Product deficiencies can threaten human health and safety. Furthermore, recalls of drugs, medical devices, manufactured products or foods are hugely expensive and can severely damage the company’s reputation. Getting things right the first time is not just desired, it is a requirement. Managing quality risk is mandatory in highly regulated industries such as the life sciences, but also in all food production and manufacturing industries, including semiconductors and consumer packaged goods. Such diverse enterprises all share the need to perform comprehensive risk assessments.
