WIN Execution Guide — CAPA Management

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 Corrective and Preventive Action (CAPA) activities by ensuring CAPAs are initiated, documented, tracked, verified, and closed in a controlled and traceable manner.

Scope

This WIN Execution Guide applies to QA-supported CAPA activities arising from deviations, audit findings, trend analysis, complaints, recalls, or other quality signals.

This Execution Guide does not define root-cause methodologies, scientific risk thresholds, or CAPA acceptance criteria. 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 CAPA approval, acceptance, effectiveness determination, and closure.

QA personnel execute CAPA workflows and prepare evidence. They do not approve or close CAPAs.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-CAPA — CAPA Record

This artifact documents initiation, tracking, verification, and final disposition of CAPAs.

Minimum evidentiary expectations include:

CAPA trigger and source (deviation, audit, trend, etc.)
Defined corrective and/or preventive actions
Assigned owners and due dates
Status tracking and supporting evidence
Effectiveness assessment and QCO closure

Auditor focus: confirmation that systemic issues are corrected and recurrence is prevented.

Section 7 — WIN (Control Requirements)

WIN-QA-CAPA

Governs the QA execution framework for CAPA management and escalation.

Ensure CAPAs are initiated when required.
Verify CAPA documentation completeness and traceability.
Track action implementation and status.
Escalate CAPAs for approval and closure.

Control outcome: quality issues are addressed systematically and prevented from recurring.

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 CAPA

Initiate a CAPA when directed by QCO or required by deviation, audit finding, or trend.
Ensure the CAPA record references the triggering event.
Document the problem statement clearly and objectively.

Step 2 — Verify CAPA Definition

Confirm corrective and preventive actions are clearly defined.
Verify responsible owners and due dates are assigned.
Incomplete CAPAs are corrected prior to escalation.

Step 3 — Track CAPA Implementation

Monitor progress against defined milestones.
Collect evidence demonstrating action completion.
Escalate overdue or stalled actions.

Step 4 — Prepare Effectiveness Evidence

Compile data demonstrating action effectiveness.
Verify alignment with QC Rules and expected outcomes.
Document objective evidence without interpretation.

Step 5 — Escalate for QCO Review

Submit the CAPA record and evidence package for QCO review.
The QCO determines acceptance, additional action, or rejection.
QCO documents effectiveness determination and closure.

Step 6 — Maintain Closure Traceability

Ensure CAPA closure is linked to originating events.
Confirm records are retained per retention requirements.
Support inclusion in management review and trending.