Calibration Documents: Freezer Temp Probe (-20°C) (CAL-0191)

Asset ID	CAL-0191
Equipment	Freezer Temp Probe (-20°C)
Equipment Type	Temperature Probe
Department	Warehouse/QA
Area/Location	Cold Storage
Process Use	GDP storage
Parameter	Temperature
Units	°C
Range Min	-30
Range Max	0
Acceptance Criteria	±0.5°C
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Freezer Temp Probe (-20°C) is performed to ensure accurate temperature measurements within the cold storage area, which is critical for maintaining Good Distribution Practice (GDP) storage conditions. Accurate temperature readings are essential for patient safety, batch quality, and data integrity, as deviations may compromise product stability and efficacy.

2. Scope

• Asset ID: CAL-0191
• Equipment Name/Type: Freezer Temp Probe (-20°C) / Temperature Probe
• Department/Area: Warehouse/QA / Cold Storage
• Process Use: GDP storage
• Parameter: Temperature
• Range: -30°C to 0°C
• Units: °C
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
• Verification: The process of confirming that an instrument is functioning correctly.
• Adjustment: The act of modifying an instrument to bring it within specified limits.
• As Found: The condition of the equipment prior to any adjustments made during calibration.
• As Left: The condition of the equipment after adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement falls 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 associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurement.
• Intermediate Check: A check performed between calibrations to ensure continued accuracy of the instrument.

4. References

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

5. Responsibilities

• Technician/Metrology: Perform calibration and document results.
• QC/QA Reviewer: Review calibration documentation and results.
• Owner Department: Ensure equipment is available and accessible for calibration.
• External Service Provider: Conduct external calibration as per the defined schedule.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm-up/stabilize as per manufacturer guidelines.
• Maintain cleanliness of the equipment and surrounding area.
• Check that the equipment is level and stable.
• Verify power supply is functioning correctly.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: [TBD]
• Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will include at least 5 points across the specified range of -30°C to 0°C, including endpoints and midpoints. It is recommended to take 3 replicate readings at each point to ensure accuracy and reliability.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the temperature probe to stabilize in the calibration environment.
3. As Found checks and data capture: Record initial temperature readings at defined points.
4. Adjustment rules: If OOT is found, escalate for adjustment as per SOP; otherwise, proceed to As Left verification.
5. As Left verification: Record final readings after any adjustments.
6. Labeling + documentation completion: Ensure all calibration records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the Freezer Temp Probe are ±0.5°C. 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 stop use if OOT is detected.
• Notification & deviation initiation: Notify relevant personnel and initiate deviation procedures.
• Impact assessment trigger: Define impact window and review of affected results/batches.
• Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
• 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
• Cleanliness checked
• Leveling confirmed
• Power supply verified

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-0191	Freezer Temp Probe (-20°C)	Temperature Probe	Warehouse/QA	Cold Storage	GDP storage	Temperature	°C	-30 to 0	±0.5°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: -30°C
• 25% of Range: -22.5°C
• 50% of Range: -15°C
• 75% of Range: -7.5°C
• Maximum: 0°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
-30°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
-22.5°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
-15°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
-7.5°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
0°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the temperature probe is clean and properly calibrated prior to use.
2. Stabilization: Allow the probe to stabilize in the cold storage environment for at least 30 minutes.
3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
4. Calculating Error: Calculate the error for each test point by subtracting the reference value from the observed value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.5°C.
6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the 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-0191	Freezer Temp Probe (-20°C)	Warehouse/QA	Cold Storage	Temperature	-30°C to 0°C	±0.5°C	180 days	ISO17025

Pre-calibration

• [ ] Verify environment conditions are stable
• [ ] Allow equipment to warm up as per SOP
• [ ] Clean the probe as necessary
• [ ] Ensure the probe is leveled
• [ ] Check validity of reference standards
• [ ] Confirm logbook is ready for entries

As Found Execution

• [ ] Set the temperature probe to specified setpoints
• [ ] Perform multiple repeats for accuracy
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment
• [ ] Stop use of the equipment immediately
• [ ] Notify relevant personnel
• [ ] Document deviation from acceptance criteria
• [ ] Trigger impact review as per SOP

As Left Verification

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

Documentation & Closure

• [ ] Update equipment label with calibration details
• [ ] Attach calibration certificate to log
• [ ] Obtain reviewer sign-off
• [ ] Update next due date in logbook

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Deviation Impact Assessment

Event Summary
Asset: Freezer Temp Probe (-20°C) Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the affected equipment
• Label/tag the equipment as out of service
• Segregate impacted work areas

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-0191	Freezer Temp Probe (-20°C)	Temperature Probe	Warehouse/QA	Cold Storage	[TBD]	[TBD]	[TBD]	Temperature: -30°C to 0°C (°C)	±0.5°C

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point	Measured Value (°C)	Pass/Fail
Point 1	[TBD]	[TBD]
Point 2	[TBD]	[TBD]
Point 3	[TBD]	[TBD]
Point 4	[TBD]	[TBD]
Point 5	[TBD]	[TBD]

As Left Results

Test Point	Measured Value (°C)	Pass/Fail
Point 1	[TBD]	[TBD]
Point 2	[TBD]	[TBD]
Point 3	[TBD]	[TBD]
Point 4	[TBD]	[TBD]
Point 5	[TBD]	[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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