Crane Scale 5000 kg (CAL-0008) – Calibration Documents

Calibration Documents: Crane Scale 5000 kg (CAL-0008)

Asset ID CAL-0008
Equipment Crane Scale 5000 kg
Equipment Type Crane Scale
Department Warehouse
Area/Location Material Handling
Process Use Material weighing
Parameter Weight
Units kg
Range Min 0
Range Max 5000
Acceptance Criteria ±0.1%
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 Crane Scale 5000 kg is performed to ensure accurate weight measurements during material handling processes. This calibration controls risks associated with inaccurate weight readings that could compromise patient safety, batch quality, and data integrity in compliance with GMP standards.

2. Scope

  • Asset ID: CAL-0008
  • Equipment Name/Type: Crane Scale 5000 kg / Crane Scale
  • Department/Area: Warehouse / Material Handling
  • Process Use: Material weighing
  • Parameter: Weight
  • Range: 0 – 5000 kg
  • Units: kg
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device against a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement device is functioning correctly.
  • Adjustment: The process of modifying a measurement device to bring it into compliance with specified standards.
  • As Found: The condition of the equipment prior to any adjustments.
  • As Left: The condition of the equipment 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 a measurement device’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 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 accessible for calibration.
  • 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 specifications.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the crane scale before use.
  • Verify power supply is stable and within required specifications.
See also  Flow Meter (WFI Loop) (CAL-0081) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0 kg, 2500 kg, 5000 kg) and midpoints.
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the crane scale to stabilize before taking measurements.
  3. As Found checks and data capture: Record initial measurements and observations contemporaneously.
  4. Adjustment rules: If OOT is detected, follow escalation procedures for adjustment.
  5. As Left verification: Confirm that the equipment is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment appropriately.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.1%

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

Pass/Fail Logic: If error is within acceptance criteria, mark as pass; otherwise, mark as fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and initiate deviation process.
  • Impact assessment trigger: Define impact window and review of 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: Calibrated date, due date, by whom, status.

13. Annexures

  • Annexure A: Calibration Data Sheet table (test points, ref, observed, error, acceptance, pass/fail; include As Found + As Left columns).
  • Annexure B: Quick checklist.
  • Annexure C: Example label text (with [TBD] placeholders).

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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-0008 Crane Scale 5000 kg Crane Scale Warehouse Material Handling Material weighing Weight kg 0 – 5000 ±0.1% 365 days External ISO17025
See also  Stability Chamber RH Probe (CAL-0181) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 kg
  • 25% of Range: 1250 kg
  • 50% of Range: 2500 kg
  • 75% of Range: 3750 kg
  • Maximum: 5000 kg

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
1250 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
2500 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
3750 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
5000 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Crane Scale is clean and free from any obstructions.
  2. Stabilization: Allow the equipment to stabilize for at least 30 minutes before calibration.
  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 against the acceptance criteria.
  6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

  • Stop use of the equipment immediately.
  • Notify the supervisor and QA department.
  • 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-0008 Crane Scale 5000 kg Warehouse Material Handling Weight 0 – 5000 kg ±0.1% 365 days ISO17025

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 properly
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for recording

As Found Execution

  • [ ] Set the equipment to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review
See also  Inline Conductivity Sensor (PW) (CAL-0094) - Calibration Documents

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Crane Scale 5000 kg
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

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-0008 Crane Scale 5000 kg Crane Scale Warehouse Material Handling [TBD] [TBD] [TBD] Weight / 0 – 5000 kg ±0.1%

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 (kg) Acceptance Criteria Pass/Fail
0 kg [TBD] ±0.1% [TBD]
1000 kg [TBD] ±0.1% [TBD]
2000 kg [TBD] ±0.1% [TBD]
3000 kg [TBD] ±0.1% [TBD]
5000 kg [TBD] ±0.1% [TBD]

As Left Results

Test Point Measured Value (kg) Acceptance Criteria Pass/Fail
0 kg [TBD] ±0.1% [TBD]
1000 kg [TBD] ±0.1% [TBD]
2000 kg [TBD] ±0.1% [TBD]
3000 kg [TBD] ±0.1% [TBD]
5000 kg [TBD] ±0.1% [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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