Calibration Documents: Refrigerator Temp Probe (2-8°C) (CAL-0190)

Asset ID	CAL-0190
Equipment	Refrigerator Temp Probe (2-8°C)
Equipment Type	Temperature Probe
Department	Warehouse/QA
Area/Location	Cold Storage
Process Use	GDP storage
Parameter	Temperature
Units	°C
Range Min	2
Range Max	8
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 Refrigerator Temp Probe (2-8°C) is performed to ensure accurate temperature readings within the specified range, thereby controlling risks associated with product integrity, patient safety, and batch quality. Accurate temperature monitoring is critical for maintaining Good Distribution Practice (GDP) storage conditions, ensuring that products remain within acceptable limits to prevent degradation and ensure compliance with regulatory standards.

2. Scope

• Asset ID: CAL-0190
• Equipment Name/Type: Refrigerator Temp Probe (2-8°C) / Temperature Probe
• Department/Area: Warehouse/QA / Cold Storage
• Process Use: GDP storage
• Parameter: Temperature
• Range: 2 – 8 °C
• Units: °C
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of comparing a measurement device to a known standard to determine its accuracy.
• Verification: The process of confirming that a measurement device operates within specified limits.
• Adjustment: The act of modifying a measurement device to bring it within specified limits.
• As Found: The condition of the equipment prior to any adjustments being made.
• As Left: The condition of the equipment after adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement exceeds the defined acceptance criteria.
• Drift: The gradual change in a measurement device’s output 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 is estimated to lie.
• Intermediate Check: A verification process performed between calibrations to ensure continued accuracy.

4. References

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

5. Responsibilities

• Technician/Metrology: Responsible for performing the calibration and documenting results.
• QC/QA Reviewer: Responsible for reviewing calibration documentation and ensuring compliance.
• Owner Department: Responsible for ensuring equipment is available and maintained.
• External Service Provider: Responsible for conducting external calibrations as per the calibration type.

6. Safety & Preconditions

• Ensure environmental controls are in place to maintain the specified temperature range.
• Allow the equipment to warm up/stabilize for at least [TBD] minutes prior to calibration.
• Ensure cleanliness of the equipment and surrounding area.
• Verify that the equipment is level and properly positioned.
• Check power supply and functionality of the equipment prior to calibration.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: Ensure all calibration certificates are current and valid.
• Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

• Minimum number of points: At least 5 points including endpoints (2°C, 8°C) and midpoints (5°C, 3°C, 7°C).
• Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the temperature probe to stabilize at the operating environment.
3. As Found checks and data capture: Record initial temperature readings at defined points.
4. Adjustment rules: If OOT is detected, follow adjustment procedures if allowed; otherwise, escalate to QA.
5. As Left verification: After adjustments, recheck and record temperature readings.
6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.5°C from the target range.

Error calculation formula: Error = Observed Value – True Value.

Pass/Fail Logic: If the absolute value of Error is less than or equal to 0.5°C, then Pass; otherwise, Fail.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use until resolved.
• Notification & deviation initiation: Notify QA and initiate deviation process.
• 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 in the logbook.
• Calibration report/certificate filing: Maintain records of calibration certificates.
• 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 checked

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-0190	Refrigerator Temp Probe (2-8°C)	Temperature Probe	Warehouse/QA	Cold Storage	GDP storage	Temperature	°C	2 – 8	±0.5°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 2°C
• 25% of Range: 3°C
• 50% of Range: 5°C
• 75% of Range: 7°C
• Maximum: 8°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
2°C	2°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
3°C	3°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
5°C	5°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
7°C	7°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
8°C	8°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the temperature probe is clean and calibrated within the last 180 days.
2. Stabilization: Allow the probe to stabilize in the cold storage environment 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 by subtracting the reference value from the observed value.
5. Evaluation: Compare the error against the acceptance criteria of ±0.5°C.
6. Documentation: Record all observed values, errors, and pass/fail results in the results table.

Deviation Instruction for OOT

• 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 By	Reviewed By	Approved By
[Signature/Date]	[Signature/Date]	[Signature/Date]

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0190	Refrigerator Temp Probe (2-8°C)	Warehouse/QA	Cold Storage	Temperature	2 – 8 °C	±0.5°C	180 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up as per SOP
• [ ] Clean the temperature probe and surrounding area
• [ ] Ensure the probe is level and properly positioned
• [ ] Confirm validity of reference standards used for calibration
• [ ] Ensure calibration logbook is ready for documentation

As Found Execution

• [ ] Set temperature setpoints for calibration
• [ ] Perform repeat measurements as per SOP
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment to prevent further use
• [ ] Stop use of the temperature probe immediately
• [ ] Notify QA and relevant personnel of the OOT condition
• [ ] Document deviation from acceptance criteria
• [ ] Trigger impact review as per SOP

As Left Verification

• [ ] Conduct post-adjustment checks to ensure accuracy
• [ ] Confirm that all measurements are within specified limits

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary
Asset: Refrigerator Temp Probe (2-8°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	Discovery Date
[TBD]	[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-0190	Refrigerator Temp Probe (2-8°C)	Temperature Probe	Warehouse/QA	Cold Storage	[TBD]	[TBD]	[TBD]	Temperature (2-8°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
1	[TBD]	[TBD]
2	[TBD]	[TBD]
3	[TBD]	[TBD]
4	[TBD]	[TBD]
5	[TBD]	[TBD]

As Left Results

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

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: __________

Checked by: ______________________ Date: __________

Approved by: ______________________ Date: __________

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