Risk Reuse
As products become more sophisticated, providing teams with easy access to shared assets, such as risk information, is a critical success factor. A centralized risk registry with logical groupings, such as risk classes, allows organizations to work collaboratively on projects. The ability to branch and merge sets of risk information enables teams to jump-start analysis of new products and reduce overall costs.
As products become more sophisticated, providing teams with easy access to shared assets, such as risk information, is a critical success factor. A centralized risk registry with logical groupings, such as risk classes, allows organizations to work collaboratively on projects. The ability to branch and merge sets of risk information enables teams to jump-start analysis of new products and reduce overall costs.
Risk Traceability
Risk traceability is the ability to associate risk management information with project information such as requirements, test cases, versions, and releases. Risk traceability allows organizations to understand risks in context. It is essential for managing change, tracking risk activities, and instilling a culture of safety and risk management throughout the organization.
Risk traceability is the ability to associate risk management information with project information such as requirements, test cases, versions, and releases. Risk traceability allows organizations to understand risks in context. It is essential for managing change, tracking risk activities, and instilling a culture of safety and risk management throughout the organization.
Risk Change Management
Risks change as analysis uncovers new information, product requirements evolve, or new adverse events are reported. Successful risk management requires a process to analyze, approve, and communicate changes to project stakeholders. It also requires traceability in order to notify individuals and teams of new information that may impact work in progress.
Risks change as analysis uncovers new information, product requirements evolve, or new adverse events are reported. Successful risk management requires a process to analyze, approve, and communicate changes to project stakeholders. It also requires traceability in order to notify individuals and teams of new information that may impact work in progress.
Risk Management Workflows
Risk management workflows help tame the complexity of managing risk-related activities throughout your product portfolio. Customizable workflows help organizations follow a structured process to manage risk in new projects, respond rapidly to escalations, or prepare for regulatory audits.
Risk management workflows help tame the complexity of managing risk-related activities throughout your product portfolio. Customizable workflows help organizations follow a structured process to manage risk in new projects, respond rapidly to escalations, or prepare for regulatory audits.
Risk Monitoring and Reporting
Monitor your overall risk levels through dashboard, reports, and matrix diagrams that let you analyze the performance of your mitigation actions at a glance. Risk monitoring and reporting helps keep all team members up to date with the latest information.
Monitor your overall risk levels through dashboard, reports, and matrix diagrams that let you analyze the performance of your mitigation actions at a glance. Risk monitoring and reporting helps keep all team members up to date with the latest information.
Failure Mode Effects Analysis (FMEA)
FMEA is a powerful technique for managing risk. The FMEA framework is built around the identification of potential failure modes, or risks. Each risk is analyzed to determine its probability, detectability (controllability), and severity. Once analyzed, risks are prioritized and classified, and a mitigation strategy developed. FMEA is widely used in safety-critical systems development and can play an important role in achieving compliance with regulatory standards.
FMEA is a powerful technique for managing risk. The FMEA framework is built around the identification of potential failure modes, or risks. Each risk is analyzed to determine its probability, detectability (controllability), and severity. Once analyzed, risks are prioritized and classified, and a mitigation strategy developed. FMEA is widely used in safety-critical systems development and can play an important role in achieving compliance with regulatory standards.
Explore FMEA
Corrective Action Preventive Action (CAPA)
CAPA improves process quality by documenting, identifying, and fixing the root cause of errors. It tracks non-conformities, which can consist of undesirable outcomes (i.e. a rash when using a medical device), production errors (i.e. a substandard paint job), and other negative outcomes. The CAPA framework enables organizations to conduct root cause analyses, improve design, manufacturing and QA processes, and continuously monitor outcomes.
CAPA improves process quality by documenting, identifying, and fixing the root cause of errors. It tracks non-conformities, which can consist of undesirable outcomes (i.e. a rash when using a medical device), production errors (i.e. a substandard paint job), and other negative outcomes. The CAPA framework enables organizations to conduct root cause analyses, improve design, manufacturing and QA processes, and continuously monitor outcomes.
Explore CAPA
