Torque Tester (Cap torque) (CAL-0265) – Calibration Documents

Calibration Documents: Torque Tester (Cap torque) (CAL-0265)

Asset ID CAL-0265
Equipment Torque Tester (Cap torque)
Equipment Type Torque Tester
Department Packaging
Area/Location Packing Line
Process Use Cap torque
Parameter Torque
Units Ncm
Range Min 0
Range Max 300
Acceptance Criteria ±2%
Calibration Frequency (days) 180
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 Torque Tester (Cap torque) is performed to ensure accurate measurement of torque applied to caps during packaging. This is critical for maintaining batch quality, ensuring patient safety, and preserving data integrity. Inaccurate torque measurements can lead to improper sealing, resulting in compromised product quality and potential risks to patient safety.

2. Scope

  • Asset ID: CAL-0265
  • Equipment Name/Type: Torque Tester (Cap torque)
  • Department/Area: Packaging
  • Process Use: Cap torque
  • Parameter: Torque
  • Range: 0 – 300 Ncm
  • Units: Ncm
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a standard to ensure accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The act of correcting a measurement instrument to ensure it meets specified standards.
  • 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 performance over time.
  • Traceability: The ability to trace the measurement results back to national or international standards.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value of a measurement lies.
  • Intermediate Check: A periodic verification 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 maintained.
  • External Service Provider: Conduct external calibration as per schedule.

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 equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply is stable and within specifications.
See also  Autoclave Timer (CAL-0152) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [TBD]
  • 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 5, including endpoints and midpoints, across the specified range of 0 to 300 Ncm. Each point will have 3 replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Torque Tester to stabilize in the operating environment.
  3. As Found checks and data capture: Measure torque at defined points and record raw observations contemporaneously.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Re-measure to confirm adjustments are within specifications.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±2% of the specified torque value. The error calculation formula is:

Error (%) = [(Observed Value – True Value) / True Value] x 100

Pass/Fail logic: If the error is within ±2%, the result is a pass; otherwise, it is a fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop its use.
  • Notification & deviation initiation: Notify relevant personnel and initiate a deviation report.
  • Impact assessment trigger: Assess the impact on results/batches produced since the last calibration.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • 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

Test Point 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
  • Cleanliness checked
  • Leveling confirmed
  • Power supply stable

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

See also  Moisture Analyzer (CAL-0011) - Calibration Documents

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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-0265 Torque Tester (Cap torque) Torque Tester Packaging Packing Line Cap torque Torque Ncm 0 – 300 ±2% 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 Ncm
  • 25% of Range: 75 Ncm
  • 50% of Range: 150 Ncm
  • 75% of Range: 225 Ncm
  • Maximum: 300 Ncm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 Ncm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
75 Ncm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
150 Ncm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
225 Ncm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
300 Ncm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Torque Tester is clean and free from any obstructions.
  2. Stabilization: Allow the equipment to stabilize for [TBD] before taking measurements.
  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 error to the acceptance criteria of ±2%.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the Torque Tester immediately.
  • Notify the supervisor and quality assurance personnel.
  • 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-0265 Torque Tester (Cap torque) Packaging Packing Line Torque 0 – 300 Ncm ±2% 180 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set the torque tester to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Micropipette 20-200 µL (CAL-0022) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation and root cause analysis
  • [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Torque Tester (Cap torque)
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

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-0265 Torque Tester (Cap torque) Torque Tester Packaging Packing Line [TBD] [TBD] [TBD] Torque: 0 – 300 Ncm ±2%

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 Measurement (Ncm) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measurement (Ncm) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [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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