WIN Execution Guide — Deviation Management

To support consistent execution of deviation identification, documentation, verification, and escalation activities, ensuring that departures from approved requirements are captured, assessed, and routed for formal quality disposition.

Scope

This WIN Execution Guide applies to QA-supported deviation handling across all GMP-relevant processes, systems, materials, and records.

This Execution Guide does not define deviation thresholds, scientific acceptability, root-cause methodology, or disposition 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 deviation disposition, including acceptance, rejection, escalation, or initiation of CAPA.

QA personnel execute deviation handling workflows and prepare evidence packages. They do not approve deviation outcomes.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-DEVIATION — Deviation Event Record

This artifact documents identification, verification, escalation, and final disposition of deviations.

Minimum evidentiary expectations include:

Description of deviation and source
Date/time and process context
Impact screening and preliminary classification
Linkage to affected materials, lots, or systems
QCO disposition and rationale

Auditor focus: confirmation that deviations are identified, documented, and resolved through a controlled quality process.

Section 7 — WIN (Control Requirements)

WIN-QA-DEVIATION

Governs the QA execution framework for deviation handling and escalation.

Ensure deviations are documented and traceable.
Verify completeness and accuracy of deviation records.
Escalate deviations requiring quality disposition.
Support investigation and CAPA initiation as directed.

Control outcome: deviations are managed consistently and resolved through formal quality oversight.

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 — Identify and Log Deviation

Identify any departure from approved procedures, specifications, rules, or system requirements.
Initiate a deviation record in the QMS without delay.
Ensure the deviation description is factual, objective, and complete.

Step 2 — Verify Deviation Completeness

Confirm affected process, material, lot, system, or document is clearly identified.
Verify date, time, personnel, and detection source are recorded.
Incomplete deviation records are corrected prior to escalation.

Step 3 — Perform Preliminary Impact Screening

Screen the deviation for potential impact to quality, safety, compliance, or data integrity.
Identify whether immediate containment or hold actions are required.
Document screening outcome without assigning root cause.

Step 4 — Prepare Evidence Package

Compile supporting records, data, and references.
Ensure traceability to QC Rules and affected requirements.
Link deviation to related lots, shipments, or events.

Step 5 — Escalate to QCO

Submit the deviation record and evidence package for QCO review.
The QCO determines disposition: accept, investigate, CAPA, hold, reject, or escalate.
Disposition rationale is documented in the AA.

Step 6 — Support Investigation & CAPA (if directed)

Support investigation activities as directed by QCO.
Ensure CAPA linkage is established when required.
Maintain traceability through closure.