Definition
The process of determining the possible consequences of an event, Deviation, change or decision for quality, safety, compliance, data, processes and an approved state.
Human Explanation
It identifies what may be affected and how significant the consequences could be.
Why it Matters
It supports proportionate investigation, corrective action, testing, documentation and any required Validation.
Conceptual Boundary
Impact Assessment is not a complete Risk Assessment; it focuses on the reach and significance of consequences from a defined event or change.
Practical Perspective
Assessment should include direct effects and indirect dependencies across systems, processes, documents, data and requirements.