Vol. Integration oflaboratory and process testing...

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Journal of Automatic Chemistry, Vol. 17, No. 4 (July-August 1995), pp. 161-162

Integration oflaboratory and process testingdata

Michael TyszkiewiczAutomated Compliance Systems, Inc., 245 Highway 22 West, Bridgewater, NewJersey 08807, USA

The author describes ACS Inc.’s Pro-LIMS system whichintegrates laboratory and process procedures. The system has beenshown to be an important toolfor quality assurance in the processmanufacturing industry.

The process industry is undergoing radical changesbecause of customer-driven requirements for lower pricesand higher quality. The 1980s brought about qualityinitiative, continuous improvement, and ISO 9000 pro-grammes that focused on industry practices and methods.Process automation systems focused strictly on processvariables and process control, while Laboratory Informa-tion Management Systems (LIMS) traditionally focusedon samples and data strictly from the laboratory perspec-tive. Functionality was developed in both of these systemsto meet end-user workflow requirements and increaseefficiency. The linking of laboratory data to the processarea--which is required to make instantaneous processdecisions--has not been widely addressed.

Current methods for integration of data

While relational database products such as Oracle havemade the exchange of information much easier, currentLIMS technology falls short of total process integration.LIMS packages use status changes of samples as triggers tosend messages and data to other systems. In order to trackdata, samples and tests are assigned a status once theyarrive in a laboratory. Some of the common statusdescriptors are pre-logged, logged (received in thelaboratory), completed and authorized. LIMS vendorsthen write routines that trigger site-specific functionalreports or actions at status changes. These actions rangefrom simple tasks like sending data in file form for anothersystem to read at sample completion, to complexprocedures such as running product-grading routines.This strategy assumes that all product quality data isowned and maintained by the laboratory. However, thisassumption only holds true at a small number ofinstallations.

Sample statuses and their limitations

The total integration of a process laboratory with theprocessing area involves more than just the exchange ofin-lab data in a timely fashion. In an area where severalprocess steps are involved in production, there are manyinteractions between the laboratory and process area, andmany human tasks and decisions affect product quality

and operational efficiency. Most ofthese take place withoutcomputer assistance or electronic documentation. Simplevisual inspections ofproduct, or physical and visual testingperformed in the process area, are critical data points thatresult in approval to continue the next process step. Thelaboratory and process area must be integrated to workas one unit to achieve high product quality and maximumefficiency. This will only be possible when process areadata and procedures that affect product quality are

integrated with in-lab data to allow statistical analysis ofthese variables for process optimization.

All LIMS systems have a limited number of status

changes. If a user needs more statuses than supplied inthe LIMS, the amount of customization necessarybecomes staggering. This phase ofthe implementation cansometimes become the most time-consuming and costlypart of a project. In many cases, product quality isdetermined at different production areas, or at inter-mediate process steps by either sophisticated equipmentor visual inspections. The incorporation of process datapoints, on-line visual inspections, and manual approvalsteps into any system, has proven to be the most difficultphase ofsystem implementation. The project team is facedwith the dilemma of heavily customizing a LIMS to addmany more status updates to accommodate all of thesemultiple steps, or modifying existing production pro-cedures to allow the software to fit the application. Eitherapproach is not justifiable, and in most cases theintegration of this data is determined to be unfeasible.

Examples from the process industry

One example of status limitations in the pharmaceuticalindustry is where several levels of approval, instead ofone, would be necessary before sending data out of thelaboratory. The major customization, maintenance, andeffort required for the work-around may still leave theend-user only partially satisfied with the end results.Another good example is in the process manufacturingindustry. A product being manufactured on a conveyorline may have hundreds of process steps and visualinspections at checkpoints. If any of the visual inspectionsare not performed, faulty materials or parts may beinstalled on the finished product, requiring costly produc-tion slowdowns, or product recalls. Handling this scenariowith current LIMS offerings is difficult, since two systemsmust be in constant communication with each otherthrough customized links, and too many process area datapoints are omitted from on-line analysis. The real-timelink from process to the quality control area is incompleteor interrupted, thereby creating loopholes in the qualityassurance process.

Automated Compliance Systems Inc. (ACS) has analysedthe integration requirements and status limitations and

M. Tyszkiewicz Integration of laboratory and process testing data

designed Pro-LIMS, which is a LIMS that addresses theneeds of the process industry.

Pro-LIMS event/action builder

Pro-LIMS was built around the theory that sampling,data entry, and reporting are events that occur on a

conveyor belt. Pro-LIMS allows users to configure theirsystem with an unlimited number of user-defined eventsand actions. Sample pulls can be scheduled on a calendarbasis or attached to processes and process steps in aMicrosoft Windows Graphical User Interface (GUI).Since processes can be broken down into an unlimitednumber of process steps, the end user can easily scheduleand link laboratory events based upon plant actions andvice versa. The linkage of process steps to events allowseasier and better definition of multi-phase batch opera-tions. The end user can also define actions and eventsbased upon shift schedules, for better definition andmanagement of continuous operations. All of the pre-logged events can then be viewed in the forecasting utility,allowing the user an approval step of the automaticallyscheduled work with a chance to cancel some or all of it,if desired.

Pro-LIMS robot chains

Another advantage of Pro-LIMS is robot chains. Robotchains are used instead of sample and test statuses tohandle data flow. ACS offers an unlimited number ofconfigurable user-defined steps that follow existingstandard operating procedures to trigger and enforcerequired actions. A robot chain can include any numberof fully computerized, computer-assisted, and humanactions that force compliance to procedures and/or forcethe order of events. The human actions may be visualinspections, product-preparation steps, or process testing,

which occurs in the process area, that can now beintegrated, enforced and electronically documented. Thepharmaceutical industry’s needs are met with simpleconfiguration of a robot chain that includes extra levelsof approval before data is transmitted to process areas.The robot chain monitor gives the end-user a tool to easilyview the in-process and finished items, so correctiveactions may begin. The transmission of the data isidentified as a process step in the chain. A processmanufacturing system that needs to monitor visualinspections of product will find robot chains to be theperfect solution. Since robot chains can force the order ofevents, the visual check and approval at a particularprocess step will immediately cause disruption of the chainif it is not completed. In this case, a background processmonitors elapsed times and notifies someone to takeaction. No quality assurance-driven events can take placeuntil the approval is given and electronically documented,thereby preventing a product from being released fromQC hold until an inspection in the process area takesplace.

Pro-LIMS benefits for process solutions

Compliance is a major issue in all industries. The issue isbeing driven by ISO 9000 in process manufacturing, theFDA in pharmaceuticals, as well as other qualityassurance programs. Adherence to compliance is a totallyprocedure-driven effort. Most of these procedures are

manual, making it extremely difficult or impossible forcurrent LIMS technology to add any value in this effort.Pro-LIMS robot chains provide a tool to configure a

system to include all laboratory and process procedures,while enforcing order and compliance to them. Theextension of these capabilities from the laboratory intothe process area totally integrates the two separate areas,which provides an important tool for quality assurance.

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