Temperature Data Logger (Single-use mapping) (CAL-0055) – Calibration Documents

Calibration Documents: Temperature Data Logger (Single-use mapping) (CAL-0055)

Asset ID CAL-0055
Equipment Temperature Data Logger (Single-use mapping)
Equipment Type Temperature Data Logger
Department Validation
Area/Location Warehouse/Cold chain
Process Use Temperature mapping
Parameter Temperature
Units °C
Range Min -40
Range Max 60
Acceptance Criteria ±0.5°C
Calibration Frequency (days) 365
Calibration Type External
Traceability ISO17025

Table of Contents

  1. Calibration SOP
  2. Calibration Protocol
  3. Calibration Checklist
  4. Deviation Impact Assessment
  5. Calibration Certificate

Calibration SOP

1. Purpose

The calibration of the Temperature Data Logger (Single-use mapping) is performed to ensure accurate temperature measurements during temperature mapping processes. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with regulatory requirements and maintaining the integrity of the cold chain.

2. Scope

  • Asset ID: CAL-0055
  • Equipment Name/Type: Temperature Data Logger (Single-use mapping)
  • Department/Area: Validation
  • Process Use: Temperature mapping
  • Parameter: Temperature
  • Range: -40°C to 60°C
  • Units: °C
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement instrument to bring it into compliance with specified standards.
  • As Found: The condition of the equipment prior to any adjustments made during calibration.
  • As Left: The condition of the equipment after calibration and any adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in the accuracy of a measurement instrument over time.
  • Traceability: The ability to trace the history, application, or location of an item through documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value of a measurement lies.
  • 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: 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 per the defined schedule.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm-up and stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment to ensure accurate readings.
  • Verify power supply is stable and within specifications.
See also  Inline Conductivity Sensor (PW) (CAL-0094) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. A minimum of 5 measurement points will be taken across the specified range of -40°C to 60°C, including endpoints and midpoints. Each point will have 3 replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the Temperature Data Logger to stabilize in the calibration environment.
  3. As Found Checks and Data Capture: Record initial readings at the defined points.
  4. Adjustment Rules: If any readings are OOT, escalate for adjustment as per SOP.
  5. As Left Verification: Record final readings after any adjustments.
  6. Labeling + Documentation Completion: Complete all required documentation and label the equipment accordingly.

Ensure all raw observations are recorded contemporaneously to maintain data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

The acceptance criteria for the Temperature Data Logger 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 the equipment and stop its use.
  • Notification & Deviation Initiation: Notify relevant personnel and initiate a deviation report.
  • Impact Assessment Trigger: Define the impact window and review affected results/batches.
  • Recalibration after Repair/Adjustment: Schedule recalibration after any necessary repairs or adjustments.
  • QA Disposition Placeholders: [TBD]

12. Records & Retention

  • Logbook entries must be maintained for all calibration activities.
  • Calibration report/certificate filing must be done as per company policy.
  • E-records if applicable: [TBD]
  • Label Content Requirements: Calibrated date, due date, by whom, 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 stable

Annexure C: Example Label Text

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

See also  Karl Fischer Titrator (Coulometric) (CAL-0141) - Calibration Documents

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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-0055 Temperature Data Logger (Single-use mapping) Temperature Data Logger Validation Warehouse/Cold chain Temperature mapping Temperature °C -40 to 60 ±0.5°C 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: -40°C
  • 25% of Range: -20°C
  • 50% of Range: 0°C
  • 75% of Range: 30°C
  • Maximum: 60°C

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
-40°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
-20°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
0°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
30°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
60°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the temperature data logger is clean and calibrated as per the previous calibration record.
  2. Stabilization: Allow the equipment to stabilize in the calibration environment for at least 30 minutes.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Determine the error by subtracting the reference value from the observed 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 falls 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 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-0055 Temperature Data Logger (Single-use mapping) Validation Warehouse/Cold chain Temperature -40 to 60 °C ±0.5°C 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per manufacturer instructions
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if applicable
  • [ ] Confirm validity of reference standards
  • [ ] Ensure logbook is ready for documentation
See also  TOC Analyzer Offline (CAL-0096) - Calibration Documents

As Found Execution

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

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Field Details
Asset Temperature Data Logger (Single-use mapping)
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

Field Details
Last Known In-Tolerance Date [TBD]
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

Summary of investigation findings: [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-0055 Temperature Data Logger (Single-use mapping) Temperature Data Logger Validation Warehouse/Cold chain [TBD] [TBD] [TBD] Temperature: -40 to 60 °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
-40 [TBD] ±0.5°C
-20 [TBD] ±0.5°C
0 [TBD] ±0.5°C
20 [TBD] ±0.5°C
60 [TBD] ±0.5°C

As Left Results

Test Point Measured Value (°C) Acceptance Criteria
-40 [TBD] ±0.5°C
-20 [TBD] ±0.5°C
0 [TBD] ±0.5°C
20 [TBD] ±0.5°C
60 [TBD] ±0.5°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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