Standard Operating Procedure for Equipment Calibration

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for calibrating microbiological testing equipment to ensure accuracy, reliability, and compliance with regulatory standards.

Scope

This SOP applies to all microbiological testing equipment used within the manufacturing facility.

Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the calibration activities and compliance with this SOP.
• Equipment Users: Responsible for initiating calibration requests and ensuring equipment readiness.
• Calibration Technicians: Responsible for performing equipment calibration according to established procedures.

Procedure

1. Identification of Equipment:
   • Compile a list of all microbiological testing equipment requiring calibration.
   • Assign unique identification numbers or codes to each piece of equipment.
2. Calibration Schedule:
   • Develop a calibration schedule based on manufacturer recommendations, regulatory requirements, and historical data.
   • Ensure that equipment is calibrated at regular intervals to maintain accuracy and reliability.
3. Calibration Procedure:
   • Follow the manufacturer’s instructions and standard operating procedures for each equipment calibration.
   • Use calibrated reference standards and instruments for accurate calibration.
4. Documentation:
   • Record all calibration activities in a designated calibration log or database.
   • Document calibration dates, results, adjustments made, and the signature of the calibration technician.
5. Review and Approval:
   • Review calibration records for completeness, accuracy, and compliance with SOP requirements.
   • Obtain approval from the designated authority before returning the equipment to service.

Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Equipment Calibration Schedule
• Calibration Log
• Equipment Manuals and Specifications

Reference

ISO 17025:2017 – General requirements for the competence of testing and calibration laboratories

SOP Version

Version 1.0