Introduction
Equipment maintenance and calibration are components of quality assurance (QA) in the medical device industry. They ensure that manufacturing processes are reliable and products meet stringent safety and efficacy standards. Proper maintenance and calibration of equipment prevent production errors, maintain compliance with regulatory requirements, and ultimately safeguard patient health.
What is equipment maintenance?
Equipment maintenance involves regular inspection, servicing, and repairing machinery and tools used to manufacture medical devices. The objective is to ensure operational efficiency, prevent breakdowns, and extend the lifespan of equipment.
Equipment maintenance and management can be preventative, predictive or corrective:
- Preventive Maintenance: Routine checks and servicing performed at predetermined intervals to prevent equipment failure. This includes cleaning, lubrication, part replacement, and software updates.
- Predictive Maintenance: This method utilises data and performance metrics to predict when equipment maintenance should be performed. By monitoring equipment conditions, manufacturers can anticipate issues and address them before they result in downtime or defects.
- Corrective Maintenance: Reactive maintenance is performed to fix malfunctioning equipment. While less ideal than preventive or predictive maintenance, it is crucial for restoring normal operations and preventing extended downtime.
Effective maintenance programs ensure all equipment operates within specified parameters, maintaining consistent product quality and reducing non-conformance risk. This is particularly critical in the medical device industry, where even minor deviations can significantly affect patient safety.
What is equipment calibration?
Calibration is the process of comparing and adjusting an instrument’s output to ensure it aligns with a known standard or reference. Regular calibration helps maintain the accuracy and precision of equipment used in the manufacturing and testing of medical devices.
Equipment calibration activities vary depending on the nature of the equipment. However, some common requirements include:
- Calibration schedule: Establishing and adhering to a calibration schedule based on the manufacturer’s recommendations, the frequency of use, and the criticality of the equipment. Regular calibration helps maintain the reliability and accuracy of instruments over time.
- Traceability: Ensuring that calibration standards are traceable to national or international standards is necessary for verifying the accuracy of measurements and maintaining compliance with regulatory requirements.
- Documentation: Keeping detailed records of all calibration activities, including the calibration date, equipment calibrated, standards used, and results provides evidence of compliance and facilitates traceability during an audit or investigation.
- Out-of-tolerance conditions: Identifying and addressing out-of-tolerance conditions where equipment measurements deviate from acceptable ranges. This involves adjusting the equipment to bring it back into compliance and assessing the impact of out-of-tolerance conditions on product quality.
Regulatory requirements and compliance
Equipment maintenance and calibration are mandated by regulatory standards, including QMS standards, to ensure the quality and safety of medical devices. Compliance activities include:
- Developing procedures for the maintenance and calibration of equipment, including schedules, methods, and responsibilities.
- Training for all personnel involved in maintenance and calibration activities.
- Internal audits to verify that maintenance and calibration procedures are followed and effectively maintain equipment performance.
- Continuous improvement through reviewing and updating maintenance and calibration procedures based on audit findings, technological advancements, or changes in regulatory requirements.
Conclusion
Equipment maintenance and calibration are integral to the quality assurance of medical devices. By ensuring that manufacturing and testing equipment are maintained and calibrated correctly, manufacturers can achieve consistent product quality, comply with regulatory requirements, and ultimately protect patient safety. Regular preventive, predictive, and corrective maintenance, along with precise calibration, form the foundation of a robust quality assurance program in the medical device industry.
Resources
- AAMI – Equipment Maintenance and Calibration Resources
(Search for medical equipment maintenance or calibration practices) - WHO – Medical Equipment Maintenance Programme Overview
- MedTech Europe – Resources on Quality and Technical Documentation
(Includes references to equipment and manufacturing environment)
European Union
EudraLex EU GMP guidelines Vol. 4 Annex 1
US FDA
21 CFR 820 (Quality System Regulation):
International Standards:
- ISO 13485:2016 - Medical devices — Quality management Systems (Sections on infrastructure, maintenance, and validation of equipment are particularly relevant)
- ISO/TR 14644 – Cleanrooms and Associated Controlled Environments
(For equipment used in cleanroom environments) - GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
(For managing and validating automated and computerised equipment)
Acceptance Criteria: The predefined standards and specifications that a device must meet during testing and evaluation to be deemed suitable for its intended use and to comply with regulatory requirements.
