Lot Acceptance Decision Specification
This specification defines the Quality Unit–approved acceptance decision criteria and decision logic governing acceptance, rejection, or further evaluation of lots based on sampling and test results.
Authoritative Quality Control specification defining lot acceptance decision criteria and decision authority. This document does not define sampling execution, statistical calculations, or laboratory test methods.
1. Purpose
To establish Quality Unit–approved decision requirements governing how sampling and test results are evaluated to determine lot acceptance, rejection, or the need for additional evaluation.
2. Scope
This specification applies to all lots of components, raw materials, in-process materials, finished products, and packaging components where sampling results are used to support quality decisions.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Warehouse Operations (WH)
- Production (PROD)
- Packaging (PKG)
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-SAMP-002
Lot acceptance decision criteria defined in this specification shall not be modified outside approved QMS change control.
4. Lot Acceptance Decision Criteria
| Sampling Outcome | Decision Requirement | Resulting Status |
|---|---|---|
| All results meet acceptance criteria | Lot may be accepted for its intended GMP use | Accepted |
| One or more results outside acceptance criteria | Lot shall not be accepted without Quality Unit evaluation | Rejected or Under Evaluation |
| Atypical, borderline, or inconclusive results | Additional evaluation or investigation is required | Under Evaluation |
| Sampling plan deviations or invalid results | Results shall not be used to support acceptance decisions | Decision Deferred |
Lot acceptance decisions shall be based on results generated from approved sampling plans and evaluated against approved acceptance criteria.
5. Decision Logic
- Lots meeting all acceptance criteria may be accepted for GMP use.
- Lots failing acceptance criteria shall not be used for GMP operations without Quality Unit approval.
- Lots requiring additional evaluation shall remain in a controlled status until final disposition is determined.
- Final lot acceptance or rejection decisions reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Results outside approved acceptance criteria
- Atypical or unexpected test results
- Sampling plan deviations impacting decision validity
- Recurring lot acceptance failures or adverse trends
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Sampling and test result records
- Lot acceptance and rejection documentation
- Deviation and investigation records
- Quality Unit decisions and approvals