Comprehensive Guide to Equipment Setup and Calibration in Medical Device Manufacturing

1) Purpose

The purpose of this SOP is to outline the standard procedures for setting up and calibrating equipment used in the manufacturing of medical devices. Proper setup and calibration ensure equipment operates efficiently, maintains accuracy, and complies with regulatory and quality standards.

2) Scope

This SOP applies to all equipment used in medical device manufacturing, including assembly tools, testing instruments, and packaging machines. It is relevant to personnel involved in maintenance, production, and quality assurance.

3) Responsibilities

– Equipment Operators: Ensure proper setup and usage of equipment as per the defined procedures.
– Maintenance Team: Perform regular calibration and maintenance of equipment and maintain logs.
– Quality Assurance (QA): Verify calibration records and ensure compliance with specifications.
– Production Supervisors: Oversee setup and calibration activities and address issues promptly.

4) Procedure

4.1 Pre-Setup Preparation
4.1.1 Ensure the equipment and work area are clean and free of debris.
4.1.2 Verify that the equipment user manual and setup instructions are accessible.
4.1.3 Confirm that the required tools and calibration standards are available.

4.2 Equipment Setup
4.2.1 Position the Equipment
– Place the equipment on a stable surface in the designated area.
– Ensure that the equipment is level and securely anchored as necessary.
4.2.2 Electrical and Mechanical Connections
– Connect the equipment to the appropriate power source and verify voltage compatibility.
– Attach mechanical components, such as belts, hoses, or fixtures, following the user manual.
4.2.3 Functional Test
– Turn on the equipment and conduct a preliminary functional test to ensure all components operate as expected.
– Report any abnormalities to the maintenance team for resolution.

4.3 Calibration Procedure
4.3.1 Determine Calibration Requirements
– Refer to the calibration schedule and equipment specifications to identify required calibration intervals and methods.
– Use traceable calibration standards certified by recognized bodies.
4.3.2 Perform Calibration
– Follow the calibration instructions provided in the equipment manual.
– Record calibration measurements and compare them to the specified tolerance limits.
4.3.3 Adjustments
– If calibration measurements fall outside the acceptable range, make adjustments as per the manual or contact the maintenance team.
4.3.4 Post-Calibration Verification
– After calibration, perform a verification test to confirm the equipment functions within the specified parameters.

4.4 Documentation and Labeling
4.4.1 Calibration Records
– Document all calibration activities, including date, equipment ID, calibration method, and results.
– Maintain these records for audit and traceability purposes.
4.4.2 Equipment Labels
– Attach a calibration label to the equipment, indicating the calibration date, due date, and initials of the person performing the calibration.

4.5 Troubleshooting and Maintenance
4.5.1 Identify Issues
– Monitor equipment during operation for signs of malfunction, such as unusual noises or inaccurate outputs.
– Report issues to the maintenance team immediately.
4.5.2 Scheduled Maintenance
– Perform routine maintenance as per the maintenance schedule to minimize downtime.
4.5.3 Repairs
– If repairs are needed, document the issue, parts replaced, and actions taken in the maintenance log.

4.6 Review and Approval
4.6.1 QA Review
– Quality assurance personnel must review calibration records and verify compliance.
4.6.2 Supervisor Approval
– Supervisors must approve the equipment setup and calibration before production use.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents

– Equipment User Manuals
– Calibration Schedules
– Calibration Records
– Maintenance Logs
– Equipment Setup Checklist

7) Reference

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

8) SOP Version

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

Annexure

Annexure 1: Equipment Setup Checklist

Equipment Name	Setup Date	Operator	Pre-Operational Checks	Status
Equipment Name	DD/MM/YYYY	Operator Name	Checks Completed	Ready for Use

Annexure 2: Calibration Log

Equipment ID	Calibration Date	Calibrated By	Results	Next Calibration Due
Equipment ID	DD/MM/YYYY	Technician Name	Within Tolerance	DD/MM/YYYY