Definition
A systematic process for identifying, assessing, controlling, communicating and reviewing risks that may affect the quality, safety or compliance of a product, process or system.
Human Explanation
It determines what may go wrong, what the consequences could be and where controls should be concentrated.
Why it Matters
Risk-based decisions align Validation and control effort with the significance of potential harm.
Conceptual Boundary
Its purpose is not to eliminate every risk but to keep risk understood, justified and controlled.
Practical Perspective
Assessments should use current knowledge and Evidence and be revisited after significant change or new information.