Brief Description:

The new laboratory information management system (LIMS), which adopts the Siemens SIMATIC IT Unilab platform to comprehensively enhance the digitization level of the quality system, was fully launched in Mengniu Group in November 2015. The project was launched in October 2013 and lasted for two years. It was implemented by the Wellthinic LIMS team in three stages, covering 36 institutional units and two research-oriented central laboratories across Mengniu nationwide. Through information technology, a brand-new and fully automated information system was established, integrating laboratory testing processes, product quality determination, and product transition control, specifically tailored for dairy testing laboratories.

Perfect integration of inspection and quality control processes:

The original inspection business processes in Mengniu Group heavily relied on manual management, where inspections of raw milk, raw materials, semi-finished products, and finished products were controlled by manual inspection plans. This manual approach was prone to human factors, errors, and inaccuracies. However, through the digitization of inspection plans, the system automatically controls the inspection frequency, ensuring a more accurate and efficient inspection process. Through the digitization of inspection plans, the system automatically controls the inspection frequency. By reviewing the inspection business processes, redundant business management procedures were identified and eliminated, which not only simplified the difficulty of business management but also achieved QA/QC system control. This optimization of inspection business processes improved the level of quality control, laying a solid foundation for the standardization of dairy inspection.

Inspection tasks are triggered based on quality monitoring plan information and distributed to the corresponding work interfaces of the testing positions according to the information of the testing positions. Sampling, sample delivery, and inspection are carried out based on the inspection tasks. Inspection data is entered manually or automatically collected, and judgments and transition control are performed according to quality standards.

The main innovations in the inspection and quality control processes are as follows:

（1）The samples of raw milk and raw materials suppliers are subject to genuine blind coding.

（2）The quality control plan is automatically executed: Quality monitoring plan information is established based on materials and factories, including testing positions, sampling points, sampling quantities, testing items, testing frequencies, and sampling tools. Inspection tasks are triggered and assigned based on the quality monitoring plan information.

（3）Quality standards are automatically judged: Quality standards include material names, testing items, testing methods, upper and lower limits of standards, and requirements for the number of digits in the reported results. When the quality of the material is determined to be qualified according to the quality standards, the inspection task is triggered to proceed to the next process. If the material is determined to be unqualified, the material is frozen, and a re-inspection task is triggered.

（4）Seamless integration with the ERP system: All online inspection tasks are automatically triggered by the ERP system. Once the LIMS inspection is completed, the judgment results are automatically fed back to the ERP system, serving as an essential foundation for Mengniu's comprehensive quality management system.

（5）Random sampling inspection function of the system: Testing items are randomly generated by the system based on "random rules". The random rules are established with the basic conditions of "random conditions + inspection items + period + maximum random number + reminder time", aiming to reduce quality control ri

（6）Customizable settings for project verification: After the initial inspection fails, reviewers can choose from various forms of further verification and confirmation, such as "confirmation," "re-testing with the original sample," "re-sampling and testing," or "verification using other methods."

（7）Strict processes for the review, re-inspection, and verification of inspection results.

Automated Integration of Laboratory Inspection Instruments:

Mengniu Group has a variety of inspection equipment, including gas chromatography, liquid chromatography, high-precision analytical balance, atomic absorption, ICP and other instruments commonly used in most laboratories, as well as some instrument types unique to the dairy industry, such as milk composition analyzer, FT-120, and somatic cell detection instrument. These instruments come from different manufacturers, have different models, and play an important role in the dairy inspection process, so the connection between these instruments and the LIMS system is particularly important. Through automated integration, the inspector only need to scan the barcode of the sample using a scanner gun, and then export the data after completing the inspection and analysis. This allows for automatic collection of the inspection data from the instrument, significantly reducing the workload of the inspection personnel, enhancing data accuracy, and ensuring the authenticity of inspection data.

The system has achieved the connection of 2,140 inspection devices of 66 different models across 36 business departments and two central laboratories nationwide in Mengniu. The average data collection rate of the instruments exceeds 90%, enabling automatic calculation of inspection data and significantly reducing the workload of laboratory inspection personnel.

The main innovations in instrument linkage are as follows:

（1）Realize the collection of data information from serial port devices and workstation equipment into electronic original records or inspection result interfaces, including the collection and application of pretreatment instrument data such as weighing on balances and titration volumes.

（2）The platform-based design of instrument data collection ensures that data from new instrument types can also be quickly collected into the system.

（3）Collection and recognition of quality control sample data such as blanks and recovery rates.

（4）Instrument data is non-modifiable, ensuring the authenticity of the data.

Comprehensive implementation of electronic original records:

Most laboratory original records are manually recorded on paper original record sheets, requiring manual calculation according to the calculation formula of the inspection method, and then transcribed into the system. The shortcomings of this method are obvious. Manual copying and calculation can easily lead to errors, and rounding off the calculation results can also increase the workload of inspectors; Tracing the inspection process has also become difficult and complex. By implementing the digitization of original records, the digitization of inspection method forms has been achieved. Users only need to input in the system, and the system automatically performs calculations, rounding, and indicator judgments. This not only reduces personnel workload, but also improves data accuracy, while ensuring data traceability.

The current system has implemented recording of over 1400 inspection methods, and the newly added methods can also be quickly implemented through configuration.

The main innovations in electronic original records are as follows:

（1）Data can be entered through various methods such as manual input or instrument linkage acquisition.

（2）Automatically calculate and round off through built-in formulas;

（3）Implement quality control data applications such as blank deduction, recovery rate application, and parallel sample calculation;

（4）Sampling and secondary sorting and self numbering of samples within positions can be carried out based on job positions;

（5）Strict review process.

Auxiliary function specifications comprehensively realize laboratory information management.

In accordance with the management requirements of the ISO/IEC 17025 system and taking into account actual management needs, we aim to achieve the informatization of seven key functions: personnel management, drug management, inspection method management, standard sample management, quality control management, cost management, and inspection information transmission management.

The main innovative points in terms of auxiliary functions are as follows:

（1）Quality standards, inspection plan updates, and automatic reminders of non-conforming information;

（2）Inspection method link for reference;

（3）Input abnormal inspection information and automatically summarize and analyze it;

（4）Drafting, reviewing, and implementing training plans, method confirmations, quality control plans, etc

（5）Establishment of technical archives for personnel training, verification, achievements, and other related aspects;

（6）The inspection costs are analyzed based on categories such as raw milk, process, and finished products, including the analysis of excessive inspection, duplicate inspection, and unplanned inspection costs.

This system covers 36 legal entities nationwide in Mengniu Company, comprehensively addressing the existing challenges in laboratory information management at home and abroad, such as the disconnection between laboratory management and quality control management, and the inability to fully and effectively implement the linkage between original inspection records and instruments. It effectively combines the personalized needs of quality management in dairy factories, establishing a comprehensively upgraded laboratory information system that is easy to operate, scientifically and rigorously managed.

By implementing automatic data warning, analysis, and real-time transmission of big data management through the system, the quality control level is comprehensively improved, providing strong guarantees for food quality and safety. At the same time, it laid the foundation for the comprehensive implementation of Industry 4.0 and ushered in a new era of laboratory information management in the dairy industry.