Tablet Thickness Gauge (CAL-0133) – Calibration Documents

Calibration Documents: Tablet Thickness Gauge (CAL-0133)

Asset ID CAL-0133
Equipment Tablet Thickness Gauge
Equipment Type Thickness Gauge
Department QC
Area/Location Instrument Room
Process Use Thickness
Parameter Length
Units mm
Range Min 0
Range Max 25
Acceptance Criteria ±0.02 mm
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 Tablet Thickness Gauge is performed to ensure the accuracy of thickness measurements, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate measurements prevent deviations that could affect product efficacy and compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0133
  • Equipment Name/Type: Tablet Thickness Gauge / Thickness Gauge
  • Department/Area: QC / Instrument Room
  • Process Use: Thickness
  • Parameter: Length
  • Range: 0 mm to 25 mm
  • Units: mm
  • 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 an instrument meets specified requirements.
  • Adjustment: The act of modifying an instrument to bring it into alignment with a standard.
  • As Found: The condition of the instrument prior to any adjustments.
  • 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 measurement accuracy 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 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 and maintained.
  • External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize as per manufacturer guidelines.
  • Maintain cleanliness of the instrument and surrounding area.
  • Check that the instrument is level before use.
  • Verify power supply is stable and within specifications.
See also  Anemometer (HVAC) (CAL-0250) - 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: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: 5 points including endpoints (0 mm, 25 mm) and midpoints (12.5 mm).
  • Replicate readings: 3 repeats at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the gauge to stabilize in the environment for at least 30 minutes.
  3. As Found checks and data capture: Measure at defined points and record all observations contemporaneously.
  4. Adjustment rules: If OOT is identified, follow adjustment procedures; if not allowed, escalate to QA.
  5. As Left verification: Measure again to confirm adjustments are within acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.02 mm

Error calculation formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of Error is less than or equal to ±0.02 mm, the measurement passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define 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 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 checked
  • Equipment warmed up
  • Cleanliness verified
  • 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-0133 Tablet Thickness Gauge Thickness Gauge QC Instrument Room Thickness Length mm 0 – 25 ±0.02 mm 365 days External ISO17025
See also  Checkweigher (Pack line) (CAL-0009) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the specified range of 0 to 25 mm:

  • Min: 0 mm
  • 25%: 6.25 mm
  • 50%: 12.5 mm
  • 75%: 18.75 mm
  • Max: 25 mm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mm [TBD] [TBD] [TBD] ±0.02 mm [TBD] [TBD] [TBD] [TBD]
6.25 mm [TBD] [TBD] [TBD] ±0.02 mm [TBD] [TBD] [TBD] [TBD]
12.5 mm [TBD] [TBD] [TBD] ±0.02 mm [TBD] [TBD] [TBD] [TBD]
18.75 mm [TBD] [TBD] [TBD] ±0.02 mm [TBD] [TBD] [TBD] [TBD]
25 mm [TBD] [TBD] [TBD] ±0.02 mm [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Tablet Thickness Gauge is clean and calibrated according to the previous calibration record.
  2. Stabilization: Allow the equipment to stabilize in the environmental conditions for at least [TBD] minutes.
  3. Performing Readings: Take three replicate measurements at each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors to the acceptance criteria of ±0.02 mm.
  6. Documentation: Record all observations, errors, and pass/fail results in the results table.

Deviation Instruction for OOT

If any measurement is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance.
  • 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-0133 Tablet Thickness Gauge QC Instrument Room Length 0 – 25 mm ±0.02 mm 365 days ISO17025

1) Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up for the required duration
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for documentation

2) As Found Execution

  • [ ] Set the gauge to specified setpoints
  • [ ] Perform repeat measurements for consistency
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations to determine results
See also  Micropipette 2-20 µL (CAL-0021) - Calibration Documents

3) OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document the deviation
  • [ ] Trigger impact review process

4) As Left Verification

  • [ ] Conduct post-adjustment checks to confirm accuracy
  • [ ] Ensure all measurements are within acceptance limits

5) 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, and accurate, with proper documentation practices followed.

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Deviation Impact Assessment

Event Summary
Asset: Tablet Thickness Gauge
Date: [TBD]
Discovered By: [TBD]
Document References: [TBD]
As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the equipment
  • Label/tag the equipment 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-0133 Tablet Thickness Gauge Thickness Gauge QC Instrument Room [TBD] [TBD] [TBD] Length: 0 – 25 mm ±0.02 mm

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measurement (mm)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [TBD]

As Left Results

Test Point Measurement (mm)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [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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