Pressure Gauge 0-16 bar (CAL-0072) – Calibration Documents

Calibration Documents: Pressure Gauge 0-16 bar (CAL-0072)

Asset ID CAL-0072
Equipment Pressure Gauge 0-16 bar
Equipment Type Pressure Gauge
Department Utilities
Area/Location Boiler/Steam
Process Use Steam pressure
Parameter Pressure
Units bar
Range Min 0
Range Max 16
Acceptance Criteria ±1%
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 Pressure Gauge 0-16 bar is performed to ensure accurate measurement of steam pressure within the Boiler/Steam area. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0072
  • Equipment Name/Type: Pressure Gauge 0-16 bar / Pressure Gauge
  • Department/Area: Utilities / Boiler/Steam
  • Process Use: Steam pressure
  • Parameter: Pressure
  • Range: 0 – 16 bar
  • Units: bar
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a 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 specifications.
  • As Found: The condition of the instrument prior to any adjustments made during calibration.
  • As Left: The condition of the instrument after adjustments have been made and verified.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in a measurement 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 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • Owner Department: Ensure equipment is available for calibration.
  • External Service Provider: Conduct calibration as per external calibration type.

6. Safety & Preconditions

  • Environmental controls: Ensure the calibration area is clean and free from contaminants.
  • Warm-up/Stabilization: Allow the pressure gauge to stabilize before calibration.
  • Cleanliness: Ensure the equipment is clean and free from any obstructions.
  • Leveling: Confirm the pressure gauge is properly leveled.
  • Power Supply Checks: Verify that the power supply is stable and within required specifications.
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7. Standards & Tools

  • Reference Standards Required: Calibration standards that are traceable to ISO17025.
  • Traceability Statement: Calibration will be performed using standards traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are valid and up-to-date.
  • 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 (0 bar, 16 bar) and midpoints (8 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 pressure gauge to stabilize at room temperature.
  3. As Found checks and data capture: Record initial readings at defined points.
  4. Adjustment rules: If OOT is found, adjust the gauge as permitted; otherwise, escalate to QA.
  5. As Left verification: Confirm that the gauge is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all necessary documentation and label the equipment.

Explicit instruction: Record raw observations contemporaneously to ensure data integrity (ALCO+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1%

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

Pass/Fail Logic: If error is within ±1%, the calibration passes; otherwise, it fails.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use until resolved.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration after any adjustments.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain records of calibration certificates.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and status.

13. Annexures

Annexure A: Calibration Data Sheet table (test points, ref, observed, error, acceptance, pass/fail; include As Found + As Left columns)

Annexure B: Quick checklist

Annexure C: Example label text (with [TBD] placeholders)

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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-0072 Pressure Gauge 0-16 bar Pressure Gauge Utilities Boiler/Steam Steam pressure Pressure bar 0 – 16 ±1% 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Min: 0 bar
  • 25%: 4 bar
  • 50%: 8 bar
  • 75%: 12 bar
  • Max: 16 bar

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 bar 0 bar [TBD] [TBD] ±0.01 bar [TBD] [TBD] [TBD] [TBD]
4 bar 4 bar [TBD] [TBD] ±0.04 bar [TBD] [TBD] [TBD] [TBD]
8 bar 8 bar [TBD] [TBD] ±0.08 bar [TBD] [TBD] [TBD] [TBD]
12 bar 12 bar [TBD] [TBD] ±0.12 bar [TBD] [TBD] [TBD] [TBD]
16 bar 16 bar [TBD] [TBD] ±0.16 bar [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 reading as: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria.
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

  • Stop use of the pressure gauge immediately.
  • Notify the QA department of the out-of-tolerance condition.
  • Open a deviation report for the incident.
  • Quarantine the 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-0072 Pressure Gauge 0-16 bar Utilities Boiler/Steam Pressure 0 – 16 bar ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up as per manufacturer’s guidelines
  • [ ] Clean the equipment as necessary
  • [ ] Level the equipment if applicable
  • [ ] Confirm validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the gauge to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review as necessary
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As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with calibration details
  • [ ] Attach calibration certificate to logbook
  • [ ] Obtain reviewer sign-off
  • [ ] 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: Pressure Gauge 0-16 bar
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

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

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-0072 Pressure Gauge 0-16 bar Pressure Gauge Utilities Boiler/Steam [TBD] [TBD] [TBD] Pressure / 0-16 / bar ±1%

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 (bar) Acceptance Criteria Pass/Fail
0 [TBD] ±1% [TBD]
4 [TBD] ±1% [TBD]
8 [TBD] ±1% [TBD]
12 [TBD] ±1% [TBD]
16 [TBD] ±1% [TBD]

As Left Results

Test Point Measured Value (bar) Acceptance Criteria Pass/Fail
0 [TBD] ±1% [TBD]
4 [TBD] ±1% [TBD]
8 [TBD] ±1% [TBD]
12 [TBD] ±1% [TBD]
16 [TBD] ±1% [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [TBD]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: __________

Checked by: ____________________ Date: __________

Approved by: ____________________ Date: __________

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