Setting the Scope

When the project team assembles, the first order of business should be to put in writing the project objectives. Why are we doing this project This should be stated in the most basic terms. 

The objective is to improve the quality of product Q from its current state of 90% purity to an improved state of 99% purity. This will permit selling of the improved product Q to a new customer. If we do this, the new eustomer will buy lOM pounds per year. This is new business and will improve our profit by 5M per year less the incremental operating costs. 

By traditional methods, a project is considered successful if it is built on time, is in the money, and technically works. This method of analyzing project success is one of the reasons returns on projects are so low. With this method, we have not measured how well we have achieved the scope. 

The success of a capital project now rests on the entire business team not just the project execution team. 

Notice, the objectives have not said anything yet about how the improvement in quality will be accomplished. The project goal is to improve profits through quality improvement. Making sure the integrated team understands this difference is critical. The goals should be stated in the most basic terms. 

---

Occasionally it is useful to write a spec that refers to more than just the before-and-after moments in time—say, i, j andj, k. Putting the time indexes in [...] sets the scope within which the states are referred to. action [i, j, k] T m (...)... 

A section on quality standards and comparative syntheses concludes the entire chapter. This section (Section 7.8) sets the scope and approach necessary to compare and contrast closely related syntheses and target structures 26 In this section, a broad utilization of many of the techniques described in the chapter are applied to peptide target structures. 

Sine wave. Set the selector switch on the scope to internal sweep. As the null point is approached, the amplitude of the sinusoidal imbalance signal will diminish. At the maximum gain setting, the scope pattern near the balance point will be a 60-Hz leakage... 

Preamble sets the scope of the invention s technical environment and class (composition, process or apparatus, and the like A method of..., Apparatus for..., A composition...). It is not limiting if it merely states the purpose of the invention however, if it breathes life and meaning into the claim (such as if it is essential to teU what is claimed or if the body of claim refers to it as antecedent support) it can become limiting. 

Here we return to a forceful and decisive role of the bulk drug process development team. Just as the chemistry sets the scope of the thermochemical process hazards, so it does in setting the environmental profile of a bulk drug process its inherent benevolence ( green chemistry) in one extreme and its highly engineered implementation, made possible by intensive and extensive abatement and waste treatment measures as the other extreme. 

A formal charter is a good way to start setting the scope. Ideally, the process of determining scope should be broad based, including stakeholders both in the company and with important trading partners. Listing supply chain issues faced by the oiganization facilitates charter development. 

Once an organization sets the scope of its own audit, it can decide whether internal personnel, personnel from a different facility, or a contractor will conduct the audit. The members of the audit team should have qualifications suitable to the contents of the audit. After forming an audit team, it plans the audit in detail. 

Risk acceptance criteria are very important to start the system. It also sets the scope and boundary to a great extent. The acceptance criteria are decided based on the tequitements from the company, authorities, and customers. Acceptance criteria should be established for all types of consequences as safety, environmental, property, and othet economical factors. 

---