Quality risk management is described by regulators via ICH-Q9, an international guidance document that addresses this subject.  Quality risk management is most often associated with validation, and project teams will try to use this concept to focus (streamline) the validation effort.  While this approach is not without merit, quality risk management is so much more than a way to reduce validation costs.

Quality risk management can be applied throughout the product and process development and manufacturing lifecycle, and it can be applied to all aspects of the manufacturing quality system.  From the early selection of process unit operations, to the identification of critical process parameters, through the application of procedures, training, and personnel qualification to control aspects of the manufacturing operation, quality risk management can be a powerful tool.

Teams that use quality risk assessments find they improve designs, facilitate design reviews, ensure a complete manufacturing quality system is developed, identify key aspects of procedures, training and maintenance programs, and reduce the cost of compliance during manufacturing operations.

Commissioning Agents has the depth of experience in many facets of quality risk management, from facility programming to equipment qualification to quality system auditing.