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Risk Management in the Medical Device Industry: How Do You Measure Your Risks?

July 6, 2016 / by Emily Ysaguirre

Risk is prevalent in all industries.  In the Life Sciences in particular, orgMeasuring_risks_in_medical_devices.jpganizations must be extremely careful to ensure the safety and quality of all products, as they affect health and well-being. It's critical for those in the medical device industry to stay on top of possible risks to ensure each product is of the highest level of quality to ensure the safety of consumers.

One of the best ways of assessing risk within the medical device industry is through automated risk management. Risk management enables companies to catch adverse events at the root cause, so you can make changes to ensure this risk doesn’t repeat itself.

In the Life Sciences, investing time into improving processes is a surefire way to ensure a product prevails. How?

By making every process a risk-based process.

The Compliance Management System’s Risk Management tool provides a history of risk and tracks identifying trends with a risk analysis across multiple departments. This provides a corporate-level report on risk and enterprise risk management. Creating visibility enables an organization to ensure continuous improvement. In allowing companies to build portfolios for individual products, the enterprise is able to leverage previous risk assessments and reset them all the way back to product design if need be. This quickly identifies the appropriate risk level, enabling risk to be filtered by criticality, rather than the order in which events enter the system.

Risk-based filtering provides companies with:

  • Automatic segregation and categorization of events at the source module level (Complaints, Audits, etc.)
  • Automatic identification and display of risk assessment for related events
  • An initial risk assessment to allow early closure of non-critical events
  • Ability to calculate risk throughout the process to guide decision-making
  • A full investigation with step-by-step root cause analysis to ensure overall impact of events
  • Automatic lookup and display of related investigations and CAPAs
  • Comprehensive Risk-Based CAPA Software action and effectiveness check plan with risk mitigation history

Using automated Risk Management processes helps companies reduce the number of CAPAs sent by filtering non-critical events form the critical events—this means you have visibility into the events that are most critical to your organization so you can make changes to prevent recurrence of these events.

View our webinar on risk-based thinking in Quality Systems

Topics: Life Sciences