Comprehensive Guide to Calibration of Quality Testing Equipment in Medical Device Manufacturing

1) Purpose

The purpose of this SOP is to establish a systematic procedure for calibrating quality testing equipment used in medical device manufacturing. Proper calibration ensures accurate, reliable measurements, compliance with regulatory standards, and the production of high-quality devices.

2) Scope

This SOP applies to all quality testing equipment, including mechanical, electrical, and electronic devices, used in medical device manufacturing. It covers initial calibration, periodic calibration, and calibration after repairs or relocation.

3) Responsibilities

– Calibration Technician: Conducts calibration activities and documents the results.
– Quality Assurance (QA): Reviews and approves calibration records, and ensures compliance with regulatory standards.
– Maintenance Team: Coordinates calibration activities and ensures equipment is ready for calibration.
– Equipment Operators: Notify the maintenance team or QA of equipment requiring calibration and avoid using uncalibrated equipment.

4) Procedure

4.1 Identification of Calibration Requirements
4.1.1 Equipment Inventory
– Maintain an inventory of all testing equipment requiring calibration, including equipment ID, location, and frequency of calibration.
– Update the inventory whenever new equipment is added or old equipment is decommissioned.

4.1.2 Calibration Schedule
– Develop a calibration schedule based on manufacturer recommendations, usage frequency, and regulatory requirements.
– Include routine calibration intervals and triggers for unscheduled calibration, such as equipment repair or relocation.

4.1.3 Labeling
– Label each piece of equipment with a unique identification number and calibration status tag indicating the last calibration date and the due date for the next calibration.

4.2 Calibration Preparation
4.2.1 Equipment Readiness
– Inspect equipment for physical damage, contamination, or loose connections before calibration.
– Ensure equipment is clean and functioning to its basic operational standards.

4.2.2 Calibration Standards
– Use reference standards traceable to national or international standards (e.g., NIST, ISO) for calibration.
– Verify the validity of calibration standards by reviewing their certification and expiry dates.

4.2.3 Environmental Conditions
– Ensure the calibration environment meets the required conditions, such as temperature, humidity, and cleanliness.
– Document environmental conditions as part of the calibration record.

4.3 Calibration Process
4.3.1 Initial Setup
– Connect the equipment to the reference standard following the manufacturer’s guidelines or calibration protocol.
– Perform a preliminary check to ensure the equipment responds as expected.

4.3.2 Calibration Procedure
– Follow the specific calibration procedure for each type of equipment as outlined in the equipment manual or approved calibration protocol.
– Record readings at various test points, ensuring that all specified ranges and parameters are tested.

4.3.3 Adjustment and Verification
– Adjust the equipment settings if deviations are identified to bring it within acceptable tolerance limits.
– Verify the adjustment by retesting the affected parameters and documenting the results.

4.3.4 Completion
– Label the equipment with an updated calibration status tag and record the results in the calibration log.

4.4 Handling Non-Conformities
4.4.1 Out-of-Tolerance Equipment
– If equipment is found out of tolerance, segregate it immediately and mark it as “Out of Service.”
– Notify the QA team and supervisor for further action, such as repair, recalibration, or replacement.

4.4.2 Impact Assessment
– Evaluate the impact of out-of-tolerance equipment on previous measurements or processes.
– Investigate and document any potential product impact, and initiate corrective actions if required.

4.5 Documentation and Record Keeping
4.5.1 Calibration Records
– Maintain detailed calibration records for each piece of equipment, including:
– Equipment ID and description
– Calibration date and due date
– Calibration results and deviations
– Technician initials and approval signatures

4.5.2 Calibration Log
– Maintain a centralized calibration log that summarizes calibration activities for all equipment.
– Include calibration history, next due date, and equipment status.

4.5.3 Certificates of Calibration
– Retain calibration certificates provided by external calibration service providers.
– Ensure certificates are stored securely and linked to the respective equipment records.

4.5.4 Record Retention
– Retain calibration records for a minimum of five years or as required by regulatory agencies.
– Ensure records are accessible during audits or inspections.

4.6 Review and Continuous Improvement
4.6.1 Periodic Review
– Conduct periodic reviews of calibration processes and records to ensure compliance with this SOP.
– Address any identified gaps or non-conformities through corrective actions.

4.6.2 Equipment Performance Monitoring
– Monitor equipment performance between calibration intervals to detect signs of drift or malfunction.
– Schedule unscheduled calibration if performance anomalies are observed.

4.6.3 Vendor Evaluation
– Evaluate external calibration service providers periodically to ensure they meet quality and traceability requirements.
– Maintain a list of approved vendors and update it based on performance reviews.

5) Abbreviations

– QA: Quality Assurance
– NIST: National Institute of Standards and Technology
– ISO: International Organization for Standardization
– SOP: Standard Operating Procedure

6) Documents

– Equipment Inventory
– Calibration Protocols
– Calibration Records
– Calibration Log
– Certificates of Calibration
– Impact Assessment Reports

7) Reference

– ISO 13485: Medical devices – Quality management systems
– ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
– FDA CFR Title 21, Part 820: Quality System Regulation
– NIST Standards: Traceability requirements for calibration

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Calibration Log Template

Equipment ID	Equipment Description	Last Calibration Date	Next Calibration Due Date	Status
ID001	Micrometer	DD/MM/YYYY	DD/MM/YYYY	Calibrated

Annexure 2: Calibration Record Template

Equipment ID	Calibration Date	Parameter Tested	Result	Technician
ID001	DD/MM/YYYY	Dimension Accuracy	Pass	Technician Name