Balance Calibration Weight 100 g (CAL-0336) – Calibration Documents

Calibration Documents: Balance Calibration Weight 100 g (CAL-0336)

Asset ID CAL-0336
Equipment Balance Calibration Weight 100 g
Equipment Type Standard Weight
Department Calibration Lab
Area/Location Metrology
Process Use Mass standard
Parameter Weight
Units g
Range Min 100
Range Max 100
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 100 g is performed to ensure the accuracy of mass measurements, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate weight measurements directly impact the reliability of analytical results and compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0336
  • Equipment Name/Type: Balance Calibration Weight 100 g / Standard Weight
  • Department/Area: Calibration Lab / Metrology
  • Process Use: Mass standard
  • Parameter: Weight
  • Range: 100 g
  • Units: g
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement standard to a known reference to determine accuracy.
  • Verification: The process of confirming that a measurement system is operating within specified limits.
  • Adjustment: The process of modifying a measurement system to bring it into compliance with specified standards.
  • As Found: The condition of the equipment prior to any adjustments or corrections.
  • As Left: The condition of the equipment after adjustments or corrections have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside specified acceptance criteria.
  • Drift: The gradual change in a measurement system’s output 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 dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A periodic check performed to ensure that equipment remains within specified limits 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 results and documentation.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • 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 before calibration.
  • Maintain cleanliness of the calibration area and equipment.
  • Check that the equipment is level before use.
  • Verify power supply is stable and within specifications.
See also  Pressure Gauge 0-10 bar (CAL-0071) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: Calibration weights certified to Class F1/E2.
  • Traceability Statement: All calibrations must be traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and 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 calibration weights and documentation.
  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 data contemporaneously.
  4. Adjustment rules: If OOT is detected, escalate for adjustment as per SOP.
  5. As Left verification: Re-measure after any adjustments to confirm compliance.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

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

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 placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use until resolved.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • 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 must be made for each calibration event.
  • Calibration report/certificate filing must be maintained in accordance with 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).

See also  Lux Meter (CAL-0261) - Calibration Documents

Annexure B: Quick checklist.

Annexure C: Example label text (with [TBD] placeholders).

⬆ Back to TOC

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-0336 Balance Calibration Weight 100 g Standard Weight Calibration Lab Metrology Mass standard Weight g 100 g Class F1/E2 365 days External ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 100 g
  • 25%: 100 g
  • 50%: 100 g
  • 75%: 100 g
  • Maximum: 100 g

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
100 g 100 g [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the calibration area is clean and free from contaminants. Gather all necessary equipment and documentation.
  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 using calibrated equipment.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria. Document any deviations.
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the asset immediately.
  • Notify the supervisor and QA.
  • 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]

⬆ Back to TOC

Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0336 Balance Calibration Weight 100 g Calibration Lab Metrology Weight 100 g Class F1/E2 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the calibration weight and surrounding area
  • [ ] Level the balance if applicable
  • [ ] Confirm validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set initial weight setpoints
  • [ ] Perform repeat measurements
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Nutraceutical Tablet Hardness Tester (CAL-0291) - Calibration Documents

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 process

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with calibration details
  • [ ] 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.

⬆ Back to TOC

Deviation Impact Assessment

Event Summary Details
Asset Balance Calibration Weight 100 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]

⬆ Back to TOC

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-0336 Balance Calibration Weight 100 g Standard Weight Calibration Lab Metrology [TBD] [TBD] [TBD] Weight / 100 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) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (g) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: __________

Checked by: ______________________ Date: __________

Approved by: _____________________ Date: __________

⬆ Back to TOC