Calibration Documents: Cold Room Temp/RH Sensor (CAL-0193)

Asset ID	CAL-0193
Equipment	Cold Room Temp/RH Sensor
Equipment Type	TempRH Sensor
Department	Warehouse
Area/Location	Cold Room
Process Use	GDP storage
Parameter	Temperature/RH
Units	°C/%RH
Range Min	-10
Range Max	30
Acceptance Criteria	±0.5°C/±5%RH
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Cold Room Temp/RH Sensor is performed to ensure accurate monitoring of temperature and relative humidity within the GDP storage area. This calibration controls risks associated with data integrity, patient safety, and batch quality by ensuring that the environmental conditions are maintained within specified limits.

2. Scope

• Asset ID: CAL-0193
• Equipment Name/Type: Cold Room Temp/RH Sensor / TempRH Sensor
• Department/Area: Warehouse / Cold Room
• Process Use: GDP storage
• Parameter: Temperature/RH
• Range: -10°C to 30°C
• Units: °C/%RH
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
• Verification: The process of confirming that a measurement instrument meets specified requirements.
• Adjustment: The process of modifying a measurement instrument to bring it into compliance with specified standards.
• As Found: The condition of the instrument prior to any adjustments.
• As Left: The condition of the instrument after adjustments have been made.
• OOT (Out of Tolerance): A condition where the instrument’s measurements fall outside the specified acceptance criteria.
• Drift: The gradual change in the output of a measurement instrument over time.
• Traceability: The ability to verify the history, location, or application of an item by means of documented recorded identification.
• Measurement Uncertainty: A parameter that characterizes the range of values within which the true value of a measurement lies.
• Intermediate Check: A verification process conducted between scheduled calibrations to ensure continued accuracy.

4. References

• Company Metrology SOP [TBD]
• ISO/IEC 17025 traceability via calibration certificates
• ALCOA+ principles

5. Responsibilities

• Technician/Metrology: Perform calibration and maintain records.
• QC/QA Reviewer: Review calibration records and ensure compliance.
• Owner Department: Ensure equipment is available and accessible for calibration.
• External Service Provider: Conduct calibration as per external calibration type.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow for warm-up/stabilization of the equipment prior to calibration.
• Maintain cleanliness of the calibration area and equipment.
• Check leveling of the equipment.
• Verify power supply stability and functionality.

7. Standards & Tools

• Reference Standards Required: [TBD]
• Traceability Statement: ISO17025
• Certificate Validity Check: Ensure all certificates are current and valid.
• Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the specified range of -10°C to 30°C. Each point will have three replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and standards.
2. Stabilization: Allow the sensor to stabilize in the calibration environment.
3. As Found Checks and Data Capture: Record initial readings at defined test points.
4. Adjustment Rules: If any readings are OOT, perform adjustments as allowed; otherwise, escalate to QA.
5. As Left Verification: Record final readings after adjustments.
6. Labeling + Documentation Completion: Ensure all records are completed and raw observations are documented contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

The acceptance criteria for the Cold Room Temp/RH Sensor are ±0.5°C for temperature and ±5%RH for relative humidity. The error calculation formula is:

Error = Observed Value – Reference Value

Pass/Fail Logic: If the absolute value of the error is within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding Rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and cease use.
• Notification & deviation initiation: Notify QA and document the deviation.
• Impact assessment trigger: Define impact window and review affected results/batches.
• Recalibration after repair/adjustment: Ensure recalibration is performed before returning to service.
• QA disposition placeholders: [TBD]

12. Records & Retention

• Logbook entries: Document all calibration activities.
• Calibration report/certificate filing: Maintain records in accordance with company policy.
• e-Records if applicable: [TBD]
• Label content requirements: Include calibrated date, due date, technician name, and status.

13. Annexures

Annexure A: Calibration Data Sheet

Test Points	Reference	Observed	Error	Acceptance	Pass/Fail	As Found	As Left
[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Annexure B: Quick Checklist

• Environmental controls verified.
• Equipment warm-up completed.
• Calibration tools prepared.
• As Found data recorded.
• Adjustments made if necessary.
• As Left data recorded.

