Measurement Uncertainty Impact Specification

This specification defines the Quality Unit–approved requirements governing how measurement uncertainty is considered when evaluating analytical results against acceptance criteria for GMP decisions.

Specification Type:
Authoritative Quality Control specification defining measurement uncertainty impact and decision authority. This document does not define statistical calculations, uncertainty estimation methods, or laboratory execution instructions.

1. Purpose

To establish Quality Unit–approved requirements for considering measurement uncertainty when interpreting analytical results, ensuring that acceptance decisions are scientifically sound, consistent, and defensible.

2. Scope

This specification applies to all GMP-relevant analytical results used to support acceptance, release, rejection, or disposition decisions where measurement uncertainty may influence result interpretation.

Applicable Business Domains include:

Quality Control (QC)
Quality Assurance (QA)
Laboratory Operations
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-ANL-003

Measurement uncertainty impact requirements defined in this specification shall not be modified outside approved QMS change control.

4. Measurement Uncertainty Impact Requirements

Impact Consideration	Requirement	Applicability
Result Interpretation	Analytical results shall be interpreted in the context of known or estimated measurement uncertainty where relevant to acceptance decisions.	GMP-relevant analytical results
Proximity to Specification Limits	Results near acceptance limits require consideration of measurement uncertainty prior to final decision-making.	Borderline or near-limit results
Consistency of Application	Measurement uncertainty considerations shall be applied consistently and not selectively to influence outcomes.	All acceptance and release decisions
Decision Transparency	Consideration of measurement uncertainty shall be documented where it impacts acceptance or rejection decisions.	Decisions influenced by uncertainty
Method & System Dependency	Measurement uncertainty considerations shall align with the demonstrated capability of the analytical method and system used.	All analytical results

Measurement uncertainty shall not be used to override clear failures of acceptance criteria or to justify acceptance of nonconforming results.

5. Decision Logic

Results clearly meeting acceptance criteria may be accepted without additional uncertainty evaluation.
Results clearly outside acceptance criteria shall not be accepted based on uncertainty considerations alone.
Results near acceptance limits require documented Quality Unit evaluation.
Final determinations regarding the impact of measurement uncertainty on acceptance decisions reside with the Quality Unit.

6. Escalation Requirements

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

Borderline results with potential uncertainty impact
Inconsistent application of uncertainty considerations
Disputes regarding interpretation of analytical results
Recurring near-limit results or trends

7. Records & Evidence

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

Analytical result records with documented uncertainty considerations
Quality Unit assessments of borderline or near-limit results
Deviation and investigation records related to result interpretation
Trend analyses identifying recurring uncertainty-related decisions

This specification defines measurement uncertainty impact and decision authority only. Statistical estimation methods, uncertainty calculations, and laboratory execution practices are defined in separate controlled documents and shall not redefine the requirements herein.