Integrated solutions for the perfect laboratory

The key to optimization potential in laboratory and quality management lies in their technical and organizational integration into the production process. With this in mind, seamlessly integrated solution concepts based on the SAP MII integration platform have been developed within the scope of the “Perfect Laboratory“ initiative – illustrated in this article using the example of a Batch Manufacturing Process.

When it comes to optimizing production processes in terms of Adaptive Manufacturing concepts, quality and laboratory management so far have been rather overlooked. However, a perfect plant includes a perfect lab: Flexible manufacturing is only possible, and able to support high quality levels, with a seamlessly working process chain cycle of both production and laboratory.  Yet observers of today’s pharmaceutical production will attest that manufacturing processes and those of quality and lab management are only very rarely integrated.  As a rule, the lab exists as an independent, self-contained organizational unit, mostly isolated from other business processes – which is exactly where the untapped optimization potential lies.  If we manage to reduce cycle times in production and laboratory by integrating processes, we will be able to react more quickly and flexibly to quality problems – concurrent with the ongoing production process.  This not only means less scrap, but also quicker processing of possible complaints.  By tapping this cost reduction potential, and together with higher customer satisfaction, laboratories can play an essential role in increasing a company’s competitiveness.

This is why SAP, together with partner companies, has enhanced the Perfect Plant concept by quality and laboratory management solutions.  As an expert in the fields of manufacturing integration and quality control, Trebing + Himstedt developed essential solution concepts for an integrated laboratory.  These concepts aim at enabling businesses to manufacture more flexibly and in higher quality while saving costs at the same time.

Key Problem Insufficient Integration
Most challenges faced by quality and lab management today can be traced back to lacking integration.  This is true both for organizational and for technical aspects and entails unnecessarily high efforts and expenses in many places.  Due to the lab’s organizational “isolation“, laboratory processes happen virtually detached from other business processes.  This is also reflected in the technical system architecture: IT systems used in the lab are generally not integrated with systems in other business units which do, however, depend on this quality information.  Therefore, it is no exception that information between shop floor and laboratory is exchanged manually, i.e. in the form of papers either printed or completed by hand which sit and wait for processing in the respective departments’ in- and out-boxes.  These delays in the information flow not only prohibit quick and flexible reaction to quality problems.  Moreover, they generally also result in double data management and thus the risk of working with inconsistent data: Whenever lab information is entered into MES or SAP systems manually and time-delayed, and stored there separately, errors and inconsistencies are built-in and always bound to happen.
But insufficient integration of cross-departmental information exchange is not the only problem.  Laboratory-internal data management is also facing ever growing challenges.  Most labs contain a multitude of increasingly complex test devices and systems of various manufacturers.  These are generally not integrated, and data logging has not yet been automated either, both in combination resulting in highly heterogeneous data structures.  Employed LIMS systems are often structured in a decentralized way, so that here as well valuable time is lost before the right pieces of information are available for deciders and policy-makers.  The challenge therefore is to bridge and resolve system inconsistencies both inside laboratory processes and upon integration with production processes.  This will minimize efforts and the risk of error in data management and will yield crucial additional hours for quality inspection.

The Perfect Laboratory – What does it look like?
So precisely how should a perfect lab be designed?  What can organizational and technical integration supported by automated processes look like? 

Primarily, the perfect lab needs to be seen as part of the perfect plant: Only as an integral part of the production process can the laboratory be the key for an integrated optimization of a company’s quality management.  That means a quicker and more synchronized process chain cycle of production and laboratory with in-process quality control.  Ideally, these in-process controls can be carried out by operator self-inspection, with shop-floor staff directly executing quality management tasks. This requires that these controls are seamlessly embedded in the work steps of the manufacturing process and user-friendly test tools can be handled intuitively.  The result of this approach is fast-track release of and usage decisions for materials and batches – much more quickly and during the ongoing production process already.  This in turn enables real-time, prompt reaction to any cases of non-conformance – preventing additional scrap.

A second key element of the perfect lab is continuous availability of production and quality information.  An integrated and consistent data management reduces double data acquisition and storage and provides high data quality.  Integrating electronic inspection equipment and lab devices enables automated data acquisition while minimizing manual effort and the error risk involved.  Seamless ERP integration and continuous availability of real-time information allows decision makers to respond more quickly and flexibly to any quality problems.

Solution Concept and Components

To meet these perfect lab requirements, SAP and partner companies have developed a concept based on the SAP Manufacturing Integration and Intelligence (SAP MII) application.  This concept contains integrated solutions for various fields of industry and application scenarios, covering tasks from goods receipt inspection via in-process control up to final inspection.
The following text presents one process industry use case employing these solution components in more detail:
 
1)    SAP MII
SAP’s flexible integration solution forms the central link between system levels: Production systems, laboratory equipment and test tools can be integrated into SAP MII for automated data acquisition.  Seamless connection to the higher SAP ERP level (QM, PP-PI) ensures data exchange in real time. 

