Water System Pressure Gauge (CAL-0321) – Calibration Documents

Calibration Documents: Water System Pressure Gauge (CAL-0321)

Asset ID CAL-0321
Equipment Water System Pressure Gauge
Equipment Type Pressure Gauge
Department Utilities
Area/Location PW/WFI
Process Use 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 Water System Pressure Gauge is performed to ensure accurate pressure measurements within the PW/WFI 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-0321
  • Equipment Name/Type: Water System Pressure Gauge / Pressure Gauge
  • Department/Area: Utilities / PW/WFI
  • Process Use: Pressure
  • Parameter: Pressure
  • Range: 0 to 16 bar
  • Units: bar
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device to a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement device operates within specified limits.
  • Adjustment: The act of correcting a measurement device to bring it within specified limits.
  • As Found: The condition of the equipment prior to any adjustments made during calibration.
  • As Left: The condition of the equipment after calibration adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in a measurement device’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 dispersion of the values attributed to a measurement.
  • Intermediate Check: A periodic check 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 maintain records.
  • QC/QA Reviewer: Review calibration records and ensure compliance.
  • Owner Department: Ensure equipment is available for calibration.
  • External Service Provider: Conduct external calibration as per schedule.

6. Safety & Preconditions

  • Ensure environmental controls are in place.
  • Allow for warm-up/stabilization of equipment as per manufacturer guidelines.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the equipment prior to calibration.
  • Verify power supply is stable and within required specifications.
See also  Incubator Temp Sensor (20-25°C) (CAL-0156) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the range of 0 to 16 bar. It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the pressure gauge to stabilize before taking measurements.
  3. As Found Checks and Data Capture: Record initial measurements and document them contemporaneously.
  4. Adjustment Rules: If OOT is detected, follow the adjustment protocol; otherwise, escalate the issue.
  5. As Left Verification: After adjustments, verify and document the final measurements.
  6. Labeling + Documentation Completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

The acceptance criteria for the calibration of the Water System Pressure Gauge is ±1%. The error calculation formula is:

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

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

Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • 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

Test Points Reference Observed Error Acceptance Pass/Fail As Found As Left
[TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Annexure B: Quick Checklist

  • Check environmental controls
  • Verify equipment cleanliness
  • Ensure proper leveling
  • Confirm power supply stability

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

See also  Ultrafiltration TMP Sensor (CAL-0310) - Calibration Documents

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-0321 Water System Pressure Gauge Pressure Gauge Utilities PW/WFI Pressure Pressure bar 0 – 16 ±1% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 bar
  • 25%: 4 bar
  • 50%: 8 bar
  • 75%: 12 bar
  • Maximum: 16 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] ±1% [TBD] [TBD] [TBD] [TBD]
4 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
8 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
12 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
16 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the pressure gauge is clean and properly installed in the system.
  2. Stabilization: Allow the system to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±1%.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance (QA) team.
  • 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-0321 Water System Pressure Gauge Utilities PW/WFI Pressure 0 – 16 bar ±1% 365 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set the gauge to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  Vacuum Gauge (-1 to 0 bar) (CAL-0073) - Calibration Documents

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

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

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Deviation Impact Assessment

Event Summary Details
Asset Water System Pressure Gauge (CAL-0321)
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 Discovery Date
[TBD] [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-0321 Water System Pressure Gauge Pressure Gauge Utilities PW/WFI [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] ISO17025

Results

As Found Results

Test Point Measured Value (bar) Acceptance Criteria Conformance
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 Conformance
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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