Calibration Documents: RTD Sensor Pt100 (CAL-0052)

Asset ID	CAL-0052
Equipment	RTD Sensor Pt100
Equipment Type	RTD Sensor
Department	Engineering
Area/Location	Utilities
Process Use	Temperature sensing
Parameter	Temperature
Units	°C
Range Min	-50
Range Max	250
Acceptance Criteria	±0.5°C
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the RTD Sensor Pt100 is performed to ensure accurate temperature sensing within the specified range of -50°C to 250°C. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

• Asset ID: CAL-0052
• Equipment Name/Type: RTD Sensor Pt100 / RTD Sensor
• Department/Area: Engineering / Utilities
• Process Use: Temperature sensing
• Parameter: Temperature
• Range: -50°C to 250°C
• Units: °C
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of an instrument against a known standard.
• Verification: The process of confirming that an instrument meets specified requirements.
• Adjustment: The process of modifying an instrument to bring it within specified limits.
• 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 instrument’s measurements fall outside the specified acceptance criteria.
• Drift: The gradual change in an instrument’s accuracy 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 performed between calibrations to ensure ongoing 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 for compliance.
• Owner Department: Ensure equipment is available and in good condition for calibration.
• External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow for warm-up/stabilization of the equipment as per manufacturer guidelines.
• Maintain cleanliness of the equipment and surrounding area.
• Check leveling of the equipment.
• 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 and valid.
• Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints, across the specified range of -50°C to 250°C. Each point will have three replicate readings to ensure accuracy.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and documentation.
2. Stabilization: Allow the RTD Sensor to stabilize at the calibration environment.
3. As Found checks and data capture: Record initial measurements and document results.
4. Adjustment rules: If OOT is detected, follow escalation procedures; adjustments are only permitted if allowed.
5. As Left verification: Confirm that the instrument is within acceptance criteria after adjustments.
6. Labeling + documentation completion: Ensure all records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

The acceptance criteria for the RTD Sensor Pt100 is ±0.5°C. The error calculation formula is:

Error = Observed Value – True 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 of the OOT condition.
• 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 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 stabilized
• Calibration documentation prepared
• All tools available

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-0052	RTD Sensor Pt100	RTD Sensor	Engineering	Utilities	Temperature sensing	Temperature	°C	-50 to 250	±0.5°C	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: -50°C
• 25% of Range: -25°C
• 50% of Range: 100°C
• 75% of Range: 175°C
• Maximum: 250°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]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
-25°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
100°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
175°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
250°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the RTD Sensor Pt100 is clean and properly connected to the calibration equipment.
2. Stabilization: Allow the sensor to stabilize at room temperature 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 observed value using the formula: Error = Observed – Ref Value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.5°C.
6. Documentation: Record all observations, errors, and pass/fail results in the results table.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

• Stop use of the RTD Sensor Pt100.
• Notify the supervisor immediately.
• 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-0052	RTD Sensor Pt100	Engineering	Utilities	Temperature	-50 to 250 °C	±0.5°C	365 days	ISO17025

1) Pre-calibration

• [ ] Verify environment conditions are within specifications
• [ ] Allow equipment to warm up as per manufacturer guidelines
• [ ] Clean the equipment as necessary
• [ ] Ensure equipment is level
• [ ] Check validity of reference standards
• [ ] Confirm logbook is ready for entries

2) As Found Execution

• [ ] Set initial setpoints
• [ ] Perform repeat measurements
• [ ] Record raw data accurately
• [ ] Perform necessary calculations

3) OOT Immediate Actions

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

4) As Left Verification

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

5) 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.

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Deviation Impact Assessment

Event Summary	Details
Asset	RTD Sensor Pt100
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

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-0052	RTD Sensor Pt100	RTD Sensor	Engineering	Utilities	[TBD]	[TBD]	[TBD]	Temperature: -50 to 250 °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)	Acceptance Criteria	Pass/Fail
Point 1	[TBD]	±0.5°C	[TBD]
Point 2	[TBD]	±0.5°C	[TBD]
Point 3	[TBD]	±0.5°C	[TBD]
Point 4	[TBD]	±0.5°C	[TBD]
Point 5	[TBD]	±0.5°C	[TBD]

As Left Results

Test Point	Measured Value (°C)	Acceptance Criteria	Pass/Fail
Point 1	[TBD]	±0.5°C	[TBD]
Point 2	[TBD]	±0.5°C	[TBD]
Point 3	[TBD]	±0.5°C	[TBD]
Point 4	[TBD]	±0.5°C	[TBD]
Point 5	[TBD]	±0.5°C	[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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