QC-SAMP-001 — Sampling Plan Governance

1. Document Control

Document ID	QC-SAMP-001
Title	Sampling Plan Governance
Document Type	Authoritative QC Specification
Owner	Quality Unit (QU)
Approver	Quality Unit (QU)
Effective Date	TBD
Version	v2.1
Change Control Reference	TBD

2. Purpose

Establish enforceable governance requirements for statistically justified, representative, and traceable sampling used to support QC acceptance, rejection, and release decisions under 21 CFR Part 111.

This specification mitigates risk of non-representative sampling, biased lot acceptance, contamination during sampling, undocumented variability, and improper supplier COA reliance.

4. Scope

Applies to sampling of components (including dietary ingredients), packaging materials, labels, in-process materials, and finished products where sampling informs QC disposition decisions.

Procedural mechanics are governed separately under controlled SOP/WIN documents.

5. Definitions

Approved Sampling Plan: QU-authorized document defining statistical basis, sample size, container logic, and acceptance criteria.
Representative Sampling: Sampling using justified statistical methodology reflective of lot heterogeneity.
Invalid Sampling Event: Sampling lacking approved plan or traceable documentation.
Reassessment Trigger: Condition requiring formal review of sampling adequacy.

6. Acceptance Criteria

Attribute	Compliant State	Nonconforming State	Invalid State	Required QMS Entry (W)	Required QU Authorization (A)
Sampling Plan Approval	Current QU-approved plan in place	Expired or superseded plan used	No documented approval	Deviation	Yes if disposition impacted
Statistical Basis	Documented statistical rationale (ANSI/ASQ Z1.4, √N rule, or equivalent)	Reduced sampling without justification	No documented statistical rationale	Deviation; Change Control if systemic	Yes if systemic change
Dietary Ingredient Identity Sampling	Each lot sampled per 21 CFR 111.75(a)(1)	Reduced sampling without QU authorization	Identity sampling omitted	Deviation	Yes
Container Selection Logic	Predefined and documented selection method	Deviation from predefined logic	No documented source container	Deviation	No
Chain of Custody	Complete lot-to-laboratory traceability	Incomplete documentation	No traceable link to lot	Deviation	Yes
Sampling Environment Control	Controlled and documented conditions	Minor deviation documented	Uncontrolled contamination exposure	Deviation; Quality Defect if contamination suspected	Yes if disposition impacted

7. Decision Logic Matrix

Trigger Condition	Execution May Continue?	Required Action	QMS Process Entry	Workflow (W)?	QU Authorization (A)?	Required Record
Compliant State	Yes	Record sampling	None	No	No	Sampling Record
Nonconforming State	Conditional — pending Deviation review	Initiate Deviation	Deviation SOP	Yes	Conditional	Deviation Record
Invalid State	No	Invalidate sample; halt use of results	Deviation SOP	Yes	Yes	Invalid Sampling Record
Reassessment Trigger	Yes	Evaluate CAPA	CAPA SOP	Yes	No	CAPA Record
Sampling Plan Modification	No	Submit Change Control	Change Control SOP	Yes	Yes	Change Record
Contamination Suspected	No	Segregate lot; initiate Quality Defect	Quality Defect SOP	Yes	Yes if disposition impacted	Quality Defect Record

8. Execution Boundaries

Sampling may proceed only when all attributes remain in Compliant State.
Sampling must stop immediately upon entry into Invalid State.
Resampling requires documented justification and Deviation entry.
Invalid sampling records cannot support release decisions.
Lot processing cannot proceed to final disposition using invalid sampling data.

9. Required Records

Approved Sampling Plan (QU authorized)
Sampling Execution Record
Chain-of-Custody Record
Deviation Record
CAPA Record (if triggered)
Change Control Record (if triggered)
Quality Defect Record (if triggered)
QU Disposition Authorization (if applicable)

10. Authority Classification (E / W / A)

E = Execute sampling and record only
W = Entry into Deviation, CAPA, Change Control, or Quality Defect workflow
A = QU authorization required where specified in Acceptance Criteria and Decision Logic Matrix

11. Control State Definitions

Compliant State: Sampling fully aligned with approved plan.
Nonconforming State: Minor deviation documented; investigation required.
Invalid State: Sampling not defensible; results unusable for release.
Record Invalidity Rule: Invalid sampling records remain part of GMP record, cannot be deleted, must reference associated Deviation ID.
Escalation Trigger: Any invalid state, contamination suspicion, or unapproved statistical reduction.
Stop-Execution Condition: Approved plan unavailable, traceability compromised, or contamination suspected.

12. Change Control

All modifications to sampling plans, statistical methodologies, identity testing reduction, or container selection logic require formal Change Control, documented impact assessment, and QU approval prior to implementation.