Balance Calibration Weight 2 g (CAL-0331) – Calibration Documents

Calibration Documents: Balance Calibration Weight 2 g (CAL-0331)

Asset ID CAL-0331
Equipment Balance Calibration Weight 2 g
Equipment Type Standard Weight
Department Calibration Lab
Area/Location Metrology
Process Use Mass standard
Parameter Weight
Units g
Range Min 2
Range Max 2
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 2 g is performed to ensure the accuracy of mass measurements within the Calibration Lab. This is critical for maintaining patient safety, ensuring batch quality, and upholding data integrity in compliance with GMP standards.

2. Scope

  • Asset ID: CAL-0331
  • Equipment Name/Type: Balance Calibration Weight 2 g / Standard Weight
  • Department/Area: Calibration Lab / Metrology
  • Process Use: Mass standard
  • Parameter: Weight
  • Range: 2 g
  • Units: g
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of measurement equipment.
  • Verification: Confirming that the equipment meets specified requirements.
  • Adjustment: 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 the specified acceptance criteria.
  • Drift: The gradual change in 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 verification of equipment 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 maintain records.
  • QC/QA Reviewer: Review calibration records and ensure compliance.
  • Owner Department: Ensure equipment is available and maintained.
  • External Service Provider: Conduct external calibrations as required.

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 calibration area and equipment.
  • Check leveling of the balance before use.
  • Verify power supply stability and functionality.
See also  Tablet Press Thickness Sensor (CAL-0211) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: Class F1/E2 calibration weights.
  • Traceability Statement: ISO17025.
  • Certificate Validity Check: Ensure all calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic:

  • Minimum number of points: 5 points including endpoints 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 balance to stabilize in the calibration environment.
  3. As Found checks and data capture: Measure the weight using the standard weight and record observations contemporaneously.
  4. Adjustment rules: If OOT, escalate to QA for further action; adjustments are not permitted unless specified.
  5. As Left verification: Confirm that the equipment is within tolerance after any adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment appropriately.

10. Acceptance Criteria & Calculations

Acceptance criteria: Class F1/E2.

Error calculation formula: Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If error falls within acceptance criteria, pass; otherwise, fail.

Rounding rule placeholder: [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 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 as per company policy.
  • 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-0331 Balance Calibration Weight 2 g Standard Weight Calibration Lab Metrology Mass standard Weight g 2 – 2 Class F1/E2 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for calibration will be selected as follows:

  • Minimum: 2 g
  • 25%: 2 g
  • 50%: 2 g
  • 75%: 2 g
  • Maximum: 2 g

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
2 g 2 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2 g 2 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2 g 2 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2 g 2 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2 g 2 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the calibration weight is clean and free from any contaminants.
  2. Stabilization: Allow the calibration weight to acclimate to the environmental conditions 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 using the formula: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

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-0331 Balance Calibration Weight 2 g Calibration Lab Metrology Weight 2 g Class F1/E2 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up for the required duration
  • [ ] Clean the calibration weight and surrounding area
  • [ ] Level the balance if applicable
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set the balance to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process
See also  Micropipette 1-5 mL (CAL-0024) - Calibration Documents

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary
Asset: Balance Calibration Weight 2 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

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-0331 Balance Calibration Weight 2 g Standard Weight Calibration Lab Metrology [TBD] [TBD] [TBD] Weight / 2 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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