How a life science company achieved compliance with a calibration analysis

Making well-informed decisions based on calibration results that comply with all relevant quality and safety requirements is a key challenge in the life sciences industry. Calibration analysis is important for every plant operator in life sciences, to help them find new insights and achieve actionable outcomes.

Improving measurement accuracy with calibration data

The customer, a large enterprise in the pharmaceutical and life sciences sector, was looking to improve its measurement accuracy in one of its sites in India. Analysis of calibration data was identified as key to achieving this improvement. The common routine calibration had not been providing data analysis at this stage. The company serves a demanding baby food market, so the product quality and process is critical.

The customer’s requirements included the following:
• Calibration of all measuring devices need to be on point
and happen regularly
• Devices can only be calibrated while the plant is shut down
• Some devices need to be calibrated once a year, others every six months

Our solution: A measurement performance analysis

Endress+Hauser’s team addressed the problem by including a measurement performance analysis. This is a separate service that can be offered on top of a calibration. This service provides transparency and insights into the calibration results to identify issues and the potential for improvement. This way the reports of the last calibration are not only used to generate the calibration certificate, but are turned into a detailed analysis. In this case, the customer’s calibration served its compliance requirements, but it struggled with data analysis, and it was impossible for it to go through all certificates individually.

Every calibration analysis consists of three parts:
• Calibration summary and metrological health report
• Analysis details
• Conclusion and recommendations

The first part enables clear visualizations with KPIs, such as the measurement reliability before and after calibration and the adjustment ratio, which provide the necessary transparency. The second part shows multiple sets of tables, which makes it easy to identify the devices that require monitoring or actions, and provides a transparent measurement reliability statement. The final part is the most important one, where the experts at Endress+Hauser carry out an in-depth analysis and provide recommendations for necessary preventive or corrective actions – tailored to the metrological needs of the client’s plant.

Improving the calibration program with concrete recommendations

For the client, the results for the installed base health showed that eight devices needed immediate attention and correction. The life sciences company concluded that it received great insights about the health of the calibrated instruments and can now plan accordingly.

Endress+Hauser has signed a three-year contract with the global life sciences company for the calibration of field instruments. All the detailed calibration results are collected in the measurement performance analysis report, which includes a management summary with visualization. All the metrological health data is then translated into concrete recommendations and corrective actions to improve the calibration program.

“Thanks to the report, we were able to gain great insights about the health of the calibrated instruments. Now we can plan actions on predictive basis.”

Optimize risk, cost and reliability

With Endress+Hauser’s help and insights from the measurement performance analysis, the company can now:

• Make well-informed decisions that comply with all relevant quality and safety requirements
• Identify measurement related risks to product quality and process compliance
• Receive a comprehensive overview of calibration results, rather than having to go through individual certificates
• Provide proof to internal and external stakeholders that calibration requirements are met

Want to see how you can optimize your calibration plan? Learn more about our calibration services and get in touch if we can help!