all procedures are being correctly followed. When done properly, management reviews provide dedicated attention from top management and connect the business’ quality activities to the spirit of continuous improvement. 

These reviews typically take the form of periodic meetings, during which cross functional teams discuss KPIs related to quality management, use data trends to identify opportunities for improvement, and review outstanding business risks.

Management reviews are fundamental to a healthy QMS, and are explicitly required by standards like ISO 13485, in which the requirements state:

Top management shall review the organization’s quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Management reviews are also included in 21 CFR Part 820, where they’re listed as one of management’s primary responsibilities in its pursuit of quality.  Management review inputs can come from as many as 12 inputs, such as complaint handling and regulatory submissions, as well as corrective and preventive actions.

How do management reviews apply to CAPA?

Management reviews play a profound role in the CAPA management process—in more ways than one. 

As part of a CAPA program, a management review represents the last phase of the process, and is essential to ensuring the program’s effectiveness. 

If we refer to our 15 Steps to a Risk-based CAPA Process, we see the final 4 steps are a function of management review:

• Review CAPA for completeness

• Approve CAPA actions

• Specify steps for effectiveness verification

• Verify the effectiveness of the CAPA

So, the spirit of management reviews are clearly alive within the actionable steps of your CAPA process. But the CAPA connection doesn’t stop there. CAPA-related metrics should be also presented during routine scheduled meetings as part of a larger discussion around the entire QMS.  

Some of these metrics include:

• CAPA aging

• CAPA trends based on causes

• Number of open CAPAs and their risk levels and current phase

• Number of CAPAs initiated out of specific functional areas 

• Number of extensions granted

It’s here that we see the symbiotic relationship between management reviews and the CAPA process—primarily that one informs the other. In fact, you’ll likely see that potential CAPAs can be identified and mitigated through management review activities. When this happens it’s a clearcut sign that your management review process is working properly by identifying important quality issues, as well as providing resources to ensure corrective action.

Best practices for CAPA management reviews

In order to maximize the benefits for CAPA, you need to get the most out of your management reviews. To do so, let’s take a look at three key tips to your CAPA management reviews.  

Establish a review board for CAPA quality

While the job of CAPA quality is the responsibility of all management, it can be helpful to designate a cross-functional team of managers that support one another in promoting an effective CAPA process. 

CAPA review boards are ideally composed of middle-level managers, from different departments, with the responsibility of improving the company’s CAPA process and procedure. This board does not need to include all of top management, but should at least include the management representative required by ISO 13485 to “ensure and promote awareness” of quality issues related to CAPA.  

Some advantages of a CAPA board for management reviews are:

• Increases visibility and oversight into open CAPA cases

• Promotes CAPA education and training opportunities

• Improves cross functional communication between departments

Findings from weekly CAPA board meetings should still be disseminated to top management for periodic management reviews, where that information should drive the decisions made relating to the CAPA process.  

Prepare for management review meeting efficiency 

Corrective and preventive actions generate a lot of data analysis, reports, and documentation, and that means a lot is on the table to discuss at a management review. 

With that in mind, management review meetings need to be a time for high-level discussion - not for quickly scanning the charts and trends for the very first time. Management review participants should have the opportunity to prepare and review the CAPA documentation as often as possible. 

Every management review, whether it’s a CAPA board or top management review, should have a planned agenda and recorded meeting minutes. During this time, every open CAPA should be discussed during the meeting, but the amount of time devoted to each CAPA should be adjusted based on the age of CAPA case.

Any discussion or actions planned that are specific to a CAPA should be documented in the individual CAPA record as well as the meeting minutes in order to stay compliant with ISO 13485.

BONUS RESOURCE: Click here to download your free copy of our Sample Management Review Template.

Leverage an automated QMS for quality CAPAs

CAPAs often take a back seat to other projects and initiatives deemed more important; however, CAPAs are enterprise-wide and impact the entire organization. They are a primary indicator of the health of your company’s quality management system. 

In order to effectively manage your CAPA process, you need an eQMS with a dedicated CAPA Management Software workspace which links your documentation together, and allows you to spot trends for preventive  measures before they require corrective actions.  

That’s where we come in. With Greenlight Guru, you’ll get the only QMS software designed by medical device professionals specifically for medical device professionals. Our comprehensive, out-of-the-box solution is based on the latest FDA and ISO best practices for CAPA.

Our purpose-built QMS solution allows you to effectively manage your risk-based CAPA process in a connected ecosystem where inputs and outputs tell the true story, so you can shift from being merely reactive to proactively preventing major issues through means that are less resource intensive.

Ready to make the switch? Contact us today for your free demo of Greenlight Guru →