Calibration Documents: Reference Thermometer (Master) (CAL-0051)

Asset ID	CAL-0051
Equipment	Reference Thermometer (Master)
Equipment Type	Reference Thermometer
Department	Calibration Lab
Area/Location	Metrology
Process Use	Calibration standard
Parameter	Temperature
Units	°C
Range Min	-50
Range Max	300
Acceptance Criteria	±0.1°C
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

---

Calibration SOP

1. Purpose

The calibration of the Reference Thermometer (Master) is performed to ensure accurate temperature measurements, which are critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate temperature readings are essential in the calibration of other instruments and processes, thereby controlling risks associated with temperature deviations.

2. Scope

• Asset ID: CAL-0051
• Equipment Name/Type: Reference Thermometer (Master)
• Department/Area: Calibration Lab / Metrology
• Process Use: Calibration standard
• Parameter: Temperature
• Range: -50°C to 300°C
• Units: °C
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of comparing a measurement standard to a known reference to determine accuracy.
• Verification: The process of confirming that a measurement system is functioning correctly.
• Adjustment: The process of modifying a measurement device to bring it into alignment with a standard.
• 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 reading 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 dispersion of the values attributed to a measured quantity.
• Intermediate Check: A periodic check 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: Perform calibration and document results.
• QC/QA Reviewer: Review calibration documentation and results for compliance.
• Owner Department: Ensure equipment is available and maintained.
• External Service Provider: [TBD] (if applicable based on calibration type).

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.

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow an As Found then As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the specified range of -50°C to 300°C. Each point will have three replicate readings taken as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the Reference Thermometer to stabilize in the calibration environment.
3. As Found checks and data capture: Measure and record the temperature at each test point.
4. Adjustment rules: If any readings are OOT, escalate for adjustment as per company policy.
5. As Left verification: Re-measure the adjusted points to confirm compliance.
6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

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

10. Acceptance Criteria & Calculations

Acceptance criteria for the Reference Thermometer is ±0.1°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.
• Notification & deviation initiation: Notify relevant personnel.
• Impact assessment trigger: Define impact window and review of affected results/batches.
• Recalibration after repair/adjustment: Schedule recalibration as necessary.
• QA disposition placeholders: [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	As Found	As Left
[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Annexure B: Quick Checklist

• Environmental controls verified
• Equipment warm-up completed
• Calibration area cleanliness confirmed
• Power supply checked

Annexure C: Example Label Text

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

⬆ Back to TOC

---

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-0051	Reference Thermometer (Master)	Reference Thermometer	Calibration Lab	Metrology	Calibration standard	Temperature	°C	-50 to 300	±0.1°C	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Min: -50°C
• 25%: -12.5°C
• 50%: 125°C
• 75%: 212.5°C
• Max: 300°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
-50°C	[TBD]	[TBD]	[TBD]	±0.1°C	[TBD]	[TBD]	[TBD]	[TBD]
-12.5°C	[TBD]	[TBD]	[TBD]	±0.1°C	[TBD]	[TBD]	[TBD]	[TBD]
125°C	[TBD]	[TBD]	[TBD]	±0.1°C	[TBD]	[TBD]	[TBD]	[TBD]
212.5°C	[TBD]	[TBD]	[TBD]	±0.1°C	[TBD]	[TBD]	[TBD]	[TBD]
300°C	[TBD]	[TBD]	[TBD]	±0.1°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the Reference Thermometer is clean and calibrated prior to use.
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.
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: Complete the results table and sign off on the calibration log.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

• Stop use of the thermometer immediately.
• Notify the supervisor and quality assurance.
• 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]

⬆ Back to TOC

---

Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0051	Reference Thermometer (Master)	Calibration Lab	Metrology	Temperature	-50 to 300 °C	±0.1°C	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up as per SOP
• [ ] Clean the equipment as per cleaning protocol
• [ ] Ensure equipment is leveled
• [ ] Check validity of reference standards
• [ ] Ensure logbook is ready for entries

As Found Execution

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

OOT Immediate Actions

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

As Left Verification

• [ ] Perform 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 is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

⬆ Back to TOC

---

Deviation Impact Assessment

Event Summary	Details
Asset	Reference Thermometer (Master)
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	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]

⬆ Back to TOC

---

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-0051	Reference Thermometer (Master)	Reference Thermometer	Calibration Lab	Metrology	[TBD]	[TBD]	[TBD]	Temperature: -50 to 300 °C	±0.1°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)	Acceptance Criteria	Pass/Fail
-50	[TBD]	±0.1°C	[TBD]
0	[TBD]	±0.1°C	[TBD]
100	[TBD]	±0.1°C	[TBD]
200	[TBD]	±0.1°C	[TBD]
300	[TBD]	±0.1°C	[TBD]

As Left Results

Test Point	Measured Value (°C)	Acceptance Criteria	Pass/Fail
-50	[TBD]	±0.1°C	[TBD]
0	[TBD]	±0.1°C	[TBD]
100	[TBD]	±0.1°C	[TBD]
200	[TBD]	±0.1°C	[TBD]
300	[TBD]	±0.1°C	[TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

⬆ Back to TOC