Document ID: WIN-WH-ENV-MONITOR
Version: 1.0
Last Change Date: 2026-01-23
Execution Owner: Warehouse (WH)
Governing Family: Quality Assurance (QA)
WIN Execution Guide — Warehouse Environmental Monitoring
Non-Authoritative Execution Guide Notice
This document provides execution guidance for Warehouse environmental monitoring
activities. Environmental requirements, limits, and escalation criteria are defined
in QA-owned policies. This WIN supports consistent execution under QA governance.
Purpose
To ensure that warehouse storage environments are routinely monitored and maintained
within approved temperature and humidity ranges to protect material identity, quality,
and suitability during storage.
Scope
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Storage Areas — All warehouse-controlled locations where GMP materials are stored, including ambient, temperature-controlled, quarantine, and approved material zones.
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Environmental Parameters — Temperature and humidity conditions applicable to warehouse storage areas, as defined by Quality Assurance.
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Execution Role — Environmental monitoring activities performed by qualified Warehouse personnel.
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Monitoring Methods — Review of automated environmental sensors and/or documented manual readings used to assess storage conditions.
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Operational Timing — Routine monitoring performed during normal warehouse operations and at defined review intervals.
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Excursion Identification — Detection of environmental conditions outside approved limits requiring escalation.
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Documentation — Recording of monitoring results, observations, and identified excursions in approved records.
Scope Clarification
This WIN defines execution boundaries only. Environmental limits, acceptance criteria,
and disposition authority are governed by Quality Assurance SOPs.
Section 6 — AA (Auditable Artifacts)
AA-WH-ENV-MONITOR — Environmental Monitoring Record
This artifact provides evidence that warehouse environmental conditions are routinely
monitored and maintained within QA-defined limits.
Minimum evidentiary expectations include:
- Location or zone monitored
- Date and time of monitoring or data review
- Temperature and humidity readings
- Identification of excursions or alarms
- Name or identifier of responsible Warehouse personnel
Auditor focus: confirmation that storage conditions are routinely monitored and that
out-of-range conditions are detected and escalated prior to material use.
Section 7 — WIN (Work Instructions / Control Requirements)
WIN-WH-ENV-MONITOR
Governs routine monitoring of warehouse environmental conditions in accordance with
QA-defined environmental and storage requirements.
- Monitor temperature and humidity in defined warehouse zones.
- Review automated sensor data or manual readings at defined frequencies.
- Document monitoring results and observations.
- Identify and escalate environmental excursions.
Control outcome: Materials are protected from environmental degradation through
documented monitoring and timely escalation of excursions.
Primary Systems: Environmental Sensors, Wherefour (as applicable)
Related Policies: SOP-QA-ENV-001 (Environmental & Storage Requirements)
BPO-Owned Execution Zone — Operational Step Sequence
Step 1 — Identify Monitoring Locations
- Environmental monitoring is performed for all designated storage zones.
- Monitoring locations are defined by rackmap, room designation, or sensor placement.
- Changes to monitoring locations require QA approval.
Step 2 — Perform Routine Monitoring or Data Review
- Warehouse personnel review environmental readings at the defined frequency.
- Monitoring may be automated (continuous sensors) or manual (logged checks).
- Readings are reviewed for compliance with QA-approved limits.
- Normal readings are documented as evidence of control.
Step 3 — Document Monitoring Results
- All readings and reviews are documented in the designated environmental record.
- Date, time, and responsible personnel are recorded.
- Missing data or sensor failures are documented and escalated.
Step 4 — Identify Environmental Excursions
- An excursion is defined as any temperature or humidity reading outside QA-approved limits.
- Alarms, alerts, or abnormal trends are treated as potential excursions.
- Materials located in affected zones are considered potentially impacted.
Step 5 — Immediate Actions for Excursions
- Stop movement or use of potentially impacted materials.
- Notify Warehouse supervision and Quality Assurance.
- Segregate affected materials as required.
- Initiate escalation per WIN-WH-QUALITY-ESCALATION.
Escalation Principle
Routine monitoring detects issues; Quality Events govern investigation and disposition.
Rule: Detect → Contain → Escalate → Document
Authority Reminder
This WIN is an execution guide. Environmental limits, acceptance criteria,
and disposition authority remain governed by Quality Assurance.