Calibration Documents: Deep Freezer Temp Probe (-80°C) (CAL-0192)

Asset ID	CAL-0192
Equipment	Deep Freezer Temp Probe (-80°C)
Equipment Type	Temperature Probe
Department	Warehouse/QA
Area/Location	Cold Storage
Process Use	Biologic storage
Parameter	Temperature
Units	°C
Range Min	-90
Range Max	-40
Acceptance Criteria	±1°C
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Deep Freezer Temp Probe (-80°C) is performed to ensure accurate temperature readings critical for biologic storage. This calibration controls risks related to patient safety, batch quality, and data integrity by maintaining the temperature within specified limits.

2. Scope

• Asset ID: CAL-0192
• Equipment Name/Type: Deep Freezer Temp Probe (-80°C) / Temperature Probe
• Department/Area: Warehouse/QA / Cold Storage
• Process Use: Biologic storage
• Parameter: Temperature
• Range: -90°C to -40°C
• Units: °C
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of a measuring instrument.
• Verification: The confirmation that a measuring instrument meets specified requirements.
• Adjustment: The process of modifying a measuring instrument to bring it into compliance with specifications.
• 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 measurement exceeds the acceptance criteria.
• Drift: The gradual change in a measurement instrument’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 asserted to lie.
• Intermediate Check: A verification process conducted 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: Perform calibration and maintain records.
• QC/QA Reviewer: Review calibration results and documentation.
• Owner Department: Ensure equipment is available and accessible for calibration.
• External Service Provider: Conduct external calibration as required.

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 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 calibration certificates are current.
• Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. A minimum of 5 measurement points will be taken, including endpoints and midpoints within the specified range of -90°C to -40°C. Each point will have 3 replicate readings to ensure accuracy.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and documentation.
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 any readings are OOT, escalate for adjustment as per SOP.
5. As Left verification: Confirm that all adjustments have brought the probe within acceptance criteria.
6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record all raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the temperature probe is ±1°C. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail logic: If the absolute value of the error is within ±1°C, 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 the impact window and review affected results/batches.
• Recalibration after repair/adjustment: Schedule recalibration as necessary.
• QA disposition: [TBD]

12. Records & Retention

• Logbook entries: Document all calibration activities.
• Calibration report/certificate filing: Maintain records as per 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; include As Found + As Left columns)

Annexure B: Quick checklist

Annexure C: Example label text (with [TBD] placeholders)

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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-0192	Deep Freezer Temp Probe (-80°C)	Temperature Probe	Warehouse/QA	Cold Storage	Biologic storage	Temperature	°C	-90 to -40	±1°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

• Min: -90°C
• 25%: -80°C
• 50%: -65°C
• 75%: -50°C
• Max: -40°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
-90°C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
-80°C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
-65°C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
-50°C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
-40°C	[TBD]	[TBD]	[TBD]	±1°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 by subtracting the reference value from the observed value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±1°C.
6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any readings fall outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the QA department.
• Open a deviation report.
• Quarantine the 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-0192	Deep Freezer Temp Probe (-80°C)	Warehouse/QA	Cold Storage	Temperature	-90°C to -40°C	±1°C	180 days	ISO17025

Pre-calibration

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

As Found Execution

• [ ] Set temperature probe to specified setpoints
• [ ] Perform repeat measurements as required
• [ ] Record raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment
• [ ] Stop use of the temperature probe
• [ ] Notify relevant personnel
• [ ] Document deviation from acceptance criteria
• [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

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

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate. Maintain complete traceability throughout the calibration process.

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Deviation Impact Assessment

Event Summary
Asset: Deep Freezer Temp Probe (-80°C) 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 service
• Segregate impacted work

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

Investigation Summary Placeholders: [TBD]

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-0192	Deep Freezer Temp Probe (-80°C)	Temperature Probe	Warehouse/QA	Cold Storage	[TBD]	[TBD]	[TBD]	Temperature: -90°C to -40°C (°C)	±1°C

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point	Measured Value (°C)	Acceptance Criteria
Point 1	[TBD]	±1°C
Point 2	[TBD]	±1°C
Point 3	[TBD]	±1°C
Point 4	[TBD]	±1°C
Point 5	[TBD]	±1°C

As Left Results

Test Point	Measured Value (°C)	Acceptance Criteria
Point 1	[TBD]	±1°C
Point 2	[TBD]	±1°C
Point 3	[TBD]	±1°C
Point 4	[TBD]	±1°C
Point 5	[TBD]	±1°C

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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