CHANGE CONTROL REPORT
PRESENT / EXISTING PROCEDURE(S)
Calibration of instruments is currently performed at fixed intervals established in approved SOPs and the calibration master schedule.
The existing program includes:
- Scheduled internal or external calibration.
- Use of traceable reference standards.
- Review of calibration certificates.
- Labelling and status identification.
- Documentation in equipment history files.
- Assessment of out-of-tolerance conditions.
Historical review indicates:
- Multiple consecutive successful calibrations.
- Stable instrument performance.
- No significant drift outside acceptance criteria.
- Preventive maintenance completed as scheduled.
- Minimal calibration-related deviations.
These data support reassessment of calibration intervals using a documented risk-based approach.
DESCRIPTION OF CHANGE (PROPOSED CHANGE)
The calibration frequency for selected equipment shall be revised following documented evaluation and QA approval.
The change shall include:
Ongoing monitoring to confirm continued suitability of revised intervals.
Review of historical calibration records.
Trending of calibration results.
Risk assessment using FMEA or equivalent methodology.
Evaluation of manufacturer recommendations.
Assessment of instrument criticality.
Revision of the calibration master schedule.
Update of SOPs and equipment history records.
Training of relevant personnel.
QA approval prior to implementation.
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CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR CHANGE IN CALIBRATION FREQUENCY
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Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/change-control-report-for-change-in-calibration-frequency/
