
488 Appendix IV
Required Criteria of Requirements Verication Possibilities
A production trial
run (PTR)
process is
implemented.
1. A standardized communication
procedure and form to control
and monitor all PTRs that
documents each step of the
process and records all approvals
and results.
2. Traceability of trial run batch is
ensured.
3. Quality reviews documented to
release product for PTR shipment
and verication process has
returned to normal production.
Example of a trial run.
Trial run validation criteria and
results (records).
Maintenance
Maintenance
organization and
strategy are
established and
deployed.
1. Maintenance process is
formalized ...