WIN Execution Guide — Document 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 document requirements, approval, version control, and change authorization resides solely with the QA Family Pack, QMS, and the Quality Control Officer (QCO).

Purpose

To support consistent execution of document control activities by ensuring quality documents are properly created, reviewed, issued, maintained, and retired in a controlled and traceable manner.

Scope

This WIN Execution Guide applies to QA-supported document lifecycle activities for controlled documents within the QMS.

This Execution Guide does not define document hierarchy, approval authority, content requirements, or retention periods. Those requirements are governed by the QA Family Pack and exercised by the QCO.

Decision Authority

The Quality Control Officer (QCO) is the sole authority for approval, issuance authorization, retirement, or exception handling for controlled documents.

QA personnel execute document workflows and prepare evidence. They do not approve, authorize, or modify document requirements.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-DOCCTRL — Document Control Log

This artifact documents the lifecycle status, approvals, and distribution of controlled documents.

Minimum evidentiary expectations include:

Document identification and version history
Revision rationale and change summary
Review and approval records
Effective dates and issuance controls
Obsolescence and archival records

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

Section 7 — WIN (Control Requirements)

WIN-QA-DOCCTRL

Governs the QA execution framework for document control.

Ensure controlled documents are reviewed and approved before use.
Prevent use of obsolete or unapproved documents.
Maintain traceable document history.
Support controlled distribution and retirement.

Control outcome: documents used in operations are current, approved, and traceable.

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 Document Action

Initiate a document record for creation, revision, or retirement.
Assign document ID, title, and document type.
Identify impacted processes and related documents.

Step 2 — Verify Document Completeness

Confirm document formatting, structure, and required sections.
Verify references, definitions, and scope are complete.
Incomplete drafts are corrected prior to routing.

Step 3 — Route for Review & Approval

Route document to required reviewers per QA Family Pack.
Collect review comments without adjudicating content.
Ensure final approval is rendered by the QCO.

Step 4 — Issue Controlled Document

Confirm approval status prior to issuance.
Assign effective date and release version.
Ensure only the approved version is available for use.

Step 5 — Retire & Archive Obsolete Documents

Remove obsolete documents from points of use.
Archive retired versions with complete history.
Ensure traceability between superseded versions.

Step 6 — Maintain Document Traceability

Update the Document Control Log.
Link documents to associated changes, CAPAs, or deviations.
Support audits with complete document history.