Activity systems, supply chains

Finally, an interesting trend in supply-chain management is improving business practices by providing capabilities to improve service for customers. One such concept is capability to promise. The idea is not just to ensure that the product is available, but that the supply chain is capable of delivering the product. This involves, for instance, capability to rapidly change the schedule to accommodate the customer order and interact with the active plant schedule. Such a system was developed at Celanese Fibers, which is integrated with a Customer Order System and enabled via a Web browser. 

Conclusion with regard to stock of hypotheses and model Two important actors of the supply chain (auxiliary producers and textile finishers) have been involved in the ARS-system. The clothing industry and the commercial enterprises (bulk good) did not participate. Although the latter supply directly to the customers, assessment systems concerning process related emissions (ARS or OKOTEX 1000) have not yet been of interest (hypotheses 8). The ARS-system and its environmental requirements for waste water motivated the commercial actors in the supply chain to apply to (to strive for ) more transparency and for an environmentally friendly (orientation in the choice of products (hypotheses 7). In addition, (at the) auxihaty producers research activities have been activated, (hypotheses 2). 

Procedural rales and the gnarantee of transparency require institutional platforms. Such platforms can be provided by the state (REACH system or internet consultation) or, for example, can be supplied product-related by the commercial actors in the various supply chains. For tlie market as a whole, this raises the question as to who assumes the active leadership role within the supply chain. 

Furthermore, REACH includes new or increased demands on the bidirectional flow of data and information in the supply chain (Tide IV) and places demands on downstream users (Tide V). For instance, REACH includes provisions on safety data sheets for substances on the candidate list (Article 31 and Annex II) and forces suppliers of articles to actively provide information for the safe use of the articles (Article 33). In addition, REACH entities consumers to, without charge, request information within 45 days on the safe use of articles containing SVHCs in concentrations above 0.1 wt% (Article 33). It remains to be seen to what extent the increased flows of information will impact on the management of chemicals. However, companies that work with environmental management systems and companies located closer to consumers in commodity chains will probably seek more actively to decrease chemical-related risks. 

In recent years, there has been an increasing regulatory focus on the marketing and supply aspects of the pharmaceutical supply chain. While these activities can be carried out manually, it is more commonplace to find that a computer system is used to support them either wholly or partially (a hybrid system). The reliance on these systems as the sole mechanism of recording information means that they should be developed to an appropriate level of compliance and vahdated for their intended use to ensure that they are able to provide a consistent output to support the regulated process. 

The distribution system may also be the initial point at which returns to the warehouse reenter the supply chain system, for example, if goods are supplied to wholesalers on a sale or return basis. Depending on the functionality and interfaces of the system, upon completion of successful deliveries, it may provide confirmation of this activity back to the Sales Order Processing System. 

The validation of marketing and supply applications encompasses exactly the same fundamental activities as any other validation exercise carried out on a system supporting activities within the supply chain that have a regulatory impact. Addressing these activities should ensure that the software is developed, and adequately tested and maintained to remove the likelihood of system... 

It is also common to find several different supply chain applications residing on the same host machine. This may impose additional complexity for the overall site validation activity should some of these have a regulatory impact and others not. Where an operating system is shared, this could result in non-GxP-critical applications operating with additional controls in order not to compromise the activities of the GxP-critical application. 

Validation needs to be completed for those systems that would support any product recall activities. Regulatory authorities expect that traceability is established throughout the supply chain to facilitate the recall of an entire lot/batch of a product if this becomes necessary to minimize, among other things, any adverse impact on patient safety. Sites may have a locally developed IT solution, a centrally supported IT solution, or may have even subcontracted this activity to a third party as part of an outsourced Sales Order Processing activity. 

For medical devices, inspectors expect to see a process improvement program in place encompassing all activities within the supply chain, including the systems that support it. Activities that would provide evidence that such a program is in place include the implementation of documented processes such as Corrective and Preventative Action (CAPA), self-inspection, and internal audits." Organizations should ensure that where an SOP has been put in place to initiate a process improvement activity, the SOP is adhered to. For example, if a quality audit SOP states that all areas shall be subject to audit at least once every 2 years, then inspectors will expect to see evidence that this has been the case. Failure to do so is likely to result in a citation similar to that issued to Krieger Medical, Inc. ... 

M. Chouinard, S. D Amours, and A.-K. Daoud, Integration of Reverse Logistics Activities within a Supply Chain Information System, Computers in Industry, 56(1), 105-124 (2005). 

All members of the supply chain should have primary management systems in place to address comphance with all applicable regulations and implementation of additional programs and practices to manage the safety and security of hazardous material transportation activities. An overall transportation safety and security management system is recommended to assist in ... 

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