WIN Execution Guide — Specification Control

Non-Authoritative Execution Guide Notice
This WIN Execution Guide is non-authoritative and supports execution of controls defined in the QA Family Pack. Authority for specification requirements, acceptance criteria, and approval resides solely with the QA Family Pack, Quality Control (QC) Rules, and the Quality Control Officer (QCO).

Purpose

To support consistent execution of specification control activities by ensuring that specifications are properly issued, verified, referenced, and maintained under formal quality control.

Scope

This WIN Execution Guide applies to QA-supported activities involving material, in-process, finished product, and label specifications used within the QMS.

This Execution Guide does not define specification limits, test methods, or scientific acceptance criteria. Those are governed by QC Rules and approved by the QCO.

Decision Authority

The Quality Control Officer (QCO) is the sole authority for approval, authorization, or exception handling related to specifications.

QA personnel execute verification, control, and traceability workflows but do not establish or modify specification requirements.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-SPEC — Specification Register

This artifact documents the lifecycle, approval status, and applicability of controlled specifications.

Minimum evidentiary expectations include:

Specification identification and version history
Associated material or product applicability
Approval and effective dates
Linkage to QC rules and test methods
Obsolescence and supersession records

Auditor focus: confirmation that current, approved specifications are in use.

Section 7 — WIN (Control Requirements)

WIN-QA-SPEC

Governs the QA execution framework for specification control.

Ensure specifications are approved prior to use.
Maintain traceability between specifications and QC rules.
Prevent use of obsolete or unauthorized specifications.
Support controlled change and escalation.

Control outcome: specifications used in operations are current, approved, and aligned with QC requirements.

Authority Statement:
The AA and WIN above are authoritative and maintained under formal change control within the QA Family Pack. This Execution Guide supports execution only.

BPO-Owned Execution Zone — WIN Execution Guide

Step 1 — Initiate Specification Action

Identify need for new, revised, or retired specification.
Assign specification ID, type, and applicable material or product.
Confirm linkage to existing QC rules.

Step 2 — Verify Specification Completeness

Confirm required sections are present (scope, limits, references).
Verify alignment with applicable QC rule identifiers.
Incomplete or inconsistent drafts are corrected prior to routing.

Step 3 — Route for Review & Approval

Route specification to required reviewers.
Ensure QC scientific ownership is identified.
Final approval is rendered by the QCO.

Step 4 — Issue Controlled Specification

Confirm approval status prior to issuance.
Assign effective date and version.
Ensure only current versions are accessible.

Step 5 — Retire & Archive Superseded Specifications

Remove obsolete specifications from points of use.
Archive retired versions with full history.
Maintain traceability between versions.

Step 6 — Maintain Specification Traceability

Update the Specification Register.
Link specifications to test results, deviations, and changes.
Support audits and inspections.