Calibration Documents: IR Thermometer (CAL-0054)

Asset ID	CAL-0054
Equipment	IR Thermometer
Equipment Type	IR Thermometer
Department	Engineering
Area/Location	Maintenance
Process Use	Surface temperature
Parameter	Temperature
Units	°C
Range Min	-20
Range Max	500
Acceptance Criteria	±2°C
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the IR Thermometer (Asset ID: CAL-0054) is performed to ensure accurate measurement of surface temperature, which is critical for maintaining data integrity and ensuring consistent batch quality. Accurate temperature readings are essential to prevent deviations that could impact product quality and patient safety.

2. Scope

• Asset ID: CAL-0054
• Equipment Name/Type: IR Thermometer
• Department/Area: Engineering / Maintenance
• Process Use: Surface temperature
• Parameter: Temperature
• Range: -20°C to 500°C
• Units: °C
• Calibration Frequency: 365 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 the instrument meets specified requirements.
• Adjustment: The process of modifying the instrument to bring it within specified limits.
• As Found: The condition of the instrument prior to any adjustments being made.
• As Left: The condition of the instrument after adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement exceeds the defined acceptance criteria.
• Drift: The gradual change in the 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 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 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 the instrument to warm-up and stabilize before calibration.
• Maintain cleanliness of the instrument and surrounding area.
• Check that the instrument is level before use.
• Verify power supply is stable and within specifications.

7. Standards & Tools

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

8. Calibration Strategy

The calibration will follow the As Found and As Left logic:

• Minimum number of points: At least 5 points including endpoints (-20°C, 0°C, 250°C, 500°C).
• Replicate readings: 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 IR Thermometer to stabilize in the calibration environment.
3. As Found checks and data capture: Record initial temperature readings at specified points.
4. Adjustment rules: If OOT is found, follow escalation procedures; adjustments are only permitted if within scope.
5. As Left verification: Confirm that the instrument is within acceptance criteria after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the instrument with calibration details.

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

10. Acceptance Criteria & Calculations

The acceptance criteria for the IR Thermometer is ±2°C. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within ±2°C, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag the equipment and stop use.
• Notification & deviation initiation: Notify relevant personnel of the OOT condition.
• 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
• Instrument stabilized
• Calibration data recorded
• Documentation completed

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-0054	IR Thermometer	IR Thermometer	Engineering	Maintenance	Surface temperature	Temperature	°C	-20 to 500	±2°C	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for calibration will be selected as follows:

• Minimum: -20 °C
• 25% of Range: 115 °C
• 50% of Range: 240 °C
• 75% of Range: 365 °C
• Maximum: 500 °C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
-20 °C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
115 °C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
240 °C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
365 °C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
500 °C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the IR Thermometer is clean and free from any obstructions.
2. Stabilization: Allow the thermometer to stabilize at room temperature for at least 30 minutes.
3. Performing Readings:
   • Take three replicate readings at each test point.
   • Record all observed values in the results table.
4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed Value – Ref Value.
5. Evaluation: Compare the calculated error against the acceptance criteria (±2°C).
6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the supervisor and quality assurance (QA) personnel.
• 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-0054	IR Thermometer	Engineering	Maintenance	Temperature	-20 to 500 °C	±2 °C	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up as per manufacturer guidelines
• [ ] Clean the equipment as necessary
• [ ] Ensure the equipment is level
• [ ] Check validity of reference standards
• [ ] Ensure logbook is ready for recording

As Found Execution

• [ ] Set the required temperature setpoints
• [ ] Perform repeat measurements
• [ ] Record raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

• [ ] Update equipment 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, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: IR Thermometer 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: [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-0054	IR Thermometer	IR Thermometer	Engineering	Maintenance	[TBD]	[TBD]	[TBD]	Temperature: -20 to 500 °C	±2°C

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

As Left Results

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