In today’s precision-driven world, where even the slightest measurement error can have significant consequences, simply calibrating equipment is no longer enough. Imagine a pharmaceutical company releasing a batch of medication based on inaccurate temperature readings, or an aerospace component failing due to minute deviations in its dimensions. These scenarios underscore the critical need for validation in calibration.
The landscape of calibration has evolved dramatically. We’ve moved from basic adjustments to comprehensive validation processes, driven by the increasing complexity of measurement systems and stricter regulatory demands. Digitalization and automation have further complicated matters, requiring more robust methods to ensure accuracy and reliability.
Validation, in its essence, is a systematic, documented process that provides a high degree of assurance that a specific process, method, or system consistently produces results meeting pre-determined acceptance criteria. In the realm of metrology, this concept is often referred to as “metrological confirmation,” a broader term that encompasses validation.
The distinct roles of calibration and validation
To fully appreciate the importance of validation, it’s crucial to understand its relationship with calibration.
Calibration
- This process involves comparing a measurement device to a known standard and, if necessary, adjusting it to minimize errors.
- The frequency of calibration, or calibration intervals, plays a vital role in maintaining measurement accuracy.
- Calibration involves complex mathematical calculations to determine and correct deviations.
- It is becoming more important to secure the information of calibrations, and that is where Blockchain Calibration Traceability can be used.
Validation
- Validation goes beyond mere adjustment; it’s about proving that the calibrated system is fit for its intended purpose.
- It encompasses “process validation,” ensuring that the entire measurement process, not just the instrument, is reliable.
- Validation considers factors such as environmental conditions, operator competence, and the overall measurement system.
- Extended Measurement Uncertainty Analysis is a key part of the validation process.
- Real-Time Validation in Calibration allows for constant monitoring of the calibration.
Calibration provides the foundation for validation, while validation verifies the effectiveness of the calibration process. They are complementary processes that work together to ensure measurement integrity.
The crucial importance of validation services: ensuring reliability and compliance
Enhanced regulatory compliance:
Validation is essential for meeting industry-specific regulations, such as FDA 21 CFR Part 11, ISO 13485, and AS9100.
It provides documented evidence of compliance during audits, reducing the risk of penalties and disruptions.
Digital ISO 17025 Validation is becoming more important for keeping digital records of validation.
Comprehensive Calibration Compliance ensures that all parts of the calibration process are compliant.
Maximizing measurement accuracy and precision:
Validation incorporates “measurement system analysis” (MSA) to assess and improve measurement accuracy.
It identifies and mitigates sources of measurement error, ensuring reliable and precise results.
High-Precision Calibration Validation is needed for industries with strict tolerances.
Statistical Calibration Accuracy Verification utilizes data analysis to verify accuracy.
Proactive risk management:
Validation helps identify potential failure modes and their impact on product quality, allowing for proactive risk mitigation.
Risk assessment tools, such as FMEA, are used to evaluate and minimize risks.
Risk-Based Metrology Validation allows for risk to be assessed before validation.
Operational efficiency and cost reduction:
By reducing the risk of product recalls and rework, validation contributes to operational efficiency and cost reduction.
It also optimizes calibration intervals, minimizing downtime and maximizing productivity.
Automated Equipment Validation can greatly increase operational efficiency.
Building customer confidence and brand reputation:
Validation demonstrates a commitment to quality, building trust with customers and strengthening brand reputation.
The components of a robust validation program: A step-by-step approach
A comprehensive validation program involves several key components:
- Validation planning: Defining clear objectives and acceptance criteria.
- Documented validation protocols: Creating detailed procedures for validation activities.
- Performance qualification (PQ): Verifying that calibrated equipment performs as intended under actual operating conditions.
- Data acquisition and analysis: Collecting and analyzing data using statistical tools.
- Validation reporting: Creating comprehensive reports that summarize results and conclusions.
- Ongoing monitoring and control: Establishing systems for continuous monitoring of calibrated equipment.
Conclusion
Validation is not merely an added expense; it’s an investment in long-term success. By ensuring measurement accuracy and regulatory compliance, validation protects your business from costly errors, enhances your reputation, and builds customer trust.
Contact Prism Calibration today to discuss your validation needs and learn how our services can benefit your business.
Author bio
Mr. Parthiv Kinariwala is a leading expert in calibration and testing services, with over 20 years of experience in the industry. As the founder of Prism Calibration, established in 2004, Mr. Kinariwala has been at the forefront of delivering precise and reliable calibration, testing, and validation solutions across various industries. His expertise in providing services that meet international calibration standards has earned the trust of major clients, including Reliance Industries, Zydus Cadila, Indian Oil, ONGC, Adani, and Tata.
With a deep understanding of instrumentation, measurement accuracy, and industrial testing, Mr. Kinariwala ensures that each client receives exceptional service tailored to their specific needs. His unwavering commitment to quality and precision has established Prism Calibration as a trusted partner for some of the largest and most respected organizations in the industry.
