ICP-OES (CAL-0116) – Calibration Documents

Calibration Documents: ICP-OES (CAL-0116)

Asset ID CAL-0116
Equipment ICP-OES
Equipment Type ICP-OES
Department QC
Area/Location Instrument Room
Process Use Elemental
Parameter Wavelength
Units nm
Range Min 160
Range Max 900
Acceptance Criteria ±2 nm
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 ICP-OES (Asset ID: CAL-0116) is performed to ensure accurate measurement of elemental wavelengths, which is critical for maintaining patient safety and batch quality. Proper calibration controls risks associated with inaccurate data that could lead to non-compliance with regulatory standards and potential harm to patients.

2. Scope

  • Asset ID: CAL-0116
  • Equipment Name/Type: ICP-OES
  • Department/Area: QC / Instrument Room
  • Process Use: Elemental
  • Parameter: Wavelength
  • Range: 160 nm – 900 nm
  • Units: nm
  • 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 the calibration is still valid.
  • Adjustment: The act of modifying an instrument to bring it within specified limits.
  • 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 falls outside the 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 that characterizes the dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A periodic check to ensure that the instrument 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 compliance with calibration schedule.
  • 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 instrument as per manufacturer guidelines.
  • Maintain cleanliness of the instrument and surrounding area.
  • Check leveling of the instrument.
  • Verify power supply stability.
See also  Density Meter (CAL-0231) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

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

  • Minimum number of points: At least 5 points including endpoints (160 nm and 900 nm) and midpoints.
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the ICP-OES to warm up for the recommended time.
  3. As Found checks and data capture: Record initial readings at specified points.
  4. Adjustment rules: If OOT is found, follow adjustment procedures; if not allowed, escalate to QA.
  5. As Left verification: Record final readings after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out and labels are affixed.

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

10. Acceptance Criteria & Calculations

Acceptance criteria for the ICP-OES calibration is ±2 nm.

Error calculation formula: Error = Observed Value – Reference Value

Pass/Fail Logic: If the absolute value of error is within acceptance criteria, then pass; otherwise, fail.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed before returning to service.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in accordance with company policy.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, by whom, 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
  • Instrument warm-up completed
  • 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-0116 ICP-OES ICP-OES QC Instrument Room Elemental Wavelength nm 160 – 900 ±2 nm 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Min: 160 nm
  • 25%: 290 nm
  • 50%: 480 nm
  • 75%: 670 nm
  • Max: 900 nm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
160 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
290 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
480 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
670 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
900 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the ICP-OES is clean and calibrated according to the manufacturer’s specifications.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±2 nm.
  6. Documentation: Record all observations and calculations in the results table.

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-0116 ICP-OES QC Instrument Room Wavelength 160 – 900 nm ±2 nm 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the equipment as per cleaning protocol
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set initial measurement setpoints
  • [ ] Perform repeat measurements as required
  • [ ] 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  Fermenter Temperature Probe (CAL-0304) - 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 in logbook

Acceptance Criteria: All measurements must be within ±2 nm of the specified range.

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

Out of Tolerance (OOT) Handling: Follow immediate actions as outlined above to ensure compliance and safety.

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Deviation Impact Assessment

Event Summary
Asset: ICP-OES
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-0116 ICP-OES ICP-OES QC Instrument Room [TBD] [TBD] [TBD] Wavelength: 160 – 900 nm ±2 nm

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 (nm) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (nm) 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: ___________

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