LIMS “Analisi” and “Lean-Lab”: the new software solutions for the optimized management of a Testing Laboratory Processes:
the considerations presented here, dealing with a subject that shifts the focus from the most common management features offered by LIMS systems, to the fact that a LIMS project should evolve in the direction of the optimization of the Testing Laboratory Processes.
Today, for laboratories and generally for companies, it is vital to offer customers a product / service that not only meets expectations, but also has a price that the customer deems proper pay. The only way to achieve this important goal, is to cut costs, ie all of that does not provide added value to the work and not be used to increase the quality of the product or service that is offered (which is the reason why the customer pays).
Polisystem Informatica, attentive to the needs of its customers, in designing your own LIMS, it is geared to providing the tools to support the customer also in addressing this issue.
The choice of a more advanced technology platform, the addition of modules and functionality, are useful implementations, but, in our view, should not be the only ones.
For several years, Polisystem Informatica collaborates with PTM Consulting, a company that offers consulting services for process optimization and product improvement. The Lean Six Sigma approach adopted by PTM Consulting and Polisystem Informatica, integrated into the LIMS project, allows the customer to implement its laboratory processes and optimized.
The methodology known as “Lean Six Sigma” combines the techniques that belong to Six Sigma (useful for the reduction of defects) to the Lean principles (useful to streamline procedures and speed up processes).
Reducing waste is obtained by redesigning all processes that do not add any value to your product or service. If you try, in fact, to analyze in depth the way you work, you will find many activities that do not add value but that go to only increase the total cost of what they provided to the customer.
Applying the principles of Six Sigma, able to make the best use of mapping techniques that will support you in visualizing the real value of every job to the product / service. Steps that do not bring value will be eliminated or, at least, revised, while those really useful will valued.
The adoption of a LIMS system, like that of Polisystem Informatica, developed from operational processes designed with Lean Six Sigma approach, is another key factor for the success of the optimization of the processes of your laboratory.
The following table presents a summary of the integrated approach:
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Lean Six Sigma (D.M.A.I.C. Cycle)
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LIMS functionality
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DEFINE: Finding Processes
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– Mapping AS-IS business processes (technique: flow charts, Analitycal Assessment “2A”, IDEF0)
– Definition of requirements (regulators, safety records and electronic signatures; technical / ITC infrastructure; process, reporting) |
– Chapters of the Project (User Requirements Specification documents; Functional Analysis; Technical Specification, Test) correspond to the Laboratory Processes defined and supported
– The requirements are an integral part of each process and are specifically mentioned in the “Validation Kit”
– The life cycle of the LIMS software development is compliant with ISO-9001/2008
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| – Document Drafting User Requirements Specification -Identification of activity/data/critical functions to impact business/product quality |
-“Validation Kit” is available; it includes the software production Documentation of the performed tests, the correlation matrix among the Standards and Processes / Steps / Operations of the LIMS to support this technology
– Test protocols are available for the installation steps and functional test (standard part) to be performed at the customer for testing – The customer can prepare an appropriate Validation Test Plan through the innovative package “ValSW“ |
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MEASURE: Detection of the current level of performance
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– Locating a suitable metrics
– Collection of quantitative data on the current level of process performance relative to the requirements identified in order to allow a subsequent categorization and identification of “what is true. |
The LIMS system is equipped with functions for the detection of process data (time, volumes, frequencies) according to various perspectives / fields: |
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ANALYTICAL
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– Numerosity Samples and test (for Type, Product, Department, Customer / Client, …)
– Number and% out of bounds (by product, date, customer, manufacturer, sampling point, ..) |
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– Processes / Phases time: Sample Acceptance, preparation, analysis, approval, delivery, ..
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– No. Test reports issued
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MANAGEMENT
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– Management Work Assignment and critical, over-allocation, reallocation, ..
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MANAGEMENT CONTROL
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| Profitability Analysis | |
| Determining Costs and Prices | |
| Quotes / Contracts: Times and volumes of workloads | |
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ANALYSE: Determination of activities “to value”
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-Evaluation of the activities to identify the “value” activities and eliminate waste
– Product evaluation to identify evidence of reduction criteria – Identification of process improvement actions – The cost / benefit assessment – Mapping of the new process (TO-BE) – Definition of KPIs (Key Process Indicators) |
The LIMS system has features that allow the reduction / elimination of waste (Re-entry of data / calculations and manual controls), the sharing of electronic data without the need to print (less paper), navigation / reporting of analytical data and process and the setting and registration of the validation activities, which, for different areas, they can be summarized as follows: |
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ANALYTICAL
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– Automatic acquisition and parametric values to Tools
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– Automation evolved Calculations and supported by the logic of Excel
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| – Automation specialist Analytical Logic (Ex. Waste Classification, Eligibility Landfill, Metals / Upgrade) |
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– Reporting to the QA / QC (Batch Analytical)
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– Statistics and Control Charts Shewhart applicable for example to: Product, Points Drawing, Tools, Operators, tests, Matrices, ..
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MANAGEMENT
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– Priorities Management and Delivery Deadlines
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– Planning activities of the Laboratory with Historical and Forecast period
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– Dynamic allocation of testing activities to Operators and management of labor Code Tools
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– State advance to sample works, department, operator, committed
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– External Sampling Planning Acceptances with automation
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DOCUMENT (less paper)
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– Replacing the paper in managing the works and loading of the test results
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– Electronic Signature and Digital
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– Form “LIMS-Doc” for the automatic integration of the documents produced by the LIMS with the Workflow Management System (eg. Management Non-compliance)
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REGULATORY
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– Management and emission test reports according to laws
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– Automation and Validation Logic Protection of calculation with the package ValProt
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– Validation / Verification Methods Validation Package with ValMeth
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– Ability to record structured information for Software Validation with package ValSW
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IMPROVE: Implementation of solutions for improvement
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– Definition and implementation of new operational procedures
– Operators Training |
Installation and configuration of the functions of LIMS identified |
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CONTROL: Monitoring of the adopted solutions
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| Every improvement initiative needs a feedback mechanism and control to ensure that you do not come back, slowly, in the situation that prevailed before the change introduced. This is reflected in the periodic monitoring and evaluation of KPI after implementation of improvement activities. |
– Evaluation Process Indicators (KPIs) and comparison with the historical
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The LIMS “Analisi” has a completely redesigned user interface, enhanced and perfected in the operational functionality, and especially re-engineered in the direction of a “Lean LIMS“.
The consulting services of PTM Consulting and software solutions Polisystem Informatica (LIMS, Software Validation, Validation Methods, logical calculation Validation) provide synergy for the realization of an integrated project innovative approach for the automation and optimization processes of the Laboratory.