Constant assessment of the potential risk in your manufacturing process and its effects on customers, processes, and workers is crucial to maintaining a seamless manufacturing process that produces products of standard quality.
ISO 14971 risk management is designed for medical devices. It includes policies, procedures, and practices for analyzing, evaluating, and controlling risk.
Orcanos is an integrated system, connecting R&D and quality management.
This allows you to close the loop. It’s not just recording risks in a database system, but to document and trace the entire flow, such as:
Risk source – Risk can be derived from multiple sources, such as Complaint, CAPA, or from a design change.
Risk Mitigation – Is mitigation by design? in that case, you can link the risk to a design control artifacts, such as requirement.
Control verification – Link test protocols to the requirement, and record verification results.
This chart illustrates the following use case:
In this use case, we see that a complaint derived a risk, and the risk mitigation is by design, so we have linked a requirement to the risk, and test case to the requirement.
We can see that the bug is not “Just” a bug, but a bug that is linked to a risk mitigation verification, and in some way the bug is related to a complaint. This information may be crucial for the team to understand.
The next illustration shows Orcanos generated traceability matrix, starting from the complaint, up to the test results of the risk mitigation verification:
The Orcanos system allows full customization and configuration of your electronic forms. It is easy as drag and drop. This capability, along with custom filters makes it easy to comply with the ISO 14971.