In a bustling laboratory, scientist Dr. Avi received a new pipette from Owl Scientific. Excited to use it, Dr. Avi encountered unexpected measurement variations. Seeking advice from wise Professor Wisebeard, Dr. Avi learned the importance of calibrating the new pipette. The professor shared a fable of a lost explorer due to an uncalibrated compass. Dr. Avi promptly arranged for accredited pipette calibration, ensuring accurate and reliable measurements. The fable taught Dr. Avi and all scientists the vital lesson: just as a compass guides an explorer, accredited pipette calibration guides a scientist toward trustworthy measurements, unlocking the path to scientific advancement.
Chances are, if you're Dr. Avi - your procurement leader also needs a strongly-grounded answer to "why should I calibrate a brand new pipette from the factory?"
When you receive a new pipette out of the box from the original equipment manufacturer (OEM), it's crucial to understand the importance of accredited calibration or verification. Here's a simple walkthrough of why this is essential:
- Getting it into the cycle for recalibration to maintain a state of control: Accredited calibration establishes the traceability of the pipette's measurements to national or international standards, ensuring the reliability and consistency of its performance. By integrating the pipette into the calibration cycle, we adhere to the principles of ISO 17025, maintaining a state of control over the measurement process and enabling the detection of any drift or deviations in performance over time. This proactive approach is essential for meeting the stringent quality and compliance requirements in regulated industries.
- Manufacturing tolerances and the realities of new OEM stock: Despite advancements in manufacturing processes, the inherent variability in components and assembly techniques can lead to deviations in the performance of individual pipettes. It may surprise you, but it has been seen that a failure rate as high as 5-10% may exist in new instrument stock. Understanding the statistical distribution of these variations and their potential impact on accuracy and precision is critical. Accredited calibration provides a comprehensive assessment of the pipette's performance, including its systematic and random errors, enabling the determination of measurement uncertainty and the establishment of appropriate tolerance limits.
- Difference between proper calibration and certificate of conformance or manufacturer's certificate: While a certificate of conformance or manufacturer's certificate may provide a snapshot of the pipette's performance at the time of manufacture, it does not account for potential variations introduced during handling, storage, or transportation. In contrast, accredited calibration involves a rigorous evaluation of the pipette's systematic and random errors, linearity, repeatability, and other relevant parameters. This detailed analysis, in accordance with ISO 8655, ensures that the pipette's performance is characterized comprehensively, providing actionable insights for adjustments and ongoing quality assurance.
- Performance after shipping, transport, and conveyance: The impact of shipping, transport, and conveyance on the pipette's performance cannot be underestimated. The realities of packaging instruments for long-voyage shipment versus delivery to your laboratory are different, generally being optimized for cost and customs, not conformance. Mechanical shock, temperature fluctuations, and exposure to environmental conditions during transit can introduce variations that affect the pipette's calibration. By subjecting the pipette to accredited calibration upon receipt, we mitigate the potential effects of these external factors, ensuring that its performance aligns with the specified accuracy and precision requirements.
In the context of ISO 17025 and ISO 8655 standards, accredited calibration or verification is essential for demonstrating the traceability and reliability of measurement results. Additionally, for industries regulated by the FDA, such as pharmaceuticals and medical devices, adherence to calibration standards is crucial for ensuring product quality, safety, and compliance with regulatory requirements.
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