Standard Operating Procedure (SOP) for Calibration Program

1. Purpose of Calibration Program

The purpose of this Standard Operating Procedure (SOP) for Calibration Program is to establish a systematic and documented calibration program within [Company Name]. This Calibration program ensures that measuring and testing equipment used in various processes are accurate, reliable, and compliant with regulatory requirements.

2. Scope of Calibration Program

This SOP for Calibration Program applies to all personnel responsible for managing, performing, or overseeing equipment calibrations within [Company Name]. It encompasses procedures for calibration scheduling, execution, documentation, and record-keeping.

3. Definitions involved in Calibration Program

3.1 Calibration:

The process of comparing a measurement device’s performance to a known standard to ensure accuracy.

3.2 Calibration Interval:

The predetermined frequency at which equipment is calibrated.

4. Responsibilities

4.1. Calibration Manager

4.1.1 Appoint a designated Calibration Manager responsible for overseeing the calibration program.

4.1.2 Ensure that the Calibration Manager has the necessary qualifications and training.

4.2. Calibration Technicians

4.2.1 Train and designate qualified Calibration Technicians responsible for performing calibrations.

4.2.2 Ensure Calibration Technicians are knowledgeable about the specific equipment they calibrate.

5. Equipment Calibration Procedure

5.1. Equipment Identification

5.1.1 Assign unique identification numbers to all equipment requiring calibration.

5.1.2 Maintain an equipment inventory list containing essential details, including equipment name, manufacturer, model, calibration interval, and location.

5.2. Calibration Scheduling

5.2.1 Establish a calibration schedule based on equipment type, criticality, and regulatory requirements.

5.2.2 Schedule calibrations with consideration for equipment usage and calibration intervals.

5.3. Calibration Execution

5.3.1 Perform calibrations using calibrated reference standards traceable to national or international standards.

5.3.2 Follow manufacturer-recommended procedures and tolerances during calibration.

5.4. Calibration Records

5.4.1 Document all calibration activities, including date, technician, equipment condition, adjustments made, and results obtained.

5.4.2 Retain calibration records for a defined period as per regulatory requirements.

5.5. Out-of-Tolerance (OOT) Equipment

5.5.1 Define procedures for handling OOT equipment, including investigation, adjustment, and re-calibration.

5.5.2 Ensure that OOT equipment is properly labeled and removed from service until re-calibrated.

6. Documentation and Recordkeeping

6.1. Calibration Certificates

6.1.1 Issue calibration certificates for each calibrated equipment item, including details of the calibration, results, and next calibration due date.

6.2. Calibration Log

6.2.1 Maintain a calibration log that tracks equipment calibrations, due dates, and status.

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