Reference Hygrometer (Master) (CAL-0061) – Calibration Documents

Calibration Documents: Reference Hygrometer (Master) (CAL-0061)

Asset ID CAL-0061
Equipment Reference Hygrometer (Master)
Equipment Type Reference Hygrometer
Department Calibration Lab
Area/Location Metrology
Process Use Calibration standard
Parameter Humidity
Units %RH
Range Min 10
Range Max 90
Acceptance Criteria ±1%RH
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 Reference Hygrometer (Master) is performed to ensure accurate measurement of humidity levels, which is critical for maintaining product quality, patient safety, and data integrity in pharmaceutical processes. Accurate humidity measurements help control environmental conditions that can affect the stability and efficacy of products.

2. Scope

  • Asset ID: CAL-0061
  • Equipment Name/Type: Reference Hygrometer (Master)
  • Department/Area: Calibration Lab / Metrology
  • Process Use: Calibration standard
  • Parameter: Humidity
  • Range: 10%RH to 90%RH
  • Units: %RH
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The process of correcting a measurement instrument to ensure it provides accurate readings.
  • As Found: The condition of the instrument prior to any adjustments being made.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement exceeds the established 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 is expected 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • 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 and stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the hygrometer before calibration.
  • Verify power supply stability and functionality.
See also  Tachometer (CAL-0263) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability: ISO17025
  • Certificate validity check: Ensure all calibration certificates are current and valid.
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

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

  • Minimum number of points: At least 5 points including endpoints (10%RH, 90%RH) and midpoints (20%RH, 50%RH, 80%RH).
  • Replicate readings at each point: 3 repeats at each measurement point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Reference Hygrometer to stabilize in the calibration environment.
  3. As Found checks and data capture: Record initial readings at all defined points.
  4. Adjustment rules: If OOT is detected, follow the adjustment protocol; otherwise, escalate to QA.
  5. As Left verification: Record final readings after adjustments.
  6. Labeling + documentation completion: Ensure all calibration data is documented and labels are affixed.

Record raw observations contemporaneously to maintain ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1%RH

Error calculation formula: Error = Observed Value – True Value

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

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

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in accordance with 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 cleanliness confirmed
  • 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-0061 Reference Hygrometer (Master) Reference Hygrometer Calibration Lab Metrology Calibration standard Humidity %RH 10 – 90 ±1%RH 365 days External ISO17025
See also  Repeater Pipette/Dispenser (CAL-0025) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 10% RH
  • 25%: 27.5% RH
  • 50%: 50% RH
  • 75%: 72.5% RH
  • Maximum: 90% RH

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
10% RH [TBD] [TBD] [TBD] ±1%RH [TBD] [TBD] [TBD] [TBD]
27.5% RH [TBD] [TBD] [TBD] ±1%RH [TBD] [TBD] [TBD] [TBD]
50% RH [TBD] [TBD] [TBD] ±1%RH [TBD] [TBD] [TBD] [TBD]
72.5% RH [TBD] [TBD] [TBD] ±1%RH [TBD] [TBD] [TBD] [TBD]
90% RH [TBD] [TBD] [TBD] ±1%RH [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Reference Hygrometer is clean and calibrated prior to use.
  2. Stabilization: Allow the equipment to stabilize in the calibration environment for at least 30 minutes.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Determine the error by subtracting the reference value from the observed value.
  5. Evaluation: Compare the error against the acceptance criteria of ±1%RH.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value is 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-0061 Reference Hygrometer (Master) Calibration Lab Metrology Humidity 10 – 90 %RH ±1%RH 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the equipment as necessary
  • [ ] Level the equipment if applicable
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set the required setpoints for calibration
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the equipment if OOT is detected
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document the deviation
  • [ ] Trigger impact review process
See also  Tablet Thickness Gauge (CAL-0133) - Calibration Documents

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label as necessary
  • [ ] Attach calibration certificate
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in logbook

Data Integrity (ALCOA+): Ensure all data is attributable, legible, contemporaneous, original, and accurate.

As Found/As Left Recording: Document all findings before and after calibration.

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Deviation Impact Assessment

Event Summary
Asset: Reference Hygrometer (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: [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-0061 Reference Hygrometer (Master) Reference Hygrometer Calibration Lab Metrology [TBD] [TBD] [TBD] Humidity: 10%RH – 90%RH ±1%RH

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 (%RH) Acceptance Criteria
10%RH [TBD] ±1%RH
30%RH [TBD] ±1%RH
50%RH [TBD] ±1%RH
70%RH [TBD] ±1%RH
90%RH [TBD] ±1%RH

As Left Results

Test Point Measured Value (%RH) Acceptance Criteria
10%RH [TBD] ±1%RH
30%RH [TBD] ±1%RH
50%RH [TBD] ±1%RH
70%RH [TBD] ±1%RH
90%RH [TBD] ±1%RH

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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