WIN Execution Guide — Change 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 control intent, approval, and disposition resides solely with the QA Family Pack and the Quality Management System (QMS).

Purpose

To support consistent execution of change control activities by ensuring proposed changes are documented, verified, assessed for impact, and routed for formal quality disposition prior to implementation.

Scope

This WIN Execution Guide applies to QA-supported changes that may impact product quality, safety, compliance, data integrity, or validated state.

This Execution Guide does not define change classification rules, validation requirements, risk acceptance criteria, or approval authority. Those requirements are governed by QC Rules, the QA Family Pack, and exercised by the Quality Control Officer (QCO).

Decision Authority

The Quality Control Officer (QCO) serves as the sole authority for change approval, rejection, deferral, or escalation.

QA personnel execute change workflows and prepare evidence. They do not approve or authorize changes.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-CHANGE — Change Control Record

This artifact documents proposed changes, impact assessments, approvals, and closure.

Minimum evidentiary expectations include:

Description and rationale for change
Impacted processes, systems, documents, or materials
Risk and impact assessment inputs
Required approvals and conditions
Implementation and verification evidence
QCO disposition and authorization

Auditor focus: confirmation that changes are evaluated and approved before implementation.

Section 7 — WIN (Control Requirements)

WIN-QA-CHANGE

Governs the QA execution framework for change control and escalation.

Ensure changes are documented and traceable.
Verify completeness of impact assessment inputs.
Prevent implementation prior to approval.
Support verification of approved changes.

Control outcome: changes are implemented in a controlled and compliant manner.

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

BPO-Owned Execution Zone — WIN Execution Guide

Step 1 — Initiate Change Request

Initiate a change record prior to implementing any modification.
Document the proposed change clearly and objectively.
Identify affected processes, systems, materials, and documents.

Step 2 — Verify Change Record Completeness

Confirm rationale, scope, and impacted areas are documented.
Verify required functional inputs are identified.
Incomplete change records are corrected before escalation.

Step 3 — Coordinate Impact Assessment Inputs

Collect impact assessment inputs from relevant functions.
Ensure quality, regulatory, validation, and data integrity impacts are addressed.
Document inputs without assigning approval.

Step 4 — Prepare Evidence Package

Compile the change record and supporting assessments.
Verify traceability to applicable QC Rules and requirements.
Confirm no implementation has occurred.

Step 5 — Escalate to QCO

Submit the change package for QCO review.
The QCO determines approval, rejection, deferral, or conditions.
QCO authorization is documented in the AA.

Step 6 — Verify Implementation & Closure

Confirm approved changes are implemented as authorized.
Verify required evidence of completion is documented.
Support closure and linkage to related CAPAs or deviations.