Business processes defining

Project initiation Install development system Define current business processes Define future business processes Conduct conference room pilot Review legacy data Data upload Readiness review Go live... 

Are R D practices linked to business practices Are work processes those needed to implement the plans Are work processes defined, disciplined, and structured Is the human side of work practices understood Are there metrics related to the goals/results of the work processes ... 

Defining Process Barriers. If a business process does not exist or simply doesn t work, the redesign team needs to know why. In some cases, the reason maybe simply that no one recognized the need for a given system similarly, a system may remain "broken" because no one realized it needed fixing, or knew how to go about it. In others, the team may... 

The level of the information flow boils down to a purely technical level where the partners agree on common protocols for transferring data. For the chemical industry, an initiative to set uniform standards is CIDX. CIDX (http //www.cidx.org) is a trade association and standards body whose mission is to improve the ease, speed and cost of conducting business electronically between chemical companies and their trading partners. It provides the Chem eStandards, a collection of defined messages and related business process guidance that companies use to understand the requests and fulfill electronic business orders and related transactions. 

The total control program monitors and provides appropriate feedback and corrective actions. Generally, activity within each business process has its own defined quality control plan. These activities include but are not limited to... 

Order execution consists of steps to process an order to achieve the final outcome. As noted earlier, this may involve a combination of an automated system, workstations, or manual operations. Management should include information services (IS) applications for all automated systems and workstations. Recording activities is necessary even with manual operations thus an IS application provides great benefit. An execution application should interface with other IS systems in compound management to handle job information and update progress in real time via a defined interfacing mechanism. However, the execution application should accurately perform the tasks independently, not as part of an inventory or order administration system to minimize the impacts of any execution system changes on the business process and the IS systems. 

Defining the business processes to be implemented by the MRP II system, either within the system or in conjunction with other interfaced systems, is a key task. SAP refers to this activity... 

Following on from the URS, a system definition consisting of Functional Design Specification (FDS) needs to be collated. The URS does not necessarily specify the chosen MRP II system, and if this is the case, the FDS will need to introduce and overview the selected MRP II system. The FDS will define the URS business processes at a transaction level. Referenced documentation published by the supplier defining the standard MRP II software product and its functionahty should be retained and maintained with the current version of the MRP II software used. It is important to identify those functions of the standard MRP II system that are used and specifically document which functions are not being used. 

Once defined, the business process transactions can be configured within the development environment of the MRP II system. There are normally instances when it is easier to amend the business process to fit the standard functionahty of the MRP II product software than to make a customized bespoke modification. Any bespoke modiflcations, like the interfaces, must be fuhy documented in design specifications, test speciflcations, and test records. One important aspect to avoid during configuration is to set up the system to accept default user entries. There have been several recalls within the pharmaceutical industry because users failed to recognize that a default entry on their MRP II systems was incorrect. It is always a good idea to have positive user confirmation of key data entry or decision points. If defaults are stih required then make them... 

Business Continuity Planning A documented process by which the recovery and continuation of critical business functions in the presence of events which significantly disrupt business operations. [Defined for this book.]... 

Specific care has to be taken to not only consider the point in time when the records are created but also what they are used for in later parts of the process. Also here, a clearly defined business process description becomes an important tool to identify where records are used. There is a serious trap in considering the paper as the official record, but nevertheless using the electronic records for GxP-relevant activities. The new Guidance for Industry specifically states ... 

Therefore, it is the first task of the business process owner to define which records under his area of responsibility are electronic records and which not. The best approach is to have a defined and documented business process. Then the records growing out of this process can be determined. In the next step, systems supporting the process are identified, and records in the system assessed. The business process definition will also be needed as a basis for the record risk assessment and validation activities of a system. An example on how this can be documented is given in Fig. 2. 

Often enough hybrid systems are legacy systems, specifically systems not supporting electronic signatures. In these cases, it is very important to define either in the system documentation and/or in procedures, the business process, and use of the records. This includes the purposes for which both records are used and also the interfaces between paper and electronic system. Table 2 illustrates an example of the use of a hybrid system. 

Putting systems in place to assure product quality is a standard business process. According to the International Standardization Organization (ISO 9000), quality assurance is defined as a set of activities whose purpose is to inspire the confidence of customers and managers that all quality requirements are being met for a product or service (ISO 9000 definitions). 

According to Hammer and Champy [714], business process reengineering (BPR) is the fundamental rethinking and radical redesign of business processes to achieve dramatic improvements in critical, contemporary measures of performance, such as cost, quality, service and speed. In the BPR literature, rather general definitions of a business process are proposed. Davenport [626], for instance, defines it as a structured, measured set of activities designed to produce a specified output for a particular customer or market. ... 

Both graphical representation and semantics of the Business Process Modeling Notation BPMN, [873]) are similar to that of UML activity diagrams. BPMN addresses the creation of process models for workflow execution and automation for this purpose mappings from BPMN to executable languages like the XML Process Definition Language XPDL, ] 1059]) and the Web Services Business Process Execution Language WS-BPEL, [887]) have been defined. 

IBM WebSphere Integration Developer (WID) and IBM WebSphere Process Server (WPS) are the existing systems which are relevant for the transfer project. WID can be used at build-time to define workflows consisting of activities that are executed automatically or by human interaction. The workflow definitions are written in the de facto standard Web Services Business Process Execution Language" (WS-BPEL) [887]. At runtime these workflows can be executed within WPS, but can neither be altered within their predefined sequences of activities nor extended by additional activities. 

Abstract. Service-oriented architectures define an architectural style for the construction of a heterogeneous application landscape. By abstracting services, business processes are decoupled from the underlying applications. This section describes how the results of the IMPROVE subproject 13, related to the model-driven development process for wrapper construction, are transferred and extended to the area of business process applications. We present an approach which yields a prototype to formally specify service descriptions and service compositions. This prototype makes it possible to evaluate and explore service-oriented architecture concepts. 

The service layer separates different views on an IT landscape [904] the business perspective, i.e. the outside view on a service is that of an atomic unit, well-defined in the terms of a business area, realizing some kind of functionality, and usable within a business process. 

Two of the most aitical steps are scope definition and later scope control. They may seem simple initially, but in real life implementation, the purpose of paperless is typically difficult to define clearly, especially as many issues that seem obvious in a traditional, paper-based business process need to be explicitly defined when established in paperless systems. Scope control as well as the project management of resources, budget and time are pitfalls where many such implementations have fallen short. 

The user requirements phase allows the pharmaceutical company to define its business needs. This is often communicated by pictorially defining the business processes, as illustrated in Figure 2.12 each business process is accompanied by a descriptive narrative describing the functional requirements of each process step. 

The structure of the support organization must reflect the tasks and responsibilities it has been assigned. This is usually defined, for example, as something like providing and maintaining appropriate IT facilities to support the information needs of the business processes. In general, its scope can be defined in two areas ... 

Most enterprises can define their business in terms of 10-15 key processes one to three strategic management processes, 5-7 core business processes, and 3-5 resource management processes. Figure 7 is an illustrative example of process definitions in the industrial products industry. 

During business measurement, the engineer also evaluates the performance of the entity taken as a whole and its key business processes, using key performance indicators (KPIs) and the collective knowledge contained in the business model. KPIs are quantitative measurements, both financial and nonfinandal, collected by an entity or by the engineer, either continuously or periodically, and used by management and the engineer to evduate performance in terms of the entity s defined business... 

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