WI-208 handover assessment at the 10:00 transition
Filled fictional example — adapt to your procedure and actual evidence.

SOURCE PACK
- The reviewed revision-5 implementation plan and the actual activation time.
- All affected batches, including prepared work; inspect pinned references, generated instructions, assignments and prerequisites.

FINDINGS
B-208-A: Already executing revision 4. The illustrative implementation plan permits it to finish on that basis.
B-208-B: Created but not started, with revision 4 assigned. Its reassignment remains unresolved.
B-208-C: Created after transition with revision 5 assigned. Other readiness requirements still apply.

NEXT WORK AND CLOSURE EVIDENCE
Manufacturing change owner
Action: Link the permitted continuation decision to B-208-A.
Evidence needed: The original instruction and the reviewed reason for continuation remain available beside the execution evidence.

Batch preparation owner
Action: Assess B-208-B’s copied content, tasks and prerequisites before reassigning its instruction.
Evidence needed: The actual prepared work agrees with the authorised revision; changing a revision label alone is insufficient.

Batch reviewer
Action: Inspect a newly created B-208-C and reconcile any batches created during transition.
Evidence needed: The assigned reference resolves to revision 5 and the applicable prerequisites are satisfied.

CONCLUSION
The default change is implemented only for the work it actually affects. B-208-B remains an open handover item until its prepared execution basis is reconciled. B-208-A’s historical instruction remains revision 4.

WORKED EVIDENCE REVIEW
Inspect what must change on the prepared batch.
Extend B-208-B with a fictional revision delta: revision 5 adds an independent setup verification before the first addition. The handover owner must inspect the prepared task list, assigned reviewers and readiness evidence, not only its instruction link. Record the specific changed requirement from the actual controlled instruction; this example does not prescribe an additional manufacturing check.
At the transition point, retain the original affected-batch list. Immediately before releasing B-208-B to start, reconcile any work created since that list was taken and inspect whether execution has begun in the meantime. If the batch has started, its treatment needs reassessment against the implementation plan; yesterday’s “not started” classification cannot govern today’s in-progress work.
Accept the reassignment only when the revision reference, executable content and prerequisites agree and the authorized treatment is recorded. If preparation cannot be updated consistently, keep start readiness unresolved while the owner decides how to correct or replace the prepared work. Retain the old preparation and its superseding relationship so the history explains the change.
ICH Q10 §3.2.3 describes evaluating, approving and implementing changes through a change-management system that addresses unintended consequences. The prepared/running/new-batch comparison is this guide’s practical application of that principle. The transition plan supplies the actual treatment for each batch.
ICH Q10: Pharmaceutical Quality System: https://database.ich.org/sites/default/files/Q10_Guideline.pdf
B-208-B revision-5 reassignment inspection — fictional extension
Item inspected: Instruction assignment
Evidence before start: Pinned WI-208 revision 5 and authorized reassignment
Unresolved mismatch: Revision label changed without the assigned reference
Item inspected: Generated steps
Evidence before start: The new setup-verification task is present in executable work
Unresolved mismatch: Copied revision-4 task list remains
Item inspected: People and prerequisites
Evidence before start: Required verifier assigned; applicable readiness evidence reviewed
Unresolved mismatch: A task exists but nobody can perform its required review
Item inspected: Execution state
Evidence before start: A fresh check confirms the batch has not started
Unresolved mismatch: The batch began while the change assessment was being prepared