Checkweigher (Pack line) (CAL-0009) – Calibration Documents

Calibration Documents: Checkweigher (Pack line) (CAL-0009)

Asset ID CAL-0009
Equipment Checkweigher (Pack line)
Equipment Type Checkweigher
Department Packaging
Area/Location Packing Line
Process Use Pack weight verification
Parameter Weight
Units g
Range Min 0
Range Max 2000
Acceptance Criteria ±0.5 g
Calibration Frequency (days) 180
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 Checkweigher (Pack line) is performed to ensure accurate weight verification during the packaging process. This is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Inaccurate weight measurements can lead to non-compliance with regulatory standards and potential risks to consumer safety.

2. Scope

  • Asset ID: CAL-0009
  • Equipment Name/Type: Checkweigher (Pack line)
  • Department/Area: Packaging
  • Process Use: Pack weight verification
  • Parameter: Weight
  • Range: 0 – 2000 g
  • Units: g
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The act of modifying a measurement instrument to bring it into compliance with specified standards.
  • As Found: The condition of the equipment prior to any adjustments or corrections.
  • As Left: The condition of the equipment after adjustments or corrections have been made.
  • OOT (Out of Tolerance): A condition where the measurement exceeds the defined acceptance criteria.
  • Drift: The gradual change in a measurement instrument’s output 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 values attributed to a measurement.
  • Intermediate Check: A quick verification of the measurement instrument’s 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 and accessible for calibration.
  • External Service Provider: Conduct external calibration as per the defined schedule.

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 that the equipment is level and properly positioned.
  • Verify power supply stability and functionality.
See also  Liquid Filler Volume Calibration (CAL-0213) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within their validity period.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the specified range of 0 – 2000 g. Each point will have three 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 checkweigher to stabilize in the operating environment.
  3. As Found checks and data capture: Record initial measurements and observations.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols; otherwise, escalate the issue.
  5. As Left verification: Confirm that the equipment is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

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

10. Acceptance Criteria & Calculations

Acceptance criteria for the Checkweigher (Pack line) is ±0.5 g. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within the 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 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: [TBD]

12. Records & Retention

  • Logbook entries must include all calibration activities.
  • Calibration report/certificate filing must be maintained for audit purposes.
  • E-records if applicable: [TBD]
  • Label content requirements: 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
  • Equipment warm-up completed
  • Cleanliness verified
  • Leveling confirmed
  • Power supply checked

Annexure C: Example Label Text

Calibration Date: [TBD]

See also  CO2 Analyzer (Incubator) (CAL-0099) - Calibration Documents

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-0009 Checkweigher (Pack line) Checkweigher Packaging Packing Line Pack weight verification Weight g 0 – 2000 ±0.5 g 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 g
  • 25% of Range: 500 g
  • 50% of Range: 1000 g
  • 75% of Range: 1500 g
  • Maximum: 2000 g

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 g 0 g [TBD] [TBD] ±0.5 g [TBD] [TBD] [TBD] [TBD]
500 g 500 g [TBD] [TBD] ±0.5 g [TBD] [TBD] [TBD] [TBD]
1000 g 1000 g [TBD] [TBD] ±0.5 g [TBD] [TBD] [TBD] [TBD]
1500 g 1500 g [TBD] [TBD] ±0.5 g [TBD] [TBD] [TBD] [TBD]
2000 g 2000 g [TBD] [TBD] ±0.5 g [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the checkweigher is clean and free from any obstructions. Verify that the equipment is calibrated and functioning properly.
  2. Stabilization: Allow the checkweigher to warm up for at least [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate measurements at each test point. Record the observed values.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed Value – Ref Value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±0.5 g.
  6. Documentation: Complete the results table and ensure all data is recorded accurately and legibly.

Deviation Instruction for OOT

If any observed value falls 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]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0009 Checkweigher (Pack line) Packaging Packing Line Weight 0 – 2000 g ±0.5 g 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the checkweigher as per cleaning procedure
  • [ ] Level the checkweigher properly
  • [ ] Confirm validity of reference standards
  • [ ] Ensure logbook is ready for documentation
See also  ICP-MS (CAL-0117) - Calibration Documents

As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the checkweigher
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review process

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

Data Integrity (ALCOA+): Ensure all data is attributable, legible, contemporaneous, original, and accurate.

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Deviation Impact Assessment

Event Summary
Asset: Checkweigher (Pack line)
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-0009 Checkweigher (Pack line) Checkweigher Packaging Packing Line [TBD] [TBD] [TBD] Weight (0 – 2000 g) ±0.5 g

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

As Left Results

Test Point Measured Value (g) 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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