Risk-based Approach for Optimizing Calibration Efforts
How to Optimize Calibration Efforts with a Risk-based Approach
Regular calibration based on a thorough process risk assessment helps stabilize production while conserving time and resources. Testing too infrequently risks undetected accuracy problems while testing too often interrupts production. Find out the right schedule for you in just two minutes and comply with the new ISO 9001 risk-based thinking approach.
The 2015 revision of ISO 9001 has brought a major change regarding the risk-based thinking approach that is found throughout the entire standard. It also impacts the calibration process. The only way to ensure that measurements deliver the kind of cost, quality, and revenue results that help improve profitability is to choose the right procedure and schedule to periodically re-calibrate your scale. Yet industrial environments are tough on weighing equipment. If scales fail or deliver inaccurate measurements, you risk production downtime, poor product quality, regulatory non-compliance, increased liability, and potential profit losses.
Risk-based thinking
Many companies are already familiar with risk-based thinking from other standards, such as Good Manufacturing Practice or safety standards. Risk is usually analyzed in two parts: The likelihood (probability) that it happens and the severity (impact) if something happens.
Impacts on calibration
Translating risk-based thinking into the calibration process starts with evaluating the impact of inaccurate weighing results on your business process. Examples are loss of material and time, out-of-specification results, production stops, product recall, and reputational damage. Additionally, the impact of wrong measurements on people and the environment has to be assessed. Finally, you must estimate how probable the detection of the faulty measurement is. The more accurate a weighing process has to be, and the higher the negative impact of faulty measurement, the more testing is required.
Optimize calibration efforts
A systematic risk-based review of your weighing process may be the most important step an organization has to take to optimize calibration efforts and comply with the revised ISO 9001 standard.
METTLER TOLEDO has developed Good Weighing Practice™, a standardized scientific methodology for secure selection, calibration and operation of weighing equipment based on a thorough risk analysis. During a consultation, our GWP® experts help you objectively assess risks related to your weighing equipment and develop the right risk-management process to prevent failures before they occur, eliminating unnecessary testing when risks are low and ensuring top performance when risks are high. We also provide the full documentation for a smooth transition to ISO 9001:2015.
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