Definition
Properties of a product or process result that must remain within appropriate limits to ensure required quality, safety and conformity.
Human Explanation
CQA identify which product characteristics matter most to quality.
Why it Matters
They guide the selection of process parameters and controls that protect the required result.
Conceptual Boundary
Not every product property is a CQA; criticality depends on its potential effect on quality, safety or conformity.
Practical Perspective
CQA provide a basis for designing the Control Strategy and defining Process Validation evidence.