Balance Calibration Weight 5 g (CAL-0332) – Calibration Documents

Calibration Documents: Balance Calibration Weight 5 g (CAL-0332)

Asset ID CAL-0332
Equipment Balance Calibration Weight 5 g
Equipment Type Standard Weight
Department Calibration Lab
Area/Location Metrology
Process Use Mass standard
Parameter Weight
Units g
Range Min 5
Range Max 5
Acceptance Criteria Class F1/E2
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 Balance Calibration Weight 5 g is performed to ensure the accuracy of mass measurements, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity in compliance with GMP standards. Accurate weight measurements are essential in pharmaceutical processes to prevent dosage errors that could impact patient health.

2. Scope

  • Asset ID: CAL-0332
  • Equipment Name/Type: Balance Calibration Weight 5 g / Standard Weight
  • Department/Area: Calibration Lab / Metrology
  • Process Use: Mass standard
  • Parameter: Weight
  • Range: 5 g
  • Units: g
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measuring instrument.
  • Verification: Confirming that a measurement device meets specified requirements.
  • Adjustment: The process of modifying a measuring instrument to bring it into compliance with specified standards.
  • As Found: The condition of the equipment before any adjustments are made.
  • As Left: The condition of the equipment 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 trace the measurement back to national or international standards.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A verification process conducted 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 calibration 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 calibration area and equipment.
  • Check that the balance is leveled before use.
  • Verify power supply is stable and within required specifications.
See also  Graduated Cylinder 100 mL (CAL-0043) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: Calibration weights certified to Class F1/E2.
  • Traceability Statement: Calibration performed in accordance with ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of test points will be five, including endpoints and midpoints. Each point will be measured in triplicate to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary equipment and reference standards.
  2. Stabilization: Allow the balance to stabilize in the calibration environment.
  3. As Found checks and data capture: Measure the weight using the standard weight and record the results.
  4. Adjustment rules: If OOT is detected, follow the adjustment protocol; if not allowed, escalate to QA.
  5. As Left verification: Re-measure to confirm adjustments are within tolerance.
  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

The acceptance criteria for this calibration is Class F1/E2. The error calculation formula is as follows:

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 initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries must be made for each calibration event.
  • Calibration report/certificate filing must be maintained.
  • 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)

See also  Compressed Air Pressure Gauge (CAL-0325) - Calibration Documents

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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-0332 Balance Calibration Weight 5 g Standard Weight Calibration Lab Metrology Mass standard Weight g 5 – 5 Class F1/E2 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: 5 g
  • 25%: 5 g
  • 50%: 5 g
  • 75%: 5 g
  • Maximum: 5 g

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
5 g 5 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the calibration area is clean and free from disturbances.
  2. Stabilization: Allow the standard weight to acclimate to 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 against the acceptance criteria.
  6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

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

  • Stop use of the equipment.
  • Notify the supervisor immediately.
  • 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-0332 Balance Calibration Weight 5 g Calibration Lab Metrology Weight 5 g Class F1/E2 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the calibration weight and balance
  • [ ] Level the balance as per manufacturer instructions
  • [ ] Confirm reference standards are valid and calibrated
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the balance to specified 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 the QA department
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP
See also  Checkweigher (Pack line) (CAL-0009) - Calibration Documents

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all results 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 the system

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

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Deviation Impact Assessment

Event Summary Details
Asset Balance Calibration Weight 5 g
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

Investigation Summary Placeholders: [TBD]

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-0332 Balance Calibration Weight 5 g Standard Weight Calibration Lab Metrology [TBD] [TBD] [TBD] Weight / 5 g / g Class F1/E2

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 (g) Acceptance Criteria Pass/Fail
1 [TBD] Class F1/E2 [TBD]
2 [TBD] Class F1/E2 [TBD]
3 [TBD] Class F1/E2 [TBD]
4 [TBD] Class F1/E2 [TBD]
5 [TBD] Class F1/E2 [TBD]

As Left Results

Test Point Measured Value (g) Acceptance Criteria Pass/Fail
1 [TBD] Class F1/E2 [TBD]
2 [TBD] Class F1/E2 [TBD]
3 [TBD] Class F1/E2 [TBD]
4 [TBD] Class F1/E2 [TBD]
5 [TBD] Class F1/E2 [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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