Closed-loop quality processes from return to change order
Standard processes built on industry best-practices allowing you to manage the chain of activities from return authorizations (RMA) through non-conformance gaps, corrective and preventative actions (CAPA), change requests (ECR), and change orders (ECO). Processes are automatically triggered based upon the outcome of a previous task which ensures rapid, managed and accurate execution through the entire change process. Reducing lead times for new and modified products which reduces the risk of costly downstream errors.
Corrective and Preventative Actions (CAPA)
Corrective and Preventative Actions process can be easily configured to meet an organization’s exact needs. This provides a graphical representation of the CAPA processes to anyone within the organization, as well as auditors. The progress of specific CAPA items are managed in real time, providing a common view of the current status of them, helping to reduce process bottlenecks. Inherent full traceability of previous CAPA processes also assists in meeting compliance needs.
Process and information traceability to aid compliance
In-progress or completed processes, whether related to change, quality, or any other discipline, are fully traceable. Easy access to view details of who signed off at each stage, and when, and other information captured in the process, such as associated components or documents. Changes to any item are also documented, including who created them, when they were created, and any subsequent modifications made. This provides a single source for much of the data required to meet auditing and compliance requirements. Reduce time spent looking for information in disparate locations, and increasing an organization’s confidence in the validity of it.
Inspection activities can be defined early in the product development process. Documentation, such as component drawings, can be embedded into the plan to help Inspection teams fully understand what is required, and plan ahead effectively. Trace-ability of an inspection activity back to the inspection plan enables tracking of that inspection activity allowing you to follow issues in the field.
Quality management reporting
Real-time, graphical reports can be easily created based upon any metrics in Fusion Lifecycle. Information around change order rates, inspection defects, CAPA results, and much more can be made freely available in bar or pie chart formats, giving them an easy to understand overview of the data created within the PLM environment. Reports are in real-time, so always up-to-date, reducing the risk of potential error often found with manually compiled reports. Using these quality management reporting capabilities can reduce the amount of effort otherwise regularly spent compiling this data from numerous disparate locations.
Drive development of new products and services to become more competitive, profitable, and valuable to customers—with significantly less cost and risk.