Glossary / Lexicon

Deutsch: Kalibrierung und Instandhaltung / Español: Calibración y Mantenimiento / Português: Calibração e Manutenção / Français: Calibration et Maintenance / Italiano: Calibrazione e Manutenzione

Calibration and maintenance in quality management are essential processes that ensure equipment, instruments, and machinery are functioning accurately and reliably, aligning with predefined standards. Calibration involves adjusting instruments to provide correct measurements, while maintenance focuses on keeping machines and systems operational to avoid malfunctions and ensure consistent quality in production or service delivery.

Description

In the quality management context, calibration refers to the process of adjusting and verifying the precision of measurement instruments, ensuring their readings are accurate when compared to a recognised standard. This is crucial for industries where precise measurements affect product quality, safety, and compliance, such as in pharmaceuticals, manufacturing, healthcare, and food processing.

Instruments used in production, inspection, or testing must undergo regular calibration to maintain their accuracy over time. This process often involves comparing the instrument's output with a standard reference to identify any deviation, followed by necessary adjustments to correct the error. Calibration helps minimise variability and defects, ensuring that products meet specifications and regulatory requirements.

On the other hand, maintenance refers to the regular servicing of machinery and equipment to ensure they are operating efficiently and without failure. In a quality management system (QMS), maintenance is critical to preventing unexpected breakdowns that can halt production or affect the quality of the final product. There are two main types of maintenance in this context:

• Preventive maintenance: Regularly scheduled inspections and servicing designed to prevent equipment failure before it occurs.
• Corrective maintenance: Actions taken after equipment has malfunctioned to restore it to proper working order.

A key aspect of both calibration and maintenance is their role in risk management. Properly maintained equipment that is regularly calibrated reduces the risk of producing defective products or having non-compliant processes. Many quality management systems, including ISO 9001, mandate regular calibration and maintenance schedules to ensure continual process improvement and consistency.

Historically, calibration has evolved alongside industrialisation. As production became more complex, so did the need for accurate measurements and reliable machinery. Over time, industries adopted international standards and procedures for calibration to ensure quality consistency, particularly in global supply chains.

Application Areas

• Manufacturing: Calibration ensures that tools like micrometers, pressure gauges, and temperature sensors are precise, while maintenance keeps machinery like CNC machines, conveyors, and robots operating smoothly.
• Healthcare: In medical laboratories and hospitals, calibration of diagnostic tools (e.g., blood pressure monitors, X-ray machines) and the maintenance of medical equipment are critical to ensuring accurate patient care.
• Pharmaceuticals: Calibration of equipment used in drug formulation, like balances and spectrophotometers, ensures correct dosages, while maintenance ensures production lines run continuously without contamination or errors.
• Aerospace: Both calibration and maintenance of instruments and equipment are vital to ensuring the safety and performance of aircraft and spacecraft.
• Food Industry: Instruments used for measuring temperature, pH levels, and moisture content require calibration to ensure food safety, while maintenance of processing equipment ensures hygiene and operational efficiency.

Well-Known Examples

• ISO 17025: This international standard focuses on the competence of calibration and testing laboratories, ensuring that they produce valid and reliable results.
• Calibration of thermometers: In industries like food processing and pharmaceuticals, precise temperature control is vital, so thermometers must be regularly calibrated to ensure they measure correctly within a specific range.
• Preventive maintenance in automotive plants: Automotive manufacturers, like Toyota, implement preventive maintenance to keep their assembly lines operational and to avoid costly downtime or product defects.

Treatment and Risks

Without regular calibration and maintenance, equipment can drift from its intended specifications, leading to inaccurate measurements, non-compliant products, or process failures. This can result in several risks:

• Product defects: Inaccurate calibration can lead to faulty measurements, causing products to fall outside specification, resulting in defective goods.
• Non-compliance: Failure to maintain calibration can lead to non-conformance with industry standards or regulations, which may result in fines, product recalls, or damage to reputation.
• Downtime: Lack of maintenance increases the likelihood of equipment breakdown, which can halt production lines, leading to costly delays and reduced productivity.
• Safety hazards: In some industries, especially healthcare and aerospace, improperly maintained or calibrated equipment can lead to serious safety risks, potentially harming patients or users.

Similar Terms

• Validation: While calibration focuses on measurement instruments, validation ensures that equipment or processes perform as intended.
• Reliability engineering: This discipline focuses on ensuring systems and equipment perform consistently over time, often through maintenance practices.
• Metrology: The science of measurement, which plays a crucial role in calibration processes.

Summary

In quality management, calibration and maintenance are vital for ensuring the accuracy and reliability of equipment used in production, testing, and service delivery. Calibration adjusts instruments to meet predefined standards, while maintenance keeps machinery in optimal working condition. These processes prevent defects, ensure compliance, and minimise operational risks, ultimately contributing to the consistent quality of products and services.

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