QC-SAMP-002 — Lot Acceptance Decision Criteria

1. Document Control

Document ID	QC-SAMP-002
Title	Lot Acceptance Decision Criteria
Document Type	Authoritative QC Specification
Owner	Quality Unit (QU)
Approver	Quality Unit (QU)
Effective Date	TBD
Version	v2.0
Change Control Reference	Formal QMS Change Control Required

2. Purpose

Establish enforceable, measurable, and regulatory-compliant decision criteria governing acceptance, rejection, invalidation, reassessment, or stop-execution of lots following QC sampling and analytical evaluation.

This specification mitigates the risk of unauthorized lot release, acceptance of invalid datasets, and uncontrolled disposition outside independent Quality Unit authority.

3. Regulatory Basis

21 CFR 111.70 — Specifications
21 CFR 111.75 — Testing and Examination
21 CFR 111.80 — Quality Control Operations
21 CFR 111.95 — Examination of Components
21 CFR 111.113 — Material Review and Disposition

4. Scope

Applies to all incoming components, packaging materials, in-process materials, and finished product lots requiring QC evaluation prior to disposition under QC-DISP-001.

Excludes sampling plan design (QC-SAMP-001) and analytical method validation.

5. Definitions

Compliant State: All specification attributes meet approved limits and sampling integrity requirements.

Nonconforming State: Any confirmed specification failure (OOS or identity mismatch).

Invalid State: Dataset integrity compromised due to documented sampling deviation, labeling error, custody gap, or analytical system failure.

Reassessment Trigger: Within-specification result demonstrating adverse trend requiring formal risk review.

Stop-Execution Condition: Confirmed identity failure or confirmed contamination event.

6. Acceptance Criteria

Condition	State Determination	Execution May Continue (E)	Mandatory QMS Entry (W)	QU Authorization Required (A)
All attributes within approved limits; sampling valid	Compliant	Yes	No	Yes (Disposition Authorization)
Any confirmed OOS or identity failure	Nonconforming	No	Yes — Deviation / Quality Defect SOP	Yes
Sampling or analytical dataset compromised	Invalid	No	Yes — Deviation SOP	Yes
Within limit but adverse trend identified	Reassessment Required	Conditional	Yes — Quality Risk Review SOP	Conditional
Confirmed identity failure or contamination	Stop-Execution	No	Yes — Immediate Deviation Entry	Yes

7. Decision Logic Matrix

Trigger Condition	Required Action	QMS Process Entry	Workflow (W)	QU Authorization (A)	Required Record
Compliant State	Proceed to disposition decision	QC-DISP-001	No	Yes	Lot Evaluation Record + QU Authorization
Nonconforming State	Enter Deviation workflow	Deviation / Quality Defect SOP	Yes	Yes	Deviation Record
Invalid State	Invalidate dataset; controlled reassessment only	Deviation SOP	Yes	Yes	Deviation Record
Stop-Execution Condition	Immediate material hold and controlled investigation	Deviation SOP	Yes	Yes	Deviation Record

8. Exception Handling

Re-sampling without documented Deviation entry is prohibited.
Identity failure mandates automatic Stop-Execution condition.
Repeated trend triggers require CAPA evaluation per CAPA SOP.
Dataset invalidation requires documented justification under Deviation.

9. Required Records

Sampling Execution Record
Analytical Test Report
Lot Evaluation Record
Deviation Record (if triggered)
CAPA Record (if triggered)
QU Disposition Authorization Record

10. Authority Classification (E / W / A)

E — Execution and recording only. No disposition authority.
W — Mandatory QMS workflow entry upon trigger condition.
A — Independent Quality Unit authorization required for final disposition.

Execution does not confer decision authority. Final quality decisions remain under independent QU authority in accordance with 21 CFR Part 111.

11. Control State Definitions

Compliant State: Meets all approved specifications; eligible for disposition review.
Nonconforming State: Exceeds one or more specification limits.
Invalid State: Dataset integrity compromised; not eligible for disposition until resolved.
Escalation Trigger: OOS, identity failure, sampling breach, adverse trend.
Stop-Execution Condition: Confirmed identity failure or confirmed contamination.

12. Change Control

Changes to this specification require formal Change Control entry, documented impact assessment, and Quality Unit approval prior to implementation.