Calibration Documents: AAS (CAL-0115)

Asset ID	CAL-0115
Equipment	AAS
Equipment Type	Atomic Absorption
Department	QC
Area/Location	Instrument Room
Process Use	Elemental
Parameter	Wavelength
Units	nm
Range Min	190
Range Max	900
Acceptance Criteria	±2 nm
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Atomic Absorption Spectrophotometer (AAS) is performed to ensure accurate measurement of elemental parameters, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Proper calibration mitigates risks associated with inaccurate readings that could lead to erroneous conclusions in quality control processes.

2. Scope

Asset ID: CAL-0115
Equipment Name/Type: Atomic Absorption Spectrophotometer (AAS)
Department/Area: QC, Instrument Room
Process Use: Elemental analysis
Parameter: Wavelength
Range: 190 nm to 900 nm
Units: nm
Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of an instrument against a standard.
• Verification: The process of confirming that an instrument meets specified requirements.
• 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 calibration and adjustments.
• OOT (Out of Tolerance): A condition where the instrument’s readings exceed 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 range of values within which the true value is asserted to lie.
• Intermediate Check: A periodic check performed to ensure 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 document results.
• QC/QA Reviewer: Review calibration documentation and results for compliance.
• Owner Department: Ensure the asset is available and maintained.
• External Service Provider: Conduct external calibrations as per the calibration type.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow adequate warm-up/stabilization time for the instrument.
• Maintain cleanliness of the instrument and surrounding area.
• Check that the instrument is level and properly positioned.
• Verify power supply stability and functionality.

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow an As Found and As Left logic. A minimum of 5 calibration points will be established, including endpoints (190 nm and 900 nm) and midpoints. Each point will have 3 replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the instrument to warm up for the specified time.
3. As Found checks and data capture: Measure the wavelength at specified points and record results contemporaneously.
4. Adjustment rules: If OOT is detected, follow adjustment protocols; if not allowed, escalate to QA.
5. As Left verification: Confirm that the instrument is within acceptance criteria after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the instrument with calibration details.

10. Acceptance Criteria & Calculations

Acceptance Criteria: ±2 nm
Error Calculation Formula: Error = Observed Value – True Value
Pass/Fail Logic: If the absolute value of the error is within acceptance criteria, the calibration passes; otherwise, it fails.
Rounding Rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag the equipment and cease use.
• Notification & deviation initiation: Notify QA and initiate deviation procedures.
• 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: 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, 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 checked
• Instrument warm-up completed
• Cleanliness verified
• Leveling confirmed
• Power supply checked

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-0115	AAS	Atomic Absorption	QC	Instrument Room	Elemental	Wavelength	nm	190 – 900	±2 nm	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for calibration will be selected as follows:

• Minimum: 190 nm
• 25% of Range: 345 nm
• 50% of Range: 495 nm
• 75% of Range: 645 nm
• Maximum: 900 nm

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
190 nm	[TBD]	[TBD]	[TBD]	±2 nm	[TBD]	[TBD]	[TBD]	[TBD]
345 nm	[TBD]	[TBD]	[TBD]	±2 nm	[TBD]	[TBD]	[TBD]	[TBD]
495 nm	[TBD]	[TBD]	[TBD]	±2 nm	[TBD]	[TBD]	[TBD]	[TBD]
645 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 AAS is clean and calibrated according to the manufacturer’s specifications.
2. Stabilization: Allow the equipment to warm up for at least [TBD] minutes.
3. Performing Readings: 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 errors to 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.
• Notify the supervisor immediately.
• 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-0115	AAS	QC	Instrument Room	Wavelength	190 – 900 nm	±2 nm	365 days	ISO17025

Pre-calibration

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

As Found Execution

• [ ] Set the instrument to specified setpoints
• [ ] Perform repeat measurements as required
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment if out of tolerance
• [ ] Stop use of the equipment immediately
• [ ] Notify the supervisor and QA
• [ ] Document deviation in the logbook
• [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

• [ ] Update equipment label with 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 Accurate, Legible, Contemporaneous, Original, and Attributable.

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Deviation Impact Assessment

Event Summary
Asset: AAS (Atomic Absorption) 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

Summary: [TBD]

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-0115	AAS	Atomic Absorption	QC	Instrument Room	[TBD]	[TBD]	[TBD]	Wavelength: 190 – 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)	Remarks
1	[TBD]	[TBD]
2	[TBD]	[TBD]
3	[TBD]	[TBD]
4	[TBD]	[TBD]
5	[TBD]	[TBD]

As Left Results

Test Point	Measured Value (nm)	Remarks
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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