1. Purpose of Actions to be Taken for Unusual Observations for Instruments During Calibration
The purpose of this Standard Operating Procedure (SOP) for Actions to be Taken for Unusual Observations for Instruments During Calibration is to establish guidelines for identifying and addressing unusual observations or discrepancies encountered during instrument calibration within [Company Name]. This procedure ensures the integrity and accuracy of calibration processes.
2. Scope of Actions to be Taken for Unusual Observations for Instruments During Calibration
This SOP for Actions to be Taken for Unusual Observations for Instruments During Calibration applies to all personnel responsible for instrument calibration within [Company Name]. It encompasses procedures for recognizing unusual observations, determining their significance, and taking appropriate actions.
3. Definitions involved in Actions to be Taken for Unusual Observations for Instruments During Calibration
3.1 Instrument Calibration:
The process of adjusting and verifying the accuracy of measuring and testing equipment.
3.2 Unusual Observation:
Any unexpected or irregular result, behavior, or condition observed during instrument calibration.
4. Responsibilities
4.1. Calibration Technician
5.1 Perform instrument calibration following established procedures.
5.2 Recognize and document any unusual observations during calibration.
4.2. Supervisor/Quality Control
6.1 Review calibration reports and documentation for unusual observations.
6.2 Determine the significance of unusual observations in consultation with relevant experts.
4.3. Instrument Custodian
7.1 Provide support and information regarding instrument history to assist in evaluating unusual observations.
7.2 Collaborate with calibration technicians to address issues with instruments.
8. Identification of Unusual Observations
8.1. During Calibration
9.1 Calibration technicians must remain vigilant for any irregularities in instrument performance during calibration.
9.2 Document unusual observations with detailed descriptions, date, time, and instrument information.
8.2. Review of Calibration Reports
10.1 Supervisors and quality control personnel review calibration reports for any noted unusual observations.
10.2 Ensure that all unusual observations are documented and reviewed.
9. Assessment of Unusual Observations
9.1. Significance Evaluation
12.1 Assess the significance of unusual observations concerning the accuracy and reliability of the instrument.
12.2 Consult experts or relevant resources as needed to determine significance.
10. Actions to be Taken
10.1. Minor Unusual Observations
14.1 Document minor unusual observations and continue with calibration if they do not affect the instrument’s accuracy.
14.2 Monitor instruments closely and report recurring minor issues for further investigation.
10.2. Major Unusual Observations
15.1 If a major unusual observation is identified and confirmed to affect the instrument’s accuracy, immediately cease calibration.
15.2 Report major issues to supervisors and quality control personnel.
15.3 Isolate the instrument and clearly label it as “out of service.”
10.3. Investigation and Resolution
16.1 Investigate the root cause of major unusual observations with the assistance of relevant experts.
16.2 Develop and implement corrective actions to address identified issues.
11. Documentation and Reporting
11.1. Records
18.1 Maintain detailed records of all unusual observations, evaluations, actions taken, and resolutions.
11.2. Reporting
19.1 Report unusual observations, actions taken, and resolution status to the relevant stakeholders.
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