Quality Risk Management is the process to ensure risks are controlled. Control over risk, providing visibility of effective control and risk communication is the primary goal of risk management. Risk management methods used to address risk exposure in certain processes, must include the key elements of risk management as defined in ICH Q9 as covered by Ascent Development Services’ (Ascent) Quality Risk Management procedure (SOP-QM-005).

The Bowtie risk assessment method will define the effectiveness of the controls within the quality management system. This method was developed with guidance from ICH E6, ICH Q9 Annex 2.

This document applies to Ascent employees and contracted personnel performing assigned duties. Ascent will implement Quality Risk Management even if Ascent procedural documents will not be used per contractual agreement with the Sponsor/Client or other CRO. This policy will cover risk management for the company and department level. Risk Management for projects are governed by the Project Management SOPs.