Definition
The process of planning, assessing, approving, implementing and documenting changes that may affect quality, safety, compliance or the effectiveness of processes and systems.
Human Explanation
A significant change is assessed before implementation, not explained only after it happens.
Why it Matters
Even a small change may affect a previously validated state or create new dependencies and risk.
Conceptual Boundary
Change Control is intended to enable informed and controlled change, not to prevent all change.
Practical Perspective
Assessment should address reason, impact, risk, approval, implementation, Verification and any required Requalification or Validation.