Burette 25 mL (CAL-0029) – Calibration Documents

Calibration Documents: Burette 25 mL (CAL-0029)

Asset ID CAL-0029
Equipment Burette 25 mL
Equipment Type Burette
Department QC
Area/Location Chemistry Lab
Process Use Titration
Parameter Volume
Units mL
Range Min 0
Range Max 25
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 25 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-0029
  • Equipment Name/Type: Burette 25 mL / Burette
  • Department/Area: QC / Chemistry Lab
  • Process Use: Titration
  • Parameter: Volume
  • Range: 0 – 25 mL
  • Units: mL
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of an instrument against a known standard.
  • Verification: The process of confirming that the instrument meets specified requirements.
  • Adjustment: The act of 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 measurements fall outside specified acceptance criteria.
  • Drift: The gradual change in the measurement accuracy of an instrument 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 the 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • 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 equipment and surrounding area.
  • Check that the burette is leveled before use.
  • Verify power supply is stable and within specifications.

7. Standards & Tools

  • Reference Standards Required: Class A volumetric standards.
  • Traceability Statement: Calibration traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]
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8. Calibration Strategy

Calibration will follow the As Found and As Left logic. A minimum of 5 measurement points will be taken, including endpoints (0 mL and 25 mL) and midpoints (12.5 mL). Each point will have 3 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 in the environment.
  3. As Found checks and data capture: Measure and record the volume at each point.
  4. Adjustment rules: If OOT is detected, follow adjustment procedures or escalate as necessary.
  5. As Left verification: Confirm that the instrument is within tolerance after adjustments.
  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 25 mL is Class A. The error calculation formula is as follows:

Error (%) = (Observed Value – True Value) / True Value x 100

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration is deemed a pass; otherwise, it is a fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease 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 of calibration certificates.
  • 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 cleaned and leveled
  • Calibration standards available
  • Documentation ready

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-0029 Burette 25 mL Burette QC Chemistry Lab Titration Volume mL 0 – 25 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 for calibration will be selected as follows:

  • Minimum (0 mL)
  • 25% of Range (6.25 mL)
  • 50% of Range (12.5 mL)
  • 75% of Range (18.75 mL)
  • Maximum (25 mL)

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]
6.25 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
12.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
18.75 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
25 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.
    • Take three replicate readings 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 (Class A).
  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 immediately.
  • Notify the supervisor and quality assurance (QA) department.
  • 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-0029 Burette 25 mL QC Chemistry Lab Volume 0 – 25 mL Class A 365 days ISO17025

1) Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up adequately
  • [ ] Clean the burette as per SOP
  • [ ] Level the burette properly
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

2) As Found Execution

  • [ ] Set initial calibration setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results

3) OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process

4) As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm that all measurements are within specified limits
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5) Documentation & Closure

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

Acceptance Criteria: Class A

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

As Found/As Left: Document the condition of the equipment before and after calibration.

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Deviation Impact Assessment

Event Summary
Asset: Burette 25 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-0029 Burette 25 mL Burette QC Chemistry Lab [TBD] [TBD] [TBD] Volume: 0 – 25 mL Class A

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] Traceable to ISO17025

Results

As Found Results

Test Point Measured Value (mL) Acceptance Criteria Pass/Fail
0 mL [TBD] Class A [TBD]
5 mL [TBD] Class A [TBD]
10 mL [TBD] Class A [TBD]
15 mL [TBD] Class A [TBD]
20 mL [TBD] Class A [TBD]
25 mL [TBD] Class A [TBD]

As Left Results

Test Point Measured Value (mL) Acceptance Criteria Pass/Fail
0 mL [TBD] Class A [TBD]
5 mL [TBD] Class A [TBD]
10 mL [TBD] Class A [TBD]
15 mL [TBD] Class A [TBD]
20 mL [TBD] Class A [TBD]
25 mL [TBD] Class A [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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