Calibration Documents: Platform Scale 300 kg (CAL-0005)

Asset ID	CAL-0005
Equipment	Platform Scale 300 kg
Equipment Type	Platform Scale
Department	Warehouse
Area/Location	Receiving
Process Use	Material weighing
Parameter	Weight
Units	kg
Range Min	0
Range Max	300
Acceptance Criteria	±0.05 kg
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Platform Scale 300 kg is performed to ensure accurate weight measurements during material weighing in the Receiving area of 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-0005
Equipment Name/Type: Platform Scale 300 kg / Platform Scale
Department/Area: Warehouse / Receiving
Process Use: Material weighing
Parameter: Weight
Range: 0 – 300 kg
Units: kg
Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of measurement equipment.
• Verification: The process of confirming that the equipment meets specified requirements.
• Adjustment: The act of modifying the equipment to bring it within specified limits.
• 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 of the acceptance criteria.
• Drift: The gradual change in the measurement accuracy 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 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 results and documentation.
• Owner Department: Ensure equipment availability and compliance.
• External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow warm-up/stabilization time for the equipment.
• Maintain cleanliness of the scale and surrounding area.
• Check leveling of the scale before use.
• Verify power supply stability.

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. A minimum of 5 measurement points will be taken across the range of 0 to 300 kg, including endpoints and midpoints. Each point will have 3 replicate readings recorded as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the scale to warm up for [TBD] minutes.
3. As Found checks and data capture: Measure and record the weight at each point.
4. Adjustment rules: If OOT is found, adjust the scale as per manufacturer guidelines; 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.

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

10. Acceptance Criteria & Calculations

Acceptance Criteria: ±0.05 kg
Error Calculation Formula: Error = Observed Value – True Value
Pass/Fail Logic: If the absolute value of 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 document the deviation.
• 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 must include calibration report/certificate filing. 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-0005	Platform Scale 300 kg	Platform Scale	Warehouse	Receiving	Material weighing	Weight	kg	0 – 300	±0.05 kg	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for calibration will be selected as follows:

• Minimum (0 kg)
• 25% of Range (75 kg)
• 50% of Range (150 kg)
• 75% of Range (225 kg)
• Maximum (300 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]	±0.05 kg	[TBD]	[TBD]	[TBD]	[TBD]
75 kg	[TBD]	[TBD]	[TBD]	±0.05 kg	[TBD]	[TBD]	[TBD]	[TBD]
150 kg	[TBD]	[TBD]	[TBD]	±0.05 kg	[TBD]	[TBD]	[TBD]	[TBD]
225 kg	[TBD]	[TBD]	[TBD]	±0.05 kg	[TBD]	[TBD]	[TBD]	[TBD]
300 kg	[TBD]	[TBD]	[TBD]	±0.05 kg	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the platform scale is clean and free from any obstructions.
2. Stabilization: Allow the scale to stabilize for at least 30 minutes before calibration.
3. Performing Readings: Take three replicate readings at each test point and record the values.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated errors to the acceptance criteria.
6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the supervisor and quality assurance (QA) personnel.
• 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-0005	Platform Scale 300 kg	Warehouse	Receiving	Weight	0 – 300 kg	±0.05 kg	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up for the required duration
• [ ] Clean the platform scale to ensure accurate measurements
• [ ] Level the scale properly before calibration
• [ ] Check validity of reference standards used for calibration
• [ ] Ensure calibration logbook is ready for data entry

As Found Execution

• [ ] Set the scale to specified setpoints
• [ ] Perform multiple repeats for accuracy
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment if out of tolerance (OOT)
• [ ] Stop use of the equipment immediately
• [ ] Notify the responsible personnel of the OOT condition
• [ ] Document the deviation in the logbook
• [ ] Trigger impact review process as necessary

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Platform Scale 300 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

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-0005	Platform Scale 300 kg	Platform Scale	Warehouse	Receiving	[TBD]	[TBD]	[TBD]	Weight (0 – 300 kg)	±0.05 kg

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point	Measured Value (kg)	Acceptance Criteria	Pass/Fail
0 kg	[TBD]	±0.05 kg	[TBD]
50 kg	[TBD]	±0.05 kg	[TBD]
100 kg	[TBD]	±0.05 kg	[TBD]
200 kg	[TBD]	±0.05 kg	[TBD]
300 kg	[TBD]	±0.05 kg	[TBD]

As Left Results

Test Point	Measured Value (kg)	Acceptance Criteria	Pass/Fail
0 kg	[TBD]	±0.05 kg	[TBD]
50 kg	[TBD]	±0.05 kg	[TBD]
100 kg	[TBD]	±0.05 kg	[TBD]
200 kg	[TBD]	±0.05 kg	[TBD]
300 kg	[TBD]	±0.05 kg	[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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