This is a ready-to-use reconciliation form for a serialized packaging batch. It proves every serial number is accounted for, which is the cleanest evidence that you control your numbers and the first thing a thorough auditor asks for. Replace every <<FILL: ...>> placeholder with your specifics. A filled specimen follows. This content is educational and general; adapt and verify it for your systems and commitments.
Header
| Field | Entry |
|---|---|
| Form title | Serial Number Reconciliation Report |
| Form number | <<FILL: FORM-ID, e.g. FRM-SER-005>> |
| Version | <<FILL: version>> |
| Parent SOP | <<FILL: serialization SOP ID>> |
| Retention | <<FILL: period, generally aligned to the 6-year DSCSA record period>> |
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Batch / packaging order | text | Yes | Packaging | At batch start |
| Product / NDC / GTIN | text / 14-digit | Yes | Packaging | At batch start |
| Serial range or number-pack ID | text | Yes | Serialization (L4) | At provisioning |
| Commissioned | integer | Yes | L2/L4 | At commissioning |
| Printed and verified good | integer | Yes | L2 (vision) | During run |
| Rejected / decommissioned | integer | Yes | L2 | During run |
| Sampled / destroyed (QC, line clearance) | integer | Yes | Packaging/QC | During and after run |
| Aggregated into cases/pallets | integer | Yes | L2 | During run |
| Shipped (EPCIS commissioned-to-shipped) | integer | Yes | L4 | At dispatch |
| Unused / returned to pool | integer | Yes | L4 | At batch close |
| Discrepancy (must be zero or explained) | integer | Yes | QA | At reconciliation |
The reconciliation identity
The counts must close. The basic balance:
Commissioned = printed-good + rejected/decommissioned + sampled/destroyed + unused/returned
and
Printed-good = aggregated = shipped + on-hand reconciled at close
Any non-zero residual is a discrepancy that must be explained and dispositioned before the batch is released. An unexplained discrepancy is a data-integrity finding, because it means a serialized unit cannot be accounted for.
Reconciliation table
| Count | Value |
|---|---|
| Commissioned | <<FILL>> |
| Printed and verified good | <<FILL>> |
| Rejected / decommissioned | <<FILL>> |
| Sampled / destroyed | <<FILL>> |
| Unused / returned to pool | <<FILL>> |
| Sum check (printed + rejected + sampled + unused) | <<FILL>> |
| Aggregated into parents | <<FILL>> |
| Shipped (EPCIS) | <<FILL>> |
| On-hand at close | <<FILL>> |
| Discrepancy (commissioned minus sum) | <<FILL: 0 or explain>> |
Acceptance criteria
- The reconciliation identity closes to zero, or every residual is explained and dispositioned by QA.
- Rejected serials are decommissioned (a decommissioning event exists), not silently dropped.
- Aggregated count equals printed-good; no orphan or cross-mapped serials.
- Shipped count in EPCIS equals the commissioned-to-shipped chain for the batch.
- The report is reviewed and approved before batch release and retained for the required period.
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Prepared by (Serialization) | <<FILL>> | ||
| Reviewed by (QA) | <<FILL>> |
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
Reconciliation for an example batch of 10,000 commissioned serials. Values are illustrative and balance to zero.
| Count | Value |
|---|---|
| Commissioned | 10,000 |
| Printed and verified good | 9,840 |
| Rejected / decommissioned | 120 |
| Sampled / destroyed | 20 |
| Unused / returned to pool | 20 |
| Sum check (printed + rejected + sampled + unused) | 10,000 |
| Aggregated into parents | 9,840 |
| Shipped (EPCIS) | 9,600 |
| On-hand at close | 240 |
| Discrepancy (commissioned minus sum) | 0 |
Read it across: 10,000 commissioned, of which 9,840 printed good (all aggregated), 120 rejected and decommissioned, 20 sampled, 20 returned to the pool. Shipped 9,600 with 240 on hand, and shipped plus on-hand equals the 9,840 good units. Discrepancy zero. Had the sum-check been 9,998 instead of 10,000, two serials would be unaccounted for and QA would hold release until the two were found (a missed reject scan, an un-aggregated unit) and the cause corrected.
Common inspection findings this form prevents
- No reconciliation of serial numbers, so the program cannot prove every number is accounted for.
- Rejected serials dropped without a decommissioning event.
- Aggregation count not equal to printed-good (orphan or cross-mapped serials).
- Shipped EPCIS count not reconciled to the commissioned chain.
- Batch released before the reconciliation closed or its discrepancy was explained.
How to adapt this form
- Set your form number and parent serialization SOP in the header.
- Map the count fields to the exact reports your L2 and L4 systems produce.
- If your process has additional states (rework, re-serialization), add a count line and fold it into the identity.
- Make QA review of a closed reconciliation a release prerequisite in your batch-record flow.