Taking a risk-based approach to optimise efforts
10 April 2017
Find the right calibration schedule and comply with the ISO 9001 risk-based thinking approach.
Regular calibration, based on a thorough process-risk assessment, can help stabilise production while conserving time and resources. Testing too infrequently risks undetected accuracy problems, while testing too often interrupts production.
The 2015 revision of ISO 9001 brought a major change regarding the risk-based thinking approach that is found throughout the entire standard. It also impacts the calibration process. Its most relevant update is the introduction of risk management in the quality management process. Risk identification, assessment and management are key activities to maintain quality. To maintain their ISO 9001 certification, companies need to adapt to the new standard by September 2018.
The only way to ensure that measurements deliver the cost, quality and revenue results that help improve profitability is to choose the right procedure and schedule to periodically re-calibrate scale. However, industrial environments are tough on weighing equipment. If scales fail or deliver inaccurate measurements, there is a risk of production downtime, poor product quality, regulatory non-compliance, increased liability and potential profit losses.
Many companies are already familiar with risk-based thinking from other standards, such as Good Manufacturing Practice or safety standards. Risk is usually analysed in two parts – the likelihood (probability) that it happens and the severity (impact) if something happens.
Translating risk-based thinking into the calibration process starts with evaluating the impact of inaccurate weighing results on the business process. Examples could include 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, it is important to 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.
A systematic risk-based review of the weighing process could be the most important step an organisation has to take to optimise calibration effort and comply with the revised ISO 9001 standard. Mettler Toledo has developed Good Weighing Practice (GWP), a standardised scientific methodology for secure selection, calibration and operation of weighing equipment based on a thorough risk analysis. During a consultation, an expert will objectively assess risks related to the weighing equipment and develop the right risk-management process to prevent failures before they occur. Eliminate unnecessary testing when risks are low and ensure top performance when risks are high. Full documentation for a transition to ISO 9001:2015 can also be provided.
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