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Difference between Validation and Calibration
15 May 2024

Difference between Validation and Calibration

Validation and calibration are both crucial processes in various fields, particularly in science, engineering, and manufacturing. While they are related concepts, they serve distinct purposes. A calibration is a process that compares a known against an unknown, whereas a validation confirms that the instrument is installed correctly. Let us understand that in detail.

What is Validation:

A validation is a detailed process of confirming that the instrument is installed correctly, that it is operating effectively, and that it is performing without error. Because a validation must test all three of these operational parameters, it is broken into three different tests: the installation qualification (IQ), the operational qualification (OQ), and the performance qualification (PQ).

Validation refers to the process of determining if a system or process meets the requirements and specifications of its intended use. It answers the question, “Are we building the right thing?” or “Is the system doing what it’s supposed to do?” Validation ensures that a product, service, or system fulfills the needs and expectations of its users or stakeholders.

Key aspects of validation

Key aspects of validation include:

  1. Requirements Verification: Validation involves confirming that the requirements set for a system or process are accurately implemented and meet the desired objectives.
  2. User Acceptance: Validation often involves user testing or evaluation to ensure that the product or system meets the needs and expectations of its intended users.
  3. Compliance: Validation may also involve ensuring that the product or system complies with relevant regulations, standards, or industry best practices.
  4. Documentation: Validation typically requires documentation of the validation process, including test plans, test results, and any deviations from expected outcomes.

Examples of Validation

Examples of validation include:

  • Testing a software application to ensure it meets user requirements and functions as intended.
  • Verifying that a manufacturing process produces products that meet quality standards and customer expectations.
  • Checking that a medical device performs safely and effectively according to its intended use.

What is calibration?

Calibration, on the other hand, is the process of comparing measurements of a device or instrument to a known standard to ensure accuracy. It answers the question, “Is the system measuring correctly?” Calibration ensures that measurements made by instruments or devices are reliable and consistent. A calibration is a process that compares a known (the standard) against an unknown (the customer’s device). During the calibration process, the offset between these two devices is quantified and the customer’s device is adjusted back into tolerance (if possible). A true calibration usually contains both “as found” and “as left” data.

Key aspects of Calibration

Key aspects of calibration include:

  1. Reference Standards: Calibration involves comparing measurements taken by a device or instrument to known reference standards that have a traceable relationship to internationally recognized measurement standards.
  2. Adjustment: If discrepancies are found during calibration, adjustments may be made to the device or instrument to bring it into alignment with the reference standard.
  3. Traceability: Calibration procedures typically include documentation that establishes traceability to national or international standards, ensuring confidence in the accuracy of measurements.
  4. Periodic Verification: Instruments and devices often require periodic calibration to ensure continued accuracy over time.

Examples of Calibration

Examples of calibration include:

  • Calibrating a thermometer against a known standard to ensure accurate temperature measurements.
  • Adjusting the settings of a weighing scale to match known weights, ensuring precise measurement of mass.
  • Checking the accuracy of a pressure gauge by comparing its readings to a calibrated pressure standard.

Summary

Validation focuses on confirming that a system or process meets its intended requirements and objectives, while calibration involves verifying the accuracy of measurements made by instruments or devices. Both processes are essential for ensuring the quality, reliability, and effectiveness of products, services, and systems in various fields.

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