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I LDS LABORATORY DATA SYSTEM(InduSoft Laboratory Data System)

LIMS I-LDS system, in other words, InduSoft Laboratory Data System, is designed for the automation, control, processing and storage of data on the operation of the plant laboratory.

LIMS I-LDS enhances the efficiency of the laboratory operation and makes the specialists of the plant and consumers of products sure in the appropriate quality control at each stage of the production process.

As the source of the data on the qualitative and quantitative test results and characteristics of controlled items, I-LDS laboratory data management system enables to integrate data into dispatch and planning systems of the plant online.

THE GENERAL DESCRIPTION OF I LDS LABORATORY DATA SYSTEM LIMS I-LDS system enables to improve quality and efficiency of the TL (hereinafter “TL”) in all aspects as well as ensure and confirm the compliance with requirements to the TL competency.

LIMS I-LDS is the information core of the quality control: • the system enables to improve quality control, providing the uniformity in performance of duties by TL employees; • the system reduces the test time, automating the computations of the measuring methods, preparation

of reporting and quality supporting documents; • the system ensures the timely submission of reliable information on the laboratory actions to the management,

including the integration of data into the information services of the plant online; • the system promotes the effectiveness of the TL team, optimizes TL business processes owing to the planning

of its work and rational use of the resources (personnel, instruments, equipment, reagents and reference standards).

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The ideology of LIMS I-LDS system is based on recommendations of the following regulatory documents:

• LIMS I-LDS was certified in the system of voluntary certification and officially registered. • FGUP of the Ural NII of Metrology has issued the expert review upon the results of metrological expertise

for the compliance with requirements to standards GOST R ISO 5725-2002, CIS 76-2014, MI 2881-2004, GOST R ISO 11095-2007, CIS 54-2002.

• LIMS I-LDS was awarded the attestation certificate by Joint-stock company “VNIINM” confirming that LIMS I-LDS complies with requirements of OST 10289-2005 (the certificate is valid up to 15.12.2020).

In the process of the system implementation the functionality of modules can be developed and extended in compliance with special requirements of the Customer. LIMS I-LDS system was developed taking into account the possible use of national languages.

1. Quality StandardsInternational Standards RF National Standards ISO 9001 GOST ISO 9001

LIMS enables to organize product control and measurement processes in compliance with requirements of ISO standard.

The following factors contribute to the above: • LIMS I-LDS backs up the laboratory operation on a full scale;• TL management is improved owing to LIMS system as the system imposes the responsibilities

for the implementation of procedures;• the system provides for the transparency of the functions and the operative access to the information;• LIMS I-LDS system ensures the traceability of all actions thus securing the reliability and integrity of test

results.

The approach to LIMS I-LDS design is based on the fact that the methodology of the system building complies with QMS methodology, which is based, primarily, on the principles of quality, stipulated in ISO international standards.

2. General Requirements to the Competency of Test and Calibration LaboratoriesInternational Standards RF National StandardsISO 9001 GOST ISO/IEK 17025

The accreditation criteria of the certification bodies which also responsible for certification of test laboratories (centers), and the relevant requirements are regulated by Decree of Ministry of economic development and trade of the Russian Federation № 682 dated October 16, 2012 (reg. Department of Justice №. 25847 dd. 12.11.2012

LIMS I-LDS system is aimed to improve the efficiency of processes which control resources, securing the data and information reliability and traceability thus stimulating the fulfillment of the technical requirements to TL competency.

3. The Accuracy (Correctness and Precision) of Methods and Measurement ResultsInternational Standards RF National StandardsISO 5725 GOST R ISO 5725

CIS-76

LIMS I-LDS application enables to improve the quality of laboratory tests owing to the automation of internal control and inter-laboratory tests. I-LDS is the laboratory data management system with extended automation potential (GOST R 53798-2010 Standard manual for LIMS).

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LIMS I LDS PRINCIPAL FUNCTIONALITYTest Planning• The registration of random specimens handed over to the

laboratory by assigning unique identification numbers.• The planning of sampling procedure at the generation

of environment monitoring schedule (EMS).• The registration of the request to execute a test

in order to track the additional tests and interact with interested parties.

