Calibration Documents: Floor Scale 2000 kg (CAL-0007)

Asset ID	CAL-0007
Equipment	Floor Scale 2000 kg
Equipment Type	Floor Scale
Department	Warehouse
Area/Location	Dispatch
Process Use	Material weighing
Parameter	Weight
Units	kg
Range Min	0
Range Max	2000
Acceptance Criteria	±0.1%
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Floor Scale 2000 kg is performed to ensure accurate weight measurements during material weighing processes in the Warehouse Dispatch area. 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-0007
Equipment Name/Type: Floor Scale 2000 kg / Floor Scale
Department/Area: Warehouse / Dispatch
Process Use: Material weighing
Parameter: Weight
Range: 0 – 2000 kg
Units: kg
Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of comparing a measurement instrument against a known standard to ensure 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 specifications.
• 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 during calibration.
• OOT (Out of Tolerance): A condition where the measurement results fall outside the specified acceptance criteria.
• Drift: The gradual change in the measurement accuracy of an instrument 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 of a measurement lies.
• Intermediate Check: A periodic verification of an 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 accessible 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 before calibration.
• Maintain cleanliness of the scale and surrounding area.
• Check leveling of the scale prior to use.
• Verify power supply is stable and within specifications.

7. Standards & Tools

Reference Standards Required: [TBD]
Traceability Statement: Calibration traceable to ISO17025 standards.
Certificate Validity Check: Ensure calibration certificates are current and valid.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the range of 0 to 2000 kg. 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 standards.
2. Stabilization: Allow the scale to stabilize in the environment for a minimum of [TBD] minutes.
3. As Found checks and data capture: Measure and record the weight at each test point.
4. Adjustment rules: If OOT is detected, follow the adjustment protocol; if not allowed, escalate to QA.
5. As Left verification: Measure and record the weight again after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record all raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the Floor Scale 2000 kg is ±0.1%.
Error Calculation Formula: Error (%) = (Observed Value – True Value) / True Value × 100
Pass/Fail Logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.
Rounding Rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag the equipment and stop its use.
• Notification & deviation initiation: Notify QA and document the deviation.
• Impact assessment trigger: Define the impact window and review affected results/batches.
• Recalibration after repair/adjustment: Schedule recalibration as necessary.
• QA disposition: [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, 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-0007	Floor Scale 2000 kg	Floor Scale	Warehouse	Dispatch	Material weighing	Weight	kg	0 – 2000	±0.1%	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum (0 kg)
• 25% of Range (500 kg)
• 50% of Range (1000 kg)
• 75% of Range (1500 kg)
• Maximum (2000 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]
500 kg	[TBD]	[TBD]	[TBD]	±0.1%	[TBD]	[TBD]	[TBD]	[TBD]
1000 kg	[TBD]	[TBD]	[TBD]	±0.1%	[TBD]	[TBD]	[TBD]	[TBD]
1500 kg	[TBD]	[TBD]	[TBD]	±0.1%	[TBD]	[TBD]	[TBD]	[TBD]
2000 kg	[TBD]	[TBD]	[TBD]	±0.1%	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the floor scale is clean and free from obstructions. Verify that the scale is calibrated within the specified frequency.
2. Stabilization: Allow the scale to stabilize for at least [TBD] minutes before taking measurements.
3. Performing Readings: Take three replicate measurements at each test point. Record all observed values.
4. Calculating Error: Calculate the error for each observed value using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.1%.
6. Documentation: Complete the results table and ensure all data is recorded accurately to maintain ALCOA+ principles.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the supervisor and QA.
• 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-0007	Floor Scale 2000 kg	Warehouse	Dispatch	Weight	0 – 2000 kg	±0.1%	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 scale accurately
• [ ] Check validity of reference standards
• [ ] Ensure calibration logbook is ready and accessible

As Found Execution

• [ ] Set initial calibration setpoints
• [ ] Perform repeat measurements as required
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment
• [ ] Stop use of the equipment immediately
• [ ] Notify relevant personnel
• [ ] Document deviation from acceptance criteria
• [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

• [ ] Update equipment label with new calibration date
• [ ] Attach calibration certificate to logbook
• [ ] 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: Floor Scale 2000 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 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-0007	Floor Scale 2000 kg	Floor Scale	Warehouse	Dispatch	[TBD]	[TBD]	[TBD]	Weight / 0 – 2000 kg	±0.1%

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%	[TBD]
500 kg	[TBD]	±0.1%	[TBD]
1000 kg	[TBD]	±0.1%	[TBD]
1500 kg	[TBD]	±0.1%	[TBD]
2000 kg	[TBD]	±0.1%	[TBD]

As Left Results

Test Point	Measured Value (kg)	Acceptance Criteria	Pass/Fail
0 kg	[TBD]	±0.1%	[TBD]
500 kg	[TBD]	±0.1%	[TBD]
1000 kg	[TBD]	±0.1%	[TBD]
1500 kg	[TBD]	±0.1%	[TBD]
2000 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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