Standard Operating Procedure for Calibration of Equipment

1) Purpose

The purpose of this SOP is to establish procedures for the calibration, maintenance, and verification of equipment to ensure accuracy, reliability, and compliance with regulatory requirements within the organization.

2) Scope

This SOP applies to all departments and personnel responsible for the calibration and maintenance of equipment used in production, testing, and quality control activities.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Calibration Manager:

Responsible for overseeing the calibration program and ensuring compliance with calibration procedures.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving calibration procedures and records.

3.3 Equipment Users:

Responsible for notifying the Calibration Manager of equipment requiring calibration and maintenance.

4) Procedure

4.1 Equipment Identification:

4.1.1 Identify equipment requiring calibration based on established calibration schedules.
4.1.2 Label equipment with unique identification numbers and calibration due dates.
4.1.3 Maintain an Equipment Calibration Schedule to track calibration activities.

4.2 Calibration Standards and Procedures:

4.2.1 Establish calibration standards and procedures for each type of equipment.
4.2.2 Ensure calibration procedures are based on manufacturer recommendations and regulatory requirements.
4.2.3 Document calibration procedures in the Equipment Calibration Manual.

4.3 Calibration Execution:

4.3.1 Perform calibration activities by trained personnel following approved procedures.
4.3.2 Use calibrated standards and equipment traceable to national or international standards.
4.3.3 Record calibration results, including deviations and adjustments made during calibration.

4.4 Calibration Records and Documentation:

4.4.1 Maintain accurate and up-to-date calibration records for each equipment.
4.4.2 Document calibration certificates, adjustment records, and calibration due dates.
4.4.3 Secure calibration records in a controlled environment accessible only to authorized personnel.

4.5 Equipment Maintenance and Verification:

4.5.1 Perform preventive maintenance on equipment as per manufacturer recommendations.
4.5.2 Verify equipment performance periodically through calibration checks and tests.
4.5.3 Address non-conformities or deviations identified during equipment verification.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Equipment Calibration Schedule
2. Equipment Calibration Manual
3. Calibration Certificates
4. Maintenance Records

7) Reference, if any

1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Calibration of Equipment Used in GMP Environment

8) SOP Version

Version 1.0