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Corrective Action and Preventive Action (CAPA) Process

Jonathan D. Rhyne
Illustration: Corrective Action and Preventive Action (CAPA) Process

Corrective Action and Preventive Action (CAPA) Process

capa software for corrective action

How Satisfied Are You with Your Corrective and Preventative Actions Process?

When organizations create processes to meet CAPA requirements, they must ensure efficiency, compliance, and effectiveness. They must also drive continuous improvement throughout the organization. Managing critical noncompliance processes manually with paper, spreadsheets, email, and non-automated methods can risk compliance and cause non-conformance or deviations.

CAPA software, or CAPA Management Software, like Nutrient Workflow, can improve your action plans to ensure desired outcomes and safeguard your organization. But, as you’ll see, this is just the start of how Nutrient Workflow can help your business.

How Does Corrective and Preventative Actions Software Help?

Nutrient Workflow offers a comprehensive CAPA solution streamlining and automating corrective and preventive action processes. Nutrient Workflow eliminates manual noncompliance process tasks such as paper forms and spreadsheets. This helps your organization stay compliant and reduces the risk of mistakes or problems.

With Nutrient Workflow, you can easily make and control action plans, give tasks to the right people, and monitor progress instantly. The software stores all important information and documents in one place, making it easy for people to access.

One of the key benefits of using Nutrient Workflow is its ability to improve the efficiency of your CAPA process. The software automates tasks, saving time for employees to focus on more important work. This increases productivity and ensures that we implement corrective actions promptly.

In addition to efficiency, Nutrient Workflow also enhances the effectiveness of your CAPA process. The software provides advanced analytics and reporting capabilities, allowing you to identify trends, track performance, and make data-driven decisions. This enables you to continuously improve your processes and prevent similar issues from occurring in the future.

Furthermore, Nutrient Workflow helps safeguard your organization by ensuring that all actions taken align with regulatory requirements and industry standards. The software checks and follows the rules, reducing errors and ensuring it takes all necessary steps.

Corrective Action Process in Nutrient Workflow

This is a process using Nutrient Workflow for reporting and fixing issues. It starts with reporting the problem and providing details and documents. Next, it undergoes examination, amendments, evaluation, and authorization.

Automated CAPA Process Example

Corrective Action Process Automated

This process and dozens of others are available to Nutrient Workflow customers. Check out our Process App library.

Types of Corrective Actions to Track with Nutrient Workflow

There are many instances of remedial measures for noncompliance in different industrial and commercial applications. Here are a few examples we see most often:

  • Deviations from company policy. In human resources language, if workers violate a business rule or process, the organization might admonish them for following such behavior. A typical instance is a staff member absenting themselves from work without prior notification. In certain cases, the infraction might necessitate a modification in the policy.

  • Major incident or quality event.  The Deepwater Horizon incident occurred in 2010. It resulted in the death of 11 workers and injuries to 17 others. Furthermore, 60,000 barrels of oil leaked into the ocean. The source of the problem was identified as the failure of heavy blades located approximately 20,000 feet below the water’s surface.
    A CAP would have been implemented for this and all comparable major incidents. In this instance, the remedial measures have resulted in worldwide modifications in design and upkeep procedures for analogous oil & gas facilities.

  • Mistakes due to human error or insufficient training.  Wrong data entry into business software can result from human mistakes or inadequate training. This could be an honest error or a consequence of insufficient training. We respond by offering more training.

  • Equipment/software safeguards —equipment or software integrated with triggers and alerts that activate when a parameter exceeds a certain tolerance level. A typical instance is when an alarm goes off on a device because the temperature surpasses pre-determined limits.

  • Tool calibration.  In the manufacturing sector, tools are frequently recalibrated to ensure they measure within established tolerance ranges.

  • Failure to comply with a process/procedure.  We didn’t adhere to the prescribed process or procedure while performing a task. How often do we become annoyed when putting together flat-pack furniture because we didn’t pay close attention to the instructions?

Nutrient Workflow Features

Process Builder

Nutrient Workflow’s graphical process designer interface enables users to create personalized task workflows through a drag-and-drop mechanism. Users can auto-allocate tasks and direct information according to their organization’s specific workflow. Additionally, they can establish alerts, reminders, and escalations to ensure continuous work progression.

Form Designer

Easily create responsive, Web-based forms to capture information. Use different fields, logic, templates, and layouts to consistently capture and route accurate data.

Custom Self-Service Portal

User-friendly portal for submitting forms, completing tasks, and tracking process status, creating a seamless experience. Enable role-based visibility to view the status of completed, pending, or in-progress tasks. Collaborate in real-time on the work you are performing.

Process Reporting

Nutrient Workflow tracks and logs all workflow processes, form data, and user actions. Monitor team progress and use KPI dashboards to measure total productivity and encourage improvements.

Process Integration

Nutrient Workflow allows customers and partners to make their workflow apps and integrate them with existing enterprise systems. This is a web service that other apps can use. It can start a process, finish tasks, update progress, and perform other two-way actions. 

Title 21 CFR Part 11 Compliance

Nutrient Workflow works with various FDA-regulated companies and organizations, and we’ve worked hard to ensure our product meets the FDA’s requirements for electronic records and signatures. The table below shows the requirements for Title 21 CFR Part 11 and Nutrient Workflow’s compliance.

Are You Looking for CAPA Software to Improve Your Corrective Actions Process?

Nutrient Workflow is a powerful process automation platform enabling you to create and implement your personalized corrective action process, which includes:

  • Reporting of Incidents

  • Task Assignments

  • Notifications, Reminders, and Escalations

  • Tracking of Processes

  • Key Performance Indicators and Reporting

  • Comprehensive Safety Audit Trail

To learn more, schedule a demo to see a live, CAPA process and learn more about our platform.

Author
Jonathan D. Rhyne Co-Founder and CEO

Jonathan joined Nutrient in 2014. As CEO, Jonathan defines the company’s vision and strategic goals, bolsters the team culture, and steers product direction. When he’s not working, he enjoys being a dad, photography, and soccer.

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