The Preparation Procedure for the Execution of Tests and Measurements• Acceptance and registration of the chemical agent. • Distribution of the chemical agents between

laboratories. • Incoming control of a chemical agent. • Accounting of standard samples (SS).• Building and approval of calibration curve (CC).• Automatic control of the calibration curve validity. • Check of calibration curve stability. • Calculations of the value (concentration) of the

component to be determined by means of the analytical response value.

The Selection and Registration of a Sample (Representative Sample) The procedure of sample data input into the system and the assignment of specific identification number.

The following parameters of the sample shall be registered in the system: • identification data (reference to the analyzed item,

sampling place, technological chain point, test item);• sample individual information (sampling time and

special parameters, stipulated in test methods or required for the laboratory);

• registration parameters (input time, an executor, unique identification number);

• if necessary, other registration attributes, featuring the sample.

Sample Labeling • Design of label shape (label fields to give the required

information: sample code, name of product, sampling date, mark “control sample”, etc.).

• Identification mark (sample labeling).• Label seal.

Environment Monitoring• Accounting and registration of environmental

conditions for TL premises.• Traceability of environmental conditions during tests.

Sample Control• Distribution of works according to the fulfillment

of metrological instructions by laboratory personnel.

• Input of primary measurements. • Mathematical processing of data, the computation

of test results (implementation of algorithm of the processed measurement results in compliance with instructions), the assessment of the acceptability of measurement results as per GOST R ISO 5725-6-2002, the determination of the average and median values.

• Сompliance with test algorithm. • Computer-aided evaluation of test results

and metrological characteristics for its compliance with requirements of regulatory documents.

Generation of Sample Test Results and Problem Solving• The distribution of powers in problem solving in

part of approval or rejection, or result adjustment, including grounds for adjustment.

Approval of Test Results• The issue of samples (sample authorization

or rejection).

After the online authorization actual test results are used in supporting and reporting documents, data integration into information services of the plant. I-LDS enables to implement the special regime of the test result authorization the access to which is regulated by the security system.

Accounting of Referee Samples • The placement of referee samples of product lots

(upon the authorization) for arbitration storage. • Accounting of samples and automatic control

of storage terms. • Traceability of additional tests of referee samples

(if necessary).

Module “TEST RECORDS”This module enables to:

• setup of test and measurement record forms; • prepare, review and approve of research (test)

protocol; • ensure the compliance with rules of approval and

registration of test and measurement results; • assign relevant rights to users; • export list of protocols.

Module “LABORATORY LOGS”This module enables to:

• prepare the list of logs; • assign the access right to logs; • setup the log forms; • perform the regular paperwork of indicator

control which characterize the external conditions

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Module “Reports” • The possible automated preparation of output

documents, using the available data, according to the established procedure of the regulatory bodies. Examples:

– list of methodological instructions, used in the laboratory;

– environment monitoring schedules; – list of logs used in the laboratory; – register of supplied and shipped products; – staff training and attestation journals; – documents of used materials and equipment; – reports in terms of number of conducted tests

in various time intervals with data filtration: test type: planned (as per environment

monitoring schedule), out-of-schedule, over-sampling, etc.;

an executor. • Package of documents as per Appendices of Quality

Certificate of accredited (attested) test laboratories, etc.

• The generation of various reports, using Editor of reports, containing the results of laboratory tests and measurements, including:

– generation of statistical data on the product quality and grouping in terms of periods: days, decades, month, etc. or according to setup parameters, for instance, in terms of shifts;

– calculations of average, minimum and maximum value;

– calculations of the determined number of deviations;

– accounting of deviations with respect to upper and lower boundaries;

– discrete changes of actual values; – preparation of summaries related to the

compliance with requirements to technological flow chart, the accounting of deviation percentage, etc.;

– calculations of the number of deviations of the technological and non-technological nature;

– graphic display of data.

REPORTS OF RESEARCH TEST AND MEASUREMENT RESULTS

in the relevant logs, for instance, the traceability of the environmental parameters (temperature, humidity, noise and vibration level), charge of shift logs, etc.;

• trace the test and measurement results and results of other works, conducted in the laboratory under specific conditions.

Preparation of Environment Monitoring Schedule in LIMS I-LDS System

Dynamical Reports

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• The data display in the form of tables and schedules to evaluate the efficiency of laboratory business processes.

• The built-in reporting LIMS I-LDS system enables to store reports in DOC, XLS, TXT, HTML PDF formats and other standard graphical formats.

