Metal Detector (Sensitivity check) (CAL-0010) – Calibration Documents

Calibration Documents: Metal Detector (Sensitivity check) (CAL-0010)

Asset ID CAL-0010
Equipment Metal Detector (Sensitivity check)
Equipment Type Metal Detector
Department Packaging
Area/Location Packing Line
Process Use Foreign metal detection
Parameter Sensitivity
Units mm
Range Min 0
Range Max 5
Acceptance Criteria As per challenge set
Calibration Frequency (days) 180
Calibration Type In-house
Traceability Traceable standards

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 Metal Detector (Sensitivity check) is performed to ensure accurate detection of foreign metal contaminants in packaging processes. This calibration controls risks related to product quality, patient safety, and compliance with regulatory standards, thereby maintaining data integrity throughout the manufacturing process.

2. Scope

  • Asset ID: CAL-0010
  • Equipment Name/Type: Metal Detector (Sensitivity check)
  • Department/Area: Packaging
  • Process Use: Foreign metal detection
  • Parameter: Sensitivity
  • Range: 0 mm to 5 mm
  • Units: mm
  • Calibration Frequency: Every 180 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of measurement equipment.
  • Verification: The confirmation that a measurement system meets specified requirements.
  • Adjustment: The process of modifying a measurement system to bring it into compliance with specifications.
  • As Found: The condition of the equipment prior to any adjustments being made.
  • As Left: The condition of the equipment after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the defined acceptance criteria.
  • Drift: The gradual change in the output of a measurement system over time.
  • Traceability: The ability to trace the history, application, or location of an item through 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 to ensure that equipment 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 equipment is available and in good condition for calibration.
  • External Service Provider: [TBD]

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer’s instructions.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply is stable and within required specifications.
See also  AAS (CAL-0115) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: Traceable standards
  • Traceability Statement: Traceable standards
  • Certificate Validity Check: [TBD]
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints and midpoints within the range of 0 mm to 5 mm.
  • 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 Metal Detector to warm up as per the manufacturer’s guidelines.
  3. As Found checks and data capture: Record initial sensitivity readings at defined points.
  4. Adjustment rules: If OOT is detected, follow the adjustment protocol; if not allowed, escalate to QA.
  5. As Left verification: Confirm that the equipment is within tolerance after adjustments.
  6. Labeling + documentation completion: Ensure all records are completed contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: As per challenge set.

Error calculation formula: [TBD]

Pass/Fail logic: [TBD]

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Inform 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: Maintain detailed records of calibration activities.
  • Calibration report/certificate filing: Ensure all documents are filed appropriately.
  • e-Records if applicable: [TBD]
  • Label content requirements: Calibrated date, due date, by whom, 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

  • Equipment clean and operational?
  • Environmental conditions within specifications?
  • All tools and standards available?
  • Calibration 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-0010 Metal Detector (Sensitivity check) Metal Detector Packaging Packing Line Foreign metal detection Sensitivity mm 0 – 5 As per challenge set 180 days In-house Traceable standards
See also  Nutraceutical Moisture Analyzer (CAL-0290) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following values:

  • Min: 0 mm
  • 25%: 1.25 mm
  • 50%: 2.5 mm
  • 75%: 3.75 mm
  • Max: 5 mm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
1.25 mm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2.5 mm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
3.75 mm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
5 mm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the metal detector is clean and free from any obstructions.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  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 calculated errors against the acceptance criteria.
  6. Documentation: Record all findings 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 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-0010 Metal Detector (Sensitivity check) Packaging Packing Line Sensitivity 0 – 5 mm As per challenge set 180 days Traceable standards

Pre-calibration

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

As Found Execution

  • [ ] Set initial sensitivity setpoints
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for analysis
See also  Stability Chamber Controller Display Temp (CAL-0182) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review as per SOP

As Left Verification

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

Documentation & Closure

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

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: Metal Detector (Sensitivity check)
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

Investigation Summary Placeholders: [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-0010 Metal Detector (Sensitivity check) Metal Detector Packaging Packing Line [TBD] [TBD] [TBD] Sensitivity: 0 – 5 mm As per challenge set

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measurement (mm)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [TBD]

As Left Results

Test Point Measurement (mm)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [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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