Calibration Documents: Compressed Air Pressure Gauge (CAL-0325)

Asset ID	CAL-0325
Equipment	Compressed Air Pressure Gauge
Equipment Type	Pressure Gauge
Department	Utilities
Area/Location	Compressed Air
Process Use	Pressure
Parameter	Pressure
Units	bar
Range Min	0
Range Max	10
Acceptance Criteria	±1%
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Compressed Air Pressure Gauge is performed to ensure accurate pressure measurements within the specified range. 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-0325
• Equipment Name/Type: Compressed Air Pressure Gauge / Pressure Gauge
• Department/Area: Utilities / Compressed Air
• Process Use: Pressure
• Parameter: Pressure
• Range: 0 to 10 bar
• Units: bar
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of comparing a measurement instrument to a known standard to ensure accuracy.
• Verification: The confirmation that a measurement system meets specified requirements.
• Adjustment: The process of modifying a measurement instrument to bring it into compliance with specifications.
• As Found: The condition of the instrument before any adjustments are made.
• As Left: The condition of the instrument after adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement falls outside the defined acceptance criteria.
• Drift: The gradual change in the measurement output of an instrument 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 of the 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 the defined schedule.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm up/stabilize as per manufacturer recommendations.
• Maintain cleanliness of the calibration area and equipment.
• Check that the equipment is leveled and stable.
• Verify power supply is stable and within specifications.

7. Standards & Tools

• Reference Standards Required: [TBD]
• Traceability Statement: Calibration performed in accordance with ISO17025.
• Certificate Validity Check: Ensure all reference standards are within their validity period.
• Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

• Minimum number of points: At least 5 points including endpoints and midpoints within the range of 0 to 10 bar.
• Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the gauge to stabilize before taking measurements.
3. As Found checks and data capture: Record initial readings and conditions.
4. Adjustment rules: If OOT, follow adjustment protocols; if not allowed, escalate to QA.
5. As Left verification: Confirm readings post-adjustment and document results.
6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% of the reading.

Error calculation formula: Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If error falls within acceptance criteria, pass; otherwise, fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use.
• Notification & deviation initiation: Inform QA and document the deviation.
• Impact assessment trigger: Review affected results/batches within the defined impact window.
• Recalibration after repair/adjustment: Schedule recalibration as necessary.
• QA disposition: [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: 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-0325	Compressed Air Pressure Gauge	Pressure Gauge	Utilities	Compressed Air	Pressure	Pressure	bar	0 – 10	±1%	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 0 bar
• 25%: 2.5 bar
• 50%: 5 bar
• 75%: 7.5 bar
• Maximum: 10 bar

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
0 bar	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
2.5 bar	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
5 bar	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
7.5 bar	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
10 bar	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the pressure gauge is clean and free from any obstructions.
2. Stabilization: Allow the gauge to stabilize at room temperature for at least 30 minutes.
3. Performing Readings: Take three replicate readings at each test point.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated errors against the acceptance criteria of ±1%.
6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the equipment.
• 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-0325	Compressed Air Pressure Gauge	Utilities	Compressed Air	Pressure	0 – 10 bar	±1%	365 days	ISO17025

Pre-calibration

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

As Found Execution

• [ ] Set gauge to specified setpoints
• [ ] Perform repeat measurements
• [ ] Record raw data accurately
• [ ] Perform necessary calculations

OOT Immediate Actions

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

As Left Verification

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

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

Field	Details
Asset	Compressed Air Pressure Gauge
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 service
• 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

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-0325	Compressed Air Pressure Gauge	Pressure Gauge	Utilities	Compressed Air	[TBD]	[TBD]	[TBD]	Pressure (0 – 10 bar)	±1%

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID	Certificate No	Due Date	Traceability Statement
[TBD]	[TBD]	[TBD]	Traceability to ISO17025

Results

As Found Results

Test Point	Measured Value (bar)	Acceptance Criteria
1	[TBD]	±1%
2	[TBD]	±1%
3	[TBD]	±1%
4	[TBD]	±1%
5	[TBD]	±1%

As Left Results

Test Point	Measured Value (bar)	Acceptance Criteria
1	[TBD]	±1%
2	[TBD]	±1%
3	[TBD]	±1%
4	[TBD]	±1%
5	[TBD]	±1%

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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