LIMS I-LDS system is the tool for the generation of reports of TL certificate (form for the preparation of laboratory certificate in compliance with such requirements as accreditation criteria stated in Decree of Ministry of Economic Development

and Trade of the Russian Federation no. 682 dated October 16, 2012 (reg. Ministry of Justice № 25847 dd. 12.11.2012), GOST R 51000.4), and in such case the online data update plays the significant role.

Module “OPERATIONAL ANALYSIS OF TEST AND MEASUREMENT RESULTS”This module enables to:

• present data on the test and measurement results in the form of tables and diagrams to evaluate the efficiency of laboratory business processes.

Module “PERSONNEL MANAGEMENT” The management of the laboratory shall guarantee the competence of all laboratory staff. The module enables to:

• receive the actual information on the laboratory staff: qualification, experience and work experience in the specific sector;

• plan the training of the laboratory staff; • control the personnel attestation terms; • keep records of personnel professional training

and skills maintenance; • generate reports automatically.

Module “CONTROL OF REGULATORY DOCUMENTS (hereinafter “RD”)”The laboratory shall develop and maintain the check procedures for all documents which are the part of the management system (developed by the laboratory) or incoming documents. Module “Control of RD” enables to:

• prepare the register of regulatory documents (regulations, standards, GOSTs, specifications (TU), etc.) used by TL, and division of such documents by levels;

• update the documents automatically; • control RD validity periods; • track RD versions, dates of change, including

the behavior of the employee who introduced the change;

• store the expired versions of documents according to the established schedule.

Module “ACCOUNTING OF THE LABORATORY EQUIPMENT”The laboratory shall be adequately equipped and each item of the equipment shall be properly identified. In addition, it is necessary to control the calibration terms, including the date of the last calibration.

Module “Accounting of the equipment” enables to: • identify the laboratory equipment, i.e. to compare

it with the following equipment: – measuring equipment (ME); – testing equipment (TE); – auxiliary equipment (AE).

• develop the information on the status of the instrument stock of the laboratory;

• assign the status: – I – properly functioning equipment (used); – K – removed from operation (not used); – P – under calibration; – R – under repair (or subject to repair); – C – shall be written off.

EXT ENDED FUNCTIONALITY OF LIMS I LDS SYSTEM

Control of Regulatory Documents

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In addition the module enables to: • compile the calibration and maintenance schedules; • record the results of the equipment maintenance; • trace the calibration terms of measuring instruments

and attestation terms of testing equipment, adjustments, repairs, etc.;

• ensure the traceability of the use of attested laboratory equipment during the tests and measurements.

Module “INTERNAL CONTROL (ILC)” The algorithms of “ILC” module of LIMS I-LDS system were developed in compliance with requirements of standards GOST R ISO 5725-2002 to the accuracy (correctness and precision) of methods, results of measurements and CIS 76 “National Uniform Measurement Assurance System. The internal quality control of the quantative chemical analysis results”, including the recommendations of the National Uniform Measurement Assurance System MI 2335-2003 “The internal quality control of the quantative chemical analysis results”.

“ILC” Module ensures the implementation of the principal types of the internal quality control (internal operative control, stability control by means of control charts (checklists), etc.) and the potential regular checks

of controllability and assessment of the quality values based on the control procedure results (by means of Shewhart charts and cumulative sum chart).

This module enables to: • register the control samples; • plot schedules of the implemented internal control

assignments; • adjust the control procedures; • conduct the inter laboratory comparison tests; • prepare reports of obtained results.

Traceability of MeasurementsThe traceability of measurements is provided owing to the extraction of data relating to tests and measurements, including the complete information on each analyzed sample:

• review of primary measurements and actual test results;

• review of R&R study; • review of environmental conditions during the tests

and measurements; • review of an executor qualification; • review of the validity periods of used regulatory

documents;

Accounting of the Equipment

The Operative Control in LIMS I-LDS System

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• review of calibration dates and metrological characteristics of the used equipment;

• available quality department procedures for used MI; • review of validity and attestation periods of used CO

(equipment); • review of valid dates of used chemical agents; • review of adjustment factors of test solutions,

including valid dates; • review of GC ratio, including valid dates; • availability of the approved protocol, its form,

signature and initials of the approving person.

Module “ACCOUNTING OF THE PRE-PACKED PRODUCTS”This module enables to conduct the automated accounting of pre-packed items (places) of accepted and delivered lots as well as obtain weighted average values of quality indicators for the specific lot of pre-packed products by means of calculations, using the actual quality indicators of analyzed delivered and accepted lots after production.

