Project review cycle

The Toyota X300 fork lift truck project design cycle is concurrent in nature spanning all the major disciplines in the process with quality assurance reviews, stipulating the use of appropriate tools and techniques at certain points. The product development process produced by General Electric is called the Tollgate Process . Again, it is concurrent in nature and includes ten review points. 

Review quality plans at each stage of the product/project life cycle for continued suitability. 

Key deliverables are capital project reviews new production leader reviews existing facility hazard reviews on a 3- to 5-year cycle research facility reviews and a formal training and awareness program. 

Assessments are only as useful as the available information (opinion and docnmentation) pertaining to the computer system under scrntiny. Snch information may be excessive, incomplete, inconsistent, or incorrect. Where there is insnfficient information to complete the GxP Assessment, a preliminary assessment may be condncted and reviewed when fnrther information becomes available dnring the later phases of the project life cycle. 

To complete the project life cycle, the Project Team should produce a Validation Report that aligns with the site Validation Plan. In addition to conhrming site validation activities, Validation Reports should conhrm the adequacy of all relevant central activities. A central Validation Snmmary Report (Quality Report) should be developed reviewing the adeqnacy and release of each appUcation/prod-... 

Remember, each pass through a review cycle has a hidden cost and extends the duration of the project. 

Project management is a business process in the project-oriented company. It starts with the project assignment and ends with the project approval. The project life cycle is divided into the sub-processes of project start, project control and project close-down. At the same time project coordination and project marketing are carried out continuously. Another possible sub-process is project crisis resolution, which is not discussed in this paper. At the end of each phase the project owner and the project team organize a milestone review and decide whether the next phase can be started or not. Those reviews reduce the technical risk fi om the management perspective. 

The project objectives should be defined as early as possible during the project life cycle. Objectives are a description of the outcomes (results) expected from the project which in most cases can be easily defined at the start of the woik, although defining objectives also means periodically reviewing the project s overall objectives and the objectives of each project phase. 

Inherent safety reviews should be considered during appropriate stages of a typical project s life cycle. Suggested timing includes ... 

The second project on which I have been working recently, in collaboration with Michele Pagano, is the mode of the degradation of p27 . p27 is an inhibitor of mammalian G1 cyclin-dependent kinases such as Cdk2/cyclin E, which is responsible for driving cells fi om G1 to the S-phase of the cell cycle (reviewed in Sherr Roberts, 1999). Levels of p27... 

In this project students review the Chapman cycle mechanism in detail and some photochemistry concepts including the photostationary state. A key element of this project is its focus on an important chemical mechanism and the use of exploratory options for predicting ozone concentrations as a function of time while reviewing other fundamental chemical kinetics concepts. Mathcad is used as the symbolic mathematics engine for solving the requisite differential equations and ample instruction is provided to students to guide them on the use of the software in this project. 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

The project validation plan is a live document that should be reviewed against each life-cycle step and any other validation milestones (as a minimum). Any changes to the plan should be identified on a revision history section within the document. The plan should be retained in the validation file and should be easily accessible. 

On satisfactory completion of the requirement review and issue of an agreed-upon FDS by the chosen supplier, the design activities can proceed. Throughout design, development, and system build, the supplier, under its project and quality plan, must allow for review of life-cycle activities and documentation in support of the pharmaceutical manufacturer s DQ. 

A research and development program on the recovery and purification of potentially useful by-product actinides from the nuclear fuel cycle was carried out some years ago in the Federal Republic of Germany as part of the "Actinides Project" (PACT). In the course of this program, procedures for the recovery of neptunium, americium and curium isotopes from power reactor fuels, as well as procedures for the processing of irradiated targets of neptunium and americium to produce heat-source isotopes, have been developed. The history of the PACT Program has been reviewed previously (1). Most of the PACT activities were terminated towards the end of 1973, when it became evident that no major commercial market for the products in question was likely to develop. 

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