CAPA Management helps you quickly identify and address quality and safety issues in your supply chain, enabling you and your suppliers to pinpoint the root cause of nonconformances and implement corrective and preventative measures. It centralizes the tracking and management of Complaints, Nonconformances, and Corrective Action Requests (CARs), supporting organizations in meeting quality, safety, and regulatory standards.
Understanding the CAPA Workflow
CAPA Management supports adaptable workflows, enabling your team to address quality issues in a way that fits your unique needs. While there isn't a rigid process, many teams follow these common steps:
- Complaints: They often come from external sources, such as customers or end consumers. Once a complaint is reviewed and deemed valid, it may indicate a nonconformance.
- Nonconformances: After identifying a nonconformance, your team investigates the root cause to determine if it stems from a supplier, raw material, or an internal process.
- Corrective Action Requests (CARs): If corrective action is needed, your team can issue a CAR to address the issue. This may involve working directly with a supplier or resolving it internally. Preventative actions are documented, and the CAR remains open for monitoring until the issue is fully resolved.
In addition to the common use cases above, this flexible design also allows you to generate CAPA records, such as nonconformances and CARs, directly from the source: e.g. an audit that failed due to one or more nonconformances, or an out-of-spec COA you received from a supplier.
Key Features of CAPA Management
TraceGains simplifies and enhances the CAPA process with the following features:
Benefits of Using CAPA Management
Learn how your team can achieve the following with CAPA Management:
- Centralized Oversight: Manage Complaints, Nonconformances, and CARs in a single tab, providing a clear overview of supply chain issues and enabling quick action.
- Comprehensive Record Association: Link related CAPA records (Complaints, Nonconformances, and CARs) to trace the progression from issue identification to resolution, ensuring full visibility into the corrective and preventative actions taken.
- Supply Chain Integration & Enhanced Traceability: Easily tie CAPA records back to your supply chain by linking them with the Supplier, Item Supplier, COA or Audit they relate to, giving broader visibility, deeper insights, and enabling quicker action to address issues you might be facing.
- Improved Documentation and Reporting: Break down and document each stage of the CAPA process - Complaints, Nonconformances, and CARs - separately while maintaining connections between them for better tracking and reporting.
Who Can Leverage CAPA Management?
CAPA Management provides value to regulatory compliance teams, quality assurance teams, and other operational leaders. It also supports executive stakeholders who are responsible for identifying, addressing, and preventing safety, quality, and other regulatory issues within the F&B supply chain.