Project description documents

OntoCAPE is the core of the integrated model which describes the concepts of chemical engineering, the specific application domain of interest in the IMPROVE project. The product data in OntoCAPE are well integrated with the Document Model by direct references from the document content description to product data elements in OntoCAPE. Likewise, the elements of the document content description link the product model in OntoCAPE to the decision and work process documentation in the Process and Decision Ontologies. 

Input data for preparation of the PHL include project description documents (narrative descriptions, sketches, preliminary drawings, artists concepts, drawings or photographs of existing similar products, and analytical trees), historical data (safety, reliability, and loss data and accident reports from similar end products and/or components), and any other relevant studies or research. 

All available project description documents and relevant historical data are used in preparing the PHL. 

Detailed project description documents and drawings are required to perform an SSHA. Additionally, relevant codes, standards, and regulations, the PHL, and the PHA for the projects should be available. Access to lessons learned and reliability data is also needed. 

Analytical trees can be used in a variety of ways in the system safety effort. The most common application of analytical trees in current system safety programs is probably the use of fault trees for fault tree analysis (FTA). However, analytical trees can also be used as planning tools, project description documents, status charts, and feeder documents for several hazard analysis techniques (including fault tree analysis). Analytical trees can be multipurpose, life cycle documents and represent one of the most useful tools available to managers, engineers, and safety professionals. 

Positive or objective trees are extremely useful planning tools. In the early stages of a project, they can be used to outline project requirements and list alternatives. As decisions are made, they evolve into graphic checklists and also make excellent status charts and project description documents. 

Analytical trees make excellent project description documents because they are relatively easy to construct and easy to understand. Many end users and some safety professionals, engineers, and managers are not skilled in reading blueprints, electrical schematics, or other technical documents. The analytical too is an excellent means for communicating project information within a system safety working group. 

If an analytical tree is not used, in addition to defining the system and clarifying the scope in terms of breadth (limits of resolution) and depth (indenture levels), a block diagram or other project description document may be required. 

Additionally, traditional project description documents (such as analytical... 

The first step in performing a fault tree analysis is to collect the appropriate project description documents, existing hazard analyses, and guidance documents and carefully review them to determine the limits, scope, and ground rules for the FTA.This review includes defining the system to be analyzed, the depth or indenture levels to be included in the effort, and, of course, the nature of the undesired event or failure to be studied. 

Review Techniques The review techniques used at the various stages of a project should be selected based on the amount of process information and detail available. Figure 23-47 depicts some typical review techniques at the various stages of a capital project. A detailed description, including the type and amount of process information required, for each review technique can be found in Guidelines for Hazard Evaluation Procedures Second Edition with Worked Examples (CCPS, 1992). The process information required for the review should be defined and documented in the review guidelines. Up-to-date and accurate process information is essential to conducting a successful review. 

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. 

Regression equations descriptive of multi-dimensional structure/ activity relationships in quantitative terms too frequently are intellectual curiosities developed retrospectively after work in optimization of the biological properties of a series by analog or homolog synthesis has been completed. Retrospective analysis serves well to document that critical factors in the relationship between structural features/physiochemical factors and biological potency are well understood and that optimum compounds have been achieved. Structure/activity understanding developed during the course of a synthesis project, however, lends direction and efficiency to the property optimization effort. 

A VMP should be divided into chapters covering different subjects. First, an introduction should state the manufacture s validation policy, general description of the scope of those validation activities covered by the VMP, and their objectives, derivation, location, and schedule. Then, it must declare all validation activities and their organizational structure in terms of personnel responsibility for the VMP, validation protocols, validation work, report and document preparation projects, approval of the same validation protocols, reports in all stages of validation processes, and the training needs in support of validation. Other requirements of the VMP are cross references to other documents and to specific characteristics of the processes that are critical for yielding a quality product. Next, all validation activities comprised in the VMP should be summarized and compiled in a matrix format. Such a matrix should provide an overview and contain all items covered by the VMP that... 

Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance qualifications. They are written to ensure test methods, and acceptance criteria are reviewed and approved before qualification of protocols. In practical terms, there are several stages for the production of protocols. First, an acceptable format needs to be agreed. No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style. However, some norms have been established. Like other controlled documents, protocols are assigned unique reference numbers and revision numbers. They are titled and numbered on every page and have a particular place for approval signatures. Other common elements in protocols tend to be brief descriptions of the item being qualified and a clear statement of responsibilities. 

Once the manufacturing projection questions have been answered, a manufacturing philosophy must be decided on. This includes deciding on documentation requirements, special materials handling, controlled substance security, cleaning validation criteria, and equipment and facility qualification requirements. Now that we know what types of batches are to be manufactured, we can be more detailed in the description of the requirements of the facility. These requirements may be based on internal as well as regulatory requirements. In fact, if a full-scale facility is already in place, this step can be completed fairly easily and quickly. Many of the policies and systems may be transferred directly into the pilot facility. And others may be transferred with only slight modifications. 

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