SMART QMS – Risk Management Module

Risk Management Monitoring System for IATF & ISO Compliance

Risk is the possibility of events or activities impeding the achievement of an organization’s strategic and operational objectives. ISO 9001: 2015 emphasizes on risk based thinking. Risk Based Thinking is not just the responsibility of management – Risk Based Thinking must become an integral part of the organizational culture.


A lack of standard risk management analysis methodologies and assessments results in enterprise-wide waste of time, money, and resources.

In environments where risk assessments are performed but are not standardized, risk evaluations may vary from one assessor to the next. Whether an appropriate action is taken depends on the particular assessor, meaning that similar issues may end up being treated differently.

A consistent approach in assessing and managing risk is crucial to successful quality management. Blue Ocean risk management software system is an integrated solution to help companies identify and mitigate long term systemic risks by tracking and analyzing the recurrence of issues.

Blue Ocean Risk Management System brings together all risk management related documentation in a single location. Blue Ocean risk management system has scheduled reporting and full search capabilities to provide insight and easy access into risk assessment and mitigation activities.

Blue Ocean Risk Management System provides employees from different departments with a simple and efficient method for participating in risk assessment and mitigation activities. Blue Ocean Risk Management System offers electronic workflows and signatures for execution, review, and approval of risk activities and documentation. Personnel can leverage a risk-based approach in multiple processes including CAPA, non-conforming material disposition, protocol development, supplier qualification activities, etc.

Key benefits and features:

  • Uniformity : Blue Ocean risk management systems gives quality and regulatory departments uniform methods to perform consistent risk analyses. Engineering and manufacturing personnel can easily document and store risk mitigation activities in product and process design.
  • Reporting Tools : Blue Ocean risk management software has analytics reports that allow analysis of risk files and risk assessments. The system’s scheduled reporting capability and intelligent threshold rules also increase management awareness.
  • Increased Management Oversight : The software’s standard methodology simplifies the application of resources in the most risk-prone areas. The Blue Ocean risk management software systems insures that organizational risk tolerance is not exceeded.

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