Risk Management Policy
Per ISO 14971, risk is defined as combination of severity and probability of a potential harm, and safety is freedom from unacceptable risk. Individual company or organization typically defines its own policy in terms of how to measure severity and probability, as well as how to evaluate risk level and acceptability.
TurboAC™ provides the capability for users to define and manage their own risk management policies, i.e. risk severity and probability scales, and risk acceptability matrix. The users can apply the policies automatically to the company-wide products with the flexibility for authorized users to make adjustment on the policy for an individual product or process.