BOD Incubator Temp Sensor (CAL-0157) – Calibration Documents

Calibration Documents: BOD Incubator Temp Sensor (CAL-0157)

Asset ID CAL-0157
Equipment BOD Incubator Temp Sensor
Equipment Type BOD Incubator
Department Microbiology
Area/Location Incubation
Process Use Microbial growth
Parameter Temperature
Units °C
Range Min 10
Range Max 60
Acceptance Criteria ±0.5°C
Calibration Frequency (days) 180
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 BOD Incubator Temperature Sensor is performed to ensure accurate temperature readings, which are critical for microbial growth processes. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity.

2. Scope

  • Asset ID: CAL-0157
  • Equipment Name/Type: BOD Incubator Temp Sensor / BOD Incubator
  • Department/Area: Microbiology / Incubation
  • Process Use: Microbial growth
  • Parameter: Temperature
  • Range: 10°C to 60°C
  • Units: °C
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement device against a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement device operates within specified limits.
  • Adjustment: The act of modifying a measurement device to bring it within specified limits.
  • As Found: The condition of the equipment before any adjustments are 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 device’s performance 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 periodic check 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 documentation.
  • QC/QA Reviewer: Review calibration results and documentation.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow the equipment to warm up and stabilize before calibration.
  • Maintain cleanliness in the calibration area.
  • Check that the equipment is level.
  • Verify power supply is stable and within specifications.
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7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (10°C, 60°C) and midpoints (25°C, 30°C, 40°C).
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the BOD Incubator to reach the operating temperature range.
  3. As Found checks and data capture: Record temperature readings at defined points.
  4. Adjustment rules: If OOT is found, adjust if permitted; otherwise, escalate to QA.
  5. As Left verification: Confirm that all adjustments bring the equipment within acceptance criteria.
  6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.5°C

Error calculation formula: Error = Observed Value – True Value

Pass/Fail logic: If the absolute value of the error is within ±0.5°C, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define impact window and review 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 for audit purposes.
  • 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
  • Calibration tools prepared
  • Documentation ready

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-0157 BOD Incubator Temp Sensor BOD Incubator Microbiology Incubation Microbial growth Temperature °C 10 – 60 ±0.5°C 180 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 10°C
  • 25% of Range: 27.5°C
  • 50% of Range: 35°C
  • 75% of Range: 42.5°C
  • Maximum: 60°C

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
10°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
27.5°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
35°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
42.5°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 BOD Incubator is clean and operational. Verify that the temperature sensor is calibrated and functioning.
  2. Stabilization: Allow the incubator to stabilize at the test points for a minimum of 30 minutes before taking readings.
  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 by subtracting the reference value from the observed value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±0.5°C.
  6. Documentation: Complete the results table and ensure all data is recorded accurately, maintaining ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and QA.
  • 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]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0157 BOD Incubator Temp Sensor Microbiology Incubation Temperature 10°C – 60°C ±0.5°C 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure incubator is warmed up to operating temperature
  • [ ] Clean the equipment as per SOP
  • [ ] Level the incubator if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set temperature setpoints as per calibration protocol
  • [ ] Perform repeat measurements for accuracy
  • [ ] Record raw data in logbook
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in logbook
  • [ ] Trigger impact review process
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As Left Verification

  • [ ] Conduct post-adjustment checks to confirm settings
  • [ ] Verify that all measurements are within acceptance limits

Documentation & Closure

  • [ ] Update equipment label with new calibration date
  • [ ] Attach calibration certificate to logbook
  • [ ] Obtain reviewer sign-off on calibration report
  • [ ] Update next due date for calibration in logbook

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Deviation Impact Assessment

Event Summary
  • Asset: BOD Incubator Temp Sensor
  • Date: [TBD]
  • Discovered By: [TBD]
  • Document References: [TBD]
  • As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the equipment
  • Label/tag the equipment as out of service
  • Segregate impacted work

Define Impact Window

  • 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

  • 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-0157 BOD Incubator Temp Sensor BOD Incubator Microbiology Incubation [TBD] [TBD] [TBD] Temperature: 10°C – 60°C ±0.5°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] ±0.5°C
Point 2 [TBD] ±0.5°C
Point 3 [TBD] ±0.5°C
Point 4 [TBD] ±0.5°C
Point 5 [TBD] ±0.5°C

As Left Results

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

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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