CAPA Management: How Software Can Help Manage and Support the CAPA Process
Shamonique Schrick
CAPA, or Corrective and Preventive Actions, are critical activities of pinpointing, addressing, and preventing issues in manufacturing facilities. While the Corrective Action is designed to correct immediate problems, the Preventive Action aims to prevent it from recurring. Here, we’ll take a closer look at the importance of CAPA management, and how software can support a seamless CAPA process.
Why Is CAPA Management Important?
CAPA management includes the processes of:
Investigating the cause of nonconformities relating to product, processes, and quality and food safety systems
Identifying the action(s) needed to correct and prevent recurrence of non-conformances
Verifying or validating the Corrective and Preventive Action to ensure that such action is effective
Ensuring all activities relating to the CAPA are documented
CAPA management is a considerable undertaking in a manufacturing facility. Compiling CAPA-related information, keeping it organized, and documenting it properly can be challenging. Reports can go overlooked, and issues may therefore never be effectively resolved. This can lead to cost, quality, and safety concerns, which could have serious implications. The importance of effective CAPA management cannot be underestimated.
Uses for CAPA Management Software
CAPA management software will naturally support incident/CAPA management, but most software solutions will support a broader variety of uses. For instance, CAPA software could help you audit non-conformance resolution, track operations and continuous improvements, and investigate incidents with root cause analyses that drive better improvements to the organization as a whole. Keep in mind that when the CAPA system is linked to data, reporting, and documents, it’s easier to drive quality improvements.
Benefits of Using Software for CAPA Management
Using a software framework like SafetyChain will ensure you’re able to manage the CAPA process with little hassle. Documentation and records are readily available and secured, which results in the following benefits:
Efficient, on-demand data retrieval and data management
Ability to track the workflow of investigations and resolutions to understand exactly where you are in the CAPA process
Ability to assign tasks to specific users or departments for enhanced collaboration
Automated reminders
Attachment of related evidence records
A controlled way to organize and report findings and activities to auditors
Ultimately, CAPA systems should make it difficult to neglect issues or let them build up. They’ll improve collaboration and prevent unnecessary meetings, emails, or other communications, all while mitigating the risks identified in the CAPA process. CAPA software also provides a full audit trail and a single source of truth for you to understand how issues are linked together, instead of getting siloed in emails or disparate systems. When all of your data is located in one place, you can perform real-time investigations without having to track people down for updates.
Dashboards
With SafetyChain, you’ll see a comprehensive landing page to see how many cases or CAPAs are currently open. It also shows you statuses so you can quickly see which are critical, complete, or late, and how many tasks are assigned to you. The system also allows you to assign due dates and owners of each CAPA, and indicate whether the case is a full-blown CAPA that needs to be addressed or not. It offers a holistic view without having to go into a spreadsheet, scroll, and hope that someone else has entered an update.
There are also different views available, with the option of filtering by date range, severity, and source of the CAPA (such as quality, product, performance, and so forth). With these options, you can quickly pinpoint what’s at risk of being late and address issues in real-time without having to schedule meetings with your whole group. These options are also customizable so you can track the data that’s most relevant to your organization. Plus, databases can be plant-specific or enterprise-wise, and may be as detailed or high-level as you’d like.
Data Inputs
Data input plays an integral role in capturing the full picture of CAPA. With SafetyChain, you can clearly identify and standardize the stages of the CAPA workflow. For instance, you can indicate whether the CAPA is open or complete, enter a target due date, and summarize what happened. As you manage the CAPA process more efficiently, you’ll reach a point where you’re more proactive than reactive with incidents.
The system also features metadata and a complete history of each incident or CAPA. As such, you’ll be able to promote accountability around the CAPA process, and you’ll also be able to refine the process for the future.
Reporting
Ideally, your CAPA management solution should have the ability to integrate QMS data. That way, you’ll have all of the necessary information at your fingertips, and the CAPA process will become more robust over time. You should also have the ability to email or print a CAPA if necessary. Reporting features should also include the ability to display all records, including any attached images, from one convenient location.
Secure Profiles for External Use
With SafetyChain, you can grant access to specific CAPA trails without providing access to your entire database. This is ideal for auditors or members of your organization who may need to access a CAPA but don’t necessarily need to see all of your plant data. During audits, this convenient feature will prevent you from having to pull up the complete CAPA register. Plus, because access is controlled, auditors will have the ability to view the CAPA but not alter or edit any records.
Best Practices for Configuring Software
To get the most from your CAPA management software, there are a few important steps you can take during configuration.
Define the needed outputs. Specifically, determine the type of reporting that will be important for your business. Knowing that will help you define the categories, stages, and sources relevant to the organization to help standardize processes.
Define needed workflows. These could be unique to different types of incidents, but you’ll want to have a clear understanding of how processes work before configuring your software, as this will promote a mature CAPA process. Think about the steps involved, including investigating, reporting, following up, and verifying incidents. For instance, SafetyChain allows you to set up automated verifications of effectiveness so you can revisit CAPAs in the future and determine whether the steps you took were successful. Without an automated reminder for follow-up, past CAPAs can easily fall off the radar.
Consider the needs of auditors. Think about both audits you’ll undergo as well as ones you’ll be performing.
Define terminology. Establishing consistent terminology is important to supporting alignment, as well as identifying needed outputs and workflows. To learn how CAPA is set up in SafetyChain, check out this Step-By-Step Guide for Using CAPA in SafetyChain.
In Conclusion
While each facility’s CAPA process may look slightly different from the next, a CAPA solution such as SafetyChain can help you avoid risks and derive business value. This is especially true when the CAPA solution is automated and linked to your maintenance systems, as this will help you take a proactive approach to root cause analysis and CAPA management.
