Risk
Managment
Preventing, controlling and
mitigating unwanted risks …
for maximum reliability
Prevent, Control and Mitigate Risks
the Minerva Way
Minerva Risk Reduction begins with the mapping of your products and processes
by creating diagrams that will help you identify, assess, evaluate, prioritize and ultimately, mitigate risks. We will use the corresponding databases to analyze the data collected, and effectively use the time of your technical, operations, and software development personnel.
The resulting risk-mitigation actions are incorporated in the designs, processes, procedures, records and software, reducing quality issues and improving productivity and on-time delivery.
Risk-Based Analysis for Failure Reduction
Minerva digitalizes manufacturing procedures and records, and uses experiences to create highly visual presentations for risk mitigation meetings. The visually supported data provides for the development of strategies to prevent process failures, which is then followed by rapid reduction and elimination of design, process and risk usage.
Expedited Risk-based Investigation Resolution and Reduction
Minerva provides on-site and virtual reliability teams combining multi-disciplinary capabilities and supported by development scientists, engineers, and visualization experts.
We diagnose and correct manufacturing issues as soon as, or before they occur; producing better, long term, corrective and preventive actions.
Risk Management
Minerva’s integrated, highly visual, digitalized approach to risk management ensures minimum risks, and failures in the product development and commercialization of Advanced Therapies and Robotic Medical Devices.
See What You Can Get:
Complete product architecture characterization
through user-friendly diagrams for fast identification or potential failures.
Comprehensive process mapping
through advanced flowcharts with proved format and structure, to identify inefficiencies and reduce risks.
Integration of databases
and risk management tools for risk analysis and risk modeling to support informed decision-making and provide real-time insights to proactively address risks.
Use of modeling languages
for mapping simplification of hardware and software architecture and provide detailed activity and deployment diagrams.
Facilitation of risk mitigation meetings
for better efficiency and use of company resources attending risk assessment meetings.
Risk files in relational databases
that centralize information and foster easier collaboration and integrated reports.
Creation of multiple risk-based deliverables
including risk file report, validation protocols, operational procedures and operational records, among others.
Alignment of risks with requirements and specifications
to ensure complete risk-based traceability and qualification activities.
Complete Risk Assessment Services
including risk assessment, risk control, risk mitigation, risk benefit analysis, and risk monitoring and communication.
Risk-based quality investigations
assessing potential risks with quality issues to prioritize investigations and corrective actions.
And quality investigations backlog reduction.
Priority-based execution
of the risk management process and reports.
Well-defined risk methodology
including root cause analysis, risk assessment and risk mitigation.
This provides a comprehensive framework for risk management in all phases of your product development, technology transfer, and market sustenance.
Improvement of risk management deliverables
like reports, risk-mitigated design packages, operational and test procedures, and data collection records.
Investigative Regulations
are followed to ensure compliance and patient safety.
Productivity
is Hope.
Increase your productivity with Minerva manufacturing failure prevention and risk mitigation services.