SOP for Temperature & Humidity Monitoring in Quality Control (QC) Department

🌡️ SOP: Temperature & Humidity Monitoring in QC Department

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🎯 Purpose

This SOP provides a standardized and regulated method for monitoring, recording, reporting, and controlling environmental conditions (temperature and humidity) in QC areas to ensure sample integrity, instrument performance, and consistent laboratory operations.

📌 Scope

This procedure applies to all controlled QC areas where ambient conditions may impact:

• Testing outcomes
• Sample stability
• Instrument performance

🔤 Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• RH: Relative Humidity
• HVAC: Heating, Ventilation & Air Conditioning

📝 Definitions

• Temperature: Degree of hotness or coldness in controlled environments
• Relative Humidity (RH): % of moisture in air relative to saturated steam at the same temperature
• Hygrometer: Calibrated digital device for continuous monitoring of temperature and RH

👥 Responsibilities

Role	Responsibility
QC Analyst/Executive	Ensure hygrometer remains ON continuously and record temperature & RH in log sheets
QC Supervisor	Review daily logs, ensure completeness, and initiate corrective actions for excursions
Quality Assurance (QA)	Review trends, deviations, and ensure compliance
Engineering / Maintenance	Ensure HVAC systems and monitoring devices are functional and calibrated

⚙️ Equipment & Materials

• Calibrated Digital Hygrometer / Thermo-Hygrometer
• Authorized Temperature & Humidity Log Sheet
• Valid Calibration Certificates
• Backup power supply (if applicable)

📝 Procedure

7.1 Preparation

• Confirm hygrometer is calibrated and installed at a representative location
• Switch ON and allow device to stabilize before taking readings

7.2 Monitoring Frequency

• Continuous monitoring using data logger (preferred)
• Manual recording: At least twice daily — start of shift and mid-shift/closing

7.3 Recording Readings

• Record on authorized log sheet:
• Date
• Time
• Temperature (°C)
• Relative Humidity (RH %)
• Recorder’s Name/Signature

✔ Acceptance Criteria

Parameter	Acceptable Range
Temperature	20°C – 25°C
Relative Humidity (RH)	40% – 60% RH

Note: Site-specific authorized limits may vary and should be justified within the log sheet.

⚠️ Deviations & Corrective Actions

• If temperature or RH values fall outside limits, notify QC Supervisor & Engineering immediately
• Investigate cause (e.g., HVAC failure, doors/windows open)
• Take corrective action (adjust HVAC, relocate samples, etc.)
• Document deviation, cause, action taken, and impact assessment in deviation report

🔧 Calibration & Maintenance

• Calibrate hygrometers as per schedule (typically every 6–12 months)
• Maintain valid calibration certificates
• Check device functionality and battery/back-up power regularly

📁 Records & Retention

• Original Temperature & Humidity Logs
• Calibration Certificates
• Deviation Reports
• Trend Analysis Reports
• All records maintained per Good Documentation Practices (GDP) and audit-ready

🎓 Training

• Personnel performing monitoring must be trained on this SOP
• Training records must be maintained and periodically reviewed
• Refresher training conducted after updates or deviations

📎 Annexure

• Annexure-I: Temperature & Humidity Monitoring Log Sheet