1000846 Speaker Data Sheet, Background

3000017 Risk Management - Principles of Lean Documents and Lean Configuration

Background

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.

During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or to the environment during all stages of a product’s life cycle and supply chain.

Risk management is a process that involves many considerations, responsibilities, personnel, and the transfer of knowledge. Given that it transcends projects and even companies, it is particularly critical that key pieces of information survive these many hand-offs.

In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents, files, and requirements.