Smoke Study Timer (CAL-0252) – Calibration Documents

Calibration Documents: Smoke Study Timer (CAL-0252)

Asset ID CAL-0252
Equipment Smoke Study Timer
Equipment Type Timer
Department HVAC
Area/Location Cleanroom
Process Use Visualization
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 Smoke Study Timer is performed to ensure accurate time measurement within the Cleanroom environment. This accuracy is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity during HVAC operations.

2. Scope

  • Asset ID: CAL-0252
  • Equipment Name/Type: Smoke Study Timer / Timer
  • Department/Area: HVAC / Cleanroom
  • Process Use: Visualization
  • Parameter: Time
  • Range: 0 to 3600 seconds
  • Units: sec
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device against a known standard to ensure accuracy.
  • Verification: The confirmation that a measurement device meets specified requirements.
  • Adjustment: The process of modifying a measurement device to bring it into compliance with standards.
  • 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 exceeds the specified acceptance criteria.
  • Drift: The gradual change in a measurement device’s performance over time.
  • Traceability: The ability to trace the measurement results back to national or international standards.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A periodic verification of a measurement device’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 document results.
  • QC/QA Reviewer: Review calibration documentation for compliance.
  • Owner Department: Ensure equipment is available and accessible for calibration.
  • External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer specifications.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the equipment prior to calibration.
  • Verify power supply stability before starting calibration.
See also  Load Cell (Bin blender) (CAL-0012) - Calibration Documents

7. Standards & Tools

  • Reference standards: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints. Each point will have three replicate readings taken to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Smoke Study Timer to stabilize for [TBD] minutes.
  3. As Found checks and data capture: Record initial readings at five points across the range.
  4. Adjustment rules: If any readings are OOT, follow the adjustment protocol; if adjustments are not allowed, escalate to QA.
  5. As Left verification: After adjustments, recheck the readings at the same five points.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

All raw observations must be recorded contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1 sec as per ASSET_JSON. 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 stop its use.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration post any adjustments.
  • 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 verified
  • Equipment warm-up completed
  • Cleanliness checked
  • Leveling confirmed
  • Power supply stable

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-0252 Smoke Study Timer Timer HVAC Cleanroom Visualization Time sec 0 – 3600 ±1 sec 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

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 Smoke Study Timer is clean and properly set up in the Cleanroom environment.
  2. Stabilization: Allow the equipment to stabilize for at least [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 ±1 sec.
  6. Documentation: Record all findings in the results table and ensure data integrity following ALCOA+ principles.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the Smoke Study Timer.
  • Notify the supervisor immediately.
  • Open a deviation report.
  • Quarantine 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-0252 Smoke Study Timer HVAC Cleanroom 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 manufacturer recommendations
  • [ ] Clean the equipment as per SOP
  • [ ] Ensure equipment is level
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for data entry

As Found Execution

  • [ ] Set the timer to specified setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for analysis
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OOT Immediate Actions

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

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

Field Details
Asset Smoke Study Timer (CAL-0252)
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 tolerance
  • Segregate impacted work

Define Impact Window

Field Details
Last Known In-Tolerance Date [TBD]
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-0252 Smoke Study Timer Timer HVAC Cleanroom [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) Pass/Fail
0 sec [TBD] [TBD]
900 sec [TBD] [TBD]
1800 sec [TBD] [TBD]
2700 sec [TBD] [TBD]
3600 sec [TBD] [TBD]

As Left Results

Test Point Measured Value (sec) Pass/Fail
0 sec [TBD] [TBD]
900 sec [TBD] [TBD]
1800 sec [TBD] [TBD]
2700 sec [TBD] [TBD]
3600 sec [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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