Annexure C: Example Label Text

Calibration Date: [TBD]
Due Date: [TBD]
Calibrated By: [TBD]
Status: [TBD]

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Calibration Protocol

Calibration Protocol

Protocol ID	Asset ID	Equipment Name	Equipment Type	Dept	Area	Process Use	Parameter	Units	Range	Acceptance Criteria	Frequency	Calibration Type	Traceability
[TBD]	CAL-0193	Cold Room Temp/RH Sensor	TempRH Sensor	Warehouse	Cold Room	GDP storage	Temperature/RH	°C/%RH	-10 to 30	±0.5°C/±5%RH	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %RH

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: -10 °C/%RH
• 25%: 5 °C/%RH
• 50%: 10 °C/%RH
• 75%: 20 °C/%RH
• Maximum: 30 °C/%RH

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
-10 °C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±5%RH	[TBD]	[TBD]	[TBD]	[TBD]
5 °C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±5%RH	[TBD]	[TBD]	[TBD]	[TBD]
10 °C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±5%RH	[TBD]	[TBD]	[TBD]	[TBD]
20 °C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±5%RH	[TBD]	[TBD]	[TBD]	[TBD]
30 °C/%RH	[TBD]	[TBD]	[TBD]	±0.5°C/±5%RH	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the Cold Room Temp/RH Sensor is clean and free from obstructions.
2. Stabilization: Allow the sensor to stabilize for at least 30 minutes before taking readings.
3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated errors against the acceptance criteria.
6. Documentation: Record all observations, calculations, and evaluations in the results table.

Deviation Instruction for OOT

• Stop use of the equipment immediately.
• Notify the Quality Assurance (QA) department.
• Open a deviation report.
• Quarantine impacted results window: [TBD]
• Await QA decision on further actions.

Approvals

Prepared	Reviewed	Approved
[Signature/Date]	[Signature/Date]	[Signature/Date]

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0193	Cold Room Temp/RH Sensor	Warehouse	Cold Room	Temperature/RH	-10 to 30 °C/%RH	±0.5°C/±5%RH	180 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are stable
• [ ] Allow sensor to warm up as per manufacturer instructions
• [ ] Clean the sensor and surrounding area
• [ ] Ensure sensor is level
• [ ] Check validity of reference standards
• [ ] Confirm logbook is ready for entries

As Found Execution

• [ ] Set sensor to specified setpoints
• [ ] Perform repeat measurements
• [ ] Record raw data accurately
• [ ] Perform necessary calculations

OOT Immediate Actions

• [ ] Tag out the equipment
• [ ] Stop use of the sensor
• [ ] Notify relevant personnel
• [ ] Document deviation
• [ ] Trigger impact review

As Left Verification

• [ ] Conduct post-adjustment checks
• [ ] Confirm measurements are within acceptance limits

Documentation & Closure

• [ ] Update calibration label
• [ ] Attach calibration certificate
• [ ] Obtain reviewer sign-off
• [ ] Update next due date

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Deviation Impact Assessment

Event Summary
Asset: Cold Room Temp/RH Sensor Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the asset
• Label/tag the asset as out of tolerance
• Segregate impacted work

Define Impact Window

Last known in-tolerance date: [TBD] to discovery date: [TBD]

Product/Batch/Test Impact Review

Batch/Study/Report ID	Results Potentially Impacted	Re-test/Re-weigh Decision
[TBD]	[TBD]	[TBD]

Data Integrity Review Prompts (ALCOA+)

• Attributable: [TBD]
• Legible: [TBD]
• Contemporaneous: [TBD]
• Original: [TBD]
• Accurate: [TBD]
• Complete: [TBD]
• Consistent: [TBD]
• Enduring: [TBD]
• Available: [TBD]

Risk Assessment

Severity	Probability	Detectability	Rationale	Overall Risk
[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Investigation Summary

Root Cause: [TBD]

CAPA Plan

Action	Owner	Due Date	Effectiveness Check
[TBD]	[TBD]	[TBD]	[TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

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Calibration Certificate

Certificate No: [TBD]

Date: [TBD]

Next Due Date: [TBD]

Asset Details

Asset ID	Equipment Name	Equipment Type	Dept	Area	Make/Model	Serial No	Location	Parameter/Range/Units	Acceptance Criteria
CAL-0193	Cold Room Temp/RH Sensor	TempRH Sensor	Warehouse	Cold Room	[TBD]	[TBD]	[TBD]	Temperature: -10 to 30 °C / RH: [TBD]	±0.5°C / ±5%RH

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID	Certificate No	Due Date	Traceability Statement
[TBD]	[TBD]	[TBD]	Traceability: ISO17025

Results

As Found Results

Test Point	Measured Value	Acceptance Criteria	Pass/Fail
Point 1	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 2	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 3	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 4	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 5	[TBD]	±0.5°C / ±5%RH	[TBD]

As Left Results

Test Point	Measured Value	Acceptance Criteria	Pass/Fail
Point 1	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 2	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 3	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 4	[TBD]	±0.5°C / ±5%RH	[TBD]
Point 5	[TBD]	±0.5°C / ±5%RH	[TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [TBD]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: _____________________ Date: ___________

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