Program: QC-IPC Program Oversight
Owner: Quality Assurance (QA)
Authority: Quality Control Officer (QCO)
Version: 1.0
Last Updated: 2026-01-23

QC-IPC Program Oversight

Program-Level Oversight Notice
This document defines governance, monitoring, and escalation expectations for in-process control (IPC) activities used to support quality decisions. It does not define execution steps, sampling techniques, or acceptance criteria. IPC rules and limits remain governed under QC Rules. Final disposition authority resides with the QCO.

1. Purpose

The QC-IPC Program establishes Quality Assurance oversight of in-process control activities performed during manufacturing and packaging. The program ensures IPC data are reliable, timely, traceable, and suitable for use in quality disposition, while maintaining clear separation between operational execution and quality decision authority.

2. Scope

This program applies to all in-process controls used to monitor, verify, or support product quality during production and packaging activities, including:

Weight checks, fill checks, and count verification
Visual inspections and line clearance verification
In-process sampling and attribute checks
Packaging code verification and reconciliation checks
Environmental and hygiene observations relevant to IPC

This program does not define how IPC activities are performed or what constitutes acceptance. Those requirements are governed by QC Rules and approved batch records.

3. Program Ownership & Authority

Role	Oversight Responsibility
QA	Owns the QC-IPC Program; monitors IPC trends, execution integrity, and escalation signals; executes QA WINs in response to program findings.
QCO	Sole authority for IPC-related quality disposition decisions, including acceptance, rejection, escalation, and conditional release.
Production / Packaging	Perform IPC activities in accordance with approved batch records, QC Rules, and controlled operational documentation.

4. IPC Governance Principles

IPC execution is an operational responsibility
IPC results provide input to quality decisions, not authority
Acceptance criteria are predefined under QC Rules
QA verifies completeness, consistency, and credibility of IPC records
All IPC deviations or anomalies require formal escalation

5. Program Monitoring & Signals

Monitoring Signal	Program Concern	QA Response
Repeated IPC failures	Process instability or control weakness	Trigger QA deviation or CAPA WIN
Missed or incomplete IPC checks	Execution or documentation failure	Escalate via QA deviation WIN
Out-of-trend IPC results	Emerging quality risk	Initiate investigation or trending review
Code or label discrepancies	Packaging compliance risk	Escalate to QCO via QA WIN

6. Relationship to QA WINs

The QC-IPC Program does not execute corrective actions. Identified issues initiate QA execution via approved WINs, including:

WIN-QA-DEVIATION
WIN-QA-NCMR
WIN-QA-CAPA
WIN-QA-RELEASE
WIN-QA-CHANGE

QA executes verification and escalation activities. The QCO renders final disposition.

7. Management Review & Continuous Improvement

QC-IPC Program performance is reviewed during Management Review and APQR. Outputs support:

Process capability evaluation
IPC effectiveness assessment
Identification of systemic risks
Continuous improvement initiatives

Authority Reminder
This program provides governance and oversight only. IPC execution rules, QA execution activities, and quality disposition authority remain governed by their respective architectural layers.