TOC Analyzer Offline (CAL-0096) – Calibration Documents

Calibration Documents: TOC Analyzer Offline (CAL-0096)

Asset ID CAL-0096
Equipment TOC Analyzer Offline
Equipment Type TOC Analyzer
Department QC
Area/Location Water Lab
Process Use TOC
Parameter TOC
Units ppb
Range Min 0
Range Max 1000
Acceptance Criteria ±5%
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 TOC Analyzer Offline is performed to ensure accurate measurement of Total Organic Carbon (TOC) levels in water samples. This calibration controls risks associated with data integrity, patient safety, and batch quality by ensuring that the equipment operates within specified limits, thereby preventing erroneous results that could impact product quality.

2. Scope

  • Asset ID: CAL-0096
  • Equipment Name/Type: TOC Analyzer Offline / TOC Analyzer
  • Department/Area: QC / Water Lab
  • Process Use: TOC
  • Parameter: TOC
  • Range: 0 – 1000 ppb
  • Units: ppb
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
  • Verification: The process of confirming that an instrument is functioning correctly.
  • Adjustment: The act of modifying an instrument to bring it into compliance with specified standards.
  • 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 measurement exceeds the specified acceptance criteria.
  • Drift: The gradual change in the output 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 associated with the result of a measurement that characterizes the range of values within which the true value is asserted to lie.
  • Intermediate Check: A periodic check of equipment performance between full 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 for calibration.
  • 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.
  • Check leveling of the equipment.
  • Verify power supply stability and functionality.
See also  Differential Pressure Transmitter 0-500 Pa (CAL-0077) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

The calibration will follow an As Found then As Left logic. A minimum of 5 calibration points will be used, including endpoints and midpoints of the specified range (0 – 1000 ppb). Each point will have 3 replicate readings taken as a best practice to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the TOC Analyzer to stabilize as per manufacturer instructions.
  3. As Found checks and data capture: Record initial readings at each calibration point.
  4. Adjustment rules: If any readings are OOT, escalate for adjustment as per SOP.
  5. As Left verification: Record final readings after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

All raw observations must be recorded contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

The acceptance criteria for the TOC Analyzer are ±5% of the target value. The error calculation formula is:

Error (%) = (Observed Value – Target Value) / Target Value × 100

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

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop its use.
  • Notification & deviation initiation: Notify relevant personnel and initiate a deviation report.
  • Impact assessment trigger: Define the 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 include calibration date, due date, technician name, and status.
  • Calibration report/certificate filing: Maintain records as per company policy.
  • E-records if applicable: [TBD]

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
  • Cleanliness checked
  • Leveling confirmed
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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See also  Balance Calibration Weight 10 g (CAL-0333) - Calibration Documents

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-0096 TOC Analyzer Offline TOC Analyzer QC Water Lab TOC TOC ppb 0 – 1000 ±5% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Minimum (0 ppb)
  • 25% of Range (250 ppb)
  • 50% of Range (500 ppb)
  • 75% of Range (750 ppb)
  • Maximum (1000 ppb)

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 ppb [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]
250 ppb [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]
500 ppb [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]
750 ppb [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]
1000 ppb [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the TOC Analyzer is clean and calibrated as per the manufacturer’s guidelines.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate measurements at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±5%.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • Open a deviation report.
  • Quarantine the 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-0096 TOC Analyzer Offline QC Water Lab TOC 0 – 1000 ppb ±5% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has been warmed up for the required duration
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the required calibration setpoints
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Inline Temp Sensor (Reactor Jacket) (CAL-0200) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: TOC Analyzer Offline
Date: [TBD]
Discovered By: [TBD]
Document References: [TBD]
As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the equipment
  • Label/Tag the equipment as out of service
  • 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-0096 TOC Analyzer Offline TOC Analyzer QC Water Lab [TBD] [TBD] [TBD] TOC / 0 – 1000 / ppb ±5%

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Result (ppb) Comments
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Result (ppb) Comments
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: ___________

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