Tank Level Transmitter (CAL-0205) – Calibration Documents

Calibration Documents: Tank Level Transmitter (CAL-0205)

Asset ID CAL-0205
Equipment Tank Level Transmitter
Equipment Type Level Transmitter
Department API
Area/Location Storage
Process Use Level monitoring
Parameter Level
Units %
Range Min 0
Range Max 100
Acceptance Criteria ±1%
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 Tank Level Transmitter is performed to ensure accurate level monitoring within the storage area of the API department. This calibration controls risks associated with inaccurate level readings that could lead to improper inventory management, potential patient safety issues, and compromised batch quality. Additionally, it supports data integrity by ensuring that recorded levels reflect true conditions.

2. Scope

  • Asset ID: CAL-0205
  • Equipment Name/Type: Tank Level Transmitter / Level Transmitter
  • Department/Area: API / Storage
  • Process Use: Level monitoring
  • Parameter: Level
  • Range: 0% to 100%
  • Units: %
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The act of correcting a measurement instrument to ensure it provides accurate readings.
  • As Found: The condition of the instrument prior to any adjustments being made.
  • As Left: The condition of the instrument 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 the accuracy of a measurement 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 of a measurement lies.
  • Intermediate Check: A periodic check performed between calibrations to ensure continued accuracy.

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 ensure compliance.
  • Owner Department: Ensure equipment is available and accessible for calibration.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer specifications.
  • Maintain cleanliness in the calibration area.
  • Check that the equipment is level and stable.
  • Verify power supply checks are completed before calibration.
See also  Flow Meter (WFI Loop) (CAL-0081) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID: [TBD]

8. Calibration Strategy

The calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0% and 100%) and midpoints (25%, 50%, 75%).
  • Replicate readings at each point: 3 repeats are recommended for accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Tank Level Transmitter to stabilize as per manufacturer guidelines.
  3. As Found checks and data capture: Record initial readings at each test point.
  4. Adjustment rules: If OOT is detected, follow adjustment procedures as per SOP; if not allowed, escalate to QA.
  5. As Left verification: After adjustments, recheck readings and document results.
  6. Labeling + documentation completion: Ensure all calibration records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the Tank Level Transmitter is ±1%.

Error Calculation Formula: Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If the error falls within ±1%, the calibration passes; otherwise, it fails.

Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop use until resolved.
  • Notification & deviation initiation: Notify QA and initiate deviation procedures.
  • Impact assessment trigger: Define impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition: [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: 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 warm-up completed
  • Calibration tools prepared
  • Documentation ready

Annexure C: Example Label Text

Calibration Date: [TBD] | Due Date: [TBD] | Calibrated By: [TBD] | Status: [TBD]

See also  Incubator Temp Sensor (30-35°C) (CAL-0155) - Calibration Documents

⬆ 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-0205 Tank Level Transmitter Level Transmitter API Storage Level monitoring Level % 0 – 100 ±1% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • 0%
  • 25%
  • 50%
  • 75%
  • 100%

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0% [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
25% [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
50% [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
75% [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
100% [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the equipment is clean and free from any obstructions.
  2. Stabilization: Allow the transmitter to stabilize for [TBD] minutes before taking readings.
  3. Performing Readings: Take three replicate readings at each test point and record the values.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors to the acceptance criteria of ±1%.
  6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and QA.
  • Open a deviation report.
  • Quarantine the 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-0205 Tank Level Transmitter API Storage Level 0% – 100% ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per manufacturer guidelines
  • [ ] Clean the equipment as necessary
  • [ ] Ensure the equipment is level
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the required 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 relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review
See also  Inline pH Sensor (Neutralization) (CAL-0204) - 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

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate. Maintain a clear audit trail for all calibration activities.

⬆ Back to TOC

Deviation Impact Assessment

Event Summary Details
Asset Tank Level Transmitter
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-0205 Tank Level Transmitter Level Transmitter API Storage [TBD] [TBD] [TBD] Level: 0-100% ±1%

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 (%) Acceptance Criteria Pass/Fail
0% [TBD] ±1% [TBD]
25% [TBD] ±1% [TBD]
50% [TBD] ±1% [TBD]
75% [TBD] ±1% [TBD]
100% [TBD] ±1% [TBD]

As Left Results

Test Point Measured Value (%) Acceptance Criteria Pass/Fail
0% [TBD] ±1% [TBD]
25% [TBD] ±1% [TBD]
50% [TBD] ±1% [TBD]
75% [TBD] ±1% [TBD]
100% [TBD] ±1% [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