01
Subject and purpose
- Product, equipment, or process name
- Research-use, engineering, or commercial purpose
- Decision this project must support
PROJECT READINESS
Start with the decision, even when documents are incomplete
An initial scope can be defined from the subject, current stage, and most concerning failure condition, even before a URS or cost sheet exists.
INPUT CHECKLIST
Four inputs before kickoff
An honest current-state view protects scope, schedule, and budget better than a polished but incomplete document set.
02
Current evidence
- Latest specification, drawings, and BOM
- Existing test, lot, and deviation records
- Open risks and planned changes
03
Responsibilities and approval
- Design authority and manufacturing accountability
- Execution, review, and approval owners
- Supplier, facility, and external test responsibilities
04
Schedule and completion
- Required quantity and target schedule
- Pass, conditional, and failure criteria
- Use, release, or next stage after completion
VALIDATION SCOPE AGENT