Standard Operating Procedure for Calibration of Equipment
1) Purpose
The purpose of this SOP is to establish procedures for the calibration of equipment to ensure accuracy, reliability, and compliance with regulatory requirements within the manufacturing facility.
2) Scope
This SOP applies to all critical equipment and instruments used in manufacturing, testing, and quality control processes that impact product quality.
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 SOPs.
3.2 Calibration Technician:
Responsible for performing equipment calibrations as per schedule and documented procedures.
3.3 Quality Assurance (QA) Specialist:
Responsible for reviewing and approving calibration records and ensuring compliance.
4) Procedure
4.1 Calibration Planning:
4.1.1 Identify equipment requiring calibration based on criticality and regulatory requirements.
4.1.2 Develop a calibration schedule specifying frequency and methods for each equipment.
4.1.3 Obtain approval of the calibration schedule from QA and relevant stakeholders.
4.2 Calibration Execution:
4.2.1 Perform pre-calibration checks and prepare equipment for calibration.
4.2.2 Use calibrated standards and methods traceable to national or international standards.
4.2.3 Record calibration data including date, technician name, and equipment conditions.
4.3 Calibration Records and Documentation:
4.3.1 Document calibration results and deviations, if any, in the Calibration Record.
4.3.2 Obtain QA approval for completed calibration records before equipment use.
4.3.3 Maintain calibration records and archive according to established document retention policies.
4.4 Out-of-Tolerance Equipment:
4.4.1 Identify and label equipment found out-of-tolerance during calibration.
4.4.2 Initiate immediate corrective actions and investigate root cause of calibration failure.
4.4.3 Implement re-calibration or adjustment of equipment as necessary.
4.5 Calibration Program Review:
4.5.1 Conduct periodic reviews of the calibration program and effectiveness.
4.5.2 Update calibration procedures and schedules based on review findings and changes in equipment or processes.
4.5.3 Communicate changes to relevant personnel and ensure training on updated procedures.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Calibration Schedule
2. Calibration Records
3. Calibration Certificates
4. Out-of-Tolerance Reports
7) Reference, if any
1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Quality System Regulation (21 CFR Part 820)
8) SOP Version
Version 1.0
