Change Capability (+)
Closed-loop, linked quality processes from return to change order
Standard workflows are provided, which can be easily configured to match an organization’s exact process.
- Return authorizations (RMA) through the raising of non-conformances
- CAPA process management
- Change requests (ECR) and ultimately to change orders (ECO)
- Automatic spawning of processes, based upon the outcome of previous ones
- Reduce lead times for new and modified products, and reduce the risk of costly downstream errors
Corrective and Preventative Actions (CAPA)
Standard Corrective and Preventative Actions process workflows are provided, which can be easily configured to match an organization’s exact process.
- Provides a graphical representation of the CAPA processes to anyone within the organization, as well as auditors
- Improves general understanding of what the process entails, and providing process proof to help meet compliance requirements
- The progress of specific CAPA items are managed real-time, helping reduce process bottlenecks
- Inherent full traceability of previous CAPA processes also assists in meeting compliance needs
Process and information traceability to aid compliance
All in-progress or completed processes, whether related to change, quality, or any other discipline, are fully traceable.
- Details of who signed off each stage, and when, and details such as associated components or documents
- All changes are fully documented, including who created them, when they were created, and any subsequent modifications made
- Provides a single source for data required to meet auditing and compliance requirements
Up-front inspection planning
Inspection activities can be defined early in the product development process.
- Visibility to Inspection teams, and other interested parties, of the requirements
- Documentation, such as component drawings, can be embedded into the plan
- Helps Inspection teams fully understand what is required, and plan ahead
- Traceability of inspection activities should the need arise for investigation following issues in the field
Quality management reporting
Real-time, graphical reports can be easily created including any quality-related data.
- Information around change order rates, inspection defects, and CAPA results can be displayed in bar or pie chart formats
- Reports are in real-time, so always up-to-date, reducing the risk of potential error.
- Quality reporting capabilities can reduce the amount of effort regularly spent compiling data