Sieve Shaker Timer (CAL-0135) – Calibration Documents

Calibration Documents: Sieve Shaker Timer (CAL-0135)

Asset ID CAL-0135
Equipment Sieve Shaker Timer
Equipment Type Sieve Shaker Timer
Department QC
Area/Location Particle Size
Process Use Sieving
Parameter Time
Units sec
Range Min 0
Range Max 3600
Acceptance Criteria ±1 sec
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 Sieve Shaker Timer (Asset ID: CAL-0135) is performed to ensure accurate measurement of time during the sieving process in the QC department. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with GMP standards.

2. Scope

  • Asset ID: CAL-0135
  • Equipment Name/Type: Sieve Shaker Timer
  • Department/Area: QC / Particle Size
  • Process Use: Sieving
  • Parameter: Time
  • Range: 0 – 3600 seconds
  • Units: sec
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device against a known standard to determine its accuracy.
  • Verification: The process of confirming that a device meets specified requirements.
  • Adjustment: The act of correcting a measurement device to bring it within specified limits.
  • As Found: The condition of the equipment prior to any adjustments made during calibration.
  • As Left: The condition of the equipment after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in the measurement accuracy of a device 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 of the calibration status of a device 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 results and documentation.
  • Owner Department: Ensure equipment is available and accessible for calibration.
  • External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

  • Environmental controls: Ensure the calibration area is clean and free from contaminants.
  • Warm-up/Stabilization: Allow the equipment to stabilize for [TBD] minutes prior to calibration.
  • Cleanliness: Ensure the equipment is clean and free from any residues.
  • Leveling: Verify that the equipment is properly leveled.
  • Power Supply Checks: Confirm that the power supply is stable and within specifications.
See also  Lux Meter (CAL-0261) - Calibration Documents

7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: Calibration is traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are valid and up-to-date.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. A minimum of 5 measurement points will be taken, including endpoints (0 sec and 3600 sec) and midpoints. Each point will have 3 replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Sieve Shaker Timer to stabilize for [TBD] minutes.
  3. As Found Checks and Data Capture: Measure the time at each of the defined points and record the data contemporaneously.
  4. Adjustment Rules: If any reading is OOT, follow the adjustment protocol; otherwise, escalate the issue.
  5. As Left Verification: After adjustments, verify that the readings are within acceptance criteria.
  6. Labeling + Documentation Completion: Complete all required documentation and label the equipment with calibration details.

10. Acceptance Criteria & Calculations

The acceptance criteria for the Sieve Shaker Timer is ±1 sec. The error calculation formula is as follows:

Error = Observed Value – Reference Value

Pass/Fail Logic: If the absolute value of the error is less than or equal to 1 sec, the calibration passes; otherwise, it fails.

Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop its use.
  • Notification & Deviation Initiation: Notify the appropriate 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 after any repairs or adjustments.
  • QA Disposition: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration Report/Certificate Filing: Maintain all calibration reports and certificates in a secure location.
  • 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

  • Equipment Cleanliness
  • Stabilization Time Confirmed
  • Calibration Standards Available
  • Documentation Ready

Annexure C: Example Label Text

Calibration Date: [TBD]
Due Date: [TBD]
Calibrated By: [TBD]
Status: [TBD]

See also  Density Meter (CAL-0231) - Calibration Documents

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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-0135 Sieve Shaker Timer Sieve Shaker Timer QC Particle Size Sieving Time sec 0 – 3600 ±1 sec 365 days External ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 sec
  • 25%: 900 sec
  • 50%: 1800 sec
  • 75%: 2700 sec
  • Maximum: 3600 sec

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 sec 0 sec [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
900 sec 900 sec [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
1800 sec 1800 sec [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
2700 sec 2700 sec [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
3600 sec 3600 sec [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Sieve Shaker Timer is clean and free from any obstructions.
  2. Stabilization: Allow the equipment to stabilize for at least [TBD] minutes before calibration.
  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 error 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 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-0135 Sieve Shaker Timer QC Particle Size Time 0 – 3600 sec ±1 sec 365 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set the timer to specified setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations
See also  Nutraceutical Tablet Hardness Tester (CAL-0291) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation
  • [ ] Trigger impact review as necessary

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all parameters 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, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary Details
Asset Sieve Shaker Timer
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use of the asset
  • Label/Tag the asset as out of service
  • Segregate impacted work

Define Impact Window

Last Known In-Tolerance Date Discovery Date
[TBD] [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/Re-Test/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-0135 Sieve Shaker Timer Sieve Shaker Timer QC Particle Size [TBD] [TBD] [TBD] Time: 0 – 3600 sec ±1 sec

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 (sec) Acceptance Criteria Pass/Fail
1 [TBD] ±1 sec [TBD]
2 [TBD] ±1 sec [TBD]
3 [TBD] ±1 sec [TBD]
4 [TBD] ±1 sec [TBD]
5 [TBD] ±1 sec [TBD]

As Left Results

Test Point Measured Value (sec) Acceptance Criteria Pass/Fail
1 [TBD] ±1 sec [TBD]
2 [TBD] ±1 sec [TBD]
3 [TBD] ±1 sec [TBD]
4 [TBD] ±1 sec [TBD]
5 [TBD] ±1 sec [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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