Adverse Event: Any untoward medical occurrence in a patient or clinical investigation subject administered a medical device, which does not necessarily have to have a causal relationship with this treatment.
Audit: A systematic, independent examination of a manufacturer’s processes, procedures, and products to ensure compliance with regulatory standards and quality requirements. Also see Internal Audit.
Authorised Representative: A natural or legal person appointed by a manufacturer to act on their behalf in carrying out specific tasks related to conformity assessment and regulatory compliance.
Biomedical Engineer and Technician: Personnel that maintain and repair medical devices to ensure their proper functionality.
Change Control: The systematic process of managing and documenting modifications to a device or its manufacturing process to ensure that all changes are assessed, approved, implemented, and tracked in compliance with regulatory standards and quality management systems.
Cleanroom: A controlled environment with a low level of pollutants, such as dust, airborne microbes, aerosol particles, and chemical vapours used in manufacturing and scientific research.
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Controlled Environment: A workspace where environmental conditions such as temperature, humidity, and particulate levels are regulated to ensure product quality and process integrity.
Corrective Maintenance: The process of diagnosing and repairing faults or failures to restore the device to its proper functioning condition.
Design Transfer: The process of transitioning a product’s design from development and manufacturing into production while ensuring all specifications and requirements are met.
Distributor: A natural or legal person in the supply chain, other than the manufacturer or importer, who makes a medical device available on the market.
Economic Operator: Any person or entity engaged in the production, distribution, import, export, or supply of medical devices.
Enterprise Resource Planning (ERP) Systems: Integrated software platforms that manage and automate core business processes across an organisation, facilitating the flow of information and improving efficiency.
Equipment Management: The systematic process of acquiring, maintaining, calibrating, and retiring equipment to ensure it remains suitable for its intended use and complies with quality and regulatory requirements.
Good Manufacturing Practices (GMP): Regulations that require manufacturers to ensure products are consistently produced and controlled according to quality standards.
International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
ISO 14971: An international standard for the application of risk management to medical devices.
Lifecycle Management: The process of overseeing a product, service, or system from its initial development through its growth, maturity, and eventual decline or disposal, ensuring optimal performance and resource utilisation at each stage.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Process Controls: The tools and methods to monitor and manage medical device manufacturing processes.
Process Performance Qualification (PPQ) Studies:
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Installation Qualification (IQ): Verifying that equipment and installations meet the required specifications.
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Operational Qualification (OQ): Confirming that equipment and processes operate correctly under defined conditions.
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Performance Qualification (PQ): Demonstrating that processes perform effectively and reproducibly in real-world conditions.
Process Verification: Uses process controls to check individual manufacturing steps and components against specifications.
Process Validation: Ensures that the entire manufacturing process, supported by process controls, reliably produces products meeting all requirements.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Quality Management System Regulation (QMSR): The U.S. Food and Drug Administration (FDA) regulation that aligns its medical device quality system requirements with ISO 13485:2016 to streamline global compliance and enhance device safety and effectiveness.
Quality System Regulation (QSR): Outlined in 21 CFR Part 820, the U.S. Food and Drug Administration (FDA) framework requires medical device manufacturers to establish and maintain a quality management system to ensure their products consistently meet applicable requirements and specifications.
Record: A documented piece of evidence detailing activities, decisions, or results, created and maintained to demonstrate compliance with regulatory requirements and quality management standards.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Risk: The combination of the probability of occurrence of harm and the severity of that harm.
Risk Analysis: The systematic use of available information to identify hazards and to estimate the risk.
Risk Assessment: The overall process comprising risk analysis and risk evaluation.
Risk Evaluation: The process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Software Validation: The documented process of ensuring that software performs as intended for its specific use within a regulated environment.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Supplier: An entity or organisation that provides materials, components, or finished products used in the manufacturing, assembly, or distribution of medical devices.
Supplier Management: Overseeing and controlling the relationships and activities with external suppliers to ensure the quality, reliability, and regulatory compliance of sourced materials and components.
User: Any individual who operates or interacts with a medical device, including healthcare professionals, patients, and caregivers.
Validation: Confirmation by examining and providing objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
Verification: The process of evaluating whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition.