Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
During the July 11 blog, we explored the aspects of risk analysis and risk estimation. But what is a risk that is deemed unacceptable?
If a risk is determined to be unacceptable, the existing risk analysis should be re-examined and the appropriate action(s) taken to meet the risk acceptability criteria. If a new hazard is identified, the four phases of risk management should be performed to ensure that the risk is being adequately controlled.
For risks that cannot be mitigated, ISO 14971 Annex J provides guidance on communicating risk. Manufacturers should explain each risk, its consequences, and how to prevent it, as well as who should receive that information and how the risk information should be disseminated. Remember that information for safety such as warning labels and guides should be your last resort. The priority order is: