Why this becomes difficult to defend
The decision exists. The basis for it may not be retrievable as one record.
The investigator is reviewing a specification change. The change is documented and implemented. The investigator asks who made the formal authorization decision — not who signed the change control.
The specification change record documents approvals and implementation. It does not document who evaluated the scientific and regulatory basis and made the formal authorization that the new specification was acceptable.
What must be retrievable
The reviewer needs more than the final outcome.
- Named individual accountable for the specification change authorization
- Scientific basis reviewed before the change was authorized
- Regulatory standard applied to the specification determination
- Authorization timestamp for the specification change
- Reasoning for why the new specification maintained product quality and compliance
Relevant proof
See how the record connects evidence, judgment, risk, and authorization.
A completed ComplianceWorxs record shows the reasoning layer that is usually hardest to reconstruct after the decision has been made.
When this is your active decision
Preserve the reasoning before the context disappears.
Use the completed proof first. When the decision is consequential enough to preserve, create an Inspection Response Record for the actual decision.