Module “CONSUMABLE GOODS”This module automates the preparation of supporting documents, stating the quality of the consumable products and enables to:

• account consumable product lots, identify transportation means, net weight, a number of loaded places;

• account cargo receivers/buyers, agreements/contracts;

• account requirements to shipped goods both in the territory of the Russian Federation in compliance with Russian regulatory documents (GOST, TU, etc.)

and intended for the export in compliance with terms of specific contracts/agreements;

• prepare reports at shipment of consumable products, i.e. receipt of final values of the product quality (average weighted, minimum and maximum values), giving the following information:

– names, sorts/grades; – cargo receivers/buyers; – packing types; – reporting periods;

• preparation of requests for issuing documents on the quality of the shipped consumable products manually and automatically when integrated into the external systems (MII SAP module).

Module “STATISTIC ANALYSIS”Module enables to:

• collect data and sequence it; • evaluate the technological flow chart; • use the quality control instruments: Pareto chart,

bar graph, checklist, scatter diagram.

Audit TraceabilityThe automatic audit of the user actions in the system registers all data changes, reviews the certain reports or logs thus ensuring the implementation of procedures in compliance with rules and standard requirements.

Security ManagementThe security management is based on:

• code access security to data in logs and classifiers, to tests and measurements;

• coding of records in database to prevent its change.

The Generation of Consumable Product Lots

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Analytical LIMS I-LDSLIMS system does not only automates the laboratory routine operations, but also maintains the production process, operation of quality systems, relations with regulatory authorities and suppliers. I-LDS analytical system enables to integrate into different corporate systems (MES, ERP) online. The integration of data

allows to conduct the joint analysis of the dependence of product quality on technological processes, supplied raw materials, including the dependence of quality of consumable product on mixing formula and claims of buyers to lots of products.

Quality Control Instruments

Flexible Generation of Analytical Reports

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The system presents the distributed application. Microsoft SQL Server is used to store regulatory and reference information and metadata. The results of laboratory research are stored on Microsoft SQL Server, but can be stored on data server online as well. At present the system maintains the operation of following servers: PI System of OSISoft company, GE Historian of GE Digital company. The list of supported servers can be extended.

I-LDS includes three client applications: workstations of an engineer, a laboratory assistant and a review workstation. The functionality of each application may be customized individually at the customer’s request through dynamic connection of external modules of application functional extension.

User’s InterfaceThe workstation of the user is Windows application with standard graphical interface resembling Microsoft Office. The relations with the user are achieved through menu, toolbars and dialogue windows:

• functionally oriented transfer field; • context dependent menu and toolbars; • generation of own menu and toolbars; • wide opportunities for data presentation:

– hierarchical classifications; – tables; – reports; – plots.

Workstation of an EngineerThis application is designed for the administering, configuration and audit of the system

I-LDS analytical system is the web-solution presenting the component of plant management systems thus enabling to prepare analytical reports for any interval.

The analytical system data storage presents the individual database, which is collected from one or several online operational databases (ODB) I-LDS.

The analytical system in the form of web application

enables to organize workstations without installing the additional software on user computers (one Internet Explorer browser, version 9 and more is enough).

The users may generate the earlier configured reports, the reports according to their own requirements, by means of the designer built-in the analytical system, and store the obtained results in the form of documents of different formats: XLS, HTML, PDF.

LIMS I LDS A RCHITECTURE

LIMS Architecture

CONCLUSIONS

The system LIMS I-LDS enables to automate all production stages starting from the delivery of raw materials to the ready consumable products. The control of all stages by LIMS I-LDS (input control, operation, production, technological control, quality control of consumable products as well as environment control, control physical factors makes it possible to:

• optimize the control of laboratory information, make it more transparent for further use in making management decisions;

• reduce risks and associated possible damages, including ecological payments and penalties; • optimize the internal resources, control over its use and ensure the compliance with legal requirements.

Workstation of a Laboratory AssistantThis application is designed for the automation of the laboratory assistant activities and implementation of functions required for the successful operation of LIMS I-LDS modules.

Review WorkstationThis application is used to display the information on the results of conducted tests to all interested specialists of the plant.

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REFERENCE I LDS

ПЕРЕРАБОТКА