Form: AQL Sampling Plan and Lot Re-Inspection Record

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

Instructions

1. Complete this form after 100 percent inspection is done and reconciliation has closed.
2. 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.
3. Pull the sample at random from the accepted units and re-inspect under qualified conditions by a qualified re-inspector.
4. 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

2. Per-class plan and result

3. Disposition

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

Filled specimen

A completed re-inspection. The Z1.4 values are illustrative; read your own.

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

1. Set your inspection level, per-class AQLs, and severity-switching rule, then read the code letters and accept/reject numbers from Z1.4.
2. Match the defect classes to your defect library.
3. Point the retention line at your records retention schedule.
4. Confirm each reference against its current published version before issue.