Platform Scale 600 kg (CAL-0006) – Calibration Documents

Calibration Documents: Platform Scale 600 kg (CAL-0006)

Asset ID CAL-0006
Equipment Platform Scale 600 kg
Equipment Type Platform Scale
Department Warehouse
Area/Location Receiving
Process Use Material weighing
Parameter Weight
Units kg
Range Min 0
Range Max 600
Acceptance Criteria ±0.1 kg
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 Platform Scale 600 kg is performed to ensure accurate weight measurements during material weighing processes in the Warehouse. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0006
  • Equipment Name/Type: Platform Scale 600 kg / Platform Scale
  • Department/Area: Warehouse / Receiving
  • Process Use: Material weighing
  • Parameter: Weight
  • Range: 0 kg to 600 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 meets specified requirements.
  • Adjustment: The act of modifying a measurement device to bring it into compliance with specifications.
  • As Found: The state of the equipment prior to any adjustments made during calibration.
  • As Left: The state of the equipment after calibration 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 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 expected 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 accessible for calibration.
  • External Service Provider: Conduct external calibration as per the calibration type.

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 scale and surrounding area.
  • Verify that the scale is properly leveled before use.
  • Check power supply for stability and reliability.
See also  CO2 Incubator RH Sensor (CAL-0307) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

The calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0 kg, 600 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 scale to stabilize in the operating environment.
  3. As Found checks and data capture: Record initial measurements before any adjustments.
  4. Adjustment rules: If OOT is found, adjust the scale as per manufacturer guidelines; if not allowed, escalate to QA.
  5. As Left verification: Record final measurements after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance Criteria: ±0.1 kg

Error Calculation Formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within the acceptance criteria, the calibration passes; otherwise, it fails.

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 for audit purposes.
  • 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
  • Scale leveled
  • Calibration standards 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-0006 Platform Scale 600 kg Platform Scale Warehouse Receiving Material weighing Weight kg 0 – 600 ±0.1 kg 365 days External ISO17025
See also  Microscope Stage Micrometer (Calibration) (CAL-0240) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 kg
  • 25% of Range: 150 kg
  • 50% of Range: 300 kg
  • 75% of Range: 450 kg
  • Maximum: 600 kg

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 kg 0 kg [TBD] [TBD] ±0.1 kg [TBD] [TBD] [TBD] [TBD]
150 kg 150 kg [TBD] [TBD] ±0.1 kg [TBD] [TBD] [TBD] [TBD]
300 kg 300 kg [TBD] [TBD] ±0.1 kg [TBD] [TBD] [TBD] [TBD]
450 kg 450 kg [TBD] [TBD] ±0.1 kg [TBD] [TBD] [TBD] [TBD]
600 kg 600 kg [TBD] [TBD] ±0.1 kg [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the platform scale is clean and free from any obstructions. Verify that the scale is calibrated within the last 365 days.
  2. Stabilization: Allow the scale to stabilize for at least 30 minutes before taking measurements.
  3. Performing Readings: Take three replicate measurements at each test point. Record the observed values.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed Value – Reference Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.1 kg.
  6. Documentation: Complete the results table and ensure all data is recorded accurately and legibly.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • Open a deviation report.
  • Quarantine the impacted results window: [TBD]
  • Await QA decision on further actions.

Approvals

Prepared By Reviewed By Approved By
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0006 Platform Scale 600 kg Warehouse Receiving Weight 0 – 600 kg ±0.1 kg 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per manufacturer guidelines
  • [ ] Clean the scale surface and surrounding area
  • [ ] Level the platform scale
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

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

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the platform scale
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review process
See also  Reference Thermometer (Master) (CAL-0051) - Calibration Documents

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Platform Scale 600 kg
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 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-0006 Platform Scale 600 kg Platform Scale Warehouse Receiving [TBD] [TBD] [TBD] Weight (0 – 600 kg) ±0.1 kg

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (kg) Acceptance Criteria Pass/Fail
0 kg [TBD] ±0.1 kg [TBD]
150 kg [TBD] ±0.1 kg [TBD]
300 kg [TBD] ±0.1 kg [TBD]
450 kg [TBD] ±0.1 kg [TBD]
600 kg [TBD] ±0.1 kg [TBD]

As Left Results

Test Point Measured Value (kg) Acceptance Criteria Pass/Fail
0 kg [TBD] ±0.1 kg [TBD]
150 kg [TBD] ±0.1 kg [TBD]
300 kg [TBD] ±0.1 kg [TBD]
450 kg [TBD] ±0.1 kg [TBD]
600 kg [TBD] ±0.1 kg [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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