WIN Execution Guide — Complaint Handling

To support consistent execution of complaint intake, verification, documentation, and escalation activities, ensuring all complaints are appropriately assessed and formally dispositioned under QA governance.

Scope

This WIN Execution Guide applies to QA-supported complaint handling activities, including intake verification, evidence collection, escalation, and documentation supporting complaint evaluation and disposition.

This Execution Guide does not define complaint classification criteria, regulatory reportability thresholds, or final disposition authority. Those decisions are governed by the QA Family Pack and executed by the Quality Control Officer (QCO).

Decision Authority

The Quality Control Officer (QCO) serves as the sole authority for complaint classification, investigation direction, regulatory escalation, and final disposition decisions.

QA personnel support execution by verifying complaint data, assembling evidence, and escalating issues. QA does not independently classify, close, or disposition complaints.

Family Pack Anchor

Section 6 — Auditable Artifacts (AA)

AA-QA-COMPLAINT — Complaint Record

This artifact documents complaint receipt, review, escalation, investigation outcome, and formal quality disposition.

Minimum evidentiary expectations include:

Complaint source, date, and description
Associated product, lot, and distribution details
Risk indicators and escalation rationale
Investigation linkage (if applicable)
Disposition authority and closure documentation

Auditor focus: confirmation that all complaints are evaluated, escalated when required, and formally dispositioned by QA authority.

Section 7 — WIN (Control Requirements)

WIN-QA-COMPLAINT

Governs the quality execution framework for complaint handling.

Ensure all complaints are captured and documented.
Verify completeness and traceability of complaint information.
Escalate complaints to the QCO for evaluation.
Maintain auditable records supporting disposition.

Control outcome: complaints are consistently handled, traceable, and governed under formal quality authority.

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 verbatim for execution support only.

BPO-Owned Execution Zone — WIN Execution Guide

Step 1 — Receive and Log Complaint

Receive complaint from customer, distributor, regulator, or internal source.
Log complaint into the QMS using the approved complaint record.
Ensure date received and source are recorded accurately.

Step 2 — Verify Complaint Information

Confirm product name, lot number, and description of issue are documented.
Identify missing or unclear information.
Request additional details if required.

Step 3 — Preliminary Risk Indicator Identification

Identify potential quality, safety, or regulatory risk indicators.
Do not classify or conclude risk level.
Flag complaints suggesting injury, illness, contamination, or mislabeling.

Step 4 — Escalate to QCO

Submit complaint record and supporting information to the QCO.
Highlight any identified risk indicators.
Escalate immediately if serious risk is suspected.

Step 5 — Support Investigation (If Directed)

Provide records, batch history, or distribution data as requested.
Coordinate with QC, Operations, or other functions for evidence collection.
Maintain documentation integrity and traceability.

Step 6 — Document Disposition and Closure

Record QCO disposition decision in the complaint record.
Ensure closure documentation is complete and approved.
Confirm linkage to CAPA, recall, or regulatory reporting if applicable.