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June 25, 2024

There’s no question about it: should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.

CAPA management is a recurring theme in U.S. Food and Drug Administration warning letters, a fact that is true across multiple industries including food, pharmaceuticals, and medical device.

And it’s not just compliance that companies need to worry about. The truth is, effective CAPA management is a basic requirement for continuous improvement. Done well, CAPA management can lead to safer, higher quality products that delight customers. Poorly managed corrective actions, on the other hand, can lead to massive recalls, financial penalties, and reputational damage.

Today’s article looks at 12 strategies for successful CAPA management using a quality management system (QMS), including:

  • How to standardize workflows and processes
  • CAPA metrics you should be tracking
  • Root cause analysis best practices
  • The essential role of risk in the CAPA process

Watch a free webinar on Document Management Best Practices for Life Sciences

1. Establish a Closed-Loop Process

For corrective actions to be effective, manufacturers need a closed-loop process for ensuring that CAPAs are completed and that implemented solutions work. Best practices and international standards such as ISO 9001 mention the Plan-Do-Check-Act approach, which covers  steps such as:

  • Documenting issues and initial containment actions
  • Investigation using the right root cause analysis tools
  • Creating the action plan and assigning tasks
  • Effectiveness checks and reporting
  • Issue follow-up via related processes such as audit management and employee training

2. Incorporate Risk Assessment into CAPAs

Risk assessment is an important step to add to any corrective action process. This can help you to:

  • Focus your resources where they are needed most
  • Determine which type of investigation is required
  • Escalate high-risk CAPAs appropriately
  • Gain visibility into where your biggest risks exist

Being able to filter your corrective actions by risk also provides a more detailed view into your CAPA process. Risk can then be incorporated into your reporting for data-driven decision-making that puts business impact front and center.

3. Standardize CAPA Workflows

Using an automated QMS, manufacturers can create standardized workflows for different types of corrective actions. For example, companies may want to create different CAPA workflows depending on the issue source, such as:

This allows for a more consistent process for handling different types of CAPAs efficiently. For instance, certain CAPAs may need to be routed to different individuals or groups, or may call for a specific investigation type.

4. Use the Right Root Cause Analysis Tool

Your QMS should come with built-in root cause analysis tools you can launch from the CAPA record to document investigations and lead you through each step. Organizations may want to designate different types of root cause analysis tools for different types of issues, such as:

  • 5 Whys: This tool is used to dig into successively deeper layers of a problem in an effort to get to the true root cause.
  • 8D: The 8D process provides a structured problem-solving approach for addressing complex or recurring issues, or those associated with high costs.
  • Failure Mode and Effects Analysis (FMEA): While typically performed when introducing new products or processes, FMEAs can also be used to explore potential causes of problems.

5. Establish an Accountability Loop

To keep corrective actions moving forward in a timely manner, manufacturers need to build in added safeguards around accountability to the action plan.

Who is responsible for each step? How will you escalate tasks that aren’t completed on time? Where does the completed CAPA need to be routed for approvals and signatures? What processes do you have in place to review CAPAs as part of your quality management review?

Establishing responsibilities, due dates, escalation rules, and approvals in the QMS creates an accountability loop that prevents CAPAs from slipping through the cracks in the face of more pressing priorities.

6. Address Frequent Issues First

While major or critical issues may seem like where you need to focus your attention, the frequency of the issue provides the real guidepost in terms of what to prioritize. That’s because even minor issues, if they are occurring on a frequent basis, have a bigger cumulative impact on the organization than one-off issues that are major or critical.

Categorizing and tracking the frequency of issues in the QMS is critical, looking at data such as where repeat CAPAs occur. Companies can also utilize frequency distributions to determine, for example, whether problems are happening at a specific part of the process.

7. Review Your Backlog

A large number of overdue corrective actions is a sign that you aren’t effectively managing CAPAs. It’s also something to watch out for from a compliance perspective, as FDA regulators and ISO auditors don’t look kindly on a huge backlog of unresolved problems—and are more likely to scrutinize the rest of your processes if they see this.

Differentiating between classes of issues based on risk can help determine where resources need to be focused. Definitions of minor, major, and critical issues may vary from one organization to another, however many target the following timelines for closure:

  • Minor: 30 days
  • Major: 45 days
  • Critical: 60 days

8. Identify Bottlenecks

CAPAs may languish for a variety of reasons; however, this creates significant risk for manufacturers as issues may snowball into larger problems over time. Bottlenecks in the process are crucial to identify to improve efficiencies while minimizing delays in CAPA completion.

There are several key elements to look at here. First, you want to look at how many issues have exceeded their target closure rate (CAPA aging) and the average time to closure for issues. Where these metrics are high, you’ll want to find out the source of the problem. In some cases, more resources may be required to adequately address problems.

9. Track CAPA KPIs

Companies that are successful with CAPA management are those that are adept at monitoring CAPA KPIs and using them to drive continuous improvement. Examples of CAPA KPIs that can be helpful to track include:

  • Number of open CAPAs
  • Average closure time
  • Number of overdue issues
  • Number of repeat CAPAs
  • Metrics on CAPA aging
  • CAPA first time through rate
  • CAPAs by issue type

10. Link CAPAs to Related Processes

In the context of the QMS, establishing a truly closed-loop process requires linking your CAPA system to other related QMS solutions, such as:

  • Document management: Where corrective actions involve updating documentation such as SOPs, processes or specifications, it’s important to have a direct link to those documents to ensure follow-through.
  • Employee training: Corrective actions may involve training tasks for individuals, so you want a way to link the corrective action documentation to employee training records for complete visibility.
  • Audit management: Verifying implementation and effectiveness of solutions developed as part of the corrective action process is critical. Adding new audit items to check helps close the loop on issues so you can see where further improvements may be needed.

11. Think Like an Auditor

To avoid compliance problems and strengthen their CAPA processes, manufacturers should look at their CAPA system through the eyes of an external auditor. Your goal should be to proactively identify gaps by asking questions like:

  • Which CAPAs have been open the longest and why?
  • Are issues and nonconformances such as out-of-spec (OOS) results being thoroughly investigated?
  • Where is CAPA documentation lacking?
  • Are risk assessments a routine part of the CAPA process?

By thinking like an auditor, companies can better prepare for external audits and inspections while continuously improving their CAPA process as a whole.

12. Document Everything

The final strategy presented here is one that is surprisingly simple, yet often overlooked: CAPA documentation. Lack of or poor CAPA documentation is a frequent cause of FDA 483 observations and warning letters, and thus must be a central point of focus for manufacturers looking to stay compliant.

There are two areas companies should focus on here: documenting CAPA details, as well as documenting the CAPA process itself.

Creating comprehensive CAPA records is much easier if you’re using an automated QMS, which allows you to document essential elements such as:

  • Source data (e.g., from complaints, nonconformances, deviations, etc.) to provide context in root cause analysis investigations
  • Investigation details and findings
  • Risk assessment results
  • Action items completed, with FDA compliant audit trails and electronic signatures
  • Effectiveness checks

With the QMS, companies can also upload supporting documentation and photographic evidence where necessary. When it comes to documentation, the strategy should be to document everything. This makes it easier to justify decisions, review why they were made, and provide comprehensive records to auditors upon request.

Conclusion

How well an organization manages its CAPAs is a barometer for how well it manages quality overall. With a well-defined process—and software to help document and coordinate the details—companies can avoid many common CAPA issues that lead to audit findings, quality escapes, and even recalls.

Download a free brochure on AssurX CAPA Management

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.