Equipment & Calibration SOP

This procedure establishes the requirements for the identification, calibration, maintenance, and control of monitoring and measuring equipment used in the production and quality control of medical devices. It ensures that equipment is suitable for its intended use, measurement results are valid and traceable, and equipment failures are properly investigated.

This procedure applies to all equipment that affects product quality, including: - Production equipment (injection molding machines, assembly fixtures, welders, etc.) - Inspection, measuring, and test equipment (calipers, gauges, testers, balances, etc.) - Environmental monitoring equipment (temperature/humidity monitors, particle counters) - Process monitoring equipment (temperature controllers, pressure transducers, flow meters) - Software used as part of monitoring and measurement (validated per applicable requirements) General-purpose equipment not used for quality-affecting measurements (e.g., office computers, general-purpose scales) is excluded.

Equipment Owner (Department Manager): Ensure equipment is used per approved procedures, report malfunctions, and schedule equipment for calibration and maintenance. Calibration Coordinator (Quality or Maintenance): Maintain the Equipment Master List and Calibration Schedule, coordinate calibration activities, manage calibration records, and investigate out-of-calibration events. Quality Assurance: Approve calibration procedures, review out-of-calibration investigations, and assess impact on product quality. External Calibration Providers: Must be accredited (e.g., ISO/IEC 17025) or demonstrate traceable measurement capability.

4.1 Equipment Identification - All quality-affecting equipment shall be assigned a unique Equipment ID and recorded on the Equipment Master List (FRM-EC-001) - Equipment shall be labeled with: Equipment ID, calibration status (sticker or tag), next calibration due date - Equipment Master List includes: equipment description, manufacturer, model, serial number, location, calibration interval, calibration provider 4.2 Equipment Qualification - New equipment shall undergo qualification before use in production or testing: - Installation Qualification (IQ): Verify equipment is installed per manufacturer specifications - Operational Qualification (OQ): Verify equipment operates within specified parameters across its operating range - Performance Qualification (PQ): Verify equipment consistently produces acceptable results under actual operating conditions - Qualification protocols and reports shall be documented and approved by Quality and the Equipment Owner 4.3 Calibration - Calibration shall be performed at defined intervals based on: manufacturer recommendations, equipment criticality, historical stability, industry practice - Typical intervals: measurement equipment (6-12 months), production equipment (per process validation or 12 months), environmental monitors (6-12 months) - Calibration shall be performed using reference standards traceable to NIST, SI units, or recognized international standards - Calibration procedures shall define: equipment, reference standards, calibration points, acceptance criteria, environmental conditions - Record calibration results including: as-found readings, adjustments made (if any), as-left readings, pass/fail determination 4.4 Calibration Providers - Internal calibration: Performed by trained personnel using qualified reference standards - External calibration: Providers must be ISO/IEC 17025 accredited or demonstrate traceability and competency - Calibration certificates shall be reviewed and retained 4.5 Out-of-Calibration (OOC) Investigation - If equipment is found out of calibration, out of tolerance, or malfunctioning: - Immediately remove from service and tag "OUT OF SERVICE" - Complete an Out-of-Calibration Investigation Form (FRM-EC-002) - Assess the impact on product tested or measured since the last successful calibration - Determine if any product needs to be re-inspected, retested, or dispositioned per NCR procedure - Evaluate whether calibration interval should be shortened 4.6 Preventive Maintenance - Establish a preventive maintenance schedule for production and critical equipment - Maintenance activities shall be documented on the Equipment Maintenance Log (FRM-EC-003) - Unscheduled maintenance and repairs shall be documented, and equipment re-qualified or recalibrated before return to service 4.7 Equipment Software Validation - Software used for monitoring and measurement shall be validated for its intended use before initial use and after changes - Validation records shall be maintained per software validation procedures

- Equipment Master List (FRM-EC-001) - Out-of-Calibration Investigation Form (FRM-EC-002) - Equipment Maintenance Log (FRM-EC-003) - Calibration records and certificates - Equipment qualification protocols and reports (IQ/OQ/PQ) - Software validation records

- ISO 13485:2016 Clause 7.6 Control of Monitoring and Measuring Equipment - FDA 21 CFR 820.72 Inspection, Measuring, and Test Equipment - ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories - SOP-NC-001 NCR Procedure