Reduced & Skip-Lot Sampling Specification

This specification defines the Quality Unit–approved requirements governing the use of reduced, skip-lot, or alternative sampling approaches for GMP materials and products.

Specification Type:
Authoritative Quality Control specification defining reduced and skip-lot sampling eligibility, acceptance criteria, and decision authority. This document does not define statistical models, sampling execution methods, or laboratory testing procedures.

1. Purpose

To establish Quality Unit–approved criteria under which reduced or skip-lot sampling approaches may be applied, ensuring that reduced sampling does not compromise material quality assurance or regulatory compliance.

2. Scope

This specification applies to sampling plans for components, raw materials, packaging components, in-process materials, and finished products where historical performance or risk assessment supports consideration of reduced or skip-lot sampling.

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-004

Reduced and skip-lot sampling eligibility and requirements defined in this specification shall not be modified outside approved QMS change control.

4. Reduced & Skip-Lot Sampling Eligibility

Eligibility Criterion	Requirement	Applicability
Historical Performance	Demonstrated history of conforming results with no unresolved quality concerns.	All materials considered for reduced or skip-lot sampling
Supplier Status	Supplier shall be in Approved status with no current restrictions.	Externally sourced materials
Material Criticality	Material criticality and impact to product quality shall be evaluated prior to applying reduced sampling.	All reduced or skip-lot sampling decisions
Sampling Plan Approval	Reduced or skip-lot sampling approaches shall be defined in an approved sampling plan.	All reduced or skip-lot sampling use
Quality Unit Approval	Application of reduced or skip-lot sampling requires explicit Quality Unit approval.	All reduced or skip-lot sampling

Reduced or skip-lot sampling shall not be applied where material risk, supplier performance, or historical data does not support reduced assurance.

5. Decision Logic

Reduced or skip-lot sampling may be applied only when all eligibility criteria are met.
Failure of any lot sampled under a reduced or skip-lot approach shall trigger immediate reassessment of the sampling plan.
Identification of adverse trends or quality concerns shall result in return to normal or increased sampling.
Final determinations regarding reduced or skip-lot sampling use reside with the Quality Unit.

6. Escalation Requirements

Quality Assurance must escalate to Quality Control or QCO when any of the following occur:

Failure of a lot sampled under reduced or skip-lot conditions
Changes in supplier qualification or performance status
Identification of adverse trends or atypical results
Concerns regarding adequacy of reduced sampling assurance

7. Records & Evidence

Records supporting compliance with this specification include, but are not limited to:

Approved sampling plans incorporating reduced or skip-lot approaches
Historical performance and trend analysis records
Quality Unit approvals for reduced or skip-lot sampling
Deviation and investigation records related to reduced sampling failures

This specification defines reduced and skip-lot sampling eligibility and decision authority only. Statistical models, sample size calculations, and sampling execution procedures are defined in separate controlled documents and shall not redefine the requirements herein.