Project initiation document

We have already established that the undertaking of a CRM project should be conducted in a controlled and logical manner. Importantly the project should be carried out not in isolation but as an integrated component of the general product lifecycle or implementation. For these reasons wider project plans should contain explicit references to the CRM activities especially in the Project Initiation Document (PID). 

Step 4 Project initiation and approval Define a project to develop and implement the proposed new method or analyzer and get it approved by the sponsor. The documentation required by the sponsor is usually company-specific, but will typically include goal, business value, critical technical issues to be addressed, ramifications, proposed approach, resources needed (including personnel time), deliverables, and timing. 

This is essentially the same document as described earlier for the Project Initiation phase but defining the scope of the supplier s role and responsibility. The Supplier Quality Plan should act as an extension to the Supplier Proposal and Contract of Supply. The Supplier Quality Plan should be approved before the Functional Specification is approved. If the supplier is an internal function of the pharmaceutical or healthcare company, these plans do not need to exist as separate documents but rather can be integrated within overall project Validation Plans, Project Plans, and Quality Plans. 

Product description In a project, the product description documents the characteristics of the physical product, service, or result sought in pursuing the project. It is established prior to project initiation and should be embellished as the project progresses. The product description should have sufficient detail to support project planning throughout the project. (Adapted from PMBOK Guide— 2000 edition )... 

Review Scheduling A review scheduhng procedure should be estabhshed that documents who is responsible for initiating the review and when the review(s) should occur during the project. The scheduling needs to balance availability of process information, review technique used, and the impact of potential review action items on project costs (i.e., early enough to minimize the cost of any potential changes to the process). The aclual amount of time needed for the review should also be stated in the procedure. On the basis of the number of project reviews required and the estimated time needed for each review, the project cost estimate should include the cost for project reviews as part of the total cost for the project. 

In order to verify performance of a given toller with whom a company has worked before, it is essential to document and understand their performance history in the five areas listed above. Good documentation of prior toller performance will allow a new engineer or new manager in charge of tolling projects to base their initial selection of candidates on accurate data. 

Most tolls involve the transfer of proprietary information from one party to the other, typically from the client company to the toller. Each party should have maintained a log of transferred documents or software code to make the return of proprietary documents a simple matter. An initial list of the documents should have been referenced in the contract or as part of the technology package. Keeping records of additional documents transferred during the course of the toll will help eliminate confusion at the end of the project. The toller may need to retain documents appropriate for their process safety system needs. 

There has been considerable and continuing investment in e-science and Grid-based computing around the world. Of particular interest for protein crystallography is the e-HTPX project funded by the UK research councils (http //www.e-htpx.ac.uk). The aim of e-HTPX is to unify the procedures of protein structure determination into a single all-encompassing interface from which users can initiate, plan, direct, and document their experiment either locally or remotely from a desktop computer. 

If the flow-sheet is not part of the documentation for a project, then a simple, but consistent, identification code should be devised. The easiest code is to use an initial letter to identify the type of equipment, followed by digits to identify the particular piece. For example, H—heat exchangers, C—columns, R—reactors. The key to the code should be shown on the flow-sheet. 

In our initial use of VIRS methods, we have chosen a diverse set of projects. These include epithermal-style precious metal mineralization (eastern and central Newfoundland), mesothermal gold mineralization (Central Newfoundland), syngenetic VMS mineralization and related alteration (Central Newfoundland), porphyry-style Mo-Cu mineralization (southern Newfoundland) and uranium mineralization in the Central Mineral Belt of Labrador. Space does not permit detailed discussion of results, but in all cases we were able to recognize distinctive alteration species and document their distribution. In some cases, results provided surprises, eg., the recognition of topaz in quartz-alunite alteration and possible Li-rich micas in VMS alteration influenced by magmatic fluids. In some cases, the resolution of species in mixed assemblages proved to be difficult, but the overall spectral patterns could still be used to discriminate alteration facies and demonstrate their superposition. 

As the result of a number of recent incidents caused by inappropriate handling of reactive chemicals, CCPS initiated a project in 2001 to develop additional management guidelines for reactive hazards. A CCPS technical steering committee documented the urgent need for... 

The documents were an incomplete subset of memoranda and reports from the MK-ULTRA program. They do include a description of some subsidiary projects, such as Bluebird, Artichoke and Derby Hat. In January, 1963 Gottlieb, at Helms direction, had already destroyed most of the other documents from the earlier CIA activities. Still others were withheld or heavily redacted. Those that remain refer to some of the experiments initiated in the 1950 s under the direction of Dr. Gottlieb. To me, they seemed scientifically imsophisticated and often done at the whim of the local agent in charge. 

The intention of this section is to provide to the reader a rapid and comprehensive reference for the most common definitions and acronyms used in mass spectrometry. Currently lUPAC has initiated a project to update and extend the definitions of terms related to the field of mass spectrometry. The definitions presented here (Table 1.6) are from the third draft document [16]. For more details and the latest updates, please consult www.msterms.com. 

A validation master plan, or other equivalent document, must be prepared and approved. This must be initiated at the earliest practical point and must be reviewed and updated throughout the project. The validation master plan must address all the relevant stages of DQ, IQ, OQ, and PQ. 

Forman kept these notes in two volumes, now bound as Ashm. 1494 and 1491 respectively, with some pages now in Sloane, 3822, fos. 6-19, 68-102. I am indebted to David Pingree for assembling a copy of these volumes in which most of the pages from Sloane 3822 are reinstated, and to Carol Kaske for providing me with a copy of this document and initiating a project to edit it. 

Several meetings took place to discuss and evaluate the structure and content of this document. Initial drafts of the document were prepared by a group of authors (listed on the title page) and coordinated by the IPCS Secretariat, Dr B.-H. Chen and Dr T. Damstra. IPCS is grateful to these authors and acknowledges the time and expertise that they so generously gave to this project. 

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