Supply chains as activity systems

The quotation above refers to the effect of the cheap revolution envisioned by the consulting firm McKinsey. The three trends cited in the quotation will increase the topple rate at which today s leading enterprises are pushed aside by competitive forces. SCM has a role to play in improving chances for survival. 

This chapter describes and applies a framework for developing the activities and associated processes for specialized supply chains. The boundaries of these supply chains can be defined by a company and its trading partners, or by a business within the business or sphere as described in Chapter 9. Chapter 11 describes how the Quality Function Deployment (QFD) technique supports the design of activity systems by gathering customer requirements. 

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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. ... 

Wanke et al. (2010) argue that the perception of logistics systems being complex is confirmed by several authors, but it is not always clear what does it mean. They defined complexity in logistics in terms of quantifiable scales and based on the notion of numerous actors or parts that are interconnected and can be captured by measures such as the company s gross revenue, its number of supphers, active customers, number of employees, number of employees involved in supply chain management, active stock keeping tmits (SKUs), number of distribution centers, orders processed and new product launches per year. 

Michael Porter, Harvard Business School professor and a thought leader on strategy, maintains that linked activities and processes are especially resistant to competitive pressures. He refers to these linked activities as activity systems. The concept of activity systems has valuable application in SCM because a well-linked supply chain is one type of activity system. 

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. 

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 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... 

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. 

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