Quality Risk Management

Who in an organization typically has ultimate accountability for QRM?

Quality risk management activities are usually, but not always, undertaken by interdisciplinary teams.

When teams are formed, they should include experts from the appropriate areas:

• Quality
• Business Development
• Engineering
• Regulatory Affairs
• Production Operations
• Sales And Marketing
• Legal
• Statistics
• Clinical

Each member of this team is responsible for coordinating quality risk management across various functions and departments in the company.

Who is Accountable?

While each team member plays some part in the QRM program, ultimately manufacturing plant team members and the Quality department are accountable. Specifically, manufacturing plant management and Quality Assurance leadership. If there is a QRM violation discovered by a regulatory body, these are the people who will be held accountable.