Calibration Documents: Hot Air Oven Temp Sensor (CAL-0154)

Asset ID	CAL-0154
Equipment	Hot Air Oven Temp Sensor
Equipment Type	Oven
Department	QC
Area/Location	Glassware
Process Use	Glassware drying
Parameter	Temperature
Units	°C
Range Min	40
Range Max	250
Acceptance Criteria	±1°C
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Hot Air Oven Temp Sensor is performed to ensure accurate temperature measurements during glassware drying processes. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with GMP standards.

2. Scope

• Asset ID: CAL-0154
• Equipment Name/Type: Hot Air Oven Temp Sensor / Oven
• Department/Area: QC / Glassware
• Process Use: Glassware drying
• Parameter: Temperature
• Range: 40°C to 250°C
• Units: °C
• Calibration Frequency: Every 180 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of an instrument.
• Verification: The confirmation that a measurement system is functioning as intended.
• Adjustment: The process of modifying an instrument to bring it into compliance with specifications.
• 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 measurement exceeds the defined acceptance criteria.
• Drift: The gradual change in the output of a measurement system 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 verification process conducted between scheduled 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 documentation.
• QC/QA Reviewer: Review calibration results and documentation.
• Owner Department: Ensure equipment is available and maintained.
• 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 leveling of the equipment.
• Verify power supply is stable and within specifications.

7. Standards & Tools

• Reference Standards: [TBD]
• Traceability Statement: ISO17025
• Certificate Validity Check: Ensure all reference standards are within calibration validity.

8. Calibration Strategy

The calibration will follow the As Found then As Left logic:

• Minimum number of points: 5 points including endpoints (40°C, 250°C) and midpoints (e.g., 100°C, 150°C).
• Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the oven to reach operating temperature.
3. As Found checks and data capture: Measure temperature at defined points and record data.
4. Adjustment rules: If OOT is detected, adjust the sensor if permitted; otherwise, escalate to QA.
5. As Left verification: Re-measure to confirm adjustments are within acceptance criteria.
6. Labeling + documentation completion: Complete all required documentation and label the equipment.

Record raw observations contemporaneously to ensure ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1°C

Error calculation formula: Error = Observed Value – Reference Value

Pass/Fail Logic: If |Error| ≤ 1°C, then Pass; otherwise, Fail.

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 needed.
• 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: 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
• Cleanliness checked
• Leveling confirmed
• Power supply stable

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-0154	Hot Air Oven Temp Sensor	Oven	QC	Glassware	Glassware drying	Temperature	°C	40 – 250	±1°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

• Min: 40 °C
• 25%: 85 °C
• 50%: 145 °C
• 75%: 205 °C
• Max: 250 °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]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
85 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
145 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
205 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]
250 °C	[TBD]	[TBD]	[TBD]	±1°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the Hot Air Oven is clean and free of any contaminants.
2. Stabilization: Allow the oven to stabilize at each test point for a minimum of 30 minutes.
3. Performing Readings: Take three replicate readings at each test point and record the values.
4. Calculating Error: Calculate the error by subtracting the reference value from the observed value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±1°C.
6. Documentation: Complete the results table with As Found and As Left values.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the Quality Assurance (QA) department.
• 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-0154	Hot Air Oven Temp Sensor	QC	Glassware	Temperature	40 – 250 °C	±1°C	180 days	ISO17025

Pre-calibration

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

As Found Execution

• [ ] Set temperature setpoints as per calibration protocol
• [ ] Perform repeat measurements 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 QA and relevant personnel
• [ ] Document deviation from acceptance criteria
• [ ] Trigger impact review as per SOP

As Left Verification

• [ ] Conduct post-adjustment checks to confirm accuracy
• [ ] Ensure all measurements are within specified limits

Documentation & Closure

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

Data Integrity (ALCOA+): Ensure all data recorded is attributable, legible, contemporaneous, original, and accurate, with proper documentation practices followed.

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Deviation Impact Assessment

Event Summary
Asset: Hot Air Oven Temp Sensor 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: [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-0154	Hot Air Oven Temp Sensor	Oven	QC	Glassware	[TBD]	[TBD]	[TBD]	Temperature: 40 – 250 °C	±1°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)	Pass/Fail
40	[TBD]	[TBD]
100	[TBD]	[TBD]
150	[TBD]	[TBD]
200	[TBD]	[TBD]
250	[TBD]	[TBD]

As Left Results

Test Point	Measured Value (°C)	Pass/Fail
40	[TBD]	[TBD]
100	[TBD]	[TBD]
150	[TBD]	[TBD]
200	[TBD]	[TBD]
250	[TBD]	[TBD]

Measurement Uncertainty Statement

[TBD]

Statement of Conformity

[TBD] Overall: Pass/Fail

Remarks

[TBD]

Signatures

Performed by: ______________________ Date: __________

Checked by: ______________________ Date: __________

Approved by: ______________________ Date: __________

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