Standard Operating Procedure (SOP)

1. Purpose:
To establish a standardized procedure for the calibration and maintenance of Quality Control (QC) instruments used to ensure that they are accurate, reliable, and functioning properly.

2. Scope:
This SOP applies to all QC instruments and equipment used for testing raw materials, in-process materials, and finished products. This includes, but is not limited to, balances, spectrophotometers, pH meters, chromatographs, and any other instruments used in the QC department.

3. Responsibility:

1. QC Personnel: Perform daily checks, calibrations, and maintain instruments.
2. Instrument Technician/Engineer: Conduct calibration and troubleshooting services.
3. QC Supervisor/Manager: Oversee the calibration schedule and ensure all equipment is calibrated and maintained.
4. Quality Assurance (QA): Review and approve calibration and maintenance records.

4. Procedure:
4.1 Instrument Identification and Documentation

• Maintain a register of all QC instruments with their identification number, model, and description.
• Document instrument manufacturer details, calibration certificates, and maintenance history.

4.2 Calibration Schedule
Establish a calibration frequency for each instrument based on manufacturer recommendations, regulatory guidelines, or internal policy (e.g., monthly, quarterly, annually).

Maintain a Calibration Log that includes the date, instrument ID, and the name of the person performing the calibration.

4.3 Pre-Calibrations Daily Checks
Perform daily checks before using instruments (e.g., balance zeroing, pH meter calibration with buffer solutions, equipment visual inspection).

Record results in the instrument logbook or electronic system.

4.4 Calibration Process

• Use certified calibration standards traceable to national or international standards.
• Follow the manufacturer’s instructions and standard operating procedures for calibration.
• If the instrument is found to be out of calibration, adjust it according to specifications.
• Record calibration results, including the calibration standard used and the deviation (if any).

4.5 Post-Calibration

• Upon successful calibration, label the instrument with the next calibration due date.
• File all calibration certificates and results for future reference and audits.
• If the instrument fails calibration, notify the QC supervisor, remove it from service, and initiate corrective actions (e.g., recalibration, repair, or replacement).

4.6 Preventive Maintenance
Establish a preventive maintenance schedule based on instrument usage, manufacturer recommendations, and internal policy.

Tasks may include:

1. Cleaning (e.g., wiping down surfaces, decontaminating samples)
2. Replacing consumables (e.g., filters, batteries)
3. Tightening components or checking for wear
4. Record all maintenance activities in the Instrument Maintenance Log.

4.7 Repair and Troubleshooting

• If instruments fail to perform within specifications, troubleshoot based on the instrument manual.
• If necessary, contact the manufacturer or a certified technician for repairs.
• Keep detailed records of the repairs, including parts replaced, technician name, and time of repair.

4.8 Documentation and Traceability

• Maintain complete records for all calibrations, maintenance activities, and repairs in both paper and/or electronic format.
• Ensure that records are kept in a centralized location for easy access during audits or inspections.
• Document corrective actions taken when instruments are out of specification.

5. References:

• Manufacturer’s Operation and Maintenance Manual
• Calibration Procedure Guidelines
• Instrument Calibration Log Template
• Preventive Maintenance Schedule Template

6. Attachments:

1. Instrument Calibration Log Template
2. Preventive Maintenance Checklist
3. Instrument Calibration Certificate Template
4. Calibration and Maintenance Training Log

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