Risk Management Connections

Overview

Risk Management is a cornerstone of a well running Quality Management System (QMS). While critical for the success of an individual product, a properly connected risk management system also provides the roadmap for driving many aspects of the QMS, including supplier controls, verification and validation activities, change controls, CAPA, and customer feedback.

Challenge

Building an integrated risk management system with living documentation that ensures risk documentation is providing the information necessary for decision making.

Approach

MEC Technical Program Managers and Subject Matter Experts will work with the client to determine the needs of their risk management system, developing the necessary processes and tools, including:

• Risk Measurement Methods
• Risk Management Plans
• Risk Acceptability
• Hazard Analyses
• Design, Process, and Use Risk Assessments
• Benefit-Risk Analyses
• Risk Management Reports

MEC Technical Program Managers and Subject Matter Experts will work with key process owners to determine the inputs and outputs of Risk Management within the quality system, then build those connections through the QMS. This has the following benefits:

• Robust Documentation – Risk documents that can be built and are easily understood by key decision makers throughout the organization, providing clear connections between risks, their causes, controls, and verification activities.
• Living Documentation – Connecting risk management system inputs with key feedback processes ensures that risk management documentation will always be current.
• Compliant Documentation – Building a comprehensive risk management file that meets the requirements of international standards and regulations.
• Risk based decision making – Having the ability to make quick decisions as necessary from existing risk documentation without continuously needing to go out and obtain new information.

Outcome

MEC helps clients focus on what is most important – ensuring a safe and effective product for their users - while also helping to build an integrated risk management system that is robust and adaptable to the needs of the client.

By Medical Engineering Consultants – Risk Management Subject Matter Expert, Earl Davis

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