Calibration Documents: Water Bath Temp Sensor (CAL-0158)

Asset ID	CAL-0158
Equipment	Water Bath Temp Sensor
Equipment Type	Water Bath
Department	QC
Area/Location	Chemistry Lab
Process Use	Heating
Parameter	Temperature
Units	°C
Range Min	20
Range Max	100
Acceptance Criteria	±0.5°C
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Water Bath Temp Sensor is performed to ensure accurate temperature readings during the heating process in the Chemistry Lab. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby supporting compliance with Good Manufacturing Practices (GMP).

2. Scope

• Asset ID: CAL-0158
• Equipment Name/Type: Water Bath Temp Sensor / Water Bath
• Department/Area: QC / Chemistry Lab
• Process Use: Heating
• Parameter: Temperature
• Range: 20°C to 100°C
• Units: °C
• Calibration Frequency: Every 180 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 an instrument is functioning correctly.
• Adjustment: The act of correcting an instrument to ensure it provides accurate readings.
• 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 readings fall outside the specified acceptance criteria.
• Drift: The gradual change in an 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 range of values within which the true value is asserted to lie.
• Intermediate Check: A periodic assessment of an instrument’s performance between calibrations.

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 in good condition for calibration.
• External Service Provider: Conduct external calibration as per schedule.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm up and stabilize before calibration.
• Maintain cleanliness of the equipment and surrounding area.
• Check that the equipment is level and stable.
• Verify power supply is functioning correctly.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: [TBD]
• Standard ID placeholders: [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 and 100°C) and midpoints (e.g., 40°C, 60°C, 80°C).
• Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and standards.
2. Stabilization: Allow the water bath to reach the desired temperature range.
3. As Found checks and data capture: Record initial temperature readings at specified points.
4. Adjustment rules: If OOT is detected, follow escalation procedures.
5. As Left verification: Confirm that adjustments bring the instrument within acceptance criteria.
6. Labeling + documentation completion: Ensure all records are filled out accurately and 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 placeholder: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use.
• Notification & deviation initiation: Inform 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: 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 checked
• Equipment warm-up completed
• Cleanliness verified
• Leveling confirmed
• Power supply checked

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-0158	Water Bath Temp Sensor	Water Bath	QC	Chemistry Lab	Heating	Temperature	°C	20 – 100	±0.5°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 20°C
• 25%: 35°C
• 50%: 60°C
• 75%: 85°C
• Maximum: 100°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]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
35°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
60°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
85°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
100°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the water bath is clean and properly set up in the designated area.
2. Stabilization: Allow the water bath to reach the desired temperature range 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 against the reference value.
5. Evaluation: Compare the calculated errors to the acceptance criteria of ±0.5°C.
6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value is 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	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-0158	Water Bath Temp Sensor	QC	Chemistry Lab	Temperature	20 – 100 °C	±0.5°C	180 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Ensure water bath is warmed up to operating temperature
• [ ] Clean the equipment as per SOP
• [ ] Level the water bath 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 multiple repeats for accuracy
• [ ] Record raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment if out of tolerance (OOT)
• [ ] Stop use of the equipment immediately
• [ ] Notify the supervisor and QA
• [ ] Document deviation in the logbook
• [ ] Trigger impact review as per SOP

As Left Verification

• [ ] Perform post-adjustment checks to confirm accuracy
• [ ] Ensure all readings are within acceptance limits

Documentation & Closure

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

Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: Water Bath 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] 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-0158	Water Bath Temp Sensor	Water Bath	QC	Chemistry Lab	[TBD]	[TBD]	[TBD]	Temperature/20-100/°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
1	[TBD]	±0.5°C
2	[TBD]	±0.5°C
3	[TBD]	±0.5°C
4	[TBD]	±0.5°C
5	[TBD]	±0.5°C

As Left Results

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