Outsourcing scope

Doing it more cheaply (outsourcing contracts can face cost escalation, or painful and expensive break clauses when the real scope of work is discovered)... 

To achieve this goal, MED restructured its operations, concentrating on manufacturing, work force, and internal group structures. The first step was to achieve a significant reduction of manufacturing capacity. To do this, the company reduced the scope of the activities that were handled internally. Many low-value-added steps - such as basic parts or cable manufacturing - were outsourced. 

Again regardless of in-house or outsource development, document a list of features and prioritize them. Break the project down into short, timeboxed iterations, each focusing on one or two of these features (Chapter 5). Do not let the iteration deadline slip. Reduce the scope of the iteration if necessary. Implement features with high business values and high business and technical risks in early iterations. Make sure each iteration delivers a production quality partial system to solicit feedback and let the system grow incrementally. The project plan should be adjusted based on the feedback. It is OK if the initial project plan is not accurate. However, it should become more and more accurate as more iterations are completed. Test and integrate early and frequently. 

It is imperative that a thorough evaluation of the internal capability of an organization is performed before any decision to outsource is made. Once the decision is made, a clear definition of the project scope is listed on a form. At a minimum, the form should identify the following items ... 

Distributors with sufficient financial resources, geographic scope and/or knowhow could benefit from these three trends and offer both chemical producers and customers significant value by handling outsourced business and services in a cost-efficient and market-effective way. 

Although the scope of application continues to grow, the routine use of LC/MS technologies are now embraced by pharmaceutical researchers. Standard methods that incorporate highly specialized features are routinely developed for a variety of novel applications. Furthermore, many LC/MS applications that deal with quantitative bioanalysis (i.e., pharmacokinetics studies) are frequently outsourced to contract analytical laboratories. Thus, the routine use of LC/MS is a benchmarked commodity for drug development. 

The scope of the work to be outsourced is driven by the specific needs of... 

It is also important to include Quality Assurance in the process leading up to the decision to outsource, the assessment and selection of the service provider, the development of quality-related aspects of the contract, and the implementation and monitoring of the agreement. This arrangement should not be executed within an IS/IT only scope. 

If in-house resources are limited and the decision is made to outsource data management activities, the planning process begins by creating a detailed scope of work statement and issuing the request for proposal (RFP). Bids should be solicited from several CROs. 

The number of SOPs and their topics depend on the scope of audits performed, the set up and size of the QA department and whether audits are outsourced to external contractors which may decrease the scope of audits conducted by internal QA members. The QA department may also be tasked with activities such as SOP management and staff training SOPs would also be needed for these areas. 

The scope of the work to be outsourced is driven by the specific needs of the sponsor. In some instances all aspects of a particular study will need to be outsourced. In other instances, CROs are needed to provide only specific ser-vices to complement an almost complete team within the sponsor company. 

Develop a scope document a detailed manufacturing project plan with all the requirements (mark requirements which can be handled internally or outsourced independent of the main CMO as OPTION ). 

Figure 8 Gantt chart for the technology transfer of the chemical process for a new bulk drug The chart shows all of the key components of the overall task, with an approximate indication of their relative positions on the time-to-market cycle and, to a less precise extent, of the relative widths of their timelines the latter can vary considerably as a function of the process scope, new plant vs. retrofit into existing plant and in-house vs. extent of outsourcing.

The decision on what parts in the project scope and product scope to purchase from outside the performing organization, how to do it, and when to do it is critical to the success of most projects. This is not only because significant parts of many project budgets are candidates for outsourcing, but because the level of uncertainty and consequently the risk involved in outsourcing are quite different from the levels of uncertainty and risk of activities performed in-house. In order to gain a... 

A concept called complementarity holds that the outsourcing and offshoring creates complementary requirements in the U.S. company that expand the scale and the scope of the U.S. enterprise. Scale refers to growth in the functions performed in the company due to its larger size. Scope refers to the mix of activities done in the home country, with a focus on higher skilled activities that displace the low-cost activities that are transferred elsewhere. So the home country concentrates on high value coordination and marketing while the supplier nation concentrates on lower value physical production. 

Some of these studies are small in size and scope, therefore, lending themselves to outsourcing. Except in cases where the BSL category would limit its location, these studies could be performed inside or outside of DoD. The construction of the new BSL4 at University of Texas Medical Branch (UTMB) provides an example of a conduit for performing even high biocontainment agent studies outside of DoD. The new DoD laboratories will have expanded capacity to do this work as well. 

Figure 4.2 Changes in the scope of outsourcing application over the last few...

Conscious hedging against the consequences of outsourcing risk consists in the application of penalties and clear terms of cooperation, with the scope of liability specified in agreements. The transfer of risk to insurance is a method rarely used. Half of respondents declared that they do not use any protection against potential problems. Conflicts and disputes are mainly resolved in line with formal procedures (64%). Some of the analysed companies, however, demonstrate a certain flexibility and conventionality (26%) as well as confidence (10%) in this respect. This means that, to a certain extent, the relationship between the supplier and the customer is based on partnership. 

Figure 6.10 Scope of information management outsourcing Source Own study,...

The key to success in outsourcing is to plan well by specifying the scope of work with attention to detail. Define the selection process, understand the scope, define the budget, and communicate this clearly in a request for proposals (RFP). Understanding the outsource contractor s ability to fully support all facets of the contract is very important, so first understand what you need to have accomplished and then identify the contractor s core competencies. Also, ask for specifics and recent successful projects. 

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