2)    “Batch Manufacturing with SAP MII” Templates (Work Instructions)
Complementary to SAP MII, SAP delivers pre-configured, cost-free best practice templates to support batch manufacturing processes. These templates provide prebuilt processes, user interfaces and contents for manufacturing preparation, execution, documentation and reporting.

The “Work Instruction“ template, providing integrated quality management among other functions, is employed within the scope of the Perfect Laboratory concept.  Trebing + Himstedt played a major role in the development of this template.  It integrates manufacturing enterprise, operations and shop floor data to support comprehensive task management and process control as well as process documentation. Further batch manufacturing information: http://www.ngpharma.eu.com/article/Batch-manufacturing-with-SAP-MII/

Perfect Integration of Batch Manufacturing Processes

The following chapter will now illustrate the solution concept by example of a batch process for pill production.  The manufacturing process consists of five consecutive steps: Weighing, blending/homogenizing, pellet pressing, coating/glazing and packing.  Production machines on the shop floor as well as test equipment in laboratory and manufacturing are integrated into SAP MII through standard or special interfaces.  This means automated migration of production and quality data and transfer to the ERP system (SAP PP-PI, QM IDI) in real time.  Automated data acquisition directly from the process control system (e.g. Siemens PCS7) or Historian (e.g. RAPID) is feasible as an additional option.

On the shop floor, the “Batch Manufacturing with SAP MII“ “Work Instruction“ template is employed at worker terminals, while an MII-based LIMS solution is used in the lab.  These two components are both integrated into SAP ERP (“Work Instructions“ with SAP PP-PI and QM, MII LIMS with SAP QM)  and are additionally provided with an interface for data exchange with each other.

Two in-process controls – one in the laboratory and one on the shop floor respectively – are part of the production process.

Work Instructions – Completing the Manufacturing Process Step by Step

To start the process, a control receipt for the selected process order is downloaded from SAP PP-PI into SAP MII.  At the same time, the respective inspection lot is loaded into SAP MII from SAP QM.  From this, the “Work Instructions“ template automatically generates an electronic work instruction which leads the worker step by step through production execution.  In an intuitive, easy-to-use web interface, operators find all necessary information and instructions they need for efficient process order execution.  These include an overview of safety instructions and other production documents, in-process quality controls and process order entries – all with digital signature.  As an additional option, print-out of labels and material lists can be triggered flexibly from within the process.

Furthermore, actual process values such as material consumption, goods receipt, staff and machine times are entered and sent to SAP ERP to ensure real-time, accurate update of batch and order information, process orders, goods issue/receipt and order settlement.  Likewise, SAP ERP quality management inspection lots are updated with the confirmed inspection data.
Throughout the entire manufacturing process, SAP ERP remains the leading system, thus avoiding double data storage or maintenance.  A local solution order queue ensures order processing on the shop floor independent of SAP availability and in the case of failure can prevent downtime and data loss.

In-Process Control in the Laboratory

The second production step, “blending/homogenizing“, shall include in-process quality control to be carried out in the lab.  Through the work instruction, workers at their operator terminals receive a “sampling” instruction and accordingly take a sample of the substance.  The LIMS used in the laboratory is already automatically notified of this sampling; lab technicians can make all preparations necessary for the analysis.  The sample is transported to the lab where it is inspected and analyzed with respective test equipment.  The test result is stored in the analysis tool and, together with inspection criteria, confirmed in real time both to SAP QM and to the batch manufacturing template/work instruction.  All these steps are completed in-process parallel to manufacturing execution.  Integrated processes and systems enable substantial savings of time and effort.

In-Process Control in the Manufacturing Process

Less complex quality controls which do not require special analysis tools, such as visual inspections, can be carried out by operators directly during the production process.  In our example, this is the case for quality control during the “pellet pressing” production step; pill quality can be checked directly by operator visual inspection.  Again the “sampling“ instruction appears in the operators‘ work instruction; workers take the sample and carry out the visual inspection according to their respective specifications.  Precondition for shop floor staff to assume some quality management tasks is an easy-to-use solution to enter and confirm the test results.  The integrated scenario enables this directly in the operator’s work instruction.  Workers enter quality criteria and test results into the respective, prebuilt input fields and comment spaces or use pre-configured catalog information.  If required, values are confirmed with an electronic signature.  Thus, confirmation to and update in SAP PP-PI and SAP QM are done at the push of a button.

Work instruction User interface of the “Batch Manufacturing with SAP MII” template

The Perfect Laboratory – One Complement on the Way to the Perfect Plant

This sole example of a batch manufacturing solution scenario shows that technical and organizational laboratory integration bears huge optimization potential.  Higher quality, increased flexibility and reduced costs are the result of an integration of production and quality management processes – as real-time availability of information enables quick and flexible reaction, and synchronized and automated processes help reduce cycle times significantly.
In this way, the “Perfect” Lab as an integral production part contributes to the “Perfect” Plant, eventually increasing a company’s competitiveness.