Quality process events such as Customer compliant, CAPA event should be recognized and managed by implementing a risk management program. A well-integrated risk management process in quality management system offers an organization many benefits. As a "before-the-event" activity, it can discover design inadequacies early in product development, avoiding costly changes or surprises during the test phase. It can also minimize the chances for physical injury and safety-related product recalls and provide some liability protection by acting as evidence of due care.

Organizations adopting leading risk management frameworks such as ISO 14971 and ICH Q9 can integrate their risk management process with every quality event and record in the quality system. Quality system should offer following key capabilities to enable a closed loop risk management program

Quality Process integration with risk management framework - Quality management modules such as CAPA, Audit, Suppliers Quality, Complaints management should integrate with risk management framework and enable organization to define and manage risk management program.


  • CAPA module can offer extended metadata to store the Impact and Likelihood of the event to help quality manager in sorting and filtering CAPA records with high priority.
  • Internal audit management module can provide extended capabilities such as facility to develop Risk Probability Number based on Impact, Likelihood and Detection (Difficult and Timeline) attributes.
  • Supplier corrective actions and customer complaints should be associated with the Impact and Likelihood to assist in risk classification.

Risk based QMS should allows integration of data from Audits, CAPA, customer complaints and other quality modules, to build the risk tolerance zone, through the dashboard reports and help in a risk management program.

Control based Risk Management Framework - Quality management practices are moving increasingly toward a systems approach that concentrates more on control of processes rather than efforts targeted toward extensive inspection and remedial actions on end products.

Quality management solution should enable organization to adopt a control-based risk management strategy. It should allow capabilities to define and maintain a centralized structure of various processes and risks. This includes processes, hardware and software components, environmental factors, associated risks, controls to address the risks and mechanisms to assess the controls. It also includes associated policies and procedures, reporting requirements and filing templates and schedules for various regulations. Assessment plans to evaluate and ensure the effectiveness of the controls can be designed and assigned to owners based on roles and responsibilities. Based on the compliance requirements and associated risk, the assessment plans can be scheduled periodically or triggered based occurrence of certain events. Assessment programs and documentation can be shared within and across processes for higher efficiency.

Risk management dashboard reports - Quality management solution should offer dashboard reports such as risk scorecards and risk heat maps to identify and mitigate risks in the organization. Executive-level dashboard and reports provide visibility into the risk analysis, helps in highlighting key risk metrics and policy compliance.

Enterprise Risk Management Capabilities - Quality management solution should offer capabilities to map quality process risks with the enterprise risks. This capability will help organizations to visualize the quality process risks in relation to overall enterprise risks such as manufacturing, regulatory and compliance risks.

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