Digital Pressure Calibrator (Master) (CAL-0075) – Calibration Documents

Calibration Documents: Digital Pressure Calibrator (Master) (CAL-0075)

Asset ID CAL-0075
Equipment Digital Pressure Calibrator (Master)
Equipment Type Pressure Calibrator
Department Calibration Lab
Area/Location Metrology
Process Use Calibration standard
Parameter Pressure
Units bar
Range Min 0
Range Max 20
Acceptance Criteria ±0.05%
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 Digital Pressure Calibrator (Master) is performed to ensure accurate pressure measurements, which are critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate calibration minimizes the risk of errors in pressure readings that could lead to compromised product quality and safety.

2. Scope

  • Asset ID: CAL-0075
  • Equipment Name/Type: Digital Pressure Calibrator (Master) / Pressure Calibrator
  • Department/Area: Calibration Lab / Metrology
  • Process Use: Calibration standard
  • Parameter: Pressure
  • Range: 0 to 20 bar
  • Units: bar
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device against a known standard to ensure accuracy.
  • Verification: The confirmation that a measurement device meets specified requirements.
  • Adjustment: The process of altering a measurement device to bring it into alignment with a standard.
  • 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 defined acceptance criteria.
  • Drift: The gradual change in the measurement accuracy of a device over time.
  • Traceability: The ability to trace the measurement results back to national or international standards.
  • Measurement Uncertainty: A parameter that quantifies the doubt about the result of a measurement.
  • Intermediate Check: A verification step performed between calibrations to ensure ongoing 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 results and documentation.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibrations as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment warm-up/stabilization time as per manufacturer guidelines.
  • Maintain cleanliness of the calibration area and equipment.
  • Check that the equipment is leveled properly.
  • Verify power supply is stable and within specifications.
See also  Inline Conductivity Sensor (WFI) (CAL-0095) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: Ensure all reference standards are within their validity period.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0 bar and 20 bar) and midpoints (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 calibrator to stabilize as per manufacturer instructions.
  3. As Found checks and data capture: Measure and record the pressure at each calibration point.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols if allowed; otherwise, escalate the issue.
  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 accordingly.

Record raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.05%

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

Pass/Fail logic: If the error is within ±0.05%, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • 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
  • Calibration area cleaned
  • 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-0075 Digital Pressure Calibrator (Master) Pressure Calibrator Calibration Lab Metrology Calibration standard Pressure bar 0 – 20 ±0.05% 365 days External ISO17025
See also  Repeater Pipette/Dispenser (CAL-0025) - Calibration Documents

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 bar
  • 25% of Range: 5 bar
  • 50% of Range: 10 bar
  • 75% of Range: 15 bar
  • Maximum: 20 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] ±0.05% [TBD] [TBD] [TBD] [TBD]
5 bar [TBD] [TBD] [TBD] ±0.05% [TBD] [TBD] [TBD] [TBD]
10 bar [TBD] [TBD] [TBD] ±0.05% [TBD] [TBD] [TBD] [TBD]
15 bar [TBD] [TBD] [TBD] ±0.05% [TBD] [TBD] [TBD] [TBD]
20 bar [TBD] [TBD] [TBD] ±0.05% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Digital Pressure Calibrator is clean and in good working condition. Verify that all necessary tools and documentation are available.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings:
    • At each test point, take three replicate measurements.
    • Record all observed values in the results table.
  4. Calculating Error: Calculate the error for each test point using the formula: Error = Observed Value – Reference Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.05%.
  6. Documentation: Complete the results table and ensure all data is recorded accurately, maintaining ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).

Deviation Instruction for OOT

If any measurement is found to be out of tolerance (OOT):

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance (QA) personnel.
  • Open a deviation report.
  • 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-0075 Digital Pressure Calibrator (Master) Calibration Lab Metrology Pressure 0 to 20 bar ±0.05% 365 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set pressure setpoints as per calibration protocol
  • [ ] Perform repeat measurements for accuracy
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results
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OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary Details
Asset Digital Pressure Calibrator (Master)
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-0075 Digital Pressure Calibrator (Master) Pressure Calibrator Calibration Lab Metrology [TBD] [TBD] [TBD] Pressure: 0 to 20 bar ±0.05%

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 Pass/Fail
0 [TBD] ±0.05% [TBD]
5 [TBD] ±0.05% [TBD]
10 [TBD] ±0.05% [TBD]
15 [TBD] ±0.05% [TBD]
20 [TBD] ±0.05% [TBD]

As Left Results

Test Point Measured Value (bar) Acceptance Criteria Pass/Fail
0 [TBD] ±0.05% [TBD]
5 [TBD] ±0.05% [TBD]
10 [TBD] ±0.05% [TBD]
15 [TBD] ±0.05% [TBD]
20 [TBD] ±0.05% [TBD]

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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