Burette 10 mL (CAL-0028) – Calibration Documents

Calibration Documents: Burette 10 mL (CAL-0028)

Asset ID CAL-0028
Equipment Burette 10 mL
Equipment Type Burette
Department QC
Area/Location Chemistry Lab
Process Use Titration
Parameter Volume
Units mL
Range Min 0
Range Max 10
Acceptance Criteria Class A
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 Burette 10 mL is performed to ensure accurate volume measurements during titration processes in the QC department. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0028
  • Equipment Name/Type: Burette 10 mL / Burette
  • Department/Area: QC / Chemistry Lab
  • Process Use: Titration
  • Parameter: Volume
  • Range: 0 – 10 mL
  • Units: mL
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of an instrument.
  • Verification: Confirming that an instrument meets specified requirements.
  • Adjustment: Modifying an instrument to bring it into compliance with specifications.
  • As Found: The condition of the instrument prior to any adjustments.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the instrument’s measurements fall outside specified limits.
  • Drift: The gradual change in an instrument’s output over time.
  • Traceability: The ability to trace the measurement results 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 periodic check of an instrument’s 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 data and documentation.
  • Owner Department: Ensure equipment is available and maintained.
  • 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 guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Verify that the burette is level before use.
  • Check power supply and ensure it is stable and within specifications.
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7. Standards & Tools

  • Reference Standards: Class A volumetric standards.
  • Traceability Statement: Calibration traceable to 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 calibration points will be five, including endpoints (0 mL and 10 mL) and midpoints (5 mL). Each point will have three replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the burette to stabilize at room temperature.
  3. As Found checks and data capture: Measure the volume at specified points and record results.
  4. Adjustment rules: If OOT is found, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Measure again to confirm adjustments are within specifications.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment.

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

10. Acceptance Criteria & Calculations

Acceptance criteria for the Burette 10 mL is Class A. 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 cease use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed before returning to service.
  • QA disposition placeholders: [TBD].

12. Records & Retention

  • Logbook entries for calibration activities.
  • Calibration report/certificate filing 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

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 cleaned and leveled.
  • Calibration standards checked for validity.
  • All documentation prepared.

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-0028 Burette 10 mL Burette QC Chemistry Lab Titration Volume mL 0 – 10 Class A 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following values:

  • 0 mL (Min)
  • 2.5 mL (25%)
  • 5.0 mL (50%)
  • 7.5 mL (75%)
  • 10 mL (Max)

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
5.0 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
7.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
10 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the burette is clean and free from any contaminants.
  2. Stabilization: Allow the burette to stabilize at room temperature for at least 30 minutes.
  3. Performing Readings:
    • Fill the burette with the calibration standard.
    • Record the initial volume.
    • Dispense the liquid to the test point and record the final volume.
    • Repeat for each test point, ensuring to take at least three replicates for accuracy.
  4. Calculating Error: Calculate the error for each test point using the formula: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria.
  6. Documentation: Complete the results table and ensure all observations are recorded accurately.

Deviation Instruction for OOT

If any results fall outside the acceptance criteria:

  • 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-0028 Burette 10 mL QC Chemistry Lab Volume 0 – 10 mL Class A 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the burette thoroughly
  • [ ] Level the burette properly
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform required repeats for accuracy
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations
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OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the QA department
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary
Asset: Burette 10 mL
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-0028 Burette 10 mL Burette QC Chemistry Lab [TBD] [TBD] [TBD] Volume: 0 – 10 mL Class A

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 (mL) Acceptance Criteria
0 mL [TBD] Class A
2 mL [TBD] Class A
5 mL [TBD] Class A
8 mL [TBD] Class A
10 mL [TBD] Class A

As Left Results

Test Point Measured Value (mL) Acceptance Criteria
0 mL [TBD] Class A
2 mL [TBD] Class A
5 mL [TBD] Class A
8 mL [TBD] Class A
10 mL [TBD] Class A

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: _____________________ Date: ____________

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