This is a ready-to-use form. Replace every <<FILL: ...>> placeholder with your own values, and read every sampling value (code letter, sample size, accept and reject numbers) from ANSI/ASQ Z1.4 for your lot size, inspection level, and AQLs.
A worked filled specimen follows the template. It is an educational aid to adapt and verify, not a source of sampling numbers.
Form control
| Field | Format | Required | Completed by | When |
|---|---|---|---|---|
| Form number | Text | Yes | Document control | On issue |
| Product and lot | Text | Yes | Inspector | At re-inspection |
| Date | Date | Yes | Inspector | At re-inspection |
Instructions
- Complete this form after 100 percent inspection is done and reconciliation has closed.
- Determine the sample from Z1.4: use the lot size and the General Inspection Level to find the sample-size code letter, then read the sample size and the accept/reject numbers for the AQL assigned to each defect class.
- Pull the sample at random from the accepted units and re-inspect under qualified conditions by a qualified re-inspector.
- Record defectives by class and disposition per the per-class accept numbers. If any class fails, do not release; open a deviation.
1. Lot and sampling inputs
| Field | Entry |
|---|---|
| Product / lot | <<FILL: product, lot>> |
| Container format | <<FILL>> |
| Lot size after 100% inspection | <<FILL: count>> |
| Reconciliation closed | Yes / No (if No, stop, deviation) |
| General Inspection Level | <<FILL: II (default) / other, with reason>> |
| Inspection severity state | Normal / Tightened / Reduced |
| Sample-size code letter (Z1.4) | <<FILL: letter>> |
| Sample size (Z1.4) | <<FILL: count>> |
2. Per-class plan and result
| Defect class | Assigned AQL | Accept number (Ac) | Reject number (Re) | Defectives found | Result |
|---|---|---|---|---|---|
| Critical | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail |
| Major | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail |
| Minor | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail |
3. Disposition
| Field | Entry |
|---|---|
| Overall result | Pass (all classes) / Fail (name class) |
| If fail: action | Deviation number <<FILL>>, 100% re-inspect or reject per investigation |
| Feedback to qualification | <<FILL: inspector or machine follow-up, if any>> |
| Re-inspector (name, signature, date) | <<FILL>> |
| QA review (name, signature, date) | <<FILL>> |
Acceptance criteria
- The sample size and accept/reject numbers were read from Z1.4 for the actual lot size, inspection level, and AQLs, not from memory.
- The sample was drawn at random from accepted units and re-inspected under qualified conditions.
- Every class met its accept number for a pass; any class over its accept number triggered a deviation, not a re-release.
- The form is complete, signed, dated, and available for disposition.
Retention
Retain with the lot record per the records retention schedule, for not less than <<FILL: retention period>>.
References
USP General Chapter <790>, Visible Particulates in Injections (acceptance sampling on the inspected lot). ANSI/ASQ Z1.4, Sampling Procedures and Tables for Inspection by Attributes (all sampling values). EU GMP Annex 1 (2022).
Confirm the current version and clause numbers of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
A completed re-inspection. The Z1.4 values are illustrative; read your own.
| Field | Entry |
|---|---|
| Product / lot | Prefilled syringe, lot 26P044 |
| Container format | 1 mL long PFS |
| Lot size after 100% inspection | 62,400 |
| Reconciliation closed | Yes |
| General Inspection Level | II |
| Inspection severity state | Normal |
| Sample-size code letter | P (example) |
| Sample size | 800 (example) |
| Defect class | Assigned AQL | Ac | Re | Found | Result |
|---|---|---|---|---|---|
| Critical | 0.10% | 1 | 2 | 0 | Pass |
| Major | 0.65% | 10 | 11 | 6 | Pass |
| Minor | 1.5% | 21 | 22 | 12 | Pass |
Overall result: Pass. All three classes were at or below their accept numbers. Had the critical class shown 2 defectives against Ac 1, the lot would have gone to a deviation with root-cause work into why the 100 percent inspection passed them, and either a full re-inspection or rejection, not release on the earlier inspection.
Common inspection findings this form prevents
- Sampling numbers worked from memory instead of read from Z1.4.
- An AQL failure quietly closed by re-release without a deviation.
- Re-inspection run before reconciliation closed, so the population sampled is uncertain.
- No record of the severity state, so switching between normal, tightened, and reduced inspection is undocumented.
How to adapt this form
- Set your inspection level, per-class AQLs, and severity-switching rule, then read the code letters and accept/reject numbers from Z1.4.
- Match the defect classes to your defect library.
- Point the retention line at your records retention schedule.
- Confirm each reference against its current published version before issue.