Calibration Documents: Torque Wrench (Packaging) (CAL-0264)

Asset ID	CAL-0264
Equipment	Torque Wrench (Packaging)
Equipment Type	Torque Wrench
Department	Engineering/Packaging
Area/Location	Maintenance
Process Use	Torque control
Parameter	Torque
Units	Nm
Range Min	0
Range Max	50
Acceptance Criteria	±4%
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Torque Wrench (Packaging) is performed to ensure accurate torque control during the packaging process. This is critical for maintaining batch quality and patient safety, as improper torque can lead to product failure or compromised integrity. Calibration also supports data integrity by ensuring that measurements are reliable and traceable.

2. Scope

• Asset ID: CAL-0264
• Equipment Name/Type: Torque Wrench (Packaging)
• Department/Area: Engineering/Packaging
• Process Use: Torque control
• Parameter: Torque
• Range: 0 – 50 Nm
• Units: Nm
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of comparing a measurement instrument against a known standard to determine its accuracy.
• Verification: The process of confirming that a measurement instrument meets specified requirements.
• Adjustment: The act of modifying a measurement instrument to bring it into compliance with specified standards.
• 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 falls outside the specified 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 asserted to lie.
• Intermediate Check: A verification process conducted between scheduled 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 results and documentation.
• Owner Department: Ensure equipment is available for calibration.
• External Service Provider: Conduct external calibration 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 calibration area and equipment.
• Check that the torque wrench is leveled before use.
• Verify power supply is stable and meets equipment requirements.

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints within the specified range of 0 to 50 Nm. 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 torque wrench to stabilize in the calibration environment.
3. As Found checks and data capture: Measure torque at designated points and record observations contemporaneously (ALCOA+).
4. Adjustment rules: If OOT is found, escalate for adjustment as per company policy.
5. As Left verification: Re-measure torque after adjustments and record results.
6. Labeling + documentation completion: Complete all required documentation and label the equipment appropriately.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±4% of the target value. The error calculation formula is as follows:

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

Pass/Fail Logic: If the error falls within ±4%, 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: Define the impact window and review affected results/batches.
• Recalibration after repair/adjustment: Schedule recalibration once adjustments are made.
• 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
• Calibration area clean
• Equipment leveled
• Power supply verified

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-0264	Torque Wrench (Packaging)	Torque Wrench	Engineering/Packaging	Maintenance	Torque control	Torque	Nm	0 – 50	±4%	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following values:

• Min: 0 Nm
• 25%: 12.5 Nm
• 50%: 25 Nm
• 75%: 37.5 Nm
• Max: 50 Nm

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
0 Nm	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
12.5 Nm	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
25 Nm	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
37.5 Nm	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]
50 Nm	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the torque wrench is clean and free from any obstructions.
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 ±4%.
6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

If any observed value is out of tolerance (OOT):

• Stop use of the torque wrench immediately.
• Notify the supervisor and quality assurance (QA) team.
• Open a deviation report.
• Quarantine the impacted results window: [TBD]
• Await QA decision on further actions.

Approvals

Prepared By	Reviewed By	Approved By
____________________ / Date: ___________	____________________ / Date: ___________	____________________ / Date: ___________

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0264	Torque Wrench (Packaging)	Engineering/Packaging	Maintenance	Torque	0 – 50 Nm	±4%	180 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up as per manufacturer’s guidelines
• [ ] Clean the torque wrench to remove any contaminants
• [ ] Ensure the torque wrench is level before calibration
• [ ] Check validity of reference standards used for calibration
• [ ] Ensure calibration logbook is ready for documentation

As Found Execution

• [ ] Set the torque wrench to specified setpoints
• [ ] Perform multiple repeats to ensure accuracy
• [ ] Record all raw data during the calibration process
• [ ] Perform necessary calculations to determine compliance

OOT Immediate Actions

• [ ] Tag out the equipment if out of tolerance (OOT)
• [ ] Stop use of the torque wrench immediately
• [ ] Notify the responsible personnel of the OOT condition
• [ ] Document the deviation in the logbook
• [ ] Trigger impact review to assess potential effects

As Left Verification

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

Documentation & Closure

• [ ] Update the calibration label with new information
• [ ] Attach the calibration certificate to the logbook
• [ ] Obtain reviewer sign-off on calibration documentation
• [ ] Update the next due date for calibration

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate. Maintain a clear audit trail for all calibration activities.

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Deviation Impact Assessment

Event Summary
Asset: Torque Wrench (Packaging) 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-0264	Torque Wrench (Packaging)	Torque Wrench	Engineering/Packaging	Maintenance	[TBD]	[TBD]	[TBD]	Torque (0 – 50 Nm)	±4%

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 (Nm)	Acceptance Criteria	Pass/Fail
1	[TBD]	±4%	[TBD]
2	[TBD]	±4%	[TBD]
3	[TBD]	±4%	[TBD]
4	[TBD]	±4%	[TBD]
5	[TBD]	±4%	[TBD]

As Left Results

Test Point	Measured Value (Nm)	Acceptance Criteria	Pass/Fail
1	[TBD]	±4%	[TBD]
2	[TBD]	±4%	[TBD]
3	[TBD]	±4%	[TBD]
4	[TBD]	±4%	[TBD]
5	[TBD]	±4%	[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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