Balance Calibration Weight 1 g (CAL-0330) – Calibration Documents

Calibration Documents: Balance Calibration Weight 1 g (CAL-0330)

Asset ID CAL-0330
Equipment Balance Calibration Weight 1 g
Equipment Type Standard Weight
Department Calibration Lab
Area/Location Metrology
Process Use Mass standard
Parameter Weight
Units g
Range Min 1
Range Max 1
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 1 g is performed to ensure the accuracy of mass measurements within the Calibration Lab. This calibration controls risks associated with inaccurate weight measurements that could impact patient safety, batch quality, and overall data integrity in compliance with GMP standards.

2. Scope

  • Asset ID: CAL-0330
  • Equipment Name/Type: Balance Calibration Weight 1 g / Standard Weight
  • Department/Area: Calibration Lab / Metrology
  • Process Use: Mass standard
  • Parameter: Weight
  • Range: 1 g
  • Units: g
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement standard to a known reference to ensure accuracy.
  • Verification: The process of confirming that a measurement system is functioning correctly.
  • Adjustment: The act of modifying a measurement system to bring it into alignment with a standard.
  • As Found: The condition of the equipment prior to calibration.
  • As Left: The condition of the equipment after calibration.
  • OOT (Out of Tolerance): A condition where the measurement exceeds the specified acceptance criteria.
  • Drift: The gradual change in a measurement 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 step 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 compliance with calibration schedules.
  • External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm-up/stabilize as per manufacturer guidelines.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the balance before use.
  • Verify power supply stability prior to calibration.
See also  Thermocouple Type K (CAL-0053) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: Class F1/E2 weights.
  • Traceability Statement: Calibration traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow an As Found then As Left logic. The minimum number of points for calibration will be 5, including endpoints and midpoints. It is recommended to take 3 replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the balance to stabilize in the calibration environment.
  3. As Found checks and data capture: Record initial measurements before any adjustments.
  4. Adjustment rules: If OOT is detected, escalate for further action; adjustments should only be made if permitted.
  5. As Left verification: Confirm that the equipment meets specifications after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out contemporaneously to maintain ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Balance Calibration Weight 1 g is Class F1/E2. The error calculation formula is: Error (%) = (Observed Value – True Value) / True Value * 100. Pass/Fail logic will be based on whether the error falls within acceptable limits. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define the impact window and review 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: 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 warmed up and stabilized.
  • Calibration area cleaned.
  • Balance leveled.
  • Power supply checked.
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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-0330 Balance Calibration Weight 1 g Standard Weight Calibration Lab Metrology Mass standard Weight g 1 – 1 Class F1/E2 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Min: 1 g
  • 25%: 1 g
  • 50%: 1 g
  • 75%: 1 g
  • Max: 1 g

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
1 g 1 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the calibration weight is clean and free from contaminants.
  2. Stabilization: Allow the equipment to stabilize in the calibration environment for at least [TBD] minutes.
  3. Performing Readings: Take at least 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 evaluations in the results table.

Deviation Instruction for OOT

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • Open a deviation report.
  • Quarantine 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-0330 Balance Calibration Weight 1 g Calibration Lab Metrology Weight 1 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
  • [ ] Confirm validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set the balance 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 QA and relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm results are within acceptance limits
See also  Stability Chamber Temp Probe (CAL-0180) - Calibration Documents

Documentation & Closure

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

Acceptance Criteria: Class F1/E2

Data Integrity (ALCOA+): Ensure all data is attributable, legible, contemporaneous, original, and accurate.

Out of Tolerance (OOT) Handling: Follow established procedures for OOT situations as outlined above.

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Deviation Impact Assessment

Event Summary
Asset: Balance Calibration Weight 1 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: [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-0330 Balance Calibration Weight 1 g Standard Weight Calibration Lab Metrology [TBD] [TBD] [TBD] Weight / 1 g / g Class F1/E2

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 (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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