Surface Contact Plate Timer (CAL-0175) – Calibration Documents

Calibration Documents: Surface Contact Plate Timer (CAL-0175)

Asset ID CAL-0175
Equipment Surface Contact Plate Timer
Equipment Type Timer
Department Microbiology
Area/Location Cleanroom
Process Use Exposure timing
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 Surface Contact Plate Timer is performed to ensure accurate exposure timing in microbiological processes. This calibration controls risks associated with inaccurate timing, which can compromise patient safety, batch quality, and data integrity.

2. Scope

  • Asset ID: CAL-0175
  • Equipment Name/Type: Surface Contact Plate Timer / Timer
  • Department/Area: Microbiology / Cleanroom
  • Process Use: Exposure timing
  • Parameter: Time
  • Range: 0 to 3600 seconds
  • Units: seconds
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement instrument to bring it into compliance with specified standards.
  • 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 during calibration.
  • 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 instrument over time.
  • Traceability: The ability to trace the history, application, or location of an item or activity 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 verification process conducted between calibrations to ensure continued accuracy.

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.
  • Owner Department: Ensure equipment is available for calibration.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply checks are completed.
See also  Balance Calibration Weight 200 g (CAL-0337) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

The 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 to 3600 seconds.
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the Surface Contact Plate Timer to stabilize as per manufacturer guidelines.
  3. As Found checks and data capture: Record initial readings before any adjustments.
  4. Adjustment rules: If OOT is found, escalate for further action as adjustments may not be permitted.
  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 raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1 sec

Error calculation formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within ±1 sec, the calibration passes.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel of OOT condition.
  • Impact assessment trigger: Define impact window and review of 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 of calibration certificates.
  • 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

  • Environmental controls verified
  • Equipment stabilized
  • As Found readings recorded
  • Adjustments made if necessary
  • As Left readings recorded
  • Documentation completed

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-0175 Surface Contact Plate Timer Timer Microbiology Cleanroom Exposure timing 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% of Range: 900 sec
  • 50% of Range: 1800 sec
  • 75% of Range: 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 [TBD] [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
900 sec [TBD] [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
1800 sec [TBD] [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
2700 sec [TBD] [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]
3600 sec [TBD] [TBD] [TBD] ±1 sec [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the timer is clean and calibrated prior to use.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking readings.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading as follows: Error = Observed Value – 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 (ALCOA+).

Deviation Instruction for OOT

If any reading 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-0175 Surface Contact Plate Timer Microbiology 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 SOP
  • [ ] Clean the equipment as per cleaning procedure
  • [ ] Level the equipment if applicable
  • [ ] Confirm reference standards are valid and calibrated
  • [ ] Ensure logbook is ready for data entry

As Found Execution

  • [ ] Set the timer to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for analysis
See also  Water Bath Temp Sensor (CAL-0158) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the supervisor/QA
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary
Asset: Surface Contact Plate 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 tolerance
  • 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-0175 Surface Contact Plate Timer Timer Microbiology 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) 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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